nivolumab showed clinical benefit. Here, we present long-term follow-up results from CheckMate 459.Methods: In CheckMate 459, 743 systemic therapyenaive patients ! 18 years of age with aHCC and Child-Pugh A liver function were randomized 1:1 to nivolumab (240 mg intravenous every 2 weeks; n ¼ 371) or sorafenib (400 mg oral twice daily; n ¼ 372). The primary endpoint was OS. Secondary endpoints were objective response rate and progression-free survival by blinded independent central review per Response Evaluation Criteria in Solid Tumors v1.1; efficacy by programmed death ligand 1 (PD-L1) tumor cell expression; and safety.Results: At a minimum follow-up of 33.6 months, nivolumab demonstrated a clinically meaningful improvement in OS versus sorafenib (median OS, 16.4 months [95% CI, 14.0e18.5] vs 14.8 months [95% CI, 12.1e17.3], respectively; hazard ratio [HR], 0.85 [95% CI, 0.72e1.00]; nominal P value ¼ 0.0522). The 33-month OS rates for nivolumab and sorafenib were 29% (95% CI, 25e34) and 21% (95% CI, 17e25), respectively. A consistent benefit was observed with nivolumab regardless of baseline PD-L1 expression (PD-L1 ! 1% HR, 0.80 [95% CI, 0.54e1.17]; PD-L1 < 1% HR, 0.84 [95% CI, 0.70e1.01]). Median OS (mOS) in patients with PD-L1 ! 1% was longer with nivolumab versus sorafenib (16.1 months [95% CI, 8.4e22.3] vs 8.6 months [95% CI, 5.7e 16.3], respectively). Among patients with hepatitis C virus (HCV) and hepatitis B virus (HBV) etiology, mOS was numerically longer with nivolumab versus sorafenib (17.5 vs 12.7 months; HR, 0.72 [95% CI, 0.51e1.02] for HCV and 16.1 vs 10.4 months; HR 0.79 [95% CI, 0.59e1.07] for HBV, respectively). Nivolumab demonstrated greater liver function preservation over time than sorafenib as evidenced by albumin-bilirubin levels and Child-Pugh scores. Seven patients (2%) in the nivolumab arm and 77 patients (21%) in the sorafenib arm received subsequent immuno-oncology therapy. Nivolumab demonstrated a more favorable safety profile compared with sorafenib, with grade 3e4 treatment-related adverse events occurring in 82 patients (22.3%) and 180 patients (49.6%), respectively. Conclusion:At a minimum follow-up of 33.6 months, 1L nivolumab monotherapy continued to demonstrate clinically meaningful survival benefit in aHCC. Nivolumab had a more favorable and manageable safety profile and greater preservation of liver function over time compared with sorafenib, consistent with previous reports, with no new or unexpected safety signals observed.
e15712 Background: Accurate selection of patients based on radiological and biological variables is crucial to avoid over treatment and unnecessary R1 resection in pancreatic cancer (PC). Methods: We retrospectively investigated 73 patients diagnosed with PC treated between January 1998 to October 2015. We applied NCCN definitions for Resectable (RD), borderline resectable (BRD) and unresectable disease(URD). Logistic regression was used to identify significant indicators of R0 resection. Odds ratios were used to compare differences of overall survivability by R0 and No surgery. Fisher’s Exact Test was used for significance on all tabulated data. Wilcoxon Rank-Sum was used for the comparison of two medians and Kruskal-Wallis to compare more than two medians, and log-rank test was used to compare Kaplan-Meyer Curves. Results: Radiologically RD comprised 21% (15/73) of total cases, 80% (12/15) of these underwent R0 resection. URD comprised 79% (58/73). Patients presenting with abdominal pain were 2.5 times (Odds Ratio; p = 0.0275) more likely to be URD. The mean tumor size for R0 resectability was 2.28 cm (n = 12). The median CA 19-9 for URD was 1473 vs 162 for RD (p = 0.0124). Stage at presentation and resectability were statistically associated. (p = 0.0002): 100% of Stage 1 (n = 4) and, 27% of Stage 2, (11/41) were resectable. Twenty-three cases were identified as BRD, 21/23 received neoadjuvant chemotherapy, 47.83% had radiological PR, 28.26% had SD and 23.91% PD. There was no association between type of Neoadjuvant treatment (Chemo XRT vs Chemotherapy) and radiological response (p = 0.8798). None of the 21 BRD patients underwent surgery. Median Overall Survival for R0 resection was 22.3 months (95% CI 15.23, 36.50) vs. 5.1 who did not have surgery (95% CI 3.55, 7.57) (p = 0.0010). Conclusions: Nearly 80% patients identified as resectable on imaging underwent R0 resection. Although there were partial responses seen in BRD patients that underwent neoadjuvant treatment eventually none underwent R0 resection. Patients presenting with abdominal pain and high CA19-9 ( > 1400 U/ml) are likely to URD. Early stage and R0 resection were associated with positive outcomes.
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