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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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