Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID)
Abstract Background Long‐term anti‐EGFR antibody treatment increases the risk of severe dermatologic toxicities. This single‐arm, phase II trial aimed to investigate the strategy of switching from cetuximab to bevacizumab in combination with FOLFIRI based on early tumor shrinkage (ETS) in patients w...
| Main Authors: | , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2024-04-01
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| Series: | Cancer Medicine |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/cam4.7107 |
| _version_ | 1797205676765741056 |
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| author | Hiroyuki Arai Takashi Tsuda Yu Sunakawa Mototsugu Shimokawa Kohei Akiyoshi Shinya Tokunaga Hirokazu Shoji Kenji Kunieda Masahito Kotaka Toshihiko Matsumoto Yusuke Nagata Takuro Mizukami Fumitaka Mizuki Kathleen D. Danenberg Narikazu Boku Takako Eguchi Nakajima |
| author_facet | Hiroyuki Arai Takashi Tsuda Yu Sunakawa Mototsugu Shimokawa Kohei Akiyoshi Shinya Tokunaga Hirokazu Shoji Kenji Kunieda Masahito Kotaka Toshihiko Matsumoto Yusuke Nagata Takuro Mizukami Fumitaka Mizuki Kathleen D. Danenberg Narikazu Boku Takako Eguchi Nakajima |
| author_sort | Hiroyuki Arai |
| collection | DOAJ |
| description | Abstract Background Long‐term anti‐EGFR antibody treatment increases the risk of severe dermatologic toxicities. This single‐arm, phase II trial aimed to investigate the strategy of switching from cetuximab to bevacizumab in combination with FOLFIRI based on early tumor shrinkage (ETS) in patients with RAS wild‐type metastatic colorectal cancer (mCRC). Methods Radiologic assessment was performed to evaluate ETS, defined as ≥20% reduction in the sum of the largest diameters of target lesions 8 weeks after the introduction of FOLFIRI plus cetuximab. ETS‐negative patients switched to FOLFIRI plus bevacizumab, whereas ETS‐positive patients continued FOLFIRI plus cetuximab for eight more weeks, with a switch to FOLFIRI plus bevacizumab thereafter. The primary endpoint was progression‐free survival. Results This trial was prematurely terminated due to poor accrual after a total enrollment of 30 patients. In 29 eligible patients, 7 were ETS‐negative and 22 were ETS‐positive. Two ETS‐negative patients and 17 ETS‐positive patients switched to FOLFIRI plus bevacizumab 8 weeks and 16 weeks after initial FOLFIRI plus cetuximab, respectively. Median progression‐free and overall survival durations were 13.4 and 34.7 months, respectively. Six (20%) patients experienced grade ≥3 paronychia, which improved to grade ≤2 by 18 weeks. Grade ≥3 acneiform rash, dry skin, and pruritus were not observed in any patients. Conclusions Our novel treatment strategy delivered acceptable survival outcomes and reduced severe dermatologic toxicities. |
| first_indexed | 2024-04-24T08:54:55Z |
| format | Article |
| id | doaj.art-f1dd28fe734a4a8888bd792971f6399b |
| institution | Directory Open Access Journal |
| issn | 2045-7634 |
| language | English |
| last_indexed | 2024-04-24T08:54:55Z |
| publishDate | 2024-04-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj.art-f1dd28fe734a4a8888bd792971f6399b2024-04-16T08:48:34ZengWileyCancer Medicine2045-76342024-04-01137n/an/a10.1002/cam4.7107Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID)Hiroyuki Arai0Takashi Tsuda1Yu Sunakawa2Mototsugu Shimokawa3Kohei Akiyoshi4Shinya Tokunaga5Hirokazu Shoji6Kenji Kunieda7Masahito Kotaka8Toshihiko Matsumoto9Yusuke Nagata10Takuro Mizukami11Fumitaka Mizuki12Kathleen D. Danenberg13Narikazu Boku14Takako Eguchi Nakajima15Department of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanDepartment of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanDepartment of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanDepartment of Biostatistics Yamaguchi University Graduate School of Medicine Ube JapanDepartment of Medical Oncology Osaka City General Hospital Osaka JapanDepartment of Medical Oncology Osaka City General Hospital Osaka JapanGastrointestinal Medical Oncology Division National Cancer Center Hospital Tokyo JapanDepartment of Medical Oncology Saku Central Hospital Advanced Care Center Saku JapanDepartment of Gastrointestinal Cancer Center Sano Hospital Kobe JapanDepartment of Internal Medicine Himeji Red Cross Hospital Himeji JapanDivision of Gastroenterology and Hepatology, Department of Internal Medicine Jikei University School of Medicine Tokyo JapanDepartment of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanCenter for Clinical Research Yamaguchi University Hospital Ube JapanLiquid Genomics, Inc. Torrance California USADepartment of Oncology and General Medicine Institute of Medical Science Hospital, University of Tokyo Tokyo JapanDepartment of Clinical Oncology St. Marianna University School of Medicine Kawasaki JapanAbstract Background Long‐term anti‐EGFR antibody treatment increases the risk of severe dermatologic toxicities. This single‐arm, phase II trial aimed to investigate the strategy of switching from cetuximab to bevacizumab in combination with FOLFIRI based on early tumor shrinkage (ETS) in patients with RAS wild‐type metastatic colorectal cancer (mCRC). Methods Radiologic assessment was performed to evaluate ETS, defined as ≥20% reduction in the sum of the largest diameters of target lesions 8 weeks after the introduction of FOLFIRI plus cetuximab. ETS‐negative patients switched to FOLFIRI plus bevacizumab, whereas ETS‐positive patients continued FOLFIRI plus cetuximab for eight more weeks, with a switch to FOLFIRI plus bevacizumab thereafter. The primary endpoint was progression‐free survival. Results This trial was prematurely terminated due to poor accrual after a total enrollment of 30 patients. In 29 eligible patients, 7 were ETS‐negative and 22 were ETS‐positive. Two ETS‐negative patients and 17 ETS‐positive patients switched to FOLFIRI plus bevacizumab 8 weeks and 16 weeks after initial FOLFIRI plus cetuximab, respectively. Median progression‐free and overall survival durations were 13.4 and 34.7 months, respectively. Six (20%) patients experienced grade ≥3 paronychia, which improved to grade ≤2 by 18 weeks. Grade ≥3 acneiform rash, dry skin, and pruritus were not observed in any patients. Conclusions Our novel treatment strategy delivered acceptable survival outcomes and reduced severe dermatologic toxicities.https://doi.org/10.1002/cam4.7107bevacizumabcetuximabearly tumor shrinkagemetastatic colorectal cancer |
| spellingShingle | Hiroyuki Arai Takashi Tsuda Yu Sunakawa Mototsugu Shimokawa Kohei Akiyoshi Shinya Tokunaga Hirokazu Shoji Kenji Kunieda Masahito Kotaka Toshihiko Matsumoto Yusuke Nagata Takuro Mizukami Fumitaka Mizuki Kathleen D. Danenberg Narikazu Boku Takako Eguchi Nakajima Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) Cancer Medicine bevacizumab cetuximab early tumor shrinkage metastatic colorectal cancer |
| title | Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) |
| title_full | Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) |
| title_fullStr | Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) |
| title_full_unstemmed | Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) |
| title_short | Switching from FOLFIRI plus cetuximab to FOLFIRI plus bevacizumab based on early tumor shrinkage in RAS wild‐type metastatic colorectal cancer: A phase II trial (HYBRID) |
| title_sort | switching from folfiri plus cetuximab to folfiri plus bevacizumab based on early tumor shrinkage in ras wild type metastatic colorectal cancer a phase ii trial hybrid |
| topic | bevacizumab cetuximab early tumor shrinkage metastatic colorectal cancer |
| url | https://doi.org/10.1002/cam4.7107 |
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