Пациенты с меланомой, получившие терапию TIL, демонстрируют низкий уровень тяжелых побочных эффектов после выписки

TOPLINE In a study at one US medical center, patients with advanced melanoma who received tumor-infiltrating lymphocyte (TIL) therapy with lifileucel had a low rate of severe side effects after hospital discharge — supporting less-intensive monitoring compared with CAR-T therapy. METHODOLOGY - Adoptive cell therapy with TILs was recently established as a therapeutic standard for patients with anti-PD1 refractory advanced melanoma, making optimal outpatient monitoring increasingly important. But little is known about TIL therapy toxicities that arise after patients go home, and many centers use the same follow-up protocols established for CAR-T therapies. - To investigate, researchers conducted a retrospective analysis of 51 patients who received lifileucel therapy (investigational or commercial) at Memorial Sloan Kettering Cancer Center in New York City between October 2020 and October 2024. - Patients received either standard lymphodepleting chemotherapy (cyclophosphamide 60 mg/kg once daily for 2 days, plus fludarabine 25 mg/m2 once daily for 4 days), or reduced-intensity therapy (cyclophosphamide 750 mg/m2 once daily for 3 days, plus fludarabine 30 mg/m2 once daily for 4 days), followed by lifileucel infusion and one to six doses of interleukin-2. - Analysis included the incidence and timing of new treatment-related adverse events (TRAEs), blood product administration, and readmissions from hospital discharge to initiation of subsequent systemic therapy or death. TAKEAWAY - Over a median follow-up of 5 months from discharge, two patients (3.9%) developed new grade 3 TRAEs, including neutropenia occurring 73 days after discharge and hypoxia occurring 104 days after discharge. - Four patients (7.8%) were readmitted for TRAEs at a median of 49 days after discharge, with readmissions due to cytopenias, dyspnea, syncope, and complications including renal thrombotic microangiopathy and immune-mediated neutropenia. - Twelve patients (24%) received at least one outpatient transfusion, with a median of two units of packed red blood cells and four units of platelets administered. - According to the researchers, the rare incidence of TRAEs and treatment-related readmissions distributed over several months suggests that intensive monitoring immediately following discharge is unlikely to meaningfully reduce risk in this population. IN PRACTICE “Overall, rates of new severe toxicity and treatment-related readmissions were low among patients discharged after lifileucel,” the study authors wrote. The findings, they added, “may inform real-world care delivery by supporting less intensive postdischarge follow-up for most patients, potentially improving quality of life and access to care in this growing patient population.” SOURCE The study, led by Mia Andreoli, MD, of Weill Cornell Medical College in New York City, was published online in JCO Oncology Practice. LIMITATIONS The relatively small sample size of patients from a single institution may limit generalizability. The median follow-up of 5 months may have missed delayed toxicities. The cohort included patients with various melanoma subtypes and treatment protocols, including different lymphodepleting chemotherapy regimens, which could introduce variability in outcomes. DISCLOSURES The research was supported by Memorial Sloan Kettering. Several co-authors reported financial relationships with multiple commercial sources, including lifileucel maker Iovance Biotherapeutics, Pfizer, Merck, Adaptimmune, and Replimune. Full disclosures are noted in the original article. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.