Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer

• Published in: British journal of cancer Vol. 104; no. 7; pp. 1071 - 1078
• Main Authors: Stemmler, H J, diGioia, D, Freier, W, Tessen, H W, Gitsch, G, Jonat, W, Brugger, W, Kettner, E, Abenhardt, W, Tesch, H, Hurtz, H J, Rösel, S, Brudler, O, Heinemann, V
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 29-03-2011; Nature Publishing Group
• Subjects: 631/92/436/108; 692/699/67/1347; 692/700/565/1436/99; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Biomedical and Life Sciences; Biomedicine; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Breast Neoplasms - pathology; Cancer Research; Capecitabine; Cisplatin - administration & dosage; Clinical Study; Deoxycytidine - administration & dosage; Deoxycytidine - analogs & derivatives; Drug Resistance; Epidemiology; Female; Fluorouracil - administration & dosage; Fluorouracil - analogs & derivatives; Gemcitabine; Gynecology. Andrology. Obstetrics; Humans; Mammary gland diseases; Medical sciences; Middle Aged; Molecular Medicine; Neoplasm Metastasis; Oncology; Tumors; Vinblastine - administration & dosage; Vinblastine - analogs & derivatives; Vinorelbine; vinorelbine; capecitabine; anthracycline resistance; gemcitabine; cisplatin; metastatic breast cancer; Antineoplastic agent; Breast disease; Gemcitabine; Capecitabine; Metastasis; Alkaloid; Cancerology; Phase II trial; Clinical trial; Advanced stage; Antimitotic; Pyrimidine nucleoside; Platinum II Complexes; Human; Fluoropyrimidine derivatives; Breast cancer; Malignant tumor; Prodrug; Cisplatin; Mammary gland diseases; Alkylating agent; Antimetabolic; Pyrimidine derivatives; Fluorine Organic compounds; Comparative study; Vinorelbine; Cancer
• ISSN: 0007-0920; 1532-1827
• DOI: 10.1038/bjc.2011.86

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.