Efficacy and Safety of Anlotinib Combined with S-1 Maintenance Therapy in Patients with Lymph Node Positive Locally Advanced Nasopharyngeal Carcinoma Following Radical Chemoradiotherapy
[Objective]To evaluate the efficacy and safety of anlotinib combined with S-1 maintenance therapy in patients with lymph node positive(N+)locally advanced nasopharyngeal carcinoma(LA-NPC)after radical chemoradio-therapy.[Methods]Ninety-five patients with stage Ⅲ～Ⅳa NPC who underwent radical chemoradiotherapy in the Affili-ated Cancer Hospital of Nanjing Medical University between June 2021 and September 2022 were retrospectively ana-lyzed.Nineteen patients received anlotinib+S-1 maintenance therapy(double-drug maintenance group),17 patients re-ceived S-1 maintenance therapy(single-drug maintenance group),and 59 patients did not receive maintenance therapy(control group).The median maintenance cycle for the double-drug maintenance group was 6(2～6),while the single-drug maintenance group had a median maintenance cycle of 7(5～15).The primary endpoint of the study was progres-sion-free survival(PFS).The efficacy and analyze the prognostic factors were evaluated by the Kaplan-Meier survival analysis and the Cox regression model.[Results]The median follow-up time was 15.5 months.The 2-year PFS for all patients was 79.9％;the 2-year PFS for the double-drug maintenance group,single-drug maintenance group,and con-trol group were 100.0％,94.7％,and 69.5％,respectively.Compared to the control group,the double-drug mainte-nance group demonstrated a significant PFS benefit(P=0.040).Multivariate analysis revealed that receiving maintenance therapy(HR=0.11,95％CI:0.01～0.93,P=0.042)and high hemoglobin level before treatment(HR=18.21,95％CI:3.44～96.37,P=0.001)were independent prognostic factors of PFS in patients with N+LA-NPC.The most common grade 1～2 adverse events during the maintenance therapy were acratia(58.4％),hand-foot syndrome(52.8％),and gastrointestinal reaction(41.7％),with no significant difference between the two maintenance treatment groups.No grade 3 adverse events was reported in all patients.[Conclusion]Anlotinib combined with S-1 maintenance therapy for 6 cycles in pa-tients with N+LA-NPC after radical chemoradiotherapy can significantly prolong PFS,and the adverse events are man-ageable.
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