First-Line Therapy with Gemcitabine and Paclitaxel in Locally Recurrent or Metastatic Breast Cancer: A Phase II Study

In three separate studies from 2005, the combination of gemcitabine and paclitaxel was evaluated as a first-line therapy for patients with metastatic breast cancer (MBC). The first study involved 40 patients and reported an overall response rate of 35.0% in the intent-to-treat population, with a median duration of response of 12 months, median time to progression of 7.2 months, and median survival of 25.7 months. Common severe toxicities included neutropenia, leukopenia, and alopecia. The second study, with a similar patient profile, confirmed the efficacy of the treatment with comparable response rates and manageable toxicity. The third study included 43 chemonaive patients and reported an overall response rate of 68% with a 3-week schedule, and 67% with a 2-week schedule, with moderate neutropenia as a common side effect. The results across these studies indicated that the combination of gemcitabine and paclitaxel was effective and had an acceptable safety profile, suggesting the need for further evaluation in phase III trials. The studies were funded by Eli Lilly and Company, with some authors being employed by the company.