In the Italian phase II noncomparative PANDA trial reported in the Journal of Clinical Oncology, Lonardi et al found that regimens adding panitumumab to modified FOLFOX (fluorouracil, leucovorin, and oxaliplatin; mFOLFOX) and to fluorouracil/leucovorin were active in the first-line treatment of elderly patients with RAS/BRAF wild-type metastatic colorectal cancer.
In the multicenter open-label trial, 183 patients aged ≥ 70 years were randomly assigned between July 2016 and April 2019 to receive panitumumab at 6 mg/kg every 2 weeks with either mFOLFOX (n = 91) or fluorouracil/leucovorin (n = 92) for up to 12 cycles followed by panitumumab maintenance. The primary endpoint was progression-free survival. The null hypothesis was median progression-free survival of 6 months.
At a median follow-up of 50.0 months (interquartile range = 45.6–56.4 months), median progression-free survival was 9.6 months (90% confidence interval [CI] = 8.8–10.9 months) in the panitumumab/mFOLFOX group and 9.0 months (90% CI = 7.7–9.9 months) in the panitumumab/fluorouracil/leucovorin group (both P < .001 vs null hypothesis).
Objective response rates were 69% (95% CI = 59%–78%) in the panitumumab/mFOLFOX group and 52% (95% CI = 42%–63%) in the panitumumab/fluorouracil/leucovorin group, with complete response in 4% and 5%, respectively. Median overall survival was 23.5 months (95% CI = 18.9–28.7 months) and 22.0 months (95% CI = 16.9–29.5 months).
Grade > 2 chemotherapy-related adverse events occurred in 60% of the panitumumab/mFOLFOX group and 37% of the panitumumab/fluorouracil/leucovorin group. The most common grade 3 or 4 adverse events in the panitumumab/mFOLFOX group were rash (25% vs 24% in panitumumab/fluorouracil/leucovorin group), diarrhea (16% vs 1%), stomatitis (10% vs 4%), neutropenia (10% vs 1%), and fatigue (8% vs 4%).
The investigators concluded, “Both mFOLFOX and fluorouracil/leucovorin [plus panitumumab] are reasonable options as initial therapy of elderly patients with RAS/BRAF wild-type metastatic colorectal cancer. Fluorouracil/leucovorin [plus panitumumab] is associated with a better safety profile.”
Sara Lonardi, MD, of the Department of Oncology, Veneto Institute of Oncology IOV-IRCCS, Padova, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by Amgen. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.