Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer

Predictive value of centrally reviewed expression of estrogen and progesterone receptors - Onternational Breast Cancer Study Group

Giuseppe Viale, Meredith M. Regan, Eugenio Maiorano, Mauro G. Mastropasqua, Rastko Golouh, Tiziana Perin, Robert W. Brown, Anikó Kovács, Komala Pillay, Christian Öhlschlegel, Stephen Braye, Piergiovanni Grigolato, Tiziana Rusca, Richard D. Gelber, Monica Castiglione-Gertsch, Karen N. Price, Aron Goldhirsch, Barry A. Gusterson, Alan S. Coates

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Abstract

Purpose: To centrally assess estrogen receptor (ER) and progesterone receptor (PgR) levels by immunohistochemistry and investigate their predictive value for benefit of chemo-endocrine compared with endocrine adjuvant therapy alone in two randomized clinical trials for node-negative breast cancer. Patients and Methods: International Breast Cancer Study Group Trial VIII compared cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for 6 cycles followed by endocrine therapy with goserelin with either modality alone in pre- and perimenopausal patients. Trial IX compared three cycles of CMF followed by tamoxifen for 5 years versus tamoxifen alone in postmenopausal patients. Central Pathology Office reviewed 883 (83%) of 1,063 patients on Trial VIII and 1,365 (82%) of 1,669 on Trial IX and determined ER and PgR by immunohistochemistry. Disease-free survival (DFS) was compared across the spectrum of expression of each receptor using the Subpopulation Treatment Effect Pattern Plot methodology. Results: Both receptors displayed a bimodal distribution, with substantial proportions showing no staining (receptor absent) and most of the remainder showing a high percentage of stained cells. Chemo-endocrine therapy yielded DFS superior to endocrine therapy alone for patients with receptor-absent tumors, and in some cases also for those with low levels of receptor expression. Among patients with ER-expressing tumors, additional prediction of benefit was suggested in absent or low PgR in Trial VIII but not in Trial IX. Conclusion: Low levels of ER and PgR are predictive of the benefit of adding chemotherapy to endocrine therapy. Low PgR may add further prediction among pre- and perimenopausal but not postmenopausal patients whose tumors express ER.

Original languageEnglish
Pages (from-to)1404-1410
Number of pages7
JournalJournal of Clinical Oncology
Volume26
Issue number9
DOIs
Publication statusPublished - 2008

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Progesterone Receptors
Estrogen Receptors
Breast Neoplasms
Tamoxifen
Methotrexate
Cyclophosphamide
Therapeutics
Disease-Free Survival
Immunohistochemistry
Goserelin
Drug Therapy
Neoplasms
Fluorouracil
Randomized Controlled Trials
Pathology
Staining and Labeling

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer : Predictive value of centrally reviewed expression of estrogen and progesterone receptors - Onternational Breast Cancer Study Group. / Viale, Giuseppe; Regan, Meredith M.; Maiorano, Eugenio; Mastropasqua, Mauro G.; Golouh, Rastko; Perin, Tiziana; Brown, Robert W.; Kovács, Anikó; Pillay, Komala; Öhlschlegel, Christian; Braye, Stephen; Grigolato, Piergiovanni; Rusca, Tiziana; Gelber, Richard D.; Castiglione-Gertsch, Monica; Price, Karen N.; Goldhirsch, Aron; Gusterson, Barry A.; Coates, Alan S.

In: Journal of Clinical Oncology, Vol. 26, No. 9, 2008, p. 1404-1410.

Research output: Contribution to journalArticle

Viale, G, Regan, MM, Maiorano, E, Mastropasqua, MG, Golouh, R, Perin, T, Brown, RW, Kovács, A, Pillay, K, Öhlschlegel, C, Braye, S, Grigolato, P, Rusca, T, Gelber, RD, Castiglione-Gertsch, M, Price, KN, Goldhirsch, A, Gusterson, BA & Coates, AS 2008, 'Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer: Predictive value of centrally reviewed expression of estrogen and progesterone receptors - Onternational Breast Cancer Study Group', Journal of Clinical Oncology, vol. 26, no. 9, pp. 1404-1410. https://doi.org/10.1200/JCO.2007.10.6393
Viale, Giuseppe ; Regan, Meredith M. ; Maiorano, Eugenio ; Mastropasqua, Mauro G. ; Golouh, Rastko ; Perin, Tiziana ; Brown, Robert W. ; Kovács, Anikó ; Pillay, Komala ; Öhlschlegel, Christian ; Braye, Stephen ; Grigolato, Piergiovanni ; Rusca, Tiziana ; Gelber, Richard D. ; Castiglione-Gertsch, Monica ; Price, Karen N. ; Goldhirsch, Aron ; Gusterson, Barry A. ; Coates, Alan S. / Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer : Predictive value of centrally reviewed expression of estrogen and progesterone receptors - Onternational Breast Cancer Study Group. In: Journal of Clinical Oncology. 2008 ; Vol. 26, No. 9. pp. 1404-1410.
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abstract = "Purpose: To centrally assess estrogen receptor (ER) and progesterone receptor (PgR) levels by immunohistochemistry and investigate their predictive value for benefit of chemo-endocrine compared with endocrine adjuvant therapy alone in two randomized clinical trials for node-negative breast cancer. Patients and Methods: International Breast Cancer Study Group Trial VIII compared cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for 6 cycles followed by endocrine therapy with goserelin with either modality alone in pre- and perimenopausal patients. Trial IX compared three cycles of CMF followed by tamoxifen for 5 years versus tamoxifen alone in postmenopausal patients. Central Pathology Office reviewed 883 (83{\%}) of 1,063 patients on Trial VIII and 1,365 (82{\%}) of 1,669 on Trial IX and determined ER and PgR by immunohistochemistry. Disease-free survival (DFS) was compared across the spectrum of expression of each receptor using the Subpopulation Treatment Effect Pattern Plot methodology. Results: Both receptors displayed a bimodal distribution, with substantial proportions showing no staining (receptor absent) and most of the remainder showing a high percentage of stained cells. Chemo-endocrine therapy yielded DFS superior to endocrine therapy alone for patients with receptor-absent tumors, and in some cases also for those with low levels of receptor expression. Among patients with ER-expressing tumors, additional prediction of benefit was suggested in absent or low PgR in Trial VIII but not in Trial IX. Conclusion: Low levels of ER and PgR are predictive of the benefit of adding chemotherapy to endocrine therapy. Low PgR may add further prediction among pre- and perimenopausal but not postmenopausal patients whose tumors express ER.",
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T1 - Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer

T2 - Predictive value of centrally reviewed expression of estrogen and progesterone receptors - Onternational Breast Cancer Study Group

AU - Viale, Giuseppe

AU - Regan, Meredith M.

AU - Maiorano, Eugenio

AU - Mastropasqua, Mauro G.

AU - Golouh, Rastko

AU - Perin, Tiziana

AU - Brown, Robert W.

AU - Kovács, Anikó

AU - Pillay, Komala

AU - Öhlschlegel, Christian

AU - Braye, Stephen

AU - Grigolato, Piergiovanni

AU - Rusca, Tiziana

AU - Gelber, Richard D.

AU - Castiglione-Gertsch, Monica

AU - Price, Karen N.

AU - Goldhirsch, Aron

AU - Gusterson, Barry A.

AU - Coates, Alan S.

PY - 2008

Y1 - 2008

N2 - Purpose: To centrally assess estrogen receptor (ER) and progesterone receptor (PgR) levels by immunohistochemistry and investigate their predictive value for benefit of chemo-endocrine compared with endocrine adjuvant therapy alone in two randomized clinical trials for node-negative breast cancer. Patients and Methods: International Breast Cancer Study Group Trial VIII compared cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy for 6 cycles followed by endocrine therapy with goserelin with either modality alone in pre- and perimenopausal patients. Trial IX compared three cycles of CMF followed by tamoxifen for 5 years versus tamoxifen alone in postmenopausal patients. Central Pathology Office reviewed 883 (83%) of 1,063 patients on Trial VIII and 1,365 (82%) of 1,669 on Trial IX and determined ER and PgR by immunohistochemistry. Disease-free survival (DFS) was compared across the spectrum of expression of each receptor using the Subpopulation Treatment Effect Pattern Plot methodology. Results: Both receptors displayed a bimodal distribution, with substantial proportions showing no staining (receptor absent) and most of the remainder showing a high percentage of stained cells. Chemo-endocrine therapy yielded DFS superior to endocrine therapy alone for patients with receptor-absent tumors, and in some cases also for those with low levels of receptor expression. Among patients with ER-expressing tumors, additional prediction of benefit was suggested in absent or low PgR in Trial VIII but not in Trial IX. Conclusion: Low levels of ER and PgR are predictive of the benefit of adding chemotherapy to endocrine therapy. Low PgR may add further prediction among pre- and perimenopausal but not postmenopausal patients whose tumors express ER.

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