Shaverdashvili Khvaramze, Reyes Vincent, Wang Hong, Mehta Dhaval, Marsh Christopher, Waas John K, VanderWeele Robert A, Peracha Sajid M, Liang Hongmei, Socinski Mark A, Gerber David E, Dowell Jonathan E, Villaruz Liza C
UPMC Hillman Cancer Center, 5150 Centre Avenue, Pittsburgh, PA, 15232, USA.
AdventHealth Cancer Institute, 2501 N. Orange Ave, Suite 689, Orlando, FL, 32804, USA.
EClinicalMedicine. 2023 Nov 21;66:102317. doi: 10.1016/j.eclinm.2023.102317. eCollection 2023 Dec.
Approximately 30-40% of patients with advanced and metastatic non-small cell lung cancer (NSCLC) present with an impaired performance status (PS). There are limited prospective data on the safety and efficacy of durvalumab in these patients.
In this single-arm phase II clinical trial (NCT02879617), patients with previously untreated Stage IIIB/IV NSCLC and ECOG PS of 2 received durvalumab 1500 mg every 28 days until progression or unacceptable toxicity. The primary endpoints were overall survival (OS) and safety determined by grade ≥3 treatment-related adverse events (TRAEs).
Between April 2017 and March 2021, 50 patients were enrolled, of whom 47 received durvalumab. With a median follow-up of 28 months, median OS was 6 months (95% CI 4-10). TRAEs grade 3 occurred in nine of 47 patients (19%, 95% CI 9%-33%). OS in patients with a PD-L1 TPS of 0, 1-49%, and ≥50% was six months (95% CI 3-15), 11 months (95% CI 4-16), and 11 months (95% CI 0-not reached (NR)), respectively. Health related quality of life (HQRL) assessed at baseline and during therapy demonstrated no statistically significant change over the course of treatment.
This study demonstrates that single agent durvalumab is safe and well tolerated in the 1st line treatment of patients with advanced NSCLC and ECOG PS of 2, with an encouraging OS benefit in patients with PD-L1 positive tumors. This trial is amongst the largest prospective studies evaluating durvalumab in the 1st line treatment of advanced stage NSCLC and a PS of 2.
AstraZeneca, NCI P30CA047904.
约30%-40%的晚期和转移性非小细胞肺癌（NSCLC）患者表现出体能状态（PS）受损。关于度伐利尤单抗在这些患者中的安全性和疗效的前瞻性数据有限。
在这项单臂II期临床试验（NCT02879617）中，既往未接受治疗的IIIB/IV期NSCLC且东部肿瘤协作组（ECOG）体能状态为2的患者每28天接受1500mg度伐利尤单抗治疗，直至疾病进展或出现不可接受的毒性。主要终点为总生存期（OS）和由≥3级治疗相关不良事件（TRAEs）确定的安全性。
2017年4月至2021年3月期间，入组50例患者，其中47例接受了度伐利尤单抗治疗。中位随访28个月，中位OS为6个月（95%CI 4-10）。47例患者中有9例发生3级TRAEs（19%，95%CI 9%-33%）。PD-L1肿瘤比例评分（TPS）为0、1%-49%和≥50%的患者的OS分别为6个月（95%CI 3-15）、11个月（95%CI 4-16）和11个月（95%CI 0-未达到（NR））。在基线和治疗期间评估的健康相关生活质量（HQRL）在治疗过程中无统计学显著变化。
本研究表明，单药度伐利尤单抗在一线治疗晚期NSCLC且ECOG体能状态为2的患者中安全且耐受性良好，在PD-L1阳性肿瘤患者中具有令人鼓舞的OS获益。该试验是评估度伐利尤单抗一线治疗晚期NSCLC和体能状态为2的最大规模前瞻性研究之一。
阿斯利康，美国国立癌症研究所（NCI）P30CA047904。
