Background: Picoplatin (Pico) has the potential for improved safety compared to other platinum agents. FOLFOX (5-FU, LV, oxaliplatin [oxali]) treatment for advanced CRC has dose-limiting oxali-related neurotoxicity. Grade (G) 3-4 neurotoxicity with single-agent Pico was <2%, suggesting that Pico may be a neuropathy-sparing alternative to oxali. This randomized phase II study evaluates Pico Q4W with Q2W FU and LV (FOLPI) vs modified FOLFOX-6 (FOLFOX) as first-line treatment for patients (pts) with advanced CRC. Methods: Pts with no prior chemotherapy for advanced CRC received LV + infusional FU per FOLFOX Q2W and Pico Q4W (150 mg/m2) or oxali Q2W (85 mg/m2). Tumor response was assessed by RECIST, adverse events (AEs) by CTCAE. Results: 51 pts received FOLPI; 50 received FOLFOX. Platinum exposure was similar between treatment arms. On FOLFOX, the most frequent G 3-4 AEs were neutropenia (22%), neuropathy (16%) and thrombocytopenia (12%). On FOLPI, the most frequent G 3-4 AEs were neutropenia (57%), thrombocytopenia (43%) and anemia (22%) with no G3-4 neuropathy. FOLPI had significantly less G 2-4 neurotoxicity than FOLFOX, p<0.0002. One FOLPI pt had febrile neutropenia, was retreated and had a CR. No pt was discontinued due to bleeding. Drug- related AEs resulting in drug discontinuation occurred in 20% of pts on both FOLPI and FOLFOX. Most pts discontinued drug for progressive disease on FOLPI and FOLFOX. Responses were: FOLPI-2 CR (4%); 13 PR (25%) and FOLFOX-3 CR (6%); 16 PR (32%). Disease control (CR+PR+SD) was 75% for FOLPI, 76% for FOLFOX. 12-month survival rates for FOLPI and FOLFOX are 52% and 55%, respectively. Conclusions: Neurotoxicity with FOLPI was less frequent and less severe compared to FOLFOX. Hematologic toxicity with FOLPI was manageable. FOLPI treatment of first-line CRC had similar disease control and survival rates to FOLFOX supporting picoplatin as a potential neuropathy-sparing alternative to the use of oxaliplatin.
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