Jama Oncology最新文献

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Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial. Bintrafusp Alfa 用于铂类药物治疗失败后的复发性或转移性宫颈癌:一项非随机对照试验。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-25 DOI: 10.1001/jamaoncol.2024.2145
Michael Birrer, Guiling Li, Mayu Yunokawa, Jung-Yun Lee, Byoung Gie Kim, Christina Pimentel Oppermann, Qi Zhou, Shin Nishio, Aikou Okamoto, Xiaohua Wu, Linda Mileshkin, Ana Oaknin, Isabelle Ray-Coquard, Kosei Hasegawa, Genevieve Jehl, Yulia Vugmeyster, Sen Zhang, Marcis Bajars, Kan Yonemori
{"title":"Bintrafusp Alfa for Recurrent or Metastatic Cervical Cancer After Platinum Failure: A Nonrandomized Controlled Trial.","authors":"Michael Birrer, Guiling Li, Mayu Yunokawa, Jung-Yun Lee, Byoung Gie Kim, Christina Pimentel Oppermann, Qi Zhou, Shin Nishio, Aikou Okamoto, Xiaohua Wu, Linda Mileshkin, Ana Oaknin, Isabelle Ray-Coquard, Kosei Hasegawa, Genevieve Jehl, Yulia Vugmeyster, Sen Zhang, Marcis Bajars, Kan Yonemori","doi":"10.1001/jamaoncol.2024.2145","DOIUrl":"10.1001/jamaoncol.2024.2145","url":null,"abstract":"<p><strong>Importance: </strong>Cervical cancer is a common and lethal cancer worldwide. Bintrafusp alfa is a first-in-class bifunctional fusion protein composed of the extracellular domain of the human transforming growth factor β receptor II (or transforming growth factor β trap) fused via a flexible linker to the C-terminus of each heavy chain of an immunoglobulin G1 antibody blocking programmed cell death 1 ligand 1.</p><p><strong>Objective: </strong>To evaluate the safety and response rates of bintrafusp alfa in patients with recurrent or metastatic cervical cancer.</p><p><strong>Design, setting, and participants: </strong>This phase 2 nonrandomized controlled trial evaluated bintrafusp alfa monotherapy in patients with recurrent or metastatic cervical cancer with disease progression during or after platinum-based chemotherapy. Data were collected from March 2020 to February 2022.</p><p><strong>Intervention: </strong>Patients received bintrafusp alfa, 1200 mg, intravenously once every 2 weeks.</p><p><strong>Main outcomes and measures: </strong>The primary end point was confirmed objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by an independent review committee.</p><p><strong>Results: </strong>At data cutoff, 146 of 203 screened patients received 1 or more doses of bintrafusp alfa; of these, the median (range) age was 53 (24-79) years. The study met its primary end point of a 95% CI above the objective response rate benchmark of 15%, with a confirmed objective response rate of 21.9% (95% CI, 15.5-29.5) per the independent review committee. Of these patients, 19 (59.4%) had a durable response of 6 months or more. At data cutoff, responses were ongoing in 13 of 32 responders (40.6%). The most common treatment-related adverse events were anemia (25 [17.1%]), rash (21 [14.4%]), hypothyroidism (15 [10.3%]), and pruritus (15 [10.3%]). Any-cause adverse events of special interest included anemia (82[56.2%]), bleeding events (81 [55.5%]), and immune-related adverse events (49 [33.6%]).</p><p><strong>Conclusions and relevance: </strong>This phase 2 nonrandomized controlled trial of bintrafusp alfa met its primary end point, which may support the potential of a bispecific therapy targeting transforming growth factor β and programmed cell death 1 ligand 1 in patients with recurrent or metastatic cervical cancer.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04246489.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11273284/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
BRCA1, BRCA2, and Associated Cancer Risks and Management for Male Patients: A Review. 男性患者的 BRCA1、BRCA2 和相关癌症风险及管理:综述。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-25 DOI: 10.1001/jamaoncol.2024.2185
Heather H Cheng, Jeffrey W Shevach, Elena Castro, Fergus J Couch, Susan M Domchek, Rosalind A Eeles, Veda N Giri, Michael J Hall, Mary-Claire King, Daniel W Lin, Stacy Loeb, Todd M Morgan, Kenneth Offit, Colin C Pritchard, Edward M Schaeffer, Brittany M Szymaniak, Jason L Vassy, Bryson W Katona, Kara N Maxwell
{"title":"BRCA1, BRCA2, and Associated Cancer Risks and Management for Male Patients: A Review.","authors":"Heather H Cheng, Jeffrey W Shevach, Elena Castro, Fergus J Couch, Susan M Domchek, Rosalind A Eeles, Veda N Giri, Michael J Hall, Mary-Claire King, Daniel W Lin, Stacy Loeb, Todd M Morgan, Kenneth Offit, Colin C Pritchard, Edward M Schaeffer, Brittany M Szymaniak, Jason L Vassy, Bryson W Katona, Kara N Maxwell","doi":"10.1001/jamaoncol.2024.2185","DOIUrl":"10.1001/jamaoncol.2024.2185","url":null,"abstract":"<p><strong>Importance: </strong>Half of all carriers of inherited cancer-predisposing variants in BRCA1 and BRCA2 are male, but the implications for their health are underrecognized compared to female individuals. Germline variants in BRCA1 and BRCA2 (also known as pathogenic or likely pathogenic variants, referred to here as BRCA1/2 PVs) are well known to significantly increase the risk of breast and ovarian cancers in female carriers, and knowledge of BRCA1/2 PVs informs established cancer screening and options for risk reduction. While risks to male carriers of BRCA1/2 PVs are less characterized, there is convincing evidence of increased risk for prostate cancer, pancreatic cancer, and breast cancer in males. There has also been a rapid expansion of US Food and Drug Administration-approved targeted cancer therapies, including poly ADP ribose polymerase (PARP) inhibitors, for breast, pancreatic, and prostate cancers associated with BRCA1/2 PVs.</p><p><strong>Observations: </strong>This narrative review summarized the data that inform cancer risks, targeted cancer therapy options, and guidelines for early cancer detection. It also highlighted areas of emerging research and clinical trial opportunities for male BRCA1/2 PV carriers. These developments, along with the continued relevance to family cancer risk and reproductive options, have informed changes to guideline recommendations for genetic testing and strengthened the case for increased genetic testing for males.</p><p><strong>Conclusions and relevance: </strong>Despite increasing clinical actionability for male carriers of BRCA1/2 PVs, far fewer males than female individuals undergo cancer genetic testing. Oncologists, internists, and primary care clinicians should be vigilant about offering appropriate genetic testing to males. Identifying more male carriers of BRCA1/2 PVs will maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761829","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
Atezolizumab Before and After Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II Nonrandomized Controlled Trial. 化疗前后使用阿替珠单抗治疗不可切除的 III 期非小细胞肺癌:一项 II 期非随机对照试验。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-25 DOI: 10.1001/jamaoncol.2024.1897
Helen J Ross, David Kozono, Xiaofei F Wang, James John Urbanic, Terence M Williams, Garth D Nelson, David P Carbone, Dongjun Chung, Ryan Robb, Woo Yul Byun, Tiffany Talabere, Carter DuFrane, Ilze Bara, Katja Schulze, Michelle Brockman, Junheng Gao, Everett E Vokes, Thomas E Stinchcombe
{"title":"Atezolizumab Before and After Chemoradiation for Unresectable Stage III Non-Small Cell Lung Cancer: A Phase II Nonrandomized Controlled Trial.","authors":"Helen J Ross, David Kozono, Xiaofei F Wang, James John Urbanic, Terence M Williams, Garth D Nelson, David P Carbone, Dongjun Chung, Ryan Robb, Woo Yul Byun, Tiffany Talabere, Carter DuFrane, Ilze Bara, Katja Schulze, Michelle Brockman, Junheng Gao, Everett E Vokes, Thomas E Stinchcombe","doi":"10.1001/jamaoncol.2024.1897","DOIUrl":"10.1001/jamaoncol.2024.1897","url":null,"abstract":"<p><strong>Importance: </strong>Outcomes for patients with unresectable stage III non-small cell lung cancer (NSCLC) treated with chemoradiation therapy (CRT) have improved with adjuvant immune checkpoint inhibitors, with a reported 5-year overall survival benefit of approximately 10% for adjuvant durvalumab vs placebo after completion of CRT without progression and with preserved performance status. Starting atezolizumab prior to CRT may allow more patients to benefit from immunotherapy.</p><p><strong>Objective: </strong>To evaluate clinical outcomes of patients treated with atezolizumab before and after CRT for unresectable stage III NSCLC.</p><p><strong>Design, setting, and participants: </strong>This single-cohort, phase II, nonrandomized controlled trial was conducted at 11 US sites. Patients with pathologically confirmed, unresectable stage III NSCLC who were treatment naive and had good performance status were enrolled between January 3, 2018, and July 24, 2019. Data were locked on March 21, 2023.</p><p><strong>Interventions: </strong>Patients received four 21-day cycles of atezolizumab, 1200 mg intravenously, with therapy administered on day 1 of each cycle. Patients not experiencing tumor progression continued to CRT (60 Gy to involved fields) concurrent with weekly carboplatin area under the curve of 2 and paclitaxel, 50 mg/m2, followed by planned consolidation carboplatin area under the curve of 6 and paclitaxel, 200 mg/m2, for two 21-day cycles. Patients not experiencing progression continued atezolizumab, 1200 mg, every 21 days to complete 1 year of therapy.</p><p><strong>Main outcomes and measures: </strong>The primary end point was the disease control rate at 12 weeks. Secondary end points were progression-free survival, overall survival, overall response rate, safety, and translational science end points.</p><p><strong>Results: </strong>A total of 62 patients (median [range] age, 63.9 [38.1-86.5] years; 32 female [51.6%]) were enrolled and received at least 1 dose of atezolizumab. The disease control rate at 12 weeks was 74.2% (80% CI, 65.7%-81.4%). Median progression-free survival was 30.0 months (95% CI, 15.8 to not evaluable), and the median overall survival was not reached. The overall survival rate at 24 months was 73.7% (95% CI, 63.4%-85.7%), and the overall response rate was 66.2%. Seventeen patients (27.4%) experienced grade 3 or higher immune-related adverse events, including 1 with grade 5 pneumonitis and 1 with grade 4 Guillain-Barré syndrome. Thirty patients (48.4%) experienced grade 3 or higher treatment-related adverse events.</p><p><strong>Conclusions and relevance: </strong>These findings suggest that neoadjuvant atezolizumab merits further study based on safety and encouraging outcomes.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03102242.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11273282/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761825","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cara. 卡拉
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-25 DOI: 10.1001/jamaoncol.2024.2188
Danielle Chammas
{"title":"Cara.","authors":"Danielle Chammas","doi":"10.1001/jamaoncol.2024.2188","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.2188","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141761830","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
Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized ControlledTrial. 前列腺癌新辅助运动疗法:一期分散非随机对照试验》。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-18 DOI: 10.1001/jamaoncol.2024.2156
Lee W Jones, Chaya S Moskowitz, Catherine P Lee, Gina A Fickera, Su S Chun, Meghan G Michalski, Kurtis Stoeckel, Whitney P Underwood, Jessica A Lavery, Umeshkumar Bhanot, Irina Linkov, Chau T Dang, Behfar Ehdaie, Vincent P Laudone, James A Eastham, Anne Collins, Patricia T Sheerin, Lydia Y Liu, Stefan E Eng, Paul C Boutros
{"title":"Neoadjuvant Exercise Therapy in Prostate Cancer: A Phase 1, Decentralized Nonrandomized ControlledTrial.","authors":"Lee W Jones, Chaya S Moskowitz, Catherine P Lee, Gina A Fickera, Su S Chun, Meghan G Michalski, Kurtis Stoeckel, Whitney P Underwood, Jessica A Lavery, Umeshkumar Bhanot, Irina Linkov, Chau T Dang, Behfar Ehdaie, Vincent P Laudone, James A Eastham, Anne Collins, Patricia T Sheerin, Lydia Y Liu, Stefan E Eng, Paul C Boutros","doi":"10.1001/jamaoncol.2024.2156","DOIUrl":"10.1001/jamaoncol.2024.2156","url":null,"abstract":"<p><strong>Importance: </strong>Observational data have shown that postdiagnosis exercise is associated with reduced risk of prostate cancer death. The feasibility and tumor biological activity of exercise therapy is not known.</p><p><strong>Objective: </strong>To identify recommended phase 2 dose of exercise therapy for patients with prostate cancer.</p><p><strong>Design, setting, and participants: </strong>This single-center, phase 1a dose-finding trial was conducted at a tertiary cancer center using a patientcentric, decentralized platform and included 53 inactive men with treatment-naive localized prostate cancer scheduled to undergo surgical resection between June 2019 and January 2023. Data were analyzed in June 2024.</p><p><strong>Intervention: </strong>Six escalated exercise therapy dose levels ranging from 90 to 450 minutes per week of individualized, moderate-intensity treadmill walking, allocated using adaptive continual reassessment. All exercise therapy sessions were conducted remotely with real-time monitoring.</p><p><strong>Main outcomes and measures: </strong>Feasibility was evaluated by relative exercise dose intensity (REDI). A dose level was considered feasible if 70% or more of patients achieved an REDI of 75% or greater. Activity end points were changes in tumor cell proliferation (Ki67) and plasma prostate-specific antigen levels between pretreatment and postintervention. Safety and changes in patient physiology were also assessed.</p><p><strong>Results: </strong>A total of 53 men were enrolled (median [IQR] age, 61 [56-66] years). All dose levels were feasible (≥75% REDI). The mean (95% CI) changes in Ki67 were 5.0% (-4.3% to 14.0%) for 90 minutes per week, 2.4% (-1.3% to 6.2%) for 150 minutes per week, -1.3% (-5.8% to 3.3%) for 225 minutes per week, -0.2% (-4.0% to 3.7%) for 300 minutes per week, -2.6% (-9.2% to 4.1%) for 375 minutes per week, and 2.2% (-0.8% to 5.1%) for 450 minutes per week. Changes in prostate-specific antigen levels were 1.0 ng/mL (-1.8 to 3.8) for 90 minutes per week, 0.2 ng/mL (-1.1 to 1.5) for 150 minutes per week, -0.5 ng/mL (-1.2 to 0.3) for 225 minutes per week, -0.2 (-1.7 to 1.3) for 300 minutes per week, -0.7 ng/mL (-1.7 to 0.4) for 375 minutes per week, and -0.9 ng/mL (-2.4 to 0.7) for 450 minutes per week. No serious adverse events were observed. Overall, 225 minutes per week (approximately 5 minutes per treatment at 5 times weekly) was selected as the recommended phase 2 dose.</p><p><strong>Conclusions and relevance: </strong>The results of this nonrandomized clinical trial suggest that neoadjuvant exercise therapy is feasible and safe with promising activity in localized prostate cancer.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT03813615.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11258635/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Exercise for Prostate Cancer-Worthy Goals but Suboptimal Trial Designs. 运动治疗前列腺癌--目标值得实现,但试验设计不够理想。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-18 DOI: 10.1001/jamaoncol.2024.2057
Marian L Neuhouser, Jeannette M Schenk, Jonathan L Wright
{"title":"Exercise for Prostate Cancer-Worthy Goals but Suboptimal Trial Designs.","authors":"Marian L Neuhouser, Jeannette M Schenk, Jonathan L Wright","doi":"10.1001/jamaoncol.2024.2057","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.2057","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635053","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
Advancing Genomic Cancer Medicine in Rural and Underserved States. 在农村和缺乏服务的州推进基因组癌症医学。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-18 DOI: 10.1001/jamaoncol.2024.1926
Jens Rueter, Edison T Liu
{"title":"Advancing Genomic Cancer Medicine in Rural and Underserved States.","authors":"Jens Rueter, Edison T Liu","doi":"10.1001/jamaoncol.2024.1926","DOIUrl":"https://doi.org/10.1001/jamaoncol.2024.1926","url":null,"abstract":"","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635052","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
Immunotherapy vs Best Supportive Care for Patients With Hepatocellular Cancer With Child-Pugh B Dysfunction. 免疫疗法与最佳支持性治疗对伴有 Child-Pugh B 功能障碍的肝细胞癌患者的疗效对比。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-18 DOI: 10.1001/jamaoncol.2024.2166
Claudia Angela Maria Fulgenzi, Bernhard Scheiner, Antonio D'Alessio, Aman Mehan, Giulia F Manfredi, Ciro Celsa, Naoshi Nishida, Celina Ang, Thomas U Marron, Linda Wu, Anwaar Saeed, Brooke Wietharn, Antonella Cammarota, Tiziana Pressiani, Matthias Pinter, Rohini Sharma, Jaekyung Cheon, Yi-Hsiang Huang, Pei-Chang Lee, Samuel Phen, Anuhya Gampa, Anjana Pillai, Andrea Napolitano, Caterina Vivaldi, Francesca Salani, Gianluca Masi, Marianna Silletta, Federica Lo Prinzi, Emanuela Di Giacomo, Bruno Vincenzi, Dominik Bettinger, Robert Thimme, Arndt Vogel, Martin Schönlein, Johann von Felden, Kornelius Schulze, Henning Wege, Peter R Galle, Mario Pirisi, Joong-Won Park, Masatoshi Kudo, Lorenza Rimassa, Amit G Singal, Paul El Tomb, Susanna Ulahannan, Alessandro Parisi, Hong Jae Chon, Wei-Fan Hsu, Giorgia Ghittoni, Calogero Cammà, Benedetta Stefanini, Franco Trevisani, Edoardo G Giannini, Alessio Cortellini, David James Pinato
{"title":"Immunotherapy vs Best Supportive Care for Patients With Hepatocellular Cancer With Child-Pugh B Dysfunction.","authors":"Claudia Angela Maria Fulgenzi, Bernhard Scheiner, Antonio D'Alessio, Aman Mehan, Giulia F Manfredi, Ciro Celsa, Naoshi Nishida, Celina Ang, Thomas U Marron, Linda Wu, Anwaar Saeed, Brooke Wietharn, Antonella Cammarota, Tiziana Pressiani, Matthias Pinter, Rohini Sharma, Jaekyung Cheon, Yi-Hsiang Huang, Pei-Chang Lee, Samuel Phen, Anuhya Gampa, Anjana Pillai, Andrea Napolitano, Caterina Vivaldi, Francesca Salani, Gianluca Masi, Marianna Silletta, Federica Lo Prinzi, Emanuela Di Giacomo, Bruno Vincenzi, Dominik Bettinger, Robert Thimme, Arndt Vogel, Martin Schönlein, Johann von Felden, Kornelius Schulze, Henning Wege, Peter R Galle, Mario Pirisi, Joong-Won Park, Masatoshi Kudo, Lorenza Rimassa, Amit G Singal, Paul El Tomb, Susanna Ulahannan, Alessandro Parisi, Hong Jae Chon, Wei-Fan Hsu, Giorgia Ghittoni, Calogero Cammà, Benedetta Stefanini, Franco Trevisani, Edoardo G Giannini, Alessio Cortellini, David James Pinato","doi":"10.1001/jamaoncol.2024.2166","DOIUrl":"10.1001/jamaoncol.2024.2166","url":null,"abstract":"<p><strong>Importance: </strong>Whether patients with Child-Pugh class B (CP-B) cancer with unresectable hepatocellular carcinoma (uHCC) benefit from active anticancer treatment vs best supportive care (BSC) is debated.</p><p><strong>Objective: </strong>To evaluate the association of immune checkpoint inhibitor (ICI)-based therapies vs BSC with overall survival (OS) of patients with uHCC and CP-B liver dysfunction.</p><p><strong>Design, setting, and participants: </strong>This retrospective, multicenter, international clinical case series examined data of patients with CP-B with uHCC who were receiving first-line ICI-based regimens from September 2017 to December 2022 whose data were extracted from an international consortium and compared with a cohort of patients with CP-B receiving BSC. Patients were treated in tertiary care centers across Europe, US, and Asia in routine clinical practice. After applying the inclusion criteria, 187 and 156 patients were left in the ICI and BSC groups, respectively. The propensity score was calculated for the following variables: age, alpha-fetoprotein levels, Child-Pugh score, extrahepatic spread, portal vein tumor thrombosis, cirrhosis, ascites, and baseline Eastern Cooperative Oncology Group performance status.</p><p><strong>Exposures: </strong>Patients in the ICI group received first-line systemic therapy with either atezolizumab plus bevacizumab (A+B) (n = 141) or nivolumab (n = 46).</p><p><strong>Main outcomes and measures: </strong>OS in the inverse probability of treatment weighting (IPTW) populations was the main outcome, and it was estimated with Kaplan-Meier method; univariable Cox regression test was used to make comparisons between the 2 groups.</p><p><strong>Results: </strong>The median age was 66 (IQR, 61-72) and 73 (IQR, 66-81) years in the ICI (33 women [18%]) and BSC groups (41 women [26%]), respectively. In the IPTW populations, median OS was significantly longer in the ICI group (7.50 months; 95% CI, 5.62-11.15) compared with BSC (4.04 months; 95% CI, 3.03-5.03; hazard ratio, 0.59; 95% CI, 0.43-0.80; P < .001). Multivariable analysis confirmed that ICI exposure was associated with a reduction of approximately 50% in the risk of death (hazard ratio, 0.55; 95% CI, 0.35-0.86; P < .001), and the presence of portal vein tumor thrombosis, an Eastern Cooperative Oncology Group performance score of greater than 1, and alpha-fetoprotein levels of 400 ng/mL or greater were associated with increased risk of death.</p><p><strong>Conclusions and relevance: </strong>The results of this case series provide comparative evidence of improved survival in association with ICI treatment compared with BSC in patients with uHCC with CP-B liver dysfunction.</p>","PeriodicalId":48661,"journal":{"name":"Jama Oncology","volume":null,"pages":null},"PeriodicalIF":28.4,"publicationDate":"2024-07-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11258634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141635054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Chemotherapy, Radiation Therapy, and Nasopharyngeal Carcinoma. 化疗、放疗和鼻咽癌。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-11 DOI: 10.1001/jamaoncol.2024.2522
Cho-Yin Lee, Ti-Hao Wang, Yung-Shuo Kao
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引用次数: 0
Chemotherapy, Radiation Therapy, and Nasopharyngeal Carcinoma. 化疗、放疗和鼻咽癌。
IF 28.4 1区 医学
Jama Oncology Pub Date : 2024-07-11 DOI: 10.1001/jamaoncol.2024.2519
Pantea Bayatfard, Sezin Yuce Sari, Gozde Yazici
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引用次数: 0
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