Breast Cancer Research and Treatment

, Volume 16, Issue 2, pp 111–117 | Cite as

Steroid hormone receptor levels and adjuvant tamoxifen in early breast cancer

Ten year results of the Naples (GUN) study
  • Sabino De Placido
  • Ciro Gallo
  • Alfredo Marinelli
  • Francesco Perrone
  • Clorindo Pagliarulo
  • Giuseppe Petrella
  • Giovanni Delrio
  • Michela D'Istria
  • Lucia Del Mastro
  • Angelo Raffaele Bianco


Ten year disease-free survival (DFS) results of the Naples randomized trial of adjuvant tamoxifen (TM), 30 mg per day for 2 years versus no therapy according to receptor levels, are reported. From Feb. 1, 1978, through Dec. 31, 1983, 308 pre- and postmenopausal patients with early breast cancer entered the trial. Estrogen receptor (ER) data were available on 239 (77.6%) patients, progesterone receptor (PgR) data on 194 (63.0%), and both receptor data on 181 (58.8%).

ER and PgR were assayed by dextran-coated charcoal technique in a single laboratory. The effect of adjuvant TM was significantly related to ER and PgR concentration of the primary tumor. The greatest TM benefit on DFS was evident in patients with the highest levels of receptors. The interaction between the treatment effect and receptor concentration was found whether ER and PgR were considered separately or together.

Key words

adjuvant therapy breast cancer endocrine therapy estrogen receptor progesterone receptor tamoxifen 


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. 1.
    McGuire WL: Hormone receptors: their role in predicting prognosis and response to endocrine therapy. Semin Oncol 5: 428–433, 1978PubMedGoogle Scholar
  2. 2.
    Byar DP, Sears ME, McGuire WL: Relationship between estrogen receptor values and clinical data in predicting the response to endocrine therapy for patients with advanced breast cancer. Europ J Cancer 15: 299–310, 1979Google Scholar
  3. 3.
    Brooks SC, Saunders DE, Singhakowinta A, Vaitkevicius VK: Relation of tumor content of estrogen and progesterone receptors with response of patient to endocrine therapy. Cancer 46: 2775–2778, 1980PubMedGoogle Scholar
  4. 4.
    Lippman ME, Allegra JC: Quantitative estrogen receptor analyses: the response to endocrine and cytotoxic chemotherapy in human breast cancer and the disease-free interval. Cancer 46: 2829–2834, 1980PubMedGoogle Scholar
  5. 5.
    Manni A, Arafah BU, Pearson OH: Estrogen and progesterone receptor in the prediction of response of breast cancer to endocrine therapy. Cancer 46: 2838–2841, 1980PubMedGoogle Scholar
  6. 6.
    Nolvadex Adjuvant Trial Organization: Controlled trial of tamoxifen as a single adjuvant agent in the management of early breast cancer. Br J Cancer 57: 608–611, 1988Google Scholar
  7. 7.
    Rutqvist LE, Cedermark B, Glas U, Johansson H, Nordenskjold B, Skoog L, Somell A, Theve T, Friberg S, Askergren J: The Stockholm trial on adjuvant tamoxifen in early breast cancer. Correlation between estrogen receptor level and treatment effect. Breast Cancer Res Treat 10: 255–266, 1987PubMedGoogle Scholar
  8. 8.
    Rose C, Thorpe SM, Andersen KW, Pedersen BV, Mouridsen HT, Blichert-Toft M, Rasmussen BB: Beneficial effect of adjuvant tamoxifen therapy in primary breast cancer patients with high oestrogen receptor values. Lancet i: 16–19, 1985Google Scholar
  9. 9.
    Breast Cancer Trials Committee, Scottish Cancer Trials Office (MRC), Edinburgh: Adjuvant tamoxifen in the management of operable breast cancer: the Scottish trial. Lancet ii: 171–175, 1987Google Scholar
  10. 10.
    Bianco AR, De Placido S, Gallo C, Pagliarulo C, Marinelli A, Petrella G, D'Istria M, Delrio G: Adjuvant therapy with tamoxifen in operable breast cancer. Lancet ii: 1095–1099, 1988Google Scholar
  11. 11.
    Early Breast Cancer Trialists' Cooperative Group: Effects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer: an overview of 61 randomized trials among 28896 women. N Engl J Med 319: 1681–1692, 1988Google Scholar
  12. 12.
    McGuire WL, De La Garza M, Chamness GC: Evaluation of estrogen receptor assays in human breast cancer tissue. Cancer Res 37: 637–639, 1977PubMedGoogle Scholar
  13. 13.
    Pichon MF, Milgrom E: Characterization and assay of progesterone receptor in human mammary carcinoma. Cancer Res 37: 464–471, 1977Google Scholar
  14. 14.
    Kaplan EL, Meier P: Nonparametric estimation from in complete observation. J Am Stat Assoc 53: 457–481, 1958Google Scholar
  15. 15.
    Mantel N: Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chem Rep 50: 163–170, 1966Google Scholar
  16. 16.
    Cox DR: Regression models and life tables. J R Stat Soc (B) 34: 187–220, 1972Google Scholar
  17. 17.
    Paridaens R, Sylvester RJ, Ferrazzi E, Legros N, Leclercq G, Heuson JC: Clinical significance of the quantitative assessment of estrogen receptors in advanced breast cancer. Cancer 46: 2889–2985, 1980PubMedGoogle Scholar
  18. 18.
    Bonomi P, Gale M, Von Roenn J, Anderson K, Johnson P, Wolter J, Economou S: Quantitative estrogen and progesterone receptor levels related to progression-free interval in advanced breast cancer patients treated with megestrol acetate or tamoxifen. Semin Oncol 15, suppl. 1: 26–33, 1988Google Scholar
  19. 19.
    Osborne CK, Yochmowitz MG, Knight WA, McGuire WL: The value of estrogen and progesterone receptors in the treatment of breast cancer. Cancer 46: 2884–2888, 1980PubMedGoogle Scholar
  20. 20.
    Horwitz KB: The central role of progesterone receptors and progestational agents in the management and treatment of breast cancer. Semin Oncol 15. suppl. 1: 14–19, 1988Google Scholar
  21. 21.
    King WJ, De Sombre ER, Jensen EV, Greene GL: Com parison of immunocytochemical and steroid-binding assays for estrogen receptor in human breast tumors. Cancer Res 45: 293–304, 1985Google Scholar
  22. 22.
    Cheng L, Binder SW, Fu YS, Lewin KJ: Methods in laboratory investigation. Demonstration of estrogen receptors by monoclonal antibody in formalin-fixed breast tumors. Lab Invest 58: 346–353, 1988PubMedGoogle Scholar
  23. 23.
    Jordan VC: The control of hormone-dependent breast cancer growth - are we talking about estrogen alone? Europ J Cancer Clin Oncol 24: 1245–1248, 1988PubMedGoogle Scholar
  24. 24.
    Knabbe C, Lippman ME, Wakefield LM, Flanders KC, Kasid A, Derynck R, Dickson RB: Evidence that transforming growth factor-β is a hormonally regulated negative growth factor in human breast cancer cells. Cell 48: 417–428, 1987PubMedGoogle Scholar

Copyright information

© Kluwer Academic Publishers 1990

Authors and Affiliations

  • Sabino De Placido
    • 1
  • Ciro Gallo
    • 2
  • Alfredo Marinelli
    • 1
  • Francesco Perrone
    • 1
  • Clorindo Pagliarulo
    • 1
  • Giuseppe Petrella
    • 3
  • Giovanni Delrio
    • 4
  • Michela D'Istria
    • 4
  • Lucia Del Mastro
    • 1
  • Angelo Raffaele Bianco
    • 1
  1. 1.Division of Medical OncologyUniversity of Naples Medical School IINaplesItaly
  2. 2.Institute of Health StatisticsUniversity of Naples Medical School INaplesItaly
  3. 3.Division of Surgical OncologyUniversity of Naples Medical School IINaplesItaly
  4. 4.Department of BiologyUniversity of Naples Medical School INaplesItaly

Personalised recommendations