临床研究阶段
肿瘤科
耐受性
实体瘤疗效评价标准
易普利姆玛
进行性疾病
不良事件通用术语标准
化疗
作者
Jonathan R. Strosberg,Nobumasa Mizuno,Toshihiko Doi,Enrique Grande,Jean-Pierre Delord,Ronnie Shapira-Frommer,Emily K. Bergsland,Manisha H. Shah,Marwan Fakih,Shunji Takahashi,Sarina Anne Piha-Paul,Bert H. O'Neil,Sajeve Samuel Thomas,Martijn P. Lolkema,Menghui Chen,Nageatte Ibrahim,Kevin Norwood,Julien Hadoux
标识
DOI:10.1158/1078-0432.ccr-19-3014
摘要
Purpose: KEYNOTE-158 (ClinicalTrials.gov identifier: NCT02628067) investigated the efficacy and safety of pembrolizumab across multiple cancers. We present results from patients with previously treated advanced well-differentiated neuroendocrine tumors (NET). Patients and Methods: Pembrolizumab 200 mg was administered every 3 weeks for 2 years or until progression, intolerable toxicity, or physician/patient decision. Tumor imaging was performed every 9 weeks for the first year and then every 12 weeks. Endpoints included objective response rate (ORR) per RECIST v1.1 by independent central radiologic review (primary) and duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety (secondary). Results: A total of 107 patients with NETs of the lung, appendix, small intestine, colon, rectum, or pancreas were treated. Median age was 59.0 years (range, 29–80), 44.9% had ECOG performance status 1, 40.2% had received ≥3 prior therapies for advanced disease, and 15.9% had PD-L1–positive tumors (combined positive score ≥1). Median follow-up was 24.2 months (range, 0.6–33.4). ORR was 3.7% (95% CI, 1.0–9.3), with zero complete responses and four partial responses (three pancreatic and one rectal) all in patients with PD-L1–negative tumors. Median DOR was not reached, with one of four responses ongoing after ≥21 months follow-up. Median PFS was 4.1 months (95% CI, 3.5–5.4); the 6-month PFS rate was 39.3%. Median OS was 24.2 months (95% CI, 15.8–32.5). Treatment-related adverse events (AE) occurred in 75.7% of patients, 21.5% of whom had grade 3–5 AEs. Conclusions: Pembrolizumab monotherapy showed limited antitumor activity and manageable safety in patients with previously treated advanced well-differentiated NETs.
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