Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 15027
© 2008 American Society of Clinical Oncology

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Abstract

Cetuximab and capecitabine as first-line treatment for elderly patients (pts) with metastatic colorectal cancer (mCRC): Preliminary results of TTD trial

Hospital 12 de Octubre, Madrid, Spain; Hospital Marqués Valdecilla, Santander, Spain; Hospital General, Alicante, Spain; Hospital Clínico Universitario San Carlos, Madrid, Spain; Hospital Santa Creu i Sant Pau, Barcelona, Spain; Complejo Hospitalario Juan Canalejo, La Coruña, Spain; Hospital Regional Universitario Carlos Haya, Málaga, Spain; Institute of Oncology Hospital Germans Trias I Pujol, Badalona, Spain; Hospital Clínico Universitario San Carlos, Madrid, Spain; Hospital Reina Sofía, Córdoba, Spain

15027

Background: Elderly pts are a special population due to comorbidity, drug altered metabolism and funcional capacity loss. We previously reported 15% overall response rate (OR) to cetuximab monotherapy as first line in elderly pts with mCRC (Sastre, ESMO 2006; Gravalos, ASCO 2007). Now we are doing this trial to determine the efficacy and tolerance of Cetuximab in combination with Capecitabine. Methods: Pts with age 70, histologically confirmed mCRC, measurable disease, KPS 80%, and adequate organs function were elegible. Not previous chemotherapy for mCRC, CNS involvement or geriatric syndromes were allowed. Treatment schedules: Cetuximab (400 mg/m² loading dose and 250 mg/m² weekly) and Capecitabine 1,250 mg/m²/12h [950 if creatinine clearance (ClCr) 30–50 mL/min] days 1–14, q3w (group A). After the first 22 pts, Capecitabine dose was reduced to 1,000 mg/m²/12h (750 if ClCr 30–50 mL/min) (group B) due to an early onset of severe nail toxicity. An ancillary study was designed to analyse prognostic/predictive factors. Results: From Aug/06 to Jul/07, 66 pts were included. Male/female 58/42%. Median age 77y. KPS 100/90/80: 31%/29%/40%. Main grade 3–4 toxicities are listed in table 1. Sixty pts are evaluable for efficacy: OR and control disease (OR + SD) were 32%/73% and 35%/93% for A and B groups, respectively. Progression free survival, duration of response, and analysis of predictive/prognostic factors will be presented at the meeting. Conclusions: In our study, Cetuximab in combination with Capecitabine (1,250 mg/m²/12h) is not well tolerated at this dose of capecitabine. A lower dose of Capecitabine (1,000 mg/m²/12h) is recommended. Preliminary results of Cetuximab plus Capecitabine suggest a higher activity than cetuximab alone but a randomized phase III trial is required.