A phase I-II study of bi-weekly paclitaxel as first-line treatment in metastatic breast cancer.
BACKGROUND
Single-agent bi-weekly paclitaxel was studied as first-line metastatic treatment for breast cancer in a phase I-II trial.


METHODS
Thirty-eight women with metastatic breast cancer were enrolled. Thirty-seven are evaluable for toxicity, 35 for response.


RESULTS
The MTD was defined at 160 mg/m2 q two weeks with dose limiting toxicity in two patients consisting of hematological toxicity (1) and neurotoxicity (2). Twenty patients were treated at 150 mg/m2, the recommended dose. Response rates were two CRs and nine PRs (overall 61%) at the RD of 150 mg/m2 and three CRs and 11 PRs for an overall RR of 67% for the two top doses.


CONCLUSIONS
The good drug tolerance, response rates, and convenience over weekly treatment suggest this may be a worthwhile regimen.
Gelmon
K A
KA
British Columbia Cancer Agency, Vancouver Centre, Canada.
Tolcher
A
A
O'Reilly
S
S
Campbell
C
C
Bryce
C
C
Shenkier
T
T
Ragaz
J
J
Ayers
D
D
Nakashima
L
L
Rielly
S
S
Dulude
H
H
D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage* / Q000627:therapeutic use
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel