Background: The primary objective of this multicenter, open-label, randomized, parallel, phase II selection trial was to compare the objective tumor response to biweekly (every 2 weeks) gemcitabine/paclitaxel, gemcitabine/carboplatin, and gemcitabine/cisplatin as first-line treatment for metastatic breast cancer. Patients and methods: Eligible patients with stage IV disease who relapsed after anthracycline failure were randomly assigned in a 1:1:1 ratio to gemcitabine (2,500 mg/m2) plus paclitaxel 150 mg/m 2 (n = 49); plus carboplatin, area under the curve = 2.5 mg/mL × min (n = 47); or plus cisplatin 50 mg/m 2 (n = 51). Study therapy continued up until a maximum of 8 cycles and follow-up continued for 24 months. Results: All patients were analyzed for efficacy and one patient was excluded from the safety analyses. The objective response was 26.5% [95% confidence interval (CI) 14.9-41.1] for gemcitabine/paclitaxel, 17.0% (95% CI 7.6-30.8) for gemcitabine/carboplatin, and 15.7% (95% CI 7.0-28.6) for gemcitabine/cisplatin. The adjusted odds ratio for tumor response was 0.33 (95% CI 0.10-1.06), P = 0.063 for gemcitabine/carboplatin versus gemcitabine/paclitaxel; 0.26 (95% CI 0.08-0.86), P = 0.027 for gemcitabine/cisplatin versus gemcitabine/paclitaxel; and 0.77 (95% CI 0.24-2.52), P = 0.671 for gemcitabine/cisplatin versus gemcitabine/carboplatin. There were no significant differences in overall survival or progression-free survival (P > 0.05). Grade 3 or 4 drug-related adverse events varied between groups and the majority of deaths (94.9%; 74/78) were related to disease progression. Conclusions: The gemcitabine-based treatments had comparable activity and tolerability. Similar survival characteristics and different toxicity profiles suggested that gemcitabine-platinum may be evaluated further in patients after anthracycline failure.
Bibliographical noteFunding Information:
Acknowledgments This study was sponsored by Eli Lilly and Company. The sponsor was involved in the design of the study, data collection and analysis, and the preparation of the manuscript, and did not impose any impediment, directly or indirectly, on the publication of the study’s results. The authors acknowledge the independent medical writing assistance provided by Serina Stretton (PhD) and Mark Woolley (PhD) of ProScribe Medical Communications, which was funded from an unrestricted financial grant from Eli Lilly and Company. ProScribe’s services complied with international guidelines for Good Publication Practice (GPP2). The authors would also like to thank all of the investigative site staff and patients who participated in the study, and Susanna Holt (Eli Lilly) for her assistance with the statistical analyses and editorial support. Part of this work was previously presented in abstract form at the 43rd Annual Meeting of the American Society of Clinical Oncology; 1–5 June 2007 (abstract #1099).
All Science Journal Classification (ASJC) codes
- Radiology Nuclear Medicine and imaging
- Pharmacology (medical)