Published online 1 October 2009
Haematologica, Vol 95, Issue 1, 87-95 doi:10.3324/haematol.2009.011221
Copyright © 2010 by Ferrata Storti Foundation

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Acute Lymphoblastic Leukemia

Concurrent intensive chemotherapy and imatinib before and after stem cell transplantation in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia. Final results of the CSTIBES02 trial

Josep-Maria Ribera¹, Albert Oriol¹, Marcos González², Belén Vidriales², Salut Brunet³, Jordi Esteve⁴, Eloy del Potro⁴, Concepción Rivas⁶, Maria-José Moreno⁷, Mar Tormo⁸, Victoria Martín-Reina⁹, Josep Sarrá¹⁰, Ricardo Parody¹¹, Jaime Pérez de Oteyza¹², Encarna Bureo¹³, Maria-Teresa Bernal¹ on behalf of the Programa Español de Tratamiento en Hematología (PETHEMA) and Grupo Español de Trasplante Hemopoyético (GETH) Groups

¹ Departments of Hematology of the Hospitals Institut Català d’Oncologia-Hospital Germans Trias i Pujol, Badalona
² Clínico, Salamanca
³ Sant Pau, Barcelona
⁴ Clínic, Barcelona
⁵ Clínico San Carlos, Madrid
⁶ Universitario, Alicante
⁷ Clínico Virgen de la Victoria, Málaga
⁸ Clínico, Valencia
⁹ Puerta del Mar, Cádiz
¹⁰ Duran y Reynals, Barcelona
¹¹ Virgen del Rocío, Sevilla
¹² Ramón y Cajal, Madrid
¹³ Marqués de Valdecilla, Santander and Central de Asturias (EMR), Spain

Correspondence: Josep-Maria Ribera, Department of Hematology of the Hospitals Institut Català d’Oncologia-Hospital Germans Trias i Pujol, Badalona, Spain. E-mail: jribera{at}iconcologia.net

Background: Imatinib, given concurrently or alternating with chemotherapy, has improved the response and survival of patients with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL) but relapses are still frequent. The aim of this study was to evaluate the feasibility and results of giving imatinib concurrently with intensive chemotherapy, stem cell transplantation and post-transplant imatinib maintenance therapy in patients with newly diagnosed Ph⁺ ALL.

Design and Methods: This was a phase II study of patients with newly diagnosed Ph⁺ ALL given standard chemotherapy, together with imatinib (400 mg/day) until stem cell transplantation, followed by imatinib maintenance therapy for all patients regardless of the molecular status of the disease.

Results: Of the 30 patients included, 27 (90%) achieved complete remission, one was resistant to treatment and two died during induction therapy. The percentages of major and complete molecular responses were 86% and 21% after induction, and 81% and 65% after consolidation, respectively. Similar results were observed assessing minimal residual disease by flow cytometry. Of the 27 patients who achieved complete remission, 21 underwent stem cell transplantation (16 allogeneic, 5 autologous). Imatinib (400 mg/day) could be administered after transplantation for a median of 3.9 months in 12 patients, although it was interrupted in 10 patients (in 2 cases because of side effects of the drug). Nine patients relapsed, four before and five after stem cell transplantation and eight patients died of transplant-related causes. With a median follow-up of 4.1 years, the probabilities (95% CI) of disease-free and overall survival were 30% (15% to 45%) and 30% (16% to 45%), respectively.

Conclusions: These results confirm that imatinib is an effective first-line treatment for adult Ph⁺ ALL when given concurrently with chemotherapy, making stem cell transplantation feasible in a high proportion of patients. However, post-transplantation imatinib administration was limited, mainly because of transplantation-derived complications rather than drug-specific toxicity.

Key words: acute lymphoblastic leukemia, Philadelphia chromosome, BCR-ABL, imatinib, intensive chemotherapy, stem cell transplantation, imatinib maintenance.

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