3597 Background: Elderly patients are frequently excluded from clinical studies due to comorbidity. However, clinical trials in this setting are needed to avoid extrapolating the results obtained in a younger population. We designed this study to evaluate the RR of a standard first-line therapy in elderly patients with MCRC. Secondary objectives were safety profile, TTP and OS Methods: Patients ≥ 72 years old with histologically confirmed MCRC, measurable disease, ECOG <2, adequate bone marrow, renal and hepatic function were included. Previous chemotherapy for advanced disease, CNS involvement or geriatric syndromes were not allowed.
TREATMENT
CPT-11, 180 mg/m2 and 5-FU, 3 g/m2 as a 48h ci, were administered biweekly until progressive disease, unbearable toxicity or consent withdrawal Results: 91 patients were included and 85 were evaluable. Median age of 77 (72-85), male/female (51/34) and ECOG PS 0-1: 100%. Primary tumor sites were colon (67%), rectum (32%) or both (1%). Main comorbidities were hypertension (46%), diabetes (18%), cardiopathy (17%) and chronic pulmonary disease (8%). Median No. of metastatic locations was 1 (33% with ≥2 sites) mainly located in liver (77%) and lung (27%). 28% of patients received previous adjuvant chemotherapy. Up to date, 919 cycles (median 12, range 1-26) were administered, with a median RDI of 91% for both CPT-11 and 5-FU. 85 patients were evaluable for toxicity. Grade 3/4 toxicity per patient were neutropenia (21%), diarrhea (17%), asthenia (13%), leukopenia (8%), abdominal pain (7%) and vomiting (6%). Only 1 patient had febrile neutropenia in 1 cycle. There were 2 treatment related deaths (diarrhea n=1, and digestive hemorrhage n=1).
EFFICACY
On an ITT analysis of 85 patients, 3 achieved CR, 27 PR, 28 SD and 15 progressed, resulting in an ORR of 35 % (95% CI: 25-46) and tumour growth control (RR + SD) in 68% of patients. With a median follow-up of 10.9 months, TTP was 8.0 months (95% CI: 6.1-9.9) and OS was 15.1 months (95% CI: 13.3-16.9) Conclusions: CPT-11 plus 5-FU is an active and feasible treatment for patients older than 72 years old with MCRC. No significant financial relationships to disclose.