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Bendamustine and rituximab in elderly patients with low‐tumour burden follicular lymphoma. Results of the LYSA phase II BRIEF study
Author(s) -
Gyan Emmanuel,
Sonet Anne,
Brice Pauline,
Anglaret Bruno,
Laribi Kamel,
Fruchart Christophe,
Tilly Hervé,
Araujo Carla,
Soubeyran Pierre,
Gonzalez Hugo,
Morineau Nadine,
NicolasVirelizier Emmanuelle,
Ghesquières Hervé,
Salles Bruno,
Bouabdallah Réda,
Orfeuvre Hubert,
Fahri Jonathan,
Couturier Olivier,
Xerri Luc,
Feugier Pierre
Publication year - 2018
Publication title -
british journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.907
H-Index - 186
eISSN - 1365-2141
pISSN - 0007-1048
DOI - 10.1111/bjh.15513
Subject(s) - bendamustine , rituximab , medicine , follicular lymphoma , regimen , international prognostic index , surgery , lymphoma , gastroenterology , neutropenia , phases of clinical research , chemotherapy
Summary The treatment of low‐tumour burden follicular lymphoma ( LTBFL ) remains a challenge. Rituximab‐based strategies may be improved by adding chemotherapy. This Lymphoma Study Association multicentre phase II study assessed rituximab and bendamustine in 63 patients with untreated LTBFL who were aged over 60 years old and had a follicular lymphoma International Prognostic Index ( FLIPI ) score ≥2. Induction comprised 4 weekly cycles of rituximab 375 mg/m 2 intravenously combined with 2 cycles of bendamustine 90 mg/m 2 days 1–2 with a 28‐day interval, followed by twelve cycles of 375 mg/m 2 rituximab maintenance therapy every 8 weeks. The primary endpoint was complete response ( CR )/unconfirmed CR ( CR u), at 12 weeks. Median age was 67·4 years and median FLIPI was 3. Ultimately, 18 patients (29%) had high tumour burden according to Groupe d'Etude des Lymphomes Folliculaires criteria. The 12‐week CR / CR u rate was 54·0% and the overall response rate was 93·7%. Surprisingly, 3 patients died during maintenance (2 sepsis, 1 neoplasm). Progression‐free survival was 85·4% at 24 months. In LTBFL patients with FLIPI ≥2, two cycles of rituximab and bendamustine result in a CR rate of 54·0%. However, the treatment‐related deaths observed do not allow this regimen to be recommended for LTBFL patients aged over 60 years. EudraCT: 2010‐020757‐14; ClinicalTrials.gov: NCT01313611.