Neoadjuvant paclitaxel for operable breast cancer: multicenter phase II trial with clinical outcomes.
OBJECTIVE
To determine the efficacy of preoperative weekly paclitaxel for patients with operable breast cancer tumors greater than 3 cm.


METHODS
Paclitaxel 80 mg/m2 weekly x 3 times every 4 weeks for 3 cycles was administered to 53 patients. Twenty-two patients were stage 11, 26 stage III, 5 stage IV Median age (range) was 53 (24-73) years, and 32 patients were negative for estrogen receptor. Thirteen patients showed HER2 overexpression.


RESULTS
Eligible cases composed of 53 patients for evaluation of response. Seven patients had a clinical complete response and 29 patients had a partial response. The overall response rate was 67.9%, including three patients with a pathological complete response. In 18 patients with HER2 overexpression, a clinical complete response was observed in 5, a partial response was observed in 9, and stable disease was found in 4. No treatment, related to grade 3 neutropenia, was given for 1 patient (2%). Other hematological and non-hematological toxicity was found in only 1 patient with fatigue.


CONCLUSIONS
Preoperative weekly paclitaxel induced a high clinical response rate with a high safety profile. HER2-overepressing tumors had a higher clinical response rate than non-HER2-overepxressing tumors (91% vs. 50%, respectively). Further studies are needed to determine whether an increase in the cycles of paclitaxel and/or adding anthracyclines may lead to higher pathological complete response and breast-conservation rates in the neoadjuvant setting.
Kimura
Morihiko
M
Department of Surgery, General Ota Hospital, Ota, Gunma 373-8585, Japan. kimuraota@yahoo.co.jp
Sano
Muneaki
M
Fujimori
Minoru
M
Nakagomi
Hiroshi
H
Negishi
Takeshi
T
Yanagita
Yasuhiro
Y
Sato
Nobuaki
N
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000201:enzymology / Q000473:pathology / Q000601:surgery; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000096:biosynthesis; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel; D018719:Erb-b2 Receptor Tyrosine Kinases