REAL-WORLD PERIOPERATIVE IMMUNOTHERAPY AND CELLULAR THERAPY IN OLDER ADULTS WITH SOLID TUMORS: A 2021-2025 MEDICARE-EMR LINKED ANALYSIS
Author(s)
Onur Baser, MA, MS, PhD1, Katarzyna Rodchenko, MA, MPH2, Jialu He, MS2, Xianxin Zhu, MS2, Nehir Yapar, BS2;
1City University of New York (CUNY), New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
1City University of New York (CUNY), New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
OBJECTIVES: Real‑world utilization, laboratory toxicity profiles, and early outcomes related to perioperative immune checkpoint inhibitors (ICIs) and adoptive cell therapies among Medicare fee‑for‑service (FFS) beneficiaries diagnosed with solid tumors was examined.
METHODS: Medicare-Enhanced Lab and Demographics (MELDTM)—100% Fee-for-service (FFS) Medicare-EMR linked dataset—was used to construct a retrospective cohort of beneficiaries aged ≥65 years who received perioperative ICIs for resectable lung/breast/gastrointestinal cancers or melanoma or CAR‑T/T-cell receptor tumor-infiltrating lymphocyte (TCR TIL) therapy for hematologic malignancies 2021-2025; claims deterministically linked to MELDTM laboratory results+EMR. Laboratory results: Captured −14 to +90 days pre-/post-surgery/infusion. Outcomes: 90‑day all‑cause mortality, unplanned readmission, and grade ≥3 lab‑defined toxicities consistent with immune‑related adverse events (irAEs) or cytokine‑release syndrome (CRS). Weighted logistic and Cox models adjusted for age, sex, comorbidity, and cancer type.
RESULTS: The cohort included 24,000 perioperative ICI patients, 4,500 cellular‑therapy recipients (median age:72 and 71 years, respectively; ~40% ≥75 years). Perioperative ICI patients had neoadjuvant/adjuvant ICI±chemotherapy within 6 months of curative‑intent surgery; cellular‑therapy patients were administered CAR‑T/TCR TIL infusion. Perioperative ICI: 90‑day mortality:2.8% vs 3.9% in matched historical surgical cohort; 90‑day unplanned readmission:16% vs 18% (90‑day mortality adjusted hazard ratio [aHR]:0.78; 95%CI:0.70-0.88). Lab‑defined grade ≥3 hepatic irAEs (ALT/AST>5×ULN) in 3.6%; grade≥3 creatinine rise in 2.9%; high‑sensitivity troponin elevations consistent with myocarditis in 0.7%. Among 4,500 cellular‑therapy recipients (large B-cell lymphoma [LBCL], other B‑cell malignancies), ≥75 years:28%. Lab‑defined grade ≥2 CRS (fever+CRP>100mg/L or ferritin>1,000ng/mL) in 32%; severe CRS‑like profiles (ferritin>5,000ng/mL/tocilizumab need) in 9%; neurotoxicity‑consistent lab abnormalities (hyponatremia, elevated CRP) in 7%. Ninety‑day mortality post-cellular therapy:6.5%; 1‑year overall survival:~70%.
CONCLUSIONS: In this large Medicare FFS cohort, perioperative ICIs were associated with modestly lower 90‑day mortality and acceptable rates of severe lab‑defined irAEs; CAR‑T and cellular therapies showed toxicity and survival profiles consistent with trial and registry data, supporting the benefit of these advanced immunotherapies in carefully selected Medicare patients.
METHODS: Medicare-Enhanced Lab and Demographics (MELDTM)—100% Fee-for-service (FFS) Medicare-EMR linked dataset—was used to construct a retrospective cohort of beneficiaries aged ≥65 years who received perioperative ICIs for resectable lung/breast/gastrointestinal cancers or melanoma or CAR‑T/T-cell receptor tumor-infiltrating lymphocyte (TCR TIL) therapy for hematologic malignancies 2021-2025; claims deterministically linked to MELDTM laboratory results+EMR. Laboratory results: Captured −14 to +90 days pre-/post-surgery/infusion. Outcomes: 90‑day all‑cause mortality, unplanned readmission, and grade ≥3 lab‑defined toxicities consistent with immune‑related adverse events (irAEs) or cytokine‑release syndrome (CRS). Weighted logistic and Cox models adjusted for age, sex, comorbidity, and cancer type.
RESULTS: The cohort included 24,000 perioperative ICI patients, 4,500 cellular‑therapy recipients (median age:72 and 71 years, respectively; ~40% ≥75 years). Perioperative ICI patients had neoadjuvant/adjuvant ICI±chemotherapy within 6 months of curative‑intent surgery; cellular‑therapy patients were administered CAR‑T/TCR TIL infusion. Perioperative ICI: 90‑day mortality:2.8% vs 3.9% in matched historical surgical cohort; 90‑day unplanned readmission:16% vs 18% (90‑day mortality adjusted hazard ratio [aHR]:0.78; 95%CI:0.70-0.88). Lab‑defined grade ≥3 hepatic irAEs (ALT/AST>5×ULN) in 3.6%; grade≥3 creatinine rise in 2.9%; high‑sensitivity troponin elevations consistent with myocarditis in 0.7%. Among 4,500 cellular‑therapy recipients (large B-cell lymphoma [LBCL], other B‑cell malignancies), ≥75 years:28%. Lab‑defined grade ≥2 CRS (fever+CRP>100mg/L or ferritin>1,000ng/mL) in 32%; severe CRS‑like profiles (ferritin>5,000ng/mL/tocilizumab need) in 9%; neurotoxicity‑consistent lab abnormalities (hyponatremia, elevated CRP) in 7%. Ninety‑day mortality post-cellular therapy:6.5%; 1‑year overall survival:~70%.
CONCLUSIONS: In this large Medicare FFS cohort, perioperative ICIs were associated with modestly lower 90‑day mortality and acceptable rates of severe lab‑defined irAEs; CAR‑T and cellular therapies showed toxicity and survival profiles consistent with trial and registry data, supporting the benefit of these advanced immunotherapies in carefully selected Medicare patients.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO143
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
SDC: Oncology