Frederick Lansigan1, Steven M Horwitz2, Lauren C Pinter-Brown3, Steven T Rosen4, Barbara Pro5, Eric D Hsi6, Massimo Federico7, Christian Gisselbrecht8, Marc Schwartz9, Lisa A Bellm10, Mark Acosta11, Andrei R Shustov12, Ranjana H Advani13, Tatyana Feldman14, Mary Jo Lechowicz15, Sonali M Smith16, Anil Tulpule17, Michael D Craig18, John P Greer19, Brad S Kahl20, Joseph W Leach21, Neil Morganstein22, Carla Casulo23, Steven I Park24, Francine M Foss25. 1. Dartmouth Hitchcock Medical Center, Hanover, New Hampshire, USA. 2. Memorial Sloan-Kettering Cancer Center, New York, New York, USA. 3. University of California, Irvine, Irvine, California, USA. 4. City of Hope, Duarte, California, USA. 5. Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois, USA. 6. Cleveland Clinic, Cleveland, Ohio, USA. 7. Centro Oncologico Modenese, Policlinico, Modena, Italy. 8. Hôpital Saint Louis, Paris, France. 9. MS Biostatistics, LLC, Clermont, Florida, USA. 10. MedNet Solutions, Minnetonka, Minnesota, USA. 11. Spectrum Pharmaceuticals Inc., Irvine, California, USA. 12. Fred Hutchinson Cancer Research Center, Seattle, Washington, USA. 13. Stanford University Medical Center, Stanford, California, USA. 14. Hackensack University Medical Center, Hackensack, New Jersey, USA. 15. Emory University, Atlanta, Georgia, USA. 16. University of Chicago, Chicago, Illinois, USA. 17. University of Southern California, Los Angeles, California, USA. 18. West Virginia University, Morgantown, West Virginia, USA. 19. Vanderbilt University Medical Center, Nashville, Tennessee, USA. 20. Washington University School of Medicine, St. Louis, Missouri, USA. 21. Virginia Piper Cancer Institute, Minneapolis, Minnesota, USA. 22. Overlook Medical Center, Summit, New Jersey, USA. 23. University of Rochester, Rochester, New York, USA. 24. Levine Cancer Institute, Chapel Hill, North Carolina, USA. 25. Yale University, New Haven, Connecticut, USA, Francine.foss@yale.edu.
Abstract
BACKGROUND: Outcomes for patients with peripheral T-cell lymphoma (PTCL) who fail to achieve complete response (CR) or relapse after front-line therapy are poor with lack of prospective outcomes data. OBJECTIVES: COMPLETE is a prospective registry of 499 patients enrolled at academic and community sites in the United States detailing patient demographics, treatment and outcomes for patients with aggressive T cell lymphomas. We report results for patients with primary refractory and relapsed disease. METHODS: Primary refractory disease was defined as an evaluable best response to initial treatment (induction ± maintenance or consolidation/transplant) other than CR, and included a partial response, progressive disease, or no response/stable disease. Relapsed disease was defined as an evaluable best response to initial treatment of CR, followed by disease progression at a later date, irrespective of time to progression. Patients were included in the analysis if initial treatment began within 30 days of enrollment and treatment duration was ≥4 days. RESULTS: Of 420 evaluable patients, 97 met the definition for primary refractory and 58 with relapsed disease. In the second-line setting, relapsed patients received single-agent therapies more often than refractory patients (52 vs. 28%; p = 0.01) and were more likely to receive single-agent regimens (74 vs. 53%; p = 0.03). The objective response rate to second-line therapy was higher in relapsed patients (61 vs. 40%; p = 0.04) as was the proportion achieving a CR (41 vs. 14%; p = 0.002). Further, relapsed patients had longer overall survival (OS) compared to refractory patients, with a median OS of 29.1 versus 12.3 months. CONCLUSIONS: Despite the availability of newer active single agents, refractory patients were less likely to receive these therapies and continue to have inferior outcomes compared to those with relapsed disease. PTCL in the real world remains an unmet medical need, and improvements in front-line therapies are needed.
BACKGROUND: Outcomes for patients with peripheral T-cell lymphoma (PTCL) who fail to achieve complete response (CR) or relapse after front-line therapy are poor with lack of prospective outcomes data. OBJECTIVES: COMPLETE is a prospective registry of 499 patients enrolled at academic and community sites in the United States detailing patient demographics, treatment and outcomes for patients with aggressive T cell lymphomas. We report results for patients with primary refractory and relapsed disease. METHODS: Primary refractory disease was defined as an evaluable best response to initial treatment (induction ± maintenance or consolidation/transplant) other than CR, and included a partial response, progressive disease, or no response/stable disease. Relapsed disease was defined as an evaluable best response to initial treatment of CR, followed by disease progression at a later date, irrespective of time to progression. Patients were included in the analysis if initial treatment began within 30 days of enrollment and treatment duration was ≥4 days. RESULTS: Of 420 evaluable patients, 97 met the definition for primary refractory and 58 with relapsed disease. In the second-line setting, relapsed patients received single-agent therapies more often than refractory patients (52 vs. 28%; p = 0.01) and were more likely to receive single-agent regimens (74 vs. 53%; p = 0.03). The objective response rate to second-line therapy was higher in relapsed patients (61 vs. 40%; p = 0.04) as was the proportion achieving a CR (41 vs. 14%; p = 0.002). Further, relapsed patients had longer overall survival (OS) compared to refractory patients, with a median OS of 29.1 versus 12.3 months. CONCLUSIONS: Despite the availability of newer active single agents, refractory patients were less likely to receive these therapies and continue to have inferior outcomes compared to those with relapsed disease. PTCL in the real world remains an unmet medical need, and improvements in front-line therapies are needed.
Authors: Ho-Young Yhim; Yael Eshet; Ur Metser; Chae-Hong Lim; Katherine Lajkosz; Keren Isaev; Matthew Cooper; Anca Prica; Vishal Kukreti; Sita Bhella; Noémie Lang; Kyung-Han Lee; Wei Xu; David Hodgson; Richard Tsang; Sang Eun Yoon; Seok Jin Kim; Won Seog Kim; Michael Crump; John Kuruvilla; Robert Kridel Journal: Blood Adv Date: 2020-11-24
Authors: Min Jung Koh; Mwanasha H Merrill; Min Ji Koh; Robert Stuver; Carolyn D Alonso; Francine M Foss; Angel M Mayor; John Gill; Marta Epeldegui; Edward Cachay; Jennifer E Thorne; Michael J Silverberg; Michael A Horberg; Keri N Althoff; Ank E Nijhawan; Kathleen A McGinnis; Jennifer S Lee; Charles S Rabkin; Sonia Napravnik; Jun Li; Jessica L Castilho; Changyu Shen; Salvia Jain Journal: Blood Adv Date: 2022-03-08