白蛋白结合型紫杉醇联合奈达铂一线治疗晚期食管癌患者的临床观察

Clinical observation of albumin-bound paclitaxel plus nedaplatin as first-line treatment in advanced esophageal squamous cell carcinoma patients

背景与目的:化疗是晚期食管癌患者的主要治疗手段,但目前尚没有标准的一线治疗方案,通过白蛋白结合型紫杉醇联合奈达铂方案治疗晚期食管癌,评价其临床疗效及安全性。方法:收集2016年2月—2019年2月之间在长海医院诊治的晚期食管癌并有可评价病灶的患者31例,一线予以白蛋白结合型紫杉醇联合奈达铂方案化疗,具体用药为:白蛋白结合型紫杉醇130 mg/m^2,第1、8天;奈达铂70 mg/m^2,第1天;每3周重复。采用实体瘤疗效评价标准(Response Evaluation Criteria in Solid Tumors,RECIST)1.1标准评估疗效,按照美国国立癌症研究所通用毒性标准(National Cancer Institute Common Toxicity Criteria,NCI-CTC)5.0评估不良反应。结果:全部31例患者均可评价疗效,其中完全缓解(complete response,CR)1例(3.2%),部分缓解(partial response,PR)20例(64.5%),疾病稳定(stable disease,SD)9例(29.0%),疾病进展(progressive disease,PD)1例(3.2%),客观缓解率(objective response rate,ORR)为67.7%,疾病控制率(disease control rate,DCR)为96.8%,中位无进展生存期(progression-free survival,PFS)为9.4个月。常见不良反应主要包括骨髓抑制、感觉神经病变、关节酸痛、肌肉酸痛、消化道反应及脱发,无毒性相关死亡病例。结论:白蛋白结合型紫杉醇联合奈达铂一线治疗晚期食管癌疗效较好,不良反应患者可耐受,值得进一步推广。

Background and purpose:Chemotherapy remains the main treatment method for metastatic esophageal squamous cell carcinoma(ESCC).However,no standard regimen has been established as first-line therapy for metastatic ESCC.The purpose of this study was to observe the clinical efficacy and safety of albumin-bound paclitaxel plus nedaplatin as first-line therapy in patients with metastatic ESCC.Methods:Clinical outcomes of 31 patients with metastatic ESCC in Changhai Hospital between Feb.2016 and Feb.2019 were analyzed.These patients received albumin-bound paclitaxel combined with nedaplatin as first-line therapy.Albumin-bound paclitaxel was administered at a dose of 130 mg/m^2 on day 1 and 8 of a 21-day cycle.Nedaplatin was administered at a dose of 70 mg/m^2 on day 1 of a 21-day cycle.Evaluation of tumor response was performed according to Response Evaluation Criteria in Solid Tumors 1.1(RECIST 1.1).Toxicities were graded using version of the National Cancer Institute Common Toxicity Criteria(NCI-CTC)5.0.Results:All patients were available for evaluation.Of the 31 patients,1 case(3.2%)got complete response(CR),20 cases(64.5%)got partial response(PR),9 cases(29.0%)had stable disease(SD)and 1 case(3.2%)had progressive disease(PD).The objective response rate(ORR)was 67.7%,the disease control rate(DCR)was 96.8%and the median progressionfree survival(PFS)was 9.4 months.The main toxicities included hematological toxicity,sensory neuropathy,arthralgia,myalgia,gastrointestinal reactions and alopecia.Conclusion:The combination of albumin-bound paclitaxel and nedaplatin is found to be an effective and tolerable option as first-line therapy for patients with metastatic ESCC.