(1) Background: The purpose of this study was to evaluate the time toxicity, or time spent in health care, of immunotherapy- versus chemotherapy-based regimens for metastatic esophageal and gastric cancers. (2) Methods: A literature search was conducted, and 18 phase III clinical trials of immune checkpoint inhibitors were selected for analysis. Health care days were calculated based on the number of days associated with receiving therapy and the adverse events reported in the clinical trials. Both the number of health care days and the median overall survival were compared among chemotherapy-only, immunotherapy-only, and chemo-immunotherapy regimens across this cohort of drug registration trials. (3) Results: The estimated median number of health care days was 37 (range of 7–52) days, or 1.2 (range of 0.2–1.7) months, compared to a median survival of 10.2 months across these 18 studies. For the chemotherapy-only regimens, the median number of health care days was 39 (range of 21–51) days, and for chemo-immunotherapy, it was 39 (range of 30–52) days. The immunotherapy-only regimens had fewer days, a median of 28 (range of 24–41),p< 0.05, compared to the other two arms. (4) Conclusions: The chemo-immunotherapy regimens did not add time toxicity compared to chemotherapy alone. The immunotherapy-only regimens had lower time toxicity compared to chemotherapy alone. In the setting of decreased time toxicity and improved overall survival, further development of immunotherapy-based regimens could improve outcomes in advanced esophageal and gastric cancers.
(1) 背景:本研究旨在评估转移性食管癌和胃癌患者接受免疫治疗与化疗方案的时间毒性,即花费在医疗保健上的时间。(2) 方法:通过文献检索,筛选出18项免疫检查点抑制剂的三期临床试验进行分析。医疗保健天数根据临床试验中报告的治疗持续时间和不良事件相关天数进行计算。在这组药物注册试验中,比较了单纯化疗、单纯免疫治疗以及化疗联合免疫治疗方案在医疗保健天数和中位总生存期方面的差异。(3) 结果:这18项研究的中位生存期为10.2个月,而估算的中位医疗保健天数为37天(范围7-52天),相当于1.2个月(范围0.2-1.7个月)。单纯化疗方案的中位医疗保健天数为39天(范围21-51天),化疗联合免疫治疗方案为39天(范围30-52天)。单纯免疫治疗方案的天数较少,中位数为28天(范围24-41天),与其他两组相比p<0.05。(4) 结论:与单纯化疗相比,化疗联合免疫治疗方案并未增加时间毒性。单纯免疫治疗方案的时间毒性低于单纯化疗。在时间毒性降低且总生存期改善的情况下,进一步开发基于免疫治疗的方案有望改善晚期食管癌和胃癌患者的预后。