摘要
目的 探讨尼妥珠单抗联合白蛋白结合型紫杉醇+顺铂(TP)方案诱导化疗在局晚期头颈部鳞癌(LA-HNSCC)患者中的疗效及不良反应.方法 回顾性收集2018年1月至2022年6月大连医科大学附属第二医院收治的65例局晚期(Ⅲ/ⅣA/ⅣB期)头颈部鳞癌(除外鼻咽癌)患者的临床信息,所有患者接受了 2～3个周期的诱导治疗(IC),序贯同步放化疗(CRT).根据诱导治疗方案分为尼妥珠单抗联合TP(Nimo-TP)组34例和TP组31例.比较两组间的近期疗效(客观缓解率)、生存结果(总生存、无进展生存、无局部区域复发生存、无远处转移生存)以及不良反应,并对影响生存结果的因素进行分析.结果 Nimo-TP组和TP组1、2年无远处转移生存率差异具有统计学意义(90.4％vs.69.5％,90.4％vs.66.0％,x2=1.81,P＜0.05).两组IC后和CRT后的客观缓解率(ORR)差异具有统计学意义(IC:67.6％vs.41.9％,x2=4.34,P=0.037;CRT:88.2％vs.67.7％,x2=4.03,P=0.045).但 Nimo-TP 组与 TP 组在 2 年总生存率、无进展生存率、无局部区域复发生存率方面差异无统计学意义(P＞0.05).多因素分析显示,Nimo-TP方案诱导治疗是无远处转移生存的独立预后因素(HR=0.27,95％CI:0.07～0.97,P=0.045);诱导治疗后达到完全或部分缓解是无进展生存和无局部区域复发生存的独立预后因素(HR=0.36,95％CI:0.17～0.76,P=0.008;HR=0.28,95％CI:0.11～0.69,P=0.006).尼妥珠单抗的加入未加重患者在诱导治疗和CRT期间的不良反应(P＞0.05).结论 尼妥珠单抗联合TP方案诱导化疗序贯同步放化疗显著提高了局晚期头颈部鳞癌患者的无远处转移生存率,且安全性高,但在总生存率、无进展生存率、无局部区域复发生存率方面提高不明显,仍需进一步的研究来证实.
Abstract
Objective To explore the efficacy and adverse reactions of nimotuzumab combined with induction chemotherapy(IC)based on albumin-bound paclitaxel plus cisplatin(TP regimen)for patients with locally advanced head and neck squamous cell carcinoma(LA-HNSCC).Methods Clinical data were collected from 65 patients with LA-HNSCC(stages Ⅲ/ⅣA/ⅣB;excluding nasopharyngeal carcinoma)who received 2-3 cycles of IC followed by concurrent chemoradiotherapy(CRT)in the Second Hospital of Dalian Medical University from January 2018 to June 2022.Based on the IC regimen,these patients were categorized into a nimotuzumab combined with TP(Nimo-TP)group(n=34)and a TP group(n=31),and their short-term efficacy[i.e.,the objective response rate(ORR)],survival outcomes[e.g.,overall survival(OS),progression-free survival(PFS),local recurrence-free survival(LRFS),and distant metastasis-free survival(DMFS)],and adverse reactions were compared.Additionally,factors affecting their survival outcomes were analyzed.Results There were statistically significant differences in 1-and 2-year DMFS between both groups(90.4％vs.69.5％,90.4％vs.66.0％,x2=1.81,P＜0.05),so did the ORRs after IC and CRT of both groups(after IC:67.6％vs.41.9％,x2=4.34,P=0.037;after CRT:88.2％vs.67.7％,x2=4.03,P=0.045).However,there was no statistically significant difference in the 2-year OS,PFS,and LRFS between both groups(P＞0.05).Multivariate analysis revealed that nimotuzumab combined with TP-based IC served as an independent prognostic factor for DMFS(HR=0.27,95％CI:0.07-0.97,P=0.045),while complete/partial response after IC acted as an independent prognostic factor for both PFS and local relapse-free survival(HR=0.36,95％CI:0.17-0.76,P=0.008;HR=0.28,95％CI:0.11-0.69,P=0.006).Notably,adding nimotuzumab did not aggravate the adverse reactions in the patients during IC and CRT(P＞0.05).Conclusions Nimotuzumab combined with TP-based induction chemotherapy followed by CRT significantly improved the DMFS of LA-HNSCC patients,exhibiting high safety.However,such therapy failed to significantly improve their OS,PFS,and LRRFS,and,thus,further research is required.
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