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Drug development trajectory of anticancer drugs after initial pediatric-eligible trials. 经过最初的儿科合格试验后抗癌药物的发展轨迹。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70433
Samantha D Martin, Danial Pitafi, Florence Bourgeois, Steven G DuBois
{"title":"Drug development trajectory of anticancer drugs after initial pediatric-eligible trials.","authors":"Samantha D Martin, Danial Pitafi, Florence Bourgeois, Steven G DuBois","doi":"10.1002/cncr.70433","DOIUrl":"10.1002/cncr.70433","url":null,"abstract":"<p><strong>Background: </strong>Attrition of new therapies is a major concern in oncology drug development. Little is known about subsequent drug development milestones once an oncology agent has entered clinical testing in children and adolescents.</p><p><strong>Methods: </strong>This study identified 191 cancer drugs that first entered clinical trials between 2005 and 2020 and for which patients <18 years were eligible. The authors tracked subsequent drug development and regulatory milestones through 2025. They calculated Kaplan-Meier cumulative incidence rates of reaching each milestone, and they calculated Cox hazard rates according to features of the drug and trial characteristics.</p><p><strong>Results: </strong>The majority (62.8%) of the 191 identified drugs were small molecule inhibitors. The majority of trials evaluated single agents (66.5%) and were multicenter trials (77.9%). At 10 years from first pediatric-eligible trials, the cumulative incidence rates of subsequent phase 1, phase 2, and phase 3 trials were 56.1%, 63.0%, and 17.7%, respectively. Of 191 drugs, 71 (37.2%) had no new trials that allowed patients <18 years of age for 5 or more years from first pediatric-eligible trial. For drugs not already approved at time of initial pediatric-eligible trial, the 10-year cumulative incidence rates for subsequent pediatric Food and Drug Administration and European Medicines Agency approval were 12.0% and 5.6%, respectively. Initial trial phase and drug regulatory status at time of initial pediatric-eligible trial were the most consistent determinants of achieving subsequent drug development milestones.</p><p><strong>Conclusions: </strong>Oncology drugs entering testing in children and adolescents are at high risk of attrition, including low rates of subsequent late phase trials and pediatric regulatory approvals.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70433"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758150","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Metabolic syndrome and risk of kidney cancer in the United States. 代谢综合征和肾癌的风险在美国。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70435
Minji Jung, Xiaoyu Wang, Sun Y Jeon, Rebecca E Graff, Zhengyi Deng, Kevin L'Espérance, Mingyi Li, Marvin E Langston, Benjamin I Chung
{"title":"Metabolic syndrome and risk of kidney cancer in the United States.","authors":"Minji Jung, Xiaoyu Wang, Sun Y Jeon, Rebecca E Graff, Zhengyi Deng, Kevin L'Espérance, Mingyi Li, Marvin E Langston, Benjamin I Chung","doi":"10.1002/cncr.70435","DOIUrl":"10.1002/cncr.70435","url":null,"abstract":"<p><strong>Background: </strong>Metabolic dysregulation may contribute to kidney cancer development through shared biological mechanisms and/or as an independent risk factor. However, evidence on this association in the US population remains limited.</p><p><strong>Objective: </strong>This study identifies associations between metabolic syndrome (MetS) and kidney cancer risk in the United States.</p><p><strong>Methods: </strong>This case-control study using administrative claims data from the MarketScan database (2007-2022) identified adult kidney cancer cases and 1:10 frequency-matched controls by age, index year, sex, insurance duration, and region. Metabolic exposures (obesity, hypertension, diabetes, and dyslipidemia) were assessed using diagnoses and prescriptions, with binary classification (MetS: ≥3 conditions; non-MetS: <3). Secondary analyses examined pre-MetS (1-2 conditions), metabolically healthy, dose-response relationships, combinations of conditions, and interaction between obesity and MetS. Multivariable logistic regression models were used to estimate odds ratios (ORs) and 95% confidence intervals (CIs).</p><p><strong>Results: </strong>A total of 48,587 kidney cancer cases and 480,714 controls were included. MetS was associated with an increased risk of kidney cancer compared with non-MetS (OR, 1.43; 95% CI, 1.39-1.47). MetS (OR, 1.83; 95% CI, 1.77-1.88) and pre-MetS (OR, 1.47; 95% CI, 1.44-1.50) were associated with a higher risk compared with metabolically healthy. Each additional condition was associated with a 22% increase in the odds (95% CI, 1.21-1.23). Multiple conditions had higher odds than a single condition. Metabolically healthy obesity (OR, 1.48) and metabolically unhealthy obesity (OR, 1.77) showed stronger associations than metabolically healthy nonobesity.</p><p><strong>Conclusion: </strong>MetS was associated with an increased risk of kidney cancer, highlighting the importance of overall metabolic health in its prevention.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70435"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758059","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Comparing the quality of dying for patients with hematological malignancy and solid tumors: A bereavement study in Japan. 血液病恶性肿瘤和实体瘤患者死亡质量的比较:日本的一项丧亲研究。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70438
Shohei Ikeda, Yusuke Hiratsuka, Yoko Nakazawa, Mitsunori Miyashita, Tatsuya Morita, Yasuyuki Okumura, Yoshiyuki Kizawa, Shohei Kawagoe, Hiroshi Yamamoto, Emi Takeuchi, Risa Yamazaki, Asao Ogawa
{"title":"Comparing the quality of dying for patients with hematological malignancy and solid tumors: A bereavement study in Japan.","authors":"Shohei Ikeda, Yusuke Hiratsuka, Yoko Nakazawa, Mitsunori Miyashita, Tatsuya Morita, Yasuyuki Okumura, Yoshiyuki Kizawa, Shohei Kawagoe, Hiroshi Yamamoto, Emi Takeuchi, Risa Yamazaki, Asao Ogawa","doi":"10.1002/cncr.70438","DOIUrl":"10.1002/cncr.70438","url":null,"abstract":"<p><strong>Background: </strong>Although research on palliative care in hematological malignancies has increased, research examining quality of death (QOD) and quality of care (QOC) in this population remains limited. This study compared QOD and QOC between patients with hematological malignancies and those with solid tumors.</p><p><strong>Methods: </strong>The authors conducted a secondary analysis of a nationwide mortality follow-up survey of bereaved family members in Japan (2017-2018). The study included 3575 decedents with hematological malignancies and 50,592 with solid tumors. Propensity score matching was performed to adjust for demographic and clinical characteristics. QOD and QOC were assessed using the Good Death Inventory (GDI) and the Care Evaluation Scale 2.0 (CES). Bivariate analyses compared the matched groups.</p><p><strong>Results: </strong>Overall, QOD and QOC were comparable between groups. However, among the GDI subdomains, patients with hematological malignancies had slightly lower scores for \"good relationships with family\" (mean difference, 0.2; 95% confidence interval [CI], 0.03-0.3) and \"preparation for death\" (mean difference, 0.2; 95% CI, 0.04-0.3). In addition, patients with hematological malignancies were less likely to die in palliative care units than those with solid tumors (mean difference, 3.9%; 95% CI, 0.4%-7.4%).</p><p><strong>Conclusions: </strong>Although overall quality measures were similar, specific QOD domains related to family relationships and preparation for death were slightly lower among patients with hematological malignancies. These findings may reflect limited opportunities for end-of-life discussions due to the unpredictable and rapidly progressive course of hematological malignancies. Enhancing communication about prognosis and goals of care and early integration of palliative care may improve end-of-life experiences.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70438"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13135128/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147809040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Poverty in the residential and surrounding counties and its impact on mortality in women with breast cancer. 居住和周边县的贫困及其对乳腺癌妇女死亡率的影响。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70414
Ifeoma Nwigwe, Ramkrishnan V Tenkasi, Michael R Desjardins, Kala Visvanathan
{"title":"Poverty in the residential and surrounding counties and its impact on mortality in women with breast cancer.","authors":"Ifeoma Nwigwe, Ramkrishnan V Tenkasi, Michael R Desjardins, Kala Visvanathan","doi":"10.1002/cncr.70414","DOIUrl":"10.1002/cncr.70414","url":null,"abstract":"<p><strong>Background: </strong>The influence of poverty on cancer outcomes beyond a woman's county of residence remains understudied, despite individuals frequently interacting within a larger ecosocial system.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted to investigate whether high poverty in residential and surrounding counties is associated with increased mortality. Women from the National Cancer Institute Surveillance, Epidemiology, and End Results database ≥20 years of age, diagnosed with primary breast cancer between 2005 and 2014, and who survived at least 1 year (N = 36,711) were included. Participants were aggregated by their county of residence and linked to their American Community Survey 5-year poverty estimates. Local Moran's I was used to categorize residential and surrounding county poverty environments as high or low using a mean cutoff. Multivariable-adjusted negative binomial regression was used to evaluate mortality relative risk (MRR) and 95% CIs for the association between residential and surrounding county poverty on all-cause mortality.</p><p><strong>Results: </strong>Women in high-poverty residential (Hr) counties had a 6% increase in death (MRR = 1.06; 95% CI, 1.01-1.10) compared to women in low-poverty residential counties (Lr). Women surrounded by high-poverty (Hs) counties had a 22% increase in death (MRR = 1.22; 95% CI, 1.13-1.31) compared to women surrounded by low-poverty (Ls) counties. The combined MRR for women in Hr-Hs, Lr-Hs, and Hr-Ls counties was 1.23 (95% CI, 1.13-1.33), 1.25 (95% CI, 1.02-1.51), and 1.08 (95% CI, 0.95-1.21), respectively, when compared to Lr-Ls counties.</p><p><strong>Conclusion: </strong>Poverty in the surrounding counties has a greater impact on mortality among survivors than residential county poverty alone. Incorporating poverty levels from both residential and surrounding counties can improve definitions of high- and low-risk regions after a breast cancer diagnosis.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70414"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147757640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
GLP-1 RAs could reduce risk of developing colorectal cancer. GLP-1 RAs可降低结直肠癌的发生风险。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70367
Leah Lawrence
{"title":"GLP-1 RAs could reduce risk of developing colorectal cancer.","authors":"Leah Lawrence","doi":"10.1002/cncr.70367","DOIUrl":"https://doi.org/10.1002/cncr.70367","url":null,"abstract":"","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70367"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147831399","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Disability-adjusted life-years from human papillomavirus-related oral cavity and pharynx cancers in US men, 2017-2021. 2017-2021年美国男性人乳头瘤病毒相关口腔和咽喉癌致残调整生命年
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70412
Harshank V Patel, Madison C Laird, Michael D Crone, Tjasa Hranjec, Vanita Motiani, Fehmida M Laxmidhar, Iman E E Mohamed, Akshay Amaraneni, Manish R Patel, Kevin A Ault, Philip J Kroth
{"title":"Disability-adjusted life-years from human papillomavirus-related oral cavity and pharynx cancers in US men, 2017-2021.","authors":"Harshank V Patel, Madison C Laird, Michael D Crone, Tjasa Hranjec, Vanita Motiani, Fehmida M Laxmidhar, Iman E E Mohamed, Akshay Amaraneni, Manish R Patel, Kevin A Ault, Philip J Kroth","doi":"10.1002/cncr.70412","DOIUrl":"10.1002/cncr.70412","url":null,"abstract":"<p><strong>Background: </strong>Squamous cell oropharyngeal cancer (OPC) incidence in men has surpassed cervical cancer in women as the most common cancer linked to high-risk human papillomavirus (HPV). However, vaccine uptake remains suboptimal in both sexes. The objectives of this study were to quantify disability-adjusted life-years (DALYs) because of HPV-associated OPC in US men from 2017 to 2021 and to highlight the potential impact of widespread vaccination.</p><p><strong>Methods: </strong>Crude incidence counts and 12-month survival rates were extracted from the National Cancer Institute's Surveillance, Epidemiology, and End Results SEER 17 database for OPC of the tonsils and tongue base. HPV-attributable cases were estimated by using population-attributable fractions. DALYs were calculated as the sum of years of life lost, years lived with disability among survivors, and years lived with disability among decedents. The annual percent change was used to assess trends.</p><p><strong>Results: </strong>From 2017 to 2021 in US men, average annual DALYs were highest for tonsillar cancers (n = 58,979), followed by base of tongue cancers (n = 40,440). DALYs decreased significantly for cancers of the tonsils (annual percent change, -2.44%) and the base of tongue (annual percent change, -4.28%). Among adults aged 65 years and older, DALYs increased for both subsites.</p><p><strong>Conclusions: </strong>Tonsillar cancers carried the highest DALY burden among HPV-associated OPCs in US men. Patients who were aged 65 years and older and were never vaccine-eligible presented significant DALY increases across all cancer subsites, emphasizing the need for gender-neutral HPV vaccination and catch-up programs for high-risk older men.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70412"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Two trials bring new advances for patients with metastatic colorectal cancer: First-line data show longer disease control in MSI-H/dMMR and higher responses in BRAF V600E. 两项试验为转移性结直肠癌患者带来了新的进展:一线数据显示MSI-H/dMMR的疾病控制时间更长,BRAF V600E的反应更高。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70368
Leah Lawrence
{"title":"Two trials bring new advances for patients with metastatic colorectal cancer: First-line data show longer disease control in MSI-H/dMMR and higher responses in BRAF V600E.","authors":"Leah Lawrence","doi":"10.1002/cncr.70368","DOIUrl":"https://doi.org/10.1002/cncr.70368","url":null,"abstract":"","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70368"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147831359","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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 chemotherapy for soft-tissue sarcoma of the extremities: A post-hoc Sarculator-based risk analysis of the EORTC 62961-ESHO 95 randomized trial. 肢体软组织肉瘤的新辅助化疗:EORTC 62961-ESHO 95随机试验的事后基于血管因子的风险分析
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70427
Markus Albertsmeier, Valeria Milani, Lars H Lindner, Gabriele Tinè, Sandro Pasquali, Dario Callegaro, Alessandro Gronchi, Hans-Roland Dürr, Alexander Klein, Dorit Di Gioia, Sultan Abdel-Rahman, Michael Schmidt, Jens Werner, Michael von Bergwelt-Baildon, Rosalba Miceli, Rolf Issels
{"title":"Neoadjuvant chemotherapy for soft-tissue sarcoma of the extremities: A post-hoc Sarculator-based risk analysis of the EORTC 62961-ESHO 95 randomized trial.","authors":"Markus Albertsmeier, Valeria Milani, Lars H Lindner, Gabriele Tinè, Sandro Pasquali, Dario Callegaro, Alessandro Gronchi, Hans-Roland Dürr, Alexander Klein, Dorit Di Gioia, Sultan Abdel-Rahman, Michael Schmidt, Jens Werner, Michael von Bergwelt-Baildon, Rosalba Miceli, Rolf Issels","doi":"10.1002/cncr.70427","DOIUrl":"10.1002/cncr.70427","url":null,"abstract":"<p><strong>Background: </strong>In the EORTC 62961-ESHO 95 randomized trial (European Organization for Research and Treatment 62961-European Society of Hyperthermia Oncology 95; ClinicalTrials.gov identifier NCT00003052), neoadjuvant chemotherapy (NAC) combined with regional hyperthermia (RHT) improved survival in patients with soft tissue sarcoma (tumor size >5 cm, grade 2 or 3, deep location). This study investigated the survival benefit of NAC + RHT in a subgroup of patients who had extremity soft tissue sarcoma (ESTS) according to risk predictions using the Sarculator nomogram.</p><p><strong>Methods: </strong>Overall survival (OS) was predicted with the Sarculator nomogram using baseline prognostic parameters. Kaplan-Meier analysis was used to estimate observed OS. A bivariable Cox model including the Sarculator score, treatment, and their interaction was fitted. Hazard ratios for OS were calculated for each decile of the Sarculator risk distribution.</p><p><strong>Results: </strong>Of 143 patients with ESTS, 135 were analyzed (NAC, n = 70; NAC + RHT, n = 65) with a median follow-up of 136 months (interquartile range, 110-183 months). Survival in the NAC + RHT group exceeded Sarculator predictions and improved compared with the group that received NAC alone (hazard ratio, 0.67; 95% confidence interval, 0.39-1.17; p = .081), with an absolute 5-year OS difference of 15.6% (95% confidence interval, 0.0%-31.4%). Risk stratification suggested greater benefit of NAC + RHT as predicted OS decreased. However, the interaction between Sarculator score and treatment was not significant (p = .495).</p><p><strong>Conclusions: </strong>This analysis of ESTS from a randomized trial confirmed the previously reported OS benefit by adding RHT to NAC. Although patients with higher predicted risk seemed to benefit more from the combined treatment, these findings do not suggest that treatment decisions should be based on risk estimates alone, supporting the use of RHT combined with chemotherapy in patients who have primary ESTS.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70427"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13110853/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758125","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies. Fianlimab是一种人淋巴细胞活化基因-3单克隆抗体,与cemiplimab联合使用:肿瘤特异性扩展队列治疗晚期恶性肿瘤。
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70396
Tae Min Kim, Stephen K Williamson, Kyriakos P Papadopoulos, Omid Hamid, Grace K Dy, Ray McDermott, Ariel Birnbaum, John M Kaczmar, Nehal Lakhani, Danny Rischin, Debashis Sarker, Afshin Dowlati, Xin-Hua Zhu, Jyoti Malhotra, Jean-Francois Pouliot, Jayakumar Mani, Laura Brennan, Fang Fang, Shuquan Chen, Mark Salvati, Israel Lowy, Ahmed Khaled, Karl D Lewis, Glenn Kroog, Matthew G Fury, Byoung Chul Cho
{"title":"Fianlimab, a human lymphocyte activation gene-3 monoclonal antibody, in combination with cemiplimab: Tumor-specific expansion cohorts in advanced malignancies.","authors":"Tae Min Kim, Stephen K Williamson, Kyriakos P Papadopoulos, Omid Hamid, Grace K Dy, Ray McDermott, Ariel Birnbaum, John M Kaczmar, Nehal Lakhani, Danny Rischin, Debashis Sarker, Afshin Dowlati, Xin-Hua Zhu, Jyoti Malhotra, Jean-Francois Pouliot, Jayakumar Mani, Laura Brennan, Fang Fang, Shuquan Chen, Mark Salvati, Israel Lowy, Ahmed Khaled, Karl D Lewis, Glenn Kroog, Matthew G Fury, Byoung Chul Cho","doi":"10.1002/cncr.70396","DOIUrl":"10.1002/cncr.70396","url":null,"abstract":"<p><strong>Background: </strong>The dose escalation phase of a first-in-human (FIH) study demonstrated acceptable safety and preliminary antitumor activity of fianlimab (anti-lymphocyte activation gene-3 [LAG-3]) as monotherapy and in combination with cemiplimab (anti-programmed cell death-1 [PD-1]). Here, the authors present safety and clinical activity data from the dose-expansion portion of the FIH study in patients with advanced non-small cell lung cancer (NSCLC), clear cell renal cell carcinoma (ccRCC), head and neck squamous cell carcinoma (HNSCC), and cutaneous squamous cell carcinoma (CSCC).</p><p><strong>Methods: </strong>Anti-PD-1/PD-L1 naive (N) or experienced (E) patients with advanced NSCLC, ccRCC, HNSCC, and CSCC were enrolled in this phase 1 study (NCT03005782). Patients received fianlimab 1600 mg plus cemiplimab 350 mg intravenously every 3 weeks for up to 24 months. The primary end point was the objective response rate (ORR) per RECIST 1.1.</p><p><strong>Results: </strong>Investigator-assessed ORR was 27% in NSCLC-N (four partial responses [PRs]), 7% in NSCLC-E (one PR), 20% in ccRCC-N (three PRs), 7% in ccRCC-E (one PR), 33% in HNSCC-N (five PRs), 7% in HNSCC-E (one PR), and 20% CSCC-E (two complete responses; one PR). The most common treatment-related treatment-emergent adverse events among patients across all cohorts were fatigue (15%), rash (12%), pruritus (10%), infusion-related reaction (10%), and adrenal insufficiency (10%).</p><p><strong>Conclusions: </strong>Fianlimab plus cemiplimab demonstrated modest clinical efficacy with an acceptable safety profile in patients with advanced malignancies across several tumor types mostly in treatment-naive patients. Further investigation is warranted.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70396"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13107917/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"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
Eligibility criteria for cancer drug trials in adult patients: Evidence from China, 2013-2021. 成人患者癌症药物试验的资格标准:来自中国的证据,2013-2021
IF 5.1 2区 医学
Cancer Pub Date : 2026-05-01 DOI: 10.1002/cncr.70425
Zhuo Ma, Yichen Zhang, Dingyi Chen, Mengyuan Fu, Kexin Han, Yi Zhang, Joseph S Ross, Luwen Shi, Zhuoling An, Xiaodong Guan
{"title":"Eligibility criteria for cancer drug trials in adult patients: Evidence from China, 2013-2021.","authors":"Zhuo Ma, Yichen Zhang, Dingyi Chen, Mengyuan Fu, Kexin Han, Yi Zhang, Joseph S Ross, Luwen Shi, Zhuoling An, Xiaodong Guan","doi":"10.1002/cncr.70425","DOIUrl":"10.1002/cncr.70425","url":null,"abstract":"<p><strong>Background: </strong>Eligibility criteria used in cancer clinical trials ensure internal validity but may restrict enrollment and limit external generalizability. The US National Cancer Institute (NCI) has recommended broader criteria, but similar guidance is lacking in China.</p><p><strong>Methods: </strong>The authors reviewed cancer clinical trials registered on China's National Medical Products Administration (NMPA) Registration and Information Disclosure Platform between 2013 and 2021. Eligibility criteria were classified as compliant or restrictive based on the US NCI recommendations. Trends over time and associations between trial characteristics and noncompliance were analyzed.</p><p><strong>Results: </strong>There were 2448 cancer clinical trials investigating anticancer drugs registered in China. Eligibility criteria for performance status (PS), organ function, and comorbidities were used in 96.3%, 74.7%, and 95.3% of trials, respectively; overall, 97.0% used at least one restrictive criterion beyond NCI's recommendations. The median number of restrictive criteria used was two (interquartile range [IQR], 1-3) for trials approved in 2013-2015, three (IQR, 2-4) for trials approved in 2016-2018, and three (IQR, 2-4) for trials approved in 2019-2021 (p < .001). Noncompliance became more frequent for PS (p = .000), cardiac function (p = .005), and prior/concurrent malignancies (p = .018) over time.</p><p><strong>Conclusions: </strong>These findings highlight a need for more inclusive and modernized eligibility criteria for the advancement of cancer clinical trials in China.</p>","PeriodicalId":138,"journal":{"name":"Cancer","volume":"132 9","pages":"e70425"},"PeriodicalIF":5.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147758112","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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