Ambulatory 2 hours infusion of 5-FU modulated by low-dose leucovorin in the palliative treatment of advanced epithelial cancer patients with low performance status

Abstract

20600 Background: In the context of palliative care, when clinically indicated for symptomatic control, chemotherapy regimens should ideally offer a fair chance of anticancer activity and clinical benefit, be feasible with a simple method of administration and have a favorable toxicity profile. We evaluated, in a cohort of advanced epithelial cancer patients, most of them already treated with multiple previous lines of chemotherapy, an adaptation of the active and well tolerated ‘de Gramont‘ regimen. Methods: Patients (pts) with histologically proven advanced epithelial neoplasms, adequate bone marrow, hepatic and renal function, ECOG status ≤ 3, were treated with EV bolus leucovorin 20 mg\/m2 D1 and D2 + 5-FU 400 mg\/m2 EV bolus D1 and D2 + a two-hours infusion of 5-FU 600 mg\/m2 D1 and D2, every two weeks. Results: Twenty pts (17 females, 3 males; mean age 54,5 years, range 44–76), with a mean of 2,3 previous lines of chemotherapy (range 0–6), received a total of 155 cycles (mean of 7 cycles/patient, range 3–19), of the adapted de Gramont regimen. The primary tumors were: breast (10 PTS), gastro-intestinal (6 PTS), ovary (2 PTS), head and neck (1 patient), unknown primary carcinoma (1 patient). The ECOG status of the pts was as follows: ECOG 1 (3 pts), ECOG 2 (12 pts), and ECOG 3 (5 pts), mean of 2,1. The partial response rate was 28% (95% CI: 8–48); 8 patients (38%) demonstrated stable disease and 1 patient had a complete response. Clinical benefit with improved performance status and/or decrease in pain was noted in 16 pts. The median time to progression was 24 weeks (95% CI: 16 - 32), and the mean overall survival was 36 weeks. No grade 4 toxicities were detected and grade 3 toxicities were as follows: leucopenia (3 pts) and anemia (1 patient). Common grade 1/2 toxicities were: hand-foot syndrome (4 pts), anemia (6 pts), mucositis (6 pts), diarrhea (6 pts), conjunctivitis (1 patient). The toxicities were managed with 20% dose reductions and/or chemotherapy delays. Overall, dose reductions occurred in 9 patients and chemotherapy delays in 13 patients. Conclusions: The adapted de Gramont Regimen, as described, is well tolerated and active in the palliative setting of patients with advanced epithelial cancer and low ECOG performance status. No significant financial relationships to disclose.