Add Oxaliplatin to FP/BEV in Older Patients with Metastatic Colorectal Cancer?

Debate continues as to whether adding oxaliplatin to fluorinated pyrimidine/bevacizumab (FP/BEV) chemotherapy in older patients with metastatic colorectal cancer (CRC) achieves an additional meaningful clinical benefit. Investigators from Japan now report results of an open-label, randomized trial in patients with unresectable metastatic CRC, either aged 70 to 74 with ECOG-PS 2 or aged 75 and older with ECOG-PS 0 to 2.

The 251 participants were treated with infusional 5-FU/leucovorin or capecitabine plus bevacizumab (5–7.5 mg/kg every 2–3 weeks), with or without oxaliplatin (85–130 mg/m² every 2–3 weeks). Median age was 80 (age ≥75, 95% of patients; ECOG-PS 0–1, 93%; ECOG-PS2, 7%). Of the patients, 58% had two or more sites of metastasis, and 43% had RAS-mutant tumors. The primary endpoint of superior progression-free survival with the addition of oxaliplatin was not met (median, 10.0 months, vs. 9.4 months without oxaliplatin). Overall survival did not differ significantly with and without oxaliplatin (median, 19.7 and 21.3 months). The response rate was significantly higher with oxaliplatin than without it (48% vs. 30%). More grade 3–4 adverse events occurred with oxaliplatin than without it (69% vs. 52%).