title: A multicenter phase II trial to determine the safety and efficacy of combination therapy with denileukin diftitox and cyclophosphamide, doxorubicin, vincristine and prednisone in untreated peripheral T-cell lymphoma: the CONCEPT study.
abstract: This phase II study to determine the safety and efficacy of denileukin diftitox (DD) and cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) enrolled patients with newly diagnosed peripheral T-cell lymphoma (PTCL). Forty-nine received DD 18 μg/kg/day (days 1, 2) with CHOP (day 3) every 21 days for ≤ 6-8 cycles. Intent-to-treat (ITT) and safety populations comprised all patients. In the ITT population, the overall response rate was 65%, median duration of response was 30 months and median progression-free survival was 12 months. Median overall survival was not attained at the end of the study, and the overall survival rate was 63.3%. The two most frequent treatment-related adverse events (AEs) were fatigue and nausea. Most frequent AEs ≥ grade 3 within the hematologic system were lymphopenia (24.5%), neutropenia (20.4%) and leukopenia (18.4%). Three treatment-related deaths occurred. DD plus CHOP was well tolerated, and progression-free and overall survival improved versus historical comparison with CHOP alone. Confirmation in larger trials is warranted.
authors.affiliation: Department of Medical Oncology, Yale Cancer Center, Yale Medical School, New Haven, CT 06520, USA. francine.foss@yale.edu
authors.forename: Francine M
authors.initials: FM
authors.lastname: Foss
authors.forename: Nelida
authors.initials: N
authors.lastname: Sjak-Shie
authors.forename: Andre
authors.initials: A
authors.lastname: Goy
authors.forename: Eric
authors.initials: E
authors.lastname: Jacobsen
authors.forename: Ranjana
authors.initials: R
authors.lastname: Advani
authors.forename: Mitchell R
authors.initials: MR
authors.lastname: Smith
authors.forename: Rami
authors.initials: R
authors.lastname: Komrokji
authors.forename: Kelly
authors.initials: K
authors.lastname: Pendergrass
authors.forename: Vanessa
authors.initials: V
authors.lastname: Bolejack
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D003520:Cyclophosphamide / Q000008:administration & dosage; D004167:Diphtheria Toxin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007376:Interleukin-2 / Q000008:administration & dosage; D016411:Lymphoma, T-Cell, Peripheral / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011241:Prednisone / Q000008:administration & dosage; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D004167:Diphtheria Toxin; D007376:Interleukin-2; D011993:Recombinant Fusion Proteins; C078456:denileukin diftitox; D014750:Vincristine; D004317:Doxorubicin; D003520:Cyclophosphamide; D011241:Prednisone