Randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma

Journal of the National Cancer Institute

Volumn 92, Issue 3, 2000, Pages 225-233

  Hortobagyi, Gabriel N ^a   Buzdar, Aman U ^a   Theriault, Richard L ^a   Valero, Vicente ^a   Frye, Debra ^a   Booser, Daniel J ^a   Holmes, Frankie A ^a   Giralt, Sergio ^a   Khouri, Issa ^a   Andersson, Borje ^a   Gajewski, James L ^a   Rondon, Gabriela ^a   Smith, Terry L ^a   Singletary, Sonja E ^a   Ames, Frederick C ^a   Sneige, Nour ^a   Strom, Eric A ^a   McNeese, Marsha D ^a   Deisseroth, Albert B ^b   Champlin, Richard E ^a  

^a UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^b YALE UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; CARBOPLATIN; CISPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; ESTROGEN RECEPTOR; ETOPOSIDE; FLUOROURACIL; FUROSEMIDE; INTERLEUKIN 2; MANNITOL; TAMOXIFEN;

ADULT; ARTICLE; AUTOTRANSPLANTATION; BREAST CARCINOMA; DIARRHEA; DOSE RESPONSE; DRUG MEGADOSE; FOLLOW UP; HEMATOPOIETIC STEM CELL; HUMAN; HUMAN CELL; HUMAN TISSUE; MORBIDITY; MUCOSA INFLAMMATION; NAUSEA; PERIPHERAL NEUROPATHY; PRIORITY JOURNAL; SURVIVAL RATE; VOMITING;

EID: 0034594653     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/92.3.225     Document Type: Article

References (43)

1. Fisher ER, Fisher B. Relationship of pathologic and some clinical discriminants to the spread of breast cancer. Int J Radiat Oncol Biol Phys 1977;2: 747-50.
2. Fisher ER, Redmond C, Fisher B. Pathologic findings from the National Surgical Adjuvant Breast Project (Protocol no. 4). VI. Discriminants for five-year treatment failure. Cancer 1980;46:908-18.
3. Buzdar AU, Gutterman JU, Blumenschein GR, Hortobagyi GN, Tashima CK, Smith TL, et al. Intensive postoperative chemoimmunotherapy for patients with stage II and stage III breast cancer. Cancer 1978;41:1064-75.
4. Hortobagyi GN, Ames FC, Buzdar AU, Kau SW, McNeese MD, Paulus D, et al. Management of stage III primary breast cancer with primary chemotherapy, surgery, and radiation therapy. Cancer 1988;62:2507-16.
5. Buzdar AU, Kau SW, Smith TL, Hortobagyi GN. Ten-year results of FAC adjuvant chemotherapy trial in breast cancer. Am J Clin Oncol 1989;12: 123-8.
6. Early Breast Cancer Trialists' Collaborative Group. Ovarian ablation in early breast cancer: overview of the randomised trials. Lancet 1996;348: 1189-96.
7. Early Breast Cancer Trialists' Collaborative Group. Tamoxifen for early breast cancer: an overview of the randomised trials. Lancet 1998;351: 1451-67.
8. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998; 352:930-42.
9. Hryniuk WM, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol 1984;2:1281-8.
10. Hryniuk W, Levine MN. Analysis of dose intensity for adjuvant chemotherapy trials in stage II breast cancer. J Clin Oncol 1986;4:1162-70.
11. Henderson IC, Hayes DF, Gelman R. Dose-response in the treatment of breast cancer: a critical review. J Clin Oncol 1988;6:1501-15.
12. Hortobagyi GN, Dunphy F, Buzdar AU, Spitzer G. Dose intensity studies in breast cancer - autologous bone marrow transplantation. In: Ragaz J, Simpson-Herren L, Lippman ME, Fisher B, editors. Effects of therapy on biology and kinetics of the residual tumor, part B: clinical aspects. 1st ed. New York (NY): Wiley-Liss; 1990, p. 195-209.
13. Amman K, Eder JP, Frei E. High-dose chemotherapy with bone marrow support for solid tumors. Important. Adv Oncol 1987;221-35.
14. Vahdat L, Antman KH. Dose-intensive therapy in breast cancer. In: Armitage JO, Antman KH. editors. High-dose cancer therapy. 2nd ed. Baltimore (MD): Williams & Wilkins; 1995. p. 802-23.
15. Peters WP. High-dose chemotherapy with autologous bone marrow transplantation for the treatment of breast cancer: Yes. In: De Vita VT Jr, Hellman S, Rosenberg SA, editors. Important advances in oncology 1995. 1st ed. Philadelphia (PA): Lippincott; 1995. p. 215-30.
16. Antman KH, Rowlings PA, Vaughan WP, Pelz CJ, Fay JW, Fields KK, et al. High-dose chemotherapy with autologous hematopoietic stem-cell support for breast cancer in North America. J Clin Oncol 1997;15: 1870-9.
17. Peters WP, Davis R, Shpall EJ, Jones R, Ross M, Marks L, et al. Adjuvant chemotherapy involving high-dose combination cyclophosphamide, cisplatin, and carmustine and autologous bone marrow support for stage II/III breast cancer involving ten or more lymph nodes (CALGB 8782): a preliminary report [abstract]. Proc ASCO 1990;9:22:A80.
18. Somlo G, Doroshow JH, Forman S, Ahn C, Leong L, Margolin K, et al. High-dose chemotherapy (HDCT) with stem cell rescue (SCR) for high-risk breast cancer (HRBC) [abstract]. Proc ASCO 1994;13: 104:A217.
19. Somlo G, Doroshow JH, Forman SJ, Odom Maryon T, Lee J, Chow W, et al. High-dose chemotherapy and stem-cell rescue in the treatment of high-risk breast cancer: prognostic indicators of progression-free and overall survival. J Clin Oncol 1997;15:2882-93.
20. Gianni AM, Siena S, Bregni M, Di Nicola M, Orefice S, Luini A, et al. Growth factor-supported high-dose sequential (HDS) adjuvant chemotherapy in breast cancer with greater than or equal to 10 positive nodes [abstract]. Proc ASCO 1992;11:69:A68.
21. deLima M, Mehra R, van Besien K, Giralt S, Rondon G, Mirza N, et al. High-dose chemotherapy (HDCT) and autologous blood and marrow transplant (BMT) for high-risk breast cancer (BC) [abstract]. Proc ASCO 1997; 16:109A:A383.
22. Hortobagyi GN, Buzdar AU, Champlin R, Gajewski J, Holmes FA, Booser D, et al. Lack of efficacy of adjuvant high-dose (HD) tandem combination chemotherapy (CT) for high-risk primary breast cancer (HRPBC)-A randomized trial [abstract]. Proc ASCO 1998;17:123a:A471.
23. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
24. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
25. Cox DR. Regression models and life tables. J R Stat Soc (B) 1972;34: 187-220.
26. Fleming ID, Cooper JS, Henson DE, Hutter RV, Kennedy BJ, Murphy GP, et al. American Joint Committee on Cancer Staging Manual. Philadelphia (PA): Lippincott-Raven: 1997. p. 171-80.
27. Hortobagyi GN, Bodey GP, Buzdar AU, Frye D, Legha SS, Malik R, et al. Evaluation of high dose versus standard FAC chemotherapy for advanced breast cancer in protected environment units: a prospective randomized study. J Clin Oncol 1987;5:354-64.
28. Buzdar AU, Yap HY, Esparza L, Holmes F, Fraschini G, Hug V, Hortobagyi GN. A comparative randomized trial of doxorubicin and cyclophosphamide in combination with fluorouracil (FAC) or etoposide (EAC) in metastatic breast cancer. Int J Exp Clin Chemother 1988;1:48-55.
29. Bonadonna G, Brusamolino E, Valagussa P, Rossi A, Brugnatelli L, Brambilla C, et al. Combination chemotherapy as an adjuvant treatment in operable breast cancer. N Engl J Med 1976;294:405-10.
30. Kuerer HM, Newman LA, Buzdar AU, Hunt KK, Dhingra K, Buchholz TA, et al. Residual metastatic axillary lymph nodes following neoadjuvant chemotherapy predict disease free survival in patients with locally advanced breast cancer. Am J Surg 1998;176:502-8.
31. Peters WP, Ross M, Vredenburgh JJ, Meisenberg B, Marks LB, Winer E, et al. High-dose chemotherapy and autologous bone marrow support as consolidation after standard-dose adjuvant therapy for high-risk primary breast cancer. J Clin Oncol 1993;11:1132-43.
32. Gianni AM, Siena S, Bregni M, Di Nicola M, Orefice S, Cusumano F, et al. Efficacy, toxicity, and applicability of high-dose sequential chemotherapy as adjuvant treatment in operable breast cancer with 10 or more involved axillary nodes: five-year results. J Clin Oncol 1997;15: 2312-21.
33. Schwartzberg LS, Birch R, West WH, Tauer KW, Wittlin F, Leff R, et al. Sequential treatment including high-dose chemotherapy with peripheral blood stem cell support in patients with high-risk stage II-III breast cancer: outpatient administration in community cancer centers. Am J Clin Oncol 1998;21:523-31.
34. Basser RL, To LB, Begley CG, Juttner CA, Maher DW, Szer J, et al. Adjuvant treatment of high-risk breast cancer using multicycle high-dose chemotherapy and filgrastim-mobilized peripheral blood progenitor cells. Clin Cancer Res 1995;1:715-21.
35. de Graaf H, Willemse PH, De Vries EG, Sleijfer DT, Mulder PO, Van der Graaf WT, et al. Intensive chemotherapy with autologous bone marrow transfusion as primary treatment in women with breast cancer and more than five involved axillary lymph nodes. Eur J Cancer 1994;30A: 150-3.
36. Rahman ZU, Frye DK, Buzdar AU, Smith TL, Asmar L, Champlin RE, et al. 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 1997;15:3171-7.
37. Garcia-Carbonero R, Hidalgo M, Paz-Ares L, Calzas J, Gomez H, Guerra JA, et al. Patient selection in high-dose chemotherapy trials: relevance in high-risk breast cancer. J Clin Oncol 1997;15:3178-84.
38. Crump M, Goss PE, Prince M, Girouard C. Outcome of extensive evaluation before adjuvant therapy in women with breast cancer and 10 or more positive axillary lymph nodes. J Clin Oncol 1996;14:66-9.
39. Rodenhuis S, Richel DJ, van der Wall E, Schornagel JH, Baars JW, Koning CC, et al. Randomised trial of high-dose chemotherapy and haemopoietic progenitor-cell support in operable breast cancer with extensive axillary lymph-node involvement. Lancet 1998;352:515-21.
40. Peters W, Rosner G, Vredenburgh J, Shpall E, Crump M, Richardson P, et al. A prospective randomized comparison of two doses of combination alkylating agents as consolidation after CAF in high-risk primary breast cancer involving ten or more axillary lymph nodes: preliminary results of CALGB 9082/SWOG 9114/NCIC MA-13 [abstract]. Proc ASCO 1999;18: 1a [abstract No. 2].
41. The Scandinavian Breast Cancer Study Group 9401. Results from a randomized adjuvant breast cancer study with high dose chemotherapy with CTCb supported by autologous bone marrow stem cells versus dose escalated and tailored FEC therapy [abstract]. Proc ASCO 1999;18:2a [abstract No. 3].
42. Bezwoda WR. Randomised, controlled trial of high dose chemotherapy (HD-CNVp) versus standard dose (CAF) chemotherapy for high risk, surgically treated, primary breast cancer (abstract). Proc ASCO 1999;18:2a [abstract No. 4].
43. Stadtmauer EA, O'Neili A, Goldstein LJ, Crilley P, Mangan KF, Ingle JN, et al. Phase III randomized trial of high-dose chemotherapy and stem cell support shows no difference in overall survival or severe toxicity compared to maintenance chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) for women with metastatic breast cancer who are responding to conventional induction chemotherapy: The "Philadelphia" Intergroup Study (PBT-1) [abstract]. Proc ASCO 1999;18:1a [abstract No. 1].