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Recurrent Fevers in a Patient With Splenomegaly. 一名脾肿大患者反复发烧。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-26 DOI: 10.1001/jamaoncol.2024.4029
Darren D'Souza,Braulio Cuesta,Jennie Y Law
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引用次数: 0
Meta-Analysis Methods for Neoadjuvant Chemoimmunotherapy for Non-Small Cell Lung Cancer-Reply. 非小细胞肺癌新辅助化学免疫疗法的 Meta 分析方法--回复。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-26 DOI: 10.1001/jamaoncol.2024.4214
Mark Sorin,Connor Prosty,Jonathan D Spicer
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引用次数: 0
Rogaratinib Plus Atezolizumab in Cisplatin-Ineligible Patients With FGFR RNA-Overexpressing Urothelial Cancer 罗格替尼联合阿特珠单抗治疗不符合顺铂治疗条件的表皮生长因子受体RNA过表达尿路上皮癌患者
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1001/jamaoncol.2024.3900
Randy F. Sweis, Pablo Gajate, Rafael Morales-Barrera, Jae-Lyun Lee, Andrea Necchi, Filippo de Braud, Nicolas Penel, Viktor Grünwald, Marco Maruzzo, Johannes Meran, Tatiane Cristine Ishida, Weichao Bao, Yinghui Zhou, Peter Ellinghaus, Jonathan E. Rosenberg
ImportanceThe oral pan–fibroblast growth factor receptor inhibitor rogaratinib previously demonstrated encouraging safety and efficacy in a phase 1 study of patients with urothelial cancer (UC) overexpressing FGFR messenger RNA (mRNA).ObjectiveTo evaluate the safety, pharmacokinetics, and preliminary efficacy of rogaratinib in combination with the programmed cell death 1 ligand 1 (PD-L1) inhibitor atezolizumab in cisplatin-ineligible patients with FGFR mRNA-positive, locally advanced/metastatic UC.Design, Setting, and ParticipantsThe FORT-2 nonrandomized clinical trial was an open-label, single-arm, multicenter study conducted between May 15, 2018, and July 16, 2021, in 30 centers across Asia, Europe, and North America. Eligible patients had locally advanced/metastatic UC with FGFR1/3 mRNA overexpression and were ineligible for cisplatin-based chemotherapy. The data analysis was completed from July 2022 to September 2022.InterventionsPatients received rogaratinib 600 mg or rogaratinib 800 mg twice daily in combination with intravenous atezolizumab 1200 mg every 21 days.Main Outcomes and MeasuresPrimary end points included safety, tolerability, and the recommended phase 2 dose (RP2D) of rogaratinib in combination with atezolizumab.ResultsAmong 153 patients screened, 73 (48%) had tumors with FGFR1/3 mRNA overexpression, and 37 patients were enrolled and treated (median [range] age, 75.0 [47.0-85.0] years; 32 [87%] male). The most common treatment-emergent adverse events (TEAEs) included diarrhea in 23 patients (62%), hyperphosphatemia in 19 (51%), and fatigue in 15 (41%). Grade 3 or higher TEAEs were reported in 27 patients (73%), and 4 grade 5 TEAEs were reported, though unrelated to treatment. The RP2D was rogaratinib 600 mg in combination with atezolizumab 1200 mg. At the RP2D, the overall response rate was 53.8% in the rogaratinib 600 mg group, including 4 patients (15%) with complete responses; 12 responders (86%) did not have an FGFR3 gene alteration, and 11 (79%) had low PD-L1 expression.Conclusions and RelevanceIn this phase 1b nonrandomized clinical trial, rogaratinib plus atezolizumab demonstrated a manageable safety profile, with no unexpected safety signals. Efficacy for this combination at the RP2D was observed in tumors with low PD-L1 and was not dependent on FGFR3 gene alterations, suggesting broad potential benefit for patients with locally advanced/metastatic UC and FGFR mRNA overexpression.Trial RegistrationClinicalTrials.gov Identifier: NCT03473756
重要性口服泛成纤维细胞生长因子受体抑制剂罗加替尼曾在一项针对过表达FGFR信使RNA(mRNA)的尿路上皮癌(UC)患者的1期研究中显示出令人鼓舞的安全性和疗效。目的评估罗加替尼联合程序性细胞死亡 1 配体 1 (PD-L1) 抑制剂阿特珠单抗治疗不符合顺铂治疗条件的 FGFR mRNA 阳性、局部晚期/转移性 UC 患者的安全性、药代动力学和初步疗效。设计、设置和参与者FORT-2非随机临床试验是一项开放标签、单臂、多中心研究,于2018年5月15日至2021年7月16日期间在亚洲、欧洲和北美的30个中心进行。符合条件的患者为局部晚期/转移性 UC,FGFR1/3 mRNA 过表达,且不符合顺铂化疗条件。干预措施患者接受罗加替尼600毫克或罗加替尼800毫克,每天两次,联合静脉注射阿特珠单抗1200毫克,每21天一次。主要结果和测量指标主要终点包括安全性、耐受性以及罗加替尼联合阿特珠单抗的2期推荐剂量(RP2D)。结果在筛选出的153名患者中,73人(48%)的肿瘤存在FGFR1/3 mRNA过表达,37名患者入组并接受治疗(中位年龄[范围]为75.0[47.0-85.0]岁;32人[87%]为男性)。最常见的治疗突发不良事件(TEAEs)包括:23 名患者(62%)出现腹泻,19 名患者(51%)出现高磷血症,15 名患者(41%)出现疲劳。27名患者(73%)报告了3级或更高的TEAE,4名患者报告了5级TEAE,但与治疗无关。RP2D是罗加替尼600毫克联合阿特珠单抗1200毫克。在RP2D时,罗加替尼600毫克组的总应答率为53.8%,其中4例患者(15%)为完全应答;12例应答者(86%)无FGFR3基因改变,11例应答者(79%)PD-L1表达较低。在PD-L1较低的肿瘤中观察到了该组合在RP2D阶段的疗效,并且不依赖于FGFR3基因的改变,这表明局部晚期/转移性UC和FGFR mRNA过表达的患者可能会广泛受益:NCT03473756
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引用次数: 0
Standardized Definitions for Efficacy End Points for Adjuvant Trials—The Updated STEEP Criteria 辅助试验疗效终点的标准化定义--最新的 STEEP 标准
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1001/jamaoncol.2024.3888
Dominik Hlauschek, Christian Fesl, Michael Gnant
This Viewpoint discusses how the inclusion or exclusion of certain events in the standardization of clinical trial end points can affect the interpretation of results.
本视点讨论了在临床试验终点标准化中纳入或排除某些事件会如何影响结果的解释。
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引用次数: 0
Chimeric Antigen Receptor T Cells Targeting CD19 and GCC in Metastatic Colorectal Cancer 靶向 CD19 和 GCC 的嵌合抗原受体 T 细胞治疗转移性结直肠癌
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1001/jamaoncol.2024.3891
Naifei Chen, Chengfei Pu, Lingling Zhao, Wei Li, Chang Wang, Ruihong Zhu, Tingting Liang, Chao Niu, Xi Huang, Haiyang Tang, Yizhuo Wang, Hang Yang, Beibei Jia, Xianyang Jiang, Guiting Han, Wensheng Wang, Dongqi Chen, Yiming Wang, Eric K. Rowinsky, Eugene Kennedy, Victor X. Lu, Guozhen Cui, Zhao Wu, Lei Xiao, Jiuwei Cui
ImportanceChimeric antigen receptor (CAR) T-cell therapy (CART) has transformed the treatment landscape of hematologic cancer, but has negligible effects for adult solid cancers. In this trial, an autologous CAR T-cell product demonstrated antitumor activity in heavily pretreated patients with metastatic colorectal cancer (mCRC).ObjectiveTo evaluate the safety and efficacy of guanylate cyclase-C (GCC19) CART in participants with metastatic colorectal cancer (mCRC).Design, Setting, and ParticipantsThis single-arm, nonrandomized, phase 1 trial was conducted at the First Hospital of Jilin University from December 3, 2020, to April 13, 2022. Data analysis was conducted from May 2022 to April 2024. Adults with relapsed and refractory mCRC expressing GCC were treated with GCC19CART, a mixture of autologous CAR T cells transduced with lentiviral vectors expressing genes that encode either CD-19 CAR or GCC CAR.Main Outcomes and MeasuresSafety and tolerability of CAR T-cell therapy targeting GCC in patients with mCRC without therapeutic options is capable of conferring a reasonable likeliness of clinical benefit. Other outcomes included objective response rate, progression-free survival, overall survival, and immune activation.ResultsOf 15 patients 9 (60%) were women, and the median (range) age was 44 (33-61) years. Treatment with GCC19CART was associated with the development of cytokine release syndrome and diarrhea in most patients, all of which were self-limited and manageable. The objective response rate was 40%, with a partial response in 2 of 8 and 4 of 7 patients treated with either 1 × 106 cells/kg or 2 × 106 cells/kg. Median overall survival was 22.8 months (95% CI, 13.4-26.1) at data cutoff; the median progress-free survival was 6.0 months in the high dose level group (95% CI, 3.0 to not available).Conclusions and RelevanceThe results of this nonrandomized clinical trial suggest that GCC19CART was safe and tolerable in heavily pretreated patients with mCRC and is the first CAR T-cell therapy known to produce objective clinical activity in refractory cancer. Given the paucity of effective therapeutics developed for colorectal cancer in recent decades, the observation that CD-19 CART target engagement can robustly induce GCC19CART target engagement sufficient to produce objective activity may serve as a foundation to develop effective cellular therapy in mCRC and other solid cancers.Trial RegistrationChinese Clinical Trial Registry: ChiCTR2000040645
重要性嵌合抗原受体(CAR)T 细胞疗法(CART)改变了血液肿瘤的治疗格局,但对成人实体瘤的疗效却微乎其微。在这项试验中,一种自体CAR T细胞产品在重度预处理的转移性结直肠癌(mCRC)患者中显示出抗肿瘤活性。目的评估鸟苷酸环化酶-C(GCC19)CART在转移性结直肠癌(mCRC)患者中的安全性和有效性。数据分析于 2022 年 5 月至 2024 年 4 月进行。表达GCC的复发性和难治性mCRC成人患者接受了GCC19CART治疗,这是一种用表达编码CD-19 CAR或GCC CAR基因的慢病毒载体转导的自体CAR T细胞混合物。主要结果和测量指标在没有治疗选择的mCRC患者中,靶向GCC的CAR T细胞疗法的安全性和耐受性能够带来合理的临床获益可能性。其他结果包括客观反应率、无进展生存期、总生存期和免疫激活。结果15名患者中有9名(60%)为女性,年龄中位数(范围)为44(33-61)岁。大多数患者在接受 GCC19CART 治疗后会出现细胞因子释放综合征和腹泻,但这些症状都是自限性的,可以控制。客观反应率为40%,在接受1×106细胞/千克或2×106细胞/千克治疗的8名患者中,有2人出现部分反应,7名患者中有4人出现部分反应。数据截止时,中位总生存期为22.8个月(95% CI,13.4-26.1个月);高剂量组的中位无进展生存期为6.0个月(95% CI,3.0-不可用)。结论与意义这项非随机临床试验的结果表明,GCC19CART在重度预处理的mCRC患者中是安全和可耐受的,是已知的首个能在难治性癌症中产生客观临床活性的CAR T细胞疗法。鉴于近几十年来针对结直肠癌开发的有效疗法很少,CD-19 CART靶点参与能强有力地诱导GCC19CART靶点参与,从而产生足够的客观活性,这一观察结果可能为开发针对mCRC和其他实体癌的有效细胞疗法奠定基础:中国临床试验注册中心
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引用次数: 0
Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non–Small Cell Lung Cancer 无法手术的 I 期非小细胞肺癌的立体定向放疗与低分次放疗对比
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-19 DOI: 10.1001/jamaoncol.2024.3089
Anand Swaminath, Sameer Parpia, Marcin Wierzbicki, Vijayananda Kundapur, Sergio Faria, Gordon S. Okawara, Theodoros K. Tsakiridis, Naseer Ahmed, Alexis Bujold, Khalid Hirmiz, Timothy Owen, Nelson Leong, Kevin Ramchandar, Edith Filion, Harold Lau, Zsolt Gabos, Robert Thompson, Brian Yaremko, Selma Mehiri, Alexander V. Louie, Kimmen Quan, Mark N. Levine, James R. Wright, Timothy J. Whelan
ImportanceStereotactic body radiotherapy (SBRT) is widely used for stage I medically inoperable non–small cell lung cancer (NSCLC), yet varied results from randomized clinical trials (RCTs) and concerns in treating centrally located tumors persist.ObjectiveTo examine whether SBRT would improve local control (LC) compared with hypofractionated conventional radiotherapy (CRT).Design, Setting, and ParticipantsThis phase 3 RCT was conducted in 16 Canadian centers. Patients with medically inoperable stage I (≤5 cm) NSCLC were randomized 2:1 to SBRT of 48 Gy in 4 fractions (peripheral NSCLC) or 60 Gy in 8 fractions (central NSCLC) vs CRT of 60 Gy in 15 fractions. Data were collected from May 2014 to January 2020, and data were analyzed from July 2022 to July 2023.InterventionsSBRT or CRT.Main Outcomes and MeasuresThe primary objective was to determine the effectiveness of SBRT compared with CRT based on LC at 3 years. Secondary outcomes included event-free survival, overall survival, and toxic effects. All radiation plans were subject to real-time/final review. Local failures were centrally adjudicated. The study was designed to detect a 3-year LC improvement of SBRT from 75% to 87.5%. The target sample size was 324 patients.ResultsOf 233 included patients, 119 (51.1%) were male, and the mean (SD) age was 75.4 (7.7) years; the median (IQR) follow-up was 36.1 (26.4-52.8) months. A total of 154 patients received SBRT and 79 received CRT. The 3-year LC was 87.6% (95% CI, 81.9%-93.4%) for SBRT and 81.2% (95% CI, 71.9%-90.5%) for CRT (hazard ratio [HR], 0.61; 95% CI, 0.31-1.20; P = .15). The HR was 1.02 (95% CI, 0.72-1.45; P = .87) for event-free survival and 1.18 (95% CI, 0.80-1.76; P = .40) for overall survival. Minimal acute toxic effects were observed. Among those randomized to SBRT, late grade 3 or 4 toxic effects occurred in 5 of 45 (11%) with central NSCLC and 2 of 109 (1.8%) with peripheral NSCLC; among those randomized to CRT, in 1 of 19 (5%) with central NSCLC and 1 of 60 (2%) with peripheral NSCLC. One patient who received SBRT for an ultracentral lesion (target overlapping proximal bronchus) experienced a possible treatment-related grade 5 event (hemoptysis).Conclusions and RelevanceThis RCT compared lung SBRT with hypofractionated CRT that included central/ultracentral tumors. No difference was detected in LC between groups. Severe toxic effects were limited, including patients with central tumors. The trial provides important prospective data evaluating SBRT; however, further research is necessary to determine if SBRT is more effective than CRT for peripheral and central NSCLC.Trial RegistrationClinicalTrials.gov Identifier: NCT03924869
重要性立体定向体放射治疗(SBRT)被广泛用于医学上无法手术的I期非小细胞肺癌(NSCLC),但随机临床试验(RCT)的结果不尽相同,治疗中心位置肿瘤的问题依然存在。目的研究与低分次常规放射治疗(CRT)相比,SBRT是否能改善局部控制(LC)。医学上无法手术的I期(≤5厘米)NSCLC患者按照2:1的比例随机接受48 Gy分4次(周边NSCLC)或60 Gy分8次(中心NSCLC)的SBRT与60 Gy分15次的CRT治疗。数据收集时间为2014年5月至2020年1月,数据分析时间为2022年7月至2023年7月。干预措施SBRT或CRT。主要结果和测量指标主要目的是根据3年后的LC确定SBRT与CRT相比的有效性。次要结果包括无事件生存期、总生存期和毒性反应。所有放射计划均接受实时/最终审查。局部失败由中央裁决。该研究旨在检测 SBRT 3 年生存率从 75% 提高到 87.5%。结果 在233例纳入患者中,119例(51.1%)为男性,平均(SD)年龄为75.4(7.7)岁;中位(IQR)随访时间为36.1(26.4-52.8)个月。共有154名患者接受了SBRT治疗,79名患者接受了CRT治疗。SBRT的3年生存率为87.6%(95% CI,81.9%-93.4%),CRT为81.2%(95% CI,71.9%-90.5%)(危险比[HR],0.61;95% CI,0.31-1.20;P = .15)。无事件生存率为 1.02 (95% CI, 0.72-1.45; P = .87),总生存率为 1.18 (95% CI, 0.80-1.76; P = .40)。急性毒性反应极小。在随机接受SBRT治疗的患者中,45例中心型NSCLC患者中有5例(11%)出现了晚期3级或4级毒性反应,109例外周型NSCLC患者中有2例(1.8%)出现了晚期3级或4级毒性反应;在随机接受CRT治疗的患者中,19例中心型NSCLC患者中有1例(5%)出现了晚期3级或4级毒性反应,60例外周型NSCLC患者中有1例(2%)出现了晚期3级或4级毒性反应。一名接受SBRT治疗超中心病灶(靶点与近端支气管重叠)的患者可能发生了治疗相关的5级事件(咯血)。两组患者的低密度脂蛋白血症无差异。严重毒性反应有限,包括中心性肿瘤患者。该试验提供了评估SBRT的重要前瞻性数据;但是,要确定SBRT是否比CRT对周围和中心NSCLC更有效,还需要进一步的研究:NCT03924869
{"title":"Stereotactic vs Hypofractionated Radiotherapy for Inoperable Stage I Non–Small Cell Lung Cancer","authors":"Anand Swaminath, Sameer Parpia, Marcin Wierzbicki, Vijayananda Kundapur, Sergio Faria, Gordon S. Okawara, Theodoros K. Tsakiridis, Naseer Ahmed, Alexis Bujold, Khalid Hirmiz, Timothy Owen, Nelson Leong, Kevin Ramchandar, Edith Filion, Harold Lau, Zsolt Gabos, Robert Thompson, Brian Yaremko, Selma Mehiri, Alexander V. Louie, Kimmen Quan, Mark N. Levine, James R. Wright, Timothy J. Whelan","doi":"10.1001/jamaoncol.2024.3089","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.3089","url":null,"abstract":"ImportanceStereotactic body radiotherapy (SBRT) is widely used for stage I medically inoperable non–small cell lung cancer (NSCLC), yet varied results from randomized clinical trials (RCTs) and concerns in treating centrally located tumors persist.ObjectiveTo examine whether SBRT would improve local control (LC) compared with hypofractionated conventional radiotherapy (CRT).Design, Setting, and ParticipantsThis phase 3 RCT was conducted in 16 Canadian centers. Patients with medically inoperable stage I (≤5 cm) NSCLC were randomized 2:1 to SBRT of 48 Gy in 4 fractions (peripheral NSCLC) or 60 Gy in 8 fractions (central NSCLC) vs CRT of 60 Gy in 15 fractions. Data were collected from May 2014 to January 2020, and data were analyzed from July 2022 to July 2023.InterventionsSBRT or CRT.Main Outcomes and MeasuresThe primary objective was to determine the effectiveness of SBRT compared with CRT based on LC at 3 years. Secondary outcomes included event-free survival, overall survival, and toxic effects. All radiation plans were subject to real-time/final review. Local failures were centrally adjudicated. The study was designed to detect a 3-year LC improvement of SBRT from 75% to 87.5%. The target sample size was 324 patients.ResultsOf 233 included patients, 119 (51.1%) were male, and the mean (SD) age was 75.4 (7.7) years; the median (IQR) follow-up was 36.1 (26.4-52.8) months. A total of 154 patients received SBRT and 79 received CRT. The 3-year LC was 87.6% (95% CI, 81.9%-93.4%) for SBRT and 81.2% (95% CI, 71.9%-90.5%) for CRT (hazard ratio [HR], 0.61; 95% CI, 0.31-1.20; <jats:italic>P</jats:italic> = .15). The HR was 1.02 (95% CI, 0.72-1.45; <jats:italic>P</jats:italic> = .87) for event-free survival and 1.18 (95% CI, 0.80-1.76; <jats:italic>P</jats:italic> = .40) for overall survival. Minimal acute toxic effects were observed. Among those randomized to SBRT, late grade 3 or 4 toxic effects occurred in 5 of 45 (11%) with central NSCLC and 2 of 109 (1.8%) with peripheral NSCLC; among those randomized to CRT, in 1 of 19 (5%) with central NSCLC and 1 of 60 (2%) with peripheral NSCLC. One patient who received SBRT for an ultracentral lesion (target overlapping proximal bronchus) experienced a possible treatment-related grade 5 event (hemoptysis).Conclusions and RelevanceThis RCT compared lung SBRT with hypofractionated CRT that included central/ultracentral tumors. No difference was detected in LC between groups. Severe toxic effects were limited, including patients with central tumors. The trial provides important prospective data evaluating SBRT; however, further research is necessary to determine if SBRT is more effective than CRT for peripheral and central NSCLC.Trial RegistrationClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http://www.w3.org/1999/xlink\" ext-link-type=\"uri\" xlink:href=\"https://clinicaltrials.gov/study/NCT03924869\">NCT03924869</jats:ext-link>","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"36 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142275593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Molecular, Socioeconomic, and Clinical Factors Affecting Racial and Ethnic Disparities in Colorectal Cancer Survival. 影响结直肠癌种族和民族存活率差异的分子、社会经济和临床因素。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-12 DOI: 10.1001/jamaoncol.2024.3666
Mahmoud Yousef,Abdelrahman Yousef,Saikat Chowdhury,Mohammad M Fanaeian,Mark Knafl,Jennifer Peterson,Mohammad Zeineddine,Kristin Alfaro,Fadl Zeineddine,Drew Goldstein,Nicholas Hornstein,Arvind Dasari,Ryan Huey,Benny Johnson,Victoria Higbie,Alisha Bent,Bryan Kee,Michael Lee,Maria Pia Morelli,Van Karlyle Morris,Daniel Halperin,Michael J Overman,Christine Parseghian,Eduardo Vilar,Robert Wolff,Kanwal P Raghav,Michael G White,Abhineet Uppal,Ryan Sun,Wenyi Wang,Scott Kopetz,Jason Willis,John Paul Shen
ImportanceDisparity in overall survival (OS) and differences in the frequency of driver gene variants by race and ethnicity have been separately observed in patients with colorectal cancer; however, how these differences contribute to survival disparity is unknown.ObjectiveTo quantify the association of molecular, socioeconomic, and clinical covariates with racial and ethnic disparities in overall survival among patients with colorectal cancer.Design, Setting, and ParticipantsThis single-center cohort study was conducted at a tertiary-level cancer center using relevant data on all patients diagnosed with colorectal cancer from January 1, 1973, to March 1, 2023. The relative contribution of variables to the disparity was determined using mediation analysis with sequential multivariate Cox regression models.Main OutcomeOS, from diagnosis date and from start of first-line chemotherapy.ResultsThe study population of 47 178 patients (median [IQR] age, 57.0 [49-66] years; 20 465 [43.4%] females and 26 713 [56.6%] males; 3.0% Asian, 8.7% Black, 8.8% Hispanic, and 79.4% White individuals) had a median (IQR) follow-up from initial diagnosis of 124 (174) months and OS of 55 (145) months. Compared with White patients, Black patients had worse OS (hazard ratio [HR], 1.16; 95% CI, 1.09-1.24; P <.001), whereas Asian and Hispanic patients had better OS (HR, 0.66; 95% CI, 0.59-0.74; P <.001; and 0.86; 95% CI, 0.81-0.92; P <.001, respectively). When restricted to patients with metastatic disease, the greatest disparity was between Black patients compared with White patients (HR, 1.2; 95% CI, 1.06-1.37; P <.001). Evaluating changes in OS disparity over 20 years showed disparity decreasing among Asian, Hispanic, and White patients, but increasing between Black patients and White patients (HRs, 1.18; 95% CI, 1.07-1.31 for 2008-2012; 1.24, 95% CI, 1.08-1.42 for 2013-2017; and 1.50; 95% CI, 1.20-1.87 for 2018-2023). Survival outcomes for first-line chemotherapy were worse for Black patients compared with White patients (median OS, 18 vs 26 months; HR, 1.30; 95% CI, 1.01-1.70). Among 7628 patients who had clinical molecular testing, APC, KRAS, and PIK3CA showed higher variant frequency in Black patients (false discovery rate [FDR], 0.01; < 0.001; and 0.01, respectively), whereas BRAF and KIT were higher among White patients (FDR, 0.001 and 0.01). Mediation analysis identified neighborhood socioeconomic status as the greatest contributor to OS disparity (29%), followed by molecular characteristics (microsatellite instability status, KRAS variation and BRAF variation, 10%), and tumor sidedness (9%).ConclusionsThis single-center cohort study identified substantial OS disparity and differing frequencies of driver gene variations by race and ethnicity. Socioeconomic status had the largest contribution but accounted for less than one-third of the disparity, with substantial contribution from tumor molecular features. Further study of the associations of genetic ancestry and
重要性在结直肠癌患者中已分别观察到总生存期(OS)的差异以及不同种族和民族驱动基因变异频率的差异;然而,这些差异是如何导致生存期差异的尚不清楚。目的量化分子、社会经济和临床协变量与结直肠癌患者总生存期的种族和民族差异之间的关系。设计、设置和参与者这项单中心队列研究是在一家三级癌症中心进行的,使用了自 1973 年 1 月 1 日至 2023 年 3 月 1 日期间诊断为结直肠癌的所有患者的相关数据。主要结果OS、从诊断日期起和从开始一线化疗起。结果研究人群中有 47 178 名患者(中位数[IQR]年龄,57.0[49-66]岁;20 465[43.4%]名女性和26 713[56.6%]名男性;3.0%为亚裔、8.7%为黑人、8.8%为西班牙裔、79.4%为白人),自初次诊断起的中位(IQR)随访时间为124(174)个月,OS为55(145)个月。与白人患者相比,黑人患者的OS较差(危险比[HR],1.16;95% CI,1.09-1.24;P<.001),而亚裔和西班牙裔患者的OS较好(HR,分别为0.66;95% CI,0.59-0.74;P<.001;和0.86;95% CI,0.81-0.92;P<.001)。如果仅限于转移性疾病患者,黑人患者与白人患者之间的差异最大(HR,1.2;95% CI,1.06-1.37;P <.001)。评估20年间OS差异的变化显示,亚裔、西班牙裔和白人患者之间的差异在缩小,但黑人患者和白人患者之间的差异在扩大(2008-2012年的HR为1.18;95% CI为1.07-1.31;2013-2017年的HR为1.24,95% CI为1.08-1.42;2018-2023年的HR为1.50;95% CI为1.20-1.87)。与白人患者相比,黑人患者一线化疗的生存结果更差(中位OS,18个月 vs 26个月;HR,1.30;95% CI,1.01-1.70)。在接受临床分子检测的7628名患者中,黑人患者中APC、KRAS和PIK3CA的变异频率较高(假发现率[FDR]分别为0.01;<0.001;和0.01),而白人患者中BRAF和KIT的变异频率较高(FDR分别为0.001和0.01)。通过中介分析发现,邻里社会经济状况是导致OS差异的最大因素(29%),其次是分子特征(微卫星不稳定性状态、KRAS变异和BRAF变异,10%)和肿瘤侧位(9%)。社会经济状况的影响最大,但只占差距的不到三分之一,肿瘤分子特征的影响也很大。需要进一步研究遗传血统和结直肠癌分子发病机制与化疗反应之间的关联。
{"title":"Molecular, Socioeconomic, and Clinical Factors Affecting Racial and Ethnic Disparities in Colorectal Cancer Survival.","authors":"Mahmoud Yousef,Abdelrahman Yousef,Saikat Chowdhury,Mohammad M Fanaeian,Mark Knafl,Jennifer Peterson,Mohammad Zeineddine,Kristin Alfaro,Fadl Zeineddine,Drew Goldstein,Nicholas Hornstein,Arvind Dasari,Ryan Huey,Benny Johnson,Victoria Higbie,Alisha Bent,Bryan Kee,Michael Lee,Maria Pia Morelli,Van Karlyle Morris,Daniel Halperin,Michael J Overman,Christine Parseghian,Eduardo Vilar,Robert Wolff,Kanwal P Raghav,Michael G White,Abhineet Uppal,Ryan Sun,Wenyi Wang,Scott Kopetz,Jason Willis,John Paul Shen","doi":"10.1001/jamaoncol.2024.3666","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.3666","url":null,"abstract":"ImportanceDisparity in overall survival (OS) and differences in the frequency of driver gene variants by race and ethnicity have been separately observed in patients with colorectal cancer; however, how these differences contribute to survival disparity is unknown.ObjectiveTo quantify the association of molecular, socioeconomic, and clinical covariates with racial and ethnic disparities in overall survival among patients with colorectal cancer.Design, Setting, and ParticipantsThis single-center cohort study was conducted at a tertiary-level cancer center using relevant data on all patients diagnosed with colorectal cancer from January 1, 1973, to March 1, 2023. The relative contribution of variables to the disparity was determined using mediation analysis with sequential multivariate Cox regression models.Main OutcomeOS, from diagnosis date and from start of first-line chemotherapy.ResultsThe study population of 47 178 patients (median [IQR] age, 57.0 [49-66] years; 20 465 [43.4%] females and 26 713 [56.6%] males; 3.0% Asian, 8.7% Black, 8.8% Hispanic, and 79.4% White individuals) had a median (IQR) follow-up from initial diagnosis of 124 (174) months and OS of 55 (145) months. Compared with White patients, Black patients had worse OS (hazard ratio [HR], 1.16; 95% CI, 1.09-1.24; P &lt;.001), whereas Asian and Hispanic patients had better OS (HR, 0.66; 95% CI, 0.59-0.74; P &lt;.001; and 0.86; 95% CI, 0.81-0.92; P &lt;.001, respectively). When restricted to patients with metastatic disease, the greatest disparity was between Black patients compared with White patients (HR, 1.2; 95% CI, 1.06-1.37; P &lt;.001). Evaluating changes in OS disparity over 20 years showed disparity decreasing among Asian, Hispanic, and White patients, but increasing between Black patients and White patients (HRs, 1.18; 95% CI, 1.07-1.31 for 2008-2012; 1.24, 95% CI, 1.08-1.42 for 2013-2017; and 1.50; 95% CI, 1.20-1.87 for 2018-2023). Survival outcomes for first-line chemotherapy were worse for Black patients compared with White patients (median OS, 18 vs 26 months; HR, 1.30; 95% CI, 1.01-1.70). Among 7628 patients who had clinical molecular testing, APC, KRAS, and PIK3CA showed higher variant frequency in Black patients (false discovery rate [FDR], 0.01; &lt; 0.001; and 0.01, respectively), whereas BRAF and KIT were higher among White patients (FDR, 0.001 and 0.01). Mediation analysis identified neighborhood socioeconomic status as the greatest contributor to OS disparity (29%), followed by molecular characteristics (microsatellite instability status, KRAS variation and BRAF variation, 10%), and tumor sidedness (9%).ConclusionsThis single-center cohort study identified substantial OS disparity and differing frequencies of driver gene variations by race and ethnicity. Socioeconomic status had the largest contribution but accounted for less than one-third of the disparity, with substantial contribution from tumor molecular features. Further study of the associations of genetic ancestry and ","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"69 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142174605","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Radiation-Associated Secondary Cancer in Patients With Breast Cancer Harboring TP53 Germline Variants. 携带 TP53 基因变异的乳腺癌患者中与辐射相关的继发性癌症
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-12 DOI: 10.1001/jamaoncol.2024.3683
Gustav Y Cederquist,Lillian A Boe,Michael Walsh,Gary M Freedman,Kara N Maxwell,Neil Taunk,Lior Z Braunstein
{"title":"Radiation-Associated Secondary Cancer in Patients With Breast Cancer Harboring TP53 Germline Variants.","authors":"Gustav Y Cederquist,Lillian A Boe,Michael Walsh,Gary M Freedman,Kara N Maxwell,Neil Taunk,Lior Z Braunstein","doi":"10.1001/jamaoncol.2024.3683","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.3683","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"59 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142174531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cervical Cancer Incidence in the US-Affiliated Pacific Islands. 隶属美国的太平洋岛屿的宫颈癌发病率。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-12 DOI: 10.1001/jamaoncol.2024.3675
Sameer V Gopalani,Jin Qin,Janos Baksa,Trevor D Thompson,Mona Saraiya,Virginia Senkomago,Paran Pordell,Youngju Jeong,Neal A Palafox,Martina Reichhardt,Lee E Buenconsejo-Lum
ImportanceThe World Health Organization has called for eliminating cervical cancer as a public health problem. Accurate and up-to-date estimates of population-based cervical cancer incidence are essential for monitoring progress toward elimination and informing local cancer control strategies, but these estimates are lacking for the US-Affiliated Pacific Islands (USAPI).ObjectiveTo calculate age-standardized incidence rates for cervical cancer in the 6 USAPI and compare these rates with rates in the US (50 states and the District of Columbia).Design, Setting, and ParticipantsThis cross-sectional study used population-based data from the Pacific Regional Central Cancer Registry for women aged 20 years or older who were diagnosed with invasive cervical cancer from January 1, 2007, to December 31, 2020. The registry comprises data on all cervical cancers from the USAPI, which include 3 US territories (American Samoa, Commonwealth of the Northern Mariana Islands, and Guam) and 3 freely associated states (Federated States of Micronesia [FSM], Republic of the Marshall Islands [RMI], and Republic of Palau). Data were analyzed from July 10, 2023, to November 28, 2023.Main Outcomes and MeasuresThe main outcome was age-standardized cervical cancer incidence rates, stratified by age, stage, and histologic code for the USAPI using population estimates from 3 different sources (US Census Bureau International Database, United Nations Population Division, and Pacific Data Hub). Rate ratios were calculated to compare incidence rates between the USAPI and the US.ResultsFrom 2007 to 2020, 409 cases of cervical cancer were diagnosed in the USAPI (median age at diagnosis, 46.0 years [25th-75th percentile, 39.0-55.0 years]), with an age-standardized incidence rate ranging from 21.7 (95% CI, 19.6-23.9) to 22.1 (95% CI, 20.0-24.4) per 100 000 women, depending on the population estimate. Incidence rates were highest in RMI, ranging from 58.1 (95% CI, 48.0-69.7) to 83.4 (95% CI, 68.3-101.0) per 100 000 women, followed by FSM, ranging from 28.7 (95% CI, 23.4-34.9) to 29.8 (95% CI, 24.3-36.3) per 100 000 women. Compared with the US, incidence rates were highest in RMI (rate ratio, 5.7 [95% CI, 4.7-6.8] to 8.2 [95% CI, 6.7-9.9]) and FSM (rate ratio; 2.8; 95% CI, 2.3-3.4). Of all cases in the USAPI, 213 (68.2%) were diagnosed at a late stage.Conclusions and RelevanceIn this cross-sectional study, cervical cancer remained a major public health issue in some USAPI, with RMI reporting the highest incidence rates. The findings suggest that improvements in human papillomavirus vaccination and cancer screening coverage through efforts tailored to the unique geographic, sociocultural, economic, and health care landscape of the USAPI may reduce the burden of cervical cancer.
重要性世界卫生组织呼吁消除宫颈癌这一公共卫生问题。准确和最新的宫颈癌发病率估计值对于监测消除宫颈癌的进展情况和为当地癌症控制策略提供信息至关重要,但美属太平洋岛屿(USAPI)却缺乏这些估计值。这项横断面研究使用了太平洋地区中央癌症登记处的人口数据,这些数据针对的是 2007 年 1 月 1 日至 2020 年 12 月 31 日期间被诊断出患有浸润性宫颈癌的 20 岁及以上女性。该登记处包括来自美国太平洋地区的所有宫颈癌数据,其中包括 3 个美国领地(美属萨摩亚、北马里亚纳群岛联邦和关岛)和 3 个自由联系州(密克罗尼西亚联邦、马绍尔群岛共和国和帕劳共和国)。主要结果和测量指标主要结果是年龄标准化的宫颈癌发病率,按年龄、分期和组织学代码进行分层,使用 3 个不同来源(美国人口普查局国际数据库、联合国人口司和太平洋数据中心)的人口估计值对美国亚太地区的宫颈癌发病率进行分析。结果从 2007 年到 2020 年,美国亚太地区共诊断出 409 例宫颈癌病例(诊断时的中位年龄为 46.0 岁 [第 25-75 百分位数,39.0-55.0 岁]),年龄标准化发病率为每 10 万名妇女中 21.7 例(95% CI,19.6-23.9 例)到 22.1 例(95% CI,20.0-24.4 例),具体取决于人口估计值。马绍尔群岛的发病率最高,每 100 000 名妇女中的发病率从 58.1(95% CI,48.0-69.7)到 83.4(95% CI,68.3-101.0)不等,其次是密克罗尼西亚联邦,每 100 000 名妇女中的发病率从 28.7(95% CI,23.4-34.9)到 29.8(95% CI,24.3-36.3)不等。与美国相比,RMI(比率比为 5.7 [95% CI, 4.7-6.8] 至 8.2 [95% CI, 6.7-9.9])和 FSM(比率比为 2.8; 95% CI, 2.3-3.4)的发病率最高。在美国亚太地区的所有病例中,有 213 例(68.2%)是在晚期确诊的。结论和相关性在这项横断面研究中,宫颈癌仍然是美国亚太地区一些国家的主要公共卫生问题,其中马绍尔群岛的发病率最高。研究结果表明,根据美国亚太地区独特的地理、社会文化、经济和医疗保健状况,提高人类乳头瘤病毒疫苗接种率和癌症筛查覆盖率,可以减轻宫颈癌的负担。
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引用次数: 0
Accrual to Radiotherapy Trials in the US-Pitfalls and Potential Solutions. 美国放疗试验的累积--陷阱与潜在解决方案。
IF 28.4 1区 医学 Q1 ONCOLOGY Pub Date : 2024-09-12 DOI: 10.1001/jamaoncol.2024.3663
Nina N Sanford,William A Hall
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引用次数: 0
期刊
JAMA Oncology
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