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

• Published in: Asia-Pacific journal of clinical oncology 2009-03, Vol.5 (1), p.32-38
• Main Authors: GOEL, Shom, ABDI, Ehtesham, LEWIS, Craig R, LINKS, Matthew, BEGBIE, Steven, CLINGAN, Philip, GANJU, Vinod, BEITH, Jane
• Format: Article
• Language: English
• Subjects: anthracycline; breast cancer; docetaxel; gemcitabine; metastatic
• ISSN: 1743-7555; 1743-7563
• DOI: 10.1111/j.1743-7563.2009.01189.x

Aim:  Gemcitabine (G) and docetaxel (D) have both shown activity in the treatment of anthracycline‐pretreated 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/m2 followed by G 800 mg/m2 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.