ABSTRACT
OBJECTIVES: Nivolumab is approved as adjuvant therapy for resected stage III/IV melanoma based on the phase 3 CheckMate 238 trial. This analysis compared outcomes from CheckMate 238 with those from the real-world Flatiron Health electronic health record-derived de-identified database in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab. MATERIALS: Outcomes included baseline characteristics, overall survival (OS) in the CheckMate 238 cohort (randomization until death or last known alive), and real-world overall survival (rwOS) in the Flatiron Health cohort (nivolumab initiation until death or data cutoff). rwOS was compared with OS using unadjusted and adjusted Cox proportional hazards models. Inverse probability of treatment weighting (IPTW) was combined with the adjusted model to reduce baseline discrepancies. RESULTS: The CheckMate 238 and real-world cohorts included 369 and 452 patients, respectively (median age, 56.0 and 63.0 years; median follow-up, 61.4 vs. 25.5 months). rwOS was not different from OS in the unadjusted (hazard ratio [HR] 1.27; 95% CI 0.92-1.74), adjusted (HR 1.01; 95% CI 0.67-1.54), and adjusted IPTW (HR 1.07; 95% CI 0.70-1.63) analyses. In the adjusted analysis, 2-year OS and rwOS rates were 84%. Median OS and rwOS were not reached. After IPTW, OS and rwOS were not different (HR 1.07; 95% CI 0.70-1.64). CONCLUSIONS: In this comparative analysis, OS in the CheckMate 238 trial was similar to rwOS in the Flatiron Health database after adjustments in patients with resected stage III melanoma (per AJCC-8) treated with adjuvant nivolumab, validating the trial results.
Subject(s)
Melanoma , Neoplasm Staging , Nivolumab , Adult , Aged , Female , Humans , Male , Middle Aged , Antineoplastic Agents, Immunological/therapeutic use , Chemotherapy, Adjuvant/methods , Melanoma/drug therapy , Melanoma/mortality , Melanoma/pathology , Melanoma/surgery , Nivolumab/therapeutic use , Skin Neoplasms/drug therapy , Skin Neoplasms/mortality , Skin Neoplasms/pathology , Skin Neoplasms/surgery , Treatment OutcomeABSTRACT
Pylephlebitis is a rare condition that is characterized by an infected thrombus of the portal vein system and was traditionally associated with a high mortality rate prior to the introduction of antibiotics. This report details a 77-year-old Chinese male found to have a splenic vein thrombosis, Parvimonas micra bacteremia, and a polymicrobial splenic abscess. The patient was treated with abscess drainage and a 6 week course of intravenous antibiotics, and a direct oral anticoagulant, apixaban 2.5 mg twice daily. To our knowledge, this is the second documented case of pylephlebitis treated with apixaban. Here, we summarize our experience treating this case of pylephlebitis and briefly report on the existing body of literature.
