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Real-world management and outcomes of immune-related adverse events in german cancer care: A multicenter analysis using the SERIO registry. 德国癌症治疗中免疫相关不良事件的真实世界管理和结果:使用SERIO注册的多中心分析。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-10 DOI: 10.1093/oncolo/oyaf275
Carolin Ertl, Dirk Tomsitz, Filippo Rizzo, Dirk Hempel, Lucie Heinzerling, Valeria Milani
{"title":"Real-world management and outcomes of immune-related adverse events in german cancer care: A multicenter analysis using the SERIO registry.","authors":"Carolin Ertl, Dirk Tomsitz, Filippo Rizzo, Dirk Hempel, Lucie Heinzerling, Valeria Milani","doi":"10.1093/oncolo/oyaf275","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf275","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) are widely used in cancer therapy, yet diagnosing and managing immune-related adverse events (irAEs) remains challenging in clinical practice. Differences in healthcare structures between university hospitals (UH) and private practices (PP) influence irAE presentation and management, often excluding the latter from analyses.</p><p><strong>Patients and methods: </strong>This retrospective study included 604 cancer patients treated with ICIs between 2014 and 2023: 323 from UH and 281 from PP. In total, 302 irAEs were reported in the Side Effect Registry Immuno-Oncology (SERIO; http://www.serio-registry.org), with 230 cases from UH and 72 from PP. Demographics, irAE characteristics, management, and outcomes were compared between settings.</p><p><strong>Results: </strong>The UH and PP cohorts showed substantial differences. IrAEs were less frequent in the PP cohort (19% vs. 51%) and less severe (grade 3/4: 35% PP vs. 40% UH). Time to diagnosis was longer in PP (136 vs. 86 days), but treatment response rates were comparable (90% PP vs. 84% UH). UH patients experienced better symptom control (24% vs. 16%) and fewer long-term sequelae (6% vs. 10%). No irAE-related mortality occurred in either group.</p><p><strong>Conclusion: </strong>Structural differences between UH and PP impact the frequency, severity, and management of irAEs. Including underrepresented care settings in real-world analysis is essential for generating robust, generalizable evidence. By enhancing collaboration between academic institutions and community-based practitioners, we aim to improve irAE outcomes and promote more equitable, evidence-based care in immuno-oncology.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145034653","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
Pyrotinib versus Pertuzumab with Trastuzumab and Taxane in HER2-Positive Metastatic Breast Cancer: A Chinese Multicenter Real-world Study. 吡罗替尼与帕妥珠单抗联合曲妥珠单抗和紫杉烷治疗her2阳性转移性乳腺癌:一项中国多中心真实世界研究
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-09 DOI: 10.1093/oncolo/oyaf277
Binliang Liu, Zongbi Yi, Can Tian, Jian Deng, Ronghua Feng, Zhe-Yu Hu, Ning Xie, Yongxin Li, Jiuda Zhao, Tao Wu, Quchang Ouyang
{"title":"Pyrotinib versus Pertuzumab with Trastuzumab and Taxane in HER2-Positive Metastatic Breast Cancer: A Chinese Multicenter Real-world Study.","authors":"Binliang Liu, Zongbi Yi, Can Tian, Jian Deng, Ronghua Feng, Zhe-Yu Hu, Ning Xie, Yongxin Li, Jiuda Zhao, Tao Wu, Quchang Ouyang","doi":"10.1093/oncolo/oyaf277","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf277","url":null,"abstract":"<p><strong>Background: </strong>THP (trastuzumab + paclitaxel + pertuzumab) and THPy (trastuzumab + paclitaxel + pyrotinib) are widely used as first-line regimens for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in China. However, direct comparative data on their efficacy and safety remain scarce. This study evaluates and compares the clinical outcomes of THPy and THP in the first-line treatment of HER2-positive MBC to guide clinical decision-making.</p><p><strong>Methods: </strong>This real-world, multicenter study analyzed HER2-positive MBC patients treated at five large breast cancer centers in China from 2020 to 2024. After propensity score matching (PSM) to minimize baseline differences, 76 patients were included. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety profile.</p><p><strong>Results: </strong>Before PSM, 145 patients were included, with the median follow-up of 9.4 months. The ORR was significantly higher in the THPy group (75.0%) compared to the THP group (56.8%; p = 0.023). Median PFS showed a trend favoring THPy (19.80 months versus [vs.] 15.57 months; Log-rank p = 0.343). After PSM, 76 patients were matched, with the median PFS of 24.33 months vs. 14.50 months for THPy and THP groups respectively. Though the difference in PFS was not statistically significant (Log-rank p = 0.309), THPy demonstrated a higher ORR compared to THP (78.9% vs. 57.9%; p = 0.048). Further subgroup analysis revealed greater benefits of THPy, particularly in patients with prior neoadjuvant therapy (hazard ratio [HR] = 0.261; 95% CI: 0.072-0.940). Regarding safety, THPy was associated with a higher incidence of grade 3/4 diarrhea (26.6% vs. 3.1%) as well as increased rates of neutropenia, anemia, alanine aminotransferase (ALT) elevation, fatigue, and peripheral neuropathy compared to THP.</p><p><strong>Conclusion: </strong>Both THP and THPy are effective first-line options for HER2-positive MBC. While THPy demonstrates a higher ORR and a trend toward longer PFS, it also carries a higher incidence of adverse events, particularly diarrhea. These findings offer preliminary insights that may help inform treatment decisions, pending further validation in prospective studies.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145031177","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
The Safety Profile of Belzutifan in Renal Tumors: Real-World Data from a Tertiary Academic Center. 贝尔祖替芬治疗肾肿瘤的安全性:来自三级学术中心的真实世界数据。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-08 DOI: 10.1093/oncolo/oyaf274
Aaron Jacob Winer, Paulo Siqueira do Amaral, Elizabeth G Ryan, Morgan A Lambrecht, Chiu-Lan Chen, Brian I Rini, Kathryn E Beckermann
{"title":"The Safety Profile of Belzutifan in Renal Tumors: Real-World Data from a Tertiary Academic Center.","authors":"Aaron Jacob Winer, Paulo Siqueira do Amaral, Elizabeth G Ryan, Morgan A Lambrecht, Chiu-Lan Chen, Brian I Rini, Kathryn E Beckermann","doi":"10.1093/oncolo/oyaf274","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf274","url":null,"abstract":"<p><strong>Background: </strong>Belzutifan is a HIF-2ɑ inhibitor approved for the treatment of tumors in von Hippel-Lindau (VHL) syndrome and sporadic metastatic clear cell renal cell carcinoma (spRCC) in the refractory setting. The efficacy and side effects of belzutifan are well-documented from clinical trials, however, real-world data examining the incidence and management of adverse events (AEs) are lacking. Our study aims to describe the AE profiles of belzutifan in spRCC and VHL populations.</p><p><strong>Methods: </strong>A retrospective analysis was conducted at Vanderbilt University Medical Center assessing patients who received belzutifan monotherapy. Primary endpoints were incidence of anemia and hypoxia. Secondary endpoints included time to onset of anemia and hypoxia, as well as management strategies.</p><p><strong>Results: </strong>Forty-four patients were identified with either spRCC (n = 22) or VHL syndrome (n = 22). Patients with spRCC were older than VHL patients (median 67 vs 41 years) and had higher rates of chronic kidney disease (36.4% vs 4.5%) and prior nephrectomy (77.3% vs 40.9%). The spRCC patients had a median follow-up time of 3.8 months vs 26.8 months in VHL patients. Any-grade anemia occurred in the majority of spRCC and VHL patients (81% and 95.5%, respectively) with a median time of 25 days in spRCC patients and 77 days in VHL patients. While no patient with VHL experienced grade 3 anemia, 41% of spRCC patients developed grade ≥3 anemia. In spRCC, grade ≥3 hypoxia developed in 54.5% and for VHL patients grade 3 hypoxia occurred in 9%. Median time to grade ≥3 hypoxia was 29 days (range 12-123) in spRCC patients and 225 days (105-345) in VHL patients. Supplemental oxygen was required in 52.5% of spRCC patients and 9.5% in VHL patients. Treatment discontinuation due to AEs occurred in 50% of spRCC patients and 13.6% of VHL patients.</p><p><strong>Conclusions: </strong>The time to onset and severity of belzutifan AEs may differ between patients with VHL syndrome and spRCC. These findings suggest the need for a patient-centered approach to monitor and manage toxicity based on disease setting.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014470","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
An Evaluation of Mission and Vision Statements from NCI-designated Cancer Centers and Their Affiliated Hospitals. 对nci指定的癌症中心及其附属医院的使命和愿景陈述的评估。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-08 DOI: 10.1093/oncolo/oyaf278
Max J Bouvette, Randall Dewees, David Seo, Jiazhang Xing, Vanessa A Moore, Anh B Lam, Changchuan Jiang, Nirmal Choradia, Ryan D Nipp
{"title":"An Evaluation of Mission and Vision Statements from NCI-designated Cancer Centers and Their Affiliated Hospitals.","authors":"Max J Bouvette, Randall Dewees, David Seo, Jiazhang Xing, Vanessa A Moore, Anh B Lam, Changchuan Jiang, Nirmal Choradia, Ryan D Nipp","doi":"10.1093/oncolo/oyaf278","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf278","url":null,"abstract":"<p><strong>Background: </strong>Effective communication of mission and vision statements (MVS) is important for medical institutions seeking to connect with patients, staff, and the community. This study assessed the composition, readability, and topics addressed within MVS among NCI-designated cancer centers and affiliated hospitals.</p><p><strong>Methods: </strong>We extracted MVS data from institutional websites for 65 NCI-designated cancer centers and their affiliated hospitals. We determined statement composition using word count and time to read. Readability was assessed using Flesch-Kincaid (FK) reading ease and grade level scores. We reviewed MVS for four themes: equity, quality care, training, and research.</p><p><strong>Results: </strong>Among 65 cancer centers, mission statements were identified for 93.9% (61/65) and vision statements for 63.1% (41/65). An affiliated university hospital was found for 59 centers; all provided a mission statement, and 86.4% (51/59) had a vision statement. Mission statements were 8-11 words longer than vision statements. MVS required advanced reading skills, with grade levels ranging from 13-17. FK reading ease analysis showed mission statements for cancer centers were significantly harder to read than those for affiliated hospitals (15.4 vs. 35.6, p = 0.001). Notably, fewer cancer centers included \"training\" than affiliated hospitals (55.7% vs. 79.7%, p = 0.005). No significant differences were found for other themes.</p><p><strong>Conclusions: </strong>Cancer centers and affiliated hospitals have MVS with readability levels beyond those recommended for patients, underscoring a need for simpler language to improve public communication. These findings offer insights into cancer center messaging, providing a foundation for enhanced communication.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145014468","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
Real-world evaluation of CDK4/6 inhibitors in hormone receptor-positive metastatic breast cancer: Prognostic effect of proton pump inhibitor use. CDK4/6抑制剂在激素受体阳性转移性乳腺癌中的实际评估:质子泵抑制剂使用的预后影响
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-02 DOI: 10.1093/oncolo/oyaf268
Bo-Fang Chen, Jiun-I Lai, Yi-Fang Tsai, Pei-Ju Lien, Yen-Shu Lin, Chin-Jung Feng, Yen-Jen Chen, Han-Fang Cheng, Ta-Chung Chao, Chun-Yu Liu, Ling-Ming Tseng, Chi-Cheng Huang
{"title":"Real-world evaluation of CDK4/6 inhibitors in hormone receptor-positive metastatic breast cancer: Prognostic effect of proton pump inhibitor use.","authors":"Bo-Fang Chen, Jiun-I Lai, Yi-Fang Tsai, Pei-Ju Lien, Yen-Shu Lin, Chin-Jung Feng, Yen-Jen Chen, Han-Fang Cheng, Ta-Chung Chao, Chun-Yu Liu, Ling-Ming Tseng, Chi-Cheng Huang","doi":"10.1093/oncolo/oyaf268","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf268","url":null,"abstract":"<p><strong>Background: </strong>This study evaluates the prognostic impact of the co-administration of proton pump inhibitors (PPI) on treatment outcomes in patients with hormone receptor-positive (HR+) metastatic and recurrent breast cancer who were receiving CDK4/6 inhibitor(CDK4/6i) treatment, providing real-world evidence to guide treatment strategies.</p><p><strong>Materials and methods: </strong>This retrospective analysis included 359 patients with HR+ metastasis and relapse breast cancer treated between 2018 and 2023. Patient characteristics and outcomes were compared between those receiving CDK4/6i plus endocrine therapy without any antacid medications and those with a combination of either PPI or H2 receptor blockers.</p><p><strong>Results: </strong>There were 55.7% patients in the no-antacid group, 33.1% in the PPI group, and 11.1% in the H2-blocker only group. Patients receiving PPI in combination with CDK4/6i and endocrine therapy had significantly shorter PFS(HR = 2.298, p < 0.001) and OS(HR = 3.03, p < 0.001). The H2 blocker group also showed a trend toward poorer PFS(HR = 1.987, p < 0.001) and OS compared to those without antiacid use (HR = 3.380, p = 0.226). These trends were shown in both the overall cohort and first-line treatment, regardless of the specific CDK4/6i used. No significant differences were observed between types of PPIs. Additionally, increased PPI usage time proportion during CDK4/6i treatment was associated with a higher risk of disease progression and mortality.</p><p><strong>Conclusion: </strong>The use of PPIs and H2 blockers, in combination with CDK4/6i is associated with adverse effects on PFS and OS in patients with HR+ metastatic or recurrent breast cancer in a real-world setting. Clinicians should exercise caution when prescribing proton pump inhibitors to patients undergoing CDK4/6 inhibitor therapy.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144978860","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
Outcomes of Palliative Porto-Mesenteric Venous Stenting in Unresectable Pancreatic Malignancies. 姑息性门静脉-肠系膜静脉支架置入术治疗不可切除胰腺恶性肿瘤的疗效。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-02 DOI: 10.1093/oncolo/oyaf267
Stella Konadu Adjei Antwi, Andrea Zironda, Alessandro Fogliati, Guido Fiorentini, Thor R Halfdanarson, Michael L Kendrick, Susanne G Warner, Cornelius A Thiels, Patrick P Starlinger, Mark J Truty, Scott M Thompson, James C Andrews, Chad J Fleming
{"title":"Outcomes of Palliative Porto-Mesenteric Venous Stenting in Unresectable Pancreatic Malignancies.","authors":"Stella Konadu Adjei Antwi, Andrea Zironda, Alessandro Fogliati, Guido Fiorentini, Thor R Halfdanarson, Michael L Kendrick, Susanne G Warner, Cornelius A Thiels, Patrick P Starlinger, Mark J Truty, Scott M Thompson, James C Andrews, Chad J Fleming","doi":"10.1093/oncolo/oyaf267","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf267","url":null,"abstract":"<p><strong>Background: </strong>Pancreatic cancer can lead to severe stenosis of the portomesenteric venous (PV/SMV) confluence due to extrinsic compression or direct invasion. This can result in venous hypertension associated with post-prandial abdominal pain, gastrointestinal bleeding, and ascites. In patients with unresectable tumors, transhepatic PV/SMV stenting has been reported, however its safety and efficacy are poorly understood.</p><p><strong>Methods: </strong>All unresectable pancreatic cancer patients referred to Interventional Radiology to undergo palliative transhepatic PV/SMV stenting (2011-2024) were collected. Patient demographics, CT scans, transhepatic venograms and clinical outcomes were reviewed.</p><p><strong>Results: </strong>129 patients were included; 92% had pancreatic ductal adenocarcinoma. Tumors were unresectable due to unreconstructable vascular involvement, metastatic disease or poor performance status. 81% were symptomatic, while the remaining 24 asymptomatic patients presented with significant venous hypertensive varices and collaterals on imaging. Complete venous occlusion was seen in 39% of patients at the PV, the SMV or the PV/SMV confluence. 97% of procedures were successful, with 4 technical failures at obtaining distal venous wire access. Adverse events occurred in 4 patients. Radiological follow-up was available in 94% patients. Post-procedural primary stent patency was 80% at a median follow-up time of 20 months. Follow-up was available in 102 of the 105 symptomatic patients, with 85% reporting an improvement in symptoms.</p><p><strong>Conclusion: </strong>Palliative transhepatic PV/SMV stenting is a technically feasible and safe procedure in well selected patients. Symptoms improvement can be seen in most patients. High volume centers should consider this technique for patients with unresectable tumors who present with symptomatic stenosis or short segment occlusion.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144978446","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
Impact of Temporary Atezolizumab and Bevacizumab Interruption on Survival in Advanced HCC: An IMbrave150 Analysis. 暂时中断阿特唑单抗和贝伐单抗对晚期HCC患者生存的影响:一项IMbrave150分析
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-02 DOI: 10.1093/oncolo/oyaf269
Xiao-Qian Xu, Wei-Ming Li, Li-Chen Shi, Hao Wang, Shun Li, Cheng Huang, Hong You, Ji-Dong Jia, You-Wen He, Yuan-Yuan Kong
{"title":"Impact of Temporary Atezolizumab and Bevacizumab Interruption on Survival in Advanced HCC: An IMbrave150 Analysis.","authors":"Xiao-Qian Xu, Wei-Ming Li, Li-Chen Shi, Hao Wang, Shun Li, Cheng Huang, Hong You, Ji-Dong Jia, You-Wen He, Yuan-Yuan Kong","doi":"10.1093/oncolo/oyaf269","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf269","url":null,"abstract":"<p><strong>Background: </strong>Atezolizumab (Atez) combined with bevacizumab (Bev) is the recommended first-line treatment for unresectable hepatocellular carcinoma (HCC). This study investigated the association of temporary Atez and Bev interruptions with clinical outcomes using IMbrave150 trial data.</p><p><strong>Patients and methods: </strong>Patient-level data from the phase 3 IMbrave150 (NCT03434379) trial were analyzed. Time-dependent Cox regression models assessed associations between temporary interruptions and overall survival (OS) and progression-free survival (PFS), adjusting for treatment duration and drug discontinuation. Subgroup analyses were stratified by event timing and treatment duration (<12 vs. ≥12 months).</p><p><strong>Results: </strong>Among 251 patients treated with Atez/Bev, 79 (31.5%) experienced Atez interruptions and 86 (34.3%) had Bev interruptions. Interruptions were not significantly associated with OS (HR = 1.57, 95% CI: 0.90-2.73 for Atez, HR = 0.50, 95% CI: 0.16-1.53 for Bev). However, both were significantly associated with improved PFS (HR = 0.56, 95% CI: 0.34-0.92 for Atez and HR = 0.61, 95% CI: 0.39-0.94 for Bev). Subgroup analyses showed that positive association of PFS and interruptions was primarily observed in patients with events or treatment duration <12 months. Early (within 6 months) and late interruptions (after 6 months) showed trends toward longer PFS but were not statistically significant (HR = 0.56, 95% CI: 0.27-1.15 and HR = 0.57, 95% CI: 0.29-1.09 for Atez, HR = 0.61, 95% CI: 0.37-1.02 and HR = 0.60, 95% CI: 0.29-1.27 for Bev).</p><p><strong>Conclusion: </strong>In this exploratory analysis, temporary interruptions of Atez or Bev were not associated with worse survival outcomes in patients with unresectable HCC. Prospective studies are needed to validate these findings.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144979236","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
ENIGMA+: a national, decentralized, remote consent study for clinical data and biospecimen collection in patients with ALK-positive advanced NSCLC. ENIGMA+:一项针对alk阳性晚期非小细胞肺癌患者临床数据和生物标本收集的全国性、分散、远程同意研究。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf217
Joyce Liang, Sarah Waliany, Andrew Do, Jennifer L Peterson, Paige Roberts, Elizabeth A Kennedy, Emily S Venanzi, Justin F Gainor, Jessica J Lin
{"title":"ENIGMA+: a national, decentralized, remote consent study for clinical data and biospecimen collection in patients with ALK-positive advanced NSCLC.","authors":"Joyce Liang, Sarah Waliany, Andrew Do, Jennifer L Peterson, Paige Roberts, Elizabeth A Kennedy, Emily S Venanzi, Justin F Gainor, Jessica J Lin","doi":"10.1093/oncolo/oyaf217","DOIUrl":"10.1093/oncolo/oyaf217","url":null,"abstract":"<p><strong>Objective: </strong>Despite advances in ALK inhibitors for ALK fusion-positive (ALK+) non-small-cell lung cancer (NSCLC), drug resistance remains a challenge. Studies of treatment outcomes and resistance biomarkers are imperative for drug development, yet patient representation can be limited. This study evaluated the feasibility of a decentralized research infrastructure to establish a clinical and biospecimen repository, broadening patient access and inclusion.</p><p><strong>Patients and methods: </strong>Patients with advanced ALK+ NSCLC across the United States were enrolled through remote informed consent. Clinical history and tumor molecular profiling data were collected at baseline and during remote follow-ups. Archival tumor and saliva biospecimens (for germline sampling) were obtained for analysis.</p><p><strong>Results: </strong>Of 87 eligible patients, 80 (92%) completed remote consent and enrolled. The clinical data collection rate was 100%, with archival tumor acquired from 80% and saliva samples from 65%. Patients represented 31 states, with 94% residing outside the study center's state and 90% receiving care elsewhere. Next-generation sequencing was conducted on 55 treatment-naïve and 18 treatment-resistant biopsies, all of whom received at least one prior second-generation ALK inhibitor, and 9 received lorlatinib. ALK resistance mutations were identified in 54% of treatment-resistant biopsies; other commonly co-altered genes included TP53 (18%) and CDKN2A/B (16%).</p><p><strong>Conclusions: </strong>This study highlights the feasibility of a decentralized design to enhance the inclusion of a broader patient population with ALK+ NSCLC. This establishes a scalable framework that may help overcome barriers to patient participation in research, with the goal of improving therapy development and patient outcomes. The Elucidating Novel Immune and Genomic Markers for ALK+ study accrual and analysis continue (NCT04881916).</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12404294/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144661091","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
Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer. 曲妥珠单抗与阿比特龙联合治疗her2表达转移性去势抵抗性前列腺癌的临床疗效
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf207
Rithika Rajendran, Coen J Lap, Siddharth Madapoosi, Angela Heiraty, Fayez Estephan, Winnie Hahn, Aarati Poudel, Victor E Nava, Ramesh Subrahmanyam, Maneesh Jain
{"title":"Clinical response to novel combination of trastuzumab deruxtecan and abiraterone in HER2-expressing metastatic castration-resistant prostate cancer.","authors":"Rithika Rajendran, Coen J Lap, Siddharth Madapoosi, Angela Heiraty, Fayez Estephan, Winnie Hahn, Aarati Poudel, Victor E Nava, Ramesh Subrahmanyam, Maneesh Jain","doi":"10.1093/oncolo/oyaf207","DOIUrl":"10.1093/oncolo/oyaf207","url":null,"abstract":"<p><p>Human Epidermal Growth Factor Receptor 2 (HER2) is expressed in approximately 60%-70% of patients with metastatic castration-resistant prostate cancer (mCRPC) and may contribute to androgen resistance. This case report describes a patient with HER2-expressing mCRPC who progressed on multiple lines of therapy and subsequently had a significant response to combination treatment with the HER2-targeting antibody-drug-conjugate (ADC) trastuzumab deruxtecan (T-DXd) and re--challenge of abiraterone, despite having progressed on this prior. Unlike other HER2-expressing malignancies, HER2 overexpression in prostate cancer (PCa) occurs in the absence of HER2 mutations and amplifications and, as such, is not detected by next--generation sequencing. Therefore, identifying patients with mCRPC who could benefit from T-DXd necessitates HER2 testing by immunohistochemistry (IHC), a practice not routinely performed. As a result, T-DXd remains underutilized in patients with mCRPC, despite a tumor-agnostic approval for patients with advanced HER2-expressing (IHC 3+) solid tumors. This case highlights the potential of combining T-DXd with androgen receptor pathway inhibitors to overcome treatment resistance and underscores the importance of routine HER2 IHC testing in patients with advanced PCa.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12401083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144602217","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
Contextualizing results of randomized trials in smoldering myeloma. 阴燃性骨髓瘤随机试验的背景分析结果。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf216
Ghulam Rehman Mohyuddin, Aaron M Goodman, Rajshekhar Chakraborty
{"title":"Contextualizing results of randomized trials in smoldering myeloma.","authors":"Ghulam Rehman Mohyuddin, Aaron M Goodman, Rajshekhar Chakraborty","doi":"10.1093/oncolo/oyaf216","DOIUrl":"10.1093/oncolo/oyaf216","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12404295/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144661089","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
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