- Gastrointestinal cancer
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Varlitinib and Paclitaxel for EGFR/HER2 Co-expressing Advanced Gastric Cancer: A Multicenter Phase Ib/II Study (K-MASTER-13)
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Dong-Hoe Koo, Minkyu Jung, Yeul Hong Kim, Hei-Cheul Jeung, Dae Young Zang, Woo Kyun Bae, Hyunki Kim, Hyo Song Kim, Choong-kun Lee, Woo Sun Kwon, Hyun Cheol Chung, Sun Young Rha
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Cancer Res Treat. 2024;56(4):1136-1145. Published online April 29, 2024
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DOI: https://doi.org/10.4143/crt.2023.1324
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
Varlitinib is a pan-human epidermal growth factor receptor (HER) inhibitor targeting epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 2 (HER2), and HER4. We present a phase Ib/II study of a combination of varlitinib and weekly paclitaxel as a second-line treatment for patients with EGFR/HER2 co-expressing advanced gastric cancer (AGC).
Materials and Methods Patients whose tumors with EGFR and HER2 overexpression by immunohistochemistry (≥ 1+) were enrolled. Varlitinib and paclitaxel were investigated every 4 weeks. After determining the recommended phase II dose (RP2D) in phase Ib, a phase II study was conducted to evaluate the antitumor activity.
Results RP2D was treated with a combination of varlitinib (300 mg twice daily) and paclitaxel. Among 27 patients treated with RP2D, the median progression-free survival and overall survival (OS) were 3.3 months (95% confidence interval [CI], 1.7 to 4.9) and 7.9 months (95% CI, 5.0 to 10.8), respectively, with a median follow-up of 15.7 months. Among 16 patients with measurable disease, the objective response rate (ORR) and disease control rate were 31% and 88%, respectively. Patients with strong HER2 expression (n=8) had a higher ORR and longer OS, whereas those with strong EGFR expression (n=3) had poorer outcomes. The most common adverse events (AEs) of any grade were neutropenia (52%), diarrhea (27%), aspartate aminotransferase/alanine transaminase elevation (22%), and nausea (19%). No treatment-related deaths or unexpected AEs resulting from treatment cessation were observed in patients with RP2D.
Conclusion A combination of varlitinib and paclitaxel displayed manageable toxicity and modest antitumor activity in patients with EGFR/HER2 co-expressing AGC who progressed after first-line chemotherapy.
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- Unraveling the future: Innovative design strategies and emerging challenges in HER2-targeted tyrosine kinase inhibitors for cancer therapy
Sixiang Zheng, Ruixian Chen, Lele Zhang, Lun Tan, Lintao Li, Fangyi Long, Ting Wang European Journal of Medicinal Chemistry.2024; 276: 116702. CrossRef
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A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10)
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Keun-Wook Lee, Dae Young Zang, Min-Hee Ryu, Hye Sook Han, Ki Hyang Kim, Mi-Jung Kim, Sung Ae Koh, Sung Sook Lee, Dong-Hoe Koo, Yoon Ho Ko, Byeong Seok Sohn, Jin Won Kim, Jin Hyun Park, Byung-Ho Nam, In Sil Choi
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Cancer Res Treat. 2023;55(4):1250-1260. Published online May 25, 2023
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DOI: https://doi.org/10.4143/crt.2023.333
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy.
Materials and Methods Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy.
Results After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%.
Conclusion Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.
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- A prognostic nomogram to predict the cancer-specific survival of patients with initially diagnosed metastatic gastric cancer: a validation study in a Chinese cohort
Ziming Zhao, Erxun Dai, Bao Jin, Ping Deng, Zulihaer Salehebieke, Bin Han, Rongfan Wu, Zhaowu Yu, Jun Ren Clinical and Translational Oncology.2024;[Epub] CrossRef
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ERRATUM: Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group
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Shinkyo Yoon, Miso Kim, Yong Sang Hong, Han Sang Kim, Seung Tae Kim, Jihun Kim, Hongseok Yun, Changhoon Yoo, Hee Kyung Ahn, Hyo Song Kim, In Hee Lee, In-Ho Kim, Inkeun Park, Jae Ho Jeong, Jaekyung Cheon, Jin Won Kim, Jina Yun, Sun Min Lim, Yongjun Cha, Se Jin Jang, Dae Young Zang, Tae Won Kim, Jin Hyoung Kang, Jee Hyun Kim
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Cancer Res Treat. 2023;55(3):1061-1061. Published online April 21, 2023
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DOI: https://doi.org/10.4143/crt.2021.1115.E
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Corrects: Cancer Res Treat 2022;54(1):1
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PDFPubReaderePub
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Recommendations for the Use of Next-Generation Sequencing and the Molecular Tumor Board for Patients with Advanced Cancer: A Report from KSMO and KCSG Precision Medicine Networking Group
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Shinkyo Yoon, Miso Kim, Yong Sang Hong, Han Sang Kim, Seung Tae Kim, Jihun Kim, Hongseok Yun, Changhoon Yoo, Hee Kyung Ahn, Hyo Song Kim, In Hee Lee, In-Ho Kim, Inkeun Park, Jae Ho Jeong, Jaekyung Cheon, Jin Won Kim, Jina Yun, Sun Min Lim, Yongjun Cha, Se Jin Jang, Dae Young Zang, Tae Won Kim, Jin Hyoung Kang, Jee Hyun Kim
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Cancer Res Treat. 2022;54(1):1-9. Published online December 13, 2021
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DOI: https://doi.org/10.4143/crt.2021.1115
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Correction in: Cancer Res Treat 2023;55(3):1061
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Abstract
PDFPubReaderePub
- Next-generation sequencing (NGS) is becoming essential in the fields of precision oncology. With implementation of NGS in daily clinic, the needs for continued education, facilitated interpretation of NGS results and optimal treatment delivery based on NGS results have been addressed. Molecular tumor board (MTB) is multidisciplinary approach to keep pace with the growing knowledge of complex molecular alterations in patients with advanced solid cancer. Although guidelines for NGS use and MTB have been developed in western countries, there is limitation for reflection of Korea’s public health environment and daily clinical practice. These recommendations provide a critical guidance from NGS panel testing to final treatment decision based on MTB discussion.
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Ming-Huang Chen, Wan-Shan Li, Bin-Chi Liao, Chiao-En Wu, Chien-Feng Li, Chia-Hsun Hsieh, Feng-Che Kuan, Huey-En Tzeng, Jen-Fan Hang, Nai-Jung Chiang, Tse-Ching Chen, Tom Wei-Wu Chen, John Wen-Cheng Chang, Yao-Yu Hsieh, Yen-Lin Chen, Yi-Chen Yeh, Yi-Hsin L Journal of Cancer Research and Practice.2024;[Epub] CrossRef - Pragmatic nationwide master observational trial based on genomic alterations in advanced solid tumors: KOrean Precision Medicine Networking Group Study of MOlecular profiling guided therapy based on genomic alterations in advanced Solid tumors (KOSMOS)-II
Sun Young Kim, Jee Hyun Kim, Tae-Yong Kim, Sook Ryun Park, Shinkyo Yoon, Soohyeon Lee, Se-Hoon Lee, Tae Min Kim, Sae-Won Han, Hye Ryun Kim, Hongseok Yun, Sejoon Lee, Jihun Kim, Yoon-La Choi, Kui Son Choi, Heejung Chae, Hyewon Ryu, Gyeong-Won Lee, Dae Youn BMC Cancer.2024;[Epub] CrossRef - Combining germline, tissue and liquid biopsy analysis by comprehensive genomic profiling to improve the yield of actionable variants in a real-world cancer cohort
I. Vanni, L. Pastorino, V. Andreotti, D. Comandini, G. Fornarini, M. Grassi, A. Puccini, E. T. Tanda, A. Pastorino, V. Martelli, L. Mastracci, F. Grillo, F. Cabiddu, A. Guadagno, S. Coco, E. Allavena, F. Barbero, W. Bruno, B. Dalmasso, S. E. Bellomo, C. M Journal of Translational Medicine.2024;[Epub] CrossRef - Clinical practice recommendations for the use of next-generation sequencing in patients with solid cancer: a joint report from KSMO and KSP
Miso Kim, Hyo Sup Shim, Sheehyun Kim, In Hee Lee, Jihun Kim, Shinkyo Yoon, Hyung-Don Kim, Inkeun Park, Jae Ho Jeong, Changhoon Yoo, Jaekyung Cheon, In-Ho Kim, Jieun Lee, Sook Hee Hong, Sehhoon Park, Hyun Ae Jung, Jin Won Kim, Han Jo Kim, Yongjun Cha, Sun Journal of Pathology and Translational Medicine.2024; 58(4): 147. CrossRef - Clinical Practice Recommendations for the Use of Next-Generation Sequencing in Patients with Solid Cancer: A Joint Report from KSMO and KSP
Miso Kim, Hyo Sup Shim, Sheehyun Kim, In Hee Lee, Jihun Kim, Shinkyo Yoon, Hyung-Don Kim, Inkeun Park, Jae Ho Jeong, Changhoon Yoo, Jaekyung Cheon, In-Ho Kim, Jieun Lee, Sook Hee Hong, Sehhoon Park, Hyun Ae Jung, Jin Won Kim, Han Jo Kim, Yongjun Cha, Sun Cancer Research and Treatment.2024; 56(3): 721. CrossRef - Nationwide precision oncology pilot study: KOrean Precision Medicine Networking Group Study of MOlecular profiling-guided therapy based on genomic alterations in advanced solid tumors (KOSMOS) KCSG AL-20-05
T.-Y. Kim, S.Y. Kim, J.H. Kim, H.A. Jung, Y.J. Choi, I.G. Hwang, Y. Cha, G.-W. Lee, Y.-G. Lee, T.M. Kim, S.-H. Lee, S. Lee, H. Yun, Y.L. Choi, S. Yoon, S.W. Han, T.-Y. Kim, T.W. Kim, D.Y. Zang, J.H. Kang ESMO Open.2024; 9(10): 103709. CrossRef - Utilizing Plasma Circulating Tumor DNA Sequencing for Precision Medicine in the Management of Solid Cancers
Yongjun Cha, Sheehyun Kim, Sae-Won Han Cancer Research and Treatment.2023; 55(2): 367. CrossRef - Mutational evolution after chemotherapy‐progression in metastatic colorectal cancer revealed by circulating tumor DNA analysis
Sheehyun Kim, Yongjun Cha, Yoojoo Lim, Hanseong Roh, Jun‐Kyu Kang, Kyung‐Hun Lee, Min Jung Kim, Ji Won Park, Seung‐Bum Ryoo, Hwang‐Phill Kim, Seung‐Yong Jeong, Kyu Joo Park, Sae‐Won Han, Tae‐You Kim International Journal of Cancer.2023; 153(3): 571. CrossRef - Establishing molecular pathology curriculum for pathology trainees and continued medical education: a collaborative work from the Molecular Pathology Study Group of the Korean Society of Pathologists
Jiwon Koh, Ha Young Park, Jeong Mo Bae, Jun Kang, Uiju Cho, Seung Eun Lee, Haeyoun Kang, Min Eui Hong, Jae Kyung Won, Youn-La Choi, Wan-Seop Kim, Ahwon Lee Journal of Pathology and Translational Medicine.2023; 57(5): 265. CrossRef - Implementation of Precision Oncology in the National Healthcare System: A Statement Proposal Endorsed by Italian Scientific Societies
Gianpiero Fasola, Maria C. Barducci, Valeria D. Tozzi, Luigi Cavanna, Saverio Cinieri, Francesco Perrone, Carmine Pinto, Antonio Russo, Anna Sapino, Francesco Grossi, Giuseppe Aprile JCO Precision Oncology.2023;[Epub] CrossRef - Development of two 410-cancer-gene panel tests for solid tumors and liquid biopsy based on genome data of 5,143 Japanese cancer patients
Yuji SHIMODA, Takeshi NAGASHIMA, Kenichi URAKAMI, Fukumi KAMADA, Sou NAKATANI, Maki MIZUGUCHI, Masakuni SERIZAWA, Keiichi HATAKEYAMA, Keiichi OHSHIMA, Tohru MOCHIZUKI, Sumiko OHNAMI, Shumpei OHNAMI, Takeshi KAWAKAMI, Kentaro YAMAZAKI, Haruyasu MURAKAMI, H Biomedical Research.2022; 43(4): 115. CrossRef - Clinical Implication of Molecular Tumor Board
Soohyeon Lee The Korean Journal of Medicine.2022; 97(5): 319. CrossRef - Somatic Mutations of TP53 Identified by Targeted Next-Generation Sequencing Are Poor Prognostic Factors for Primary Operable Breast Cancer: A Single-Center Study
Jung Ho Park, Mi Jung Kwon, Jinwon Seo, Ho Young Kim, Soo Kee Min, Lee Su Kim Journal of Breast Cancer.2022; 25(5): 379. CrossRef
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S-1 Based Doublet as an Adjuvant Chemotherapy for Curatively Resected Stage III Gastric Cancer: Results from the Randomized Phase III POST Trial
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Choong-kun Lee, Minkyu Jung, Hyo Song Kim, Inkyung Jung, Dong Bok Shin, Seok Yun Kang, Dae Young Zang, Ki Hyang Kim, Moon Hee Lee, Bong-Seog Kim, Kyung Hee Lee, Jae-Ho Cheong, Woo Jin Hyung, Sung Hoon Noh, Hyun Cheol Chung, Sun Young Rha
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Cancer Res Treat. 2019;51(1):1-11. Published online February 5, 2018
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DOI: https://doi.org/10.4143/crt.2018.028
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
We conducted a randomized, multicenter, phase III trial to compare S-1 plus docetaxel (DS) with S-1 plus cisplatin (SP) as adjuvant chemotherapy for stage III gastric cancer patients.
Materials and Methods
Stage III gastric cancer patients who had received curative gastrectomy with D2 lymphadenectomy were randomized into equal groups to receive adjuvant chemotherapy of eight cycles of DS (S-1 70 mg/m2 /day on days 1-14 plus docetaxel 35 mg/m2 on days 1 and 8) every 3 weeks or SP (S-1 70 mg/m2 /day on days 1-14 plus cisplatin 60 mg/m2 on day 1) every 3 weeks. The primary endpoint was 3-year disease-free survival (DFS) rate.
Results
Between November 2010 and July 2013, 153 patients (75 patients to DS and 78 patients to SP) were enrolled from 8 institutions in Korea. After the capecitabine plus oxaliplatin was approved based on the CLASSIC study, itwas decided to close the study early. With a median follow-up duration of 56.9 months, the 3-year DFS rate between two groups was not significantly different (49.14% in DS group vs. 52.5% in SP group). The most common grade 3-4 adverse event was neutropenia (42.7% in DS and 38.5% in SP, p=0.351). SP group had more grade 3-4 anemia (1.3% vs. 11.5%, p=0.037), whereas grade 3-4 hand-foot syndrome (4.1% vs. 0%, p=0.025) and mucositis (10.7% vs. 2.6%, p=0.001) were more common in DS group. Fifty-one patients (68%) in DS group and 52 (66.7%) in SP group finished planned treatment.
Conclusion
Our findings suggest that SP or DS is an effective and tolerable option for patients with curatively resected stage III gastric cancer.
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- Efficacy and safety of docetaxel plus S-1-based therapy in gastric cancer: a quantitative evidence synthesis of randomized controlled trials
Hui-Fen Lv, Li-Feng Qin, Rui-Zhi Ran, Xue-Ping Jiang, Fang-Yu Zhao, Bo Li Frontiers in Pharmacology.2024;[Epub] CrossRef - A novel method of bedside hyperthermic intraperitoneal chemotherapy as adjuvant therapy for stage-III gastric cancer
Lili Liu, Li Sun, Ning Zhang, Cheng-gong Liao, Haichuan Su, Jie Min, Yang Song, Xue Yang, Xiaofeng Huang, Dongxu Chen, Yu Chen, Hong-wei Zhang, Helong Zhang International Journal of Hyperthermia.2022; 39(1): 239. CrossRef - Comment on “post-discharge oral nutritional supplements with dietary advice in patients at nutritional risk after surgery for gastric cancer: A randomized clinical trial”
Qiang Hu, Yuanshui Sun Clinical Nutrition.2021; 40(3): 1438. CrossRef - THE ROLE OF ADJUVANT CHEMOTHERAPY IN THE TREATMENT OF LOCALLY ADVANCED GASTRIC CANCER
A. A. Bobryshev, M. M. Davudov, M. N. Narimanov, S. B. Polycarpova, V. Y. Kirsanov, V. N. Blindar Siberian journal of oncology.2021; 20(1): 133. CrossRef - Multidisciplinary treatment strategy for locally advanced gastric cancer: A systematic review
Kotaro Sugawara, Yoshikuni Kawaguchi, Yasuyuki Seto, Jean-Nicolas Vauthey Surgical Oncology.2021; 38: 101599. CrossRef - Surgery alone, adjuvant tegafur/gimeracil/octeracil (S-1), or platinum-based chemotherapies for resectable gastric cancer: real-world experience and a propensity score matching analysis
Chih-Chieh Yen, Yan-Shen Shan, Ying-Jui Chao, Ting-Kai Liao, I-Shu Chen, Hsuan-Yi Huang, I-Ting Liu, Chia-Jui Yen BMC Cancer.2021;[Epub] CrossRef - Treatment of Locally Advanced Gastric Cancer (LAGC): Back to Lauren’s Classification in Pan–Cancer Analysis Era?
Ina Valeria Zurlo, Michele Basso, Antonia Strippoli, Maria Alessandra Calegari, Armando Orlandi, Alessandra Cassano, Mariantonietta Di Salvatore, Giovanna Garufi, Emilio Bria, Giampaolo Tortora, Carlo Barone, Carmelo Pozzo Cancers.2020; 12(7): 1749. CrossRef - A systematic review and network meta-analysis protocol of adjuvant chemotherapy regimens for resected gastric cancer
Long Ge, Liangying Hou, Qingxia Yang, Yiting Wu, Xiue Shi, Jiang Li, Kehu Yang Medicine.2019; 98(7): e14478. CrossRef - Prognostic and Predictive Factors for the Curative Treatment of Esophageal and Gastric Cancer in Randomized Controlled Trials: A Systematic Review and Meta-Analysis
Tom van den Ende, Emil ter Veer, Rosa M. A. Mali, Mark I. van Berge Henegouwen, Maarten C. C. M. Hulshof, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven Cancers.2019; 11(4): 530. CrossRef - COMplot, A Graphical Presentation of Complication Profiles and Adverse Effects for the Curative Treatment of Gastric Cancer: A Systematic Review and Meta-Analysis
Tom van den Ende, Frank A. Abe Nijenhuis, Héctor G. van den Boorn, Emil ter Veer, Maarten C. C. M. Hulshof, Suzanne S. Gisbertz, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven Frontiers in Oncology.2019;[Epub] CrossRef - Cutting-edge evidence of adjuvant treatments for gastric cancer
Dai Shimizu, Mitsuro Kanda, Yasuhiro Kodera, Junichi Sakamoto Expert Review of Gastroenterology & Hepatology.2018; 12(11): 1109. CrossRef
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Treatment Patterns and Changes in Quality of Life during First-Line Palliative Chemotherapy in Korean Patients with Advanced Gastric Cancer
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Jin Won Kim, Jong Gwang Kim, Byung Woog Kang, Ik-Joo Chung, Young Seon Hong, Tae-You Kim, Hong Suk Song, Kyung Hee Lee, Dae Young Zang, Yoon Ho Ko, Eun-Kee Song, Jin Ho Baek, Dong‐Hoe Koo, So Yeon Oh, Hana Cho, Keun-Wook Lee
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Cancer Res Treat. 2019;51(1):223-239. Published online October 19, 2018
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DOI: https://doi.org/10.4143/crt.2018.073
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
The purpose of this study was to evaluate chemotherapy patterns and changes in quality of life (QOL) during first-line palliative chemotherapy for Korean patients with unresectable or metastatic/recurrent gastric cancer (GC).
Materials and Methods
Thiswas a non-interventional, multi-center, prospective, observational study of 527 patients in Korea. QOL assessments were conducted using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 and QLQ-STO22 every 3 months over a 12-month period during first-line palliative chemotherapy. The specific chemotherapy regimens were selected by individual clinicians.
Results
Most patients (93.2%) received combination chemotherapy (mainly fluoropyrimidine plus platinum) as their first-line palliative chemotherapy. The median progression-free survival and overall survival were 8.2 and 14.8 months, respectively. Overall, “a little” changes (differences of 5-10 points from baseline)were observed in some of the functioning or symptom scales; none of the QOL scales showed either “moderate” or “very much” change (i.e., ≥ 11 point difference from baseline). When examining the best change in each QOL domain from baseline, scales related to some aspects of functioning, global health status/QOL, and most symptoms revealed significant improvements (p < 0.05). Throughout the course of first-line palliative chemotherapy, most patients’ QOL was maintained to a similar degree, regardless of their actual response to chemotherapy.
Conclusion
This observational study provides important information on the chemotherapy patterns and QOL changes in Korean patientswith advanced GC. Overall, first-line palliative chemotherapy was found to maintain QOL, and most parameters showed an improvement compared with the baseline at some point during the course.
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Z.A. Wainberg, P.C. Enzinger, S. Qin, K. Yamaguchi, J. Wang, X. Zhou, A. Gnanasakthy, K. Taylor, A. Yusuf, I. Majer, A. Jamotte, Y.-K. Kang ESMO Gastrointestinal Oncology.2024; 6: 100095. CrossRef - Impact of systemic cancer treatment on quality of life and mental well-being: a comparative analysis of patients with localized and advanced cancer
Adán Rodríguez-Gonzalez, Alberto Carmona-Bayonas, Raquel Hernandez San Gil, Patricia Cruz-Castellanos, Mónica Antoñanzas-Basa, David Lorente-Estelles, María Jose Corral, Manuel González-Moya, Oscar Alfredo Castillo-Trujillo, Emilio Esteban, Paula Jiménez- Clinical and Translational Oncology.2023; 25(12): 3492. CrossRef - Reminiscence therapy-based care program alleviates anxiety and depression, as well as improves the quality of life in recurrent gastric cancer patients
Xing Wu, Weiwei Zhang Frontiers in Psychology.2023;[Epub] CrossRef - Toxicities and Quality of Life during Cancer Treatment in Advanced Solid Tumors
Eun Mi Lee, Paula Jiménez-Fonseca, Rocio Galán-Moral, Sara Coca-Membribes, Ana Fernández-Montes, Elena Sorribes, Esmeralda García-Torralba, Laura Puntí-Brun, Mireia Gil-Raga, Juana Cano-Cano, Caterina Calderon Current Oncology.2023; 30(10): 9205. CrossRef - Psychosocial functioning in individuals with advanced oesophago-gastric cancer: a mixed methods systematic review
Cara Ghiglieri, Martin Dempster, Sam Wright, Lisa Graham-Wisener BMC Palliative Care.2023;[Epub] CrossRef - Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial)
Keun-Wook Lee, Ik-Joo Chung, Min-Hee Ryu, Young Iee Park, Byung-Ho Nam, Ho-Suk Oh, Kyung Hee Lee, Hye Sook Han, Bong-Gun Seo, Jae-Cheol Jo, Hyo Rak Lee, Jin Won Kim, Sook Ryun Park, Sang Hee Cho, Yoon-Koo Kang Gastric Cancer.2021; 24(1): 156. CrossRef - Effect of early tumor response on the health-related quality of life among patients on second-line chemotherapy for advanced gastric cancer in the ABSOLUTE trial
Kazumasa Fujitani, Kohei Shitara, Atsuo Takashima, Keisuke Koeda, Hiroki Hara, Norisuke Nakayama, Shuichi Hironaka, Kazuhiro Nishikawa, Yutaka Kimura, Kenji Amagai, Hisashi Hosaka, Yoshito Komatsu, Ken Shimada, Ryohei Kawabata, Hideki Ohdan, Yasuhiro Kode Gastric Cancer.2021; 24(2): 467. CrossRef - Quality-of-Life Assessment in Patients Receiving Palliative Chemotherapy: Call for Action
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Kerstin Schütte, Christian Schulz, Kristina Middelberg-Bisping Best Practice & Research Clinical Gastroenterology.2021; 50-51: 101727. CrossRef - Influencing Factors and Effects of Treatment on Quality of Life in Patients With Gastric Cancer—A Systematic Review
Sophia Kristina Rupp, Andreas Stengel Frontiers in Psychiatry.2021;[Epub] CrossRef - Chronological changes in quality of life and body composition after gastrectomy for locally advanced gastric cancer
Ki Bum Park, Ji Yeon Park, Seung Soo Lee, Ho Young Chung, Oh Kyoung Kwon Annals of Surgical Treatment and Research.2020; 98(5): 262. CrossRef - Viennese risk prediction score for Advanced Gastroesophageal carcinoma based on Alarm Symptoms (VAGAS score): characterisation of alarm symptoms in advanced gastro-oesophageal cancer and its correlation with outcome
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Multicenter Phase II Study of Oxaliplatin, Irinotecan, and S-1 as First-line Treatment for Patients with Recurrent or Metastatic Biliary Tract Cancer
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Changhoon Yoo, Boram Han, Hyeong Su Kim, Kyu-pyo Kim, Deokhoon Kim, Jae Ho Jeong, Jae-Lyun Lee, Tae Won Kim, Jung Han Kim, Dae Ro Choi, Hong Il Ha, Jinwon Seo, Heung-Moon Chang, Baek-Yeol Ryoo, Dae Young Zang
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Cancer Res Treat. 2018;50(4):1324-1330. Published online January 8, 2018
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DOI: https://doi.org/10.4143/crt.2017.526
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Abstract
PDFSupplementary MaterialPubReaderePub
- Purpose
Although gemcitabine plus cisplatin has been established as the standard first-line chemotherapy for patients with advanced biliary tract cancer (BTC), overall prognosis remains poor. We investigated the efficacy of a novel triplet combination of oxaliplatin, irinotecan, and S-1 (OIS) for advanced BTC.
Materials and Methods
Chemotherapy-naive patientswith histologically documented unresectable or metastatic BTC were eligible for this multicenter, single-arm phase II study. Patients received 65 mg/m2 oxaliplatin (day 1), 135 mg/m2 irinotecan (day 1), and 40 mg/m2 S-1 (twice a day, days 1-7) every 2 weeks. Primary endpoint was objective response rate. Targeted exome sequencing for biomarker analysis was performed using archival tissue.
Results
In total, 32 patients were enrolled between October 2015 and June 2016. Median age was 64 years (range, 40 to 76 years), with 24 (75%) male patients; 97% patients had metastatic or recurrent disease. Response rate was 50%, and median progression-free survival and overall survival (OS) were 6.8 months (95% confidence interval [CI], 4.8 to 8.8) and 12.5 months (95% CI, 7.0 to 18.0), respectively. The most common grade 3-4 adverse events were neutropenia (32%), diarrhea (6%), and peripheral neuropathy (6%). TP53 and KRAS mutations were the most frequent genomic alterations (42% and 32%, respectively), and KRAS mutations showed a marginal relationship with worse OS (p=0.07).
Conclusion
OIS combination chemotherapy was feasible and associated with favorable efficacy outcomes as a first-line treatment in patients with advanced BTC. Randomized studies are needed to compare OIS with gemcitabine plus cisplatin.
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Citations
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L. Perkhofer, A. W. Berger, A. K. Beutel, E. Gallmeier, S. Angermeier, L. Fischer von Weikersthal, T. O. Goetze, R. Muche, T. Seufferlein, T. J. Ettrich BMC Cancer.2019;[Epub] CrossRef
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The Clinical Utility of FDG PET-CT in Evaluation of Bone Marrow Involvement by Lymphoma
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Ho Young Kim, Ju-Seok Kim, Dae Ro Choi, Hyeong Su Kim, Jung Hye Kwon, Geun-Doo Jang, Jung Han Kim, Joo Young Jung, Hun Ho Song, Young Kyung Lee, Soo Kee Min, Hee Sung Hwang, Hwa Jung Kim, Dae Young Zang, Hyo Jung Kim
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Cancer Res Treat. 2015;47(3):458-464. Published online November 24, 2014
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DOI: https://doi.org/10.4143/crt.2014.091
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Abstract
PDFPubReaderePub
- Purpose
Bone marrow biopsy is a standard method for the evaluation of bone marrow infiltration by lymphoma; however, it is an invasive and painful procedure. Fluorodeoxyglucose positron emission tomography–computed tomography (FDG PET-CT) is a noninvasive imaging technique with the potential to detect bone marrow involvement by lymphoma. Materials and Methods We retrospectively reviewed medical records of lymphoma patients. All patients were examined by FDG PET-CT and iliac crest bone marrow biopsy for initial staging work-up. Results The study population comprised 94 patients (median age, 60 years; 56 males) with Hodgkin’s lymphoma (n=8) or non-Hodgkin’s lymphoma (n=86). Maximum standardized uptake values on the iliac crest of patients with lymphoma infiltrated bone marrow were significantly higher than those of patients with intact bone marrow (2.2±1.2 g/mL vs. 1.3±0.4 g/mL; p=0.001). The calculated values for FDG PET-CT during evaluation of bone marrow involvement were as follows: sensitivity 50%, specificity 96%, positive predictive value 80%, negative predictive value 85%, and positive likelihood ratio (LR+) 11.7. The value of LR+ was 16.0 in patients with aggressive subtypes of non-Hodgkin’s lymphoma (NHL). Conclusion FDG PET-CT could not replace bone marrow biopsy due to the low sensitivity of FDG PET-CT for detection of bone marrow infiltration in lymphoma patients. Conversely, FDG PET-CT had high specificity and LR+; therefore, it could be a useful tool for image-guided biopsy for lymphoma staging, especially for aggressive subtypes of NHL. In addition, unilateral bone marrow biopsy could be substituted for bilateral bone marrow biopsy in lymphoma patients with increased FDG uptake on any iliac crest.
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- FDG PET/CT versus Bone Marrow Biopsy for Diagnosis of Bone Marrow Involvement in Non-Hodgkin Lymphoma: A Systematic Review
Jawaher Almaimani, Charalampos Tsoumpas, Richard Feltbower, Irene Polycarpou Applied Sciences.2022; 12(2): 540. CrossRef - Comparison of the RECIST and EORTC PET criteria in the tumor response assessment: a pooled analysis and review
Jung Han Kim, Bum Jun Kim, Hyun Joo Jang, Hyeong Su Kim Cancer Chemotherapy and Pharmacology.2017; 80(4): 729. CrossRef - Comparison of the RECIST and PERCIST criteria in solid tumors: a pooled analysis and review
Seon Jeong Min, Hyun Joo Jang, Jung Han Kim Oncotarget.2016; 7(19): 27848. CrossRef
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A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naive Cancer Patients
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Geundoo Jang, Hun Ho Song, Keon Uk Park, Hyeong Su Kim, Dae Ro Choi, Jung Hye Kwon, Ho Young Kim, Boram Han, Jung Han Kim, Joo Young Jung, Hyo Jung Kim, Dae Young Zang
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Cancer Res Treat. 2013;45(3):172-177. Published online September 30, 2013
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DOI: https://doi.org/10.4143/crt.2013.45.3.172
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Abstract
PDFPubReaderePub
- PURPOSE
Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naive patients with solid cancers. MATERIALS AND METHODS Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m2; range 50 to 75 mg/m2) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV. RESULTS The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations. CONCLUSION RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.
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- Ramosetron Versus Ondansetron in Combination With Aprepitant and Dexamethasone for the Prevention of Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting: A Multicenter, Randomized Phase III Trial, KCSG PC10-21
Hyo Jung Kim, Sang Won Shin, Eun-Kee Song, Na-Ri Lee, Jun Suk Kim, Jin Seok Ahn, Hwan-Jung Yun, Yo-Han Cho, Keon Uk Park, Si-Young Kim, Joung Soon Jang, Sang-We Kim, Hyun Woo Lee, Se Ryeon Lee, Yang Soo Kim, Soon Nam Lee, Yoon Ho Ko, Hwa Jung Kim, Jin-Hyo The Oncologist.2015; 20(12): 1440. CrossRef - Assessment of low-dose cisplatin as a model of nausea and emesis in beagle dogs, potential for repeated administration
Hannah Kenward, Ludovic Pelligand, Jonathan Elliott Experimental Brain Research.2014; 232(8): 2685. CrossRef - Anticipatory nausea in animal models: a review of potential novel therapeutic treatments
Erin M. Rock, Cheryl L. Limebeer, Linda A. Parker Experimental Brain Research.2014; 232(8): 2511. CrossRef
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Randomized, Multicenter, Phase III Trial of Heptaplatin 1-hour Infusion and 5-Fluorouracil Combination Chemotherapy Comparing with Cisplatin and 5-Fluorouracil Combination Chemotherapy in Patients with Advanced Gastric Cancer
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Kyung Hee Lee, Myung Soo Hyun, Hoon-Kyo Kim, Hyung Min Jin, Jinmo Yang, Hong Suk Song, Young Rok Do, Hun Mo Ryoo, Joo Seop Chung, Dae Young Zang, Ho-Yeong Lim, Jong Youl Jin, Chang Yeol Yim, Hee Sook Park, Jun Suk Kim, Chang Hak Sohn, Soon Nam Lee
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Cancer Res Treat. 2009;41(1):12-18. Published online March 31, 2009
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DOI: https://doi.org/10.4143/crt.2009.41.1.12
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Abstract
PDFPubReaderePub
- Purpose
Heptaplatin (Sunpla) is a cisplatin derivative. A phase IIb trial using heptaplatin resulted in a 34% response rate with mild nephrotoxicity. We conducted a randomized phase III trial of heptaplatin plus 5-FU compared with cisplatin plus 5-FU in patients with advanced gastric cancer. Materials and MethodsOne hundred seventy-four patients (heptaplatin, n=88; cisplatin, n=86) from 13 centers were enrolled. The eligibility criteria were as follows: patients with pathologically-proven adenocarcinoma, chemonaive patients, or patients who had received only single adjuvant chemotherapy, and who had a measurable or evaluable lesion. On day 1, heptaplatin (400 mg/m2) or cisplatin (60 mg/m2) was given over 1 hour with 5-FU (1 gm/m2) on days 1~5 every 4 weeks. ResultsAt the time of survival analysis, the median overall survival was 7.3 months in the 5-FU + heptaplatin (FH) arm and 7.9 months in the 5-FU + cisplatin (FP) arm (p=0.24). Of the FH patients, 34.2% (complete response [CR], 1.3%; partial response [PR], 32.9%) experienced a confirmed objective response compared with 35.9% (CR 0%, PR 35.9%) of FP patients (p=0.78). The median-time-to-progression was 2.5 months in the FH arm and 2.3 months in the FP arm. The incidence of neutropenia was higher with FP (28%) than with FH (16%; p=0.06); grade 3~4 nausea and vomiting were more frequent in the FP than in the FH arm (p=0.01 and p=0.05, respectively). The incidence of increased proteinuria and creatininemia was higher with FH than with FP; however, there was no statistical difference. There were no treatment-related deaths. ConclusionHeptaplatin showed similar effects to cisplatin when combined with 5-FU in advanced gastric cancer patients with tolerable toxicities.
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Madhavi Sahadevan, Mullainathan Sundaram, Karunagaran Subramanian Chemical Physics Letters.2024; 842: 141191. CrossRef - Cisplatin Resistance in Cancer Therapy: Causes and Overcoming Strategies
S. Shruthi, K. Bhasker Shenoy ChemistrySelect.2024;[Epub] CrossRef - Recent Advances on Pt-Based Compounds for Theranostic Applications
Giulia Ferrari, Ines Lopez-Martinez, Thomas Wanek, Claudia Kuntner, Diego Montagner Molecules.2024; 29(15): 3453. CrossRef - Hallmarks of anticancer and antimicrobial activities of corroles
Vinay K. Sharma, Yehuda G. Assaraf, Zeev Gross Drug Resistance Updates.2023; : 100931. CrossRef - Application of Approved Cisplatin Derivatives in Combination Therapy against Different Cancer Diseases
Dobrina Tsvetkova, Stefka Ivanova Molecules.2022; 27(8): 2466. CrossRef - Second and third-row transition metal compounds containing benzimidazole ligands: An overview of their anticancer and antitumour activity
Galdina V. Suárez-Moreno, Delia Hernández-Romero, Óscar García-Barradas, Óscar Vázquez-Vera, Sharon Rosete-Luna, Carlos A. Cruz-Cruz, Aracely López-Monteon, Jesús Carrillo-Ahumada, David Morales-Morales, Raúl Colorado-Peralta Coordination Chemistry Reviews.2022; 472: 214790. CrossRef - Metalofármacos en la terapia contra el cáncer
Elizabeth Márquez López, Esmeralda Sánchez Pavón, Rodolfo Peña Rodríguez, Delia Hernández Romero, José M. Rivera Villanueva, Raúl Colorado Peralta, David Morales Morales TECNOCIENCIA Chihuahua.2022; 16(3): e1010. CrossRef - Platinum(IV) anticancer agents; are we en route to the holy grail or to a dead end?
Dan Gibson Journal of Inorganic Biochemistry.2021; 217: 111353. CrossRef - Monofunctional Platinum(II) Anticancer Agents
Suxing Jin, Yan Guo, Zijian Guo, Xiaoyong Wang Pharmaceuticals.2021; 14(2): 133. CrossRef - Pt(IV) Prodrugs with NSAIDs as Axial Ligands
Daniil Spector, Olga Krasnovskaya, Kirill Pavlov, Alexander Erofeev, Peter Gorelkin, Elena Beloglazkina, Alexander Majouga International Journal of Molecular Sciences.2021; 22(8): 3817. CrossRef - Multi-action Pt(IV) anticancer agents; do we understand how they work?
Dan Gibson Journal of Inorganic Biochemistry.2019; 191: 77. CrossRef - TOXview: a novel graphical presentation of cancer treatment toxicity profiles
Lok Lam Ngai, Emil ter Veer, Héctor G. van den Boorn, E. Hugo van Herk, Jessy Joy van Kleef, Martijn G. H. van Oijen, Hanneke W. M. van Laarhoven Acta Oncologica.2019; 58(8): 1138. CrossRef - Photoactivated platinum-based anticancer drugs
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Sergey A. Shein, Ilya I. Kuznetsov, Tatiana O. Abakumova, Pavel S. Chelushkin, Pavel A. Melnikov, Anna A. Korchagina, Dmitry A. Bychkov, Irina F. Seregina, Mikhail A. Bolshov, Alexander V. Kabanov, Vladimir P. Chekhonin, Natalia V. Nukolova Molecular Pharmaceutics.2016; 13(11): 3712. CrossRef - Condensations of single DNA molecules induced by heptaplatin and its chiral isomer
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Laparoscopic Assisted Distal Rectal Cancer Resection with Preoperative Concurrent Chemoradiotherapy
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Bong Hwa Lee, Mi Young Chang, Sung Kook Park, Taeik Eum, Hyun Joo Shin, Nam Kyu Ro, Chang Nam An, Hae Wan Lee, Lee Su Kim, Hyoung-Chul Park, Hoon Sik Bae, Dae Young Zang, Richard L Whelan
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Cancer Res Treat. 2007;39(1):10-15. Published online March 31, 2007
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DOI: https://doi.org/10.4143/crt.2007.39.1.10
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Abstract
PDFPubReaderePub
- Purpose
Anatomy of deep pelvis, narrow distal margin and tumor invasion into neighbor organ are obstacles for curative radical resection for advanced cancer of distal rectum. Technically, laparoscopic application after downstaging the tumor with preoperative concurrent chemotherapy (CCRT) may give a solution to overcome the anatomical difficulties. We compared the results of laparoscopic surgery in the patients who received CCRT with those of patients who had conventional surgery. Materials and MethodsA continuous infusion of 5FU plus leucovorin and radiotherapy (50.4 Gy) in 28 fractions was given each patient as CCRT. They underwent D2 radical resection with TME and ANP for the rectal cancer in 4 weeks. ResultsThirty three patients had laparoscopic resection such as LAR, colo-anal anastomosis and APR. The results were compared with 12 cases of the conventional resections. As a result of preoperative CCRT, the cancer was down-staged in 71%. Two year disease free survival was 75% and 74% in the group of conventional and laparoscopic resection, respectively (p=0.427). Ileus, voiding difficulty and leakage after surgery were not different between two groups. Weakness of ejaculation was noted in 9~11% of both groups. The DFS of the preoperative CCRT followed by radical resection in the groups with a response was more favorable than that in the group with progressive or stable disease. ConclusionRadical resection of advanced distal rectal cancer could be done with performing a laparoscopic assisted operation after CCRT induced down-staging. We may suggest that laparoscopic assisted resection is a good treatment option as it doesn't increase the complications and it has a compatible survival rate to conventional surgery.
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- DPYD,TYMS,TYMP,TK1, andTK2Genetic Expressions as Response Markers in Locally Advanced Rectal Cancer Patients Treated with Fluoropyrimidine-Based Chemoradiotherapy
Ming-Yii Huang, Chan-Han Wu, Chun-Ming Huang, Fu-Yen Chung, Ching-Wen Huang, Hsiang-Lin Tsai, Chin-Fan Chen, Shiu-Ru Lin, Jaw-Yuan Wang BioMed Research International.2013; 2013: 1. CrossRef
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A Phase II Study of Paclitaxel and Cisplatin Combination Chemotherapy in Advanced Non-small-cell Lung Cancer
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Jung Ae Lee, Keun Seok Lee, Jin Seok Ahn, Jae Ho Byun, Hun Ho Song, Dae Young Zang, Young Iee Park, Young Suk Park, Eun Kyung Mo, Dong Kyu Kim, Myung Goo Lee, In Gyu Hyun, Ki Suck Jung, Soo Mee Bang, Gye Young Park, Jeong Woong Park, Eun Kyung Cho, Seong Hwan Jeong, Dong Bok Shin, Jae Hoon Lee
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Cancer Res Treat. 2003;35(3):239-244. Published online June 30, 2003
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DOI: https://doi.org/10.4143/crt.2003.35.3.239
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Abstract
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- PURPOSE
Paclitaxel and cisplatin, active drugs in the treatment of non-small-cell lung cancer (NSCLC), have been found to be synergistic and less myelotoxic in combination when the paclitaxel is given 24 hr prior to the cisplatin.
Their antitumor activity and toxicity in patients with advanced NSCLC has been evaluated herein. MATERIALS AND METHODS: Seventy-four chemonaive patients, with advanced NSCLC, were enrolled. Paclitaxel, 175 mg/m2, was administered on day 1, followed 24 hr later by cisplatin, 75 mg/m2, on day 2. RESULTS: The overall response rate, median time to progression and median survival time were 51%, 7.1 months (95% confidence interval (CI), 5.5~8.7 months) and 13.7 months (95% CI, 11.3~16.1 months), respectively. There were significant differences in the overall survival rates in relation to stage and the ECOG performance status(PS).
The toxicity was mainly nonhematological. Grade > or =3 neuropathy occurred in 2 (3%) patients, myalgia in 3 (4%), and bone pain in 3 (4%). The hematological toxicity was mild, and no grade 3 or 4 neutropenia was observed. CONCLUSION The combination of paclitaxel and cisplatin is an effective and tolerable treatment regimen for advanced NSCLC during first line chemotherapy. The main toxicity was nonhematological, such as peripheral neuropathy, myalgia and bone pain, whereas the hematological toxicity itself was mild.
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- The Efficacy and Safety of Padexol® (Paclitaxel) and Cisplatin for Treating Advanced Non-small Cell Lung Cancer
Hoon-Kyo Kim, Jun Suk Kim, Hun Mo Ryoo, Dong Gun Shin, Byoung Young Shim, Kyong Hwa Park, Sung Hwa Bae, Chi Hong Kim Cancer Research and Treatment.2006; 38(2): 66. CrossRef
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A Small Cell Lung Cancer Concurrently Diagnosed with Paraneoplastic Dermatomyositis
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Hyung Seok Lee, Dae Young Zang, Young Il Seo, Dong Gyu Kim, Eun Jung Kim, Jin Seok Ahn, Hye Rim Park
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Cancer Res Treat. 2003;35(2):161-164. Published online April 30, 2003
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DOI: https://doi.org/10.4143/crt.2003.35.2.161
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Abstract
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- Dermatomyositis is an inflammatory myopathy, of unknown etiology, which is characterized by cutaneous rashes, accompanied by progressive and symmetric proximal muscle weakness. Especially in older people, the incidences of malignant conditions appear to be increased in dermatomyositis patients, and the prognosis is very poor.
Because dermatomyositis may occur as a paraneoplastic syndrome, extensive screening tests, for an occult malignant neoplasm, should be conducted in older dermatomyositis patients. We experienced a case of small cell lung cancer, which had a very rapid and catastrophic clinical course, in a 63-year-old male patient with dermatomyositis. We report this case, and review the literature on the relationship of dermatomyositis and malignancy.
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Citations
Citations to this article as recorded by
- Ground-glass opacity heralding invasive lung adenocarcinoma with prodromal dermatomyositis: a case report
Andrew J. Beel, David S. Demos, Alfred Chung, Charles Liao, Natalie S. Lui Journal of Cardiothoracic Surgery.2018;[Epub] CrossRef - A case report of dermatomyositis associated with small cell lung cancer
Wha-Yong Lee, Jack Kastelik, Anne Campbell, Ged Avery, Damian McGivern, Mike Lind Tumori Journal.2012; 98(6): e158. CrossRef
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The Survival and Financial Benefit of Investigator-Initiated Trials Conducted by Korean Cancer Study Group
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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 Yun, Byung-Ho Nam, Dae Young Zang
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Received April 30, 2024 Accepted July 8, 2024 Published online July 10, 2024
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DOI: https://doi.org/10.4143/crt.2024.421
[Epub ahead of print]
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Abstract
PDFPubReaderePub
- Purpose
The Korean Cancer Study Group (KCSG) is a nationwide cancer clinical trial group dedicated to advancing investigator-initiated trials (IITs) by conducting and supporting clinical trials. This study aims to review IITs conducted by KCSG and quantitatively evaluate the survival and financial benefits of IITs for patients.
Materials and Methods We reviewed IITs conducted by KCSG from 1998 to 2023, analyzing progression-free survival (PFS) and overall survival (OS) gains for participants. PFS and OS benefits were calculated as the difference in median survival times between the intervention and control groups, multiplied by the number of patients in the intervention group. Financial benefits were assessed based on the cost of investigational products provided.
Results From 1998 to 2023, KCSG conducted 310 IITs, with 133 completed and published. Of these, 21 were included in the survival analysis. The analysis revealed that 1,951 patients in the intervention groups gained a total of 2,558.4 months (213.2 years) of PFS and 2,501.6 months (208.5 years) of OS, with median gains of 1.31 months in PFS and 1.58 months in OS per patient. When analyzing only statistically significant results, PFS and OS gain per patients was 1.69 months and 3.02 months, respectively. Investigational drug cost analysis from six available IITs indicated that investigational products provided to 252 patients were valued at 10,400,077,294 won (approximately 8,046,481 US dollars), averaging about 41,270,148 won (approximately 31,930 US dollars) per patient.
Conclusion Our findings, based on analysis of published research, suggest that IITs conducted by KCSG led to survival benefits for participants and, in some studies, may have provided financial benefits by providing investment drugs.
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Association between Tumor Size at the Time of Disease Progression and Survival Outcomes
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Chi Hoon Maeng, Bum Jun Kim, Myung-Ju Ahn, In Sil Choi, Dae Young Zang, Bo-Hyung Kim, Minji Kwon, Dae Seog Heo, Bhumsuk Keam
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Received July 24, 2024 Accepted October 20, 2024 Published online October 22, 2024
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DOI: https://doi.org/10.4143/crt.2024.690
[Accepted]
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Abstract
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- Purpose
This study evaluates the prognostic significance of tumor size at disease progression (PD) and depth of response (DOR) in cancer patients.
Materials and Methods
We performed post hoc analysis using data from six prospective clinical trials conducted by the Korean Cancer Study Group. Patients with tumor size at PD was categorized into ‘Mild PD’ and ‘Significant PD’ based on the cutoff values of relative change from baseline using maximally selected rank statistics. The overall survival (OS) and progression-free survival (PFS) were compared between PD and DOR categories.
Results
Among the 194 evaluable patients, 130 experienced PD. A 35.48% decrease from baseline in tumor size at PD was chosen for the cutoff between mild and significant PD for OS (mild PD: tumor size from the baseline ≤ −35.48%; significant PD > −35.48%). The mild PD had superior OS compared to the significant PD (25.8 vs. 12.8 months; Hazard ratio [HR] 0.47, 95% CI 0.266-0.843, p=0.009). When using an exploratory cutoff based on whether the tumor size was below vs. exceeded from the baseline (mild PD: tumor size from the baseline ≤ 0%; significant PD > 0%), OS remained significantly longer in the mild PD (17.1 vs. 11.8 months; HR 0.60, 95% CI 0.392-0.932, p=0.021). The greatest DOR was associated with the longest OS and PFS (p<0.001 for both).
Conclusion
Tumor size at PD and DOR were significant prognostic factors for progressive disease. Maintaining a sufficiently reduced tumor size even during PD was associated with better survival outcomes.
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Predictive Value of the nProfiler 1 Assay for the Efficacy of Adjuvant S-1-Based Doublet Chemotherapy in Stage III Gastric Cancer: A Post-Hoc Analysis of a Randomized Phase III Trial
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Dong Ki Lee, Choong-kun Lee, Hyo Song Kim, Sun Jin Sym, Dae Young Zang, Ki Hyang Kim, Joo Han Lim, Hae Su Kim, Kyung Hee Lee, Heon Yung Gee, Sun Young Rha, Hyunki Kim, Minkyu Jung
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Received July 25, 2024 Accepted November 9, 2024 Published online November 12, 2024
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DOI: https://doi.org/10.4143/crt.2024.705
[Accepted]
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Abstract
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- Purpose
The nProfiler 1 Stomach Cancer Assay (nProfiler1), designed to predict responses to fluorouracil-based adjuvant chemotherapy, measures the expression of four gastric cancer target genes (GZMB, WARS, SFRP4, and CDX1). The randomized phase III POST trial aimed to compare the efficacies of two adjuvant S-1-based doublet chemotherapies: S-1 plus cisplatin (SP) and S-1 plus docetaxel (DS). This study aimed to validate the nProfiler1 assay using a distinct cohort from the POST trial.
Materials and Methods
The nProfiler1 assay stratifies patients into three groups (low-risk, intermediate-risk, and high-risk) using the prognostic single-patient classifier and two groups (chemotherapy-benefit and no-benefit) using the predictive single-patient classifier. The nProfiler1 assay was applied to formalin-fixed paraffin-embedded slides obtained from the POST trial. Disease-free survival (DFS) and overall survival (OS), including 5-year survival rates, were calculated for the enrolled patients.
Results
Of the 153 patients in the POST trial, 118 were included in the post-hoc analysis. With a median follow-up of 57.9 months, no significant difference in DFS or OS was observed between the SP and DS groups. The prognostic single-patient classifier predicted the OS in the SP group (p=0.0425) but not in the DS group (p=0.5940). The chemotherapy-benefit group exhibited numerically longer DFS than the no-benefit group in the SP and DS groups.
Conclusion
The nProfiler1 assay offers valuable insights into the prognosis and efficacy of adjuvant chemotherapy based on fluorouracil plus platinum doublet regimens but not docetaxel-containing regimens. Further validation with larger patient cohorts and different regimens is warranted.
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