A phase two trial evaluating FOLFIRI plus aflibercept after failure of FOLFOXIRI plus bevacizumab in patients with unresectable metastatic colorectal cancer
- 01.02.2025
- Original Article
Erschienen in:
- Verfasst von
- Koji Ando
- Hironaga Satake
- Mototsugu Shimokawa
- Hisateru Yasui
- Yuji Negoro
- Tatsuya Kinjo
- Junya Kizaki
- Kenji Baba
- Hiroyuki Orita
- Keiji Hirata
- Sanae Sakamoto
- Akitaka Makiyama
- Hiroshi Saeki
- Akihito Tsuji
- Hideo Baba
- Eiji Oki
- Erschienen in
- International Journal of Clinical Oncology | Ausgabe 3/2025
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.
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- Titel
- A phase two trial evaluating FOLFIRI plus aflibercept after failure of FOLFOXIRI plus bevacizumab in patients with unresectable metastatic colorectal cancer
- Verfasst von
-
Koji Ando
Hironaga Satake
Mototsugu Shimokawa
Hisateru Yasui
Yuji Negoro
Tatsuya Kinjo
Junya Kizaki
Kenji Baba
Hiroyuki Orita
Keiji Hirata
Sanae Sakamoto
Akitaka Makiyama
Hiroshi Saeki
Akihito Tsuji
Hideo Baba
Eiji Oki
- Publikationsdatum
- 01.02.2025
- Verlag
- Springer Nature Singapore
- Erschienen in
-
International Journal of Clinical Oncology / Ausgabe 3/2025
Print ISSN: 1341-9625
Elektronische ISSN: 1437-7772 - DOI
- https://doi.org/10.1007/s10147-025-02701-9
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