Lenalidomide in combination with R-ESHAP in patients with relapsed or refractory diffuse large B-cell lymphoma: a phase 1b study from GELTAMO group
Corresponding Author
Alejandro Martín
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Correspondence: Alejandro Martín, Department of Haematology, Complejo Asistencial Universitario de Salamanca-IBSAL, Paseo de San Vicente 58-182, Salamanca 37007, Spain.
E-mail: [email protected]
Search for more papers by this authorAlba M. Redondo
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Search for more papers by this authorIván Dlouhy
Department of Haematology, Hospital Clinic, Barcelona, Spain
Search for more papers by this authorAntonio Salar
Department of Haematology, Hospital del Mar, Barcelona, Spain
Search for more papers by this authorEva González-Barca
Department of Haematology, Institut Català D'Oncologia Duran I Reynals, L'Hospitalet de Llobregat, Spain
Search for more papers by this authorMiguel Canales
Department of Haematology, Hospital Universitario La Paz, Madrid, Spain
Search for more papers by this authorSantiago Montes-Moreno
Department of Pathology, Hospital Universitario Marqués de Valdecilla, IFIMAV, Santander, Spain
Search for more papers by this authorEnrique M. Ocio
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Centro de Investigación del Cáncer, IBMCC/CSIC-Universidad de Salamanca, Salamanca, Spain
Search for more papers by this authorArmando López-Guillermo
Department of Haematology, Hospital Clinic, Barcelona, Spain
Search for more papers by this authorDolores Caballero
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Search for more papers by this authorthe Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO)
Search for more papers by this authorCorresponding Author
Alejandro Martín
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Correspondence: Alejandro Martín, Department of Haematology, Complejo Asistencial Universitario de Salamanca-IBSAL, Paseo de San Vicente 58-182, Salamanca 37007, Spain.
E-mail: [email protected]
Search for more papers by this authorAlba M. Redondo
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Search for more papers by this authorIván Dlouhy
Department of Haematology, Hospital Clinic, Barcelona, Spain
Search for more papers by this authorAntonio Salar
Department of Haematology, Hospital del Mar, Barcelona, Spain
Search for more papers by this authorEva González-Barca
Department of Haematology, Institut Català D'Oncologia Duran I Reynals, L'Hospitalet de Llobregat, Spain
Search for more papers by this authorMiguel Canales
Department of Haematology, Hospital Universitario La Paz, Madrid, Spain
Search for more papers by this authorSantiago Montes-Moreno
Department of Pathology, Hospital Universitario Marqués de Valdecilla, IFIMAV, Santander, Spain
Search for more papers by this authorEnrique M. Ocio
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Centro de Investigación del Cáncer, IBMCC/CSIC-Universidad de Salamanca, Salamanca, Spain
Search for more papers by this authorArmando López-Guillermo
Department of Haematology, Hospital Clinic, Barcelona, Spain
Search for more papers by this authorDolores Caballero
Department of Haematology, Hospital Universitario de Salamanca-IBSAL, Salamanca, Spain
Search for more papers by this authorthe Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO)
Search for more papers by this authorSummary
Diffuse 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.
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