Clinical trial

Breast Cancer Research and Treatment

, Volume 119, Issue 1, pp 145-153

First online:

The effect of body mass index on overall and disease-free survival in node-positive breast cancer patients treated with docetaxel and doxorubicin-containing adjuvant chemotherapy: the experience of the BIG 02-98 trial

  • Evandro de AzambujaAffiliated withInstitut Jules Bordet and Université Libre de Bruxelles (U.L.B)
  • , Worta McCaskill-StevensAffiliated withNational Cancer Institute, National Institutes of Health
  • , Prudence FrancisAffiliated withPeter MacCallum Cancer Centre and St Vincent’s Hospital, Australian New Zealand Breast Cancer Trials GroupAustralian New Zealand Breast Cancer Trials GroupInternational Breast Cancer Study Group
  • , Emmanuel QuinauxAffiliated withInternational Drug Development Institute
  • , John P. A. CrownAffiliated withSt. Vincent’s Hospital
  • , Malou VicenteAffiliated withBr.E.A.S.T. Data Centre
  • , Rosa GiulianiAffiliated withMedical Oncology Unit, S. Camillo-Forlanini Hospital
  • , Bo NordenskjöldAffiliated withUniversitetssjukhuset, Oncology
  • , Jorge GutiérezAffiliated withClinica Las Condes
    • , Michael AnderssonAffiliated withDepartment of Oncology, The Finsen Centre, Copenhagen University Hospital
    • , Mireia Margeli VilaAffiliated withHospital Germans Trias I Pujol
    • , Raimund JakeszAffiliated withUniversity of Vienna, General Hospital
    • , Jan DemolAffiliated withHeilig Hart Ziekenhuis
    • , Joanna DewarAffiliated withSir Charles Gairdner Hospital
    • , Armando SantoroAffiliated withIstituto Clinico Humanitas
    • , Ana LluchAffiliated withHospital Clinico Universitario
    • , Steven OlsenAffiliated withSanofi-aventis
    • , Richard D. GelberAffiliated withDepartment of Biostatistics and Computational Biology, Dana-Farber Cancer Institute
    • , Angelo Di LeoAffiliated withSandro Pitigliani Medical Oncology Unit, Hospital of Prato
    • , Martine Piccart-GebhartAffiliated withInstitut Jules Bordet and Université Libre de Bruxelles (U.L.B) Email author 

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Background: Obesity has been shown to be an indicator of poor prognosis for patients with primary breast cancer (BC) regardless of the use of adjuvant systemic therapy. Patients and methods: This is a retrospective analysis of 2,887 node-positive BC patients enrolled in the BIG 02-98 adjuvant study, a randomised phase III trial whose primary objective was to evaluate disease-free survival (DFS) by adding docetaxel to doxorubicin-based chemotherapy. In the current analysis, the effect of body mass index (BMI) on DFS and overall survival (OS) was assessed. BMI was obtained before the first cycle of chemotherapy. Obesity was defined as a BMI ≥ 30 kg/m². Results: In total, 547 (19%) patients were obese at baseline, while 2,340 (81%) patients were non-obese. Estimated 5-year OS was 87.5% for non-obese and 82.9% for obese patients (HR 1.34; P = 0.013). Estimated 5-years DFS was 75.9% for non-obese and 70.0% for obese patients (HR 1.20; P = 0.041). In a multivariate model, obesity remained an independent prognostic factor for OS and DFS. Conclusions: In this study, obesity was associated with poorer outcome in node-positive BC patients. Given the increasing prevalence of obesity worldwide, more research on improving the treatment of obese BC patients is needed.


Breast cancer Obesity BMI Adjuvant chemotherapy Docetaxel Node-positive