@article{371a9980962f4f07bbc26f09e7e895b2,
title = "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",
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.",
keywords = "Adjuvant therapy, Chemotherapy, Early-stage breast cancer, Estrogen receptor, Hormonal therapy, Lymph node positive",
author = "{The International Breast Cancer Study Group} and {Australian New Zealand Breast Cancer Trials Group} and Marco Colleoni and Shari Gelber and Edda Simoncini and Olivia Pagani and Gelber, {Richard D.} and Price, {Karen N.} and Monica Castiglione-Gertsch and Coates, {Alan S.} and Aron Goldhirsch and B. Th{\"u}rlimann and M. Castiglione and Collins, {J. P.} and {Cort{\'e}s Funes}, H. and M. Green and A. Hiltbrunner and Holmberg, {S. B.} and Hossfeld, {D. K.} and I. L{\'a}ng and J. Lindtner and F. Paganetti and Rudenstam, {C. M.} and R. Stahel and Senn, {H. J.} and A. Veronesi and G. Egli and M. Rabaglio and R. Studer and B. Ruepp and R. Maibach and E. Marbot and M. Strausak and R. Gelber and B. Cole and M. Regan and D. Zahrieh and Z. Sun and J. Bernhard and Ch H{\"u}rny and B. Gusterson and G. Viale and L. Blacher and J. Celano and M. Isley and R. Hinkle and S. Lippert and K. Scott and D. Crivellari and S. Monfardini and E. Galligioni and Magri, {M. D.}",
note = "Funding Information: We thank the patients, physicians, nurses, and data managers who participated in the International Breast Cancer Study Group trials. We acknowledge Joie Celano for data management. We further acknowledge support for central coordination, data management, and statistics provided by the Swiss Group for Clinical Cancer Research, the Frontier Science and Technology Research Foundation, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group (National Health Medical Research Council grant numbers 890028, 920876, 950328, 980379, 141711), the American Cancer Society (RPG-90-013-08-PBP), and the USA National Cancer Institute (CA-75362), Swedish Cancer Society. We also acknowledge support for the Cape Town participants from the Cancer Association of South Africa, and for the St Gallen participants from the Foundation for Clinical Cancer Research of Eastern Switzerland, and Orion-Farmos (for medication for Trial 14-93).",
year = "2007",
month = jul,
day = "1",
doi = "10.1093/annonc/mdm091",
language = "English (US)",
volume = "18",
pages = "1177--1184",
journal = "Annals of Oncology",
issn = "0923-7534",
publisher = "Oxford University Press",
number = "7",
}