Pembrolizumab After Two or More Lines of Previous Therapy in Patients With Recurrent or Metastatic SCLC: Results From the KEYNOTE-028 and KEYNOTE-158 Studies

IntroductionPembrolizumab has shown clinical benefit in patients with previously treated recurrent or metastatic SCLC in the phase 1b multicohort study KEYNOTE-028 (NCT02054806) and the phase 2 multicohort study KEYNOTE-158 (NCT02628067). We present a pooled analysis of patients from KEYNOTE-028 and KEYNOTE-158 who had received two or more lines of previous therapy for SCLC.MethodsEligible patients were aged 18 years and above, had histologically or cytologically confirmed incurable recurrent or metastatic SCLC, had an Eastern Cooperative Oncology Group performance status of 1 and below, and had received two or more lines of previous therapy. Patients in KEYNOTE-028 were required to have a programmed death ligand 1 (PD-L1)–positive tumor. Patients received pembrolizumab (10 mg/kg every 2 weeks in KEYNOTE-028 or 200 mg every 3 weeks in KEYNOTE-158) for up to 2 years. The primary end point was objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1, which is presented here per independent review.ResultsEighty-three patients who had received two or more lines of previous therapy (KEYNOTE-028, n = 19; KEYNOTE-158, n = 64) were included. Median follow-up duration was 7.7 (range, 0.5–48.7) months. Objective response rate was 19.3% (95% confidence interval: 11.4–29.4); two patients had complete response (one with a PD-L1–positive tumor), and 14 patients had partial response (13 with PD-L1–positive tumors). The median duration of response was not reached (range, 4.1‒35.8+ mo; plus sign indicates ongoing response); 61% of responders had responses lasting 18 months or longer. Fifty-one patients (61.4%) experienced any-grade treatment-related adverse events; eight patients (9.6%) had grade 3 or higher events.ConclusionsPembrolizumab exhibited durable antitumor activity in a subset of patients with recurrent or metastatic SCLC who had undergone two or more previous lines of therapy, regardless of PD-L1 expression. Pembrolizumab was well tolerated.     

干扰素在恶性淋巴瘤自体移植后早期干预的应用

目的:观察非霍奇金淋巴瘤（non-Hodgkin's lymphoma，NHL）患者自体造血干细胞移植（autologous hematopoietic stem cell transplantation，ASCT）术后应用重组人α-2b干扰素（α-2b IFN）进行早期干预治疗的临床疗效。方法:选取18例行ASCT的NHL患者为研究对象，移植前疾病评估均未达到完全缓解（complete remission，CR），试验组血象恢复后给予IFN 3 000 000 U次/隔日干预治疗，3个月后停用；对照组未行干扰素干预治疗，分析总体疗效及两组对比的生存情况。结果:随访中位时间为34（10~50）个月，患者中位生存时间为37（31~45）个月，3年总体无进展生存（progressive free survival，PFS）、总生存（overall survivial，OS）分别为54.7%、66.8%。ASCT后试验组1年内无疾病复发，2年内复发率为12.5%；对照组1年内复发率为20%，2年内复发率为30%。结论:NHL患者在ASCT后给予重组人α-2b IFN早期干预治疗，患者耐受性好，可能降低移植后早期复发率。     

医养结合型养老机构卫生服务质量指标体系构建研究

目的:构建基于SERVQUAL模型的医养结合型养老机构卫生服务质量评价指标体系。方法:围绕医养结合型养老机构卫生服务的概念、特性、内涵、内容等,采用文献研究法、半结构式访谈法、Delphi—AHP法等定性与定量相结合的研究方法,构建指标体系并确定指标权重。结果:构建了具有7个一级指标,27个二级指标和77个三级指标的养老机构卫生服务质量评价指标体系。指标体系三轮咨询专家权威系数Cr均高于0.84,专家综合权威性系数均高于0.83;总体专家协调系数Kendall W第一、二轮为0.309,第三轮为0.706,且均通过显著性检验;内容效度指数I-CVI介于0.90~1.00之间,S-CVI为0.94,kappa值均高于0.74;信度系数Cronbachα总体为0.972,各维度Cronbachα系数在0.792~0.921之间。评价指标体系具有较好的稳定性、可靠性和一致性。结论:本研究建立的评价指标体系有利于医养结合型养老机构全面建立贴近老年人卫生服务需求的内设医疗机构,改善机构内卫生服务质量。在对指标体系进行应用时,可转化为机构中老年人对各指标项目的感受(P)与期望(E),以两者的差值(P-E)代表机构的卫生服务质量。根据专家赋权结果,应重点加强医养结合养老机构对可靠性、有效性、经济性等指标项目的建设。