Abstract 522TiP
Background
A strategy combining induction polychemotherapy (IP) follow by a maintenance treatment with fluoropyrimidine alone or combined with bevacizumab are two standards in metastatic colorectal cancer (mCRC). Nevertheless, no trial has compared these two options during maintenance period.
Trial design
BEVAMAINT is a multicenter, randomized, phase III trial comparing fluoropyrimidine monotherapy and bevacizumab + fluoropyrimidine as maintenance treatment after IP in mCRC. The primary endpoint is the time-to-treatment failure (TTF). TTF will be calculated from date of randomization to first radiological progression or death or start of a new chemotherapy or end of maintenance treatment without introduction of further chemotherapy. We expected a 2 months improvement from 6 months in the monotherapy arm to 8 months in the combination arm (HR=0.75). Based on a two-sided α risk of 5% and a power of 80%, using Schoenfeld method, 379 events are required. The enrolment of 400 patients is planned. The randomization is performed after 4 to 6 months of IP that may be a doublet or a triplet +/- bevacizumab, cetuximab or panitumumab. Stratification factor are: Center, objective tumor response vs stabilization after induction chemotherapy, performance status 0-1 vs 2, 5-fluorouracil vs capecitabine and primary tumor resected vs not. At the time of enrolment, the patients should have a stable disease or a tumor response after IP, have recovered from adverse event of IP and have a metastatic disease still unresectable. Capecitabine or bi-weekly 5-fluorouracil + folinic acid are both accepted for maintenance chemotherapy. An evaluation with thoraco-abdomino-pelvic CT scan or MRI is performed every 9 weeks. Dosage of CEA and circulating tumor DNA are planned at enrollment and during follow-up. The maintenance treatment will be discontinue in the event of major toxicity, progression or patient refusal. After discontinuation the investigator may re-introduce IP or prescribe a second line treatment. The enrollment has started in January 2020.
Clinical trial identification
NCT04188145.
Editorial acknowledgement
This study was supported by a grant from the French Ministry of Health (PHRC-K18-167)
Legal entity responsible for the study
CHU of Dijon, France.
Funding
Programme Hospitalier de Recherche Clinique (PHRC), INCa and from the French Ministry of Health (PHRC-K18-167) (grant).
Disclosure
T. Aparicio: Honoraria (institution), Travel/Accommodation/Expenses: Roche; Honoraria (self): Ipsen; Honoraria (self): Amgen; Travel/Accommodation/Expenses: Bayer; Honoraria (institution): Servier; Honoraria (self): Sanofi; Honoraria (self): Bioven. All other authors have declared no conflicts of interest.