Abstract
BACKGROUND: Immunotherapy is the cornerstone of treatment for many cancers. The effectiveness of immunotherapy in hospitalized patients is unknown due to the exclusion of this fragile population from clinical trials. This study evaluates the efficacy of immunotherapy in fragile hospitalized patients. METHOD: We conducted a single-center retrospective study involving 49 patients who started an immunotherapy (IO) during a hospitalization or within 3 months after a hospitalization at the Centre Hospitalier de l'Université de Sherbrooke (CHUS). Efficacy analysis included objective response rate (ORR), overall survival (OS), and progression-free survival (PFS). RESULTS: Immunotherapy resulted in 30.6% of all grades combined and 18.4% of grade three to four immune-related adverse events (irAE). Efficacy outcomes were inferior in the fragile cohort of patients with ORR of 38.9%, PFS of 2.8 months (95% CI [2.17-3.35]), and OS of 3.2 months (95% CI [1.60-4.84]). Performance status of ECOG three to four compared to ECOG zero predicts poor OS (HR 5.666 [1.207-26.594]; p = 0.028) and PFS (HR 4.136 [0.867-19.733]; p = 0.075). Fitness to receive four to six cycles (HR 0.335 [0.152-0.0.738]; p < 0.007) or more predicts greater OS compared to one to three cycles of immunotherapy. Low levels of serum albumin (HR 0.917 [0.852-0.987]; p = 0.021) and elevated levels of serum LDH (HR 2.224 [1.469-3.367]; p < 0.001) are associated with a reduced OS. CONCLUSION: The effectiveness of immunotherapy in fragile hospitalized patients is compromised, although they exhibit significant irAE. Excellent performance status, fitness to receive many IO treatments, and normal levels of serum LDH and albumin may be useful in selecting patients who will benefit from immunotherapy.