Abstract 443TiP
Background
The conversion treatment with FOLFOXIRI and bevacizumab (Bev) in patients with RAS mutant (MUT), irresectable metastatic colorectal cancer (mCRC) may lead to secondary surgical and/or ablative interventions, which are associated with improved survival. Data suggest that more patients could undergo secondary interventions than actually reported. The availability might be improved by central monitoring for these options.
Trial design
FIRE-7 (NCT04852250) is a prospective, randomized, open label, multicenter non-interventional trial that evaluates the impact of an additional virtual centralized multidisciplinary tumour board (MTB) [arm A] vs. local standard practice [arm B] on the secondary intervention rate in treatment-naive RAS MUT mCRC patients undergoing up to 12 cycles of induction treatment (FOLFOXIRI plus Bev). The virtual centralized MTB can be requested after 4 to 6 and 8 to 12 cycles of treatment using pseudonymized imaging. A recommendation for interventional options is delivered electronically to the respective center. The accomplishment of this recommendation is voluntary. A total of 130 patients is planned to be randomly assigned in a 1:1 fashion to either treatment arm A (n=65) or treatment arm B (n=65). After a maximum of 12 cycles induction treatment, maintenance with fluoropyrimidine plus Bev is recommended. De-escalation of treatment is permitted in case of unacceptable toxicity. The primary study endpoint is the secondary intervention rate in curative intention of one organ. To increase this rate from expected 15 % in local standard practice to at least 35 %, a sample size of 114 patients (130 in total including 12 % drop-out) is needed to achieve 80% power with a significance level of 0.05. Secondary endpoints include objective response rate according to RECIST 1.1 criteria, overall and progression-free survival rates at 6, 12, and 16 months as well as safety and tolerability according to NCI-CTCAE. Currently, 9 out of the planned 40 German study sites are opened for recruitment and 5 patients have been randomized. The primary study endpoint is estimated to be evaluated in 2025.
Clinical trial identification
NCT04852250.
Editorial acknowledgement
Legal entity responsible for the study
University Hospital, LMU Munich, Munich, Germany.
Funding
Amgen.
Disclosure
A. Stahler: Financial Interests, Personal, Invited Speaker: Roche, Servier, Tacho Pharmaceutical; Financial Interests, Personal, Other, Travel expenses and accommodation: Roche, Merck KGaA, Amgen, Pfizer, Lilly Oncology. K. Heinrich: Financial Interests, Personal, Invited Speaker: Roche; Financial Interests, Personal, Other, Travel and accommodation: Amgen, Celgene, Lilly Oncology. S. Stintzing: Financial Interests, Personal, Advisory Board: Amgen, Bayer, Lilly, Pierre_Fabre, Merck KgaA, MSD, Roche, Sanofi, Taiho, Takeda; Financial Interests, Personal, Invited Speaker: Leo Pharma; Financial Interests, Institutional, Research Grant: Merck KGaA, Pierre-Fabre, Roche. A. Kurreck: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical, Servier; Financial Interests, Personal, Other, Travel and accommodation: Roche, Medac. A.H.S. Alig: Financial Interests, Personal, Advisory Role: Roche; Financial Interests, Personal, Other, Travel and accommodation: Pfizer, Roche, Lilly Oncology, Novartis, PharmaMar. D.P. Modest: Financial Interests, Personal, Advisory Role: Merck Serono, Amgen, Roche, Servier, Bristol-Myers Squibb, Merck MSD, Lilly Oncology, Incyte, Taiho Pharmaceuticals, Pierre Fabre, G1, Onkowissen.de; Financial Interests, Institutional, Research Grant: Roche, Amgen. V. Heinemann: Financial Interests, Personal, Invited Speaker: Roche, Celgene, Amgen, Sanofi, Merck KGaA, Sirtex Medical, Baxalta, Eli Lilly, Boehringer Ingelheim, Taiho Pharmaceutical, Servier; Financial Interests, Personal, Advisory Role: Merck KGaA, Amgen, Roche, Sanofi, Boehringer Ingelheim, Celgene, Sirtex Medical, Baxalta, Servier, Halozyme, Merck MSD, Bristol-Myers Squibb. All other authors have declared no conflicts of interest.