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Annals of Oncology Advance Access originally published online on April 11, 2007
Annals of Oncology 2007 18(7):1177-1184; doi:10.1093/annonc/mdm091
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© 2007 European Society for Medical Oncology

breast cancer

Effects of a treatment gap during adjuvant chemotherapy in node-positive breast cancer: results of International Breast Cancer Study Group (IBCSG) Trials 13-93 and 14-93

The International Breast Cancer Study Group

* Correspondence to: Dr Marco Colleoni, Division of Medical Oncology, European Institute of Oncology, 20141 Milan, Italy. Tel: +39-2-57489439; Fax: +39-2-57489412; E-mail: marco.colleoni{at}ieo.it

Background: The International Breast Cancer Study Group (IBCSG) conducted two complementary randomized trials to assess whether a treatment-free gap during adjuvant chemotherapy influenced outcome.

Patients and methods: From 1993 to 1999, IBCSG Trials 13-93 and 14-93 enrolled 2215 premenopausal and postmenopausal women with axillary node-positive, operable breast cancer. All patients received cyclophosphamide (Cytoxan, C) plus either doxorubicin (Adriamycin, A) or epirubicin (E) for four courses followed immediately (No Gap) or after a 16-week delay (Gap) by classical cyclophosphamide, methotrexate, and fluorouracil (CMF) for three courses. The median follow-up was 7.7 years.

Results: The Gap and No-Gap groups had similar disease-free survival (DFS) and overall survival (OS). No identified subgroup showed a statistically significant difference, but exploratory subgroup analysis noted a trend towards decreased DFS for Gap compared with No Gap for women with estrogen receptor (ER)-negative tumors not receiving tamoxifen, especially evident during the first 2 years.

Conclusions: A 16-week gap between adjuvant AC/EC and CMF provided no benefit and may have increased early recurrence rates in patients with ER-negative tumors.

Key words: adjuvant therapy, chemotherapy, early-stage breast cancer, estrogen receptor, hormonal therapy, lymph node positive

Received for publication December 26, 2006. Revision received February 12, 2007. Revision received February 13, 2007. Accepted for publication February 13, 2007.


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