Methodological arguments for the necessity of randomized trials in high-dose chemotherapy for breast cancer

Breast Cancer Research and Treatment

Volumn 54, Issue 1, 1999, Pages 31-38

  Schmoor, Claudia ^a   Schumacher, Martin ^b  

^a UNIVERSITY OF FREIBURG   (Germany)

^b NONE

Author keywords

Breast cancer; High dose chemotherapy; Randomized trials; Stem cell transplantation

Indexed keywords

ANTINEOPLASTIC AGENT;

ARTICLE; BREAST CANCER; CLINICAL TRIAL; DRUG MEGADOSE; FEMALE; HEMATOPOIETIC STEM CELL; HUMAN; METHODOLOGY; PATIENT COMPLIANCE; PRIORITY JOURNAL;

AGE FACTORS; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; EVALUATION STUDIES; FEMALE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; LYMPHATIC METASTASIS; PROGNOSIS; RANDOMIZED CONTROLLED TRIALS; SURVIVAL RATE; TRANSPLANTATION, AUTOLOGOUS;

EID: 0032955670     PISSN: 01676806     EISSN: None     Source Type: Journal    
DOI: 10.1023/A:1006111821492     Document Type: Article

References (34)

1. 1. Smith GA, Henderson IC: High-dose chemotherapy (HDC) with autologous bone marrow transplantation (AMBT) for the treatment of breast cancer: The jury is still out. In: DeVita VT, Hellman S, Rosenberg SA (eds) Important Advances in Oncology. Philadelphia, Lippincott, 1995, pp 201-214
2. 2. Zujewski J, Nelson A, Abrams J: Much ado about not . . . enough data: high-dose chemotherapy with autologous stem cell rescue for breast cancer. J Natl Cancer Inst 90: 200-209, 1998
3. 3. Matthews J: NCI Survey explores the M.D.'s perspective on ABMT trials (News). J Natl Cancer Inst 87: 1510-1511, 1995
4. 4. Gradishar WJ, Tallman MS, Abrams JS: High-dose chemotherapy for breast cancer. Ann Int Med 125: 599-604, 1996
5. 5. Smigel K: Women flock to ABMT for breast cancer without final proof (News). J Natl Cancer Inst 87: 952-955, 1995
6. 6. Schmoor C, Schumacher M: High-dose chemotherapy as adjuvant treatment for breast cancer - some statistical arguments. Onkologie 19: 78-80, 1996
7. 7. Schumacher M, Bastert G, Bojar H, Hühner K, Olschewski M, Sauerbrei W, Schmoor, C, Beyerle C, Neumann RLA, Rauschecker HF, for the German Breast Cancer Study Group (GBSG): Randomized 2×2 trial evaluating hormonal treatment and the duration of chemotherapy in node-positive breast cancer patients. J Clin Oncol 12: 2086-2093, 1994
8. 8. Bezwoda WR, Seymour L, Dansey RD: High-dose chemotherapy with hematopoietic rescue as primary treatment for metastatic breast cancer: a randomized trial. J Clin Oncol 13: 2483-2489, 1995
9. 9. Kennedy MJ: High-dose chemotherapy of breast cancer: Is the question answered? (Editorial). J Clin Oncol 13: 2477-2479, 1995
10. 10. Reeht A: High-dose chemotherapy for metastatic breast cancer. J Clin Oncol 14: 684-685 (letter), 1996
11. 11. Cohen MH: Dose-intensive metastatic breast cancer chemotherapy. J Clin Oncol 14: 685-686 (letter), 1996
12. 12. Subar M: Risk stratification for high-dose chemotherapy in metastatic breast cancer. J Clin Oncol 14: 686-687 (letter), 1996
13. 13. Spiridonidis CH, Laufman LR, Rhodes V, Jones J: High-dose chemotherapy for metastatic breast cancer. J Clin Oncol 14: 686 (letter), 1996
14. 14. Peters WP, Jones RB, Vredenburgh J, Shpall EJ, Hussein A, Elkordy M, Rubing P, Ross M, Berry D: A large prospective, randomized trial of high-dose combination alkylating agents (CPB) with autologous cellular support (ABMS) as consolidation for patients with metastatic breast cancer achieving complete remission after intensive doxorubicin-based induction therapy (AFM). Proc Am Soc Clin Oncol 15: 121 (abstr), 1996
15. 15. Antman KH, Rowlings PA, Vaughan WP, Pelz CJ, Fay JW, Fields KK, Freytes CO, Gale RP, Hillner BE, Holland HK, Kennedy MJ, Klein JP, Lazarus HM, McCarthy PL Jr, Saez R, Spitzer G, Stadtmauer EA, Williams SF, Wolff S, Sabocinski KA, Armitage JO, Horowitz MM: High-dose chemotherapy with autologous hematopoietic stem-cell support for breast cancer in North America. J Clin Oncol 15: 1870-1879, 1997
16. 16. Peters WP, Ross M, Vredenburgh JJ, Meidenberg B, Marks LB, Winer E, Kurtzberg J, Bast RC Jr, Jones R, Shpall E, Wu K, Rosner G, Gilbert C, Mathias B, Coniglio D, Petros W, Henderson IC, Norton L, Weiss RB, Budman D, Hurd D: High-dose chemotherapy and autologous bone marrow support as consolidation after standard-dose adjuvant therapy for high-risk primary breast cancer. J Clin Oncol 11: 1132-1143, 1993
17. 17. Peters WP, Dansey R, Klein J, Berry D: High-dose chemotherapy for high-risk primary breast cancer. In: Salmon SE (ed) Adjuvant Therapy of Cancer VIII. Philadelphia, Lippincott, 1997, pp 117-122
18. 18. Zander A, Krüger W, Zeller W, Jonat W, Hossfeld D: Hochdosischemotherapie und autologe Blutstammzell-transplantation (APBSCT) beim Mammakarzinom. Intensivmedizin im Dialog-Sonderheft Onkologie 17: 1-4, 1994
19. 19. Kanz L, Brugger W: Hochdosischemotherapie beim Mammakarzinom. Onkologie 1: 229-232, 1995
20. 20. Hurd DD, Peters WP, for the Cancer and Leukemia Group B: Randomized, comparative study of high-dose (with autologous bone marrow support) versus low-dose cyclophosphamide, cisplatin and carmustine as consolidation to adjuvant cyclophosphamide, doxorubicin, and fluorouracil for patients with operable stage II or III breast cancer involving 10 or more axillary lymph nodes (CALGB Protocol 9082). J Natl Cancer Inst Monographs 19: 41-14, 1995
21. 21. Peters WP: High-dose chemotherapy with autologous bone marrow transplantation for the treatment of breast cancer: Yes, In: DeVita VT, Hellman S, Rosenberg SA (eds) Important advances in oncology, Philadelphia, Lippincott, 1995, pp 215-230
22. 22. Byar DP, Simon RM, Friedewald WT, Schlesselman JJ, DeMets DL, Ellenberg JH, Gail M, Ware JH: Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 295: 74-80, 1976
23. 23. Pocock SJ: Clinical Trials. New York, Wiley, 1983.
24. 24. Green SB, Byar DP: Using observational data from registries to compare treatments: the fallacy of omnimetries. Stat Med 3: 361-370, 1984
25. 25. Crump M, Goss PE, Prince M, Girourard C: Outcome of extensive evaluation before adjuvant therapy in women with breast cancer and 10 or more positive axillary lymph nodes. J Clin Oncol 14: 66-69, 1996
26. 26. Rahman ZU, Frye DK, Buzdar AU, Hortobagyi G: A retrospective analysis to evaluate the impact of selection process for high-dose chemotherapy on the outcome of patients with metastatic breast cancer. Proc Am Soc Clin Oncol 14: 94 (abstr), 1995
27. 27. Rahman ZU, Frye DK, Buzdar AU, Smith TL, Asmar L, Champlin RE, Hortobagyi GN: Impact of selection process on response rate and long-term survival of potential high-dose chemotherapy candidates treated with standard-dose doxorubicin-containing chemotherapy in patients with metastatic breast cancer. J Clin Oncol 15: 3171-3177, 1997
28. 28. Garcia-Carbonero R, Hidalgo M, Paz-Ares L, et al.: Patient selection in high-dose chemotherapy trials: relevance in high-risk breast cancer. J Clin Oncol 15: 3178-3184, 1997
29. 29. Schmoor C, Olschewski M, Schmacher M: Randomized and non-randomized patients in clinical trials: Experiences with comprehensive cohort studies. Stat Med 15: 263-271, 1996
30. 30. Bloom HJS, Richardson WW: Histological tumor grading and prognosis in breast cancer. Br J Cancer 11: 339-377, 1957
31. 31. McCarthy M: Unproven breast-cancer therapy widely used in USA. Lancet 347: 1617, 1996
32. 32. de Vries EGE, ten Vergert EM, Mastenbrock CG, Dalesio O, Rodenhuis S: Breast cancer studies in the Netherlands (letter). Lancet 348: 407-408, 1996
33. 33. Rodenhuis S, Richel DJ, van der Wall E, Schornagel JH, Baars JW, Koning CCE, Petersc JL, Borger JH, Nooijen WJ, Bakx R, Dalesio O, Rutgers E: Randomized trial of high-dose chemotherapy and haemopoietic progenitor-cell support in operable breast cancer with extensive axillary lymph-node involvement. Lancet 352: 515-521, 1998
34. 34. Hortobagyi GN, Buzdar AU, Champlin R, Gajewski J, Holmes FA, Booser D, Valero V, Theriault RL: Lack of efficacy of adjuvant high-dose (HD) tandem combination chemotherapy (CT) for high-risk primary breast cancer (HRPBC): a randomized trial. Proc Am Soc Clin Oncol 17: (abstr 417), 1998