Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma.

Autor: Evens AM; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Advani RH; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Helenowski IB; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Fanale M; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Smith SM; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Jovanovic BD; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Bociek GR; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Klein AK; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Winter JN; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Gordon LI; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY., Hamlin PA; Andrew M. Evens, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Ranjana H. Advani, Stanford University, Stanford, CA; Irene B. Helenowski, Borko D. Jovanovic, Jane N. Winter, and Leo I. Gordon, Northwestern University Feinberg School of Medicine; Jane N. Winter and Leo I. Gordon, Robert H. Lurie Comprehensive Cancer Center; Sonali M. Smith, University of Chicago, Chicago, IL; Michelle Fanale, University of Texas MD Anderson Cancer Center, Houston, TX; Gregory R. Bociek, University of Nebraska, Omaha, NE; Andreas K. Klein, Tufts Medical Center, Boston, MA; and Paul A. Hamlin, Memorial Sloan Kettering Cancer Center, New York, NY.
Jazyk: angličtina
Zdroj: Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2018 Oct 20; Vol. 36 (30), pp. 3015-3022. Date of Electronic Publication: 2018 Sep 04.
DOI: 10.1200/JCO.2018.79.0139
Abstrakt: Purpose: To improve the curability of older patients with newly diagnosed Hodgkin lymphoma.
Patients and Methods: We conducted a multicenter phase II study that administered brentuximab vedotin (Bv) sequentially before and after standard doxorubicin, vinblastine, and dacarbazine (AVD) for untreated patients with Hodgkin lymphoma age 60 years or older. After two lead-in doses of single-agent Bv (1.8 mg/kg once every 3 weeks), patients received six cycles of AVD chemotherapy followed by four consolidative doses of Bv in responding patients.
Results: Patient characteristics included median age of 69 years (range, 60 to 88 years), 63% male, median Eastern Cooperative Oncology Group performance status 1, 81% stage III to IV disease, 60% International Prognostic Score 3 to 7, median Cumulative Illness Rating Scale-Geriatric comorbidity score of 7 (52% grade 3 to 4); and 12% had loss of instrumental activities of daily living at diagnosis. Thirty-seven (77%) of 48 patients completed six cycles of AVD, and 35 patients (73%) received at least one Bv consolidation. Overall response and complete remission rates after initial Bv lead-in dose were 18 (82%) of 22 and 8 (36%) of 22, respectively, and 40 (95%) of 42 and 34 (90%) of 42, respectively, after six cycles of AVD among 42 response-evaluable patients. Twenty (42%) of 48 patients experienced a grade 3 to 4 adverse event, most commonly neutropenia (44%), febrile neutropenia and pneumonia (8%), or diarrhea (6%); 33% had grade 2 peripheral neuropathy, which was reversible in a majority of patients. By intent-to-treat, the 2-year event-free survival, progression-free survival, and overall survival rates were 80%, 84%, and 93%, respectively. Furthermore, 2-year progression-free survival rates for patients with a Cumulative Illness Rating Scale-Geriatric comorbidity score of ≥ 10 versus < 10 were 45% versus 100%, respectively ( P < .001), and with baseline loss versus no loss of instrumental activities of daily living were 25% versus 94% ( P < .001), respectively, the latter persisting on multivariable analyses.
Conclusion: Altogether, sequential Bv-AVD was well tolerated and was associated with robust outcomes. Furthermore, geriatric-based measures were strongly associated with patient survival.
Databáze: MEDLINE