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, Australian New Zealand Breast Cancer Trials Group

Research output: Contribution to journalArticle

10 Scopus citations

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 languageEnglish (US)
Pages (from-to)1177-1184
Number of pages8
JournalAnnals of Oncology
Volume18
Issue number7
DOIs
StatePublished - Jul 1 2007

Keywords

  • Adjuvant therapy
  • Chemotherapy
  • Early-stage breast cancer
  • Estrogen receptor
  • Hormonal therapy
  • Lymph node positive

ASJC Scopus subject areas

  • Hematology
  • Oncology

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