1. ¹Service of Medical Oncology, H La Paz, Universidad Autónoma de Madrid, Paseo de la Castellana 261, Madrid 28046, Spain
2. ²Service of Medical Oncology, H Arnau Vilanova, Avda. Alcalde Roure 80, Lérida 25006, Spain
3. ³Service of Medical Oncology, H Lozano Blesa, C/San Juan Bosco 15, Zaragoza 50009, Spain
4. ⁴Service of Medical Oncology, H Virgen de la Salud, Avda. Barber 35, Toledo 45004, Spain
5. ⁵Service of Medical Oncology, H San Pedro de Alcántara Avda. Millán Astray s/n10003, Cáceres, Spain
6. ⁶Service of Medical Oncology, H Sagunto, Avda. Ramón y Cajal s/n46520, Valencia, Spain
7. ⁷Service of Medical Oncology, H General Universitario, Avda. Tres Cruces s/n46014, Valencia, Spain
8. ⁸Service of Medical Oncology, H Obispo Polanco, Avda. Ruiz Jarabo s/n44002, Teruel, Spain
9. ⁹Service of Medical Oncology, H de la Creu Roja, Avda. Josep Molins 29-41, Hospitalet de Llobregat, 08906 Barcelona, Spain
10. ¹⁰Service of Medical Oncology, H Príncipe de Asturias, Ctra. Alcalá-Meco s/n Alcalá de Henares, 28880 Madrid, Spain

Correspondence: Dr J Feliu, E-mail: jfeliu.hulp@salud.madrid.org

Received 28 November 2005; Revised 13 February 2006; Accepted 15 February 2006; Published online 21 March 2006.

Abstract

The purpose of this phase II trial was to determine the efficacy and safety of the XELOX (capecitabine/oxaliplatin) regimen as first-line therapy in the elderly patients with metastatic colorectal cancer (MCRC). A total of 50 patients with MCRC aged 70 years received oxaliplatin 130 mg m^-2 on day 1 followed by oral capecitabine 1000 mg m^-2 twice daily on days 1–14 every 3 weeks. Patients with creatinine clearance 30–50 ml min^-1 received a reduced dose of capecitabine (750 mg m^-2 twice daily). By intent-to-treat analysis, the overall response rate was 36% (95% CI, 28–49%), with three (6%) complete and 15 (30%) partial responses. In total, 18 patients (36%) had stable disease and 14 (28%) progressed. The median times to disease progression and overall survival were 5.8 months (95% CI, 3.9–7.8 months) and 13.2 months (95% CI, 7.6–16.9 months), respectively. Capecitabine was well tolerated: grade 3/4 adverse events were observed in 14 (28%) patients: 11 (22%) diarrhoea, eight (16%) asthenia, seven (14%) nausea/vomiting, three (6%) neutropenia, three (6%) thrombocytopenia, and two (4%) hand–foot syndrome. There was one treatment-related death from diarrhoea and sepsis. In conclusion, XELOX is well tolerated in elderly patients, with respectable efficacy and a meaningful clinical benefit response. Given its ease of administration compared with combinations of oxaliplatin with 5-FU/LV, it represents a good therapeutic option in the elderly.