Background: A systematic review of the evidence for gemcitabine chemotherapy, alone or in combination, in women with metastatic/advanced breast cancer was undertaken in order to determine gemcitabine's role in the first-line and/or second-line or greater setting.
Methods: MEDLINE, EMBASE, the American Society of Clinical Oncologists, San Antonio Breast Cancer Symposium proceedings, and the Cochrane Library were searched through September 2006 for randomized controlled trials and non-randomized phase two trials.
Results: Eighty-three trials were identified, including four randomized phase III trials. All of the phase III trials included first-line patients. Two of the phase III trails demonstrated clinical benefit with gemcitabine-based chemotherapy in terms of superior efficacy or less toxicity while two phase III trials found no clinical benefit based on less efficacy or increased toxicity. Although 78 phase II trials of gemcitabine alone or in combination with other chemotherapy agents were identified, few combinations showed results compelling enough to warrant randomized trials.
Conclusion: Available data do not support the acceptance of gemcitabine as a standard therapeutic option in women with metastatic breast cancer in the third-line or greater setting, nor should it be considered as first-line therapy in anthracycline naïve women. Gemcitabine appears to be most effective when administered with a taxane (docetaxel/paclitaxel) in the first- or second-line setting, with gemcitabine/taxane combinations representing a viable alternative to currently accepted taxane combinations such as capecitabine/docetaxel. There is no evidence at this time to support the use of gemcitabine triplets, given the equal efficacy to anthracycline triplets and the added toxicity.