Cancer Research and Treatment

Original Articles

Gastrointestinal cancer

Effectiveness and Safety of Regorafenib and TAS-102 in Patients with Metastatic Colorectal Cancer: A Nationwide Population-Based Study in Taiwan: Ya-Wen Chang, Chun-Nan Kuo, Chia-Lun Chang, Jason C. Hsu, Yu Ko; Cancer Res Treat. 2025;57(3):830-839. Published online November 18, 2024; DOI: https://doi.org/10.4143/crt.2024.376

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Purpose
This study aimed to examine the real-world effectiveness and safety of regorafenib and trifluridine/tipiracil (TAS-102) in metastatic colorectal cancer (mCRC) patients in Taiwan.
Materials and Methods
Data were extracted from Taiwan’s National Health Insurance Research Database to evaluate the clinical outcomes of mCRC patients treated with either regorafenib or TAS-102 between 2016 and 2019. Overall survival (OS) was compared using Kaplan-Meier curves and Cox’s proportional hazard models, adjusting for age, sex, Quan-CCI score, liver metastases, number of metastatic sites, and the use of anti–epidermal growth factor receptor medications. Additionally, OS was compared between regorafenib monotherapy and TAS-102 monotherapy, excluding patients who had received both regorafenib and TAS-102.
Results
A total of 2,608 patients in the regorafenib group and 521 patients in the TAS-102 group were identified. The median OS was 6.5 months for regorafenib and 7.5 months for TAS-102, with a significant difference observed (p=0.001). The mean duration of treatment was similar for regorafenib and TAS-102 (108 days vs. 101 days) with no significant difference. The safety profiles of the two drugs were distinct; a higher proportion of patients in the regorafenib group had hypertension and hand-foot skin reaction while nausea and vomiting were more common in the TAS-102 group. In the subgroup analysis, patients receiving TAS-102 monotherapy showed significantly longer OS than those receiving regorafenib monotherapy.
Conclusion
The findings of this study indicated that TAS-102 had superior survival outcomes compared to regorafenib in mCRC patients. This study provides insights into the effectiveness and safety profiles of regorafenib and TAS-102 in Taiwan.

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Optimizing third-line and beyond therapies for metastatic colorectal cancer in Taiwan: an evidence-based consensus
Pei-Hung Chang, Meng-Che Hsieh, Hao-Wei Teng, Yi-Hsin Liang, Hong-Hwa Chen, Hung-Chih Hsu, Jeng-Kai Jiang, Feng-Fan Chiang, Johnson Lin, Been-Ren Lin, Yao-Yu Hsieh, Tao-Wei Ke, Feng-Che Kuan, Wen-Shih Huang, Bo-Wen Lin, Yu-Yao Chang, Yu-Li Su, William Tzu
Therapeutic Advances in Medical Oncology.2026;[Epub] CrossRef
A single-arm phase II trial of UGT1A1 genotype–guided high-dose irinotecan rechallenge in refractory metastatic colorectal cancer
Hana Kim, Joohyun Hong, Sun-Young Kong, Moon Ki Choi
Frontiers in Oncology.2026;[Epub] CrossRef

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Circulating Tumor DNA Dynamics and Treatment Outcome of Regorafenib in Metastatic Colorectal Cancer: Dae-Won Lee, Yoojoo Lim, Hwang-Phill Kim, Su Yeon Kim, Hanseong Roh, Jun-Kyu Kang, Kyung‑Hun Lee, Min Jung Kim, Seung-Bum Ryoo, Ji Won Park, Seung-Yong Jeong, Kyu Joo Park, Gyeong Hoon Kang, Sae-Won Han, Tae-You Kim; Cancer Res Treat. 2023;55(3):927-938. Published online March 7, 2023; DOI: https://doi.org/10.4143/crt.2023.268

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Purpose
Circulating tumor DNA (ctDNA) is emerging as a valuable non-invasive tool to identify tumor heterogeneity and tumor burden. This study investigated ctDNA dynamics in metastatic colorectal cancer patients treated with regorafenib.
Materials and Methods
In this prospective biomarker study, plasma cell-free DNA (cfDNA) samples obtained at baseline, at the first response evaluation after 2 cycles of treatment, and at the time of progressive disease were sequenced using a targeted next-generation sequencing platform which included 106 genes.
Results
A total of 285 blood samples from 110 patients were analyzed. Higher baseline cfDNA concentration was associated with worse progression-free survival (PFS) and overall survival (OS). After 2 cycles of treatment, variant allele frequency (VAF) in the majority of ctDNA mutations decreased with a mean relative change of –31.6%. Decreases in the VAF of TP53, APC, TCF7L2, and ROS1 after 2 cycles of regorafenib were associated with longer PFS. We used the sum of VAF at each time point as a surrogate for the overall ctDNA burden. A reduction in sum (VAF) of ≥ 50% after 2 cycles was associated with longer PFS (6.1 vs. 2.7 months, p=0.002), OS (11.3 vs. 5.9 months, p=0.001), and higher disease control rate (86.3% vs. 51.1%, p < 0.001). VAF of the majority of the ctDNA mutations increased at the time of disease progression, and VAF of BRAF increased markedly.
Conclusion
Reduction in ctDNA burden as estimated by sum (VAF) could be used to predict treatment outcome of regorafenib.

Citations

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Circulating cell-free DNA and circulating tumor DNA as a prognostic biomarker in metastatic spine disease, is there a role?
Hayley A. Granberg, Anas M. Bardeesi, Joshua H. Weinberg, Mark Damante, Tugce Kutuk, Joshua D. Palmer, Bryan Ladd, Siri S. Khalsa, David S. Xu, Stephanus Viljoen, Andrew Grossbach
Neurosurgical Review.2026;[Epub] CrossRef
Systematic review and meta-analysis of studies assessing circulating tumor DNA kinetics in metastatic colorectal cancer
L.B. Callesen, K.-L.G. Spindler
ESMO Gastrointestinal Oncology.2026; 11: 100314. CrossRef
A Systematic Review and Meta-Analysis of the Efficacy and Safety of Regorafenib in the Treatment of Metastatic Colorectal Cancer
Bingjun Liang, Ming Tang, Chao Huang, Yidian Yang, Yue He, Shengrong Liao, Weizeng Shen
Journal of Gastrointestinal Cancer.2025;[Epub] CrossRef
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Gastric Cancer.2025; 28(4): 620. CrossRef
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Anja Holz, Bidisha Paul, Antonia Zapf, Klaus Pantel, Simon A. Joosse
Cancer Treatment Reviews.2025; 139: 102999. CrossRef
Whole-exome ctDNA sequencing reveals intratumoral heterogeneity and drivers of relapse in locally advanced head and neck cancer
G. Bruixola, J. Martín-Arana, F. Gimeno-Valiente, J.A. Carbonell-Asins, B. García-Micó, B. Martínez-Castedo, D. González-Camblor, N. Grimalt, M. García-Bartolomé, C. Alfaro-Cervelló, V. Escorihuela, M.E. Iglesias, M. Maroñas, D. Dualde, A. Cervantes, N. T
ESMO Open.2025; 10(12): 105904. CrossRef
Regorafenib and metronomic capecitabine, cyclophosphamide, and aspirin in refractory metastatic colorectal cancer: results from the REPROGRAM-01 single-arm phase II trial
A. El Kaddissi, A. Vienot, J.-D. Fumet, A. Meurisse, T. Nguyen, E. Klajer, A. Bouard, L. Spehner, F. Fein, M. Stouvenot, E. Dochy, M. Rebucci-Peixoto, H. Almotlak, J. Henriquez, Z. Selmani, D. Vernerey, E. Hervouet, A. Folletet, S. Kim, F. Ghiringhelli, C
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Parisa Malekzadeh, Mary S. Brady
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Variant allele frequency in circulating tumor DNA correlated with tumor disease burden and predicted outcomes in patients with advanced breast cancer
Jianxin Zhong, Hanfang Jiang, Xiaoran Liu, Hao Liao, Feng Xie, Bin Shao, Shidong Jia, Huiping Li
Breast Cancer Research and Treatment.2024; 204(3): 617. CrossRef
Stage-Specific Plasma Metabolomic Profiles in Colorectal Cancer
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Journal of Clinical Medicine.2024; 13(17): 5202. CrossRef
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Nature Communications.2024;[Epub] CrossRef
The Diagnostic Utility of cfDNA and ctDNA in Liquid Biopsies for Gastrointestinal Cancers over the Last Decade
Nur Rahadiani, Marini Stephanie, Amelia Fossetta Manatar, Ening Krisnuhoni
Oncology Research and Treatment.2024; 48(3): 125. CrossRef
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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
A Phase II Exploratory Study to Identify Biomarkers Predictive of Clinical Response to Regorafenib in Patients with Metastatic Colorectal Cancer Who Have Failed First-Line Therapy
Karen Gambaro, Maud Marques, Suzan McNamara, Mathilde Couetoux du Tertre, Cyrla Hoffert, Archana Srivastava, Anna Schab, Thierry Alcindor, Adrian Langleben, Lucas Sideris, Mahmoud Abdelsalam, Mustapha Tehfe, Felix Couture, Gerald Batist, Petr Kavan
International Journal of Molecular Sciences.2023; 25(1): 43. CrossRef

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Efficacy and Safety of Regorafenib in Korean Patients with Advanced Gastrointestinal Stromal Tumor after Failure of Imatinib and Sunitinib: A Multicenter Study Based on the Management Access Program: Myoung Kyun Son, Min-Hee Ryu, Joon Oh Park, Seock-Ah Im, Tae-Yong Kim, Su Jin Lee, Baek-Yeol Ryoo, Sook Ryun Park, Yoon-Koo Kang; Cancer Res Treat. 2017;49(2):350-357. Published online July 19, 2016; DOI: https://doi.org/10.4143/crt.2016.067

Abstract PDF PubReader ePub

Purpose
The aim of this study was to confirm the efficacy and safety of regorafenib for advanced gastrointestinal stromal tumors (GISTs) reported in the GRID phase III trial in Korean patients.
Materials and Methods
Fifty-seven Korean patientswith advanced GISTwho experienced both imatinib and sunitinib failure were enrolled in the management access program between December 2012 and November 2013 and treated with regorafenib (160 mg orally once daily in a 3 weeks on /1 week off).
Results
None of the patients achieved a complete or partial response while 25 patients (44%) showed stable disease for ≥ 12 weeks. With a median follow-up of 12.7 months (range, 0.2 to 27.6 months), the median progression-free survival and overall survival were 4.5 months (95% confidence interval [CI], 3.8 to 5.3) and 12.9 months (95% CI, 8.1 to 17.7), respectively. Interestingly, 15 patients (26%) experienced an exacerbation of their cancer-related symptoms (abdominal pain in eight and abdominal distension in five) during the rest period for regorafenib, but all were ameliorated upon the resumption of regorafenib. The most common grade 3 or 4 adverse event was a hand-foot skin reaction (25%). The regorafenib dose was reduced in 44 patients (77%) due to toxicity, which manifested mainly as a handfoot skin reaction (n=31).
Conclusion
This study confirmed the efficacy and safety of regorafenib for advanced GIST after imatinib and sunitinib failure in Korean patients. Considering the exacerbation of the cancer-related symptoms observed during the rest periods, further exploration of the continuous dosing schedule of regorafenib is warranted in future clinical trials.

Citations

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The Evolving Role of Second- and Third-Generation Tyrosine Kinase Inhibitors in Gastrointestinal Malignancies: Advances in Targeted Therapy with Sunitinib, Regorafenib, and Avapritinib
Piotr Kawczak, Tomasz Bączek
Journal of Clinical Medicine.2026; 15(1): 317. CrossRef
English version of Japanese Clinical Practice Guidelines 2022 for gastrointestinal stromal tumor (GIST) issued by the Japan Society of Clinical Oncology
Seiichi Hirota, Ukihide Tateishi, Yuji Nakamoto, Hidetaka Yamamoto, Shinji Sakurai, Hirotoshi Kikuchi, Tatsuo Kanda, Yukinori Kurokawa, Haruhiko Cho, Toshirou Nishida, Akira Sawaki, Masato Ozaka, Yoshito Komatsu, Yoichi Naito, Yoshitaka Honma, Fumiaki Tak
International Journal of Clinical Oncology.2024; 29(6): 647. CrossRef
A randomised phase 2 study of continuous or intermittent dosing schedule of imatinib re-challenge in patients with tyrosine kinase inhibitor-refractory gastrointestinal stromal tumours
Hyung-Don Kim, Changhoon Yoo, Min-Hee Ryu, Yoon-Koo Kang
British Journal of Cancer.2023; 129(2): 275. CrossRef
Case Report: Should Regorafenib be prescribed as a continuous schedule in gastrointestinal stromal tumors? Three case reports on Regorafenib personalized schedule
Maria Susanna Grimaudo, Alice Laffi, Nicolò Gennaro, Roberta Fazio, Federico D’Orazio, Laura Samà, Licia Vanessa Siracusano, Federico Sicoli, Salvatore Lorenzo Renne, Armando Santoro, Alexia Francesca Bertuzzi
Frontiers in Oncology.2023;[Epub] CrossRef
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Marin Golčić, Robin L. Jones, Paul Huang, Andrea Napolitano
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Charlotte Margareta Brinch, Ninna Aggerholm-Pedersen, Estrid Hogdall, Anders Krarup-Hansen
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Special Article

Asian Consensus Guidelines for the Diagnosis and Management of Gastrointestinal Stromal Tumor: Dong-Hoe Koo, Min-Hee Ryu, Kyoung-Mee Kim, Han-Kwang Yang, Akira Sawaki, Seiichi Hirota, Jie Zheng, Bo Zhang, Chin-Yuan Tzen, Chun-Nan Yeh, Toshirou Nishida, Lin Shen, Li-Tzong Chen, Yoon-Koo Kang; Cancer Res Treat. 2016;48(4):1155-1166. Published online June 24, 2016; DOI: https://doi.org/10.4143/crt.2016.187

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Gastrointestinal stromal tumors (GISTs) are the most common mesenchymal tumors originating in the gastrointestinal tract. With the introduction of molecular-targeted therapy for GISTs which has yielded remarkable outcomes, these tumors have become a model of multidisciplinary oncological treatment. Although Western clinical guidelines are available for GISTs, such as those published by the National Comprehensive Cancer Network (NCCN) and the European Society of Medical Oncology (ESMO), the clinical situations in Asian countries are different from those in Western countries in terms of diagnostic methods, surgical approach, and availability of new targeted agents. Accordingly, we have reviewed current versions of several GIST guidelines published by Asian countries (Japan, Korea, China, and Taiwan) and the NCCN and ESMO and discussed the areas of dissensus. We here present the first version of the Asian GIST consensus guidelines that were prepared through a series of meetings involving multidisciplinary experts in the four countries. These guidelines provide an optimal approach to the diagnosis and management of GIST patients in Asian countries.

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Original Article

Regorafenib as Salvage Treatment in Korean Patients with Refractory Metastatic Colorectal Cancer: Seung Tae Kim, Tae Won Kim, Kyu-pyo Kim, Tae-You Kim, Sae-Won Han, Ji Yun Lee, Sung Hee Lim, Min-Young Lee, Haesu Kim, Young Suk Park; Cancer Res Treat. 2015;47(4):790-795. Published online December 2, 2014; DOI: https://doi.org/10.4143/crt.2014.126

Abstract PDF PubReader ePub

Purpose
Regorafenib, an oral multi-targeted tyrosine kinase inhibitor, is considered the new standard of care in patients with chemotherapy-refractory colorectal cancers (CRCs). However, there are no data on this drug in Korean patients.
Materials and Methods
We evaluated patients who received oral regorafenib 160 mg once daily during the first 3 weeks of each 4-week cycle between August 2013 and September 2013. All patients had previously progressed fluorouracil, irinotecan, and oxaliplatin with or without biologic agents such as cetuximab or bevacizumab.
Results
Thirty-two patients were enrolled (median age, 57 years; male:female ratio, 20:12; Eastern Cooperative Oncology Group performance status [0-1:2], 31:1; colon:rectum, 21:11). The overall response rate was 3.1% and the disease control rate was 50.0% (95% confidence interval [CI]) with one partial response and 15 patients with stable disease. The median progression-free survival was 4.2 months (95% CI, 3.1 to 5.2 months) and the median overall survival has not yet been reached. The most common adverse events of grade two or higher related to regorafenib were hand-foot skin reaction (25%), mucositis (19%), abdominal pain (9%), and liver function test (LFT) abnormalities (9%). Grade 3 or 4 toxicities included LFT abnormalities (9%), abdominal pain (9%), rash (6%), anemia (3%), leukopenia (3%), neutropenic fever (3%), and fatigue (3%). There was no treatment-related death.
Conclusion
Regorafenib appears to have promising activity and tolerable toxicity profiles in Korean patients with refractory CRC, consistent with the CORRECT trial findings.

Citations

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