Lenalidomide in combination with intravenous rituximab (REVRI) in relapsed/refractory primary CNS lymphoma or primary intraocular lymphoma: a multicenter prospective ‘proof of concept’ phase II study of the French Oculo-Cerebral lymphoma (LOC) Network and the Lymphoma Study Association (LYSA)
| Autor: | Khê Hoang-Xuan, Emmanuel Gyan, M Le Garff-Tavernier, Valérie Touitou, F. Morschhauser, Vassili Soumelis, M. Chevrier, O Chinot, M. Laadhari, Hervé Ghesquières, Anna Schmitt, Sylvain Choquet, Cécile Moluçon-Chabrot, I. Turbiez, Nathalie Cassoux, Carole Soussain, Patrick Beauchesne, E. Nicolas-Virelizier, Caroline Houillier, A. Savignoni, Remy Gressin |
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| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty business.industry Primary central nervous system lymphoma Phases of clinical research Hematology medicine.disease Gastroenterology Lymphoma 03 medical and health sciences Regimen 030104 developmental biology 0302 clinical medicine Oncology hemic and lymphatic diseases 030220 oncology & carcinogenesis Internal medicine Medicine Rituximab Intraocular lymphoma business Diffuse large B-cell lymphoma Lenalidomide medicine.drug |
| Zdroj: | Annals of Oncology. 30:621-628 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdz032 |
| Popis: | Background Primary central nervous system lymphomas (PCNSLs) are mainly diffuse large B-cell lymphomas (DLBCLs) of the non-germinal center B-cell (non-GCB) subtype. This study aimed to determine the efficacy of rituximab plus lenalidomide (R2) in DLBCL–PCNSL. Patients and methods Patients with refractory/relapsed (R/R) DLBCL–PCNSL or primary vitreoretinal lymphoma (PVRL) were included in this prospective phase II study. The induction treatment consisted of eight 28-day cycles of R2 (rituximab 375/m2 i.v. D1; lenalidomide 20mg/day, D1-21 for cycle 1; and 25mg/day, D1-21 for the subsequent cycles); in responding patients, the induction treatment was followed by a maintenance phase comprising 12 28-day cycles of lenalidomide alone (10mg/day, D1-21). The primary end point was the overall response rate (ORR) at the end of induction (P0=10%; P1=30%). Results Fifty patients were included. Forty-five patients (PCNSL, N=34; PVRL, N=11) were assessable for response. The ORR at the end of induction was 35.6% (95% CI 21.9–51.2) in assessable patients and 32.0% (95% CI 21.9–51.2) in the intent-to-treat analysis, including 13 complete responses (CR)/unconfirmed CR (uCR; 29%) and 3 partial responses (PR; 7%). The best responses were 18 CR/uCR (40%) and 12 PR (27%) during the induction phase. The maintenance phase was started and completed by 18 and 5 patients, respectively. With a median follow-up of 19.2months (range 1.5–31), the median progression-free survival (PFS) and overall survival (OS) were 7.8months (95% CI 3.9–11.3) and 17.7months (95% CI 12.9 to not reached), respectively. No unexpected toxicity was observed. The peripheral baseline CD4/CD8 ratio impacted PFS [median PFS=9.5months (95% CI, 8.1–14.8] for CD4/CD8≥1.6; median PFS=2.8months, [95% CI, 1.1–7.8) for CD4/CD8 Conclusions The R2 regimen showed significant activity in R/R PCNSL and PVRL patients. These results support assessments of the efficacy of R2 combined with methotrexate-based chemotherapy as a first-line treatment of PCNSL. Clinical trials number NCT01956695. |
| Databáze: | OpenAIRE |
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