Efficacy of Reduced Dose Intensity FOLFOX-4 As First Line Palliative Chemotherapy in Elderly Patients with Advanced Colorectal Cancer (CRC)

3720 Background: Elderly patients are underrepresented in clinical trials, and are often denied of palliative chemotherapy due to limited evidence of efficacy and fear of toxicities. To minimize toxicity and improve compliance of chemotherapy in elderly patients with advanced CRC, reduced dose intensity (mini-) FOLFOX-4 regimen was used as a first-line palliative chemotherapy. Methods: Using a prospective database, we analyzed efficacy and toxicity of mini-FOLFOX-4 regimen as first-line palliative chemotherapy in advanced CRC patients (older than 70 years of age) in Seoul Municipal Boramae Hospital and Seoul National University Bundang Hospital between Jan 2001 and Aug 2004. Schedule: L-OHP 65 mg/m2 on D1 + 5FU 300 mg/m2 iv bolus on D1, 2 + 5FU 450 mg/m2 continuous infusion over 22 hours on D1, 2 + Leucovorin 150 mg/m2 iv on D1, 2, every 2 weeks until progression, unacceptable toxicity or patient refusal. Response was assessed according to WHO criteria, and toxicity to NCI/CTEP CTC. Results: 27 patients were enrolled. M/F = 22/5, metastatic/recurrent = 9/18, colon/rectal = 17/10, PS = 1 in 16 patients, 2 in 10, and 3 in 1. Median age was 74 years (70–83). Total of 117 cycles were delivered. 22 patients were evaluable for response with an overall response rate of 31.8% (1 CR, 6 PR, 11 SD and 5 PD). Median progression-free survival was 7.1 months (95% CI: 4.3–9.9). Overall survival was 13.5 months (95% CI: 10.8–16.2). The main side effect was grade (G) 1/2 anemia and neutropenia, observed in 24.3% and 13.5% of total cycle given. There were no G4 toxicities and only one patient suffered from G3 neuropathy and vomiting. There was one episode of febrile neutropenia. Performance status and body weight was maintained throughout chemotherapy cycles. Conclusions: “Mini-FOLFOX-4” is well tolerated with acceptable toxicity without compromising objective response rate or survival in elderly patients with advanced CRC. No significant financial relationships to disclose.