Division of Medical Oncology and Hematology, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; Department of Oncology, University of Toronto, Toronto, Ontario, Canada.
Department of Oncology, University of Toronto, Toronto, Ontario, Canada; Division of Medical Oncology and Hematology, Princess Margaret Cancer, Centre, Toronto, Ontario, Canada.
Cancer Treat Res Commun. 2023;34:100678. doi: 10.1016/j.ctarc.2022.100678. Epub 2022 Dec 30.
Durvalumab following chemoradiation in unresectable stage III non-small cell lung cancer (NSCLC) has led to improved outcomes. The schedule of administration has been determined by pharmacokinetic studies. This study evaluates real-world efficacy and safety outcomes of extended dosing (ED) vs. standard dosing (SD) of durvalumab.
Stage III NSCLC patients treated at the Cancer center of Southeastern Ontario with consolidative durvalumab from March 2017-December 2020 were included. Patient characteristics and outcomes were evaluated through retrospective review. Comparisons were made using chi-square and t-tests. Kaplan-Meier curves were used to analyze overall survival (OS).
A total of 35 patients were included; 15 (43%) switched to ED. Distant recurrence rates were higher in the ED group (53% vs. 20%, p = 0.07), with no differences in the sites of disease recurrence. A similar proportion of patients were alive in the ED vs. SD group (93% vs. 80%, p = 0.3), with no significant difference in OS. There were less grade 3 or greater immune-related adverse events in the ED group (0% vs. 20%). Treatment discontinuation occurred in 47% vs. 50% in the ED vs. SD groups, respectively, owing to toxicity in 20% of patients in the ED group vs. 40% in the SD group.
Extended dosing has similar efficacy and toxicity to standard dosing; however, there was a higher rate of toxicity necessitating discontinuation in the SD group, which may have impacted the clinical decision-making to switch to ED. Our data is limited by a small sample size and should be further validated in larger cohorts.
在不可切除的 III 期非小细胞肺癌（NSCLC）中，durvalumab 联合放化疗可改善预后。给药方案是根据药代动力学研究确定的。本研究评估了扩展剂量（ED）与 durvalumab 标准剂量（SD）在真实世界中的疗效和安全性结果。
纳入 2017 年 3 月至 2020 年 12 月在安大略省东南部癌症中心接受巩固性 durvalumab 治疗的 III 期 NSCLC 患者。通过回顾性研究评估患者特征和结局。采用卡方检验和 t 检验进行比较。采用 Kaplan-Meier 曲线分析总生存期（OS）。
共纳入 35 例患者，其中 15 例（43%）转为 ED。ED 组远处复发率较高（53% vs. 20%，p=0.07），但疾病复发部位无差异。ED 组与 SD 组的存活患者比例相似（93% vs. 80%，p=0.3），OS 无显著差异。ED 组 3 级或更高级别的免疫相关不良事件发生率较低（0% vs. 20%）。ED 组和 SD 组分别有 47%和 50%的患者因毒性而停药，ED 组中有 20%的患者和 SD 组中有 40%的患者因毒性而停药。
扩展剂量与标准剂量具有相似的疗效和毒性；然而，SD 组因毒性而停药的发生率较高，这可能影响了转为 ED 的临床决策。我们的数据受到样本量小的限制，应在更大的队列中进一步验证。
