Clinical Study

Capecitabine and Vinorelbine as First-Line Treatment in Elderly Patients (65 Years) with Metastatic Breast Cancer
A Phase II Trial (SAKK 25/99)
D. Hess^a, D. Köberle^a, B. Thürlimann^a, O. Pagani^b, A. Schönenberger^c, S. Mattmann^d, C. Rochlitz^e, D. Rauch^f, J.C. Schuller^g, P. Ballabeni^g, K. Ribi^g, on behalf of the Swiss Group for Clinical Cancer Research (SAKK)

^aDepartment of Internal Medicine, Division of Oncology-Hematology, Kantonsspital St. Gallen, St. Gallen,
^bOspedale San Giovanni, Bellinzona,
^cKantonsspital Aarau, Aarau,
^dKantonsspital Luzern, Luzern,
^eKantonsspital Basel, Basel,
^fSpital Thun, Thun, and
^gSAKK, Bern, Switzerland

Address of Corresponding Author

Oncology 2007;73:228-237 (DOI: 10.1159/000127414)

  Key Words

• Advanced disease
• Breast cancer
• Capecitabine
• Elderly patients
• Phase II trial
• Vinorelbine

  Abstract

Background: We evaluated previously established regimens of capecitabine plus vinorelbine in older patients with advanced breast cancer stratified for presence versus absence of bone metastases. Patients and Methods: Patients 65 years who had received no prior chemotherapy for advanced breast cancer received up to six 21-day cycles of vinorelbine 20 mg/m² i.v. on days 1 + 8 with oral capecitabine on days 1-14 (1,000 vs. 1,250 mg/m² daily in patients with vs. without bone involvement). Results: Median age was 72 years in patients with bone metastases (n = 47) and 75 years in patients without bone metastases (n = 23). Response rates were 43% (95% confidence interval, CI, 28.3-58.8) and 57% (95% CI = 34.5-76.8), respectively. Median time to progression was 4.3 (95% CI = 3.5-6.0 months) and 7.0 months (CI = 4.1-8.3), respectively. Neutropenia was the most common toxicity, with grade 3/4 occurring in 43 and 39%, respectively. Pulmonary embolism was seen in 5 and grade 3 thrombosis in 3 patients. Other toxicities were mild to moderate. Conclusions: These regimens of capecitabine and vinorelbine are active and well tolerated in patients with advanced breast cancer 65 years. Response rates were comparable to published results. The lower capecitabine doses appeared appropriate given the advanced age, bone involvement and prior radiotherapy.

Copyright © 2008 S. Karger AG, Basel

  Author Contacts

Dr. D. Hess
Department of Internal Medicine
Division of Oncology-Hematology, Kantonsspital
CH-9007 St. Gallen (Switzerland)
Tel. +41 71 494 1111, Fax +41 71 494 6317, E-Mail dagmar.hess@kssg.ch

  Article Information

Received: September 6, 2007
Accepted: September 8, 2007
Published online: April 17, 2008
Number of Print Pages : 10
Number of Figures : 5, Number of Tables : 8, Number of References : 23