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)

Bibliographic Details
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)
Authors: 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
Source: Cancer Medicine, Vol 13, Iss 7, Pp n/a-n/a (2024)
Publisher Information: Wiley, 2024.
Publication Year: 2024
Collection: LCC:Neoplasms. Tumors. Oncology. Including cancer and carcinogens
Subject Terms: bevacizumab, cetuximab, early tumor shrinkage, metastatic colorectal cancer, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
More Details: 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.
Document Type: article
File Description: electronic resource
Language: English
ISSN: 2045-7634
Relation: https://doaj.org/toc/2045-7634
DOI: 10.1002/cam4.7107
Access URL: https://doaj.org/article/f1dd28fe734a4a8888bd792971f6399b
Accession Number: edsdoj.f1dd28fe734a4a8888bd792971f6399b
Database: Directory of Open Access Journals
More Details
ISSN:20457634
DOI:10.1002/cam4.7107
Published in:Cancer Medicine
Language:English