Oxaliplatin In Combination With 5-Fluorouracil (Fu) In A 48-Hour Continuous Infusion (Ci) As First-Line Chemotherapy For Elderly Patients (Pts) With Metastatic Colorectal Cancer (Mcrc). Ttd Phase Ii Trial

4057 Background: We previously reported a 35% overall response rate (ORR) with 5-FU CI (TTD schedule without modulation) plus CPT-11 as first line therapy in elderly pts with mCRC (Sastre et al. J Clin Oncol 23; 3545–51, 2005). The present study was carried out also in elderly pts to determine the efficacy (ORR as primary endpoint) and safety of oxaliplatin in combination with the same 5-FU schedule. Methods: Pts >72 y. with histologically confirmed mCRC, measurable disease, ECOG < 0–2, no previous adjuvant oxaliplatin and no prior treatment for metastatic disease. Treatment: Oxaliplatin 85 mg/m2 plus 5-FU 3,000 mg/m2 as a 48-hour CI q2w until progressive disease, undesirable toxicity or consent withdrawal. Results: 134 pts were included and 129 (96%) were eligible. Median age: 76y (72–85), male/female: 63/37%, and ECOG 0/1/2: 42/53/5%. Main comorbidities were hypertension (44%), diabetes (17%) and EPOC (11%). Median No of metastatic locations was 1 (37% with > 2 sites) mainly located in liver (77%) and lung (29%). 21% of pts received previous adjuvant chemotherapy. Efficacy: On an ITT analysis of 129 pts, ORR and control disease (ORR+SD) were 52% and 80% respectively. With a median follow-up of 14 months, median progression free survival and overall survival were 9 and 16.2 months respectively. 48 pts (37%) received 2 or more lines of chemotherapy mainly based in CPT-11. Seven pts (5.4%) followed resection of liver metastasis, of which 5 were complete. Grades 3–4 toxicities included anemia (2%), asthenia (9%), neutropenia (17%), febrile neutropenia (2%), thrombocytopenia (5%), diarrhoea (11%), nausea/vomiting (5/4%) and neurotoxicity grade 3 (18%). There was one treatment related death (pneumonia). Conclusion: To our knowledge this is the largest phase II prospective study in elderly pts with mCRC. The schedule seems to be effective and compared favourably with those reported in the literature in this population. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration sanofi-aventis