1. Results From a Prospective, Open-Label, Phase II Trial of Bendamustine in Refractory or Relapsed T-Cell Lymphomas: The BENTLY Trial
- Author
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Arnaud Jaccard, Momar Diouf, Gandhi Damaj, Thierry Lamy, Pascale Cony-Makhoul, Krimo Bouabdallah, Bertrand Joly, Roch Houot, Guillaume Cartron, Steven Le Gouill, Emmanuel Gyan, Remy Gressin, Jean-Pierre Vilque, Bachra Choufi, Marie-Christine Béné, Sophie Park, Michael Bubenheim, Laurence Sanhes, Aline Schmidt-Tanguy, Laurent Voillat, Jean-Marc Schiano-de Collela, Anne Banos, Alain Saad, Olivier Tournilhac, Jean-Pierre Marolleau, Antoine Martin, CHU Amiens-Picardie, Institut d'oncologie/développement Albert Bonniot de Grenoble (INSERM U823), Université Joseph Fourier - Grenoble 1 (UJF)-CHU Grenoble-EFS-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Bordeaux [Bordeaux], CHU Montpellier, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Hôpital Duchenne, CH Boulogne sur Mer, CIC - Tours, Centre Hospitalier Régional Universitaire de Tours (CHRU Tours)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital de Bayonne, Centre Hospitalier de la Côte Basque (CHCB), CHU Limoges, Hôpital Cochin [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), CHU Clermont-Ferrand, Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC), Centre Hospitalier Chalon-sur-Saône William Morey, Hôpital Sud-Fancilien, CH Sud-Fancilien, Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), Hôpital de Béziers, CH Béziers, Centre Hospitalier d'Annecy, Centre hospitalier d'Annecy, Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN), Hôpital de Perpignan, Centre Hospitalier Saint Jean de Perpignan, CHU Rouen, Normandie Université (NU), Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Hôpital Avicenne [AP-HP], Institut National de la Santé et de la Recherche Médicale (INSERM)-EFS-CHU Grenoble-Université Joseph Fourier - Grenoble 1 (UJF), CH de la Côte Basque, UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU), and Le Corre, Morgane
- Subjects
Male ,MESH: Remission Induction ,Cancer Research ,medicine.medical_treatment ,Salvage therapy ,MESH: Antineoplastic Agents, Alkylating ,Gastroenterology ,MESH: Aged, 80 and over ,0302 clinical medicine ,Bendamustine Hydrochloride ,Prospective Studies ,Aged, 80 and over ,MESH: Aged ,education.field_of_study ,MESH: Middle Aged ,Remission Induction ,MESH: Neoplasm Staging ,MESH: Follow-Up Studies ,Middle Aged ,MESH: Lymphoma, T-Cell, Peripheral ,Prognosis ,MESH: Drug Resistance, Neoplasm ,MESH: Lymphoma, T-Cell, Cutaneous ,Lymphoma, T-Cell, Cutaneous ,MESH: Salvage Therapy ,3. Good health ,Survival Rate ,Oncology ,030220 oncology & carcinogenesis ,Nitrogen Mustard Compounds ,Female ,MESH: Neoplasm Recurrence, Local ,medicine.drug ,Adult ,Bendamustine ,medicine.medical_specialty ,MESH: Survival Rate ,Population ,[SDV.BC]Life Sciences [q-bio]/Cellular Biology ,Neutropenia ,MESH: Prognosis ,03 medical and health sciences ,Refractory ,Internal medicine ,[SDV.BBM] Life Sciences [q-bio]/Biochemistry, Molecular Biology ,medicine ,Humans ,[SDV.BBM]Life Sciences [q-bio]/Biochemistry, Molecular Biology ,education ,Antineoplastic Agents, Alkylating ,[SDV.BC] Life Sciences [q-bio]/Cellular Biology ,Survival rate ,Aged ,Neoplasm Staging ,Salvage Therapy ,Chemotherapy ,MESH: Humans ,business.industry ,MESH: Nitrogen Mustard Compounds ,Lymphoma, T-Cell, Peripheral ,MESH: Adult ,medicine.disease ,MESH: Male ,MESH: Prospective Studies ,Lymphoma ,Surgery ,Drug Resistance, Neoplasm ,Neoplasm Recurrence, Local ,business ,MESH: Female ,Follow-Up Studies ,030215 immunology - 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/m2 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.
- Published
- 2013