Protracted Results of Dose-Intensive Therapy using Cyclophosphamide, Carmustine, and Continuous Infusion Etoposide with Autologous Stem Cell Support in Patients with Relapse or Refractory Hodgkin's Disease: A Phase II Study from the North American Marrow Transplant Group

Donald R. Fleming University of Louisville, School of Medicine, James Graham Brown Cancer Center, Division of Hematology/Oncology, 529 South Jackson Street, Room 230, Louisville, KY, 40202; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Steven N. Wolf Vanderbrlt Universrty Medical Center, Bone Marrow Transplantation Program 808 Oxford House, Vanderbilr University, Nashville, TN, 37232; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Joseph W. Fay Baylor University Medical Center, Charles A. Sammons Cancer Center, Blood and Marrow Transplantation Services, 3535 Worth Street, Dallas, TX, 75246; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Randy A. Brown Washington University School of Medicine, Division of Bone Marrow Transplantation and Stem Cell Biology, 660 South Euclid, Box 8007, Saint Louis, MO, 63110; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Joseph P. Lynch West Virginia University Medical Center, Mary Babb Randolph Cancer Center, Bone Marrow Transplanration Program, Section of Hematology/Oncology, I Medical Center Drive, Morgantown, WV, 26506; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Brian J. Bolwell Cleveland Clinic Foundrrtion, 9500 Euclid Avenue, Cleveland, OH, 44106, USA; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Don A. Stevens University of Louisville, School of Medicine, James Graham Brown Cancer Center, Division of Hematology/Oncology, 529 South Jackson Street, Room 230, Louisville, KY, 40202; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Stacy A. Goodman Vanderbrlt Universrty Medical Center, Bone Marrow Transplantation Program 808 Oxford House, Vanderbilr University, Nashville, TN, 37232; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

John P. Greer Vanderbrlt Universrty Medical Center, Bone Marrow Transplantation Program 808 Oxford House, Vanderbilr University, Nashville, TN, 37232; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Richard S. Stein Vanderbrlt Universrty Medical Center, Bone Marrow Transplantation Program 808 Oxford House, Vanderbilr University, Nashville, TN, 37232; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Luis A. Pineiro Baylor University Medical Center, Charles A. Sammons Cancer Center, Blood and Marrow Transplantation Services, 3535 Worth Street, Dallas, TX, 75246; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Robert H. Collins Baylor University Medical Center, Charles A. Sammons Cancer Center, Blood and Marrow Transplantation Services, 3535 Worth Street, Dallas, TX, 75246; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Linda Jane Goldsmith University of Louisville, School of Medicine, James Graham Brown Cancer Center, Division of Hematology/Oncology, 529 South Jackson Street, Room 230, Louisville, KY, 40202; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Geoffrey P. Herzig Washington University School of Medicine, Division of Bone Marrow Transplantation and Stem Cell Biology, 660 South Euclid, Box 8007, Saint Louis, MO, 63110; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

Roger H. Herzig University of Louisville, School of Medicine, James Graham Brown Cancer Center, Division of Hematology/Oncology, 529 South Jackson Street, Room 230, Louisville, KY, 40202; Department of Biostatistics, Health Sciences Center, 500 South Preston Street, Room 230, Louisville, KY, 40202

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Abstract

To determine the long-term results of high-dose chemotherapy and stem cell support in relapsed or primary refractory Hcdgkin disease patients. One hundred and thirty-one patients with relapsed or primary refractory Hodgkin's disease were treated with a dose-intensive therapy protocol consisting of etoposide (2400 mg/m² continuous intravenous infusion) cyclophosphamide (7200 mg/m² intravenously), and carmustine (3o(Moo mg/m² intravenously) CBVi. All patients had previously failed conventional chemoradiotherapy. Severe toxicities were related to infectious, hepatic, and pulmonary complications. Fatal, regimen-related tox-icity was 19%; liver and lung dysfunction, as well as infection, were the most frequent problems. Ninety-one (69%) of the patients achieved a complete response (CR) (95% CI = 59% to 75%) after CBVi and autologous stem cell infusion. With a median follow-up of 5.1 years (range 3.0 to 9.5 years), overall and event-free survival are 44% (95% CI = 33% to 47%) and 38% (95% CI = 28% to 46%) respectively. While univariate analysis did not reveal a statistically significant variable to predict a better response, responsiveness to therapy demonstrated a trend. We conclude that CBVi is an effective therapy for relapsed or refractory Hodgkin's disease, producing long-term, durable remissions.

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Protracted Results of Dose-Intensive Therapy using Cyclophosphamide, Carmustine, and Continuous Infusion Etoposide with Autologous Stem Cell Support in Patients with Relapse or Refractory Hodgkin's Disease: A Phase II Study from the North American Marrow Transplant Group

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Protracted Results of Dose-Intensive Therapy using Cyclophosphamide, Carmustine, and Continuous Infusion Etoposide with Autologous Stem Cell Support in Patients with Relapse or Refractory Hodgkin's Disease: A Phase II Study from the North American Marrow Transplant Group

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