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著者: Christophe Fermé, Houchingue Eghbali, Jacobus H Meerwaldt, Chantal Rieux, Jacques Bosq, Françoise Berger, Théodore Girinsky, Pauline Brice, Mars B van't Veer, Jan A Walewski, Pierre Lederlin, Umberto Tirelli, Patrice Carde, Eric Van den Neste, Emmanuel Gyan, Mathieu Monconduit, Marine Diviné, John M M Raemaekers, Gilles Salles, Evert M Noordijk, Geert-Jan Creemers, Jean Gabarre, Anton Hagenbeek, Oumédaly Reman, Michel Blanc, José Thomas, Brigitte Vié, Johanna C Kluin-Nelemans, Fernando Viseu, Joke W Baars, Philip Poortmans, Pieternella J Lugtenburg, Christian Carrie, Jérôme Jaubert, Michel Henry-Amar, EORTC-GELA H8 Trial
雑誌名: N Engl J Med. 2007 Nov 8;357(19):1916-27. doi: 10.1056/NEJMoa064601.
Abstract/Text
BACKGROUND: Treatment of early-stage Hodgkin's disease is usually tailored in line with prognostic factors that allow for reductions in the amount of chemotherapy and extent of radiotherapy required for a possible cure.
METHODS: From 1993 to 1999, we identified 1538 patients (age, 15 to 70 years) who had untreated stage I or II supradiaphragmatic Hodgkin's disease with favorable prognostic features (the H8-F trial) or unfavorable features (the H8-U trial). In the H8-F trial, we compared three cycles of mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) combined with doxorubicin, bleomycin, and vinblastine (ABV) plus involved-field radiotherapy with subtotal nodal radiotherapy alone (reference group). In the H8-U trial, we compared three regimens: six cycles of MOPP-ABV plus involved-field radiotherapy (reference group), four cycles of MOPP-ABV plus involved-field radiotherapy, and four cycles of MOPP-ABV plus subtotal nodal radiotherapy.
RESULTS: The median follow-up was 92 months. In the H8-F trial, the estimated 5-year event-free survival rate was significantly higher after three cycles of MOPP-ABV plus involved-field radiotherapy than after subtotal nodal radiotherapy alone (98% vs. 74%, P<0.001). The 10-year overall survival estimates were 97% and 92%, respectively (P=0.001). In the H8-U trial, the estimated 5-year event-free survival rates were similar in the three treatment groups: 84% after six cycles of MOPP-ABV plus involved-field radiotherapy, 88% after four cycles of MOPP-ABV plus involved-field radiotherapy, and 87% after four cycles of MOPP-ABV plus subtotal nodal radiotherapy. The 10-year overall survival estimates were 88%, 85%, and 84%, respectively.
CONCLUSIONS: Chemotherapy plus involved-field radiotherapy should be the standard treatment for Hodgkin's disease with favorable prognostic features. In patients with unfavorable features, four courses of chemotherapy plus involved-field radiotherapy should be the standard treatment. (ClinicalTrials.gov number, NCT00379041 [ClinicalTrials.gov].).
Copyright 2007 Massachusetts Medical Society.
PMID 17989384 N Engl J Med. 2007 Nov 8;357(19):1916-27. doi: 10.1056/NEJMoa064601.
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