LIFE AFTER CAR‐T CELLS: A PROSPECTIVE STUDY EVALUATING THE PERSONAL, SOCIAL AND PROFESSIONAL OUTCOMES AFTER CAR‐T CELL THERAPY IN LYMPHOMA PATIENTS

Abstract

Introduction: CD19 CAR-T cells have been approved for the treatment of relapse/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). With these adoptive immunotherapies, about 30-40% of patients achieve prolonged remissions, most of whom are likely to be cured. However, little is known about life after CAR-T cells. Thus, we initiated a prospective study to evaluate the personal, social and professional outcomes after CAR-T cell therapy in lymphoma patients. Methods: This is a prospective, observational, multicenter study, conducted at the University Hospitals of Rennes and Toulouse (France). All adult patients treated with CAR-T cells (Yescarta® or Kymriah®) for R/R DLBCL are eligible. Primary objective is to describe health-related quality of life (HRQoL) changes during the first year after CAR-T cell therapy using the EORTC QLQ-C30 and FACT-Lym questionnaires. Secondary objectives are to describe the dynamic changes of other personal, social, and professional parameters including anxiety and depression (HAD scale), cognitive state (FACT-Cog), fatigue (FACT-Fatigue), sexuality (SqoL), posttraumatic stress disorder (PTSD), social and professional reintegration, supportive care measures. These outcomes are correlated with baseline characteristics of the patients and his disease, as well as with response to therapy, adverse events, and biological parameters. Patients fill the questionnaires before leukapheresis, immediately before CAR-T infusion, and then 3 months, 6 months and one year after CAR-T infusion. Adverse events are prospectively collected by dedicated nurses who call patients daily until day 21, twice a week until day 28, once a week until month 2, every other week until month 3, once a month until month 6, and once every 3 months until month 12. Results: This first patient was enrolled in November 2020. To date, 30 patients were included in the study: 19 male and 11 female, median age is 65 years (range, 19-75) and median number of prior lines is 2 (range, 2-5). Median follow up is 3.2 months (range, 0-12) for the entire cohort. Six patients have completed their 6 months follow-up. Among the 5 patients with available HRQoL at 6 months, 3 patients (60%) presented a clinically significant improvement of their global HRQoL level. Conclusions: This prospective study will provide a better understanding of the personal, social, and professional outcomes of patients who have been treated with CAR-T cells. These data will be of importance to better inform patients who undergo CAR-T cell therapy, identify needs for improvement in quality of life after CAR-T cell therapy, and better appreciate the social and economic impact of these treatments. Our preliminary data suggest that HRQoL is improved in most patients. These results will be updated at the meeting.