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01-08-2009 | Clinical Trial

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

Authors: Olivia Pagani, Shari Gelber, Edda Simoncini, Monica Castiglione-Gertsch, Karen N. Price, Richard D. Gelber, Stig B. Holmberg, Diana Crivellari, John Collins, Jurij Lindtner, Beat Thürlimann, Martin F. Fey, Elizabeth Murray, John F. Forbes, Alan S. Coates, Aron Goldhirsch, for the International Breast Cancer Study Group

Published in: Breast Cancer Research and Treatment | Issue 3/2009

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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Goldhirsch A, Wood WC, Gelber RD et al (2007) Progress and promise: highlights of the international expert consensus on the primary therapy of early breast cancer 2007. Ann Oncol 18:1133–1144. doi:10.1093/annonc/mdm271 PubMedCrossRef

Early Breast Cancer Trialists’ Collaborative Group (2005) Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 365:1687–1717. doi:10.1016/S0140-6736(05)66544-0 CrossRef

Goldhirsch A, Coates AS, Gelber RD et al (2006) First select the target: better choice of adjuvant treatments for breast cancer patients. Ann Oncol 17:1772–1776. doi:10.1093/annonc/mdl398 PubMedCrossRef

Berry DA, Cirrincione C, Henderson IC et al (2006) Estrogen-receptor status and outcomes of modern chemotherapy for patients with node-positive breast cancer. JAMA 295:1658–1667. doi:10.1001/jama.295.14.1658 PubMedCrossRef

Crivellari D, Bonetti M, Castiglione-Gertsch M et al (2000) Burdens and benefits of adjuvant cyclophosphamide, methotrexate, and fluorouracil and tamoxifen for elderly patients with breast cancer: The International Breast Cancer Study Group Trial VII. J Clin Oncol 18:1412–1422PubMed

Namer M, Fargeot P, Roché H et al (2006) Improved disease-free survival with epirubicin-based chemoendocrine adjuvant therapy compared with tamoxifen alone in one to three node-positive, estrogen-receptor-positive, postmenopausal breast cancer patients: results of French Adjuvant Study Group 02 and 07 trials. Ann Oncol 17:65–73. doi:10.1093/annonc/mdj022 PubMedCrossRef

Wils JA, Bliss JM, Coombes MG et al (1999) Epirubicin plus tamoxifen versus tamoxifen alone in node-positive post menopausal patients with breast cancer: a randomized trial of the International Collaborative Cancer Group. J Clin Oncol 17:1988–1998PubMed

Rivkin SE, Green S, Metch B et al (1994) Adjuvant CMFVP versus tamoxifen versus concurrent CMFVP and tamoxifen for postmenopausal, node-positive, and estrogen receptor-positive breast cancer patients: A Southwest Oncology Group Study. J Clin Oncol 12:2078–2085PubMed

Regan MM, Gelber RD (2005) Predicting response to systemic treatments: learning from the past to plan for the future. Breast 14:582–593. doi:10.1016/j.breast.2005.08.021 PubMedCrossRef

10.

Albain K, Barlow W, O’Malley F et al (2004) Concurrent (CAFT) versus sequential (CAF-T) chemohormonal therapy (cyclophosphamide, doxorubicin, 5-fluorouracil, tamoxifen) versus T alone for postmenopausal, node-positive, estrogen (ER) and/or progesterone (PgR) receptor-positive breast cancer: mature outcomes and new biologic correlates on phase III intergroup trial 0100 (SWOG-8814). Breast Cancer Res Treat 88:(abstr 37)

11.

The International Breast Cancer Study Group (1997) Effectiveness of adjuvant chemotherapy in combination with tamoxifen for node-positive postmenopausal breast cancer patients. J Clin Oncol 15:1385–1393

12.

Colleoni M, Li S, Gelber RD et al (2005) Timing of CMF chemotherapy in combination with tamoxifen in postmenopausal women with breast cancer: role of endocrine responsiveness of the tumor. Ann Oncol 16:716–725. doi:10.1093/annonc/mdi163 PubMedCrossRef

13.

International Breast Cancer Study Group (2004) Toremifene and tamoxifen are equally effective for early-stage breast cancer: first results of International Breast Cancer Study Group Trials 12–93 and 14–93. Ann Oncol 15:1749–1759. doi:10.1093/annonc/mdh463 CrossRef

14.

Kaplan EL, Meier P (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457–481. doi:10.2307/2281868 CrossRef

15.

Greenwood M (1926) The natural duration of cancer. Her Majesty’s Stationary Office, London, pp 1–26

16.

Mantel N (1966) Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 50:163–170PubMed

17.

Cox DR (1972) Regression models and life-tables (with discussion). J R Stat Soc [Ser A] 34:187–220

18.

Cuzick J (2005) Forest plots and the interpretation of subgroups. Lancet 365:1308. doi:10.1016/S0140-6736(05)61026-4 PubMedCrossRef

19.

Bonetti M, Gelber RD (2000) A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Stat Med 19:2595–2609. doi:10.1002/1097-0258(20001015)19:19<2595::AID-SIM562>3.0.CO;2-MPubMedCrossRef

20.

Bonetti M, Gelber RD (2004) Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 5:465–481. doi:10.1093/biostatistics/kxh002 PubMedCrossRef

21.

Chebil G, Bendahl P-O, Idvall I, Ferno M (2003) Comparison of immunohistochemical and biochemical assay of steroid receptors in primary breast cancer. Acta Oncol 42:719–725. doi:10.1080/02841860310004724 PubMedCrossRef

22.

Harvey JM, Clark GM, Osborne CK, Allred DC (1999) Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol 17:1474–1481PubMed

23.

Regan MM, Viale G, Mastropasqua MG et al (2006) Re-evaluating adjuvant breast cancer trials: assessing hormone receptor status by immunohistochemical versus extraction assays. J Natl Cancer Inst 98:1571–1581PubMedCrossRef

24.

Coates AS, Keshaviah A, Thürlimann B et al (2007) Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1–98. J Clin Oncol 25:486–492. doi:10.1200/JCO.2006.08.8617 PubMedCrossRef

25.

Howell A, Cuzick J, Baum M et al (2005) Results of the ATAC (arimidex, tamoxifen, alone or in combination) trial after completion of 5 years’ adjuvant treatment for breast cancer. Lancet 365:60–62. doi:10.1016/S0140-6736(05)74803-0 PubMedCrossRef

26.

Viale G, Regan MM, Maiorano E et al (2007) Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer:BIG 1–98. J Clin Oncol 25:3846–3852. doi:10.1200/JCO.2007.11.9453 PubMedCrossRef

27.

van’t Veer LJ, Paik S, Hayes DF (2005) Gene expression profiling of breast cancer: a new tumor marker. J Clin Oncol 23:1631–1635. doi:10.1200/JCO.2005.12.005 PubMedCrossRef

28.

Cobleigh MA, Tabesh B, Bitterman P et al (2005) Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res 11:8623–8631. doi:10.1158/1078-0432.CCR-05-0735 PubMedCrossRef

29.

Albain K, Barlow W, Shak S et al (2008) Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal, node-positive, ER-positive breast cancer (S8814, INT0100). San Antonio breast cancer symposium 2007 late breaker abstract #10 http://www.abstracts2view.com/sabcs/view.php?nu=SABCS07L_1165. Accessed 02 Jan 2008

30.

Sparano JA (2006) TAILORx: trial assigning individualized options for treatment (Rx). Clin Breast Cancer 7:347–350. doi:10.3816/CBC.2006.n.051 PubMedCrossRef

31.

Bogaerts J, Cardoso F, Buyse M et al (2006) Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial. Nat Clin Pract Oncol 3:540–551. doi:10.1038/ncponc0591 PubMedCrossRef

32.

Thürlimann B, Price KN, Gelber RD et al (2008) 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 2008(Feb):8 (Epub ahead of press)

33.

Regan MM, Pagani O, Walley B et al (2008) SOFT/TEXT/PERCHE Steering Committee and the International Breast Cancer Study Group (2008) Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol 19:1231–1241PubMedCrossRef

Title: 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
Authors: Olivia Pagani
Shari Gelber
Edda Simoncini
Monica Castiglione-Gertsch
Karen N. Price
Richard D. Gelber
Stig B. Holmberg
Diana Crivellari
John Collins
Jurij Lindtner
Beat Thürlimann
Martin F. Fey
Elizabeth Murray
John F. Forbes
Alan S. Coates
Aron Goldhirsch
for the International Breast Cancer Study Group
Publication date: 01-08-2009
Publisher: Springer US
Published in: Breast Cancer Research and Treatment / Issue 3/2009
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI: https://doi.org/10.1007/s10549-008-0225-9

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