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| 1 | 帕博利珠单抗单用或与放疗联用治疗转移性非小细胞肺癌:两个随机试验的汇总分析显示文摘背景放疗可以提高整个机体对免疫治疗的应答。在Ⅱ期PEMBRO-RT研究和Ⅰ/Ⅱ期MDACC研究中,患有转移性非小细胞肺癌(NSCLC)的患者被随机分配入组,接受免疫治疗(帕博利珠单抗)+放疗联合疗法,或免疫治疗单一疗法。当上述2个研究单独分析时,联合疗法组显示出潜在获益。由于每个研究的样本量较小,缓解率和结局并未显示出统计学意义,然而却有显著的临床获益。因此,本研究进行汇总分析,来判断放疗是否会改善转移性NSCLC患者的免疫治疗应答。方法PEMBRO-RT和MDACC研究纳入标准:患者年龄≥18岁,患有转移性NSCLC,且有≥1处未经放疗照射的病灶,以便进行射野外应答监测。PEMBRO-RT研究纳入曾接受过化疗患者,MDACC研究纳入曾接受过治疗或新诊断患者。2个研究中的患者均未接受过免疫治疗。在PEMBRO-RT研究中患者被等比例随机分配入组,并根据吸烟状态进行分层(分为<10年组和≥10年组)。MDACC研究的患者根据放疗计划可行性被等比例随机分配入2个受试组。由于联合治疗组的干预本质,每个研究中的放疗均不适用盲法。在2个研究中,不论是否进行放疗,均静脉滴入帕博利珠单抗(每3周200 mg)。在PEMBRO-RT研究中,在放疗(24 Gy 3次分割照射)结束后1周给予第1剂帕博利珠单抗。在MDACC研究中,在第1次放疗(50 Gy 4次分割照射或45 Gy 15次分割照射)同时给予帕博利珠单抗。仅检测未经照射病灶的应答。本研究的终点为最佳射野外(远隔)应答率(ARR)、最佳射野外疾病控制率(ACR)、12周时ARR、12周时ACR、无进展生存期(PFS)和总生存期(OS)。2个研究的意向治疗(ITT)人群均纳入分析。PEMBRO-RT研究(NCT02492568)和MDACC研究(NCT02444741)均在ClinicalTrials.gov上注册。发现纳入148例患者,76例接受帕博利珠单抗治疗,72例接受帕博利珠单抗+放疗治疗。所有患者随访时间中位数为33个月[四分位距(IQR):32.4~33.6]。148例患者中124例(84%)组织学特征为非鳞癌,111例(75%)患者曾经接受过化疗。组间没有基线特征差异,包括PD-L1表达状态和转移灶体积。最常见的照射部位为肺转移灶(39%,28/72)、胸腔内淋巴结(21%,15/72)和非原发灶(17%,12/72)。帕博利珠单抗组和联合治疗组的最佳ARR分别为19.7%(15/76)和41.7%(30/72),OR=2.96,95%CI:1.42~6.20,P=0.0039;最佳ACR分别为43.4%(33/76)和65.3%(47/72),OR=2.51,95%CI:1.28~4.91,P=0.0071;PFS中位数分别为4.4(IQR:2.9~5.9)和9.0个月(IQR:6.8~11.2),HR=0.67,95%CI:0.45~0.99,P=0.045;OS中位数分别为8.7(IQR:6.4~11.0)和19.2个月(IQR:14.6~23.8),OR=0.67,95%CI:0.54~0.84,P=0.0004。在汇总分析中没有发现新的安全问题。解读帕博利珠单抗免疫疗法+放疗显著提高转移性NSCLC患者的应答和改善治疗结局。这些结果需要在三期临床试验中进行验证。 | 陈大卫(翻译) 于金明(校对) Willemijn S M E Theelen Vivek Verma Brian P Hobbs Heike M U Peulen Joachim G J V Aerts Idris Bahce Anna Larissa N Niemeijer Joe Y Chang Patricia M de Groot Quynh-Nhu Nguyen Nathan I Comeaux George R Simon Ferdinandos Skoulidis Steven H Lin Kewen He Roshal Patel John Heymach Paul Baas James W Welsh | 2021 | 中华肿瘤防治杂志2021，28，24： | 49 |
| 2 | Model combining pre-transplant tumor biomarkers and tumor size shows more utility in predicting hepatocellular carcinoma recurrence and survival than the BALAD models显示文摘AIM To assess the performance of BALAD, BALAD-2 and their component biomarkers in predicting outcome of hepatocellular carcinoma(HCC) patients after liver transplant.METHODS BALAD score and BALAD-2 class are derived from bilirubin, albumin, alpha-fetoprotein(AFP), Lens culinaris agglutinin-reactive AFP(AFP-L3), and des-gammacarboxyprothrombin(DCP). Pre-transplant AFP, AFP-L3 and DCP were measured in 113 patients transplanted for HCC from 2000 to 2008. Hazard ratios(HR) for recurrence and death were calculated. Univariate and multivariate regression analyses were conducted. C-statistics were used to compare biomarker-based to predictive models. RESULTS During a median follow-up of 12.2 years, 38 patients recurred and 87 died. The HRs for recurrence in patients with elevated AFP, AFP-L3, and DCP defined by BALAD cut-off values were 2.42(1.18-5.00), 1.86(0.98-3.52), and 2.83(1.42-5.61), respectively. For BALAD, the HRs for recurrence and death per unit increased score were 1.48(1.15-1.91) and 1.59(1.28-1.97). For BALAD-2, the HRs for recurrence and death per unit increased class were 1.45(1.06-1.98) and 1.38(1.09-1.76). For recurrence prediction, the combination of three biomarkers had the highest c-statistic of 0.66 vs. 0.64, 0.61, 0.53, and 0.53 for BALAD, BALAD-2, Milan, and UCSF, respectively. Similarly, for death prediction, the combination of three biomarkers had the highest c-statistic of 0.66 vs 0.65,0.61, 0.52, and 0.50 for BALAD, BALAD-2, Milan, and UCSF. A new model combining biomarkers with tumor size at the time of transplant(S-LAD) demonstrated the highest predictive capability with c-statistics of 0.71 and 0.69 for recurrence and death. CONCLUSION BALAD and BALAD-2 are valid in transplant HCC patients, but less predictive than the three biomarkers in combination or the three biomarkers in combination with maximal tumor diameter(S-LAD). | Nicha Wongjarupong Gabriela M Negron-Ocasio Roongruedee Chaiteerakij Benyam D Addissie Essa A Mohamed Kristin C Mara William S Harmsen J Paul Theobald Brian E Peters Joseph G Balsanek Melissa M Ward Nasra H Giama Sudhakar K Venkatesh Denise M Harnois Michael R Charlton Hiroyuki Yamada Alicia Algeciras-Schimnich Melissa R Snyder Terry M Therneau Lewis R Roberts | 2018 | World Journal of Gastroenterology2018，24，12： | 5 |
| 3 | Kinetics and products of the TiO2 photocatalytic degradation of 2-chlorobiphenyl in water显示文摘 | Chai S H Wang Y B Brian B | 1998 | Chemosphere1998，36，7： | 1 |
| 4 | A Systematic Review and Meta analysis Evaluating Completeness and Outcomes o{ Robotic Tbyroidectomy 显示文摘 | Brian Hung Hin Lang M S Carloa K H | 2014 | The Laryngoscope2014，125，2： | 1 |
| 5 | Fish assemblages associated with artificial reefs of concrete aggregates or quarry stone offshore Miami Beach,Florida,USA显示文摘 | BRIAN K W BRUCE H RICHARD E S | 2002 | Aquatic Living Resources2002，15，2： | 1 |
| 6 | Near infrared spectroscopy in the forest products industry显示文摘 | Chi-Leung S O Brian KV Leslie H G | 2004 | Forest Products Journal2004，54，3： | 1 |
| 7 | Tacrolimus for the treatment of fistulas in patients with crohn’s disease: a randomized, placebo-controlled trial显示文摘 | William J Sandborn Daniel H Present Kim L Isaacs Douglas C Wolf Eugene Greenberg Stephen B Hanauer Brian G Feagan Lloyd Mayer Therese Johnson Joseph Galanko Christopher Martin Robert S Sandler | 2003 | Gastroenterology2003，，2： | 1 |
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| 9 | , Under- standing academic information seeking habits through analysis of web server log files: the case of the teach- ers college library website 显示文摘 | Asunka S Chae H S Hughes Brian | 2009 | Journal of Academic Li- brarianship2009，35，1： | 1 |
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| 11 | The First Determination of the Energy Difference between Solid-State Conformers by X-ray Diffraction显示文摘 | Charles J S Brian J H Kitti A | 1987 | J Am Chem Soc1987，109，： | 1 |
| 12 | Cytoreductive Surgery with Intraperitoneal Hyperthermic Chemotherapy for advanced Cancer显示文摘 | Jason J H Brian W L Parry S | 2004 | The Society for Surgery of the Alimentary Tract2004，8，4： | 1 |
| 13 | Review of literature on catalysts for biomass gasification显示文摘 | DAVID S BRIAN K JULIAN R H R | 2001 | Fuel Processing Technology2001，73，3： | 1 |
| 14 | Evaluation of trapping mechanisms in geologic CO2 sequestration: Case study of SACROC northern platform, a 35-year CO2 injection site显示文摘 | Weon S H Brian J | 2010 | American Journal of Science2010，310，4： | 1 |
| 15 | Determining economic benefits of satellite data in short-range forecasting显示文摘 | David S Brian A Barry H | 1981 | American Meteorological Society1981，62，10： | 1 |
| 16 | An estimation method for the semiparametric mixed effects model显示文摘 | TAO H BRIAN S Y MICHAEL A N | 1999 | Biometrics1999，55，1： | 1 |
| 17 | Products of emymatic decompmosition of chrome-tanned leather waste显示文摘 | Langmaier S Brian H Keeth H | 1999 | J Soc Leather Tech Chem1999，，83： | 1 |
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