Status of High-Dose Chemotherapy for Breast Cancer: A Review

Biology of Blood and Marrow Transplantation

Volumn 6, Issue 5, 2000, Pages 476-495

  Nieto, Yago ^a   Champlin, Richard E ^b   Wingard, John R ⁱ   Vredenburgh, James J ^c   Elias, Anthony D ^d   Richardson, Paul ^d   Glaspy, John ^e   Jones, Roy B ^a   Stiff, Patrick J ^f   Bearman, Scott I ^a   Cagnoni, Pablo J ^a   McSweeney, Peter A ^a   LeMaistre, C Fred ^g   Pecora, Andrew L ^h   Shpall, Elizabeth J ^a  

^a UNIVERSITY OF COLORADO   (United States)

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

^c DUKE UNIVERSITY   (United States)

^d DANA FARBER CANCER INSTITUTE   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f LOYOLA UNIVERSITY CHICAGO   (United States)

^g South Texas Cancer Institute   (United States)

^h Northern New Jersey Cancer Associates   (United States)

ⁱ Health Sciences Center ^*

Author keywords

Breast cancer; High dose chemotherapy; Stem cell transplantation

Indexed keywords

ANTINEOPLASTIC AGENT; TUMOR MARKER;

BONE MARROW DISEASE; BREAST TUMOR; CELL SEPARATION; CHEMICALLY INDUCED DISORDER; CLINICAL TRIAL; COMPARATIVE STUDY; CONTROLLED CLINICAL TRIAL; DISEASE FREE SURVIVAL; DOSE RESPONSE; FEMALE; FOLLOW UP; FORECASTING; FRANCE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMAN; LIFE TABLE; METASTASIS; METHODOLOGY; MORTALITY; MULTICENTER STUDY; MULTIMODALITY CANCER THERAPY; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PHASE 3 CLINICAL TRIAL; PROGNOSIS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; REMISSION; RETROSPECTIVE STUDY; REVIEW; RISK; SALVAGE THERAPY; TREATMENT OUTCOME; TUMOR RECURRENCE; UNITED STATES;

ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BONE MARROW DISEASES; BREAST NEOPLASMS; CELL SEPARATION; CLINICAL TRIALS, PHASE II; CLINICAL TRIALS, PHASE III; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; FOLLOW-UP STUDIES; FORECASTING; FRANCE; HEMATOPOIETIC STEM CELL TRANSPLANTATION; HUMANS; LIFE TABLES; MULTICENTER STUDIES; NEOPLASM METASTASIS; NEOPLASM RECURRENCE, LOCAL; PATIENT SELECTION; PHILADELPHIA; PROGNOSIS; PROSPECTIVE STUDIES; RANDOMIZED CONTROLLED TRIALS; REMISSION INDUCTION; RESEARCH DESIGN; RETROSPECTIVE STUDIES; RISK; SALVAGE THERAPY; TREATMENT OUTCOME; TUMOR MARKERS, BIOLOGICAL; UNITED STATES;

EID: 0034567765     PISSN: 10838791     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1083-8791(00)70019-X     Document Type: Article

References (179)

1. Peters WP, Henner WD, Bast RC, Schnipper L, Frei E III. Novel toxicities associated with high dose combination alkylating agents in autologous bone marrow support. In: Dicke KA, Spitzer G, Zander AR, eds. Autologous Bone Marrow Transplantation: Proceedings of the First International Symposium. Houston, TX: University of Texas Cancer Center, MD Anderson Hospital; 1986:231-235.
2. Antman KH, Rowlings PA, Vaughan WP, et al. High-dose chemotherapy with autologous hematopoietic stem-cell support for breast cancer in North America. J Clin Oncol. 1997;15:1870-1879.
3. Hryniuk W, Busch H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984;2: 1281-1288.
4. Hryniuk W, Frei E III, Wright FA. A single scale for comparing dose-intensity of all chemotherapy regimens in breast cancer: summation dose-intensity. J Clin Oncol. 1998;16:3137-3147.
5. Fossati R, Confalonieri C, Torri V, et al. 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.
6. Hryniuk W, Levine MN. Analysis of dose intensity for adjuvant chemotherapy trials in stage II breast cancer. J Clin Oncol. 1986;4:1162-1170.
7. Bonadonna G, Valagussa P. Dose-response effect of adjuvant chemotherapy in breast cancer. N Engl J Med. 1981;304:10-15.
8. Tannock IF, Boyd NF, DeBoer G, et al. A randomized trial of two dose levels of cyclophosphamide, methotrexate, and fluorouracil chemotherapy for patients with metastatic breast cancer. J Clin Oncol. 1988;6:1377-1387.
9. Hortobagyi GN, Bodey GP, Buzdar AU, 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;5:354-364.
10. Winer E, Berry D, Duggan D, et al. Failure of higher dose paclitaxel to improve outcome in patients with metastatic breast cancer: results from CALGB 9342 [abstract]. Proc Am Soc Clin Oncol. 1998;17:101a.
11. Habeshaw T, Paul R, Jones R, et al. 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.
12. Bastholt L, Dalmark M, Gjedde SB, et al. 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;14:1146-1155.
13. 2) in the FEC regimen significantly increases response rate: an international randomized phase III study in metastatic breast cancer. Ann Oncol. 1997;8:155-162.
14. Focan C, Andrien JM, Closon MT, et al. Dose-response relationship of epirubicin-based first-line chemotherapy for advanced breast cancer: a prospective randomized trial. J Clin Oncol. 1993;11:1253-1263.
15. Fountzilas G, Athanassiades A, Giannakkais T, et al. A randomized study of epirubicin monotherapy every four or every two weeks in advanced breast cancer: a Hellenic Cooperative Oncology Group study. Ann Oncol. 1997;8:1213-1220.
16. Wood WC, Budman DR, Korzun AH, et al. Dose and dose intensity of adjuvant chemotherapy for stage II, node-positive breast carcinoma. N Engl J Med. 1994;330:1253-1259.
17. Budman DR, Berry DA, Cirrincione CT, et al. Dose and dose intensity as determinants of outcome in the adjuvant treatment of breast cancer. J Natl Cancer Inst. 1999;91:286-287.
18. Bonneterre J, Roché H, Bremond A, et al. Results of a randomized trial of adjuvant chemotherapy with FEC 50 vs. FEC 100 in high risk node-positive breast cancer patients [abstract]. Proc Am Soc Clin Oncol. 1998;17:124a.
19. Fisher B, Anderson S, Wickerham DL, et al. Increased intensification and total dose of cyclophosphamide in a doxorubicincyclophosphamide regimen for the treatment of primary breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-22. J Clin Oncol. 1997;15:1858-1869.
20. Fisher B, Anderson S, DeCillis A, et al. Further evaluation of intensified and increased total dose of cyclophosphamide for the treatment of primary breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-25. J Clin Oncol. 1999;17:3374-3388.
21. Henderson IC, Berry D, Demetri G, et al. Improved disease-free and overall survival from the addition of sequential paclitaxel but not from the escalation of doxorubicin dose level in the adjuvant chemotherapy of patients with node-positive primary breast cancer [abstract]. Proc Am Soc Clin Oncol. 1998;17:101a.
22. Greenberg PA, Hortobagyi GN, Smith TL, et al. Long-term follow-up of patients with complete remission following combination chemotherapy for metastatic breast cancer. J Clin Oncol. 1996;14:2197-2205.
23. Sledge GW Jr, Neuberg D, Ingle J, et al. Phase III trial of doxorubicin (A) vs. paclitaxel (T) vs. doxorubicin + paclitaxel (A + T) as first-line therapy for metastatic breast cancer (MBC): an intergroup trial. Proc Am Soc Clin Oncol. 1997;16:1a.
24. Frei E III, Canellos GP. Dose: a critical factor in cancer chemotherapy. Am J Med. 1980;69:585-594.
25. Frei E III, Antman K, Teicher B, Eder P, Schnipper L. Bone marrow autotransplantation for solid tumors: prospects. J Clin Oncol. 1989;7:515-526.
26. Peters WP, Eder JP, Henner WD, et al. High-dose combination chemotherapy with autologous bone marrow support: a phase I trial. J Clin Oncol. 1986;4:646-654.
27. Eder JP, Antman K, Peters W, et al. High-dose combination alkylating agent chemotherapy with autologous bone marrow support for metastatic breast cancer. J Clin Oncol. 1986;4:1592-1597.
28. Eder JP, Elias A, Shea TC, et al. A phase I-II study of cyclophosphamide, thiotepa, and carboplatin with autologous bone marrow transplantation in solid tumor patients. J Clin Oncol. 1990;8:1239-1245.
29. Williams SF, Bitran JD, Kaminer L, et al. A phase I-II study of bialkylator chemotherapy, high-dose thiotepa, and cyclophosphamide with autologous bone marrow reinfusion in patients with advanced cancer. J Clin Oncol. 1990;5:260-265.
30. Peters WP, Shpall EJ, Jones RB, et al. High-dose combination chemotherapy with bone marrow support as initial treatment for metastatic breast cancer. J Clin Oncol. 1988;6:1368-1376.
31. Peters WP, Dansey R. New concepts in the treatment of breast cancer using high-dose chemotherapy. Cancer Chemother Pharmacol. 1997;40(suppl):S88-S93.
32. Jones RB, Shpall EJ, Ross M, et al. AFM induction chemotherapy followed by intensive alkylating agent consolidation with autologous bone marrow support (ABMS) for advanced breast cancer: current results [abstract]. Proc Am Soc Clin Oncol. 1990;7:121.
33. Rizzieri DA, Vredenburgh JJ, Chao NJ, et al. Long term disease free survival for patients with metastatic breast cancer undergoing aggressive induction therapy followed by high dose therapy with hematopoietic support [abstract]. Blood. 1998;92:323a.
34. Antman K, Ayash L, Elias A, et al. A phase II study of high-dose cyclophosphamide, thiotepa, and carboplatin with autologous bone marrow support in women with measurable advanced breast cancer responding to standard-dose therapy. J Clin Oncol. 1992;10:102-110.
35. Williams SF, Gilewski T, Mick R, et al. High-dose consolidation therapy with autologous stem cell rescue in stage IV breast cancer: follow-up report. J Clin Oncol. 1992;10:1743-1747.
36. Laport GF, Grad G, Grinblatt DL, et al. High-dose chemotherapy consolidation with autologous stem cell rescue in metastatic breast cancer: a 10-year experience. Bone Marrow Transplant. 1998;21:127-132.
37. Jones RB, Shpall EJ, Shogan J, et al. The Duke AFM program: intensive induction chemotherapy for metastatic breast cancer. Cancer. 1990;66:431-436.
38. Carter DL, Marks LB, Bean JM, et al. Impact of consolidation radiotherapy in patients with advanced breast cancer treated with high-dose chemotherapy and autologous bone marrow rescue. J Clin Oncol. 1999;17:887-893.
39. Decker DA, Ahman DL, Bisel HF, et al. Complete responders to chemotherapy in metastatic breast cancer: characterization and analysis. JAMA. 1979;242:2075-2079.
40. Powles TJ, Smith IE, Ford HT, et al. Failure of chemotherapy to prolong survival in a group of patients with metastatic breast cancer. Lancet. 1980;1:580-582.
41. Smith GA, Henderson IC. High-dose chemotherapy (HDC) with autologous bone marrow transplantation (ABMT) for the treatment of breast cancer: the jury is still out. In: Hellman S, Rosenberg SA, eds. JB Lippincott Company, Philadelphia, PA; 1995:201-214.
42. Rahman ZU, Frye DK, Buzdar AU, 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;15:3171-3177.
43. Dunphy FR, Spitzer G, Rossiter JE, et al. Factors predicting long-term survival for metastatic breast cancer patients treated with high-dose chemotherapy and bone marrow support. Cancer. 1994;73;2157-2167.
44. Ayash LJ, Wheeler C, Fairclough D, et al. Prognostic factors for prolonged progression-free survival with high-dose chemotherapy with autologous stem-cell support for advanced breast cancer. J Clin Oncol. 1995;13:2043-2049.
45. Doroshow JH, Somlo G, Ahn C, et al. Prognostic factors predicting progression-free and overall survival in patients with responsive metastatic breast cancer treated with high-dose chemotherapy and bone marrow stem cell reinfusion [abstract]. Proc Am Soc Clin Oncol. 1995;14:319a.
46. Rizzieri DA, Vredenburgh JJ, Jones R, et al. Prognostic and predictive factors for patients with metastatic breast cancer undergoing aggressive induction therapy followed by high-dose chemotherapy with autologous stem-cell support. J Clin Oncol. 1999;17:3064-3074.
47. Bewick T, Chadderton T, Conlon M, et al. Expression of C-erbB-2/HER-2 in patients with metastatic breast cancer undergoing high-dose chemotherapy and autologous blood stem cell support. Bone Marrow Transplant. 1999;24:377-384.
48. Rowlings PA, Williams SF, Antman KH, et al. Factors correlated with progression-free survival after high-dose chemotherapy and hematopoietic stem cell transplantation for metastatic breast cancer. JAMA. 1999;282:1335-1343.
49. Nieto Y, Cagnoni PJ, Shpall EJ, et al. Phase II trial of high-dose chemotherapy with autologous stem cell transplant for stage IV patients with minimal metastatic disease. Clin Cancer Res. 1999;5: 1731-1737.
50. Abraham R, Nagy T, Goss PE, Crump M. High dose chemotherapy and autologous blood stem cell support in women with breast carcinoma and isolated supraclavicular lymph node metastases. Cancer. 2000;88:790-795.
51. Peters WP, Jones RB, Vredenburgh J, et al. 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) [abstract]. Proc Am Soc Clin Oncol. 1996;15:121a.
52. Stadtmauer EA, O'Neill A, Goldstein LJ, et al. Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. N Engl J Med. 2000;342:1069-1076.
53. Livingston R, Crowley J. Commentary on PBT-1 study of high-dose consolidation versus standard therapy in metastatic breast cancer. J Clin Oncol. 1999;17(suppl 11S):22-24.
54. Lotz J-P, Curé H, Janvier M, et al. High-dose chemotherapy (HD-CT) with hematopoietic stem cells transplantation (HSCT) for metastatic breast cancer (MBC): results of the French Protocol PEGASE 04 [abstract]. Proc Am Soc Clin Oncol. 1999;18:43a.
55. Madan B, Broadwater G, Rubin P, et al. Improved survival with consolidation high-dose cyclophosphamide, cisplatin and carmustine (HD-CPB) compared with observation in women with metastatic breast cancer (MBC) and only bone metastases treated with induction adriamycin, 5-fluorouracil and methotrexate (AFM): a phase III prospective randomized comparative trial [abstract]. Proc Am Soc Clin Oncol. 2000;19:48a.
56. Berry D, Broadwater G, Klein JP, et al. High-dose versus standard chemotherapy in metastatic breast cancer: comparison of Cancer and Leukemia Group B trials with data from the Autologous Blood and Marrow Transplant Registry. Submitted for publication.
57. Sledge GW, Loehrer PJ, Roht BJ, Einhorn LH. Cisplatin as first-line therapy for metastatic breast cancer. J Clin Oncol. 1988;6: 1811-1814.
58. Martín M, Díaz-Rubio E, Casado A, et al. Carboplatin: an active drug in metastatic breast cancer. J Clin Oncol. 1992;10:433-437.
59. Tew K, Colvin OM, Chabner BA. Alkylating agents. In: BA Chabner, DL Longo, eds. Cancer Chemotherapy and Biotherapy. 2nd ed. Philadelphia, PA: Lippincott-Raven; 1996:297-332.
60. Huitema ADR, Tibben MM, Kerbusch TH, et al. Simultaneous determination of thiotepa, cyclophosphamide and some metabolites in plasma using capillary gas chromatography. J Chromatogr B Biomed Appl. 1998;716:177-186.
61. Chen T-L, Passos-Coelho JL, Noe DA, et al. Nonlinear pharmacokinetics of cyclophosphamide in patients with metastatic breast cancer receiving high-dose chemotherapy followed by autologous bone marrow transplantation. Cancer Res. 1996;55:810-816.
62. Nieto Y, Xu X, Cagnoni PJ, et al. Nonpredictable pharmacokinetic behavior of high-dose cyclophosphamide in combination with cisplatin and 1,3-bis(2-chloroethyl)-1-nitrosourea. Clin Cancer Res. 1999;5:747-751.
63. Busse D, Busch FW, Bohnenstengel F, et al. Dose escalation of cyclophosphamide in patients with breast cancer: consequences for pharmacokinetics and metabolism. J Clin Oncol. 1997;15:1885-1896.
64. Doroshow JH. Anthracyclines and anthracenediones. In: Chabner BA, Longo DL, eds. Cancer Chemotherapy and Biotherapy. 2nd ed. Philadelphia, PA: Lippincott-Raven; 1996:409-434.
65. Eisenhauer EA, Ten Bokkel Huinink WW, Swenerton KD, et al. European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion. J Clin Oncol. 1994;12:2654-2666.
66. Kohn EC, Sarosy G, Bicher A, et al. Dose-intense taxol: high response rate in patients with platinum-resistant recurrent ovarian cancer. J Natl Cancer Inst. 1994;86:18-24.
67. Raymond E, Hanauske A, Faivre S, et al. Effects of prolonged versus short-term exposure paclitaxel on human tumor colony-forming units. Anticancer Drugs. 1997;8:379-385.
68. Hanauske AR, Degen D, Hilsenbeck SG, et al. Effects of Taxotere and Taxol in vitro colony formation of freshly explanted human tumour cells. Anticancer Drugs. 1992;3:121-124.
69. García P, Braguer D, Carkes G, et al. Comparative effects of taxol and taxotere on two different human carcinoma cell lines. Cancer Chemotber Pharmacol 1994;34:335-343.
70. Von Hoff DD. The taxoids: same roots, different drugs. Semin Oncol. 1997;24(suppl 13):S13-3 to S13-10.
71. Somlo G, Doroshow JH, Forman SJ, et al. High-dose doxorubicin, etoposide, and cyclophosphamide with stem cell reinfusion in patients with metastatic or high-risk primary breast cancer. Cancer. 1994;15:1678-1685.
72. Donehower RC, Rowinsky EK, Grochow LB, Longnecker SM, Ettinger DS. Phase I trial of taxol in patients with advanced cancer. Cancer Treat Rep. 1987;71:1171-1177.
73. Aapro MS, Zulian G, Alberto P, et al. Phase I and pharmacokinetic study of RP 569876 in a new ethanol-free formulation of Taxotere. Ann Oncol. 1992;3(suppl 5):208.
74. Extra JM, Rousseau F, Bruno R, et al. Phase I and pharmacokinetic study of Taxotere (RP 569876; NSC 628503) given as a short intravenous infusion. Cancer Res. 1993;53:1037-1042.
75. Stemmer SM, Cagnoni PJ, Shpall EJ, et al. High-dose paclitaxel, cyclophosphamide, and cisplatin with autologous hematopoietic progenitor-cell support: a phase I trial. J Clin Oncol. 1996;14: 1463-1472.
76. Holmes FA, Walters RS, Theriault RL, et al. Phase II trial of taxol, an active drug in the treatment of metastatic breast cancer. J Natl Cancer Inst. 1991;83:1797-1805.
77. Smith RE, Brown AM, Mamounas EP, et al. Randomized trial of 3-hour versus 24-hour infusion of high-dose paclitaxel in patients with metastatic or locally advanced breast cancer: National Surgical Adjuvant Breast and Bowel Project protocol B-26. J Clin Oncol. 1999;17:3403-3411.
78. Buzdar AU, Singletary E, Theriault RL, et al. Prospective evaluation of paclitaxel versus combination chemotherapy with fluorouracil, doxorubicin, and cyclophosphamide as neoadjuvant therapy in patients with operable breast cancer. J Clin Oncol. 1999;17:3412-3417.
79. Fields KK, Elfenbein GJ, Perkins JB, et al. High versus standard dose chemotherapy for the treatment of breast cancer. Ann N Y Acad Sci. 1995;770:288-304.
80. Mayordomo JI, Yubero A, Cajal R, et al. Phase I trial of high-dose paclitaxel in combination with cyclophosphamide, thiotepa and carboplatin with autologous peripheral blood stem cell rescue [abstract]. Proc Am Soc Clin Oncol. 1997;16:102a.
81. Vahdat LT, Papadopoulos KP, Balmaceda C, et al. Phase I trial of sequential high-dose chemotherapy with escalating dose paclitaxel, melphalan and cyclophosphamide, thiotepa, and carboplatin with peripheral blood progenitor support in women with responding metastatic breast cancer. Clin Cancer Res. 1998;4:1689-1695.
82. Elias AD, Richardson P, Avigan D, et al. Phase I development of double cycle stem cell supported high dose chemotherapy (HDC) for metastatic breast cancer (BC): the DFCI/BIDMC experience [abstract]. Proc Am Soc Clin Oncol. 1999;18:123a.
83. Valero V. Docetaxel as single-agent therapy in metastatic breast cancer: clinical efficacy. Semin Oncol. 1997;24(suppl 13):S13-11 to S13-18.
84. Valero V, Holmes FA, Walters RS, et al. Phase II study of docetaxel: a new, highly effective antineoplastic agent in the management of patients with anthracycline-resistant metastatic breast cancer. J Clin Oncol. 1995;13:2886-2894.
85. Ravdin PAM, Burns HA III, Cook G, et al. Phase II trial of docetaxel in advanced anthracycline-resistant or anthracenedione-resistant breast cancer. J Clin Oncol. 1995;13:2879-2885.
86. Chan S, Friedrichs K, Noel D, et al. Prospective randomized trial of docetaxel versus doxorubicin in patients with metastatic breast cancer. J Clin Oncol. 1999;17:2341-2354.
87. Nieto Y, Cagnoni PJ, Shpall EJ, et al. Phase I trial of docetaxel (DTX) (Taxotere) with peripheral blood progenitor cell (PBPC) support, with melphalan and carboplatin, in refractory advanced cancer [abstract]. Proc Am Soc Clin Oncol. 2000;19:56a.
88. Dunphy FR, Spitzer G, Buzdar AU, et al. Treatment of estrogen receptor-negative or hormonally refractory breast cancer with double high-dose chemotherapy intensification and bone marrow support. J Clin Oncol. 1990;8:1207-1216.
89. Crown J, Kritz A, Vahdat L, et al. Rapid administration of multiple cycles of high-dose myelosuppressive chemotherapy in patients with metastatic breast cancer. J Clin Oncol. 1993;11:1144-1149.
90. Shapiro CL, Ayash L, Webb IJ, et al. Repetitive cycles of cyclophosphamide, thiotepa, and carboplatin intensification with peripheral-blood progenitor cells and filgrastim in advanced breast cancer patients. J Clin Oncol. 1997;15:674-683.
91. Ayash LJ, Elias A, Wheeler C, et al. Double dose-intensive chemotherapy with autologous marrow and peripheral-blood progenitor-cell support for metastatic breast cancer: a feasibility study. J Clin Oncol. 1994;12:37-44.
92. Rodenhuis S, Westermann A, Holtkamp MJ, et al. Feasibility of multiple courses of high-dose cyclophosphamide, thiotepa, and carboplatin for breast cancer or germ cell cancer. J Clin Oncol. 1996;14:1473-1483.
93. Broun ER, Sridhara R, Sledge GW, et al. Tandem autotransplantation for the treatment of metastatic breast cancer. J Clin Oncol. 1995;13:2050-2055.
94. Ayash LJ, Elias A, Schwartz G, et al. Double dose-intensive chemotherapy with autologous stem-cell support for metastatic breast cancer: no improvement in progression-free survival by the sequence of high-dose melphalan followed by cyclophosphamide, thiotepa, and carboplatin. J Clin Oncol. 1996;14:2984-2992.
95. Bitran JD, Samuels B, Klein L, et al. Tandem high-dose chemotherapy supported by hematopoietic progenitor cells yields prolonged survival in stage TV breast cancer. Bone Marrow Transplant. 1996;17:157-162.
96. Vahdat L, Papadopoulos K, Tiersten A, et al. Tandem high dose chemotherapy with paclitaxel, melphalan, and cytoxan, thiotepa, and carboplatin with peripheral blood progenitor support in patients with responding metastatic breast cancer [abstract]. Proc Am Soc Clin Oncol. 2000;19:65a.
97. Hu WW, Negrin RS, Stockerl-Goldstein K, et al. Four-cycle high-dose therapy with hematopoietic support for metastatic breast cancer: no improvement in outcomes compared with single-course high-dose therapy. Biol Blood Marrow Transplant. 2000;6:58-69.
98. Teicher BA, Ara G, Keyes SR, et al. Acute in vivo resistance in high-dose therapy. Clin Cancer Res. 1998;4:483-491.
99. Frei E III, Ara G, Teicher B, et al. Double high-dose chemotherapy with stem cell rescue (HD-SCR) in patients with breast cancer: effect of sequence. Cancer Chemother Pharmacol. 2000;45: 239-246.
100. Bonadonna G, Valagussa P. Adjuvant systemic therapy for resectable breast cancer. J Clin Oncol. 1985;3:259-275.
101. Bonadonna G, Zambetti M, Valagussa P. Sequential or alternating doxorubicin and CMF regimens in breast cancer with more than three positive nodes: ten-year results. JAMA. 1995;273:542-547.
102. Hryniuk W, Levine MN. Analysis of dose intensity for adjuvant chemotherapy trials in stage II breast cancer. J Clin Oncol. 1986;4:1162-1170.
103. Peters WP, Ross M, Vredenburgh JJ, 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;11:1132-1143.
104. Peters WP, Berry D, Vredenburgh JJ, et al. Five year follow-up of high-dose combination alkylating agents with ABMT as consolidation after standard-dose CAF for primary breast cancer involving ≥10 axillary lymph nodes (Duke/CALGB 8782) [abstract]. Proc Am Soc Clin Oncol. 1995;14:317a.
105. Gianni AM, Siena S, Bregni M, et al. Efficacy, toxicity and applicability of high-dose chemotherapy as adjuvant treatment in operable breast cancer with 10 or more involved axillary nodes: five-year results. J Clin Oncol. 1997;15:2312-2321.
106. Buzzoni R, Bonadonna G, Valagussa P, et al. Adjuvant chemotherapy with doxorubicin plus cyclophosphamide, methotrexate and fluorouracil in the treatment of resectable breast cancer with more than three positive nodes. J Clin Oncol. 1991;9:2134-2140.
107. Bearman SI, Overmoyer BA, Bolwell BJ, et al. High-dose chemotherapy with autologous peripheral blood progenitor cell support for primary breast cancer in patients with 4-9 involved axillary lymph nodes. Bone Marrow Transplant. 1997;20:931-937.
108. Hussein A, Plummer M, Vredenburgh J, et al. High-dose chemotherapy (HDC) with cyclophosphamide, cisplatin, and BCNU (CPB) and autologous bone marrow and peripheral blood progenitor cells for stage II/III breast cancer involving 4-9 axillary lymph nodes [abstract]. Proc Am Soc Clin Oncol. 1996;15:350a.
109. De Graaf H, Willemse PHB, De Vries EGE, 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:150-153.
110. Hudis C, Seidman A, Baselga J, et al. Sequential dose-dense doxorubicin, paclitaxel, and cyclophosphamide for resectable high-risk breast cancer: feasibility and efficacy. J Clin Oncol. 1999;17:93-100.
111. Jaiyesimi IA, Buzdar AU, Hortobagyi G. Inflammatory breast cancer: a review. J Clin Oncol. 1992;10:1014-1024.
112. Thomas F, Arriagada R, Spielmann M, et al. Pattern of failure in patients with inflammatory breast cancer treated by alternating radiotherapy and chemotherapy. Cancer. 1995;76:2286-2290.
113. Ayash L, Elias A, Ibrahim J, et al. High-dose multimodality therapy with autologous stem cell support for stage IIIB breast cancer. J Clin Oncol. 1998;16:1000-1007.
114. Cagnoni PJ, Nieto Y, Shpall EJ, et al. High-dose chemotherapy with autologous progenitor cell support as part of combined modality therapy for inflammatory breast cancer. J Clin Oncol. 1998;16:1661-1668.
115. Viens P, Penault-Llorca F, Jacquemier J, et al. High-dose chemotherapy and haematopoietic stem cell transplantation for inflammatory breast cancer: pathologic response and outcome. Bone Marrow Transplant. 1998;21:249-254.
116. Somlo G, Doroshow JH, Forman SJ, 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;15:2882-2893.
117. Adkins D, Brown R, Trinkaus K, et al. Outcomes of high-dose chemotherapy and autologous stem-cell transplantation in stage IIIB inflammatory breast cancer. J Clin Oncol. 1999;17:2006-2014.
118. Nieto Y, Cagnoni PJ, Xu X, et al. Predictive model for relapse after high-dose chemotherapy with peripheral blood progenitor cell support for high-risk primary breast cancer. Clin Cancer Res. 1999;5:3425-3431.
119. Bolwell BJ, Andresen SW, Pohlman BL, et al. The prognostic importance of the axillary lymph node ratio in autologous transplantation for high-risk stage II-III breast cancer [abstract]. Proc Am Soc Clin Oncol. 2000;19:57a.
120. Prosper F, Sola C, Hornedo J, et al. Prognostic factors for relapse after high-dose chemotherapy (HDC) and stem cell transplant (SCT) in patients with high risk breast cancer (HRBC) [abstract]. Proc Am Soc Clin Oncol. 2000;19:147a.
121. Bitran JD, Samuels B, Trujillo Y, et al. Her2/neu overexpression is associated with treatment failure in women with high-risk stage II and stage IIIA breast cancer (> 10 involved lymph nodes) treated with high-dose chemotherapy and autologous hematopoietic progenitor cell support following standard-dose adjuvant chemotherapy. Clin Cancer Res. 1996;2:1509-1513.
122. Nieto Y, Cagnoni PJ, Nawaz S, et al. Evaluation of the predictive value of Her-2/neu overexpression and p53 mutations in high-risk primary breast cancer patients treated with high-dose chemotherapy and autologous stem-cell transplantation. J Clin Oncol. 2000;18:2070-2080.
123. Crump M, Goss PE, Prince M, et al. Outcome of extensive evaluation before adjuvant therapy in women with breast cancer and ten or more positive axillary lymph nodes. J Clin Oncol. 1996;14:66-69.
124. García-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. 1997;15:3178-3184.
125. Rodenhuis S, Richel DJ, van der Wall E, et al. Randomised trial of high-dose chemotherapy and haemopoietic progenitor-cell support in operable breast cancer with extensive axillary involvement. Lancet. 1998;352:515-521.
126. Hortobagyi GN, Buzdar AU, Theriault RL, et al. Randomized trial of high-dose chemotherapy and blood cell autografts for high-risk primary breast carcinoma. J Natl Cancer Inst. 2000;92: 225-233.
127. Dunphy FR, Spitzer G, Buzdar AU, et al. Treatment of estrogen receptor-negative or hormonally refractory breast cancer with double high-dose chemotherapy intensification and bone marrow support. J Clin Oncol. 1990;8:1207-1216.
128. Neidhart JE, Kohler W, Stidley C, et al. A phase I study of repeated cycles of high-dose cyclophosphamide, etoposide and cisplatin administered without bone marrow transplantation. J Clin Oncol. 1990;8:1728-1738.
129. Peters WP, Rosner G, Vredenburgh J, 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 Am Soc Clin Oncol. 1999;18:1a.
130. Hortobagyi GN. High-dose chemotherapy for primary breast cancer: facts versus anecdotes. J Clin Oncol. 1999;17(suppl 11S):25-29.
131. Marks LB, Fitzgerald TJ, Laurie F, et al. Preliminary analysis of radiotherapy data from CALGB 9082: variability of treatment fields for local/regional breast cancer and the impact of high dose chemotherapy on the ability to deliver radiation therapy [abstract]. Int J Radiat Oncol Biol Phys. 1999;45(suppl):195a.
132. Winer EP, Herndon J, Peters WP, et al. Quality of life in patients with breast cancer randomized to high dose chemotherapy with bone marrow support vs. intermediate dose chemotherapy: CALGB 9066 (companion protocol to CALGB 9082) [abstract]. Proc Am Soc Clin Oncol. 1999;18:412a.
133. The Scandinavian 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 Am Soc Clin Oncol. 1999;18:2a.
134. Antman KH. Critique of the high-dose chemotherapy studies in breast cancer: a positive look at the data. J Clin Oncol. 1999;17(suppl 11S):30-35.
135. Rodenhuis S, Bontenbal M, Beex L, et al. Randomized phase III trial of high-dose chemotherapy with cyclophosphamide, thiotepa and carboplatin in operable breast cancer with 4 or more axillary lymph nodes [abstract]. Proc Am Soc Clin Oncol. 2000;19:74a.
136. Philip T, Chauvin F, Bron D, et al. PARMA international protocol: pilot study on 50 patients and preliminary analysis of the ongoing randomized study (62 patients). Ann Oncol. 1991;2(suppl): 57-64.
137. Bron D, Philip T, Guglielmi C, et al. The PARMA international randomized study in relapsed non-Hodgkin's lymphoma: analysis on the first 153 preincluded patients [abstract]. Exp Hematol. 1991;19:546.
138. Philip T, Guglielmi C, Hagenbeek A, et al. Autologous bone marrow transplantation as compared with salvage chemotherapy in relapses of chemotherapy-sensitive non-Hodgkin's lymphoma. N Engl J Med. 1995;333:1540-1545.
139. Ross AA, Cooper BW, Lazarus HM, et al. Detection and viability of tumor cells in peripheral blood stem cell collections from breast cancer patients using immunocytochemical and clonogenic assay techniques. Blood. 1993;82:2605-2610.
140. Schoenfeld A, Kruger KH, Gomm J, et al. The detection of micrometastases in the peripheral blood and bone marrow of patients with breast cancer using immunohistochemistry and reverse transcriptase polymerase chain reaction for keratin 19. Eur J Cancer. 1997;33:854-861.
141. Datta YH, Adams PT, Drobyski WR, Ethier SP, Terry VH, Roth MS. Sensitive detection of occult breast cancer by the reverse-transcriptase polymerase chain reaction. J Clin Oncol. 1994;12:475-482.
142. Fields KK, Elfenbein GJ, Trudeau WL. Clinical significance of bone marrow metastases in patients with breast cancer undergoing high-dose chemotherapy and autologous bone marrow transplantation. J Clin Oncol. 1996;14:1868-1876.
143. Franklin W, Shpall EJ, Archer P, et al. Immunocytochemical detection of breast cancer cells in marrow and peripheral blood of patients undergoing high dose chemotherapy with autologous stem cell support. Breast Cancer Res Treat. 1996;41:1-13.
144. Sharp JC, Kessinger A, Mann S, et al. Detection and clinical significance of minimal tumor cell contamination of peripheral blood stem cell harvests. Int J Cell Cloning. 1992;10(suppl 1):92-94.
145. Vredenburgh J, Silva O, Broadwater G, et al. The significance of tumor contamination in the bone marrow from high-risk primary breast cancer patients treated with high-dose chemotherapy and hematopoietic support. Biol Blood Marrow Transplantation. 1997;3:91-97.
146. Umiel T, Moss TJ, Cooper B, et al. The prognostic value of bone marrow micrometastases in stage II/III breast cancer patients undergoing autologous transplant (ABMT) therapy [abstract]. Proc Am Soc Clin Oncol. 1998;17:79a.
147. Solano C, Badia B, Benet I, et al. Prognostic significance of contaminating tumor cell in apheresis in high-risk breast cancer patients treated with peripheral blood stem cell transplantation [abstract]. Proc Am Soc Clin Oncol. 2000;19:122a.
148. Cooper BW, Moss TJ, Ross AA, Ybanez J, Lazarus HM. Occult tumor contamination of hematopoietic stem-cell product does not affect clinical outcome of autologous transplantation in patients with metastatic breast cancer. J Clin Oncol. 1998;16:3509-3517.
149. Shpall EJ, Jones RB, Bast RC, et al. 4-Hydroperoxycyclophosphamide purging of breast cancer from the mononuclear cell fraction of bone marrow in patients receiving high-dose chemotherapy and autologous marrow support: a phase I trial. J Clin Oncol. 1991;9:85-93.
150. Shpall EJ, Bast RC, Joines WT, et al. Immunomagnetic purging of breast cancer from bone marrow for autologous transplantation. Bone Marrow Transplant. 1991;7:145-151.
151. Anderson IC, Shpall EJ, Leslie DS, et al. Elimination of malignant clonogenic breast cancer cells from human bone marrow. Cancer Res. 1989;49:4659-4664.
152. Vredenburgh JJ, Hussein A, Rubin P, et al. High-dose chemotherapy and immunomagnetically purged peripheral blood progenitor cells and bone marrow for metastatic breast carcinoma [abstract]. Proc Am Soc Clin Oncol. 1996;15:339.
153. Krause DS, Fackler MJ, Civin CI, Stratford May W. CD34: structure, biology and clinical utility. Blood. 1996;87:1-13.
154. Shpall EJ, Jones RB, Bearman SI, et al. Transplantation of enriched CD34-positive autologous marrow into breast cancer patients following high-dose chemotherapy: influence of CD34-positive peripheral-blood progenitors and growth factors on engraftment. J Clin Oncol. 1994;12:28-36.
155. Shpall EJ, LeMaistre CF, Holland K, et al. A prospective randomized trial of buffy coat versus CD34-selected autologous bone marrow support in high-risk breast cancer patients receiving high-dose chemotherapy. Blood. 1997;90:4313-4320.
156. Cornetta K, Yanovich S, Rosenfeld C, et al. High dose chemotherapy and stem cell transplant in breast cancer: a randomized multicenter study of CD34 selection [abstract]. Biol Blood Marrow Transplant. 2000;6:141a.
157. + cell selection and breast cancer cell purging in peripheral blood progenitor cell samples used for hematopoietic rescue after high-dose therapy. Clin Cancer Res. 1999;5:1035-1040.
158. Douer D, Levine A, Anderson WF, et al. High-dose chemotherapy and autologous bone marrow plus peripheral blood stem cell transplantation for patients with lymphoma or metastatic breast cancer: use of marker genes to investigate hematopoietic reconstitution in adults. Hum Gene Ther. 1996;7:669-684.
159. Hanania EG, Fu S, Roninson I, Zu Z, Deisseroth AB. Resistance to taxol chemotherapy produced in mouse marrow cells by safety-modified retroviruses containing a human MDR-1 transcription unit. Gene Ther. 1995;2:279-284.
160. Hanania EG, Fu S, Zu Z, Hegewisch-Becker S, et al. Chemotherapy resistance to taxol in clonogenic progenitor cells following transduction of CD34 selected marrow and peripheral blood cells with a retrovirus that contains the MDR-1 chemotherapy resistance gene. Gene Ther. 1995;2:285-294.
161. Rahman Z, Kavanagh J, Champlin R, et al. Chemotherapy immediately following autologous stem-cell transplantation in patients with advanced breast cancer. Clin Cancer Res. 1998;4:2717-2721.
162. De Magalhaes-Silverman M, Bloom E, Lembersky B, et al. High-dose chemotherapy and autologous stem cell support followed by posttransplantation doxorubicin as initial therapy for metastatic breast cancer. Clin Cancer Res. 1997;3:193-197.
163. Kennedy MJ, Vogelsang GB, Beveridge RA, et al. Phase I trial of intravenous cyclosporine to induce graft-versus-host disease in women undergoing autologous bone marrow transplantation for breast cancer. J Clin Oncol. 1993;11:478-484.
164. Kennedy MJ, Vogelsang GB, Jones RJ, et al. Phase I trial of interferon gamma to potentiate cyclosporine-induced graft-versus-host disease in women undergoing autologous bone marrow transplantation for breast cancer. J Clin Oncol. 1994;12:249-257.
165. Stiff PJ, Bayer R, Tan S, et al. High-dose chemotherapy combined with escalating doses of cyclosporin A and an autologous bone marrow transplant for the treatment of drug-resistant solid tumors: a phase I clinical trial. Clin Cancer Res. 1995;1:1495-1502.
166. Steinman RM. The dendritic cell system and its role in immunogenicity. Annu Rev Immunol. 1991;9:271-296.
167. Ueno NT, Rondón G, Mirza NQ, et al. Allogeneic peripheral-blood progenitor-cell transplantation for poor-risk patients with metastatic breast cancer. J Clin Oncol. 1998;16:986-993.
168. Khouri IF, Keating M, Körbling M, et al. Transplant-lite: induction of graft-versus-malignancy using fludarabine-based nonablative chemotherapy and allogeneic blood progenitor-cell transplantation as treatment for lymphoid malignancies. J Clin Oncol. 1998;16:2817-2824.
169. McSweeney PA, Storb R. Mixed chimerism: preclinical studies and clinical applications. Biol Blood Marrow Transplant. 1999;5: 192-203.
170. Press OW, Eary JF, Appelbaum FR, et al. Radiolabeled-antibody therapy of B-cell lymphoma with autologous bone marrow support. N Engl J Med. 1993;329:1219-1224.
171. Kaminski MS, Fig LM, Zasadny KR, et al. Imaging, dosimetry, and radioimmunotherapy with iodine 131-labeled anti-CD37 antibody in B-cell lymphoma. J Clin Oncol. 1992;10:1696-1711.
172. Kaminski MS, Gribbin T, Estes J, et al. I-131 antibody for previously untreated follicular lymphoma: clinical and molecular remissions [abstract]. Proc Am Soc Clin Oncol. 1998;17:2a.
173. 90Y-hu-BrE-3 followed by autologous hematopoietic stem cell support (ASCS) in patients with refractory metastatic breast cancer [abstract]. Biol Blood Marrow Transplant. 2000;6:138a.
174. Slamon DJ, Clark G, Wong S, et al. Human breast cancer: correlation of relapse and survival with amplification of the Her-2/neu oncogene. Science. 1987;235:177-182.
175. HER2/neu-overexpressing metastatic breast cancer. J Clin Oncol. 1996;14:737-744.
176. Cobleigh MA, Vogel CL, Tripathy D, et al. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol. 1999;17:2639-2648.
177. Pegram MD, Konecny G, Slamon DJ. The molecular and cellular biology of HER2/neu gene amplificatin/overexpression and the clinical development of Herceptin (trastuzumab) therapy for breast cancer. Cancer Treat Res. 2000;103:57-75.
178. HER2/neu monoclonal antibody plus cisplatin in patients with HER2/neu-overexpressing metastatic breast cancer refractory to chemotherapy treatment. J Clin Oncol. 1998;16:2659-2671.
179. Slamon D, Leyland-Jones B, Shak S, et al. Addition of Herceptin? (humanized anti-her2 antibody) to first line chemotherapy for her2 overexpressing metastatic breast cancer markedly increases anticancer activity: a randomized, multinational controlled phase III trial [abstract]. Proc Am Soc Clin Oncol. 1998;17:98a.