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Annals of Oncology Advance Access published online on August 27, 2009
Annals of Oncology, doi:10.1093/annonc/mdp359
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Capecitabine in combination with oxaliplatin or irinotecan in elderly patients with advanced colorectal cancer: results of a randomized phase II study

G. Rosati1,*, S. Cordio2, R. Bordonaro3, G. Caputo2, G. Novello3, G. Reggiardo4 and L. Manzione1

1 Medical Oncology Unit, S. Carlo Hospital, Potenza
2 Medical Oncology Unit, Garibaldi Nesima Hospital
3 Medical Oncology Unit, Vittorio Emanuele Hospital, Catania
4 Biostatistic Unit Medi Service, Genova, Italy

* Correspondence to: Dr G. Rosati, Via Sanremo, 197, 85100 Potenza, Italy. Tel: +39-0971-612273; Fax: +39-0971-613000; E-mail: oncogerry{at}yahoo.it

Background: To determine the efficacy and tolerability of capecitabine combined with oxaliplatin (CAPOX) or irinotecan (CAPIRI) as first-line treatment in patients with advanced/metastatic colorectal cancer aged ≥70 years.

Patients and methods: Patients aged ≥70 years were randomly assigned to receive CAPOX [oxaliplatin 65 mg/m2 intravenously (i.v.) days 1 and 8 and capecitabine 1000 mg/m2 orally b.i.d. days 1–14; q21d] or CAPIRI (irinotecan 80 mg/m2 i.v. days 1 and 8 and capecitabine 1000 mg/m2 orally b.i.d. days 1–14; q21d). The primary study end point was overall response rate (ORR).

Results: Ninety-four patients were enrolled. In an intent-to-treat analysis, 2 complete responses (CRs) and 16 partial responses (PRs) were reported with CAPOX (ORR 38%), and 2 CRs and 15 PRs with CAPIRI (ORR 36%; P = 0.831). Median time to progression was 8 months for CAPOX and 7 months for CAPIRI (P = 0.195), with median survival times of 19.3 months and 14.0 months (P = 0.165), respectively. Global health status was improved in 45% and in 21% of patients in the CAPOX and CAPIRI arms, respectively. The most common treatment-related grade 3–4 adverse events in CAPIRI versus CAPOX patients were diarrhea (32% versus 15%; P = 0.052) and neutropenia (23% versus 6%; P = 0.021).

Conclusion: CAPOX and CAPIRI had similar efficacy in elderly patients, although CAPOX seemed to be better tolerated.

advanced colorectal cancer, capecitabine, elderly, irinotecan, oxaliplatin

Received for publication April 10, 2009. Revision received June 13, 2009. Accepted for publication June 15, 2009.


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