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著者: Simonetta Viviani, Pier Luigi Zinzani, Alessandro Rambaldi, Ercole Brusamolino, Alessandro Levis, Valeria Bonfante, Umberto Vitolo, Alessandro Pulsoni, Anna Marina Liberati, Giorgina Specchia, Pinuccia Valagussa, Andrea Rossi, Francesco Zaja, Enrico M Pogliani, Patrizia Pregno, Manuel Gotti, Andrea Gallamini, Delia Rota Scalabrini, Gianni Bonadonna, Alessandro M Gianni, Michelangelo Foundation, Gruppo Italiano di Terapie Innovative nei Linfomi, Intergruppo Italiano Linfomi
雑誌名: N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340.
Abstract/Text
BACKGROUND: BEACOPP, an intensified regimen consisting of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone, has been advocated as the new standard of treatment for advanced Hodgkin's lymphoma, in place of the combination of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD).
METHODS: We randomly assigned 331 patients with previously untreated and unfavorable Hodgkin's lymphoma (stage IIB, III, or IV, or an international prognostic score of ≥3 on a scale of 0 to 7, with higher scores indicating increased risk), to receive either BEACOPP or ABVD, each followed by local radiotherapy when indicated. Patients with residual or progressive disease after the initial therapy were to be treated according to a state-of-the-art high-dose salvage program. The median follow-up period was 61 months.
RESULTS: The 7-year rate of freedom from first progression was 85% among patients who had received initial treatment with BEACOPP and 73% among those who had received initial treatment with ABVD (P=0.004), and the 7-year rate of event-free survival was 78% and 71%, respectively (P=0.15). A total of 65 patients (20 in the BEACOPP group, and 45 in the ABVD group) went on to receive the intended high-dose salvage regimen. As of the cutoff date, 3 of the 20 patients in the BEACOPP group and 15 of the 45 in the ABVD group who had had progressive disease or relapse after the initial therapy were alive and free of disease. After completion of the overall planned treatment, including salvage therapy, the 7-year rate of freedom from a second progression was 88% in the BEACOPP group and 82% in the ABVD group (P=0.12), and the 7-year rate of overall survival was 89% and 84%, respectively (P=0.39). Severe adverse events occurred more frequently in the BEACOPP group than in the ABVD group.
CONCLUSIONS: Treatment with BEACOPP, as compared with ABVD, resulted in better initial tumor control, but the long-term clinical outcome did not differ significantly between the two regimens. (Funded by Fondazione Michelangelo; ClinicalTrials.gov number, NCT01251107.).
PMID 21774708 N Engl J Med. 2011 Jul 21;365(3):203-12. doi: 10.1056/NEJMoa1100340.
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