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
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.