Journal of Clinical Oncology, 2008 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 26, No 15S (May 20 Supplement), 2008: 1054
© 2008 American Society of Clinical Oncology

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Abstract

Randomised trial comparing gemcitabine plus vinorelbine (Gem/Vin), gemcitabine plus cisplatin (Gem/Cis), and gemcitabine plus capecitabine (Gem/Cap) in pretreated metastatic breast cancer (MBC)

Onkologische Praxis, Hildesheim, Germany; University of Munich, Klinikum Grosshadern, Munich, Germany; Onkologische Praxis, Goslar, Germany; University of Freiburg, Freiburg, Germany; University of Schleswig-Holstein, Kiel, Germany; Schwarzwald-Baar Clinic, Villingen-Schwenningen, Germany; Klinikum Magdeburg GmbH, Magdeburg, Germany; Onkologische Praxis am Bethanien-Krankenhaus, Frankfurt, Germany; Onkologische Praxis Elisenhof, Munich, Germany

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Background: Breast cancer patients are increasingly exposed to anthracyclines and/or taxanes during perioperative therapy. Reinduction with these agents for treatment of metastatic disease is frequently limited by drug resistance or cumulative toxicity. Consequently, there is a need to develop new regimens free of anthracyclines or taxanes. Methods: This randomised phase II trial investigated pretreated MBC patients who were attributed to one of three gemcitabine-based regimens applied at 3-week intervals. Patients received either Gem/Vin (gemcitabine 1,000 mg/m² days 1+8 plus vinorelbine 25 mg/m² days 1+8) or Gem/Cis (gemcitabine 1,000mg/m² days 1+8 plus cisplatin 30 mg/m² days 1+8) or Gem/Cap (gemcitabine 1,000 mg/m² days 1+8 plus capecitabine 650 mg/m² bid orally days 1+14). ORR was evaluated as a primary end-point, while TTP, OS, and safety were analysed as secondary endpoints. Results: 134 eligible MBC patients were randomized and received either Gem/Vin (n=41), Gem/Cis (n=44), or Gem/Cap (n=49). Baseline characteristics regarding median age (58 vs 59 vs 61 years), and estrogen receptor positivity of the primary tumor (46% vs 49% vs 38%) were well balanced between Gem/Vin, Gem/Cis, and Gem/Cap treatment arms. All patients had previously received anthracyclines for adjuvant or palliative therapy. A median of 3 cycles was performed. According to an ITT analysis, overall response rates were in the Gem/Vin arm 32.5% (95% CI, 18.6–49.1%), in the Gem/Cis arm 47.7% (95% CI, 32.5–63.3%), and in the Gem/Cap arm 30.6% (95% CI, 18.3–45.4%). Progression-free survival for Gem/Vin, Gem/Cis, and Gem/Cap was 5.8 months, (95% CI, 3.9–8.2), 7.3 months (95% CI, 5.8–10.4), and 8.2 months (4.3–9.1), respectively, while overall survival was 17.8 months (12.5–37.2), 13.2 months (11.1–24.8), and 20.2 months (17.0–34.3), respectively. When overall grade 3–4 toxicities were compared, no significant difference between arms was detected (chi-square test). Conclusions: Three gemcitabine-based chemotherapy regimens, independent of anthracyclines and taxanes, were shown to be effective treatment options for pretreated MBC patients.

Author Disclosure

Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Lilly Germany Lilly Germany Lilly Germany

Abstract presentation from the 2008 ASCO Annual Meeting