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26 "Se Hoon Park"
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Original Articles
Genitourinary cancer
Neoadjuvant Cisplatin-Based Chemotherapy Followed by Selective Bladder Preservation Chemoradiotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder: Post Hoc Analysis of Two Prospective Studies
Sung Wook Cho, Sung Hee Lim, Ghee Young Kwon, Chan Kyo Kim, Won Park, Hongryull Pyo, Jae Hoon Chung, Wan Song, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
Cancer Res Treat. 2024;56(3):893-897.   Published online February 15, 2024
DOI: https://doi.org/10.4143/crt.2024.015
AbstractAbstract PDFPubReaderePub
Purpose
Bladder preservation chemoradiotherapy (CRT) in patients with a clinical complete response (cCR) following cisplatin-based neoadjuvant chemotherapy (NAC) is a promising treatment strategy for muscle-invasive bladder urothelial carcinoma (MIBC). A combined analysis of raw data from two prospective phase II studies was performed to better evaluate the feasibility of selective bladder preservation CRT.
Materials and Methods
The analysis was based on primary efficacy data from two independent studies, including 76 MIBC patients receiving NAC followed by bladder preservation CRT. The efficacy data included metastasis-free survival (MFS) and disease-free survival (DFS). For the present analysis, starting point of survival was defined as the date of commencing CRT.
Results
Among 76 patients, 66 had a cCR following NAC. Sixty-four patients received gemcitabine and cisplatin (GC) combination chemotherapy in neoadjuvant setting, and 12 received nivolumab plus GC. Bladder preservation CRT following NAC was generally well-tolerated, with low urinary tract symptoms being the most common late complication. With a median follow-up of 64 months, recurrence was recorded in 43 patients (57%): intravesical only (n=20), metastatic only (n=16), and both (n=7). In 27 patients with intravesical recurrence, transurethral resection, and Bacillus Calmette-Guerin treatment was given to 17 patients. Salvage cystectomy was performed in 10 patients. Median DFS was 46.3 (95% confidence interval [CI], 25.1 to 67.5) months, and the median MFS was not reached. Neither DFS nor MFS appeared to be affected by any of the baseline characteristics. However, DFS was significantly longer in patients with a cCR than in those without (hazard ratio, 0.465; 95% CI, 0.222 to 0.976).
Conclusion
The strategy of NAC followed by selective bladder preservation CRT based on the cCR is feasible in the treatment of MIBC. A standardized definition of cCR is needed to better assess disease status post-NAC.

Citations

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  • News and prospects on radiotherapy for bladder cancer: Is trimodal therapy becoming the gold standard?
    Olivier Riou, Christophe Hennequin, Jonathan Khalifa, Paul Sargos
    Cancer/Radiothérapie.2024; 28(6-7): 623.     CrossRef
  • 2,884 View
  • 148 Download
  • 1 Web of Science
  • 1 Crossref
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Adjuvant Chemotherapy for Upper Tract Urothelial Carcinoma: A Real-World, Retrospective Study
Junho Lee, Sung Hee Lim, Jae Hoon Chung, Wan Song, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
Cancer Res Treat. 2024;56(3):871-876.   Published online January 16, 2024
DOI: https://doi.org/10.4143/crt.2023.1226
AbstractAbstract PDFPubReaderePub
Purpose
The aim of this retrospective study was to evaluate the efficacy of adjuvant cisplatin-based chemotherapy in patients with locally advanced upper tract urothelial carcinoma (UTUC), administered following radical nephroureterectomy.
Materials and Methods
Patients with UTUC, arising from renal pelvis or ureter, staged pT3/T4 or N+ were treated with adjuvant chemotherapy following surgery. The chemotherapy consisted of gemcitabine 1,000 mg/m2 on days 1 and 8, cisplatin 70 mg/m2 on day 1. Treatment was repeated every 3 weeks for up to 4 cycles. Endpoints included disease-free survival (DFS), metastasis-free survival (MFS), and safety.
Results
Among 89 eligible patients, 85 (95.5%) completed at least 3 cycles of adjuvant chemotherapy. Chemotherapy was well tolerated, the main toxicities being mild-to-moderate gastrointestinal toxic effects and pruritus. With a median follow-up of 37 months, median DFS was 30 months (95% confidence interval, 22 to 39), and the median MFS was not reached. The 3-year DFS and MFS were 44% and 56%, respectively. Multivariate analyses revealed that the main factor associated with DFS and MFS was the lymph node involvement, whereas age, T category, grade, or the primary site of UTUC were not significantly associated with DFS or MFS.
Conclusion
Adjuvant cisplatin-based chemotherapy after radical surgery of pT3/T4 or N+ UTUC was feasible and may demonstrate benefits in DFS and MFS. Whether novel agents added to the chemotherapy regimen, as a concurrent combination or maintenance, impacts on survival or reduces the development of metastases remains to be studied.

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  • Cisplatin/gemcitabine

    Reactions Weekly.2024; 2027(1): 127.     CrossRef
  • 2,567 View
  • 120 Download
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Real-World Study Evaluating Safety and Effectiveness of Axitinib in Korean Patients with Renal Cell Carcinoma after Failure of One Prior Systemic Therapy
Sang Joon Shin, Jae Lyun Lee, Tae Gyun Kwon, Byoung Young Shim, Ho Seok Chung, Sang-Hee Kim, Se Hoon Park
Cancer Res Treat. 2023;55(2):643-651.   Published online November 28, 2022
DOI: https://doi.org/10.4143/crt.2022.883
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
This post-marketing surveillance (PMS) study was conducted to monitor the usage of axitinib (Inlyta) in clinical practice of Korean patients with advanced renal cell carcinoma (RCC) with disease progression during or after a prior systemic therapy in real world.
Materials and Methods
In this multicenter, observational study, patients indicated for oral axitinib 5 mg twice daily as second-line therapy for advanced RCC were followed up under routine clinical practices, and their safety and effectiveness outcomes were collected.
Results
Between 2012 and 2021, 125 patients were enrolled, and data from 111 patients were analyzed. Median age was 65 years (range, 30 to 84 years), 81% was male, and 110 (99%) had clear cell RCC. The median daily dose of axitinib was 10 mg (range, 4.36 to 15.95 mg) with a median administration period of 5.6 months (range, 15 to 750 days). Eighty-three percentage of patients experienced any grade of adverse events, 71% of which were related to study treatment, including diarrhea (36%), hypertension (21%), stomatitis (17%), decreased appetite (14%), palmar-plantar erythrodysesthesia syndrome (12%), and asthenia (11%). Most adverse events were generally well tolerated and manageable, with 13% of grade ≥ 3. Axitinib dose reduction was required in 20% of the adverse events and discontinuation in 8%. Median progression-free survival was 12.4 months (95% confidence interval [CI], 9.6 to 18.9). Objective responses were observed in 30% of patients (95% CI, 21 to 39) with 4% of complete response and 26% of partial response.
Conclusion
No new safety signal was found in the present PMS study of Korean RCC patients. Axitinib showed consistent outcomes in terms of effectiveness and safety confirming that the drug is a valid option for second-line therapy in patients with advanced RCC in a real-world setting.

Citations

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  • Axitinib

    Reactions Weekly.2024; 1991(1): 45.     CrossRef
  • 4,675 View
  • 162 Download
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Neoadjuvant Nivolumab Plus Gemcitabine/Cisplatin Chemotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder
Hongsik Kim, Byong Chang Jeong, Joohyun Hong, Ghee Young Kwon, Chan Kyo Kim, Won Park, Hongryull Pyo, Wan Song, Hyun Hwan Sung, Jung Yong Hong, Se Hoon Park
Cancer Res Treat. 2023;55(2):636-642.   Published online October 6, 2022
DOI: https://doi.org/10.4143/crt.2022.343
AbstractAbstract PDFPubReaderePub
Purpose
The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscle-invasive bladder urothelial carcinoma (MIBC).
Materials and Methods
In a prospective phase II trial, patients with cT2-T4a N0 MIBC who were eligible for cisplatin and medically appropriate to undergo radical cystectomy (RC) were enrolled. Treatment with nivolumab 3 mg/kg on days 1 and 15 plus GC (cisplatin 70 mg/m2 on day 1, and gemcitabine 1,000 mg/m2 on days 1, 8, and 15) was repeated every 28 days up to 3 or 4 cycles, depending on the surgery schedules. The primary endpoint was pathologic complete response (pCR, ypT0). Secondary endpoints included pathologic downstaging (≤ ypT1), disease-free survival (DFS), and safety.
Results
Between September 2019 and October 2020, 51 patients were enrolled. Neoadjuvant N+GC was well tolerated. Among 49 patients who completed neoadjuvant N+GC, clinical complete response (cCR) was achieved in 59% of intent-to-treat (ITT) population. RC was performed in 34 (69%) patients. pCR was achieved in 24% (12/49) of ITT population and 35% (12/34) of RC patients. Median DFS was not reached. Over a median follow-up of 24 months, 12 patients experienced disease recurrence and were treated with palliative therapy or surgery. Although 12 patients declined surgery and were treated with concurrent chemoradiotherapy, DFS was longer in patients with cCR after neoadjuvant therapy than those without. Preoperative programmed death-ligand 1 (PD-L1) did not correlate with pCR or pathologic downstaging rates.
Conclusion
Neoadjuvant N+GC was feasible and provided meaningful pathologic responses in patients with MIBC, regardless of baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).

Citations

Citations to this article as recorded by  
  • Evaluating Neoadjuvant Immunochemotherapeutic Response for Bladder Carcinoma Using Amide Proton Transfer-Weighted MRI
    Lingmin Kong, Bei Weng, Qian Cai, Ling Ma, Wenxin Cao, Yanling Chen, Long Qian, Yan Guo, Junxing Chen, Huanjun Wang
    Academic Radiology.2025;[Epub]     CrossRef
  • Efficacy and safety of neoadjuvant PD-1 inhibitors or PD-L1 inhibitors for muscle invasive bladder cancer: a systematic review and meta-analysis
    Shibo Huang, Yanping Huang, Chunyan Li, Yiwen Liang, Miaoyan Huang, Raoshan Luo, Weiming Liang
    Frontiers in Immunology.2024;[Epub]     CrossRef
  • What’s new about the tumor microenvironment of urothelial carcinoma?
    João Queirós Coelho, Maria João Ramos, Ridhi Ranchor, Rita Pichel, Laura Guerra, Hugo Miranda, Joana Simões, Sérgio Xavier Azevedo, Joana Febra, António Araújo
    Clinical and Translational Oncology.2024; 26(7): 1549.     CrossRef
  • A bibliometric insight into neoadjuvant chemotherapy in bladder cancer: trends, collaborations, and future avenues
    Yi Huang, Chengxiao Liao, Zefeng Shen, Yitong Zou, Weibin Xie, Qinghua Gan, Yuhui Yao, JunJiong Zheng, Jianqiu Kong
    Frontiers in Immunology.2024;[Epub]     CrossRef
  • Bladder-sparing treatment using tislelizumab combined with gemcitabine/cisplatin in selected patients with muscle-invasive bladder cancer: a real-world study
    Cheng Luo, Shuhang Luo, Wumier Wusimanjiang, Zongren Wang, Ping Liu, Bin Wang, Dan Yuan, Hao Lin, Abai Xu, Nan Deng, Kaihui Wu, Xuejin Zhu, Peng Xu, Junxing Chen, Bin Huang
    Clinical and Translational Oncology.2024; 26(7): 1759.     CrossRef
  • Neoadjuvant Cisplatin-Based Chemotherapy Followed by Selective Bladder Preservation Chemoradiotherapy in Muscle-Invasive Urothelial Carcinoma of the Bladder: Post Hoc Analysis of Two Prospective Studies
    Sung Wook Cho, Sung Hee Lim, Ghee Young Kwon, Chan Kyo Kim, Won Park, Hongryull Pyo, Jae Hoon Chung, Wan Song, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
    Cancer Research and Treatment.2024; 56(3): 893.     CrossRef
  • Perioperative Durvalumab with Neoadjuvant Chemotherapy in Operable Bladder Cancer
    Thomas Powles, James W.F. Catto, Matthew D. Galsky, Hikmat Al-Ahmadie, Joshua J. Meeks, Hiroyuki Nishiyama, Toan Quang Vu, Lorenzo Antonuzzo, Pawel Wiechno, Vagif Atduev, Ariel G. Kann, Tae-Hwan Kim, Cristina Suárez, Chao-Hsiang Chang, Florian Roghmann, M
    New England Journal of Medicine.2024; 391(19): 1773.     CrossRef
  • Klassische Chemotherapie, Immuntherapie oder adjuvante Strahlentherapie – Wie können wir die onkologischen Ergebnisse der radikalen Zystektomie verbessern?
    Pia Paffenholz, Stefanie Zschäbitz
    Die Urologie.2024; 63(10): 994.     CrossRef
  • Recent developments in perioperative combination therapy in muscle-invasive bladder cancer
    Jan-Jaap J. Mellema, Bas W.G. van Rhijn, Michiel S. van der Heijden
    Current Opinion in Urology.2023; 33(5): 404.     CrossRef
  • 5,897 View
  • 278 Download
  • 6 Web of Science
  • 9 Crossref
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Gastrointestinal cancer
A Phase II Study of Preoperative Chemoradiotherapy with Capecitabine Plus Simvastatin in Patients with Locally Advanced Rectal Cancer
Hyunji Jo, Seung Tae Kim, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Jeong Il Yu, Hee Chul Park, Doo Ho Choi, Yoonah Park, Yong Beom Cho, Jung Wook Huh, Seong Hyeon Yun, Hee Cheol Kim, Woo Yong Lee, Won Ki Kang
Cancer Res Treat. 2023;55(1):189-195.   Published online June 8, 2022
DOI: https://doi.org/10.4143/crt.2021.1527
AbstractAbstract PDFPubReaderePub
Purpose
The purpose of this phase II trial was to evaluate whether the addition of simvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, to preoperative chemoradiotherapy (CRT) with capecitabine confers a clinical benefit to patients with locally advanced rectal cancer (LARC).
Materials and Methods
Patients with LARC (defined by clinical stage T3/4 and/or lymph node positivity) received preoperative radiation (45-50.4 Gy in 25-28 daily fractions) with concomitant capecitabine (825 mg/m2 twice per day) and simvastatin (80 mg, daily). Curative surgery was planned 4-8 weeks after completion of the CRT regimen. The primary endpoint was pathologic complete response (pCR). The secondary endpoints included sphincter-sparing surgery, R0 resection, disease-free survival, overall survival, the pattern of failure, and toxicity.
Results
Between October 2014 and July 2017, 61 patients were enrolled; 53 patients completed CRT regimen and underwent total mesorectal excision. The pCR rate was 18.9% (n=10) by per-protocol analysis. Sphincter-sparing surgery was performed in 51 patients (96.2%). R0 resection was achieved in 51 patients (96.2%). One patient experienced grade 3 liver enzyme elevation. No patient experienced additional toxicity caused by simvastatin.
Conclusion
The combination of 80 mg simvastatin with CRT and capecitabine did not improve pCR in patients with LARC, although it did not increase toxicity.

Citations

Citations to this article as recorded by  
  • Effects of Hyperlipidemia on Osseointegration of Dental Implants and Its Strategies
    Haiyang Sun, Shuhuai Meng, Junyu Chen, Qianbing Wan
    Journal of Functional Biomaterials.2023; 14(4): 194.     CrossRef
  • 5,613 View
  • 162 Download
  • 1 Web of Science
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Genitourinary cancer
Genomic Sequencing for Bladder Urothelial Carcinoma and Its Clinical Implications for Immunotherapy
Ryul Kim, Jung Yong Hong, Jeeyun Lee, Ghee Young Kwon, Byong Chang Jeong, Se Hoon Park
Cancer Res Treat. 2022;54(3):894-906.   Published online November 17, 2021
DOI: https://doi.org/10.4143/crt.2021.854
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
This study aimed to explore the genomic and transcriptomic landscape of bladder cancer (BC) and its implication for treatment with an immune checkpoint inhibitor (ICI).
Materials and Methods
We analyzed whole-exome and -transcriptome sequences of tumor samples from 64 BC patients who underwent surgical resection with either transurethral resection or radical cystectomy. For exploratory purposes, programmed death-ligand 1 (PD-L1) expression was evaluated in a subset of patients (n=57) including those treated with ICI (n=8).
Results
We identified frequent molecular dysregulations in chromatin regulatory genes (KDM6A, ARID1A, MLL2, and STAG2) and recurrent copy number alterations. Thirty-five samples (54.7%) were PD-L1–positive (PD-L1 combined positive score ≥ 1) with a significantly higher exonic tumor mutational burden (TMB) compared to PD-L1–negative BC samples (p=0.010). We observed that various immune-responsive pathways, including the PD-L1 signaling pathway, were enriched significantly in PD-L1–positive BCs. Interestingly, genes in the CTLA4 pathway were enriched significantly in PD-L1–positive BC as well. Among eight patients who received ICI, progressive disease was confirmed in one patient, whose tumor had low exonic TMB, negative PD-L1 status, and a relatively colder microenvironment.
Conclusion
Gaining new insights into the molecular landscape of BC will improve treatment strategies. Our analysis suggests a rationale for studying dual checkpoint inhibition against BC.

Citations

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  • The role of lysine-specific demethylase 6A (KDM6A) in tumorigenesis and its therapeutic potentials in cancer therapy
    Li-Juan Chen, Xin-Yang Xu, Xiao-Dan Zhong, Yan-Jun Liu, Ming-Hui Zhu, Fan Tao, Chang-Yun Li, Qiu-Sheng She, Guan-Jun Yang, Jiong Chen
    Bioorganic Chemistry.2023; 133: 106409.     CrossRef
  • A novel cuproptosis-related lncRNAs signature predicts prognostic and immune of bladder urothelial carcinoma
    Zheng Zhou, Yusong Zhou, Wei Liu, Jing Dai
    Frontiers in Genetics.2023;[Epub]     CrossRef
  • Implication of KDM6A in Bladder Cancer
    Marianne Matar, Gilles Prince, Ibrahim Hamati, Maria Baalbaky, Jonas Fares, Marc Aoude, Charbel Matar, Hampig Raphael Kourie
    Pharmacogenomics.2023; 24(9): 509.     CrossRef
  • Subsequent Systemic Therapy following Platinum and Immune Checkpoint Inhibitors in Metastatic Urothelial Carcinoma
    Joohyun Hong, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
    Biomedicines.2022; 10(8): 2005.     CrossRef
  • Antineoplastics

    Reactions Weekly.2022; 1933(1): 61.     CrossRef
  • Cuproptosis-related lncRNA signatures predict prognosis and immune relevance of kidney renal papillary cell carcinoma
    Tongjin Xie, Bin Liu, Dongbo Liu, Yusong Zhou, Qingping Yang, Dai Wang, Mengjie Tang, Wei Liu
    Frontiers in Pharmacology.2022;[Epub]     CrossRef
  • 7,493 View
  • 245 Download
  • 5 Web of Science
  • 6 Crossref
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Rare Cancer
Clinical Experience of Male Primary Choriocarcinoma at the Samsung Medical Center
Young Sok Ji, Se Hoon Park
Cancer Res Treat. 2021;53(3):874-880.   Published online December 7, 2020
DOI: https://doi.org/10.4143/crt.2020.1066
AbstractAbstract PDFPubReaderePub
Purpose
The objective of this study was to describe and analyze the clinicopathological features of primary choriocarcinoma (PCC) observed in male patients treated at the Samsung Medical Center between 1996 and 2020.
Materials and Methods
We reviewed the clinical records of 14 male patients with PCC retrospectively to assess their demographic, histological, and clinical characteristics at the time of diagnosis as well as identify the treatment outcomes.
Results
The median age of the patients was 33 years. The primary tumor site was the testicles in seven cases (50%), the mediastinum in six cases (43%), and the brain in one case (7%). The most common metastatic site was the lungs (79%), followed by the brain (43%). All patients with PCC received cytotoxic chemotherapy. Twelve patients had records of their response to cytotoxic chemotherapy; of these 12 patients, eight (8/12, 67%) achieved an objective response, and four (4/12, 33%) achieved stable disease response as the best response during chemotherapy.
Conclusion
It is known that most male PCC patients eventually develop resistance to cytotoxic chemotherapy and die. Factors such as poor response to chemotherapy, high disease burden, brain metastasis, and hemoptysis at the time of diagnosis are associated with shorter survival time in male PCC patients. Programmed death-1/programmed death-ligand 1 blockade therapy can be a salvage treatment for chemotherapy-resistant male PCC patients.

Citations

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  • Primary retroperitoneal choriocarcinoma with lung and liver metastasis in a male patient: case report
    Guimei Wang, Ronghui Li
    Oncologie.2024; 26(1): 167.     CrossRef
  • A poor prognostic male choriocarcinoma with multiple systemic metastases: a case report and the literature review
    Wenpeng Huang, Zuohuan Zheng, Zheng Bao, Xiaoyan Xiao, Liming Li, Zhaonan Sun, Lei Kang
    Frontiers in Medicine.2024;[Epub]     CrossRef
  • Pediatric primary extragonadal choriocarcinoma - A study on male patients at a single tertiary medical institution
    Jui-Ju Tseng, Chi-Yen Chen, Chiung-Wen Liang, Fang-Liang Huang
    Pediatrics & Neonatology.2024;[Epub]     CrossRef
  • Comparative analysis of testicular and nontesticular choriocarcinoma: a population-based study
    Sakhr Alshwayyat, Maen S. Soudi, Marwa T. Qaddoura, Tala A. Alshwayyat, Obada Ababneh, Hamdah Hanifa, Ramez M. Odat, Rami S. AlAzab
    Annals of Medicine & Surgery.2024; 86(12): 6951.     CrossRef
  • The tumor or inflammation? a case report on primary pulmonary choriocarcinoma
    Na Wang, Nan Zhang, Xinyue Zhang, Yuanyuan Wang, Yajie Fu, Lingfei Guo, Changhu Liang, Mengru Yu
    Frontiers in Oncology.2023;[Epub]     CrossRef
  • Pure testicular choriocarcinoma, a rare and highly malignant subtype with challenging treatment: A case report and review of the literature
    Na Lei, Li-Li Lei, Chao-Hong Wang, Chao-Rong Mei
    Molecular and Clinical Oncology.2023;[Epub]     CrossRef
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    Reactions Weekly.2022; 1890(1): 41.     CrossRef
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    Andrea M. Johnson, Christiana M. Johnson, Zena Khalil, Maria Stitzel, Deanna Teoh
    Gynecologic Oncology Reports.2022; 43: 101064.     CrossRef
  • Extragonadal Germ Cell Tumors of the Mediastinum and Retroperitoneum
    David Aguiar Bujanda, Daniel Pérez Cabrera, Laura Croissier Sánchez
    American Journal of Clinical Oncology.2022; 45(12): 493.     CrossRef
  • 7,046 View
  • 155 Download
  • 10 Web of Science
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Atezolizumab in Patients with Pretreated Urothelial Cancer: a Korean Single-Center, Retrospective Study
Joon Young Hur, Youjin Kim, Ghee-Young Kwon, Minyong Kang, Hyun Hwan Sung, Hwang Gyun Jeon, Byong Chang Jeong, Seong Il Seo, Seong Soo Jeon, Hyun Moo Lee, Su Jin Lee, Se Hoon Park
Cancer Res Treat. 2019;51(4):1269-1274.   Published online January 9, 2019
DOI: https://doi.org/10.4143/crt.2018.604
AbstractAbstract PDFPubReaderePub
Purpose
Treatment targeting immune checkpoint with programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors has demonstrated efficacy and tolerability in the treatment of metastatic urothelial carcinoma (mUC). We investigated the efficacy and safety of atezolizumab in mUC patients who failed platinum-based chemotherapy.
Materials and Methods
A retrospective study using the Samsung Medical Center cancer chemotherapy registry was performed on 50 consecutive patients with mUC treated with atezolizumab, regardless of their PD-L1(SP142) status, as salvage therapy after chemotherapy failure between May 2017 and June 2018. Endpoints included overall response rate (RR), progression-free survival (PFS), and safety.
Results
Among 50 patients, men constituted 76% and the median age was 68 years (range, 46 to 82 years). Twenty-three patients (46%) received atezolizumab as second-line therapy. PD-L1 (SP142) status IC0/1 and IC2/3 were found in 21 (42%) and 21 (42%) of patients, respectively; in eight patients (16%), PD-L1 (SP142) expression was not available. Atezolizumab was generally well tolerated, with pruritus and fatigue being the most commonly observed toxicities. As a result, partial response was noted in 20 patients (40%), with 12 (24%) stable diseases. RRwas higherin IC2/3 (62%) than in IC0/1 patients (24%, p=0.013). The median PFS was 7.4 months (95% confidence interval, 3.4 to 11.4 months). As expected, PFS also was significantly longer in IC2/3 patients than in IC0/1 (median, 12.7 vs. 2.1 months; p=0.005). PFS was not significantly influenced by age, sex, performance status, number of previous chemotherapy, site of metastases, or any of the baseline laboratory parameters.
Conclusion
In this retrospective study, atezolizumab demonstrated clinically efficacy and tolerability in unselected mUC patients who failed platinum-based chemotherapy.

Citations

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  • Real-world data of atezolizumab in patients with previously treated locally advanced or metastatic urothelial bladder cancer
    Rocío Díaz Acedo, Mercedes Galvan Banqueri, Silvia Artacho Criado, Eva María Fernández Parra, Rocío Jiménez Galán, Ana Isabel Gago Sánchez, Juan Francisco Marín Pozo, María José Martínez Bautista
    International Journal of Clinical Pharmacy.2024; 46(2): 382.     CrossRef
  • Subsequent Systemic Therapy following Platinum and Immune Checkpoint Inhibitors in Metastatic Urothelial Carcinoma
    Joohyun Hong, Hyun Hwan Sung, Byong Chang Jeong, Se Hoon Park
    Biomedicines.2022; 10(8): 2005.     CrossRef
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    Inkeun Park, Jae Lyun Lee
    The Korean Journal of Internal Medicine.2020; 35(4): 834.     CrossRef
  • 7,525 View
  • 283 Download
  • 3 Web of Science
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Comparison of the 7th and the 8th AJCC Staging System for Non-metastatic D2-Resected Lymph Node–Positive Gastric Cancer Treated with Different Adjuvant Protocols
Jeong Il Yu, Do Hoon Lim, Jeeyun Lee, Won Ki Kang, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Seung Tae Kim, Su Jin Lee, Sung Kim, Tae Sung Sohn, Jun Ho Lee, Ji Yeong An, Min Gew Choi, Jae Moon Bae, Heejin Yoo, Kyunga Kim
Cancer Res Treat. 2019;51(3):876-885.   Published online October 1, 2018
DOI: https://doi.org/10.4143/crt.2018.401
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The purpose of this study was to compare prognostic differentiation performances of the 7th and the 8th edition of American Joint Commission on Cancer (AJCC) staging system for gastric cancer (GC) patients.
Materials and Methods
A total of 1,633 GC patients who underwent curative D2 resection followed by adjuvant chemotherapy alone (CA) or concurrent chemo-radiotherapy (CCRT) from 2004 to 2013 were included. Concordance index (c-index) was applied to compare the discriminatory ability.
Results
In the 8th edition, migration of stage was detected in 248 patients (15.2%). Among them, 121 patients were up-staged while 127 patients were down-staged. Overall, there was no statistically significant difference in the discriminatory ability between the 7th and 8th editions. The new edition of staging system, however, showed a trend of better prognostic performance not only in recurrence-free survival (c-index=0.734; 95% confidence interval [CI], 0.706 to 0.762 in the 7th edition vs. c-index=0.740; 95% CI, 0.712 to 0.768 in the 8th edition; p=0.14), but also in overall survival (c-index=0.717; 95% CI, 0.688 to 0.745 in the 7th edition vs. c-index=0.722; 95% CI, 0.694 to 0.751 in the 8th edition; p=0.19), especially in stage III. This finding was repeated in the subgroup analysis regardless of adjuvant CA or CCRT.
Conclusion
Generally, the 8th edition of AJCC staging system had failed to show a superior discriminatory ability for curatively D2 resected GC patients than the 7th edition, although there was a trend of better prognostic performance of the new edition, regardless of adjuvant treatment method.

Citations

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  • An analysis of the relationship of triglyceride glucose index with gastric cancer prognosis: A retrospective study
    Chao Cai, Cheng Chen, Xiuli Lin, Huihui Zhang, Mingming Shi, Xiaolei Chen, Weisheng Chen, Didi Chen
    Cancer Medicine.2024;[Epub]     CrossRef
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Phase II Study of Dovitinib in Patients with Castration-Resistant Prostate Cancer (KCSG-GU11-05)
Yoon Ji Choi, Hye Sook Kim, Se Hoon Park, Bong-Seog Kim, Kyoung Ha Kim, Hyo Jin Lee, Hong Suk Song, Dong-Yeop Shin, Ha Young Lee, Hoon-Gu Kim, Kyung Hee Lee, Jae Lyun Lee, Kyong Hwa Park
Cancer Res Treat. 2018;50(4):1252-1259.   Published online January 2, 2018
DOI: https://doi.org/10.4143/crt.2017.438
AbstractAbstract PDFPubReaderePub
Purpose
Fibroblast growth factor (FGF) signals are important in carcinogenesis and progression of prostate cancer. Dovitinib is an oral, pan-class inhibitor of vascular endothelial growth factor receptor (VEGFR), platelet-derived growth factor receptor, and fibroblast growth factor receptor (FGFR). We evaluated the efficacy and toxicity of dovitinib in men with metastatic castration resistant prostate cancer (mCRPC).
Materials and Methods
This study was a single-arm, phase II, open-label, multicenter trial of dovitinib 500 mg/day (5-days-on/2-days-off schedule). The primary endpointwas 16-week progression-free survival (PFS). Secondary endpoints were overall survival (OS), toxicity and prostate-specific antigen (PSA) response rate. Biomarker analyses for VEGFR2, FGF23, and FGFR2 using multiplex enzyme-linked immunosorbent assay was performed.
Results
Forty-four men were accrued from 11 hospitals. Eighty percent were post-docetaxel. Median PSA was 100 ng/dL, median age was 69, 82% had bone metastases, and 23% had liver metastases. Median cycles of dovitinibwas 2 (range, 0 to 33). Median PFSwas 3.67 months (95% confidence interval [CI], 1.36 to 5.98) and median OS was 13.70 months (95% CI, 0 to 27.41). Chemotherapy-naïve patients had longer PFS (17.90 months; 95% CI, 9.23 to 28.57) compared with docetaxel-treated patients (2.07 months; 95% CI, 1.73 to 2.41; p=0.001) and the patients with high serum VEGFR2 level over median level (7,800 pg/mL) showed longer PFS compared with others (6.03 months [95% CI, 4.26 to 7.80] vs. 1.97 months [95% CI, 1.79 to 2.15], p=0.023). Grade 3 related adverse events were seen in 40.9% of patients. Grade 1-2 nausea, diarrhea, fatigue, anorexia, and all grade thrombocytopenia are common.
Conclusion
Dovitinib showed modest antitumor activity with manageable toxicities in men with mCRPC. Especially, patients who were chemo-naïve benefitted from dovitinib.

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Pazopanib for the Treatment of Non-clear Cell Renal Cell Carcinoma: A Single-Arm, Open-Label, Multicenter, Phase II Study
Ki Sun Jung, Su Jin Lee, Se Hoon Park, Jae-Lyun Lee, Se-Hoon Lee, Jae Yun Lim, Jung Hun Kang, Suee Lee, Sun Young Rha, Kyung Hee Lee, Ho Young Kim, Ho Yeong Lim
Cancer Res Treat. 2018;50(2):488-494.   Published online May 22, 2017
DOI: https://doi.org/10.4143/crt.2016.584
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The optimal treatment strategy for patients with metastatic non-clear cell type renal cell carcinoma (nccRCC) remains unclear. Although several inhibitors of vascular endothelial growth factor have recently shown efficacy against nccRCC, the clinical benefit of pazopanib in nccRCC has not been analyzed. We therefore designed a single-arm, open-label, phase II study to determine the efficacy and safety of pazopanib in patients with nccRCC.
Materials and Methods
Patientswith locally advanced or metastatic nccRCC, exceptfor collecting duct or sarcomatoid type, received 800 mg/day of pazopanib daily until progression of disease or intolerable toxicity. One cyclewas defined as 4weeks and tumorresponsewas evaluated every two cycles. The primary objective was overall response rate (ORR).
Results
A total of 29 eligible patients were enrolled at nine centers in Korea from December 2012 and September 2014. The median age of the patients was 58 years (range, 27 to 76 years) and 21 patients (72%) were male. Regarding histology type, 19 patients had papillary, three had chromophobe, two had unclassified and five had unknown non-clear cell type. Of 28 evaluable patients, eight achieved a confirmed partial response with ORR of 28%. The median progression-free survival was 16.5 months (95% confidence interval, 10.9 to 22.1) and median overall survival was not reached. Sixteen patients (55%) experienced treatment-related toxicity of grade 3 or more, but most adverse events were overcome through dose reduction and delay.
Conclusion
In this prospective phase II study, pazopanib demonstrated promising activity and tolerable safety profile in patients with metastatic nccRCC.

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A Randomized Phase II Study of Leucovorin/5-Fluorouracil with or without Oxaliplatin (LV5FU2 vs. FOLFOX) for Curatively-Resected, Node-Positive Esophageal Squamous Cell Carcinoma
Sung Hee Lim, Young Mog Shim, Se Hoon Park, Hong Kwan Kim, Young Soo Choi, Myung-Ju Ahn, Keunchil Park, Jae Ill Zo, Jong-Mu Sun
Cancer Res Treat. 2017;49(3):816-823.   Published online November 9, 2016
DOI: https://doi.org/10.4143/crt.2016.417
AbstractAbstract PDFSupplementary MaterialPubReaderePub
Purpose
The optimal perioperative treatment for resectable esophageal squamous cell carcinoma (ESCC) remains controversial. We evaluated the efficacy and safety of leucovorin and 5-fluorouracil (LV5FU2) and LV5FU2 plus oxaliplatin (FOLFOX) combination chemotherapies administered adjuvantly for curatively-resected, node-positive ESCC.
Materials and Methods
Patients with pathologically node-positive esophageal cancer after curative R0 resection were enrolled and randomly assigned to receive LV5FU2 or FOLFOX biweekly for up to eight cycles. The primary endpoint was disease-free survival (DFS).
Results
Between 2011 and 2015, 62 patients were randomized into the two treatment groups (32 in the LV5FU2 arm and 30 in the FOLFOX arm). The median age was 60 years and both groups had similar pathologic characteristics in tumor, nodal status, and location. Treatment completion rates were similarly high in both groups. The DFS rate at 12 months was 67% in the LV5FU2 group and 63% in the FOLFOX group with a hazard ratio of 1.3 (95% confidence interval [CI], 0.66 to 2.62). After a median follow-up period of 27 months, the median DFS was 29.6 months (95% CI, 4.9 to 54.2) in the LV5FU2 arm and 16.8 months (95% CI, 7.5 to 26.1) in the FOLFOX arm (p=0.428), respectively, while the median overall survival was not reached in either arm. Grade 3 or 4 neutropenia was more frequent in patients in the FOLFOX arm than the LV5FU2 arm (20.0% vs. 3.1%).
Conclusion
The addition of oxaliplatin (FOLFOX) did not lead to better efficacy compared to LV5FU2 chemotherapy in an adjuvant setting in node-positive ESCC patients.

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    Jong-Mu Sun
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    Vincent T Janmaat, Ewout W Steyerberg, Ate van der Gaast, Ron HJ Mathijssen, Marco J Bruno, Maikel P Peppelenbosch, Ernst J Kuipers, Manon CW Spaander
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Is There a Role for Adjuvant Therapy in R0 Resected Gallbladder Cancer?: A Propensity Score-Matched Analysis
Se-Il Go, Young Saing Kim, In Gyu Hwang, Eun Young Kim, Sung Yong Oh, Jun Ho Ji, Haa-Na Song, Se Hoon Park, Joon Oh Park, Jung Hun Kang
Cancer Res Treat. 2016;48(4):1274-1285.   Published online February 12, 2016
DOI: https://doi.org/10.4143/crt.2015.502
AbstractAbstract PDFPubReaderePub
Purpose
The purpose of this study is to assess the role of adjuvant therapy in stage I-III gallbladder cancer (GBC) patients who have undergone R0 resection.
Materials and Methods
Clinical data were collected on 441 consecutive patients who underwent R0 resection for stage I-III GBC. Eligible patients were classified into adjuvant therapy and surveillance only groups. Propensity score matching (PSM) between the two groups was performed, adjusting clinical factors.
Results
In total, 84 and 279 patients treated with adjuvant therapy and followed up with surveillance only, respectively, were included in the analysis. Before PSM, the 5-year relapse-free survival (RFS) rate was lower in the adjuvant therapy group than in the surveillance only group (50.8% vs. 74.8%, p < 0.001), although there was no statistically significant difference in the 5-year overall survival (OS) rate (66.2% vs. 79.5%, p=0.089). After the PSM, baseline characteristics became comparable and there were no differences in the 5-year RFS (50.8% vs. 64.8%, p=0.319) and OS (66.2% vs. 70.4%, p=0.703) rates between the two groups.
Conclusion
The results suggest that fluoropyrimidine-based adjuvant therapy is not indicated in stage I-III GBC patients who have undergone R0 resection.

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    Jiong-Jie Yu, Xin-Fei Xu, Tian Yang
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    Luxi Yin, Qi Xu, Jingjing Li, Qing Wei, Jieer Ying
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A Retrospective Analysis for Patients with HER2-Positive Gastric Cancer Who Were Treated with Trastuzumab-Based Chemotherapy: In the Perspectives of Ethnicity and Histology
Jun Ho Yi, Jung Hun Kang, In Gyu Hwang, Hee Kyung Ahn, Hyun Jin Baek, Soon Il Lee, Do Hyoung Lim, Young-Woong Won, Jun Ho Ji, Hyo Song Kim, Sun Young Rha, Sung Yong Oh, Kyung Eun Lee, Taekyu Lim, Chi Hoon Maeng, Moon Jin Kim, Seung Tae Kim, Jeeyun Lee, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang, Se Hoon Park
Cancer Res Treat. 2016;48(2):553-560.   Published online August 10, 2015
DOI: https://doi.org/10.4143/crt.2015.155
AbstractAbstract PDFPubReaderePub
Purpose
While the Trastuzumab for Gastric Cancer (ToGA) trial demonstrated the efficacy and safety of trastuzumab-based chemotherapy in HER2-positive metastatic gastric cancer, the overall survival (OS) benefit was not found in Asian and diffuse-type cancer patients. The aim of the study is to investigate predictive markers for trastuzumab-based chemotherapy.
Materials and Methods
Data of patients with HER2-positive gastric cancer treated with trastuzumab-based chemotherapy were analyzed retrospectively.
Results
A total of 168 Asian patients were included. The median age was 60 years (range, 27 to 85 years) and the male:female ratio was 118 (70.2%):50 (29.8%). Fourteen (8.3%), 63 (37.5%), 75 (44.6%), and 11 (6.5%) patients had well, moderately, poorly-differentiated tubular adenocarcinoma and signet ring cell carcinoma, respectively. With 14 complete responses and 73 partial responses, the response rate was 50.6%. The median progression-free survival (PFS) was 10.2 months (95% confidence interval [CI], 8.7 to 11.7), and the median OS was 18.5 months (95% CI, 16.4 to 50.6). Next, we investigated the effect of poorly-differentiated histology (PDH, poorly-differentiated tubular adenocarcinoma+signet ring cell carcinoma) on clinical outcomes. The median PFS (8.9 months vs. 11.5 months, p=0.16) was slightly inferior in PDH patients, and the median OS was significantly shorter in PDH patients (14.6 months vs. 19.0 months, p=0.025).
Conclusion
While subset analysis of the ToGA trial demonstrated that trastuzumab-based chemotherapy may not be beneficial for Asians and patients with PDH, our data may suggest that even in Asian patients and patients with PDH, trastuzumab-based chemotherapy could be associated with improved clinical outcomes in patients with HER2-positive gastric cancer.

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    Maria Cristina Riascos, Jacques A. Greenberg, Federico Palacardo, Rodrigo Edelmuth, V. Colby Lewis, Anjile An, Haythem Najah, Hala Al Asadi, Parima Safe, Brendan M. Finnerty, Paul J. Christos, Thomas J. Fahey, Rasa Zarnegar
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The Role of Plasma Chromogranin A as Assessment of Treatment Response in Non-functioning Gastroenteropancreatic Neuroendocrine Tumors
Moonjin Kim, Sujin Lee, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Won Ki Kang, Seung Tae Kim
Cancer Res Treat. 2016;48(1):153-161.   Published online March 7, 2015
DOI: https://doi.org/10.4143/crt.2014.183
AbstractAbstract PDFPubReaderePub
Purpose
Chromogranin A (CgA) has been considered to be valuable not only in the diagnosis but also in monitoring the disease response to treatment. However, only a few studies have been published on this issue. We purposed to evaluate whether biochemical response using plasma CgA level is reliable in concordance with the clinical response of grade 1-3 nonfunctiong gastroenteropancreatic neuroendocrine tumors (GEP-NETs). Materials and Methods Between March 2011 and September 2013, a total of 27 cases in 18 patients were analysed, clinically and radiologically while serial CgA tests were also conducted during treatment. Tumor responses were defined by both Response Evaluation Criteria in Solid Tumors (RECIST) criteria ver. 1.1 and biochemical criteria based on the CgA level.
Results
Among the 27 cases analysed, no difference in the basal CgA level was observed with regard to gender, primary tumor site, tumor grade (World Health Organization classification), liver metastasis, number of metastatic site, and line of chemotherapy. The overall response rate (RR) by RECIST criteria ver. 1.1 was six out of the 27 cases (22.2%) and eight out of the 27 cases (29.6%) for biochemical RR. The overall concordance rates of the response based on RECIST and biochemical criteria were 74%. In grades 1 and 2 GEP-NETs (n=17), the concordance rate of the disease control was 94.1%. There was a significant difference for progression- free survival (PFS) between responders and non-responder in accordance to biochemical criteria (35.73 months vs. 5.93 months, p=0.05). Conclusion This study revealed that changes of the plasma CgA levels were associated with tumour response. Additionally, biochemical response based on serial CgA may be a predictive marker for PFS in GEP-NETs.

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    Clarisse Dromain, Marianne Pavel, Maxime Ronot, Niklaus Schaefer, Dalvinder Mandair, Delphine Gueguen, Catherine Cheng, Olivier Dehaene, Kathryn Schutte, David Cahané, Simon Jégou, Félix Balazard
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    N. V. Lyubimova, Yu. S. Timofeev, T. K. Churikova, A. A. Markovich, G. S. Emelianova, I. S. Stilidi, N. E. Kushlinskii
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    Yoshihide Nanno, Hirochika Toyama, Ippei Matsumoto, Kyoko Otani, Sadaki Asari, Tadahiro Goto, Tetsuo Ajiki, Yoh Zen, Takumi Fukumoto, Yonson Ku
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    Kyong Joo Lee, Jae Hee Cho, Sang Hyub Lee, Si Young Song, Kwang Hyuk Lee, Seok Jeong, Ji Kon Ryu, Sang Myung Woo, Seungmin Bang, Jong Kyun Lee, Tae Hoon Lee, Woo Hyun Paik, Yong Tae Kim, Woo Jin Lee
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Current Status and Challenges of Cancer Clinical Trials in Korea
Byoung Yong Shim, Se Hoon Park, Soonil Lee, Jin-Soo Kim, Kyoung Eun Lee, Yoon-Koo Kang, Myung-Ju Ahn
Cancer Res Treat. 2016;48(1):20-27.   Published online March 2, 2015
DOI: https://doi.org/10.4143/crt.2014.317
AbstractAbstract PDFPubReaderePub
Purpose
Cancer clinical trials in Korea have rapidly progressed in terms of quantity and quality during the last decade. This study evaluates the current status of cancer clinical trials in Korea and their associated problems. Materials and Methods We analyzed the clinical trials approved by the Korea Food and Drug Administration (KFDA) between 2007 and 2013. A nationwide on-line survey containing 22 questions was also performed with several cooperative study groups and individual researchers in 56 academic hospitals.
Results
The number of cancer clinical trials approved by the KFDA increased almost twofold from 2007 to 2013. The number of sponsor-initiated clinical trials (SITs) increased by 50% and investigator-initiated clinical trials (IITs) increased by almost 640%. Three hundred and fortyfour clinical trials were approved by the KFDA between 2012 and 2013. At the time of the on-line survey (August 2013), 646 SITs and 519 IITs were ongoing in all hospitals. Six high volume hospitals were each conducting more than 50 clinical trials, including both SITs and IITs. Fifty-six investigators (31%) complained of the difficulties in raising funds to conduct clinical trials. Conclusion The number of cancer clinical trials in Korea rapidly increased from 2007 to 2013, as has the number of multicenter clinical trials and IITs run by cooperative study groups. Limited funding for IIT is a serious problem, and more financial support is needed both from government agencies and public donations from non-profit organizations.

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    Bum Jun Kim, Chi Hoon Maeng, Bhumsuk Keam, Young-Hyuck Im, Jungsil Ro, Kyung Hae Jung, Seock-Ah Im, Tae Won Kim, Jae Lyun Lee, Dae Seog Heo, Sang-We Kim, Keunchil Park, Myung-Ju Ahn, Byoung Chul Cho, Hoon-Kyo Kim, Yoon-Koo Kang, Jae Yong Cho, Hwan Jung Yu
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    Do Yeun Kim, Yun Gyoo Lee, Bong-Seog Kim
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    Yoojoo Lim, Jee Min Lim, Won Jae Jeong, Kyung-Hun Lee, Bhumsuk Keam, Tae-Yong Kim, Tae Min Kim, Sae-Won Han, Do Youn Oh, Dong-Wan Kim, Tae-You Kim, Dae Seog Heo, Yung-Jue Bang, Seock-Ah Im
    Cancer Research and Treatment.2017; 49(4): 1033.     CrossRef
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Changes in the Mean Corpuscular Volume after Capecitabine Treatment Are Associated with Clinical Response and Survival in Patients with Advanced Gastric Cancer
Hyun Ae Jung, Hyun-Jun Kim, Chi Hoon Maeng, Se Hoon Park, Jeeyun Lee, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang
Cancer Res Treat. 2015;47(1):72-77.   Published online August 21, 2014
DOI: https://doi.org/10.4143/crt.2013.172
AbstractAbstract PDFPubReaderePub
Purpose
Capecitabine is known to increase mean corpuscular volume (MCV). To define the incidence of capecitabine-induced macrocytosis and its association with chemotherapy outcomes, we investigated data of 89 patients with advanced gastric cancer (AGC) who were enrolled in a randomized chemotherapy trial involving capecitabine. Materials and Methods Chemotherapy-naïve AGC patients were treated with capecitabine (1,000 mg/m2/day on days 1-14) plus cisplatin (75 mg/m2 on day 1), with or without epirubicin (50 mg/m2 on day 1). Complete blood counts including MCV were measured at baseline and on day 1 of each 3-week chemotherapy course. Macrocytosis was defined as a MCV increase > 10 fL from baseline. Multivariate Cox proportional hazards models were used for analysis of the impact of clinical and MCV values on chemotherapy outcomes. Results At baseline, the mean MCV was 88.2 fL (normal range, 80 to 100 fL). During chemotherapy, MCV increased in a dose-dependent manner with a mean increase of 11.3 fL. MCV elevation after capecitabine treatment in 74 patients (90%) and 44 patients (42%) developed macrocytosis. Results of multivariate analysis showed that development of macrocytosis was independent of baseline hemoglobin level, liver metastasis, performance status, or liver function. The number of chemotherapy cycles showed strong association with development of macrocytosis and hematologic adverse events. In addition, a significant association was observed between macrocytosis and clinical response or survival. Conclusion Macrocytosis developed with more frequent and prolonged use of capecitabine. It is possible that association with treatment outcomes warrants further investigation.

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    Gerd Jomrich, Maximilian Gruber, Elisabeth S. Gruber, Jakob Mühlbacher, Sanja Radosavljevic, Lavinia Wilfing, Daniel Winkler, Gerald Prager, Christian Reiterer, Barbara Kabon, Helmuth Haslacher, Klaus Sahora, Martin Schindl
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Chemotherapy in Advanced Gastric Cancer Patients Associated with Disseminated Intravascular Coagulation
In Gyu Hwang, Jin Hwa Choi, Se Hoon Park, Sung Yong Oh, Hyuk-Chan Kwon, Soon Il Lee, Do Hyoung Lim, Gyeong-Won Lee, Jung Hun Kang
Cancer Res Treat. 2014;46(1):27-32.   Published online January 15, 2014
DOI: https://doi.org/10.4143/crt.2014.46.1.27
AbstractAbstract PDFPubReaderePub
PURPOSE
Little is known about the clinical features of advanced gastric cancer (AGC) combined with disseminated intravascular coagulation (DIC). The main objective of this study was to determine the clinical outcome of patients with AGC complicated by DIC.
MATERIALS AND METHODS
We conducted a retrospective review of 68 AGC patients diagnosed with DIC at four tertiary medical centers between January 1995 and June 2010.
RESULTS
Sixty eight patients were included. The median age was 55 years (range, 25 to 78 years). Nineteen patients received chemotherapy, whereas 49 patients received only best supportive care (BSC). The median overall survival (OS) of the 68 patients was 16 days (95% confidence interval [CI], 11 to 21 days). Significantly prolonged OS was observed in the chemotherapy group, with a median survival of 61 days compared to 9 days in the BSC group (p<0.001, log-rank test). Age and previous chemotherapy were another significant factors that were associated with OS in univariate analysis. In multivariate analysis, age (> or =65 vs. <65; hazard ratio [HR], 0.38; 95% CI, 0.18 to 0.78; p<0.001), chemotherapy (BSC vs. chemotherapy; HR 0.31; 95% CI, 0.15 to 0.63; p<0.001), and previous chemotherapy (yes or no; HR, 0.49; 95% CI, 0.25 to 0.98; p<0.045) were consistently independent prognostic factors that impacted OS.
CONCLUSION
Our study showed that patients with AGC complicated by DIC had very poor OS, and suggested that chemotherapy might improve OS of these patients.

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Nomogram to Predict Treatment Outcome of Fluoropyrimidine/Platinum-Based Chemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Hyun Ae Jung, Antoine Adenis, Jeeyun Lee, Se Hoon Park, Chi Hoon Maeng, Silvia Park, Hee Kyung Ahn, Young Mog Shim, Nicolas Penel, Young-Hyuck Im
Cancer Res Treat. 2013;45(4):285-294.   Published online December 31, 2013
DOI: https://doi.org/10.4143/crt.2013.45.4.285
AbstractAbstract PDFPubReaderePub
PURPOSE
The degree of benefit from palliative chemotherapy differs widely among patients with metastatic esophageal squamous cell carcinoma (MESCC). The purpose of this study was to develop and validate a prognostic nomogram to predict survival and aid physicians and patients in the decision-making process regarding treatment options.
MATERIALS AND METHODS
Clinicopathologic variables and treatment outcomes of 239 patients who were diagnosed with MESCC and received either fluorouracil/cisplatin (FP) or capecitabine/cisplatin (XP) as first-line chemotherapy were reviewed. A nomogram was developed as a prognostic scoring system incorporating significant clinical and laboratory variables based on a multivariate Cox proportional hazards regression model. An independent series of 61 MESCC patients treated with FP served as an independent data set for nomogram validation.
RESULTS
No difference in response rate was observed between the FP group (44.8%) and the XP group (54.2%). Similarly, no significant differences in median progression-free survival and median overall survival were observed between regimen groups. Multivariate analysis showed that poor performance status (Eastern Cooperative Oncology Group [ECOG] status> or =2), weight loss (10% of the weight loss for 3 months), low albumin level (< or =3.5 g/dL), and absence of previous esophagectomy at the time of chemotherapy were significantly associated with low OS in both groups (p<0.05). Based on these findings, patients were classified into favorable (score, 0 to 90), intermediate (91-134), and poor (>135) prognostic groups. The median survival for those with a favorable ECOG was 13.8 months (95% confidence interval [CI], 10.8 to 18.6 months), for intermediate 11.2 months (95% CI, 8.7 to 11.9 months), and for poor, 7.0 months (95% CI, 3.6 to 10.0 months). External validation of the nomogram in a different patient cohort yielded significantly similar findings.
CONCLUSION
The nomogram described here predicts survival in MESCC patients and could serve as a guide for the use of FP/XP chemotherapy in MESCC patients.

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Outcomes of Third-Line Docetaxel-Based Chemotherapy in Advanced Gastric Cancer Who Failed Previous Oxaliplatin-Based and Irinotecan-Based Chemotherapies
Min Jeong Lee, In Gyu Hwang, Joung-Soon Jang, Jin Hwa Choi, Byeong-Bae Park, Myung Hee Chang, Seung Tae Kim, Se Hoon Park, Myoung Hee Kang, Jung Hun Kang
Cancer Res Treat. 2012;44(4):235-241.   Published online December 31, 2012
DOI: https://doi.org/10.4143/crt.2012.44.4.235
AbstractAbstract PDFPubReaderePub
PURPOSE
Little is known about outcomes in the use of third-line chemotherapy in cases of advanced gastric cancer (AGC). The primary aim of this retrospective study was to evaluate outcomes of docetaxel-based chemotherapy in patients with AGC that progressed after both oxaliplatin-based and irinotecan-based regimens.
MATERIALS AND METHODS
Eligible patients were those with AGC who had previous chemotherapy including fluoropyrimidine and oxaliplatin as well as fluoropyrimidine and irinotecan and who received subsequent docetaxel-based chemotherapy. Thirty-five patients were retrospectively recruited from 5 medical centers in Korea. Patients received either weekly or 3 weekly with docetaxel +/- cisplatin.
RESULTS
Thirty-one out of 35 patients were evaluated for treatment response. A total of 94 cycles of chemotherapy (median, 2; range, 1 to 7) were administered. The overall response rate was 14.3%, and the disease control rate was 45.7%. The median progression-free survival (PFS) was 1.9 months (95% confidence interval [CI], 1.1 to 2.7 months). The median overall survival (OS) was 3.6 months (95% CI, 2.8 to 4.4 months). PFS and OS were significantly prolonged in patients of the Eastern Cooperative Oncology Group, with performance status of 0 or 1 in multivariate analysis (PFS: hazard ratio[HR], 0.411; 95% CI, 0.195 to 0.868; p=0.020 and OS: HR, 0.390; 95% CI, 0.184 to 0.826; p=0.014, respectively). Four of the 35 patients enrolled in the study died due to infection associated with neutropenia.
CONCLUSION
Our findings suggest that salvage docetaxel-based chemotherapy is a feasible treatment option for AGC patients with good performance status (PS), whereas chemotherapy for patients with poor PS (PS< or =2) should be undertaken with caution for those who previously failed oxaliplatin- and irinotecan-based regimens.

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A Retrospective Study of First-Line Combination Chemotherapy in Advanced Colorectal Cancer: A Korean Single-Center Experience
Soon Il Lee, Se Hoon Park, Do Hyoung Lim, Keon Woo Park, Jeeyun Lee, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang
Cancer Res Treat. 2011;43(2):96-101.   Published online June 30, 2011
DOI: https://doi.org/10.4143/crt.2011.43.2.96
AbstractAbstract PDFPubReaderePub
PURPOSE
Fluoropyrimidine-based combination chemotherapy, in combination with either oxaliplatin or irinotecan, has demonstrated efficacy and tolerability in treatment of advanced colorectal cancer (ACC).
MATERIALS AND METHODS
Between January 2006 and December 2007, a total of 478 ACC patients were treated with combination chemotherapy in first-line settings. Combination therapies included: 5-fluorouracil, folinic acid plus oxaliplatin (FOLFOX, n=172), 5-fluorouracil, folinic acid plus irinotecan (FOLFIRI, n=95), capecitabine plus oxaliplatin (XELOX, n=155), and capecitabine plus irinotecan (XELIRI, n=56). FOLFOX and FOLFIRI were repeated every 2 weeks, whereas XELOX and XELIRI were repeated every 3 weeks until occurrence of disease progression or unacceptable toxicity, or until a patient chose to discontinue treatment.
RESULTS
The median age was 58 years (range, 19 to 84 years) and the median chemotherapy durations for FOLFOX, FOLFIRI, XELOX, and XELIRI were 4.9, 4.5, 5.7, and 5.4 months, respectively. Combination chemotherapy regimens were generally well tolerated. The estimated median progression-free-survival (PFS) for all patients was 6.8 months (95% confidence interval, 6.3 to 7.3 months). No statistically significant difference in PFS was found among regimens used as first-line chemotherapy. Sixty percent (n=290) of patients received second or further lines of therapy after failure.
CONCLUSION
Fluoropyrimidine-based combination chemotherapy regimens appear to be equally active and tolerable as first-line therapy for ACC.

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Oxaliplatin-Induced Chronic Peripheral Neurotoxicity: A Prospective Analysis in Patients with Colorectal Cancer
Kyung Kee Baek, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang, Yong Beom Cho, Seong Hyeon Yun, Hee Cheol Kim, Woo Yong Lee, Ho-Kyung Chun
Cancer Res Treat. 2010;42(4):185-190.   Published online December 31, 2010
DOI: https://doi.org/10.4143/crt.2010.42.4.185
AbstractAbstract PDFPubReaderePub
Purpose

Oxaliplatin-induced chronic peripheral neurotoxicity (OXCPN) manifests as a loss of sensation and dysesthesia in the distal extremities, which may impair daily activities and increase in incidence with the amount of oxaliplatin delivered. The variation in the reported incidence and severity of OXCPN may be a consequence of differences in the baseline characteristics of patients.

Materials and Methods

This was a prospective study (ClinicalTrials.gov, NCT00977717) in which OXCPN was recorded for all consecutive colon cancer patients treated at Samsung Medical Center (Seoul, Korea) with oxaliplatin-based combination chemotherapy. The primary endpoint was the incidence of severe OXCPN (grade 2 lasting for >7 days, or grade 3). The association of severe OXCPN and pretreatment parameters was evaluated using a multivariate regression model.

Results

Between Jan 2008 and Feb 2010, 100 patients treated with adjuvant folinic acid/fluorouracil plus oxaliplatin (FOLFOX) and 266 patients treated with capecitabine plus oxaliplatin (XELOX) or FOLFOX for advanced disease were registered into our study. The median cumulative dose of oxaliplatin was 796 mg/m2 (range, 85 to 1,583 mg/m2). Severe OXCPN was observed in 126 (34%) patients. Overall, 43 patients discontinued chemotherapy due to toxicity: 23 without severe OXCPN and 20 with severe OXCPN. In univariate analysis, severe OXCPN was frequently observed in patients with age ≥55 years (p<0.01), stage II or III (p<0.01), adjuvant setting (p=0.01), FOLFOX (p<0.01), performance status of 0 (p=0.02), and those with no prior chemotherapy (p<0.01). In a multivariate regression model, the number of chemotherapy cycles and the cumulative oxaliplatin dose were not associated with the development of severe OXCPN.

Conclusion

We failed to find a significant association between patient characteristics at baseline and the development of severe OXCPN after oxaliplatin-based combination chemotherapy. Pharmacogenomic profiling using genome-wide association study in these patients is underway.

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Predictive Value of the ERCC1 Expression for Treatment Response and Survival in Advanced Gastric Cancer Patients Receiving Cisplatin-based First-line Chemotherapy
Jina Yun, Kyoung-Mee Kim, Seung Tae Kim, Jung-Hoon Kim, Jung A Kim, Jee Hyun Kong, Soo Hyeon Lee, Young-Woong Won, Jong-Mu Sun, Jeeyun Lee, Se Hoon Park, Joon Oh Park, Young Suk Park, Ho Yeong Lim, Won Ki Kang
Cancer Res Treat. 2010;42(2):101-106.   Published online June 30, 2010
DOI: https://doi.org/10.4143/crt.2010.42.2.101
AbstractAbstract PDFPubReaderePub
Purpose

The aim of this study was to determine whether the ERCC1 expression is effective to predict the clinical outcomes of patients with advanced gastric cancer (AGC) and who were treated with cisplatin-based first-line chemotherapy.

Materials and Methods

A total of 89 measurable AGC patients received cisplatin and capecitabine, with or without epirubicin, as a part of a randomized phase II study. Patients were included for the current molecular analysis if they had received two or more cycles of chemotherapy, their objective tumor responses were measured and if their paraffin-embedded tumor samples were available. The ERCC1 expression was examined by performing immunohistochemical (IHC) staining, and the patients were divided into two groups (positive or negative) according to the presence of IHC staining of the tumor cell nuclei.

Results

Of the 32 eligible patients, 21 patients (66%) had tumor with a positive expression of ERCC1 and the remaining 11 patients had tumor with a negative ERCC1-expression. The ERCC1-negative patients achieved a higher response rate than that of the ERCC1-positive patients (44% vs. 28%, respectively), although the difference was not statistically significant (p=0.42). The median survival time for the all patients was 14.6 months (95% CI: 13.6 to 15.6 months). The one-year survival rate was similar for the ERCC1-negative patients (61%) and the ERCC1-positive patients (70%).

Conclusion

In the current study, the tumor ERCC1 expression by IHC staining could not predict the clinical response or survival of AGC patients who were treated with cisplatin-based first-line chemotherapy. The ERCC1 protein expression does not appear to be a useful tool for the selection of tailored chemotherapy for these patients.

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Oxaliplatin, 5-fluorouracil and Leucovorin (FOLFOX-4) Combination Chemotherapy as a Salvage Treatment in Advanced Gastric Cancer
Young Saing Kim, Junshik Hong, Sun Jin Sym, Se Hoon Park, Jinny Park, Eun Kyung Cho, Jae Hoon Lee, Dong Bok Shin
Cancer Res Treat. 2010;42(1):24-29.   Published online March 31, 2010
DOI: https://doi.org/10.4143/crt.2010.42.1.24
AbstractAbstract PDFPubReaderePub
Purpose

This study was designed to determine the efficacy and safety of FOLFOX-4 chemotherapy as a salvage treatment for patients with advanced gastric cancer (AGC).

Materials and Methods

The AGC patients with an ECOG performance status of 0~1 and progressive disease after prior treatments were registered onto this phase II trial. The patients received oxaliplatin (85 mg/m2 on day 1), leucovorin (200 mg/m2 on days 1 and 2) and 5-fluorouracil (400 mg/m2 as a bolus and 600 mg/m2 as a 22-hour infusion on days 1 and 2) every 2 weeks.

Results

For the 42 treated patients, a total of 228 chemotherapy cycles (median: 5, range: 1~12) were administered. Twenty-nine patients (69%) received FOLFOX-4 chemotherapy as a third-(50%) or fourth-line (19%) treatment. On the intent-to-treat analysis, 9 patients (21%) achieved a partial response, which was maintained for 4.6 months. The median progression-free survival and overall survival were 3.0 months and 6.2 months, respectively. The frequently encountered toxicities were neutropenia and gastrointestinal side effects, including anorexia. Although there was one possible treatment-related death, the toxicity profiles were generally predictable and manageable.

Conclusion

Salvage chemotherapy with FOLFOX-4 is an effective and tolerable regimen for those heavily pretreated AGC patients who have a good performance status.

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A Pilot Study of Cisplatin, Irinotecan, Leucovorin and 5-fluorouracil (PILF) Combination Chemotherapy for Advanced Gastric Cancer
Se Hoon Park, Soo Yeon Jeon, Kwang Il Ko, Eunmi Nam, Soo-Mee Bang, Eun Kyung Cho, Dong Bok Shin, Jae Hoon Lee, Woon Ki Lee, Min Chung
Cancer Res Treat. 2006;38(3):121-125.   Published online June 30, 2006
DOI: https://doi.org/10.4143/crt.2006.38.3.121
AbstractAbstract PDFPubReaderePub
Purpose

Irinotecan, in combination with leucovorin/5-fluorouracil (FU) or with cisplatin, is known to be active for treating advanced gastric cancer (AGC). This pilot study evaluated a novel three-drug combination of irinotecan, leucovorin/FU and cisplatin as a first-line treatment of AGC. The primary endpoint was to assess the feasibility in anticipation of conducting a larger phase II study.

Materials and Methods

Chemotherapy-naive AGC patients received irinotecan 150 mg/m2 on day 1, and leucovorin 200 mg/m2 and a 22-h infusion of FU 1000 mg/m2 on days 1 and 2. Cisplatin 30 mg/m2 was administered on day 2. Treatment was repeated every 2 weeks until disease progression or unacceptable toxicity.

Results

Of the 17 eligible patients, two patients had an ECOG performance status of 2 and their median age was 48 years (range: 31 to 69). A total of 117 chemotherapy cycles were delivered (median: 6, range: 1 to 12). The causes of treatment discontinuation were disease progression in 9 patients (53%), refusal (35%) and toxicity (12%). Although grade 3 or 4 neutropenia (41% of patients) was the major toxicity that required dose adjustments, only one episode of febrile neutropenia occurred. Grade 3 or 4 nausea and vomiting, diarrhea and fatigue were observed in 35%, 35% and 29% of patients, respectively. None of the patients died of toxicity during treatment. Of the 16 patients who were evaluable for response, 7 (44%) experienced a partial response.

Conclusion

This novel multi-drug combination was tolerated well in patients with AGC. Based on the encouraging efficacy and tolerability, a randomized phase II study is ongoing in this disease setting.

Citations

Citations to this article as recorded by  
  • Randomized phase II study of irinotecan, leucovorin and 5-fluorouracil (ILF) versus cisplatin plus ILF (PILF) combination chemotherapy for advanced gastric cancer
    S.H. Park, E. Nam, J. Park, E.K. Cho, D.B. Shin, J.H. Lee, W.K. Lee, M. Chung, S.I. Lee
    Annals of Oncology.2008; 19(4): 729.     CrossRef
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A Phase II Study of Weekly Paclitaxel, Cisplatin and Concurrent Radiation Therapy for Locally-Advanced Unresectable Non-Small Cell Lung Cancer: Early Closure due to Lack of Efficacy
Se Hoon Park, Mi Kyung Kim, Sun Young Kyung, Young-Hee Lim, Chang Hyeok An, Jeong Woong Park, Seong Hwan Jeong, Jae Woong Lee, Kyu Chan Lee, Eun Kyung Cho, Soo Mee Bang, Dong Bok Shin, Jae Hoon Lee
Cancer Res Treat. 2004;36(5):293-297.   Published online October 31, 2004
DOI: https://doi.org/10.4143/crt.2004.36.5.293
AbstractAbstract PDFPubReaderePub
Purpose

In this phase II study, the efficacy and safety of weekly paclitaxel concomitant with cisplatin and thoracic radiotherapy (TRT) was evaluated in patients with locally-advanced unresectable non-small cell lung cancer (NSCLC).

Materials and Methods

Patients with stage III NSCLC (without pleural effusion or cervical lymphadenopathy) received TRT (63 Gy in 35 fractions over 7 weeks) with concurrent weekly cisplatin 20 mg/m2 and paclitaxel 40 mg/m2/week infused over 3 hours. In patients without evidence of disease progression, the administration of a further 2 cycles of consolidation chemotherapy, consisting of paclitaxel 175 mg/m2 and cisplatin 75 mg/m2, were planned after completion of the TRT.

Results

Between Feb 2000 and Dec 2002, 20 patients were entered into the study; 13 completed all 7 weeks of treatment (median 7.6 weeks; range 3.3 to 9.4). Seven out of 16 (43.8%) objective responses were observed, with 15 (75%) patients experiencing at least one episode of grade 3/4 toxicity. The main toxicities were moderate to severe neutropenia and gastrointestinal toxicity.

Conclusion

The unsatisfactory response rate and the high incidence of grade 3/4 hematologic and non-hematologic toxicities, including 7 early discontinuations of treatment and exceeding the study stopping rules, prompted the early closure of the study. In view of the activity observed, the protocol was amended to protracted continuous infusion paclitaxel, cisplatin and concurrent TRT.

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