- The combination of 5-fluorouracil and leucovorin (5FU/LV) monochemotherapy plus panitumumab might be a reasonable option in elderly patients with RAS-BRAF wt mCRC.
- Further investigations in phase 3 trials are warranted.
Why this matters
- Empirical dose reductions are frequently adopted for elderly patients.
- Doublet chemotherapy plus anti-EGFR is a choice in RAS-BRAF wt mCRC, but data on elderly patients are limited.
- Fluoropyrimidine monotherapy is a recommended option for elderly patients, but no data are available on the role of the combination with an anti-EGFR.
- Patients aged ≥70 with unresectable and previously untreated RAS-BRAF wt mCRC were included in this prospective, open-label, multicenter phase 2 randomized trial.
- Patients were randomized to FOLFOX-panitumumab (group A, n=92) or 5FU/LV-panitumumab (group B, n=93) for up to 12 cycles followed by panitumumab maintenance until progression.
- Primary endpoint: progression-free survival (PFS).
- Secondary endpoints included overall response rate (ORR) and safety profile.
- No formal comparison between groups was planned.
- Funding: GONO Group and Amgen.
- The primary endpoint was met in both groups: median PFS was 9.6 and 9.1 months in groups A and B, respectively (median follow-up 20.5 months).
- ORR (group A: 65%, group B: 57%) and disease control rate (group A: 88%, group B: 86%) were similar between groups.
- A lower incidence of side effects was observed with the monochemotherapy.
“Data from other first-line studies in KRAS/NRAS/BRAF wt CRC are not generalizable to this population and previous prospective randomized trials in this group of patients were not biomarker selected. The study is helping define personalized treatments and find the right drug [for] the right patient,” said Michael S. Lee. Assistant Professor of Medicine, Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill.