Objective To compare the anti-tumor efficacy and safety of PD-1/PD-L1 immune checkpoint inhibitors (ICIs) for advanced non-small cell lung cancer (NSCLC) presenting with or without KRAS mutation.
Methods From October 2015 to October 2019, clinical data about patients with advanced NSCLC who had been administrated with PD-1/PD-L1 ICIs monotherapy in the first medical center of Chinese PLA General Hospital were retrospectively analyzed. A total of 28 KRAS-positive patients (21 males and 7 females with median age of 63 years) and 30 KRAS-negative patients (22 males and 8 females with median age of 67 years) were included. The patients were administrated with Nivolumab (3 mg/kg, intravenous infusion once per two weeks, four weeks as a treatment cycle) or Pembrolizumab (2 mg/kg, intravenous infusion once per three weeks, three weeks as a treatment cycle). Clinical outcomes and adverse events were evaluated among KRAS-mutant and KRAS wild-type patients every 2 treatment cycles.
Results No significant difference was observed in objective response rate (ORR, 25% vs 20%, P=0.648) and disease control rate (DCR, 64.3% vs 63.3%, P=0.940) between the KRAS-mutant group and wild-type group. The follow-up lasted to January 2020. The median PFS was 5.85 months (95% CI: 0.00 to 12.26) in KRAS-mutant group compared with 6.74 months (95% CI: 3.79 to 9.68) in wild-type group, and the median OS was 17.68 months (95% CI: 13.44 to 21.91) in KRAS-mutant group, while 15.70 months (95% CI: 2.66 to 28.75) in the KRAS wild-type group, without significant difference (P > 0.05). The adverse events profile was similar in the two subgroups, with adverse events rate of 60.7% in the KRAS-mutant group versus 56.7% in the wild-type group (P=0.754).
Conclusion PD-1/PD-L1 ICIs are potential and safe therapeutic options for advanced NSCLC patients, regardless of KRAS mutation status.
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