Phase II trial of the use of paclitaxel and gemcitabine as a salvage treatment in metastatic breast cancer

Citation
Am. Murad et al., Phase II trial of the use of paclitaxel and gemcitabine as a salvage treatment in metastatic breast cancer, AM J CL ONC, 24(3), 2001, pp. 264-268
Citations number
32
Categorie Soggetti
Oncology
Journal title
AMERICAN JOURNAL OF CLINICAL ONCOLOGY-CANCER CLINICAL TRIALS
ISSN journal
02773732 → ACNP
Volume
24
Issue
3
Year of publication
2001
Pages
264 - 268
Database
ISI
SICI code
0277-3732(200106)24:3<264:PITOTU>2.0.ZU;2-F
Abstract
The purpose of this study was to evaluate gemcitabine plus paclitaxel in he avily pretreated patients with metastatic breast cancer (MBC). Patients wit h MBC with second or third relapse to anthracycline-containing regimens rec eived a 3-hour infusion of paclitaxel 175 mg/m(2) on day 1, and gemcitabine 1.0 g/m(2) on days 1, 8, and 15, every 28 days. Because of unacceptable th rombocytopenia seen in the first 5 patients, the gemcitabine schedule was c hanged to days 1 and 8 (G-1,8) for the remainder of the study, every 21 day s. Twenty-nine patients (median age, 46 years; range, 32-68 years) received 137 cycles (median: 4 per patient). The regimen was well tolerated. World Health Organization grades III and IV thrombocytopenia were observed in 5 ( 18.5%) of the first 27 cycles (G-1,8,15), and in 6 (5.4%) of the 110 subseq uent cycles (G-1,8)-p = 0.04 for the difference between schedules. Five pat ients had grade I and two had grade III neuropathy. Eight patients had grad e III neutropenia, two had grade ni neutropenia associated with fever (G-1, 8,15), and eight had grades I and II myalgia and fatigue. There were 16 (55 %) objective responses (95% CI 36-73%); 5 (17%) complete responses, 11 (38% ) partial responses (35% CI 3-30% and 19-56%, respectively), and 6 (20.5%) patients with stable disease. Median response duration was 8 months (range, 4-26 months). Median overall survival was 12 months (range, 4-28+ months), and 1-year and 2-year survival rates were 45% and 30%, respectively. This phase Il study demonstrated a manageable toxicity profile with the gemcitab ine day 1, 8 schedule in combination with paclitaxel and significant and pr omising activity in heavily pretreated patients with MBC. A confirmatory ph ase III trial is warranted.