| 胡演坤,朱焕锋,张煜婕,等.局部晚期伴淋巴结阳性鼻咽癌患者根治性放化疗后行安罗替尼联合替吉奥维持治疗的安全性及疗效分析[J].肿瘤学杂志,2024,30(4):306-313. |
| 局部晚期伴淋巴结阳性鼻咽癌患者根治性放化疗后行安罗替尼联合替吉奥维持治疗的安全性及疗效分析 |
| Efficacy and Safety of Anlotinib Combined with S-1 Maintenance Therapy in Patients with Lymph Node Positive Locally Advanced Nasopharyngeal Carcinoma Following Radical Chemoradiotherapy |
| 投稿时间：2024-01-01 |
| DOI：10.11735/j.issn.1671-170X.2024.04.B007 |
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| 中文关键词: 鼻咽肿瘤 局部晚期 淋巴结阳性 维持治疗 安罗替尼 替吉奥 |
| 英文关键词:nasopharyngeal neoplasms locally advanced lymph node positive maintenance therapy Anlotinib S-1 |
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| 中文摘要: |
| 摘 要：［目的］ 探讨淋巴结阳性局部晚期鼻咽癌患者根治性放化疗后接受安罗替尼联合替吉奥维持治疗的安全性及疗效。［方法］ 回顾性分析2021年6月至2022年9月在南京医科大学附属肿瘤医院接受根治性放化疗的95例Ⅲ～Ⅳa期（除N0外）鼻咽癌患者的临床资料，其中接受安罗替尼+替吉奥维持治疗19例（双药维持组），接受替吉奥单药维持治疗17例（单药维持组），不接受维持治疗59例（对照组）。双药维持组的中位维持周期为6（2～6）个，单药维持组为7（5～15）个。主要研究终点为无进展生存（progression-free survival，PFS）率。采用Kaplan-Meier法和Cox风险模型进行疗效评估并分析预后影响因素。 ［结果］ 中位随访时间15.5个月。全部患者2年PFS率为79.9%，双药维持组、单药维持组和对照组的2年PFS率分别为100.0%、94.7%和69.5%。与对照组相比，双药维持组具有显著的PFS获益（P=0.040）。多因素分析显示，接受维持治疗（保护因素）（HR=0.11，95%CI：0.01～0.93，P=0.042）、治疗前高血红蛋白水平（危险因素）（HR=18.21，95%CI：3.44～96.37，P=0.001）是影响患者PFS的独立预后因素。维持治疗期间，常见的1～2级不良反应为乏力（58.4%）、手足综合征（52.8%）和胃肠道反应（41.7%），但两个维持治疗组间不良事件发生率差异无统计学意义。全部患者均未出现＞3级急性毒性反应。［结论］ 根治性放化疗后安罗替尼联合替吉奥维持治疗6个周期可改善局部晚期伴淋巴结阳性鼻咽癌患者的PFS，且安全性良好。 |
| 英文摘要: |
| Abstract：［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 chemoradiotherapy. ［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 received 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 progression-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 control group were 100.0%， 94.7%， and 69.5%， respectively. Compared to the control group， the double-drug maintenance 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 patients with N+ LA-NPC after radical chemoradiotherapy can significantly prolong PFS， and the adverse events are manageable. |
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