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Sarina A. Piha-Paul Do-Youn Oh Makoto Ueno David Malka Hyun Cheol Chung Adnan Nagrial Robin K. Kelley Willeke Ros Antoine Italiano Kazuhiko Nakagawa Hope S. Rugo Filippo de Braud Andrea Iolanda Varga Aaron Hansen Hui Wang Suba Krishnan Kevin G. Norwood Toshihiko Doi 《International journal of cancer. Journal international du cancer》2020,147(8):2190-2198
We present data from patients with advanced biliary tract cancer (BTC) receiving pembrolizumab in the KEYNOTE-158 (NCT02628067; phase 2) and KEYNOTE-028 (NCT02054806; phase 1b) studies. Eligible patients aged ≥18 years from both studies had histologically/cytologically confirmed incurable BTC that progressed after standard treatment regimen(s), measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, Eastern Cooperative Oncology Group performance status 0/1, and no prior immunotherapy. Programmed death ligand 1 (PD-L1)-positive tumors were required for eligibility in KEYNOTE-028 only. Patients received pembrolizumab 200 mg every three weeks (KEYNOTE-158) or 10 mg/kg every two weeks (KEYNOTE-028) for ≤2 years. Primary efficacy endpoint was objective response rate (ORR) by RECIST v1.1. Response assessed by independent central review is reported. KEYNOTE-158 enrolled 104 patients and KEYNOTE-028 enrolled 24 patients. Median (range) follow-up was 7.5 months (0.6-34.3) in KEYNOTE-158 and 5.7 months (0.6-55.4) in KEYNOTE-028. In KEYNOTE-158, ORR was 5.8% (6/104; 95% CI, 2.1%-12.1%); median duration of response (DOR) was not reached (NR) (range, 6.2-26.6+ months). Median (95% CI) OS and PFS were 7.4 (5.5-9.6) and 2.0 (1.9-2.1) months. Among PD-L1-expressers (n = 61) and PD-L1-nonexpressers (n = 34), respectively, ORR was 6.6% (4/61) and 2.9% (1/34). In KEYNOTE-028, ORR was 13.0% (3/23; 95% CI, 2.8%-33.6%); median DOR was NR (range, 21.5-53.2+ months). Median (95% CI) OS and PFS were 5.7 (3.1-9.8) and 1.8 (1.4-3.1) months. Grade 3 to 5 treatment-related adverse events occurred in 13.5% of patients in KEYNOTE-158 (no grade 4; grade 5 renal failure, n = 1) and 16.7% in KEYNOTE-028 (no grade 4/5). In summary, pembrolizumab provides durable antitumor activity in 6% to 13% of patients with advanced BTC, regardless of PD-L1 expression, and has manageable toxicity. 相似文献
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Samir Gupta MD MDCS AGAF Balambal Bharti MBBS MPH PhD Dennis J. Ahnen MD Daniel D. Buchanan PhD Iona C. Cheng PhD MPH Michelle Cotterchio PhD Jane C. Figueiredo PhD Steven J. Gallinger MD MSc Robert W. Haile DrPH MPH Mark A. Jenkins PhD Noralane M. Lindor MD Finlay A. Macrae MD AGAF Loïc Le Marchand MD PhD Polly A. Newcomb PhD MPH Stephen N. Thibodeau PhD Aung Ko Win MBBS MPH PhD Maria Elena Martinez PhD 《Cancer》2020,126(13):3013-3020
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N. Cody Schaal Raushan A. Salaam Michael Stevens Alex Stubner 《Journal of occupational and environmental hygiene》2019,16(5):329-335
The purpose of this investigation was to characterize noise levels in spaces designated as “effective quiet” areas on a U.S. Navy aircraft carrier. Noise dosimetry samples were collected in 15 designated spaces, representing 15 noise measurements, while at-sea during airwing carrier qualifications. Equivalent sound level (Leq) measurements were collected during flight operations (Leq (flt ops)), non-flight operations (Leq (non-flt ops)), and over 24-hr periods (Leq (24-hr)). These data were compared to the 70 dBA American Conference of Governmental Industrial Hygienists (ACGIH®) Threshold Limit Value (TLV®) for “effective quiet” areas intended for temporary threshold shift recovery when personnel live and work in a potentially noise hazardous environment for periods greater than 24?hr. The monitored areas were selected based on personnel occupancy/use during off-duty time periods. Areas were classified by either (1) leisure areas that included mess (eating areas), gyms, lounges, an internet cafe, and the fantail social area or (2) berthing (sleeping) areas. The Leq measurements in decibels “A” weighted (dBA) were compared to determine significant differences between Leq (flt ops), Leq (non-flt ops), and Leq (24-hr) and were compared between leisure area and berthing area. Measured noise levels according to time period ranged as follows: (1) Leq (24-hr): 70.8–105.4 dBA; (2) Leq (flt ops): 70–101.2 dBA; and (3) Leq (non-flt ops): 39.4–104.6 dBA. All area measurements over the 24-hr period and during flight operations and 46.7% of the areas during the non-flight operation time period exceeded the “effective quiet” 70 dBA ACGIH TLV. Mean Leqs were 15 dBA higher during flight operations compared to non-flight operations in “effective quiet” areas (p?=?0.001). The Leqs in leisure areas were significantly higher than berthing areas by approximately 21 dBA during non-flight operation periods (p?=?0.001). Results suggest noise levels in “effective quiet” areas frequented by aircraft carrier personnel during off-duty hours when at-sea may inhibit auditory recovery from occupational noise exposures that occur on-duty. 相似文献
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Stepanova E. S. Makarenkova L. M. Chistyakov V. V. Rybakov Yu. L. Gukasov V. M. Fedotcheva T. A. Parshin V. A. Votyakov V. A. Shimanovskii N. L. 《Pharmaceutical Chemistry Journal》2019,52(12):1016-1020
Pharmaceutical Chemistry Journal - An HPLC-MS method for simultaneous quantitative determination of a novel gestagenic pharmaceutical and two of its metabolites in rat and rabbit blood sera was... 相似文献