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

• Published in: Journal of clinical oncology Vol. 21; no. 12; pp. 2320 - 2325
• Main Authors: FEDERICO, Massimo, BELLEI, Monica, DI RENZO, Nicola, GOLDSTONE, Anthony, CARELLA, Angelo Michele, BRICE, Pauline, BRUGIATELLI, Maura, NAGLER, Arnon, GISSELBRECHT, Christian, MORETTI, Luciano, COLOMBAT, Philippe, LUMINARI, Stefano, FABBIANO, Francesco
• Format: Journal Article
• Language: English
• Published: Baltimore, MD American Society of Clinical Oncology 15.06.2003; Lippincott Williams & Wilkins
• Subjects: Adolescent; Adult; Antineoplastic agents; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; Bleomycin; Chi-Square Distribution; Combined Modality Therapy; Combined treatments (chemotherapy of immunotherapy associated with an other treatment); Dacarbazine; Doxorubicin; Female; Hematopoietic Stem Cell Transplantation; Hodgkin Disease - pathology; Hodgkin Disease - therapy; Humans; Lomustine; Male; Mechlorethamine; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Prednisone; Procarbazine; Survival Analysis; Transplantation, Autologous; Treatment Outcome; Vinblastine; Vincristine; Antineoplastic agent; Prognosis; Nitrosoureas; Stem cell; Hematopoietic cell; Autograft; Isomerases; Cytarabine; Lymphoproliferative syndrome; Melphalan; Graft; Advanced stage; Antimitotic; High dose; Pyrimidine nucleoside; Human; DNA topoisomerase (ATP-hydrolysing); Drug combination; Enzyme; Carmustine; Etoposide; Enzyme inhibitor; Hodgkin disease; Malignant hemopathy; Lymphoma; Induction treatment; Podophyllotoxine derivatives; Alkylating agent; Chemotherapy; Antimetabolic; Combined treatment; Therapeutic protocol; Comparative study
• ISSN: 0732-183X; 1527-7755
• DOI: 10.1200/JCO.2003.11.103

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). 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. 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). 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.