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Grupo de pesquisadores belgas e franceses comparou a evolução de dois grupos de pacientes submetidos a transplante simples ou duplo de células tronco para tratamento do mieloma múltiplo. Todos os participantes do ensaio (399 no total) foram submetidos a altas doses de quimioterapia antes do procedimento. Os resultados do estudo, publicados na semana passada na revista The New England Journal of Medicine, mostram que os pacientes submetidos ao duplo transplante exibem probabilidades de sobrevida livre de recidiva significativamente maiores.
The New England Journal of Medicine
Single versus Double Autologous Stem-Cell Transplantation for Multiple Myeloma
Michel Attal, M.D., Jean-Luc Harousseau, M.D., Thierry Facon, M.D., François Guilhot, M.D., Chantal Doyen, M.D., Jean-Gabriel Fuzibet, M.D., Mathieu Monconduit, M.D., Cyrille Hulin, M.D., Denis Caillot, M.D., Reda Bouabdallah, M.D., Laurent Voillat, M.D., Jean-Jacques Sotto, M.D., Bernard Grosbois, M.D., Regis Bataille, M.D., for the InterGroupe Francophone du Myélome
ABSTRACT
Background We conducted a randomized trial of the treatment of multiple myeloma with high-dose chemotherapy followed by either one or two successive autologous stem-cell transplantations.
Methods At the time of diagnosis, 399 previously untreated patients under the age of 60 years were randomly assigned to receive a single or double transplant.
Results A complete or a very good partial response was achieved by 42 percent of patients in the single-transplant group and 50 percent of patients in the double-transplant group (P=0.10). The probability of surviving event-free for seven years after the diagnosis was 10 percent in the single-transplant group and 20 percent in the double-transplant group (P=0.03). The estimated overall seven-year survival rate was 21 percent in the single-transplant group and 42 percent in the double-transplant group (P=0.01). Among patients who did not have a very good partial response within three months after one transplantation, the probability of surviving seven years was 11 percent in the single-transplant group and 43 percent in the double-transplant group (P<0.001). Four factors were significantly related to survival: base-line serum levels of beta2-microglobulin (P<0.01) and lactate dehydrogenase (P<0.01), age (P<0.05), and treatment group (P<0.01).
Conclusions As compared with a single autologous stem-cell transplantation after high-dose chemotherapy, double transplantation improves overall survival among patients with myeloma, especially those who do not have a very good partial response after undergoing one transplantation.
Source Information
From the Departments of Hematology and Biostatistics, Hôpital Purpan, Toulouse, France (M.A.); Hôtel Dieu, Nantes, France (J.-L.H., R. Bataille); Hôpital C. Huriez, Lille, France (T.F.); Centre Hospitalier la Mileterie, Poitiers, France (F.G.); Centre Universitaire Saint Luc, Brussells, Belgium (C.D.); Hôpital du Cimiez, Nice, France ( J.-G.F.); Centre Henri Becquerel, Rouen, France (M.M.); Centre Hospitalier Brabois, Nancy, France (C.H.); Centre Hospitalier Le Bocage, Dijon, France (D.C.); Institut Paoli Calmettes, Marseilles, France (R. Bouabdallah); Hôpital Jean Minjoz, Besançon, France (L.V.); Hôpital Albert Michallon, Grenoble, France (J.-J.S.); and Hôpital Sud, Rennes, France (B.G.).
Address reprint requests to Dr. Attal at the Service d'Hématologie, Hôpital Purpan, Place du Dr. Baylac, 31059 Toulouse, France, or at attal.m@chu-toulouse.fr.
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