Bibliographic Details
| Title: |
A phase two trial evaluating FOLFIRI plus aflibercept after failure of FOLFOXIRI plus bevacizumab in patients with unresectable metastatic colorectal cancer. |
| Authors: |
Ando, Koji, Satake, Hironaga, Shimokawa, Mototsugu, Yasui, Hisateru, Negoro, Yuji, Kinjo, Tatsuya, Kizaki, Junya, Baba, Kenji, Orita, Hiroyuki, Hirata, Keiji, Sakamoto, Sanae, Makiyama, Akitaka, Saeki, Hiroshi, Tsuji, Akihito, Baba, Hideo, Oki, Eiji |
| Source: |
International Journal of Clinical Oncology; Mar2025, Vol. 30 Issue 3, p514-523, 10p |
| Subject Terms: |
OVERALL survival, COLORECTAL cancer, PROGRESSION-free survival, CANCER chemotherapy, METASTASIS |
| Abstract: |
Background: FOLFOXIRI plus bevacizumab (BEV) is an option for first-line treatment of metastatic colorectal cancer (mCRC). However, there is no consensus on the optimal treatment strategy when disease progresses. The EFFORT open-label, multicenter, single-arm phase II study investigated whether FOLFIRI plus aflibercept retains activity after progression of FOLFOXIRI plus BEV treatment. Methods: The patients with unresectable mCRC who failed first-line FOLFOXIRI plus BEV received FOLFIRI plus aflibercept. The primary endpoint was progression-free survival (PFS) in the full analysis set (FAS). Angiogenic biomarkers were measured before treatment initiation. Results: From April 2019 to May 2021, 35 patients were enrolled and 34 were analysed in the FAS population (men, 18; median age, 63 years [range: 32–78]). The primary tumor was left-sided in most cases (23/34), 23 patients were RAS mutant, 3 patients had BRAF V600E mutation and 27 patients had liver metastases. The primary end-point was met with a median PFS of 4.3 months [80% confidence interval [CI] 3.7–5.1]. Median overall survival was 15.2 months [95% CI 8.9–22.7]. Per RECIST, there were 1 complete response, 4 partial responses, 21 stable diseases and 8 disease progressions. Overall response rate was 14.7% [95% CI 5.0–31.1], and disease control rate was 76.5% [95% CI 58.8–89.3]. Responses were more common in patients with high VEGF-C, low VEGF-D and low PlGF levels before treatment. Conclusion: FOLFIRI plus aflibercept, administered after failure of FOLFOXIRI plus BEV, is effective and has a manageable safety profile. This regimen may be a useful second-line treatment option for these patients. [ABSTRACT FROM AUTHOR] |
|
Copyright of International Journal of Clinical Oncology is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.) |
| Database: |
Complementary Index |
