Demographics By Age Group (AG) and Line of Therapy (LOT) in Chronic Lymphocytic Leukemia (CLL) Patients (Pts) Treated in US Practices from the Connect® CLL Registry

Abstract

Introduction: CLL pts who qualify for participation in clinical trials are often thought of as a highly selected population. Therefore whether safety and efficacy data from these trials can be generalized to all CLL pts treated in the community setting is unknown. Prospective, observational studies can provide significant insight into pt and disease characteristics as well as practice patterns in different clinical settings. Here we report on baseline demographics and clinical characteristics for 1495 pts who participated in the Connect CLL observational study and were followed prospectively. Methods: Connect®CLL is a non study-specific intervention treatment registry which collects data on the management and outcomes of CLL pts in clinical, academic and community practices in the US. Clinical information was prospectively collected for pts treated in community (n=1312), academic (n=155), or government (n=28) centers in the US between March 2010 – Jan 2014. Pts eligible for treatment or on treatment not more than 2 months were eligible for enrollment. Here we report on the baseline demographics and clinical characteristics of a large CLL cohort stratified by AG, LOT and type of treatment center. Results: In total,1,495 pts were accrued with a median age at enrollment of 69 (range 22–99). Pts were Caucasian (92.2%), African American (6.9%), and male (63.7%). Median duration from diagnosis until initial therapy was 3.7 years (range 0-32). Age of enrolled pts was as follows; 527 pts age = 70 mL/min, ECOG 0-1; 18% of patients on LOT1 and 12% of pts on LOT=2 would satisfy these criteria. They represent 36% of eligible pts from academic treating institutions and 13% from community/government centers. Only 20% of patients on LOT1 would satisfy enrollment criteria for CLL8 (FCR vs. FC; Hallek; Lancet 2010) CLL 10 (BR vs FCR; [NCT00769522][1]). which did not have enrollment restrictions for age. Conclusions : Baseline characteristics of pts with CLL vary by age, LOT, and type of treatment center. In this large prospective observational study, our data confirms that older pts typically have a worse ECOG PS, more medical comorbidities, more advanced disease when initiating therapy and a lower probability of being treated at an academic medical center. Based on inclusion criteria used for entry in either CLL10 or CLL8, fewer than 20% of pts satisfy age, renal clearance, and fitness profile to be considered suitable for aggressive chemoimmunotherapy in the front line setting. This observation supports the notion that current clinical trial data might not always be applicable to the general CLL population seen in the community and argues for designing clinical trials that are more generalizable to the broader pt population. Disclosures Sharman: Gilead: Research Funding; Calistoga: Honoraria; Phamacyclics: Honoraria, Research Funding; Celgene: Consultancy, Research Funding; TG therapeutics: Research Funding; Roche: Research Funding. Mato: Millennium: Speakers Bureau; Celgene: Speakers Bureau; Genentech: Speakers Bureau. Kay: Celgene: Research Funding. Kipps: Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Lamanna: Genentech-Abbvie: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Gilead: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Infinity: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding. Weiss: Celgene: Consultancy; Phamacyclics: Consultancy; Gilead: Consultancy. Nabhan: Celgene: Honoraria, Research Funding. Flinn: Celgene: Research Funding. Grinblatt: Celgene: Honoraria, Speakers Bureau. Kozloff: Celgene: Consultancy. Farber: Alexion: Equity Ownership, Speakers Bureau; Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Speakers Bureau; Janssen/Pharmacyclics: Speakers Bureau; Seattle Genetics: Speakers Bureau; Genentech: Membership on an entity's Board of Directors or advisory committees. Sullivan: Celgene: Employment, Equity Ownership. Street: Celgene: Employment, Equity Ownership. Swern: Celgene: Employment, Equity Ownership. Flowers: TG Therapeutics: Research Funding; Phamacyclics: Research Funding; Acerta: Research Funding; Abbvie: Research Funding; Infinity: Research Funding; Lymphoma Research Foundation: Membership on an entity's Board of Directors or advisory committees; Janssen: Research Funding; Spectrum: Research Funding; Gilead: Research Funding; Genentech: Unpaid consultancy Other; Millennium: Research Funding, Unpaid consultancy, Unpaid consultancy Other; Seattle Genetics: Consultancy; Prescription Solutions: Consultancy; Celgene: Unpaid consultancy Other. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00769522&atom=%2Fbloodjournal%2F124%2F21%2F3338.atom