Journal of Clinical Oncology, 2004 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 22, No 14S (July 15 Supplement), 2004: 3597
© 2004 American Society of Clinical Oncology

This Article Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Marcuello, E. Articles by Diaz-Rubio, E. Search for Related Content PubMed Articles by Marcuello, E. Articles by Diaz-Rubio, E.

Abstract

Biweekly irinotecan (CPT-11) plus 5-FU as first-line chemotherapy for elderly patients with metastatic colorectal cancer (MCRC). Final results of the Spanish Digestive Group (TTD) study

H. Santa Creu i Sant Pau, Barcelona, Spain; H.C. San Carlos, Madrid, Spain; H. G., Alicante, Spain; Institut Catala D'Oncologia, Barcelona, Spain; H. Carlos Haya, Malaga, Spain; H. Miguel Servet, Zaragoza, Spain; H. Germans Trias i Pujol, Barcelona, Spain

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.

Abstract presentation from the 2004 ASCO Annual Meeting