Detailed analysis of a randomized phase III trial: can the tolerability of capecitabine plus docetaxel be improved without compromising its survival advantage?
Open Access
- 1 September 2006
- journal article
- research article
- Published by Elsevier BV in Annals Of Oncology
- Vol. 17 (9), 1379-1385
- https://doi.org/10.1093/annonc/mdl134
Abstract
Background: In a phase III trial, 3-weekly capecitabine (1250 mg/m2 twice daily days 1–14) plus docetaxel (75 mg/m2 day 1) demonstrated significantly superior overall survival to 3-weekly docetaxel (100 mg/m2 day 1). We report a retrospective analysis of the impact of capecitabine/docetaxel dose reduction on safety and efficacy. Patients and methods: Safety and efficacy data were analyzed retrospectively according to the actual doses of capecitabine and docetaxel administered. Results: More patients receiving capecitabine/docetaxel (65%) had dose reductions for adverse events than docetaxel alone (35%). In most patients requiring dose reduction with the combination (80%), capecitabine and docetaxel were simultaneously reduced to 950 mg/m2 and 55 mg/m2, respectively. Subsequently, there were fewer cycles (17%) with grade 3/4 adverse events than with the full doses (34%). Time to progression and overall survival appeared to be similar in patients starting the second cycle with reduced doses of capecitabine/docetaxel and those who continued to receive full doses of capecitabine/docetaxel for at least the first four cycles. Conclusions: Capecitabine/docetaxel dosing flexibility allows management of side-effects without compromising efficacy. This retrospective analysis, as well as multiple phase II studies of taxanes with reduced-dose capecitabine, shows that reducing the starting dose of capecitabine with docetaxel is a reasonable strategy for the treatment of patients with metastatic breast cancer. In addition, reducing the dose of both agents may be appropriate.This publication has 16 references indexed in Scilit:
- Randomized Phase III Trial of Capecitabine Compared With Bevacizumab Plus Capecitabine in Patients With Previously Treated Metastatic Breast CancerJournal of Clinical Oncology, 2005
- Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancerEuropean Journal Of Cancer, 2004
- Multicenter phase II study of oral capecitabine (Xeloda“) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapyAnnals Of Oncology, 2003
- Multicenter, Phase II study of capecitabine in taxane-pretreated metastatic breast carcinoma patientsCancer, 2001
- Capecitabine (Xeloda) in 162 patients with paclitaxel-pretreated mbc: updated results and analysis of dose modificationEuropean Journal Of Cancer, 2001
- A phase I and pharmacokinetic study of the combination of capecitabine and docetaxel in patients with advanced solid tumoursBritish Journal of Cancer, 2000
- Preferential activation of capecitabine in tumor following oral administration to colorectal cancer patientsCancer Chemotherapy and Pharmacology, 2000
- Prospective Randomized Trial of Docetaxel Versus Mitomycin Plus Vinblastine in Patients With Metastatic Breast Cancer Progressing Despite Previous Anthracycline-Containing ChemotherapyJournal of Clinical Oncology, 1999
- Multicenter Phase II Study of Capecitabine in Paclitaxel-Refractory Metastatic Breast CancerJournal of Clinical Oncology, 1999
- Design of a novel oral fluoropyrimidine carbamate, capecitabine, which generates 5-fluorouracil selectively in tumours by enzymes concentrated in human liver and cancer tissueEuropean Journal Of Cancer, 1998