Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial. - Archive ouverte HAL Access content directly
Journal Articles Journal of Clinical Oncology Year : 2013

Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial.

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Gandhi Damaj
  • Function : Author
Guillaume Cartron
Bachra Choufi
  • Function : Author
Emmanuel Gyan
  • Function : Author
Anne Banos
  • Function : Author
Arnaud Jaccard
  • Function : Author
  • PersonId : 972533
Olivier Tournilhac
Alain Saad
  • Function : Author
Michael Bubenheim
Roch Houot
Momar Diouf
  • Function : Author
Jean-Pierre Marolleau
  • Function : Author
  • PersonId : 887235
  • IdRef : 06981676X
Antoine Martin
Thierry Lamy
  • Function : Author

Abstract

PURPOSE: To determine the efficacy and safety of bendamustine as a single agent in refractory or relapsed T-cell lymphomas. PATIENTS AND METHODS: Patients with histologically confirmed peripheral T-cell lymphoma (PTCL) or cutaneous T-cell lymphoma who progressed after one or more lines of prior chemotherapy received bendamustine at 120 mg/m(2) per day on days 1 through 2 every 3 weeks for six cycles. The primary end point was overall response rate (ORR). Secondary end points were duration of response (DOR), progression-free survival (PFS), and overall survival (OS). RESULTS: Of the 60 patients included, 27 (45%) were refractory to their last prior chemotherapy, and the median duration of the best previous response was 6.6 months. Histology was predominantly angioimmunoblastic lymphadenopathy and PTCL not otherwise specified. The disease was disseminated in the majority of patients (87%). The median number of previous lines of chemotherapy was one (range, one to three). Twenty patients (33%) received fewer than three cycles of bendamustine, mostly because of disease progression. In the intent-to-treat population, the ORR was 50%, including complete response in 17 patients (28%) and partial response in 13 patients (22%). Bendamustine showed consistent efficacy independent of major disease characteristics. The median values for DoR, PFS, and OS were 3.5, 3.6, and 6.2 months, respectively. The most frequent grade 3 to 4 adverse events were neutropenia (30%), thrombocytopenia (24%), and infections (20%). CONCLUSION: Bendamustine showed an encouraging high response rate across the two major PTCL subtypes, independent of age and prior treatment, with acceptable toxicity in refractory or relapsed T-cell lymphoma.
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Dates and versions

inserm-00868869 , version 1 (02-10-2013)

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Gandhi Damaj, Rémy Gressin, Krimo Bouabdallah, Guillaume Cartron, Bachra Choufi, et al.. Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial.. Journal of Clinical Oncology, 2013, 31 (1), pp.104-10. ⟨10.1200/JCO.2012.43.7285⟩. ⟨inserm-00868869⟩
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