食管和胃食管交界处癌(ESO/GEJ)切除患者的辅助免疫治疗的资格和工作量影响

T.H. Lee , S. Gill
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引用次数: 0

摘要

CheckMate (CM) 577试验证实了12个月的辅助纳武单抗治疗食管(ESO)/胃食管交界处(GEJ)癌患者在新辅助放化疗后残留病理病变的有效性。Nivolumab现在是不列颠哥伦比亚省(BC)批准和资助的一种治疗方案。本回顾性研究考察了其在现实世界中的适用性和资源意义。材料和方法我们对2016年1月至2020年12月接受CROSS放化疗的BC癌患者进行了伦理委员会批准的图表审查。根据CM577和GIAJNIV标准确定患者资格。我们通过预测MD和化疗就诊次数来评估nivolumab的资源影响,并根据CM577试验预测G3/4毒性事件。结果677例患者(63% ESO, 37% GEJ;74%腺癌和25%鳞状细胞癌)。在460例切除的患者中,有79%的患者有病理病变残留。68% (n = 249)和88% (n = 321)分别符合CM577和GIAJNIV标准的辅助nivolumab治疗条件。在不列颠哥伦比亚省,这相当于每年约60名患者,导致768次额外化疗和潜在的相同数量的医学博士就诊,每年总计256个医学博士工作小时。G3/4毒性率为34%,估计每年有20名患者可能需要医疗干预。结论辅助纳武单抗是ESO/GEJ肿瘤切除术患者的重要治疗选择。我们的研究结果表明,相当一部分(88%)残留病理疾病的患者将有资格接受12个月的治疗。除治疗费用外,新治疗适应症的实施应考虑对肿瘤学家的额外工作量影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Eligibility and workload implications of adjuvant immunotherapy in patients with resected esophageal and gastroesophageal junction (ESO/GEJ) cancer

Background

The CheckMate (CM) 577 trial demonstrated the efficacy of 12 months of adjuvant nivolumab for esophageal (ESO)/gastroesophageal junction (GEJ) cancer patients with residual pathological disease after neoadjuvant chemoradiation. Nivolumab is now an approved and funded regimen in British Columbia (BC). This retrospective study examines its real-world eligibility and resource implications.

Materials and methods

We conducted an ethics board-approved chart review of patients who underwent CROSS chemoradiation at BC Cancer from January 2016 to December 2020. Patient eligibility was determined per CM577 and GIAJNIV criteria. We assessed the resource impact of nivolumab by projecting the number of MD and chemotherapy visits, and anticipated G3/4 toxicity events per the CM577 trial.

Results

We identified 677 patients (63% ESO and 37% GEJ; 74% adenocarcinomas and 25% squamous cell carcinomas). Among the 460 who had resection, 79% had residual pathological disease. 68% (n = 249) and 88% (n = 321) were eligible for adjuvant nivolumab per CM577 and GIAJNIV criteria, respectively. In BC, this equates to ∼60 patients/year, resulting in 768 additional chemotherapy and potentially an equal number of MD visits, totaling 256 MD workhours annually. With a 34% G3/4 toxicity rate, an estimated 20 patients/year may require medical intervention.

Conclusions

Adjuvant nivolumab is an important treatment option for resected ESO/GEJ cancer patients. Our findings suggest that a substantial portion (88%) of those with residual pathological disease would be eligible for 12 months of therapy. In addition to treatments costs, the implementation of new therapy indications should consider the additional workload impact on oncologists.
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