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RESULTS FROM SCHOLAR-1: OUTCOMES IN PATIENTS WITH REFRACTORY AGGRESSIVE DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL)
Author(s): ,
Christian Gisselbrecht
Affiliations:
LYSARC,Pierre-Bénite,France
,
Annette E Hay
Affiliations:
NCIC Clinical Trials Group at Queen's University,Kingston,Canada
,
Sattva Swarup Neelapu
Affiliations:
The University of Texas MD Anderson Cancer Center,Houston,United States
,
Umar Farooq
Affiliations:
Mayo Clinic / University of Iowa Carver College of Medicine,Rochester / Iowa City,United States
,
Eric Van Den Neste
Affiliations:
LYSARC,Pierre-Bénite,France
,
Mohamed Amin Ahmed
Affiliations:
The University of Texas MD Anderson Cancer Center,Houston,United States
,
Brian K Link
Affiliations:
Mayo Clinic / University of Iowa Hospitals and Clinics,Rochester / Iowa City,United States
,
Michael Crump
Affiliations:
NCIC Clinical Trials Group at Queen's University,Kingston,Canada
,
James R Cerhan
Affiliations:
Mayo Clinic / University of Iowa Hospitals and Clinics,Rochester / Iowa City,United States
,
Liting Zhu
Affiliations:
NCIC Clinical Trials Group at Queen's University,Kingston,Canada
,
Sami Boussetta
Affiliations:
LYSARC,Pierre-Bénite,France
,
Lei Feng
Affiliations:
The University of Texas MD Anderson Cancer Center,Houston,United States
,
Matthew J Maurer
Affiliations:
Mayo Clinic / University of Iowa Hospitals and Clinics,Rochester / Iowa City,United States
,
Lynn Navale
Affiliations:
Kite Pharma, Inc.,Santa Monica,United States
,
Jeffrey S Wiezorek
Affiliations:
Kite Pharma, Inc.,Santa Monica,United States
,
William Y Go
Affiliations:
Kite Pharma, Inc.,Santa Monica,United States
John Kuruvilla
Affiliations:
NCIC Clinical Trials Group at Queen's University,Kingston,Canada
(Abstract release date: 05/19/16) EHA Library. Gisselbrecht C. 06/11/16; 135237; S481
Dr. Christian Gisselbrecht
Dr. Christian Gisselbrecht
Contributions
Abstract
Abstract: S481

Type: Oral Presentation

Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15

Location: Hall A1

Background
Non-Hodgkin lymphoma (NHL) is the most prevalent hematologic malignancy in the US and the fifth most deadly cancer with nearly 19,790 deaths/year in the US. DLBCL is the most common NHL subtype, representing 25-35% of new cases annually. Although five-year survival rates in the first-line setting range from 30-50%, approximately 1 in 3 of these patients will be refractory to or relapse post treatment. Diverse therapeutic outcomes are observed in these patients with relapsed/refractory aggressive DLBCL. The international, multi-cohort Retrospective Non-Hodgkin Lymphoma Research (SCHOLAR-1) was designed to study outcomes in patients with refractory DLBCL.

Aims
The aim of SCHOLAR-1 was to retrospectively evaluate response rate and overall survival in patients with refractory DLBCL to serve as a benchmark for future clinical trials in this underserved population.

Methods
Eligibility criteria included refractory DLBCL, which was defined as progressive disease (PD) or stable disease (SD) as best response to chemotherapy (duration of SD < 12 months and at least 4 cycles of first-line or 2 cycles of later line therapy) or relapse ≤ 12 months after autologous stem cell transplantation. All patients must have received an anthracycline as part of a prior regimen. In addition, all patients with CD20-positive disease must have received prior treatment with an anti-CD20 monoclonal antibody. SCHOLAR-1 included data from 2 phase 3 studies (LYSARC-CORAL and Canadian Cancer Trials Group (CCTG)-LY.12) and 2 observational cohorts (MD Anderson Cancer Center [MDACC] and Mayo Clinic / University of Iowa [MC/IA] Specialized Program of Research Excellence). Response rates and overall survival were estimated from the time that salvage therapy was initiated.

Results
Among 861 patients with DLBCL, 597 patients with refractory disease were identified. Response rates ranged from 19% to 36% (complete responses from 2% to 18%). Median survival was poor, ranging from 4.6 months to 6.9 months across cohorts. Data for each study or cohort are shown in the table below.Abbreviations: ASCT, autologous stem cell transplantation; CR, complete response; NA, not applicable (based on study design); OS, overall survival; PR, partial response; RR, response rate; tx, treatment

Conclusion
This is the first study to define patient outcomes for those with refractory DLBCL in a large group of patients. Outcomes were similar across cohorts. Our results suggest that patients with refractory, aggressive DLBCL represent a homogenous population with a response rate of 20% - 30% and median overall survival of approximately 6 mos. These consistently poor outcomes represent a significant unmet need in patients with refractory DLBCL.



Session topic: Diffuse large B-cell lymphoma

Keyword(s): Diffuse large B cell lymphoma, Outcome, Survival
Abstract: S481

Type: Oral Presentation

Presentation during EHA21: On Saturday, June 11, 2016 from 17:00 - 17:15

Location: Hall A1

Background
Non-Hodgkin lymphoma (NHL) is the most prevalent hematologic malignancy in the US and the fifth most deadly cancer with nearly 19,790 deaths/year in the US. DLBCL is the most common NHL subtype, representing 25-35% of new cases annually. Although five-year survival rates in the first-line setting range from 30-50%, approximately 1 in 3 of these patients will be refractory to or relapse post treatment. Diverse therapeutic outcomes are observed in these patients with relapsed/refractory aggressive DLBCL. The international, multi-cohort Retrospective Non-Hodgkin Lymphoma Research (SCHOLAR-1) was designed to study outcomes in patients with refractory DLBCL.

Aims
The aim of SCHOLAR-1 was to retrospectively evaluate response rate and overall survival in patients with refractory DLBCL to serve as a benchmark for future clinical trials in this underserved population.

Methods
Eligibility criteria included refractory DLBCL, which was defined as progressive disease (PD) or stable disease (SD) as best response to chemotherapy (duration of SD < 12 months and at least 4 cycles of first-line or 2 cycles of later line therapy) or relapse ≤ 12 months after autologous stem cell transplantation. All patients must have received an anthracycline as part of a prior regimen. In addition, all patients with CD20-positive disease must have received prior treatment with an anti-CD20 monoclonal antibody. SCHOLAR-1 included data from 2 phase 3 studies (LYSARC-CORAL and Canadian Cancer Trials Group (CCTG)-LY.12) and 2 observational cohorts (MD Anderson Cancer Center [MDACC] and Mayo Clinic / University of Iowa [MC/IA] Specialized Program of Research Excellence). Response rates and overall survival were estimated from the time that salvage therapy was initiated.

Results
Among 861 patients with DLBCL, 597 patients with refractory disease were identified. Response rates ranged from 19% to 36% (complete responses from 2% to 18%). Median survival was poor, ranging from 4.6 months to 6.9 months across cohorts. Data for each study or cohort are shown in the table below.Abbreviations: ASCT, autologous stem cell transplantation; CR, complete response; NA, not applicable (based on study design); OS, overall survival; PR, partial response; RR, response rate; tx, treatment

Conclusion
This is the first study to define patient outcomes for those with refractory DLBCL in a large group of patients. Outcomes were similar across cohorts. Our results suggest that patients with refractory, aggressive DLBCL represent a homogenous population with a response rate of 20% - 30% and median overall survival of approximately 6 mos. These consistently poor outcomes represent a significant unmet need in patients with refractory DLBCL.



Session topic: Diffuse large B-cell lymphoma

Keyword(s): Diffuse large B cell lymphoma, Outcome, Survival

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