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Comparison of the Results of the Treatment of Adolescents and Young Adults With Standard-Risk Acute Lymphoblastic Leukemia With the Programa Español de Tratamiento en Hematología Pediatric-Based Protocol ALL-96

Josep-María Ribera, Albert Oriol, Miguel-Angel Sanz, Mar Tormo, Pascual Fernández-Abellán, Eloy del Potro, Eugenia Abella, Javier Bueno, Ricardo Parody, Pilar Bastida, Carlos Grande, Inmaculada Heras, Concepción Bethencourt, Evarist Feliu, Juan-José Ortega

From the Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol, Badalona; Hospital La Fe; Hospital Clínico Universitario, Valencia; Hospital General, Alicante; Hospital Clínico San Carlos; Hospital Doce de Octubre, Madrid; Hospital del Mar; Hospital Vall d'Hebron, Barcelona; Hospital Universitario Virgen del Rocío, Sevilla; Hospital Morales Meseguer, Murcia; and the Hospital Universitario Carlos Haya, Málaga, Spain

Corresponding author: Josep-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: Retrospective studies have shown that adolescents and young adults with acute lymphoblastic leukemia (ALL) treated with pediatric protocols have better outcomes than similarly aged patients treated with adult protocols, but prospective studies comparing adolescents and young adults using pediatric schedules are scarce. The ALL-96 protocol was addressed to compare the toxicity and results of a pediatric-based protocol in adolescents (age 15-18 years) and young adults (age 19-30 years) with standard-risk (SR) ALL.

Patients and Methods: Adolescents (n = 35) and young adults (n = 46) received a standard five-drug/5-week induction course followed by two cycles of early consolidation, maintenance with monthly reinforcement cycles up to 1 year in continuous complete remission (CR) and 1 year with standard maintenance chemotherapy up to 2 years in CR.

Results: Adolescents and young adults were comparable in the main pretreatment ALL characteristics. The CR rate was 98% and. after a median follow-up of 4.2 years, 6-year event-free survival (EFS) and overall survival (OS) were 61% (95% CI, 51% to 72%) and 69% (95% CI, 59% to 79%), respectively, with no differences between adolescents and young adults. The hematologic toxicity in consolidation and reinforcement cycles was higher in young adults than in adolescents. Slow response to induction therapy was the only parameter associated with poor EFS (34% v 67%) and OS (40% v 76%).

Conclusion: The response to the pediatric ALL-96 protocol was identical in adolescents and young adults despite a slight increase in hematologic toxicity observed in adults. This justifies the age-unrestricted use of pediatric regimens to treat patients with SR ALL.

Supported in part by Grants No. 97/1049 from the Fondo de Investigaciones Sanitarias, RD/060020/1056 from Retics, and FIJC P-EF/04 from the José Carreras International Leukemia Foundation.

Presented at the 12th Congress of the European Hematology Association, June 7-10, 2007, Neue Messe Vienna, Austria.

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