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Capecitabine As First-Line Treatment for Patients Older Than 70 Years With Metastatic Colorectal Cancer: An Oncopaz Cooperative Group Study

From the Hospital La Paz de Madrid; Hospital Puerta del Mar de Cadiz, Madrid; Hospital Clinico de Zaragoza, Zaragoza; Hospital Cruz Roja de Barcelona, Barcelona; Hospital San Pedro de Alcántara de Cáceres, Cáceres; Hospital General Universitario de Valencia, Valencia; Hospital Obispo Polanco de Teruel, Teruel; Hospital San Jorge de Huesca, Huesca; Hospital Universitario de Santiago de Compostela, Santiago de Compostela; Hospital Virgen de la Salud de Toledo, Toledo, Spain

Address reprint requests to J. Feliu, MD, Medical Oncology Service, La Paz Hospital, P de la Castellana, 261-28046, Madrid, Spain; e-mail: jfeliu.hulp{at}salud.madrid.org

PURPOSE: To determine the tolerability of capecitabine in elderly patients with advanced colorectal cancer (CRC).

PATIENTS AND METHODS: Fifty-one patients with advanced CRC who were 70 years and considered ineligible for combination chemotherapy received oral capecitabine 1,250 mg/m² twice daily on days 1 to 14 every 3 weeks. Patients with a creatinine clearance of 30 to 50 mL/min received a dose of 950 mg/m² twice daily.

RESULTS: A total of 248 cycles of capecitabine were administered (median, five cycles; range, one to eight cycles). The overall response rate was 24% (95% CI, 15% to 41%), including two complete responses (CR; 4%) and 10 partial responses (PR; 20%). Disease control (CR + PR + stable disease) was achieved in 67% of patients. The median times to disease progression and overall survival were 7 months (95% CI, 6.4 to 9.5 months) and 11 months (95% CI, 8.6 to 13.3 months), respectively. Of the 35 patients evaluated for clinical benefit response, 14 (40%; 95% CI, 24% to 58%) showed clinical benefit. Capecitabine was well tolerated. Treatment-related grade 3 and 4 adverse events were observed in only six patients (12%), and the most common events were diarrhea, hand-foot syndrome, and thrombocytopenia. One patient (2%) had an episode of angina, but no treatment-related deaths were reported.

CONCLUSION: Our findings suggest that capecitabine is effective and well tolerated in elderly patients with advanced CRC who are considered ineligible for combination chemotherapy.

Supported by Hoffmann-La Roche Inc, Nutley, NJ.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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