VALENTINO Study: Comparing Maintenance Therapies in Metastatic Colorectal Cancer
Posted: Monday, August 12, 2019
The results of the phase II VALENTINO study showed that maintenance therapy with single-agent panitumumab was inferior to panitumumab plus fluorouracil/leucovorin in terms of progression-free survival in patients with RAS wild-type metastatic colorectal cancer. These maintenance regimens were assessed after 4-month induction therapy with panitumumab plus oxaliplatin–based doublet chemotherapy. The study, which was conducted by Filippo Pietrantonio, MD, of Fondazione IRCCS Instituto Nazionale dei Tumori, Milan, Italy, and colleagues, was published in JAMA Oncology.
“The clinical decision making on treatment de-escalation and its timing should be dynamically managed by physicians by taking into account several factors, such as available evidence, patient preference, baseline patient- and disease-related characteristics, specific drug toxicities, and response to induction treatment,” the authors concluded.
The study included 229 patients randomly assigned 1:1 to receive first-line chemotherapy with panitumumab plus FOLFOX4 (leucovorin, fluorouracil [5-FU], oxaliplatin) for 8 cycles. Maintenance therapy consisted of panitumumab plus 5-FU/leucovorin (arm A; n = 117)) or panitumumab (arm B; n = 112).
The 10-month progression-free survival for arm A was 59.9% compared with 49% for arm B. The median progression-free survival for arm A was 12.0 months compared with 9.9 months for arm B. Average follow-up was 18 months, and overall survival did not significantly differ between the two arms at this juncture.
There was a higher incidence of grade 3 or greater treatment-related adverse events in arm A than arm B (42.4% vs. 20.3%). The incidence of panitumumab-related adverse events was 31.8% in arm A versus 16.4% in arm B.
Disclosure: The study authors’ disclosure information may be found at jamanetwork.com.