Capecitabine and irinotecan in elderly patients with advanced or metastatic gastro-intestinal tumors

18619 Background: Capecitabine and Irinotecan exhibit single-agent activity in gastro-intestinal tumors. Their combination seems safe and effective. Adult patients with advanced or metastatic gastric or colorectal cancers were enrolled separately in 2 phase II trials dealing with the combination of both drugs. The aim of this study was to evaluate retrospectively the toxicities and the safety profile of this combination in elderly patients (≥ 65 years) as first line therapy for advanced or metastatic gastro-intestinal cancers. Methods: Patients with advanced or metastatic adenocarcinomas of the colon or the stomach aged 65 years or more were treated with the combination of: Irinotecan 80 mg/m 2 IV d1,8,15, and Capecitabine 1250 mg/m 2 orally d 1–14, Q 4w. Toxicities were graded according to the NCI common toxicities criteria version 3. Results: 24 naïve-chemotherapy patients were included. Median age was 68 years (extremes 65 to 88). Primary tumor was stomach, colon, and rectum in 13, 9, and 2 cases respectively. Frequent sites of metastases were liver (18), lymph nodes (8), peritoneum (7), and lung (5). They received 113 cycles with median number 4.7/patient, and extremes 1 to 14. Serious toxicities graded as IV were universally absent. Grade III anemia, diarrhea, and vomiting were encountered in 1, 1, and 2 patients respectively. Grade II anemia, leucopenia, diarrhea, alopecia, fatigue, and vomiting were recorded in 5, 2, 4, 2, 2, and 6 patients respectively. Hand-foot syndrome was observed as only grade I in 2 patients. There was no febrile neutropenia. In the other hand, objective response was encountered in 9 patients (37.5%), with median response duration of 6 months (extremes 1 to 15). After a median follow-up of 36 months, 19 patients died from progression of their disease with mean overall survival of 5.5 months (extremes 1 to 28). Conclusion: The combination of Irinotecan and Capecitabine according to our schedule revealed an excellent safety profile with easily manageable toxicities. This schedule is highly suitable for elderly patients. No significant financial relationships to disclose.