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Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group

AutorMartín, Alejandro; Redondo, Alba; Dlouhy, Iván; Salar, Antonio; González-Barca, Eva; Canales, Miguel; Montes-Moreno, Santiago; Ocio, Enrique M. ; López-Guillermo, Armando; Caballero, Maria Dolores
Palabras claveSalvage
Lenalidomide
Diffuse large B-cell lymphoma
R-ESHAP
Rituximab
Fecha de publicación2016
EditorJohn Wiley & Sons
CitaciónBritish Journal of Haematology 173(2): 245-252 (2016)
ResumenDiffuse large B-cell lymphoma (DLBCL) patients failing rituximab-containing therapy have a poor outcome with the current salvage regimens. We conducted a phase 1b trial to determine the maximum tolerated dose (MTD) of lenalidomide in combination with R-ESHAP (rituximab, etoposide, cisplatin, cytarabine, methylprednisolone) (LR-ESHAP) in patients with relapsed or refractory DLBCL. Efficacy data were collected as a secondary objective. Subjects received 3 cycles of lenalidomide at escalating doses (5, 10 or 15 mg) given on days 1-14 of every 21-day cycle, in combination with R-ESHAP. Responding patients received BEAM (carmustine, etoposide, cytarabine, melphalan) followed by autologous stem-cell transplantation. Lenalidomide 10 mg/d was identified as the MTD because, in the 15 mg cohort, one patient experienced dose-limiting toxicity (grade 3 angioedema) and two patients had mobilization failure. A total of 19 patients (3, 12 and 4 in the 5, 10 and 15 mg cohorts, respectively) were evaluable. All toxicities occurring during LR-ESHAP cycles resolved appropriately and no grade 4-5 non-haematological toxicities were observed. The complete remission and overall response rates were 47·4% and 78·9%, respectively. With a median follow-up of 24·6 (17·4-38·2) months, the 2-year progression-free survival and overall survival were 44% and 63%, respectively. In conclusion, the LR-ESHAP regimen is feasible and yields encouraging outcomes.
DescripciónOn behalf of the Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO).
URIhttp://hdl.handle.net/10261/168586
Identificadoresdoi: 10.1111/bjh.13945
e-issn: 1365-2141
issn: 0007-1048
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