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High-Dose Therapy and Autologous Stem-Cell Transplantation Versus Conventional Therapy for Patients With Advanced Hodgkin’s Lymphoma Responding to Front-Line Therapy

Massimo Federico, Monica Bellei, Pauline Brice, Maura Brugiatelli, Arnon Nagler, Christian Gisselbrecht, Luciano Moretti, Philippe Colombat, Stefano Luminari, Francesco Fabbiano, Nicola Di Renzo, Anthony Goldstone, Angelo Michele Carella for the EBMT/GISL/ANZLG/SFGM/GELA Intergroup HD01 Trial

From the Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Modena; Divisione di Ematologia, IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo; Divisione di Ematologia, Azienda Ospedaliera Papardo, Messina; Divisione di Ematologia, Centro Trapianti Midollo Osseo USL 3, Pesaro; Divisione di Ematologia, Ospedale Cervello, Palermo; Servizio di Oncologia Medica ed Ematologia, Ospedale Oncologico Regionale, Rionero in Vulture, Italy; Institut d’Hematologie, Hopital Saint-Louis, Paris; Service D’ Oncologie Medicale et des Maladies des Sang, Unitè de Greffe de Moelle Osseuse, Centre Hopital Bretonneau, Tours Cedex, France; Bone Marrow Transplant Department, Chaim Sheba Medical Center, Tel-Hashemer, Israel; and Department of Haematology, University College London, London, United Kingdom.

Address reprint requests to Massimo Federico, MD, Dipartimento di Oncologia ed Ematologia, Università di Modena e Reggio Emilia, Centro Oncologico Modenese, via del Pozzo, 71 41100 Modena, Italy; email: federico{at}unimore.it.

Purpose: To determine whether high-dose therapy (HDT) with autologous stem-cell transplantation (ASCT) should be included in the initial consolidative treatment of patients with advanced, unfavorable Hodgkin’s lymphoma (HL).

Patients and Methods: One hundred sixty-three patients achieving complete remission (CR) or partial remission (PR) with four initial courses of doxorubicin, bleomycin, vinblastine, and dacarbazine, or other doxorubicin-containing regimens, were randomly assigned to receive HDT plus ASCT (83 patients) versus four courses of conventional chemotherapy (80 patients). Unfavorable HL was defined as the presence of at least two of the following poor prognostic factors: high lactate dehydrogenase level, large mediastinal mass (greater than at least 33% of the thoracic diameter), more than one extranodal site, low hematocrit level, and inguinal involvement.

Results: At the end of the treatment program, 92% of patients in arm A and 89% in arm B achieved a CR (P = .6). After a median follow-up of 48 months, the 5-year failure-free survival rates were 75% (95% confidence interval [CI], 65 to 85) in arm A and 82% (95% CI, 73 to 90) in arm B (P = .4). The 5-year overall survival rates were 88% (95% CI, 80 to 96) in arm A and 88% (95% CI, 79 to 96) in arm B (P = .99). The 5-year relapse-free survival rates were 88% in arm A (95% CI, 80 to 96) and 94% in arm B (95% CI, 88 to 100), and the difference was not significant (P = .3).

Conclusion: Patients with advanced unfavorable HL achieving CR or PR after four courses of doxorubicin-containing regimens have a favorable outcome with conventional chemotherapy. No benefit from an early intensification with HDT and ASCT was shown.

Supported by grants from "Associazione Angela Serra per la Ricerca sul Cancro," Modena, Consiglio Nazionale delle Ricerche (no. 92.02122.PF 39), Roma, and "Associazione Italiana per la Ricerca sul Cancro" (1993), Milano, Italy.

Massimo Federico and Angelo Michele Carella contributed equally to this study.

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