Cancer Treatment Reviews
Volume 26, Issue 3 , Pages 151-168 , June 2000

Systematic reviews of chemotherapy and endocrine therapy in metastatic breast cancer

  • M. Stockler

      Affiliations

    • Department of Medical Oncology, Royal Prince Alfred Hospital, Camperdown, NSW 2050, Australia
    • Department of Medicine, University of Sydney, Sydney, NSW 2006, Australia
    • NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW 1450, Australia
    • ,
  • N.R.C. Wilcken

      Affiliations

    • Department of Medicine, University of Sydney, Sydney, NSW 2006, Australia
    • Department of Medical Oncology and Palliative Care, Westmead Hospital, Westmead, NSW 2145, Australia
    • ,
  • D. Ghersi

      Affiliations

    • NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW 1450, Australia
    • ,
  • R.John Simes

      Affiliations

    • Department of Medical Oncology, Royal Prince Alfred Hospital, Camperdown, NSW 2050, Australia
    • NHMRC Clinical Trials Centre, University of Sydney, Locked Bag 77, Camperdown, NSW 1450, Australia

References 

    REFERENCES
  1. Lancet. 1992;339:1–14
  2. National Health and Medical Research Council (Australia), Clinical Practice Guidelines for the Management of Early Breast Cancer. Canberra, Australian Government Publishing Service, 1995
  3. Stockler, M. Wilcken, N. Ghersi, D. Simes, R. J. The Management of Advanced Breast Cancer: Systematic Reviews of Randomised Controlled Trials Regarding the Use of Cytotoxic Chemotherapy and Endocrine Therapy. Sydney, NHMRC National Breast Cancer Centre, 1996
  4. Liddle, J. Williamson, M. Irwig, L. Method for Evaluating Research and Guideline Evidence. Sydney, New South Wales Department of Health, 1996
  5. Simes RJ. Confronting publication bias: a cohort design for meta-analysis. Stat Med. 1987;6:11–29
  6. Kiang DT, Gay J, Goldman A, Kennedy BJ. A randomized trial of chemotherapy and hormonal therapy in advanced breast cancer. New Engl J Med. 1985;313:1241–1246
  7. Ahmann DL, Green SJ, Bisel HF, Ingle JN, Hahn RG, Lee RA. An evaluation of early or delayed adjuvant chemotherapy in premenopausal patients with advanced breast cancer undergoing oophorectomy: a later analysis. Am J Clin Oncol. 1982;5:355–358
  8. Rossof AH, Gelman R, Creech RH. Randomized evaluation of combination chemotherapy vs. observation alone following response or stabilization after oophorectomy for metastatic breast cancer in premenopausal women. Am J Clin Oncol. 1982;5:253–259
  9. Bezwoda WR, Derman D, De Moor NG, Lange M, Levin J. Treatment of metastatic breast cancer in oestrogen receptor positive patients. A randomized trial comparing tamoxifen alone versus tamoxifen plus CMF. Cancer. 1982;50:2747–2750
  10. J Clin Oncol. 1986;4:186–193
  11. Abe O, Asaishi K, Izuo M, Enomoto K, Koyama H, Tominaga T. Effects of medroxyprogesterone acetate therapy on advanced or recurrent breast cancer and its influences on blood coagulation and the fibrinolytic system. Surg Today. 1995;25:701–710
  12. Falkson G, Falkson HC, Glidewell O, Weinberg V, Leone L, Holland J. Improved remission rates and remission duration in young women with metastatic breast cancer following combined oophorectomy and chemotherapy: a study of Cancer and Leukemia Group B. Cancer. 1979;43:2215–2222
  13. Ejlertsen B, Pfeiffer P, Pedersen D, Mouridsen HT, Rose C, Overgaard M. Decreased efficacy of cyclophosphamide, epirubicin and 5-fluorouracil in metastatic breast cancer when reducing treatment duration from 18 to 6 months. Eur J Cancer. 1993;29A:527–531
  14. Coates A, Gebski V, Bishop JF, Jeal PN, Woods RL, Snyder R. Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. New Engl J Med. 1987;317:1490–1495
  15. Harris AL, Cantwell BM, Carmichael J, Wilson R, Farndon J, Dawes P. Comparison of short-term and continuous chemotherapy (mitozantrone) for advanced breast cancer [see comments,Lancet 1990;335: 853–854, 1033]. Lancet. 1990;335:186–190
  16. Carmo-Pereira J, Costa FO, Henriques E, Godinho F, Cantinho-Lopes MG, Sales-Luis A. A comparison of two doses of adriamycin in the primary chemotherapy of disseminated breast carcinoma. Br J Cancer. 1987;56:471–473
  17. Riccardi A, Giordano M, Brugnatelli S, Ucci G, Danova M, Mora O. Different doses of epirubicin associated with fixed doses of cyclophosphamide and 5-fluorouracil: a randomised study in advanced breast cancer [letter]. Eur J Cancer. 1995;31A:1549–1551
  18. Focan C, Andrien JM, Closon MT, Dicato M, Driesschaert P, Focan-Henrard D. Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: a prospective randomized trial. J Clin Oncol. 1993;11:1253–1263
  19. Tannock IF, Boyd NF, DeBoer G, Erlichman C, Fine S, Larocque G. A randomized trial of two dose levels of cyclophosphamide, methotrexate, and fluorouracil chemotherapy for patients with metastatic breast cancer [see comments: J Clin Oncol 1989; 7: 403–4]. J Clin Oncol. 1988;6:1377–1387
  20. J Clin Oncol. 1991;9:305–312
  21. Walters RS, Frye D, Buzdar AU, Holmes FA, Hortobagyi GN. A randomized trial of two dosage schedules of mitomycin C in advanced breast carcinoma. Cancer. 1992;69:476–481
  22. Marschner N, Kreienberg R, Souchon R, Rath U, Eggeling B, Voigtmann . Evaluation of the importance and relevance of dose intensity using epirubicin and cyclophosphamide in metastatic breast cancer: interim analysis of a prospective randomized trial. Sem Oncol. 1994;21:10–16
  23. Hortobagyi GN, Bodey GP, Buzdar AU, Frye D, Legha SS, Malik R. Evaluation of high-dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study. J Clin Oncol. 1987;5:354–364
  24. Ceci G, Bisagni G, Cocconi G, Rodino C, Belsanti V, Bertusi M. Cisplatin and VP16 in metastatic breast carcinoma as a third-line chemotherapy: a randomized study comparing low versus high doses of cisplatin. Tumori. 1995;81:241–244
  25. Habeshaw T, Paul J, Jones R, Stallard S, Stewart M, Kaye SB. Epirubicin at two dose levels with prednisolone as treatment for advanced breast cancer: the results of a randomized trial. J Clin Oncol. 1991;9:295–304
  26. Bastholt L, Dalmark M, Gjedde SB, Pfeiffer P, Pedersen D, Sandberg E. Dose-response relationship of epirubicin in the treatment of postmenopausal patients with metastatic breast cancer: a randomized study of epirubicin at four different dose levels performed by the Danish Breast Cancer Cooperative Group. J Clin Oncol. 1996;14:1146–1455
  27. Ebbs SR, Saunders JA, Graham H, A’Hern RP, Bates T, Baum M. Advanced breast cancer. A randomised trial of epidoxorubicin at two different dosages and two administration systems. Acta Oncologica. 1989;28:887–892
  28. Bezwoda WR, Seymour L, Dansey RD. High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial [see comments: J Clin Oncol 1995;13: 2477–9 and 1996;14: 685–7]. J Clin Oncol. 1995;13:2483–2489
  29. Boccardo F, Rubagotti A, Rosso R, Santi L. Chemotherapy with or without tamoxifen in postmenopausal patients with late breast cancer. A randomized study. J Steroid Biochem. 1985;23:1123–1127
  30. Falkson G, Holcroft C, Gelman RS, Tormey DC, Wolter JM, Cummings FJ. Ten-year follow-up study of premenopausal women with metastatic breast cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 1995;13:1453–1458
  31. Mouridsen HT, Rose C, Engelsmann E, Sylvester R, Rotmensz N. Combined cytotoxic and endocrine therapy in postmenopausal patients with advanced breast cancer. A randomized EORTC study of CMF vs CMF + tamoxifen. J Steroid Biochem. 1985;23:1141–1146
  32. Tominaga T, Abe O, Ohshima A, Hayasaka H, Uchino J, Abe R. Comparison of chemotherapy with or without medroxyprogesterone acetate for advanced or recurrent breast cancer. Eur J Cancer. 1994;30A:959–964
  33. Viladiu P, Alonso MC, Avella A, Beltran M, Borras J, Ojeda B. Chemotherapy versus chemotherapy plus hormonotherapy in postmenopausal advanced breast cancer patients. A randomized trial. Cancer. 1985;56:2745–2750
  34. Perry MC, Kardinal CG, Korzun AH, Ginsberg SJ, Raich PC, Holland JF. Chemohormonal therapy in advanced carcinoma of the breast: Cancer and Leukemia Group B protocol 8081. J Clin Oncol. 1987;5:1534–1545
  35. Gundersen S, Kvinnsland S, Klepp O, Lund E, Hannisdal E, Host H. Chemotherapy with or without high-dose medroxyprogesterone acetate in ooestrogen-receptor-negative advanced breast cancer. Norwegian Breast Cancer Group. Eur J Cancer. 1992;28:390–394
  36. Muss HB, Case LD, Capizzi RL, Cooper MR, Cruz J, Jackson D. High-versus standard-dose megestrol acetate in women with advanced breast cancer: a phase III trial of the Piedmont Oncology Association. J Clin Oncol. 1990;8:1797–1805
  37. Raats JI, Falkson G, Falkson HC. A study of fadrozole, a new aromatase inhibitor, in postmenopausal women with advanced metastatic breast cancer. J Clin Oncol. 1992;10:111–116
  38. Falkson G, Raats JI, Falkson HC. Fadrozole hydrochloride, a new nontoxic aromatase inhibitor for the treatment of patients with metastatic breast cancer. J Steroid Biochem Mol Biol. 1992;43:161–165
  39. Robustelli della Cuna G, Pannuti F, Martoni A, Camaggi CM, Strocchi E, Da Prada GA. Aminoglutethimide in advanced breast cancer: prospective, randomized comparison of two dose levels. Italian Cooperative Group. Anticancer Res. 1993;13:2367–2371
  40. Cavalli F, Goldhirsch A, Jungi F, Martz G, Alberto P. Randomized trial of low-versus high-dose medroxyprogesterone acetate in the induction treatment of postmenopausal patients with advanced breast cancer. J Clin Oncol. 1984;2:414–419
  41. Gallagher CJ, Cairnduff F, Smith IE. High dose versus low dose medroxyprogesterone acetate: a randomized trial in advanced breast cancer. Eur J Cancer Clin Oncol. 1987;23:1895–1900
  42. Hayes DF, Van Zyl JA, Hacking A, Goedhals L, Bezwoda WR, Mailliard . Randomized comparison of tamoxifen and two separate doses of toremifene in postmenopausal patients with metastatic breast cancer. J Clin Oncol. 1995;13:2556–2566
  43. Bajetta E, Zilembo N, Buzzoni R, Noberasco C, Di Leo A, Bartoli C. Endocrinological and clinical evaluation of two doses of formestane in advanced breast cancer. Br J Cancer. 1994;70:145–150
  44. Powles TJ, Gordon C, Coombes RC. Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer with tamoxifen-aminoglutethimide-danazol compared to tamoxifen used alone. Cancer Res. 1982;42:3458s–3460s
  45. Beltran M, Alonso MC, Ojeda MB, Izquierdo A, Ferrer J, Pico C. Alternating sequential endocrine therapy: tamoxifen and medroxyprogesterone acetate versus tamoxifen in postmenopausal advanced breast cancer patients. Ann Oncol. 1991;2:495–499
  46. Gill PG, Gebski V, Snyder R, Burns I, Levi J, Byrne M. Randomized comparison of the effects of tamoxifen, megestrol acetate, or tamoxifen plus megestrol acetate on treatment response and survival in patients with metastatic breast cancer [see comments: Ann Oncol 1993;4: 712–13]. Ann Oncol. 1993;4:741–744
  47. Boccardo F, Rubagotti A, Perrotta A, Amoroso D, Balestrero M, De . Ovarian ablation versus goserelin with or without tamoxifen in pre-perimenopausal patients with advanced breast cancer: results of a multicentric Italian study. Ann Oncol. 1994;5:337–342
  48. Jonat W, Kaufmann M, Blamey RW, Howell A, Collins JP, Coates A. A randomised study to compare the effect of the luteinising hormone releasing hormone (LHRH) analogue goserelin with or without tamoxifen in pre- and perimenopausal patients with advanced breast cancer. Eur J Cancer. 1995;31A:137–142
  49. Ingle JN, Twito DI, Schaid DJ, Cullinan SA, Krook JE, Mailliard JA. Combination hormonal therapy with tamoxifen plus fluoxymesterone versus tamoxifen alone in postmenopausal women with metastatic breast cancer. Cancer. 1991;67:886–891
  50. Ingle JN, Twito DI, Schaid DJ, Cullinan SA, Krook JE, Mailliard JA. Randomized clinical trial of tamoxifen alone or combined with fluoxymesterone in postmenopausal women with metastatic breast cancer. J Clin Oncol. 1988;6:825–831
  51. Gundersen S, Kvinnsland S, Lundgren S, Klepp O, Lund E, Bormer O. Cyclical use of tamoxifen and high-dose medroxyprogesterone acetate in advanced oestrogen receptor positive breast cancer. Breast Cancer Res Treat. 1990;17:45–50
  52. Bishop JF, Smith JG, Jeal PN, Murray R, Drummond RM, Pitt P. The effect of danazol on tumour control and weight loss in patients on tamoxifen therapy for advanced breast cancer: a randomised double-blind placebo controlled trial. Eur J Cancer. 1993;29A:814–818
  53. Heinonen E, Alanko A, Grohn P, Rissanen P. Nandrolone decanoate added to tamoxifen in the treatment of advanced breast cancer. Breast Cancer Res Treat. 1985;5:75–80
  54. De Lena M, Tommasi S, Schittulli F, Lorusso V, Paradiso A. Sequential alternate administration of tamoxifen and medroxyprogesterone acetate in advanced breast cancer: clinical-biological randomized study. Tumori. 1990;76:190–195
  55. Muss HB, Wells HB, Paschold EH, Black WR, Cooper MR, Capizzi RL. Megestrol acetate versus tamoxifen in advanced breast cancer: 5-year analysis – a phase III trial of the Piedmont Oncology Association. J Clin Oncol. 1988;6:1098–1106
  56. van Veelen H, Willemse PH, Tjabbes T, Schweitzer MJ, Sleijfer DT. Oral high-dose medroxyprogesterone acetate versus tamoxifen. A randomized crossover trial in postmenopausal patients with advanced breast cancer. Cancer. 1986;58:7–13
  57. Ingle JN, Krook JE, Green SJ, Kubista TP, Everson LK, Ahmann DL. Randomized trial of bilateral oophorectomy versus tamoxifen in premenopausal women with metastatic breast cancer. J Clin Oncol. 1986;4:178–285
  58. Perez Carrion R, Alberola Candel V, Calabresi F, Michel RT, Santos R, Delozier T. Comparison of the selective aromatase inhibitor formestane with tamoxifen as first-line hormonal therapy in postmenopausal women with advanced breast cancer. Ann Oncol. 1994;5 (Suppl 7):S19–S24
  59. Smith IE, Harris AL, Morgan M, Gazet JC, McKinna JA. Tamoxifen versus aminoglutethimide versus combined tamoxifen and aminoglutethimide in the treatment of advanced breast carcinoma. Cancer Res. 1982;42:3430s–3433s
  60. Castiglione-Gertsch M, Pampallona S, Varini M, Cavalli F, Brunner K, Senn HJ. Primary endocrine therapy for advanced breast cancer: to start with tamoxifen or with medroxyprogesterone acetate? [see comments: Ann Oncol 1993;4: 712–13]. Ann Oncol. 1993;4:735–740
  61. Gale KE, Andersen JW, Tormey DC, Mansour EG, Davis TE, Horton J. Hormonal treatment for metastatic breast cancer. An Eastern Cooperative Oncology Group Phase III trial comparing aminoglutethimide to tamoxifen. Cancer. 1994;73:354–361
  62. Ingle JN, Ahmann DL, Green SJ, Edmonson JH, Creagan ET, Hahn RG. Randomized clinical trial of megestrol acetate versus tamoxifen in paramenopausal or castrated women with advanced breast cancer. Am J Clin Oncol. 1982;5:155–160
  63. Muss HB, Case LD, Atkins JN, Bearden JD, Cooper MR, Cruz JM. Tamoxifen versus high-dose oral medroxyprogesterone acetate as initial endocrine therapy for patients with metastatic breast cancer: a Piedmont Oncology Association study [see comments: J Clin Oncol 1994;12: 2515–2516]. J Clin Oncol. 1994;12:1630–1638
  64. Buchanan RB, Blamey RW, Durrant KR, Howell A, Paterson AG, Preece PE. A randomized comparison of tamoxifen with surgical oophorectomy in pemenopausal patients with advanced breast cancer. J Clin Oncol. 1986;4:1326–1330
  65. Martoni A, Longhi A, Canova N, Pannuti F. High-dose medroxyprogesterone acetate versus oophorectomy as first-line therapy of advanced breast cancer in premenopausal patients. Oncology. 1991;48:1–6
  66. Buzdar AU, Smith R, Vogel C, Bonomi P, Keller AM, Favis G. Fadrozole HCL (CGS-16949A) versus megestrol acetate treatment of postmenopausal patients with metastatic breast carcinoma: results of two randomized double blind controlled multiinstitutional trials. Cancer. 1996;77:2503–2513
  67. Garcia-Giralt E, Ayme Y, Carton M, Daban A, Delozier T, Fargeot P. Second and third line hormonotherapy in advanced post-menopausal breast cancer: a multicenter randomized trial comparing medroxyprogesterone acetate with aminoglutethimide in patients who have become resistant to tamoxifen. Breast Cancer Res Treat. 1993;24:139–145
  68. Canney PA, Priestman TJ, Griffiths T, Latief TN, Mould JJ, Spooner D. Randomized trial comparing aminoglutethimide with high-dose medroxyprogesterone acetate in therapy for advanced breast carcinoma. J Natl Cancer Inst. 1988;80:1147–1151
  69. Lundgren S, Gundersen S, Klepp R, Lonning PE, Lund E, Kvinnsland S. Megestrol acetate versus aminoglutethimide for metastatic breast cancer. Breast Cancer Res Treat. 1989;14:201–206
  70. Priestman T, Baum M, Jones V, Forbes J. Treatment and survival on advanced breast cancer. Br Med J. 1978;2:1673–1674
  71. Gregory RK, Powles TJ, Chang J, Ashley S. A randomized trial of six versus twelve courses of chemotherapy in metastatic carcinoma of the breast. Eur J Cancer. 1997;33:2194–2197
  72. Stockler M, Wilcken N, Coates A. Chemotherapy for metastatic breast cancer – when is enough enough?. Eur J Cancer. 1997;33:2147–2148
  73. Guidance for Purchasers. Improving Outcomes in Breast Cancer: the Research Evidence. Leeds, NHS Executive, 1996
  74. Fossati R, Confalonieri C, Torri V. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol. 1998;16:3439–3460
  75. Berlin J. Does blinding of readers affect the results of meta-analyses? [letter]. Lancet. 1997;350:185–186
  76. Kornblith AB, Hollis DR, Zuckerman E. Effect of megestrol acetate on quality of life in a dose response trial in women with advanced breast cancer. J Clin Oncol. 1993;11:2081–2089
  77. Weiss RB, Rifkin RM, Stewart MF, Theriault RL, Williams LA, Herman AA, et al. High-dose chemotherapy for high-risk primary breast cancer: an on-site review of the Bezwoda study. Lancet. 2000;355:99–1003
  78. Cleaton-Jones P. Scientific misconduct in a breast-cancer chemotherapy trial: response of University of the Witwatersrand. Lancet. 2000;355:1011
  79. Stadtmauer, E. A. O’Neill, A. Goldstein, L. J. et al., Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. N Engl J Med

☆ Funded by the Australian National Health and Medical Research Council National Breast Cancer Centre.

PII: S0305-7372(99)90161-5

doi: 10.1053/ctrv.1999.0161

Cancer Treatment Reviews
Volume 26, Issue 3 , Pages 151-168 , June 2000

Article Tools