Phase 3 study comparing the use of docetaxel on an every-3-week versus weekly schedule in the treatment of metastatic breast cancer.
BACKGROUND
Previous studies have evaluated 3-week and weekly docetaxel schedules in patients with metastatic breast cancer (MBC). The varying efficacy results and toxicity profiles noted in these earlier studies led to a comparison of the schedules to determine which was safer and more efficacious.


METHODS
A phase 3 clinical trial was conducted in patients with MBC who were treated with docetaxel either every 3 weeks or once weekly to determine and compare response rate and duration, time to disease progression, progression-free survival (PFS), overall survival (OS), and toxicity. Patients were randomized to receive docetaxel at a starting dose of either 75 mg/m(2) every 3 weeks or 35 mg/m(2) weekly for 3 consecutive weeks followed by 1 week of rest.


RESULTS
A total of 118 patients underwent efficacy analysis; 59 patients were randomized to the every-3-week treatment arm and 59 to the weekly arm. The response rate was 35.6% (95% confidence interval [95% CI], 23.6-49.1%) for the every-3-week arm versus 20.3% (95% CI, 11.0-32.8%) for the weekly arm. There was no statistical difference between the every 3-week and the weekly treatment arms with regard to median PFS (5.7 months vs 5.5 months; P= .46) or OS (18.3 months vs 18.6 months, respectively; P= .34). There was a higher overall toxicity rate (grades 3 and 4, according to the National Cancer Institute Common Toxicity Criteria [version 2.0]) in the every-3-week treatment arm versus the weekly treatment arm (88.1% vs 55.9%, respectively; P= .0001).


CONCLUSIONS
Compared with patients who received weekly docetaxel, those who received docetaxel every 3 weeks had a higher response rate but experienced similar PFS and OS and a more pronounced toxicity.
Rivera
Edgardo
E
Department of Breast Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
Mejia
Jaime A
JA
Arun
Banu K
BK
Adinin
Rosnie B
RB
Walters
Ronald S
RS
Brewster
Abenaa
A
Broglio
Kristine R
KR
Yin
Guosheng
G
Esmaeli
Bita
B
Hortobagyi
Gabriel N
GN
Valero
Vicente
V
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006801:Humans; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage*
D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel