Phase II study of gemcitabine and docetaxel in combination for the treatment of metastatic breast cancer

Abstract

Aim: Gemcitabine (G) and docetaxel (D) have both shown activity in the treatment of anthracyclinepretreated patients with metastatic breast cancer. This phase II study was designed to evaluate the safety and efficacy of the GD combination. Methods: Patients with measurable locally advanced or metastatic breast cancer who had previously received anthracycline-based therapy were eligible. The patients received D 40 mg/m 2 followed by G 800 mg/m 2 IV on days 1 and 8 every 3 weeks for a maximum of eight cycles. Results: Thirty patients were enrolled and received a median of five cycles (range 0-8). Of these, 24 were evaluable for efficacy, with an overall response rate of 29.2% (95% CI, 12.6-51.1%). An additional 36.7% had a stable disease for an overall clinical benefit of 65.9%. The median duration of response was 2.1 months (95% CI, 2.0-3.6 months) and the median time to disease progression was 5.5 months (95% CI, 2.0-8.9 months). The median survival time was 16.7 months (95% CI, 7.3-32.0 months). Myelosuppression was the major toxicity, with grade 3/4 neutropenia in 73.3% of patients and febrile neutropenia in 6.7%. Conclusion: Weekly G and D is an active and safe regimen in treating metastatic breast cancer. The response rate was lower than that previously reported for this combination, which may relate to the lower doses used and the weekly D schedule. It may be worthwhile to further explore this combination to determine the optimal dosing schedule.

Identification of genes associated with chemosensitivity to SAHA/taxane combination treatment in taxane-resistant breast cancer cells

“…One strategy to overcome chemoresistance is the use of combination chemotherapy, which is associated with potentially higher response rates and improved time to progression. However, the combination of cytotoxic agents has increased toxicity and a debatable overall survival benefit [5]. There is an urgent need to develop novel combination agents to overcome taxane resistance in the treatment of MBC.…”