Randomized trial of low-dose interleukin-2 vs cyclosporine A and interferon-γ after high-dose chemotherapy with peripheral blood progenitor support in women with high-risk primary breast cancer

Bone Marrow Transplantation

Volumn 40, Issue 3, 2007, Pages 267-272

  Vahdat, L T ^a   Cohen, D J ^b   Zipin, D ^c   Lo, K S ^d   Donovan, D ^a   Savage, D ^c   Tiersten, A ^b   Nichols, G ^c   Troxel, A ^e   Hesdorffer, C S ^f  

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b NEW YORK UNIVERSITY   (United States)

^c Columbia University ^*  (United States)

^d STAMFORD HOSPITAL   (United States)

^e UNIVERSITY OF PENNSYLVANIA   (United States)

^f JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CIPROFLOXACIN; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; DOXORUBICIN; FLUCONAZOLE; GAMMA INTERFERON; INTERLEUKIN 2; MESNA; TAMOXIFEN; TAXANE DERIVATIVE; THIOTEPA;

ADULT; ADULT RESPIRATORY DISTRESS SYNDROME; AMINOTRANSFERASE BLOOD LEVEL; ARTICLE; BACTEREMIA; BREAST CANCER; CANCER IMMUNOTHERAPY; CANCER RADIOTHERAPY; CANCER STAGING; CANCER SURVIVAL; CARDIOTOXICITY; CLINICAL TRIAL; COLITIS; CONFIDENCE INTERVAL; CONGESTIVE HEART FAILURE; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE FREE SURVIVAL; DRUG ERUPTION; DRUG FATALITY; DRUG MEGADOSE; DRUG TOLERABILITY; ESOPHAGITIS; FEMALE; FOLLOW UP; HIGH RISK PATIENT; HUMAN; HYPERBILIRUBINEMIA; INFECTION; LIVER TOXICITY; LOW DRUG DOSE; MAJOR CLINICAL STUDY; NAUSEA; NEPHROTOXICITY; PARTIAL MASTECTOMY; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; SEPSIS; SIDE EFFECT; STOMATITIS; SURVIVAL RATE; TREATMENT OUTCOME; URINARY TRACT INFECTION; VOMITING;

ADOLESCENT; ADULT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; ANTIVIRAL AGENTS; BREAST NEOPLASMS; CARBOPLATIN; CYCLOPHOSPHAMIDE; CYCLOSPORINE; DISEASE-FREE SURVIVAL; FEMALE; FOLLOW-UP STUDIES; HUMANS; IMMUNOSUPPRESSIVE AGENTS; IMMUNOTHERAPY; INJECTIONS, INTRAVENOUS; INTERFERON TYPE II; INTERLEUKIN-2; MIDDLE AGED; PERIPHERAL BLOOD STEM CELL TRANSPLANTATION; SURVIVAL RATE; THIOTEPA; TRANSPLANTATION CONDITIONING;

EID: 34547190648     PISSN: 02683369     EISSN: 14765365     Source Type: Journal    
DOI: 10.1038/sj.bmt.1705692     Document Type: Article

References (43)

1. Roche H, Viens P, Biron P, Lotz JP, Asselain B. High-dose chemotherapy for breast cancer: The French PEGASE experience. Cancer Control 2003; 10: 42-47.
2. Crown J, Lind M, Gould A, Verrill M, Twelves C, Coleman R et al. High-dose chemotherapy with autograft(PBP) support is not superior to cyclophosphamide, methotrexate and 5-FU following doxorubicin induction in patients with breast cancer and 4 or more involved axillary lymph nodes: The Anglo-Celtic I study. Proc Amer Soc Clin Oncol 2002; 21: 42a (abstract 166).
3. Nitz UA, Mohrmann S, Fischer J, Lindemann W, Berdel WE, Jackisch C et al. Comparison of rapidly cycled tandem high-dose chemotherapy plus peripheral-blood stem-cell support versus dose-dense conventional chemotherapy for adjuvant treatment of high-risk breast cancer: Results of a multicentre phase III trial. Lancet 2005; 366: 1935-1944.
4. Rodenhuis S, Bontenbal M, Beex LV, Wagstaff J, Richel DJ, Nooij MA et al. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med 2003; 349: 7-16.
5. Tallman MS, Gray R, Robert NJ, LeMaistre CF, Osborne CK, Vaughan WP et al. Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell transplantation in high-risk breast cancer. N Engl J Med 2003; 349: 17-26.
6. Peters WP, Rosner GL, Vredenburgh JJ, Shpall EJ, Crump M, Richardson PG et al. Prospective, randomized comparison of high-dose chemotherapy with stem-cell support versus intermediate-dose chemotherapy after surgery and adjuvant chemotherapy in women with high-risk primary breast cancer: A report of CALGB 9082, SWOG 9114, and NCIC MA-13. J Clin Oncol 2005; 23: 2191-2200.
7. Hanrahan EO, Broglio K, Frye D, Buzdar AU, Theriault RL, Valero V et al. Randomized trial of high-dose chemotherapy and autologous hematopoietic stem cell support for high-risk primary breast carcinoma: follow-up at 12 years. Cancer 2006; 106: 2327-2336.
8. Weiden PL, Flournoy N, Thomas ED, Prentice R, Fefer A, Buckner CD et al. Antileukemic effect of graft-versus-host disease in human recipients of allogeneic-marrow grafts. N Engl J Med 1979; 300 1068-1073.
9. Glazier A, Tutschka PJ, Farmer ER, Santos GW. Graft-versus-host disease in cyclosporin A-treated rats after syngeneic and autologous bone marrow reconstitution. J Exp Med 1983; 158: 1-8.
10. Hess AD, Fischer AC, Beschorner WE. Effector mechanisms in cyclosporine A-induced syngeneic graft-versus-host disease. Role of CD4+ and CD8+ T lymphocyte subsets. J Immunol 1990; 145: 526-533.
11. Geller RB, Esa AH, Beschorner WE, Frondoza CG, Santos GW, Hess AD. Successful in vitro graft-versus-tumor effect against an Ia-bearing tumor using cyclosporine-induced syngeneic graft-versus-host disease in the rat. Blood 1989; 74: 1165-1171.
12. Sorokin R, Kimura H, Schroder K, Wilson DH, Wilson DB. Cyclosporine-induced autoimmunity. Conditions for expressing disease, requirement for intact thymus, and potency estimates of autoimmune lymphocytes in drug-treated rats. J Exp Med 1986; 164: 1615-1625.
13. Hess A, Noga S. Cyclosporine-induced syngeneic graft-versus-host-disease: An immunotherapeutic approach after autologous bone marrow transplantation. Int J Cell Cloning 1992; 10: 179.
14. Hess AD, Thoburn CJ. Immunobiology and immunotherapeutic implications of syngeneic/autologous graft-versus-host disease. Immunol Rev 1997; 157: 111-123.
15. Miura Y, Ueda M, Zeng W, Wang H, Takami A, Yamazaki H et al. Induction of autologous graft-versus-host disease with cyclosporin A after peripheral blood stem cell transplantation: Analysis of factors affecting induction. J Allergy Clin Immunol 2000; 106: S51-S57.
16. Jones RJ, Vogelsang GB, Hess AD, Farmer ER, Mann RB, Geller RB et al. Induction of graft-versus-host disease after autologous bone marrow transplantation. Lancet 1989; 1: 754-757.
17. Vogelsang G, Bitton R, Piantadosi S, Altomonte V, Horn T, Jones R et al. Immune modulation in autologous bone marrow transplantation: cyclosporine and gamma-interferon trial. Bone Marrow Transplant 1999; 24: 637-640.
18. Kennedy MJ, Vogelsang GB, Beveridge RA, Farmer ER, Altomonte V, Huelskamp AM 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.
19. Kennedy MJ, Vogelsang GB, Jones RJ, Farmer ER, Hess AD, Altomonte V 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.
20. Cheever MA, Greenberg PD, Fefer A, Gillis S. Augmentation of the anti-tumor therapeutic efficacy of long-term cultured T lymphocytes by in vivo administration of purified interleukin 2. J Exp Med 1982; 155: 968-980.
21. Rosenberg SA, Mule JJ, Spiess PJ, Reichert CM, Schwarz SL. Regression of established pulmonary metastases and subcutaneous tumor mediated by the systemic administration of high-dose recombinant interleukin 2. J Exp Med 1985; 161: 1169-1188.
22. Rosenberg SA, Lotze MT, Muul LM, Chang AE, Avis FP, Leitman S et al. A progress report on the treatment of 157 patients with advanced cancer using lymphokine-activated killer cells and interleukin-2 or high-dose interleukin-2 alone. N Engl J Med 1987; 316: 889-897.
23. Ault KA, Antin JH, Ginsburg D, Orkin SH, Rappeport JM, Keohan ML et al. Phenotype of recovering lymphoid cell populations after marrow transplantation. J Exp Med 1985; 161: 1483-1502.
24. Armitage RJ, Goldstone AH, Richards JD, Cawley JC. Lymphocyte function after autologous bone marrow transplantation (BMT): A comparison with patients treated with allogeneic BMT and with chemotherapy only. Br J Haematol 1986; 63: 637-647.
25. Singer CR, Tansey PJ, Burnett AK. T lymphocyte reconstitution following autologous bone marrow transplantation. Clin Exp Immunol 1983; 51: 455-460.
26. Welte K, Ciobanu N, Moore MA, Gulati S, O'Reilly RJ, Mertelsmann R. Defective interleukin 2 production in patients after bone marrow transplantation and in vitro restoration of defective T lymphocyte proliferation by highly purified interleukin 2. Blood 1984; 64 380-385.
27. Meropol NJ, Porter M, Vaickus RPPL, Loewen GM, Creaven PJ, Wilkes KA et al. Low dose interleukin-2 (IL-2): Daily subcutaneous injection results in selective in vivo expansion of natural killer (NK) cells with minimal toxicity. Proc Am Clin Oncol 1994; 13: 296.
28. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
29. Pan Q, Kleer CG, van Golen KL, Irani J, Bottema KM, Bias C et al. Copper deficiency induced by tetrathiomolybdate suppresses tumor growth and angiogenesis. Cancer Res 2002; 62: 4854-4859.
30. Soiffer RJ, Murray C, Cochran K, Cameron C, Wang E, Schow PW et al. Clinical and immunologic effects of prolonged infusion of low-dose recombinant interleukin-2 after autologous and T-cell-depleted allogeneic bone marrow transplantation. Blood 1992; 79: 517-526.
31. Candido K, Shimizu K, McLaughlin J, Kunkel P, Fuller R, Redman B et al. Local administration of dendritic cells inhibits established breast tumor growth: Implication for apoptosis-inducing agents. Cancer Res 2001; 61: 228-236.
32. Tong Y, Song W, Crystal RG. Combined intratumoral injection of bone marrow-derived dendritic cells systemic chemotherapy to treat pre-existing murine tumors. Cancer Res 2001; 61: 7530-7535.
33. Avigan D, Vasir D, Gong J, Wu Z, Borges V, Uhl L et al. Vaccination with dendritic cell (DC)-breast cancer fusions induces tumor specific immunity and clinical response in patients with metastatic breast cancer. Proc Am Soc Hem 2002; 100, abstract 2651.
34. Nesselhut T, Matthes C, Marx D, Chang R, Nesselhut J, Cillien N et al. Cancer therapy with immature monocyte-derived dendritic cells in patients with advanced breast cancer. Proc Am Soc Clin Oncol 2005; 23, abstract 2528.
35. Chui S, Clay T, Hobeika A, Venturi C, Osada T, Khan S et al. Dendritic cell vaccination following high dose chemotherapy with autologous stem cell support for breast cancer: Long term follow-up. Proc Amer Soc Clin Oncol 2003; 22, abstract 682.
36. Scbuetz F, Diel I, Beckhove P, Ehlert K, Schirrmacher V, Schneeweiss A et al. Cellular immunotherapy in late stage breast cancer patients with reactivated autologous Memory T-cells derived from bone marrow. Proc Am Soc Clin Oncol 2005; 23: 714.
37. Lum LG, Sen M. Activated T-cell and bispecific antibody immunotherapy for high-risk breast cancer. Bench to bedside. Acta Haematol 2001; 105: 130-136.
38. Carella AM, Beltrami G, Corsetti MT, Nati S, Musto P, Scalzulli P et al. Reduced intensity conditioning for allograft after cytoreductive autograft in metastatic breast cancer. Lancet 2005; 366: 318-320.
39. Bishop MR, Fowler DH, Marchigiani D, Castro K, Kasten-Sportes C, Steinberg SM et al. Allogeneic lymphocytes induce tumor regression of advanced metastatic breast cancer. J Clin Oncol 2004; 22: 3886-3892.
40. Folkman J. Anti-angiogenesis: New concept for therapy of solid tumors. Ann Surg 1972; 175: 409-416.
41. Folkman J. Angiogenesis in cancer, vascular, rheumatoid and other disease. Nat Med 1995; 1: 27-31.
42. Tosetti F, Ferrari N, De Flora S, Albini A. Angioprevention: angiogenesis is a common and key target for cancer chemopreventive agents. FASEB J 2002; 16: 2-14.
43. Brewer GJ, Dick RD, Grover DK, LeClaire V, Tseng M, Wicha M et al. Treatment of metastatic cancer with tetrathiomolybdate, an anticopper, antiangiogenic agent: Phase I study. Clin Cancer Res 2000; 6 1-10.