title: Results from a prospective, open-label, phase II trial of bendamustine in refractory or relapsed T-cell lymphomas: the BENTLY trial.
abstract: OBJECTIVE
  To determine the efficacy and safety of bendamustine as a single agent in refractory or relapsed T-cell lymphomas.
  
  
  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%).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centre Hospitalier Universitaire, Amiens, France. damaj.gandhi@chu-amiens.fr
authors.forename: Gandhi
authors.initials: G
authors.lastname: Damaj
authors.forename: Rémy
authors.initials: R
authors.lastname: Gressin
authors.forename: Krimo
authors.initials: K
authors.lastname: Bouabdallah
authors.forename: Guillaume
authors.initials: G
authors.lastname: Cartron
authors.forename: Bachra
authors.initials: B
authors.lastname: Choufi
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Gyan
authors.forename: Anne
authors.initials: A
authors.lastname: Banos
authors.forename: Arnaud
authors.initials: A
authors.lastname: Jaccard
authors.forename: Sophie
authors.initials: S
authors.lastname: Park
authors.forename: Olivier
authors.initials: O
authors.lastname: Tournilhac
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Schiano-de Collela
authors.forename: Laurent
authors.initials: L
authors.lastname: Voillat
authors.forename: Bertrand
authors.initials: B
authors.lastname: Joly
authors.forename: Steven
authors.initials: S
authors.lastname: Le Gouill
authors.forename: Alain
authors.initials: A
authors.lastname: Saad
authors.forename: Pascale
authors.initials: P
authors.lastname: Cony-Makhoul
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Vilque
authors.forename: Laurence
authors.initials: L
authors.lastname: Sanhes
authors.forename: Aline
authors.initials: A
authors.lastname: Schmidt-Tanguy
authors.forename: Michael
authors.initials: M
authors.lastname: Bubenheim
authors.forename: Roch
authors.initials: R
authors.lastname: Houot
authors.forename: Momar
authors.initials: M
authors.lastname: Diouf
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Marolleau
authors.forename: Marie-Christine
authors.initials: MC
authors.lastname: Béné
authors.forename: Antoine
authors.initials: A
authors.lastname: Martin
authors.forename: Thierry
authors.initials: T
authors.lastname: Lamy
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D000069461:Bendamustine Hydrochloride; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016410:Lymphoma, T-Cell, Cutaneous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D009367:Neoplasm Staging; D009588:Nitrogen Mustard Compounds / Q000627:therapeutic use*; D011379:Prognosis; D011446:Prospective Studies; D012074:Remission Induction; D016879:Salvage Therapy; D015996:Survival Rate
chemical_list: D018906:Antineoplastic Agents, Alkylating; D009588:Nitrogen Mustard Compounds; D000069461:Bendamustine Hydrochloride