Patient Characteristics and Initial Treatment Patterns in the United States for the Most Common Subtypes of Peripheral T-Cell Lymphoma (PTCL)
Authors: Pinter-Brown Lauren , Foss Francine M. , Carson Kenneth R. , Horwitz Steven M. , Rosen Steven T. , Pro Barbara , Federico Massimo , Gisselbrecht Christian , Hsi Eric D. , Shustov Andrei R. , Advani Ranjana , Feldman Tatyana , Lechowicz Mary Jo , Smith Sonali , Tulpule Anil , Greer John P. , Kahl Brad S. , Leach Joseph , Morganstein Neil , Casulo Carla , Park Steven I. 
Published: October 2019

Abstract
Background: Comprehensive Oncology Measures for Peripheral T-Cell Lymphoma Treatment (COMPLETE) is the largest registry of prospectively treated PTCL patients in the United States. Patients are enrolled at the initial diagnosis of PTCL and within 30 days of starting treatment. Data on demographics, clinical characteristics, diagnosis, therapy delivered as induction or salvage, and outcomes are collected.
Methods: For this report, we examined baseline characteristics and induction treatment patterns for patients with the 3 most common subtypes of PTCL: PTCL not otherwise specified (NOS), anaplastic large cell lymphoma (ALCL) and angioimmunoblastic T-cell lymphoma (AITL). Only data from locked records are reported. Locked records are those that have been reviewed and digitally signed by the treating investigator.
Results: Five hundred patients were enrolled from February 2010 until January 2014. As of July 2014, there were 257 locked baseline records and 188 locked treatment records for patients with a diagnosis of PTCL-NOS, ALCL or AITL. The mean age of these patients was 60 (range: 51-70). Most were male (66%) and white (78%). At study entry, 234 (91%) had an ECOG performance status of 0-1, 190 (74%) had Ann Arbor stage of III/IV, and 120 (47%) had one or more B symptoms. Half of the patients had extranodal disease. Mean international prognostic index (IPI) score was 2 (range 0-5). For staging, a PET/CT was the most common radiographic method used (58% of patients), and for pathologic diagnosis, on average, 10 phenotypic and ~1 genetic markers were assessed. For baseline characteristics reported here, patients treated at academic centers had more extranodal disease, a higher IPI score and tended to have more advanced disease compared to patients treated in the community. The primary intent of initial therapy was a cure for 89% of patients and 60% received an anthracycline or anthracycline plus etoposide-containing regimen. A minority of patients (21%) participated in a clinical trial for PTCL. Further details on induction therapy can be found in the table below.
Table Initial Treatment Characteristics Total Academic Community Initial Treatment Approach* N=188 n=158 n=30 Induction chemotherapy (CT) alone 125 (66%) 102 (65%) 23 (77%) Induction CT + consolidation or maintenance 11 (6%) 10 (6%) 1 (3%) Stem cell transplant 36 (19%) 33 (21%) 3 (10%) Local radiotherapy +/- chemotherapy 10 (5%) 7 (4%) 3 (10%) Observation/best supportive care 6 (3%) 6 (4%) 0 (0%) Induction Regimens N=186 n=154 n=32 CHOP/CHOP-like 76 (41%) 56 (36%) 20 (63%) CHOP/CHOP-like + etoposide 37 (20%) 30 (20%) 7 (22%) Gemcitabine-based regimen 6 (3%) 6 (4%) 0 (0%) Platinum-based regimen 5 (3%) 5 (3%) 0 (0%) Other 62 (33%) 57 (37%) 5 (15%) Number of Cycles of Induction CT Median, Inter-Quartile Range (Cycles) 5 (2-6) 5 (2-6) 5 (1-6) Type of Transplant Performed N=36 n=33 n=3 Autologous 34 (94%) 31 (94%) 3 (100%) Allogeneic 2 (6%) 2 (6%) 0 (0%)
*5 patients received CNS prophylaxis with selected treatments shown above
CHOP=cyclophosphamide, doxorubicin, prednisone, and vincristine
Conclusions: Early results from the first prospective US-based registry of newly diagnosed patients with PTCL-NOS, ALCL and AITL show that beyond CHOP-based therapy, there is little consensus on initial management of these patients. These data strongly support the need to develop evidence-based approaches for this rare and heterogeneous group of patients.

Disclosures
Pinter-Brown: Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Foss:spectrum: Research Funding; seattle genetics: Research Funding; Merck: Research Funding; Celgene: Honoraria, Research Funding; Millenium: Honoraria, Membership on an entity's Board of Directors or advisory committees. Carson:Spectrum: Consultancy; Celgene: Consultancy, Speakers Bureau. Horwitz:Celgene: Consultancy, Research Funding; Millennium: Consultancy, Research Funding; Seattle Genetics: Consultancy, Research Funding; Spectrum: Research Funding; Infinity: Research Funding; Kiowa-Kirin: Research Funding; Amgen: Consultancy; Bristol-Myers Squibb: Consultancy. Rosen:Allos: Consultancy, Honoraria. Gisselbrecht:Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Hsi:Daiichi-Sankyo: Consultancy; Allos: Research Funding; Seattle Genetics: Speakers Bureau; Eli Lilly: Research Funding; Abbott: Research Funding; Cellerant Therapeutics: Research Funding; BD Biosciences: Research Funding; Millennium: Research Funding. Advani:Seattle Genetics: Research Funding. Lechowicz:Spectrum: Consultancy; Seattle Genetics: Consultancy; Janssen: Consultancy; Millennium: Consultancy. Smith:Allos/Spectrum: Consultancy, Membership on an entity's Board of Directors or advisory committees. Kahl:Allos : Research Funding. Park:Teva: Research Funding; Seattle Genetics: Research Funding; Janssen: Travel funding, Travel funding Other.