Maintenance therapy with panitumumab alone vs panitumumab plus fluorouracil-leucovorin in patients with RAS wild-type metastatic colorectal cancer: A phase 2 randomized clinical trial
JAMA Sep 20, 2019
Pietrantonio F, Morano F, Corallo S, et al. - Through an open-label, phase 2 randomized clinical trial done from July 7, 2015, through October 27, 2017, at multiple Italian centers, of 229 individuals with RAS wild-type, unresectable metastatic colorectal adenocarcinoma who had not received former treatment for metastatic disease, researchers ascertained whether maintenance therapy with single-agent panitumumab was noninferior to panitumumab plus fluorouracil and leucovorin subsequent to a 4-month induction treatment regimen. Patients were randomized to arm A (n = 117) or arm B (n = 112). The occurrence of a total of 169 disease progression or death events was noted at a median follow-up of 18.0 months. Arm B was inferior. Ten-month PFS was 59.9% and 49.0% in arm A vs arm B, respectively. During maintenance, arm A had a greater incidence of grade 3 or higher treatment-related adverse events and panitumumab-related adverse events, in comparison with arm B. Therefore, maintenance therapy with single-agent panitumumab was lower in patients with RAS wild-type metastatic colorectal cancer, in terms of PFS in comparison with panitumumab plus fluorouracil-leucovorin, which slightly raised the treatment toxic impacts.
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