Phase 2 study of intensified chemotherapy and allogeneic hematopoietic stem cell transplantation for older patients with acute lymphoblastic leukemia
| Autor: | Kristen E. Stevenson, Julie D. Asch, Jonathan E. Kolitz, Karen K. Ballen, David P. Steensma, Julia Foster, Martha Wadleigh, Daniel J. DeAngelo, Eyal C. Attar, Amir T. Fathi, Ilene Galinsky, Christine Connolly, Craig Devoe, Philip C. Amrein, Donna Neuberg, Richard Stone |
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| Rok vydání: | 2016 |
| Předmět: |
Oncology
Cancer Research medicine.medical_specialty Vincristine Asparaginase business.industry medicine.medical_treatment Induction chemotherapy Hematopoietic stem cell transplantation Surgery Transplantation 03 medical and health sciences chemistry.chemical_compound 0302 clinical medicine chemistry 030220 oncology & carcinogenesis Internal medicine medicine Clinical endpoint Clofarabine business Survival rate 030215 immunology medicine.drug |
| Zdroj: | Cancer. 122:2379-2388 |
| ISSN: | 0008-543X |
| Popis: | BACKGROUND Outcomes among older patients with acute lymphoblastic leukemia remain poor. This study sought to determine the efficacy of an intensified, multi-agent approach derived from a Dana-Farber consortium trial in younger adults for patients older than 50 years (trial identifier NCT00973752). METHODS The primary endpoint was overall survival (OS) at 1 year. Patients received induction chemotherapy with vincristine, prednisone, doxorubicin, and pegylated asparaginase. Imatinib was incorporated for Philadelphia chromosome–positive disease. After induction, the first consolidation incorporated clofarabine. Patients in remission could proceed to allogeneic hematopoietic cell transplantation (HCT) after induction and consolidation I. Those not receiving HCT went on to receive central nervous system, consolidation II, and continuation phases of treatment. RESULTS Thirty patients were enrolled: 19 achieved a complete remission (CR) after induction and 1 achieved CR after consolidation I for a CR rate of 67%. Sixteen patients underwent HCT. The proportion surviving at 1 year was 63%, and this met the primary endpoint. The 2-year OS rate was 52% (n = 30), and the 2-year disease-free survival rate was 52% for patients achieving CR (n = 20). There was no survival advantage among those undergoing HCT. Therapy-related hyperbilirubinemia prompted adjustments and limitations to asparaginase dosing. CONCLUSIONS Intensified chemotherapy can result in improved outcomes in comparison with historical data. Additional studies of similarly intensive regimens are warranted in this population. Cancer 2016. © 2016 American Cancer Society. |
| Databáze: | OpenAIRE |
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