Cancer Research and Treatment

Original Articles

Concept of Depth of Invasion can Improve Staging Performance in Patients with Resected Distal Cholangiocarcinoma: Validation of the American Joint Committee on Cancer Staging System: Won-Gun Yun, Yoon Soo Chae, Youngmin Han, Young Jae Cho, Hye-Sol Jung, Wooil Kwon, Joon Seong Park, Haeryoung Kim, Kyoung Bun Lee, Jin-Young Jang; Received April 12, 2025 Accepted August 22, 2025 Published online August 25, 2025; DOI: https://doi.org/10.4143/crt.2025.406 [Accepted]

Abstract PDF: Purpose
The American Joint Committee on Cancer (AJCC) staging system for distal cholangiocarcinoma (dCC) has evolved significantly. However, the prognostic correlation of the newly proposed staging system remains unclear. Therefore, we aimed to compare the staging performance between AJCC 7th and 8th editions for dCC.
Materials and Methods
We reviewed pathological slides of consecutive patients who underwent resection for dCC between 2000 and 2022. According to the AJCC 8th edition, depth of invasion was defined as the distance from the basement membrane of adjacent normal or dysplastic epithelium to the deepest tumor invasion. We analyzed changes in the T category from the AJCC 7th to 8th edition and assessed overall survival and recurrence based on these staging systems.
Results
Among 428 patients, application of the 8th edition resulted in down-staging of 272 (63.6%) patients and up-staging of only 13 (3.0%). Lymph node metastases were identified in 150 (35.1%) patients, with 29 (6.8%) having ≥ 4 metastatic nodes. The C-indices for overall survival and recurrence are 0.557 and 0.569 for the T stage of the AJCC 7th edition, and 0.606 and 0.631 for that of the AJCC 8th edition (95% confidence interval for delta: 0.005–0.092 for survival, 0.023–0.100 for recurrence). Additionally, the T category of the 8th edition correlated more strongly with lymph node metastases than that of the 7th edition.
Conclusion
In dCC, the T category of the AJCC 8th edition demonstrates improved prognostic correlation and better alignment with lymph node metastases compared to that of the 7th edition.

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A Phase II Study of Daratumumab in Combination with Bortezomib and Dexamethasone in Patients with Multiple Myeloma Who Received One Prior Line of Therapy (KMM1906): Kwai Han Yoo, Sang Eun Yoon, Ka-Won Kang, Jun Ho Yi, Min Kyoung Kim, Hyo Jung Kim, Sung-Hyun Kim, Joon Seong Park, Sung-Hoon Jung, Je-Jung Lee, Chang-Ki Min, Jae Hoon Lee, Duck Cho, Kihyun Kim; Received April 18, 2025 Accepted June 27, 2025 Published online June 30, 2025; DOI: https://doi.org/10.4143/crt.2025.426 [Epub ahead of print]

Abstract PDF Supplementary Material: Purpose
Daratumumab combined with bortezomib and dexamethasone (DVd) has been established as the standard treatment for relapsed/refractory multiple myeloma (MM) based on pivotal phase 3 trials. A subgroup analysis demonstrated enhanced efficacy in the second-line setting, although the fixed duration of bortezomib administration remained a limitation. Therefore, we conducted a phase II trial evaluating continuous bortezomib as maintenance in a DVd regimen for second-line treatment
Materials and Methods
This phase II study (KCT0004352) enrolled patients with MM receiving second-line DVd therapy: daratumumab (16 mg/kg IV, weekly for cycles 1-3, every 3 weeks for cycles 4-8, every 4 weeks thereafter), bortezomib (1.3 mg/m² subcutaneously, twice weekly for cycles 1-8, biweekly thereafter), and dexamethasone (20 mg IV or orally on treatment days), as in the pivotal trial. After nine cycles, daratumumab and bortezomib were continued until progression or unacceptable toxicity. The primary endpoint was a ≥ very good partial response (VGPR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and minimal residual disease (MRD) negativity assessed by EuroFlow-based next-generation flow in bone marrow.
Results
Between June 2020 and 2021, 26 patients (median age, 72 years) from 10 Korean centers were enrolled. All had one prior treatment line; 73% had prior bortezomib, and 69% had prior immunomodulators. At a median follow-up of 25.4 months, 65% discontinued due to progression, death, or withdrawal. VGPR or better was achieved in 65%, with 23% MRD-negative. Median PFS was 21.8 months; OS was not reached. The 24-month OS rate was 69.2%. Grade 3 adverse events included thrombocytopenia and lymphopenia; 31% had serious adverse events, and 65% required dose modifications.
Conclusion
Continuous DVd therapy showed promising efficacy and manageable toxicity as a second-line option.

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Hematologic malignancy

Real-World Experience of Weekly Carfilzomib in Combination with Cyclophosphamide and Dexamethasone in Multiple Myeloma Relapsed/Refractory to Bortezomib and Lenalidomide: Cheongin Yang, Changgon Kim, Kunye Kwak, Ka-Won Kang, Yong Park, Byung Soo Kim, Seong Hyun Jeong, Joon Seong Park, Yoon Seok Choi; Cancer Res Treat. 2026;58(1):320-328. Published online April 25, 2025; DOI: https://doi.org/10.4143/crt.2025.418

Abstract PDF Supplementary Material PubReader ePub: Purpose
This retrospective study evaluated the efficacy and safety of a weekly carfilzomib, cyclophosphamide, and dexamethasone (KCd) regimen in patients with relapsed or refractory multiple myeloma (RRMM) who had been previously treated with both bortezomib- and lenalidomide-containing regimens.
Materials and Methods
We conducted a retrospective analysis of 33 patients with RRMM who received the KCd regimen between March 2020 and February 2024. All patients had prior exposure to both bortezomib and lenalidomide, and the majority (93.9%) were refractory to lenalidomide. Carfilzomib was administered once weekly at 70 mg/m² (after a step-up dose), along with oral cyclophosphamide and dexamethasone. Treatment response was assessed according to the International Myeloma Working Group criteria, and survival outcomes were analyzed.
Results
The overall response rate was 66.7%, including a complete response or better in 15.1% of patients and a very good partial response or better in 42.4%. With a median follow-up of 31.7 months, the median progression-free survival was 13.5 months (95% confidence interval, 11.47 to 15.53), while the median overall survival was not reached. The most common grade ≥ 3 adverse event was neutropenia (15.2%). Non-hematologic grade ≥ 3 toxicities were infrequent and manageable.
Conclusion
The weekly KCd regimen demonstrated encouraging efficacy and tolerability in a heavily pretreated RRMM population. These findings support its use as a feasible treatment option, particularly in patients refractory to lenalidomide.

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Intensified First Cycle of Rituximab Plus Eight Cycles of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisolone with Rituximab Chemotherapy for Advanced-Stage or Bulky Diffuse Large B-Cell Lymphoma: A Multicenter Phase II Consortium for Improving Survival of Lymphoma (CISL) Study: Yu Ri Kim, Jin Seok Kim, Won Seog Kim, Hyeon Seok Eom, Deok-Hwan Yang, Sung Hwa Bae, Hyo Jung Kim, Jae Hoon Lee, Suk-Joong Oh, Sung-Soo Yoon, Jae-Yong Kwak, Chul Won Choi, Min Kyoung Kim, Sung Young Oh, Hye Jin Kang, Seung Hyun Nam, Hyeok Shim, Joon Seong Park, Yeung-Chul Mun, Cheolwon Suh, the Korean Society of Hematology Lymphoma Working Party; Cancer Res Treat. 2023;55(4):1355-1362. Published online March 30, 2023; DOI: https://doi.org/10.4143/crt.2023.271

Abstract PDF Supplementary Material PubReader ePub

Purpose
This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL).
Materials and Methods
Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy.
Results
Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016).
Conclusion
Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.

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Design, Conduct, and Analysis of Externally Controlled Trials
Jiali Liu, Minghong Yao, Mingqi Wang, Wan Jie, Yanmei Liu, Xiaochao Luo, Jiayidaer Huan, Kelin Deng, Ke Deng, Kang Zou, Ying Zhang, Ling Li, Xin Sun
JAMA Network Open.2025; 8(9): e2530277. CrossRef

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Validation of the 8th AJCC Cancer Staging System for Pancreas Neuroendocrine Tumors Using Korean Nationwide Surgery Database: Yunghun You, Jin-Young Jang, Song Cheol Kim, Yoo-Seok Yoon, Joon Seong Park, Chol Kyoon Cho, Sang-Jae Park, Jae Do Yang, Woo Jung Lee, Tae Ho Hong, Keun Soo Ahn, Chi-Young Jeong, Hyeon Kook Lee, Seung Eun Lee, Young Hoon Roh, Hee Joon Kim, Hongbeom Kim, In Woong Han; Cancer Res Treat. 2019;51(4):1639-1652. Published online April 19, 2019; DOI: https://doi.org/10.4143/crt.2019.023

Abstract PDF PubReader ePub

Purpose
The 8th edition of the American Joint Committee on Cancer (AJCC) staging system for pancreatic neuroendocrine tumor (PNET) included several significant changes. We aim to evaluate this staging system compared to the 7th edition AJCC staging system and European Neuroendocrine Tumors Society (ENETS) system.
Materials and Methods
We used Korean nationwide surgery database (2000-2014). Of 972 patients who had undergone surgery for PNET, excluding patients diagnosed with ENETS/World Health Organization 2010 grade 3 (G3), only 472 patients with accurate stage were included.
Results
Poor discrimination in overall survival rate (OSR) was noted between AJCC 8th stage III and IV (p=0.180). The disease-free survival (DFS) curves of 8th AJCC classification were well separated between all stages. Compared with stage I, the hazard ratio of II, III, and IV was 3.808, 13.928, and 30.618, respectively (p=0.007, p < 0.001, and p < 0.001). The curves of OSR and DFS of certain prognostic group in AJCC 7th and ENETS overlapped. In ENETS staging system, no significant difference in DFS between stage IIB versus IIIA (p=0.909) and IIIA versus IIIB (p=0.291). In multivariable analysis, lymphovascular invasion (p=0.002), perineural invasion (p=0.003), and grade (p < 0.001) were identified as independent prognostic factors for DFS.
Conclusion
This is the first large-scale validation of the AJCC 8th edition staging system for PNET. The revised 8th system provides better discrimination compared to that of the 7th edition and ENETS TNM system. This supports the clinical use of the system.

Citations

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Prognostic Factors and Scoring Model for Survival in Metastatic Biliary Tract Cancer: Hyung Soon Park, Ji Soo Park, You Jin Chun, Yun Ho Roh, Jieun Moon, Hong Jae Chon, Hye Jin Choi, Joon Seong Park, Dong Ki Lee, Se-Joon Lee, Dong Sup Yoon, Hei-Cheul Jeung; Cancer Res Treat. 2017;49(4):1127-1139. Published online February 6, 2017; DOI: https://doi.org/10.4143/crt.2016.538

Abstract PDF Supplementary Material PubReader ePub

Purpose
Metastatic biliary tract cancer (mBTC) has a dismal prognosis. In this study, an independent dataset of patients with mBTC was used to implement and validate a routine clinico-laboratory parameter-based scoring model for risk group identification.
Materials and Methods
From September 2006 to February 2015, 482 patients with mBTC were assigned randomly (ratio, 7:3) into investigational (n=340) and validation datasets (n=142). The continuous variables were dichotomized using a normal range or the best cutoff values determined using the Contal and O'Quigley statistical methods. Following a Cox’s proportional hazard model, the scoring model was derived by summing the rounded chi-square scores for the factors identified by multivariate analysis.
Results
The performance status (Eastern Cooperative Oncology Group 3-4), hypoalbuminemia (< 3.4 mg/dL), carcinoembryonic antigen (≥ 9 ng/mL), neutrophil-to-lymphocyte ratio (≥ 3.0), and carbohydrate antigen 19-9 (≥ 120 U/mL) were identified as independent prognosticators (Harrell’s C index, 0.682; integrated area under the curve, 0.653). Survival was clearly correlated with the risk groups (low, intermediate, and high, 14.0, 7.3, and 2.3 months, respectively; p < 0.001). The prognosis was also discriminative in the validation data set (median survival, 16.7, 7.5, and 1.9 months, respectively; p < 0.001). Chemotherapy did not offer any survival benefits for high-risk patients.
Conclusion
These proposed prognostic criteria for mBTC can facilitate accurate patient risk stratification and treatment-related decision-making.

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Cancer Research and Treatment.2024; 56(2): 602. CrossRef
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Jianfei Lai, Chen Fang, Guohua Zhang, Chao Shi, Feng Yu, Weiguo Gu, Jianxiong Deng, Jingbiao Xu, Chaoxing Liu, Feng Qiu
Frontiers in Bioscience-Landmark.2024;[Epub] CrossRef
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Valerie Gunchick, Rachel L McDevitt, Elizabeth Choi, Katherine Winslow, Mark M Zalupski, Vaibhav Sahai
The Oncologist.2023; 28(6): 531. CrossRef
Development of a nomogram to predict survival in advanced biliary tract cancer
Hiroshi Imaoka, Masafumi Ikeda, Shogo Nomura, Chigusa Morizane, Takuji Okusaka, Masato Ozaka, Satoshi Shimizu, Kentaro Yamazaki, Naohiro Okano, Kazuya Sugimori, Hirofumi Shirakawa, Nobumasa Mizuno, Sohei Satoi, Hironori Yamaguchi, Rie Sugimoto, Kunihito G
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Prognostic Role of a New Index Tested in European and Korean Advanced Biliary Tract Cancer Patients: the PECS Index
Giulia Rovesti, Francesco Leone, Giovanni Brandi, Lorenzo Fornaro, Mario Scartozzi, Monica Niger, Changhoon Yoo, Francesco Caputo, Roberto Filippi, Mariaelena Casagrande, Nicola Silvestris, Daniele Santini, Luca Faloppi, Andrea Palloni, Massimo Aglietta,
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Sri Harsha Tella, Anuhya Kommalapati, Mitesh J Borad, Amit Mahipal
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Prognostic Scoring Index for Patients with Metastatic Pancreatic Adenocarcinoma: Hyung Soon Park, Hye Sun Lee, Ji Soo Park, Joon Seong Park, Dong Ki Lee, Se-Joon Lee, Dong Sup Yoon, Min Goo Lee, Hei-Cheul Jeung; Cancer Res Treat. 2016;48(4):1253-1263. Published online February 3, 2016; DOI: https://doi.org/10.4143/crt.2015.400

Abstract PDF PubReader ePub

Purpose
This study focused on implementation of a prognostic scoring index based on clinico-laboratory parameters measured routinely on admission in metastatic pancreatic cancer patients.
Materials and Methods
Records from 403 patients of metastatic disease were analyzed retrospectively. Continuous variables were dichotomized according to the normal range or the best cut-off values statistically determined by Contal and O’Quigley method, and then analyzed in association with prognosis—overall survival (OS), using Cox’s proportional hazard model. Scores were calculated by summing the rounded chi-square scores for the factors that emerged in the multivariate analysis.
Results
Performance status, hemoglobin, leucocyte count, neutrophil-lymphocyte ratio, and carcinoembryonic antigen were independent factors for OS. When patients were divided into three risk groups according to these factors, median survival was 11.7, 6.2, and 1.3 months for the low, intermediate, and high-risk groups, respectively (p < 0.001). Palliative chemotherapy has a significant survival benefit for low and intermediate-risk patients (median OS; 12.5 months vs. 5.9 months, p < 0.001 and 8.0 months vs. 2.0 months, p < 0.001, respectively).
Conclusion
We advocate the use of a multivariable approach with continuous variables for prognostic modeling. Our index is helpful in accurate patient risk stratification and may aid in treatment selection.

Citations

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Su-Hyeong Park, In-Cheon Kang, Seung-Soo Hong, Ha-Yan Kim, Ho-Kyoung Hwang, Chang-Moo Kang
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Ichiro Seto, Hisashi Yamaguchi, Yoshiaki Takagawa, Yusuke Azami, Kanako Takayama, Motohisa Suzuki, Masanori Machida, Yuntao Dai, Nor Shazrina Binti Sulaiman, Yasuhiro Kikuchi, Takahiro Kato, Noriyuki Nishino, Yasushi Teranishi, Masao Murakami
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Catherine Owusuaa, Simone A. Dijkland, Daan Nieboer, Agnes van der Heide, Carin C. D. van der Rijt
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Liane J. Ioannou, Ashika D. Maharaj, John R. Zalcberg, Jesse T. Loughnan, Daniel G. Croagh, Charles H. Pilgrim, David Goldstein, James G. Kench, Neil D. Merrett, Arul Earnest, Elizabeth A. Burmeister, Kate White, Rachel E. Neale, Sue M. Evans
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Jin Shang, Xiao Han, Haoran Zha, Haitao Tao, Xiaoyan Li, Fang Yuan, Guangying Chen, Lijie Wang, Junxun Ma, Yi Hu
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Giuseppe Colloca, Antonella Venturino
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Michael Shusterman, Erin Jou, Andreas Kaubisch, Jennifer W. Chuy, Lakshmi Rajdev, Santiago Aparo, Justin Tang, Nitin Ohri, Abdissa Negassa, Sanjay Goel
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Piera Gargiulo, Daniel Dietrich, Richard Herrmann, György Bodoky, Thomas Ruhstaller, Werner Scheithauer, Bengt Glimelius, Simona Berardi, Sandro Pignata, Peter Brauchli
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Yongping Zhou, Qian Wei, Junsheng Fan, Sijin Cheng, Wenzhou Ding, Zhiyuan Hua
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A Contemporary Review of the Treatment Landscape and the Role of Predictive and Prognostic Biomarkers in Pancreatic Adenocarcinoma
Irene S. Yu, Winson Y. Cheung
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Lingyun Liu, Wei Wang, Yi Zhang, Jianting Long, Zhaohui Zhang, Qiao Li, Bin Chen, Shaoqiang Li, Yunpeng Hua, Shunli Shen, Baogang Peng
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Marek Sierzega, Marzena Lenart, Magdalena Rutkowska, Marta Surman, Bozenna Mytar, Andrzej Matyja, Maciej Siedlar, Jan Kulig
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Angélique Vienot, Guillaume Beinse, Christophe Louvet, Louis de Mestier, Aurélia Meurisse, Francine Fein, Bruno Heyd, Denis Cleau, Christelle d’Engremont, Anne-Claire Dupont-Gossart, Zaher Lakkis, Christophe Tournigand, Olivier Bouché, Benoît Rousseau, Ci
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Sven H Loosen, Ulf P Neumann, Christian Trautwein, Christoph Roderburg, Tom Luedde
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Randy C. Bowen, Nancy Ann B. Little, Joshua R. Harmer, Junjie Ma, Luke G. Mirabelli, Kyle D. Roller, Andrew Mackay Breivik, Emily Signor, Alec B. Miller, Hung T. Khong
Oncotarget.2017; 8(19): 32171. CrossRef

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Surgery Alone Versus Surgery Followed by Chemotherapy and Radiotherapy in Resected Extrahepatic Bile Duct Cancer: Treatment Outcome Analysis of 336 Patients: Jung Ho Im, Jinsil Seong, Ik Jae Lee, Joon Seong Park, Dong Sup Yoon, Kyung Sik Kim, Woo Jung Lee, Kyung Ran Park; Cancer Res Treat. 2016;48(2):583-595. Published online July 22, 2015; DOI: https://doi.org/10.4143/crt.2015.091

Abstract PDF PubReader ePub

Purpose
This study analyzed the outcomes of patients with resected extrahepatic bile duct cancer (EHBDC) in order to clarify the role of adjuvant treatments in these patients.
Materials and Methods
A total of 336 patients with EHBDC who underwent curative resection between 2001 and 2010 were analyzed retrospectively. The treatment types were as follows: surgery alone (n=168), surgery with chemotherapy (CTx, n=90), surgery with radiotherapy (RT) alone (n=29), and surgery with chemoradiotherapy (CRT, n=49).
Results
The median follow-up period was 63 months. The 5-year rates of locoregional failure-free survival (LRFFS), distant metastasis-free survival (DMFS), progression-free survival (PFS), and overall survival (OS) for all patients were 56.5%, 59.7%, 36.6%, and 42.0%, respectively. In multivariate analysis, surgery with RT and CRT was a significant prognostic factor for LRFFS, and surgery with CTx was a significant prognostic factor for DMFS, and surgery with CTx, RT, and CRT was a significant prognostic factor for PFS (p < 0.05). Surgery with CTx and CRT showed association with superior OS (p < 0.05), and surgery with RT had marginal significance (p=0.078). In multivariate analysis of the R1 resection patients, surgery with CRT showed significant association with OS (p < 0.05).
Conclusion
Adjuvant RT and CTx may be helpful in improving clinical outcomes of patients with resected EHBDC who have a high risk of disease recurrence, particularly R1 resection patients. Conduct of additional prospective, larger-scale studies will be required in order to confirm the benefit of adjuvant RT and CTx in these patients.

Citations

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Intracavitary 166 Holmium - chitosan Complex Therapy in Patients with Malignant Peritoneal or Pleural Effusions: Do Yeun Cho, Hyun Soo Kim, Joon Seong Park, Cheol Kweon Jeong, Jin Hyuk Choi, Ho Yeong Lim, Chan Hee Park, Mi Son Chun, Young Mi Kim, Kyung Bae Park, Hugh Chul Kim; J Korean Cancer Assoc. 1999;31(6):1297-1306.

Abstract PDF: PURPOSE
Most malignant peritoneal or pleural effusions caused by advanced malignancy are unresponsive to systemic chemotherapy except for chemotherapy sensitive tumors, and they are equally ineffective to regional therapy or radiotherapy. Thus, for the purpose of palliating the symptoms related to malignant effusion and to reduce fluid reaccumulations, we evaluated the therapeutic feasibility and efficacy of intracavitary ' Ho-CHICO (chito- san complex) instillation for intractable malignant effusions.
MATERIALS AND METHODS
Thirty one patients with cytologically or pathologically proven malignant effusions underwent intracavitary 166Ho-CHICO therapy from May 1996 to March 1998 at Ajou University Hospital. The subjective and objective responses were evaluated 4 weeks after the treatment, including the changes of symptoms, weight, abdominal girth, doses of diuretics, frequencies and amounts of repeat aspirations for fluid reaccumulations, and imaging studies of chest radiograph and ultrasounds.
RESULTS
The response rates treated with Ho-CHICO were 50% in patients with peritoneal effusion and 46% in patients with pleural effusion (overall 49%). The response rates between 166Ho-CHICO doses of 50-80 mCi and 90-100 mCi were similar (50% vs 47%). Response rate of 70% was noted in patients with even distribution of radioisotope on the post-therapy scan, but, the response rate was lower in cases with focal (44%) and uneven (29%) distribution pattern. There was no difference in response by the effusion sites. All patients tolerated intracavitary 166Ho-CHICO instillation well, although the majority of patients experienced Grade I/II side effects such as pain, fever, weakness and dyspnea. But, no serious complications of Grade lII or IV degree were observed with 166Ho-CHICO therapy.
CONCLUSION
Intracavitary 166Ho-CHICO instillation was clinically efficacious in controlling malignant effusions without a significant toxicity seen with conventional sclerotic therapy. The therapeutic modality appeared to offer similar benefits obtained with the conventional intracavitary therapy.

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