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Comparison of Intensive Chemotherapy, Allogeneic, or Autologous Stem-Cell Transplantation As Postremission Treatment for Children With Very High Risk Acute Lymphoblastic Leukemia: PETHEMA ALL-93 Trial

Jose-Maria Ribera, Juan-José Ortega, Albert Oriol, Pilar Bastida, Carlota Calvo, José-María Pérez-Hurtado, María-Elvira González-Valentín, Victoria Martín-Reina, Antonio Molinés, Fernando Ortega-Rivas, Maria-José Moreno, Concepción Rivas, Izaskun Egurbide, Inmaculada Heras, Concepción Poderós, Eva Martínez-Revuelta, José-Maria Guinea, Eloy del Potro, Guillermo Deben

From the Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol; Hospital Universitari Vall d'Hebron, Barcelona; Hospital Infantil Miguel Servet, Zaragoza; Hospital Universitario Virgen del Rocío, Sevilla; Hospital Materno-Infantil Carlos Haya, Málaga; Hospital Universitario Virgen de la Victoria, Málaga; Hospital Puerta del Mar, Cadiz; Hospital Materno Infantil, Las Palmas; Hospital Río Carrión, Palencia; Hospital General, Alicante; Hospital de Aranzazu, San Sebastián; Hospital Morales Meseguer, Murcia; Hospital Xeral, Vigo; Hospital Central de Asturias; Hospital Txagorritxu, Vitoria; Hospital Clínico San Carlos, Madrid; and Hospital Juan Canalejo, La Coruña, Spain

Address reprint requests to Jose-María Ribera, Servicio de Hematología Clínica, Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, C/ Canyet S/N, 08916 Badalona, Spain; e-mail: jribera{at}iconcologia.net

Purpose The optimal postremission therapy for children with very high-risk (VHR) acute lymphoblastic leukemia (ALL) is not well established. This randomized trial compared three options of postremission therapy: chemotherapy and allogeneic or autologous stem-cell transplantation (SCT).

Patients and Methods All 106 VHR-ALL patients received induction with five drugs followed by intensification with three cycles of chemotherapy. Patients in complete remission (CR) with an HLA-identical family donor were assigned to allogeneic SCT (n = 24) and the remaining were randomly assigned to autologous SCT (n = 38) or to delayed intensification followed by maintenance chemotherapy up to 2 years in CR (n = 38).

Results Overall, 100 patients achieved CR (94%). With a median follow-up of 6.5 years, 5-year disease-free survival (DFS) and overall survival (OS) probabilities were 45% (95% CI, 37% to 54%) and 48% (95% CI, 40% to 57%), respectively. The three groups were comparable in the main pretreatment ALL characteristics. Intention-to-treat analysis showed no differences for donor versus no donor in DFS (45%; 95% CI, 27% to 65% v 45%; 95% CI, 37% to 55%) and OS (48%; 95% CI, 30% to 67% v 51%; 95% CI, 43% to 61%), as well as for autologous SCT versus chemotherapy comparisons (DFS: 44%; 95% CI, 29% to 60% v 46%; 95% CI, 32% to 62%; OS: 45%; 95% CI, 31% to 62% v 57%; 95% CI, 43% to 73%). No differences were found within the different subgroups of ALL and neither were differences observed when the analysis was made by treatment actually performed.

Conclusion This study failed to prove that, when a family donor is available, allogeneic SCT produces a better outcome than autologous SCT or chemotherapy in children with VHR-ALL.

Supported by Grant No. 97/1049 from Fondo de Investigaciones Sanitarias and Grant No. FIJC P-EF/04 from José Carreras International Leukemia Foundation.

Presented in part at the 47th Annual Meeting of the American Society of Hematology, Atlanta, GA, December 10-13, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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