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Phase II study of preoperative sequential FEC and docetaxel predicts of pathological response and disease free survival.

Authors :
Masakazu Toi
Seigo Nakamura
Katsumasa Kuroi
Hiroji Iwata
Shinji Ohno
Norikazu Masuda
Mikihiro Kusama
Kosuke Yamazaki
Kazuhumi Hisamatsu
Yasuyuki Sato
Masahiro Kashiwaba
Hiroshi Kaise
Masafumi Kurosumi
Hitoshi Tsuda
Futoshi Akiyama
Yasuo Ohashi
Yuichi Takatsuka
Source :
Breast Cancer Research & Treatment; Aug2008, Vol. 110 Issue 3, p531-539, 9p, 4 Charts, 2 Graphs
Publication Year :
2008

Abstract

Abstract   Purpose This multicenter phase II study examined the impact of pathological effect on survival after preoperative chemotherapy in Japanese women with early stage breast cancer. Patients and methods Prior to surgery, patients received four cycles of FEC (fluorouracil 500 mg/m2, epirubicin 100 mg/m2, cyclophosphamide 500 mg/m2 q3w) followed by four cycles of docetaxel (75 mg/m2 q3w). Primary endpoint was 3 year disease free survival (DFS) stratified by the absence or presence of Quasi-pCR (QpCR; absence of invasive tumor or only focal residual tumor cells). Secondary endpoints were predictors for QpCR, clinical response, breast conservation rate, and safety. Results Between June 2002 and June 2004, 202 women were enrolled. Among 191 assessable patients, 25% achieved QpCR. With 40 months median follow-up, 3 year DFS was estimated at 91% for all patients. 3 year DFS for patients with QpCR was 98% vs. 89% without QpCR (hazard ratio 0.38 [95% Confidence Interval 0.09–0.84], P = 0.0134). HER2 status and response to FEC were independent predictors of QpCR. The overall clinical response was 75%; 85% of patients achieved breast conservation. Grade 3/4 neutropenia was the most common adverse event, observed in 44% and 35% of patients during FEC and docetaxel, respectively. Treatment related side effects were manageable; there were no treatment related fatalities. Conclusion FEC followed by docetaxel is an active and manageable preoperative regimen for women with early stage breast cancer. QpCR following preoperative chemotherapy predicts favorable DFS. HER2 overexpression and clinical response to FEC predict QpCR. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01676806
Volume :
110
Issue :
3
Database :
Complementary Index
Journal :
Breast Cancer Research & Treatment
Publication Type :
Academic Journal
Accession number :
33649472