Abstract
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.
Original language | English |
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Pages (from-to) | 1177-1184 |
Number of pages | 8 |
Journal | Annals of Oncology |
Volume | 18 |
Issue number | 7 |
DOIs | |
Publication status | Published - Jul 2007 |
Keywords
- Adjuvant therapy
- Chemotherapy
- Early-stage breast cancer
- Estrogen receptor
- Hormonal therapy
- Lymph node positive
ASJC Scopus subject areas
- Cancer Research
- Oncology