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Abstract: We designed a phase 1-2 study to evaluate the safety and the efficacy of increasing doses of bendamustine (160 mg/m2, 180 mg/m2, and 200 mg/m2 given on days ?7 and ?6) coupled with fixed doses of etoposide, cytarabine, and melphalan (BeEAM regimen) as the conditioning regimen to autologous stem cell transplantation for resistant/relapsed lymphoma patients. Forty-three patients (median age, 47 years) with non-Hodgkin (n = 28) or Hodgkin (n = 15) lymphoma were consecutively treated. Nine patients entered the phase 1 study; no patients experienced a dose-limiting toxicity. Thirty-four additional patients were then treated in the phase 2. A median number of 6 × 106 CD34+ cells/kg (range, 2.4-15.5) were reinfused. All patients engrafted, with a median time to absolute neutrophil count > 0.5 × 109/L of 10 days. The 100-day transplantation-related mortality was 0%. After a median follow-up of 18 months, 35 of 43 patients (81%) are in complete remission, whereas 6 of 43 relapsed and 2 of 43 did not respond. Disease type (non-Hodgkin lymphomas vs Hodgkin disease) and disease status at transplantation (chemosensitive vs chemoresistant) significantly influenced DFS (P = .01; P = .007). Remarkably, 4 of 43 (9%) patients achieved the first complete remission after receiving the high-dose therapy with autologous stem cell transplantation. In conclusion, the new BeEAM regimen is safe and effective for heavily pretreated lymphoma patients. The study was registered at European Medicines Agency (EudraCT number 2008-002736-15).
Fuente: Blood, 2011, 118(12), 3419-3425
Editorial: American Society of Hematology
Año de publicación: 2011
Nº de páginas: 7
Tipo de publicación: Artículo de Revista
DOI: 10.1182/blood-2011-04-351924
ISSN: 0006-4971,1528-0020
Leer publicación
VISANI, GIUSEPPE
MALERBA, LARA
STEFANI, PIETRO MARIA
CAPRIA, SAVERIA
GALIENI, PIERO
GAUDIO, FRANCESCO
SPECCHIA, GIORGINA
MELONI, GIOVANNA
GHERLINZONI, FILIPPO
GIARDINI, CLAUDIO
FALCIONI, SADIA
CUBERLI, FRANCESCA
GOBBI, MARCO
SARINA, BARBARA
SANTORO, ARMANDO
FERRARA, FELICETTO
ROCCHI, MARCO
ENRIQUE MARIA OCIO SAN MIGUEL
CABALLERO, MARIA DOLORES
ISIDORI, ALESSANDRO
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