A phase II study of gemcitabine plus paclitaxel in patients with metastatic breast cancer and prior anthracycline treatment.
ABSTRACT To investigate the efficacy and safety of gemcitabine-paclitaxel in Chinese patients with metastatic breast cancer following anthracycline failure in a multicenter, open-label, single-arm, phase II clinical trial.
Chinese female patients with unresectable, locally recurrent or metastatic breast cancer who had relapsed after neo-adjuvant anthracycline-based chemotherapy were included. All patients had measurable disease and an Eastern Cooperative Oncology Group performance status of 0 or 1 at baseline. Gemcitabine (1250 mg/m(2) )-paclitaxel (175 mg/m(2) ) was administered on a 3-weekly schedule until disease progression, and patients were followed up for 12 months (post-enrollment). The primary end point was objective response rate; secondary end points included duration of response, progression-free survival and overall survival.
Overall 60 patients were enrolled. Their mean age was 46.9 (SD ± 9.0) years and 90% of patients had metastatic disease. All patients had previously received chemotherapy. A total of 48 patients (80%) completed the 12-month follow up, and 40 patients (67%) completed at least six cycles of study therapy. The objective response rate (complete response + partial response) was 50% (95% CI: 36.6-63.4). Median duration of response was 5.6 months (95% CI: 4.4-7.6) and median progression-free survival was 7.6 months (95% CI: 5.8-8.8). Overall survival at 12 months was 87% (95% CI: 77.9-95.2). Laboratory toxicities were primarily hematologic, including Grade 3 and 4 neutropenia (n = 27 [45%]) and leukopenia (n = 18 [30%]). Eight patient deaths (13%) were not treatment-related.
Gemcitabine-paclitaxel combination therapy is an active and well-tolerated chemotherapy regimen, with expected and manageable toxicity in Chinese patients with metastatic breast cancer.
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ABSTRACT: The incidence of breast cancer in China is increasing at a rate greater than the global average. For treatment of metastatic breast cancer, a phase 3 trial of 529 patients (study JHQG) found that the combination of gemcitabine, a cytotoxic nucleoside analog, and paclitaxel, a taxane, significantly improved both overall and progression-free survival compared with paclitaxel monotherapy. As ethnic differences in the safety and efficacy of some anticancer therapies have been reported, this review provides oncologists treating East Asian patients with an evidence base to extrapolate results of the predominately Caucasian phase 3 JHQG study to their patients. Three phase 2 studies in Chinese or Japanese patients with metastatic breast cancer are reviewed with reference to the global study JHQG. The results of pharmacokinetic, efficacy and safety analyses are descriptively compared between the global and Asian studies. Peak and total drug exposure values differed by less than 10% across the studies. Response rate, overall and progression-free survival values were similar, although values from the Asian studies for each of these parameters were slightly higher. Asian patients had higher rates of hematologic toxicities but lower rates of other adverse events. Examination of the data from three studies of the gemcitabine-paclitaxel combination reveals no clinically significant ethnic differences in efficacy and safety between East Asian patients and their global counterparts. Given its demonstrated efficacy and safety profile, the gemcitabine-paclitaxel regimen should be one of the standard treatments for East Asian patients with metastatic breast cancer.Asia-Pacific Journal of Clinical Oncology 10/2013; · 0.91 Impact Factor