The following is a summary of “Initial Panitumumab Plus Fluorouracil, Leucovorin, and Oxaliplatin or Plus Fluorouracil and Leucovorin in Elderly Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The PANDA Trial by the GONO Foundation,” published in the December 2023 issue of Oncology by Lonardi, et al.
For a study, researchers sought to evaluate the efficacy of panitumumab (PAN) combined with modified fluorouracil, leucovorin, and oxaliplatin (mFOLFOX) or fluorouracil plus leucovorin (5-FU + LV) as the initial treatment in elderly patients diagnosed with metastatic colorectal cancer (mCRC) harboring RAS/BRAF wild-type tumors.
Conducted as the PANDA trial, the randomized phase II noncomparative study involved treatment-naïve patients aged 70 years and above with unresectable RAS/BRAF wild-type mCRC. Patients were randomly assigned to receive either mFOLFOX + PAN (arm A) or 5-FU + LV + PAN (arm B) for up to 12 cycles, followed by PAN maintenance. The primary endpoint was progression-free survival (PFS). A sample size of 90 patients per arm was aimed at, assuming a median PFS time ≤6 months as the null hypothesis and a target PFS ≥9.65, with 90% power and 5% type I error.
From July 2016 to April 2019, 91 patients were allocated to arm A and 92 to arm B. At a median follow-up of 50.0 months, arm A exhibited a median PFS of 9.6 months, whereas arm B had a median PFS of 9.0 months (P < .001 in each arm). Arm A demonstrated an overall response rate of 69%, while arm B had a rate of 52%. Median overall survival was 23.5 and 22.0 months in arms A and B, respectively. The grade >2 chemotherapy-related adverse events rate was 60% and 37% for arms A and B, respectively. Baseline G8 and Chemotherapy Risk Assessment Scale for High-Age Patients scores were prognostic but did not correlate with efficacy and safety.
Both mFOLFOX and 5-FU + LV + PAN were reasonable initial therapy choices for elderly patients with RAS/BRAF wild-type mCRC. 5-FU + LV + PAN, exhibiting a more favorable safety profile, can be considered an advantageous option.