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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
- Source :
- Digital.CSIC. Repositorio Institucional del CSIC, instname
- Publication Year :
- 2016
- Publisher :
- John Wiley & Sons, 2016.
-
Abstract
- On behalf of the Grupo Español de Linfomas y Trasplante Autólogo de Médula Ósea (GELTAMO).<br />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.<br />This study was supported (in part) by research funding from Celgene Corporation.
- Subjects :
- Oncology
Adult
Male
medicine.medical_specialty
Adolescent
Maximum Tolerated Dose
Salvage therapy
03 medical and health sciences
Young Adult
0302 clinical medicine
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Refractory Diffuse Large B-Cell Lymphoma
Humans
Lenalidomide
Etoposide
Aged
Salvage Therapy
Dose-Response Relationship, Drug
business.industry
Remission Induction
Cytarabine
Hematology
Diffuse large B-cell lymphoma
Middle Aged
R-ESHAP
medicine.disease
Surgery
Thalidomide
Transplantation
Treatment Outcome
030220 oncology & carcinogenesis
Chronic Disease
Prednisone
Salvage
Female
Lymphoma, Large B-Cell, Diffuse
Cisplatin
Neoplasm Recurrence, Local
business
ESHAP
Rituximab
030215 immunology
medicine.drug
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Digital.CSIC. Repositorio Institucional del CSIC, instname
- Accession number :
- edsair.doi.dedup.....fd8489d79a303064510ae206ec4613b5