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Blood, 15 June 2006, Vol. 107, No. 12, pp. 4636-4642. Prepublished online as a Blood First Edition Paper on February 14, 2006; DOI 10.1182/blood-2005-11-4429.
CLINICAL TRIALS AND OBSERVATIONS Long-term results and competing risk analysis of the H89 trial in patients with advanced-stage Hodgkin lymphoma: a study by the Groupe d'Etude des Lymphomes de l'Adulte (GELA)From the Department of Medicine, Institut Gustave Roussy, Villejuif Cedex, France; Hopital Saint-Louis, Paris, France; Centre Hospitalier Universitaire (CHU) de Dijon, Dijon, France; CHU Henri Mondor, Creteil, France; Universite Catholique de Louvain, Yvoir, Belgium; Hospices Civils de Lyon, Pierre-Benite, France; Centre Becquerel, Rouen, France; CHU de Limoges, Limoges, France; CHU de Besancon, Besancon, France; CHU de Caen, Caen, France; and Centre Hospitalier de Chambery, Chambery, France.
From 1989 to 1996, 533 eligible patients with stage IIIB/IV Hodgkin lymphoma (HL) were randomly assigned to receive 6 cycles of hybrid MOPP/ABV (mechlorethamine, vincristine, procarbazine, prednisone/Adriamycin [doxorubicin], bleomycin, vinblastine; n = 266) or ABVPP (doxorubicin, bleomycin, vinblastine, procarbazine, prednisone; n = 267). Patients in complete remission (CR) or partial response of at least 75% after 6 cycles received 2 cycles of consolidation chemotherapy (CT) (n = 208) or subtotal nodal irradiation (RT) (n = 210). A better survival probability was observed after ABVPP alone: the 10-year overall survival (OS) estimates were 90% for ABVPPx8, 78% for MOPP/ABVx8, 82% for MOPP/ABV with RT, and 77% for ABVPPx6 with RT (P = .03); and the 10-year disease-free survival (DFS) estimates were 70%, 76%, 79%, and 76%, respectively (P = .09). The 10-year DFS estimates for patients treated with consolidation CT or RT were 73% and 78% (P = .07), and OS estimates were 84% and 79%, respectively (P = .29). These results showed that RT was not superior to consolidation CT after a doxorubicin-induced CR in patients with advanced HL. An analysis of competing risks identified age more than 45 years as a significant risk factor for death, relapse, and second cancers. Prospective evaluation of late adverse events may improve the management of patients with HL.
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