Abstract：
Consolidation immunotherapy with the PD-L1 inhibitor durvalumab following concurrent chemoradiotherapy (cCRT) has shown a significant survival improvement and is now a standard of care in patients with unresectable stage III or non-operable non-small cell lung cancer (NSCLC).
In this early access program cohort, demographic, disease characteristics and safety data were collected for 576 patients from 188 centers, who received durvalumab 10 mg/kg intravenous infusion every 2 weeks, until disease progression or unacceptable toxicity or for a maximum of 12 months following cCRT. Durvalumab exposure data were available for 402 patients.
Overall, 576 patients were included, 72.9% were men, median age 64.0 years, 52.3% had a stage IIIB disease. PD-L1 status captured in 445 (77%) patients was positive (48.1%), negative (32.6%), unknown (19.3%). At the end of cCRT, adverse events (AEs) all grade ≤ 2, were reported in 22.7% of patients, mainly esophagitis (6.3%). The main reasons of discontinuation were completion of the planned 12 months of consolidation treatment (42.1% patients), disease progression (28.6%) and adverse events (19.5%). Treatment completion was similar in PDL-1 positive and PDL-1 negative patients groups. 20.7% patients had a SAE drug reaction and 17.7% stopped treatment mainly due to SAE. ADR rate and early treatment discontinuation were higher in patients > 70 years old. Death due to AEs occurred in 7 patients, 2 had interstitial lung disease.
Safety data with durvalumab consolidation after cCRT in a large cohort of patients with stage III NSCLC are reported in this real-life cohort. Consistent data were reported both in the PD-L1 positive and PD-L1 negative NSCLC patients in daily practice.
In this early access program cohort, demographic, disease characteristics and safety data were collected for 576 patients from 188 centers, who received durvalumab 10 mg/kg intravenous infusion every 2 weeks, until disease progression or unacceptable toxicity or for a maximum of 12 months following cCRT. Durvalumab exposure data were available for 402 patients.
Overall, 576 patients were included, 72.9% were men, median age 64.0 years, 52.3% had a stage IIIB disease. PD-L1 status captured in 445 (77%) patients was positive (48.1%), negative (32.6%), unknown (19.3%). At the end of cCRT, adverse events (AEs) all grade ≤ 2, were reported in 22.7% of patients, mainly esophagitis (6.3%). The main reasons of discontinuation were completion of the planned 12 months of consolidation treatment (42.1% patients), disease progression (28.6%) and adverse events (19.5%). Treatment completion was similar in PDL-1 positive and PDL-1 negative patients groups. 20.7% patients had a SAE drug reaction and 17.7% stopped treatment mainly due to SAE. ADR rate and early treatment discontinuation were higher in patients > 70 years old. Death due to AEs occurred in 7 patients, 2 had interstitial lung disease.
Safety data with durvalumab consolidation after cCRT in a large cohort of patients with stage III NSCLC are reported in this real-life cohort. Consistent data were reported both in the PD-L1 positive and PD-L1 negative NSCLC patients in daily practice.
摘要：
在同步放化疗（cCRT）后，使用PD-L1抑制剂durvalumab进行的巩固免疫疗法已显示出显着的生存率改善，并且现在已成为不可切除的III期或不可手术的非小细胞肺癌（NSCLC）患者的标准护理。
在这个早期访问计划队列中，人口统计学,收集了来自188个中心的576名患者的疾病特征和安全性数据，每2周接受durvalumab10mg/kg静脉输注，直到疾病进展或不可接受的毒性或cCRT后最多12个月。Durvalumab暴露数据可用于402例患者。
总的来说，包括576名患者，72.9%是男性，中位年龄64.0岁，52.3%患有IIIB期疾病。445例（77%）患者的PD-L1状态为阳性（48.1%），阴性(32.6%)，未知（19.3%）。在cCRT结束时，所有≤2级的不良事件（AE），在22.7%的患者中报告，主要为食管炎(6.3%)。停药的主要原因是完成计划的12个月的巩固治疗（42.1％的患者），疾病进展（28.6%）和不良事件（19.5%）。PDL-1阳性和PDL-1阴性患者组的治疗完成情况相似。20.7%的患者出现SAE药物反应，17.7%的患者因SAE停止治疗。>70岁患者的ADR发生率和早期停药率较高。7例患者因不良事件死亡，2有间质性肺病。
在这个真实队列中报道了大量III期NSCLC患者cCRT后durvalumab巩固的安全性数据。在日常实践中，PD-L1阳性和PD-L1阴性NSCLC患者的数据一致。
在这个早期访问计划队列中，人口统计学,收集了来自188个中心的576名患者的疾病特征和安全性数据，每2周接受durvalumab10mg/kg静脉输注，直到疾病进展或不可接受的毒性或cCRT后最多12个月。Durvalumab暴露数据可用于402例患者。
总的来说，包括576名患者，72.9%是男性，中位年龄64.0岁，52.3%患有IIIB期疾病。445例（77%）患者的PD-L1状态为阳性（48.1%），阴性(32.6%)，未知（19.3%）。在cCRT结束时，所有≤2级的不良事件（AE），在22.7%的患者中报告，主要为食管炎(6.3%)。停药的主要原因是完成计划的12个月的巩固治疗（42.1％的患者），疾病进展（28.6%）和不良事件（19.5%）。PDL-1阳性和PDL-1阴性患者组的治疗完成情况相似。20.7%的患者出现SAE药物反应，17.7%的患者因SAE停止治疗。>70岁患者的ADR发生率和早期停药率较高。7例患者因不良事件死亡，2有间质性肺病。
在这个真实队列中报道了大量III期NSCLC患者cCRT后durvalumab巩固的安全性数据。在日常实践中，PD-L1阳性和PD-L1阴性NSCLC患者的数据一致。
