Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer
| Autor: | W. Abenhardt, W. Brugger, S Rösel, W Jonat, W. Freier, O. Brudler, Volker Heinemann, H J Hurtz, Hans-Joachim Stemmler, H Tesch, Gerald Gitsch, H W Tessen, E. Kettner, D diGioia |
|---|---|
| Rok vydání: | 2011 |
| Předmět: |
Adult
Oncology Cancer Research medicine.medical_specialty medicine.medical_treatment cisplatin Breast Neoplasms Neutropenia Vinblastine Vinorelbine Deoxycytidine anthracycline resistance Capecitabine Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Neoplasm Metastasis Lung cancer Aged Chemotherapy business.industry capecitabine gemcitabine Middle Aged medicine.disease Metastatic breast cancer Gemcitabine Fluorouracil Clinical Study Female metastatic breast cancer business medicine.drug |
| Zdroj: | British Journal of Cancer |
| ISSN: | 1532-1827 0007-0920 |
| Popis: | Background: An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory. Methods: Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m−2 plus vinorelbin 25 mg m−2 on days 1+8 (GemVin), or plus cisplatin 30 mg m−2 on days 1+8 (GemCis), or plus capecitabine 650 mg m−2 b.i.d. orally days 1–14 (GemCap), q3w. The primary end point was response rate. Results: A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ⩾grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand–foot syndrome in 2.0% of the GemCap patients (per patient analysis). Conclusions: This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer. |
| Databáze: | OpenAIRE |
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