Randomized Phase 2 Study Comparing Pathological Responses of Resected Colorectal Cancer Metastases after Bevacizumab with mFOLFOX6 or FOLFIRI (BEV-ONCO Trial)

Baldin, Paméla;Carrasco, Javier;Beniuga, Gabriela;Mourin, Anne;Van den Eynde, Marc;et.al.
(2022) Cancers — Vol. 14, n° 5, p. 1183 [1-16] (2022)

Files

BaldinPCancers2022.pdf
  • Open Access
  • Adobe PDF
  • 1.85 MB
Download

Details

Authors
Show more
Abstract
(en) Retrospective studies reported that preoperative oxaliplatin-based chemotherapy increased pathological response (PR) in patients resected for colorectal liver metastases (CRLM). This multicenter prospective randomized (1/1) phase II trial evaluated PR on resected CRLM after preoperative mFOLFOX6 (arm A) or FOLFIRI (arm B) + bevacizumab. The primary endpoint was the major pathological response rate (MPRR), defined as the percentage of patients presenting CRLMs with mean tumor regression grade (TRG) < 3. Secondary endpoints included safety, progression-free survival (PFS) and overall survival (OS). Out of 65 patients, 57 patients (28 and 29 in arm A/B) were resected for CRLM (one patient with lung metastases). Clinical and treatment characteristics were similar in both arms. One-month postoperative complications were 39.3%/31.0% in arm A/B (p = 0.585). MPRR and complete PR were 32.1%/20.7% (p = 0.379) and 14.3%/0.0% (p = 0.052) in arm A/B, respectively. PFS and OS were not different. Patients with PR among all CRLMs (max TRG ≤ 3; 43.8% of patients) had a lower risk of relapse (PFS: HR = 0.41, 95%CI = 0.204−0.840, p = 0.015) and a tendency towards better survival (OS: HR = 0.34, 95%CI = 0.104−1.114, p = 0.075). The homogeneity of PR was associated with improved PFS/OS. This trial fails to demonstrate a significant increase in MPRR in patients treated with mFOLFOX6-bevacizumab but confirms PR as an important prognostic factor.
Affiliations

Citations

  • APA
  • Chicago
  • FWB

Baldin, P., Carrasco, J., Beniuga, G., Mourin, A., Demolin, G., Roland, S., D’Hondt, L., Vergauwe, P., Van Daele, D., Mailleux, M., Sinapi, I., De Cuyper, A., Blétard, N., Massart, B., Delos, M., Castella, M.-L., van Maanen, A., & Van den Eynde, M. (2022). Randomized Phase 2 Study Comparing Pathological Responses of Resected Colorectal Cancer Metastases after Bevacizumab with mFOLFOX6 or FOLFIRI (BEV-ONCO Trial). Cancers, 14(5), 1183 [1-16]. https://doi.org/10.3390/cancers14051183 (Original work published 2022)