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Is chemotherapy necessary for premenopausal women with lower-risk node-positive, endocrine responsive breast cancer? 10-year update of International Breast Cancer Study Group Trial 11-93

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Abstract

Introduction International Breast Cancer Study Group (IBCSG) Trial 11-93 is the largest trial evaluating the role of the addition of chemotherapy to ovarian function suppression/ablation (OFS) and tamoxifen in premenopausal patients with endocrine-responsive early breast cancer. Methods IBCSG Trial 11-93 is a randomized trial comparing four cycles of adjuvant chemotherapy (AC: doxorubicin or epirubicin, plus cyclophosphamide) added to OFS and 5 years of tamoxifen versus OFS and tamoxifen without chemotherapy in premenopausal patients with node-positive, endocrine-responsive early breast cancer. There were 174 patients randomized from May 1993 to November 1998. The trial was closed before the target accrual was reached due to low accrual rate. Results Patients randomized tended to have lower risk node-positive disease and the median age was 45. After 10 years median follow up, there remains no difference between the two randomized treatment groups for disease-free (hazard ratio = 1.02 (0.57–1.83); P = 0.94) or overall survival (hazard ratio = 0.97 (0.44–2.16); P = 0.94). Conclusion This trial, although small, offers no evidence that AC chemotherapy provides additional disease control for premenopausal patients with lower-risk node-positive endocrine-responsive breast cancer who receive adequate adjuvant endocrine therapy. A large trial is needed to determine whether chemotherapy adds benefit to endocrine therapy for this population.

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Acknowledgments

We thank the patients, physicians, nurses, and data managers who participated in this International Breast Cancer Study Group (IBCSG) trial. The IBCSG is funded by the Swedish Cancer Society, The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group (NHMRC grant number 940892), the Frontier Science and Technology Research Foundation, the Swiss Group for Clinical Cancer Research (SAKK), Cancer Research Switzerland/Oncosuisse, the Foundation for Clinical Research of Eastern Switzerland (OSKK), and the United States National Cancer Institute (CA-75362).

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Authors and Affiliations

  1. Senology Center of Eastern Switzerland, Kantonsspital, St. Gallen, Switzerland

    Beat Thürlimann

  2. Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland

    Beat Thürlimann

  3. IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA

    Karen N. Price & Richard D. Gelber

  4. IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA

    Richard D. Gelber

  5. Harvard School of Public Health, Boston, MA, USA

    Richard D. Gelber

  6. Department of Surgery, Sahlgrenska University Hospital, Goteborg, Sweden

    Stig B. Holmberg

  7. Centro di Riferimento Oncologico, Aviano, Italy

    Diana Crivellari

  8. Department of Medicine, European Institute of Oncology, Milan, Italy

    Marco Colleoni

  9. Department of Surgery, Royal Melbourne Hospital, Parkville, VIC, Australia

    John Collins

  10. Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calgary Mater Newcastle, Newcastle, NSW, Australia

    John F. Forbes

  11. IBCSG Coordinating Center, Effingerstrasse 40, 3008, Bern, Switzerland

    Monica Castiglione-Gertsch

  12. International Breast Cancer Study Group, Bern, Switzerland

    Alan S. Coates

  13. University of Sydney, Sydney, NSW, Australia

    Alan S. Coates

  14. Department of Medicine, European Institute of Oncology, Milan, Italy

    Aron Goldhirsch

  15. Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

    Aron Goldhirsch

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  1. Beat Thürlimann
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  2. Karen N. Price
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  5. Diana Crivellari
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  6. Marco Colleoni
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  7. John Collins
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  8. John F. Forbes
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  9. Monica Castiglione-Gertsch
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  10. Alan S. Coates
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  11. Aron Goldhirsch
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Corresponding author

Correspondence to Beat Thürlimann.

Appendix

Appendix

International Breast Cancer Study Group

Participants and authors Trial 11-93

  • Scientific Committee: A. Goldhirsch, A.S. Coates (Co-Chairs)

  • Foundation Council: B. Thürlimann (President), M. Castiglione-Gertsch, A.S. Coates, R.D. Gelber, A. Goldhirsch, M. Green, A. Hiltbrunner, S.B. Holmberg, D.K. Hossfeld, I. Láng, R. Stahel, M. de Stoppani, A. Veronesi

  • Coordinating Center, Bern, Switzerland: M. Castiglione-Gertsch (CEO), B. Thürlimann (Study Chair), A. Hiltbrunner (Director), G. Egli, M. Rabaglio, R. Maibach, E. Marbot, R. Studer, M. Schärlig-Strausak

  • Statistical Center, Dana-Farber Cancer Institute, Boston, MA, USA: R.D. Gelber (Group Statistician), K.N. Price (Scientific Director), M.M. Regan, B. Cole, Z. Sun, D. Zahrieh, S. Gelber, A. Giobbie-Hurder

  • Data Management Center: Frontier Science & Technology Research Foundation, Amherst, NY, USA: L. Blacher (Director), J. Celano, R. Hinkle, M. Isley, T. Scolese

  • Pathology Office: B. Gusterson, G. Viale, E. Mallon

  • Quality of Life Office: J. Bernhard, Ch. Hürny, H. Gusset, N. Mathys, B. Cliffe

  • West Swedish Breast Cancer Study Group, Göteborg, Sweden: C.M. Rudenstam, A. Wallgren, S. Ottosson-Lönn, R. Hultborn, G. Colldahl-Jädeström, E. Cahlin, J. Mattsson, S. B.Holmberg, O. Ruusvik, L.G. Niklasson, S. Dahlin, G. Karlsson, B. Lindberg, A. Sundbäck, S. BergegÂrdh, O. Groot, L.O. Dahlbäck, H. Salander, C. Andersson, M. Heideman, A. Nissborg, A. Wallin, G. Claes, T. Ramhult, J.H. Svensson, P. Liedberg, A. Nilsson, G. Havel, G. Oestberg, S. Persson, M. Suurķ la, J. Matusik

  • Centro di Riferimento Oncologico, Aviano, Italy: A. Veronesi, D. Crivellari, S. Monfardini, E. Galligioni, M.D. Magri, A. Buonadonna, S. Massarut, C. Rossi, E. Candiani, A. Carbone, R. Volpe, M. Roncadin, M. Arcicasa, F. Coran, S. Morassut

  • Istituto Europeo di Oncologia, Milano, Italy: A. Goldhirsch, M. Colleoni, G. Martinelli, G. Peruzzotti, L. Orlando, F. Nolè, R. Torrisi, A. Luini, R. Orecchia, G. Viale, F. Peccatori, F. de Braud, A. Costa, S. Zurrida, P. Veronesi, V. Sacchini, V. Galimberti, M. Intra, U. Veronesi

  • General Hospital, Gorizia, Italy: S. Foladore, L. Foghin, G. Pamich, C. Bianchi, B. Marino, A. Murgia, V. Milan

  • Spedali Civili & Fondazione Beretta, Brescia, Italy: E. Simoncini, G. Marini, P. Marpicati, M. Braga, P. Grigolato, L. Lucini

  • The Institute of Oncology, Ljubljana, Slovenia: J. Lindtner, D. Erzen, T. Cufer, J. Cervek, O. Cerar, B. Zakotnik, E. Majdic, R. Golouh, J. Lamovec, J. Jancar, I. Vrhovec, M. Kramberger

  • Madrid Breast Cancer Group, Madrid, Spain: H. Cortès-Funes, D. Mendiola, C. Gravalos, Colomer, M. Mendez, F. Cruz Vigo, P. Miranda, A. Sierra, F. Martinez-Tello, A. Garzon, S. Alonso, A. Ferrero, C. Vargas

  • Australian New Zealand Breast Cancer Trials Group (ANZ BCTG): Operations Office, University of Newcastle: J.F. Forbes, D. Lindsay (Head of Data Management)

    • Calgary Mater Newcastle, Waratah, Newcastle, Australia: J.F. Forbes, J. Bishop, S. Bray, J. Stewart, S. Ackland, A. Bonaventura, D. Jackson, H. Foster, S. Cox, R. Gourlay, R. Sillar, P. O’Brien, C. Hamilton, J. Denham, S. Brew

    • The Cancer Council Victoria, University of Melbourne, Australia: J. Collins, R. Snyder, E. Abdi, R. Basser, I. Burns, M. Chipman, J. Chirgwin, R. Drummond, P. Francis, M. Green, P. Gregory, S. Hart, M. Henderson, P. Kitchen, R. McLennan, C. Murphy, S. Neil, M. Pitcher, G. Richardson, A. Rodger, M. Schwarz

    • Royal Adelaide Hospital, Adelaide, Australia: I. Olver, A. Robertson, P. Gill, M.L. Carter, P. Malycha, E. Yeoh, G. Ward, A.S.Y. Leong, J. Lommax-Smith, D. Hoosfall, R. D’Angelo

    • Sir Charles Gairdner Hospital, Nedlands, Western Australia: M. Byrne, G. van Hazel, J. Dewar, M. Buck, G. Sterret, D. Ingram, D. Hastrich, D. Joseph, F. Cameron

    • University of Sydney, Dubbo Base Hospital and Royal Prince Alfred Hospital, Sydney, Australia: M.H.N. Tattersall, A.S. Coates, F. Niesche, R. West, S. Renwick, J. Donovan, P. Duval, R. J. Simes, A. Ng, D. Glenn, R.A. North, J. Beith, RG. O’Connor, M. Rice, G. Stevens, J. Grassby, S. Pendlebury, C. McLeod, M. Boyer, A. Sullivan, J. Hobbs

    • Auckland Breast Cancer Study Group, Auckland, New Zealand: R.G. Kay, V.J. Harvey, C.S. Benjamin, P. Thompson, A. Bierre, M. Miller, B. Hochstein, A. Lethaby, J. Webber

  • SAKK (Swiss Group for Clinical Cancer Research):

    • Inselspital, Bern: M.F. Fey, M. Castiglione-Gertsch, E. Dreher, H. Schneider, S. Aebi, K. Buser, J. Ludin, G. Beck, A. Haenel, J.M. Lüthi, H.J. Altermatt, M. Nandedkar

    • Kantonsspital, St. Gallen: H.J. Senn, B. Thürlimann, Ch. Oehlschlegel, G. Ries, M. Töpfer, U. Lorenz, A. Ehrsam, B. Späti, E. Vogel

    • Ospedale San Giovanni, Bellinzona: F. Cavalli, O. Pagani, H. Neuenschwander, L. Bronz, C. Sessa, M. Ghielmini, T. Rusca, P. Rey, J. Bernier, E. Pedrinis, T. Gyr, L. Leidi, G. Pastorelli, A. Goldhirsch, G. Caccia

    • Kantonsspital, Basel: R. Herrmann, C.F. Rochlitz, J.F. Harder, O. Köchli, U. Eppenberger, J. Torhorst

    • Centre Hospitalier Universitaire Vandois, Lausanne: L. Perey, S. Leyvraz, P. Anani, C. Genton, F. Gomez, P. De Grandi, P. Reymond, R. Mirimanoff, M. Gillet, J.F. Delaloye

    • Hôpital Cantonal, Geneva: P. Alberto, H. Bonnefoi, P. Schäfer, F. Krauer, M. Forni, M. Aapro, R. Egeli, R. Megevand, E. Jacot-des-Combes, A. Schindler, B. Borisch, S. Diebold

    • Kantonsspital Graubünden, Chur: F. Egli, P. Forrer, A. Willi, R. Steiner, J. Allemann, T. Rüedi, A. Leutenegger, U. Dalla Torre.

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Thürlimann, B., Price, K.N., Gelber, R.D. et al. Is chemotherapy necessary for premenopausal women with lower-risk node-positive, endocrine responsive breast cancer? 10-year update of International Breast Cancer Study Group Trial 11-93. Breast Cancer Res Treat 113, 137–144 (2009). https://doi.org/10.1007/s10549-008-9912-9

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