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.
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。