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Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12–93

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Abstract

To compare the efficacy of chemoendocrine treatment with that of endocrine treatment (ET) alone for postmenopausal women with highly endocrine responsive breast cancer. In the International Breast Cancer Study Group (IBCSG) Trials VII and 12–93, postmenopausal women with node-positive, estrogen receptor (ER)-positive or ER-negative, operable breast cancer were randomized to receive either chemotherapy or endocrine therapy or combined chemoendocrine treatment. Results were analyzed overall in the cohort of 893 patients with endocrine-responsive disease, and according to prospectively defined categories of ER, age and nodal status. STEPP analyses assessed chemotherapy effect. The median follow-up was 13 years. Adding chemotherapy reduced the relative risk of a disease-free survival event by 19% (P = 0.02) compared with ET alone. STEPP analyses showed little effect of chemotherapy for tumors with high levels of ER expression (P = 0.07), or for the cohort with one positive node (P = 0.03). Chemotherapy significantly improves disease-free survival for postmenopausal women with endocrine-responsive breast cancer, but the magnitude of the effect is substantially attenuated if ER levels are high.

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Acknowledgments

We thank the patients, physicians, nurses, and data managers who have participated in the International Breast Cancer Study Group (see Appendix) trials, now and for the past 30 years. The IBCSG is funded in part by: Swiss Group for Clinical Cancer Research (SAKK), Frontier Science and Technology Research Foundation (FSTRF), The Cancer Council Australia, Australian New Zealand Breast Cancer Trials Group (National Health Medical Research Council), National Cancer Institute (CA-75362), Swedish Cancer Society, Cancer Research Switzerland/Oncosuisse, Cancer Association of South Africa, Foundation for Clinical Cancer Research of Eastern Switzerland (OSKK).

Author information

Authors and Affiliations

  1. Oncology Institute of Southern Switzerland, Ospedale Italiano, Viganello, Lugano, Switzerland

    Olivia Pagani

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

    Olivia Pagani

  3. IBCSG Statistical Center, Dana-Farber Cancer Institute and Frontier Science and Technology Research Foundation, Boston, MA, USA

    Shari Gelber & Richard D. Gelber

  4. Oncologia Medica-Spedali Civili, Brescia, Italy

    Edda Simoncini

  5. IBCSG Coordinating Center, Bern, Switzerland

    Monica Castiglione-Gertsch

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

    Karen N. Price

  7. Department of Biostatistics and Computational Biology, Dana Farber Cancer Institute, 44 Binney Street, Boston, MA, 02115, USA

    Karen N. Price

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

    Stig B. Holmberg

  9. Centro di Riferimento Oncologico, Aviano, Italy

    Diana Crivellari

  10. Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia

    John Collins

  11. The Institute of Oncology, Ljubljana, Slovenia

    Jurij Lindtner

  12. Senology Center of Eastern Switzerland, Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St. Gallen, Switzerland

    Beat Thürlimann

  13. Department of Medical Oncology, Swiss Group for Clinical Cancer Research (SAKK), Inselspital, Bern, Switzerland

    Martin F. Fey

  14. Groote Shuur Hospital, University of Cape Town, Cape Town, South Africa

    Elizabeth Murray

  15. Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, NSW, Australia

    John F. Forbes

  16. International Breast Cancer Study Group, University of Sydney, Sydney, Australia

    Alan S. Coates

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

    Aron Goldhirsch

  18. Oncology Institute of Southern Switzerland, Bellinzona, Switzerland

    Aron Goldhirsch

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Consortia

for the International Breast Cancer Study Group

Corresponding authors

Correspondence to Olivia Pagani or Karen N. Price.

Appendix

Appendix

Participants in IBCSG Trials VII and 12–93

Scientific Committee

A. Goldhirsch, A. S. Coates (Co-Chairs)

Foundation Council

(Members from 1998 to 2008): S. Aebi, A. S. Coates, M. Colleoni, J. P. Collins, H. Cortés Funes, R. D. Gelber, A. Goldhirsch, M. Green, A. Hiltbrunner, S. B. Holmberg, P. Karlsson, I Kössler, I. Láng, J. Lindtner, F Paganetti M. de Stoppani, C.-M. Rudenstam, H.-J. Senn, R. Stahel, B. Thürlimann, A. Veronesi

Coordinating Center

A. Hiltbrunner (Director); G. Egli, M. Rabaglio, R. Maibach, R. Studer, B. Ruepp, D. Bärtschi, M. Schärlig-Strausak

Bern, Switzerland

Study Chairs

M. Castiglione, O. Pagani and Edda Simoncini (Study Chairs)

Statistical Center

R. Gelber (Group Statistician), K. Price, B. Cole, S. Gelber, M. Regan, Z. Sun, A. Giobbie-Hurder, L. Nickerson

Harvard School of Public Health and Dana-Farber Cancer Institute, Boston, MA, USA

Data Management Center

L. Blacher (Director), R. Hinkle, J. Celano, T. Scolese

Frontier Science & Tech. Res. Found.

Amherst, NY, USA

Pathology Office

B. Gusterson, G. Viale, E. Mallon

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

Spedali Civili & Fondazione Beretta, Brescia, Italy

E. Simoncini (Study Chair), G. Marini, P. Marpicati, L. Lucini, P. Grigolato, L. Morassi, R. Farfaglia, A. M. Bianchi

General Hospital, Gorizia, Italy

S. Foladore, L. Foghin, G. Pamich, C. Bianchi, B. Marino, A. Murgia, V. Milan

Groote Schuur Hospital and University of Cape Town, Rep. of South Africa

E. Murray, D. M. Dent, A. Gudgeon, E. Murray, I. D. Werner, A. Hacking, A. Tiltman, E. McEvoy, J. Toop

Sandton Oncology Center, Johannesburg, Rep. of South Africa

D. Vorobiof, M. Chasen, G. C. Mohammed

University of Düsseldorf, Düsseldorf, Germany

A. E. Schindler, P. Faber, H. G. Schnürch, H. Bender, H. Bojar

West Swedish Breast Cancer Study Group, Göteborg, Sweden

C. M. Rudenstam, S. B. Holmberg, P. Karlsson, A. Wallgren, S. Ottosson-Lönn, R. Hultborn, G. Colldahl-Jädeström, E. Cahlin, J. Mattsson, 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. Oestberg, S. Persson, J. Matusik

European Institute of Oncology, Milano, Italy

A. Goldhirsch, M. Colleoni, G. Peruzotti, G. Viale, G. Renne, G. Mazzarol, G. Martinelli, L. Orlando, F. Nolè, R. Torrisi, S. Dellapasqua, G. Curigliano, T. De Pas, F. de Braud, S. Cinieri, F. Peccatori, A. Luini, R. Orecchia, A. Costa, S. Zurrida, P. Veronesi, V. Sacchini, V. Galimberti, M. Intra, U. Veronesi

Ospedale S. Eugenio, Rome, Italy

M. Antimi, M. Minelli, V. Bellini, R. Porzio, E. Pernazza, G. Santeusanio, L. G. Spagnoli

The Institute of Oncology, Ljubljana, Slovenia

J. Lindtner, D. Erzen, T. Cufer, E. Majdic, B. Stabuc, R. Golouh, J. Lamovec, J. Jancar, I. Vrhovec, M. Kramberger, J. Novak, M. Naglas, M. Sencar, J. Cervek, S. Sebek, O. Cerar, A. Plesnicar, B. Zakotnik

Madrid Breast Cancer Group, Madrid, Spain

H. Cortès-Funes, C. 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

Statistical Center, NHMRC CTC, University of Sydney:

R. J. Simes, E. Beller, C. Stone, V. Gebski

The Cancer Council Victoria (formerly Anti-Cancer Council of Victoria), Melbourne, Australia

J. Collins, R. Snyder, E. Abdi, R. Basser, R. Bennett, P. Briggs, P. Brodie, W. I. Burns, M. Chipman, J. Chirgwin, R. Drummond, P. Ellims, D. Finkelde, P. Francis, J. Funder, T. Gale, M. Green, P. Gregory, J. Griffiths, G. Goss, L. Harrison, S. Hart, M. Henderson, V. Humenuik, P. Jeal, P. Kitchen, G. Lindeman, B. Mann, J. McKendrick, R. McLennan, R. Millar, C. Murphy, S. Neil, I. Olver, M. Pitcher, A. Read, D. Reading, R. Reed, G. Richardson, A. Rodger, I. Russell, M. Schwarz, L. Sisely, R. Stanley, M. Steele, J. Stewart, C. Underhill, J. Zalcberg, A. Zimet

Flinders Medical Centre, Bedford Park, South Australia

S. Birrell, M. Eaton, C. Hoffmann, B. Koczwara, C. Karapetis, T. Malden, W. McLeay, R. Seshadri

Calgary Mater Newcastle, Newcastle, Australia

J. F. Forbes, J. Stewart, D. Jackson, R. Gourlay, J. Bishop, S. Cox, S. Ackland, A. Bonaventura, C. Hamilton, J. Denham, P. O’Brien, M. Back, S. Brae, A. Price, R. Muragasu, H. Foster, D. Clarke, R. Sillar, I. MacDonald, R. Hitchins

Gold Coast Hospital, Queensland, Australia

Royal Adelaide Hospital, Adelaide, Australia

I. N. Olver, D. Keefe, M. Brown, P. G. Gill, A. Taylor, A. Robertson, P. G. Gill, M. L. Carter, P. Malycha, E. Yeoh, G. Ward, A. S. Y. Leong, J. Lommax-Smith, D. Horsfall, R. D’Angelo, E. Abdi, J. Cleary, F. Parnis

Royal Perth Hospital, Perth, Australia.

E. Bayliss

Sir Charles Gairdner Hospital, Nedlands, Western Australia

M. Byrne, G. van Hazel, J. Dewar, M. Buck, D. Ingram, G. Sterrett, P. M. Reynolds, H. J. Sheiner, K. B. Shilkin, R. Hahnel, S. Levitt, D. Kermode, H. Hahnel, D. Hastrich, D. Joseph, F. Cameron

University of Sydney, Dubbo Base Hospital and Royal Prince Alfred Hospital, Sydney, Australia

M. H. N. Tattersall, A. Coates, F. Niesche, R. West, S. Renwick, J. Donovan, P. Duval, R. J. Simes, A. Ng, D. Glenn, R. A. North, J. Beith, R. G. O’Connor, M. Rice, G. Stevens, J. Grassby, S. Pendlebury, C. McLeod, M. Boyer, A. Sullivan, J. Hobbs, R. Fox, D. Hedley, D. Raghavan, D. Green, T. Foo, T. J. Nash, J. Grygiel, D. Lind

Prince of Wales, Randwick, NSW, Australia

C. Lewis, M. Friedlander

Auckland Breast Cancer Study Group, Auckland, New Zealand

R. G. Kay, I. M. Holdaway, V. J. Harvey, C. S. Benjamin, P. Thompson, A. Bierre, M. Miller, B. Hochstein, A. Lethaby, J. Webber, M. F. Jagusch, L. Neave, B. M. Mason, B. Evans, J. F. Carter, J. C. Gillman, D. Mack, D. Benson-Cooper, J. Probert, H. Wood, J. Anderson, L. Yee, G. C. Hitchcock, A. Lethaby, J. Webber, D. Porter

Waikato Hospital, Hamilton, New Zealand

I. Kennedy, G. Round, J. Long

SAKK (Swiss Group for Clinical Cancer Research):

 

Inselspital, Bern

M. F. Fey, S. Aebi, M. Castiglione-Gertsch, E. Dreher, K. Buser, J. Ludin, G. Beck, 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

Oncology Institute of Southern Switzerland, Ospedale San Giovanni, Bellinzona

F. Cavalli, O. Pagani (Study Chair), H. Neuenschwander, C. Sessa, M. Ghielmini, E. Zucca, J. Bernier, E. S. Pedrinis, T. Rusca, E. Passega, L. Bronz, P. Rey, M. Galfetti, W. Sanzeni, T. Gyr, L. Leidi, G. Pastorelli, M. Varini, S. Longhi, C. Cafaro-Greco, R. Graffeo, A. Goldhirsch

Kantonsspital, Basel

R. Herrmann, C. F. Rochlitz, J. F. Harder, O. Köchli, U. Eppenberger, J. Torhorst

Hôpital des Cadolles, Neuchâtel

D. Piguet, P. Siegenthaler, V. Barrelet, R. P. Baumann

Kantonsspital, Zürich

B. Pestalozzi, C. Sauter, U. Haller, U. Metzger, P. Huguenin, R. Caduff

Centre Hospitalier Universitaire, Lausanne

L. Perey, K. Zaman, S. Leyvraz, P. De Grandi, W. Jeanneret-Sozzi, R. Mirimanoff, J. F. Delaloye

Hôpital Cantonal, Geneva

M. Nobahar, 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, A. Willi, R. Steiner. J. Allemann, T. Rüedi, A. Leutenegger, U. Dalla Torre

Kantonsspital Aarau

A. Schönenberger, M. Wernli, M. Bargetzi, W. Mingrone, P. Schmid, E. Bärtschi, K. Beretta

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Pagani, O., Gelber, S., Simoncini, E. et al. Is adjuvant chemotherapy of benefit for postmenopausal women who receive endocrine treatment for highly endocrine-responsive, node-positive breast cancer? International Breast Cancer Study Group Trials VII and 12–93. Breast Cancer Res Treat 116, 491–500 (2009). https://doi.org/10.1007/s10549-008-0225-9

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