Mayo Clinic, Rochester, MN
Kitsada Wudhikarn , Radhika Bansal , Arushi Khurana , Matthew Hathcock , N. Nora Bennani , Jonas Paludo , Jose Caetano Villasboas , Yucai Wang , Patrick B. Johnston , Stephen M. Ansell , Yi Lin
Background: Obesity is associated with a pro-inflammatory state and immune dysregulation. Retrospective studies indicate that obesity could affect toxicities and outcomes after immunotherapies including checkpoint inhibitors and allogeneic stem cell transplant. Currently, there are no data specifically on outcomes for obese patients who receive chimeric antigen receptor T (CAR-T) cells. We described the clinical outcome in obese patients with large B cell lymphoma (LBCL) who received axicabtagene ciloleucel (axi-cel). Methods: We analyzed the effect of body weight (BW) and body mass index (BMI) on toxicities and outcomes of 78 adults with LBCL who received axi-cel between June 2016 and October 2020 at Mayo Clinic. Obesity was defined as having BMI of 30 or higher. Results: Of 78 patients, 22 (28%) and 19 (24%) were classified as overweight (BMI 25-29.99 kg/m2) and obese (BMI ≥30 kg/m2), respectively. Baseline characteristics were not statistically significantly different between non-obese and obese patients. The median delivered dose of fludarabine was similar between non-obese and obese patients (89 [0-105] vs 88 [56-94] mg/m2, P=0.32) whereas the median delivered dose of cyclophosphamide was lower in non-obese patients (1503 [1077-1525] vs 1512 [1021-1660] mg/m2, P=0.01). The 30-days cumulative incidence of CRS and ICANS were similar between non-obese and obese patients. BW and BMI were not associated with CRS or ICANS. The overall response rate was 66% (CR 47%) and 68% (CR 53%) in non-obese and obese group, respectively (P=0.83). The 1-year event free survival (EFS) and overall survival (OS) was 34.6% and 64.5%, neither were different between non-obese and obese patients (EFS 35.8% vs. 30.7%, P=0.60; OS 59.4% vs. 83.9%, P=0.18). The 1-year cumulative incidence of relapse and non-relapse mortality was comparable (60.8% vs. 69.0%, P=0.40 and 3.4% vs. 0%, P=0.42). In the Cox proportional hazards model, higher dose of fludarabine, but not cyclophosphamide, was associated with better EFS and OS; however, neither obesity nor BW were associated with toxicities and outcomes. Conclusions: In our study, Obesity was not associated with risk of toxicities or adverse survival outcomes. The effect of obesity on the pattern of LD chemotherapy dosing including toxicities and outcomes after CAR-T warrants further exploration.
Non-Obese (N=59) | Obese (N=19) | P-value | |
---|---|---|---|
Best Response Complete Response Partial Response | 28 (47.4%) 11 (18.6%) | 10 (52.6%) 3 (15.8%) | 0.83 |
Incidence of CRS | 83.1% (70.2-90.4) | 85.2% (55.4-94.4) | 0.23 |
Incidence of ICANS | 47.5% (33.0-58.8) | 63.2% (33.6-79.6) | 0.23 |
1-year incidence of NRM | 3.4% (0-8.0) | 0.0% (0.0-0.0) | 0.42 |
1-year incidence of relapse | 60.8% (47.4-74.2) | 69.3% (46.8-91.8) | 0.40 |
1-year EFS | 35.8% (25.0-51.4) | 30.7% (15.4-61.1) | 0.60 |
1-year OS | 59.4% (47.1-74.9) | 83.9% (68.7-100.0) | 0.18 |
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