A phase II study of gemcitabine plus paclitaxel in patients with metastatic breast cancer and prior anthracycline treatment.
OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Gemcitabine-paclitaxel combination therapy is an active and well-tolerated chemotherapy regimen, with expected and manageable toxicity in Chinese patients with metastatic breast cancer.
Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing, China. bhxu@hotmail.com
Binghe
B
Xu
Zhenzhou
Z
Shen
Zefei
Z
Jiang
Zhongzhen
Z
Guan
Xiaoqing
X
Zhang
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
D018943:Anthracyclines; D003841:Deoxycytidine; D017239:Paclitaxel; D000093542:Gemcitabine