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Phase 3 Clinical Trials Evaluating Poly(ADP-Ribose) Polymerase Inhibition Plus Immunotherapy for First-Line Treatment of Advanced Ovarian Cancer. 3期临床试验评估Poly(adp -核糖)聚合酶抑制加免疫治疗一线治疗晚期卵巢癌。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-17 DOI: 10.1093/oncolo/oyaf270
B J Rimel, Eric Pujade-Lauraine, Kathleen Moore, Jacobus Pfisterer, Sileny Han, David Cibula, Anna Reyners, Andrés Redondo, Christos Papadimitriou, Ram Eitan, Sandro Pignata, Rosalind Glasspool, Mansoor Raza Mirza, Lubomir Bodnar, Linda Duska, Diane Provencher, Rébécca Phaëton, Manjinder Bains, Elif Coskuncay, Anne Claire Hardy-Bessard
{"title":"Phase 3 Clinical Trials Evaluating Poly(ADP-Ribose) Polymerase Inhibition Plus Immunotherapy for First-Line Treatment of Advanced Ovarian Cancer.","authors":"B J Rimel, Eric Pujade-Lauraine, Kathleen Moore, Jacobus Pfisterer, Sileny Han, David Cibula, Anna Reyners, Andrés Redondo, Christos Papadimitriou, Ram Eitan, Sandro Pignata, Rosalind Glasspool, Mansoor Raza Mirza, Lubomir Bodnar, Linda Duska, Diane Provencher, Rébécca Phaëton, Manjinder Bains, Elif Coskuncay, Anne Claire Hardy-Bessard","doi":"10.1093/oncolo/oyaf270","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf270","url":null,"abstract":"<p><p>Ovarian cancer is the second deadliest gynecologic malignancy globally. Current standard of care first-line therapy for newly diagnosed advanced epithelial ovarian cancer is surgery and platinum-based chemotherapy (±bevacizumab), followed by maintenance therapy with a poly(ADP-ribose) polymerase (PARP) inhibitor, bevacizumab, or a combination of the two. Although anti-programmed cell death (PD) protein 1 and anti-PD ligand 1 antibodies (PD-[L]1 inhibitors) have shown benefit in several solid tumors, their effect in ovarian cancer remains uncertain. Several trials are evaluating PD-(L)1 inhibitors in combination with first-line platinum-based chemotherapy and PARP inhibitor maintenance treatment. Here, we review trial designs to understand key similarities and differences for future assessments of the results. The clinical trials registry \"ClinicalTrials.gov\" was searched using keywords, including ovarian cancer and niraparib, olaparib, or rucaparib. Search results were then filtered for phase 3 and manually reviewed to identify trials evaluating combinations of PARP inhibitors and PD-(L)1 inhibitors in the first-line setting. Four trials, ENGOT-OV44/FIRST (NCT03602859), ENGOT-OV46/AGO-OVAR 23/GOG-3025/DUO-O (NCT03737643), ENGOT-OV43/GOG-3036/KEYLYNK-001 (NCT03740165), and ENGOT-OV45/GOG-3020/ATHENA (NCT03522246), were identified. Of these, FIRST, DUO-O, and KEYLYNK-001 are evaluating both first-line use in combination with chemotherapy and maintenance, whereas ATHENA focuses on maintenance after a response to chemotherapy; however, DUO-O and KEYLYNK-001 do not include a PARP inhibitor in the comparator arm, limiting the ability to compare the added benefit of immunotherapy over the current standard of care. Results of these trials will determine whether PARP inhibitor and PD-(L)1 inhibitor combination with or without bevacizumab can improve patient outcomes.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093017","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
Finding Voice. 发现声音。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-17 DOI: 10.1093/oncolo/oyaf289
Grace S Kao
{"title":"Finding Voice.","authors":"Grace S Kao","doi":"10.1093/oncolo/oyaf289","DOIUrl":"10.1093/oncolo/oyaf289","url":null,"abstract":"<p><p>This narrative essay explores the experience of a cancer survivor confronting progressive voice loss after head and neck cancer treatment. Through his evolving relationship with speech, identity, and connection, both patient and psychologist reflect on the meaning and presence of voice, spoken and otherwise, as a tool for healing, expression, and connection.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12517739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093063","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
Enhancing the interpretation of real-world quality of life in patients with HR+/HER2- advanced breast cancer enrolled in the POLARIS study. 加强POLARIS研究中HR+/HER2晚期乳腺癌患者真实生活质量的解释。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-15 DOI: 10.1093/oncolo/oyaf281
Gabrielle Rocque, Joanne L Blum, Yan Ji, Timothy Pluard, John Migas, Shailendra Lakhanpal, Erin Jepsen, Eric Gauthier, Yao Wang, Monica Z Montelongo, Joseph C Cappelleri, Connie Chen, Meghan S Karuturi, Debu Tripathy
{"title":"Enhancing the interpretation of real-world quality of life in patients with HR+/HER2- advanced breast cancer enrolled in the POLARIS study.","authors":"Gabrielle Rocque, Joanne L Blum, Yan Ji, Timothy Pluard, John Migas, Shailendra Lakhanpal, Erin Jepsen, Eric Gauthier, Yao Wang, Monica Z Montelongo, Joseph C Cappelleri, Connie Chen, Meghan S Karuturi, Debu Tripathy","doi":"10.1093/oncolo/oyaf281","DOIUrl":"https://doi.org/10.1093/oncolo/oyaf281","url":null,"abstract":"<p><strong>Background: </strong>In this study, we aimed to enhance and contextualize the interpretation of patient-reported scores on global health status (GHS) and quality of life (QoL) from the EORTC QLQ-C30 questionnaire into more meaningful terms using data from POLARIS.</p><p><strong>Methods: </strong>Proportions of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced/metastatic breast cancer (ABC/mBC) treated with palbociclib plus endocrine therapy with \"favorable\" (numeric scores 5 - 7) and \"unfavorable\" (numeric scores ≤ 4) responses were determined at baseline and months 6, 12, and 18.</p><p><strong>Results: </strong>Between January 2017 and January 2023, 1250 patients were enrolled and received ≥ 1 palbociclib dose. EORTC QLQ-C30 GHS/QoL domain completion rates were 93.4%, 66.5%, 49.5%, and 42.3% at baseline and months 6, 12, and 18, respectively. For Question 29 (GHS), the proportion of patients with a favorable response significantly increased by ∼13% to 69.3% by month 6, which was maintained at month 12 (68.6%) and month 18 (70.0%). For Question 30 (QoL), the proportion of patients with a favorable response significantly increased by ∼9% to 74.5% by month 6, which was maintained at month 12 (75.0%) and month 18 (73.4%).</p><p><strong>Conclusions: </strong>The proportions of patients with HR+/HER2- ABC/mBC indicating a favorable response on GHS and QoL questions of the EORTC QLQ-C30 increased early on after the start of palbociclib treatment and were preserved through month 18 across the overall study population and most evaluated subgroups. This simple interpretation of GHS and QoL scores is intended to enhance their meaning to benefit patients and other stakeholders.</p><p><strong>Clinical trial registration: </strong>NCT03280303; registered September 12, 2017.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145093018","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
Circulating Tumor DNA detection in cancer: a comprehensive overview of current detection methods and prospects. ctDNA在癌症中的检测:当前检测方法和前景的综合概述。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf204
Ana Regina de Abreu, Ayla Wyninckx, Timon Vandamme, Ken Op de Beeck, Guy Van Camp, Marc Peeters, Pierre Laurent-Puig, Julien Taieb, Valerie Taly, Leonor Benhaim
{"title":"Circulating Tumor DNA detection in cancer: a comprehensive overview of current detection methods and prospects.","authors":"Ana Regina de Abreu, Ayla Wyninckx, Timon Vandamme, Ken Op de Beeck, Guy Van Camp, Marc Peeters, Pierre Laurent-Puig, Julien Taieb, Valerie Taly, Leonor Benhaim","doi":"10.1093/oncolo/oyaf204","DOIUrl":"10.1093/oncolo/oyaf204","url":null,"abstract":"<p><p>Complete oveview of ctDNA detection methods.The analysis of circulating tumor DNA (ctDNA) has emerged as a major minimally invasive biomarker in oncology. Numerous methods exist for ctDNA detection and should be selected based on the specific oncological context. PCR-based methods are often preferred for their sensitivity and cost-effectiveness; however, they are limited to a narrower range of genes. In contrast, NGS-based methods enable comprehensive cancer genotyping and more efficient identification of actionable mutations. Moreover, the growing number of emerging approaches, such as third--generation sequencing and fragmentomics, highlights the increasing technical complexity of ctDNA detection. Overall, this review provides insights into the advantages and limitations of various detection strategies that can help improve clinical care for patients.</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/PMC12450317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144664078","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
Risk of peritoneal metastasis following minimally invasive colectomy for locally advanced colon cancer: a systematic review and meta-analysis. 局部晚期结肠癌微创结肠切除术后腹膜转移的风险:系统回顾和荟萃分析。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf218
Robert Connor Chick, Samantha M Ruff, Ryan Heslin, Matthew R Porembka, Patricio M Polanco, Alex C Kim
{"title":"Risk of peritoneal metastasis following minimally invasive colectomy for locally advanced colon cancer: a systematic review and meta-analysis.","authors":"Robert Connor Chick, Samantha M Ruff, Ryan Heslin, Matthew R Porembka, Patricio M Polanco, Alex C Kim","doi":"10.1093/oncolo/oyaf218","DOIUrl":"10.1093/oncolo/oyaf218","url":null,"abstract":"<p><strong>Background: </strong>Locally advanced (T4) colon cancer is a significant risk factor for peritoneal metastasis (PM). Although laparoscopic colectomy (LC) is considered oncologically safe, the risk of PM in patients with T4 disease undergoing LC remains unclear. Prior systematic reviews demonstrated equivalent overall survival between LC and open colectomy (OC). However, comparison of LC and OC for peritoneal recurrence is lacking.</p><p><strong>Methods: </strong>A systematic review, conducted according to PRISMA guidelines, identified 247 abstracts, of which 46 full texts were reviewed. Studies including both LC and OC that reported peritoneal recurrence were included. Case reports and conference abstracts were excluded. Pooled effect size for proportion of, and hazard ratio (HR) for, peritoneal recurrence were calculated using a random-effects model with inverse variance weighting.</p><p><strong>Results: </strong>Nine studies met inclusion criteria. All were retrospective cohort studies; most considered \"conversion to open\" as laparoscopic procedures. Pooled odds ratio was 1.61 (P = .011, I2 = 0.62), and HR was 1.24 (P < .001, I2 = 0.10) for developing peritoneal metastases. Risk of bias was assessed as low or moderate for all studies. Quality of evidence was low.</p><p><strong>Conclusions: </strong>Laparoscopic colectomy is associated with an increased risk of peritoneal recurrence compared with open colectomy for T4 colon cancer. Although selection bias in these nonrandomized studies should favor laparoscopic surgery, LC was associated with an increased risk of peritoneal recurrence. LC should be approached with caution for cT4 colon cancer. Strategies to mitigate the risk of peritoneal recurrence in T4 colon cancer, such as neoadjuvant chemotherapy or adjuvant intraperitoneal chemotherapy, should be further explored in prospective studies.</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/PMC12445660/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144664079","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
Efficacy outcomes between tarlatamab and real-world physicians' choice of therapies for previously treated extensive stage small cell lung cancer. Tarlatamab和现实世界医生选择治疗先前治疗过的广泛期小细胞肺癌的疗效结果
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf256
Jessie Wang, Gautam Sajeev, Xinglei Chai, Rumbidzai Takundwa, Franziska Dirnberger, Xerxes Pundole, Malaika Pastel, Hongbo Yang, Umit Tapan
{"title":"Efficacy outcomes between tarlatamab and real-world physicians' choice of therapies for previously treated extensive stage small cell lung cancer.","authors":"Jessie Wang, Gautam Sajeev, Xinglei Chai, Rumbidzai Takundwa, Franziska Dirnberger, Xerxes Pundole, Malaika Pastel, Hongbo Yang, Umit Tapan","doi":"10.1093/oncolo/oyaf256","DOIUrl":"10.1093/oncolo/oyaf256","url":null,"abstract":"<p><strong>Background: </strong>Tarlatamab, a bispecific T-cell engager immunotherapy, showed durable response with promising survival outcomes in patients with previously treated small cell lung cancer (SCLC) in the phase 2 DeLLphi-301 study. Given the lack of a comparator in DeLLphi-301, this analysis aimed to evaluate the relative efficacy of tarlatamab against physicians' choice of therapies in real-world practice.</p><p><strong>Patients and methods: </strong>This analysis compared the outcomes of patients in DeLLphi-301 who received tarlatamab 10 mg (n = 97) with patients in real-world cancer clinics captured in the Flatiron Health database who received third or later-line comparator therapies for SCLC (n = 184). Propensity score weighting was used to adjust for differences in key prognostic factors between cohorts. Overall survival (OS), progression-free survival (PFS), time to treatment discontinuation (TTD), time to next treatment or death (TTNTD), and objective response rate (ORR) were compared after weighting.</p><p><strong>Results: </strong>Tarlatamab was associated with significantly longer OS, PFS, TTD, and TTNTD, and higher ORR vs comparator therapies. After weighting, the hazard ratios (95% confidence interval [CI]) of tarlatamab vs comparator therapies were 0.45 (0.30, 0.68) for OS, 0.61 (0.43, 0.90) for PFS, 0.57 (0.39, 0.84) for TTD, and 0.45 (0.30, 0.66) for TTNTD. The odds ratio for ORR was 2.80 (95% CI, 1.44, 5.83).</p><p><strong>Conclusion: </strong>The study findings suggest that tarlatamab offers potential clinical benefits relative to comparator treatments. This analysis underscores the potential of tarlatamab to become a new therapeutic option for previously treated SCLC, a disease that has historically been associated with extremely poor outcomes and limited treatment options.</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/PMC12459094/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144979159","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
An interdisciplinary challenge: responsibilities in German cancer-related fatigue management from the professional and patient perspective. 跨学科的挑战:从专业和患者的角度看德国癌症相关疲劳管理的责任。
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf233
Anna S Wagner, Marlena Milzer, Karen Steindorf, Senta Kiermeier, Truong D Nguyen, Martina E Schmidt, Imad Maatouk
{"title":"An interdisciplinary challenge: responsibilities in German cancer-related fatigue management from the professional and patient perspective.","authors":"Anna S Wagner, Marlena Milzer, Karen Steindorf, Senta Kiermeier, Truong D Nguyen, Martina E Schmidt, Imad Maatouk","doi":"10.1093/oncolo/oyaf233","DOIUrl":"10.1093/oncolo/oyaf233","url":null,"abstract":"<p><strong>Objectives: </strong>Due to its complexity, the management of cancer-related fatigue (CRF) is best based on an interdisciplinary care approach. Thus, we examined the preferred and the actual distribution of responsibilities from the perspectives of healthcare professionals and patients.</p><p><strong>Materials and methods: </strong>An online survey was conducted among physicians (N = 148), nurses (N = 184), and psycho-oncologists (N = 144) in Germany. The participants evaluated a series of statements and selected the professional disciplines that they deemed most responsible for specific tasks in CRF management. Data were complemented with the patient perspective. Experiences of cancer patients (N = 1,179) were assessed by questionnaires. Data from the healthcare professional and patient perspective were analyzed descriptively. For comparisons between professional groups, Kruskal-Wallis H tests and subsequent Dunn-Bonferroni tests were used.</p><p><strong>Results: </strong>Healthcare professionals and patients agreed on a lack of interdisciplinary collaboration on CRF. Professionals valued the necessity of addressing CRF and educating patients, which was not mirrored in patient experiences. Physicians in aftercare and rehabilitation were overall perceived as main actors in CRF management. Nurses and psycho-oncologists frequently considered their own discipline as responsible for most of the tasks.</p><p><strong>Conclusion: </strong>It is necessary not only to define task-related responsibilities in standardized operating procedures but to foster interprofessional collaboration in the management of CRF.</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/PMC12422314/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144735516","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
A tale of two TROP-2 antibody-drug conjugates: a comparative saga of datopotamab deruxtecan and sacituzumab govitecan. 两个TROP-2 adc的故事:dato不达单抗Deruxtecan (Dato-DXd)和Sacituzumab Govitecan (SG)的比较
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf251
Sanad Alhushki, Sameer Deshmukh, Benjamin Levy, Aakash Desai
{"title":"A tale of two TROP-2 antibody-drug conjugates: a comparative saga of datopotamab deruxtecan and sacituzumab govitecan.","authors":"Sanad Alhushki, Sameer Deshmukh, Benjamin Levy, Aakash Desai","doi":"10.1093/oncolo/oyaf251","DOIUrl":"10.1093/oncolo/oyaf251","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/PMC12445656/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838597","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
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
Risk of myelodysplastic syndrome and acute myeloid leukemia related to PARP inhibitor maintenance line in real-world ovarian cancer patients. 卵巢癌患者骨髓增生异常综合征和急性髓系白血病风险与PARP抑制剂维持线相关
IF 4.2 2区 医学
Oncologist Pub Date : 2025-09-01 DOI: 10.1093/oncolo/oyaf243
Alberto Farolfi, Chiara Casadei, Nicola Gentili, Sara Testoni, Francesca Rusconi, Emilio Francesco Giunta, Nicole Brighi, Giorgia Gurioli, Daniela Montanari, Gema Hernandez Ibarburu, Ugo De Giorgi
{"title":"Risk of myelodysplastic syndrome and acute myeloid leukemia related to PARP inhibitor maintenance line in real-world ovarian cancer patients.","authors":"Alberto Farolfi, Chiara Casadei, Nicola Gentili, Sara Testoni, Francesca Rusconi, Emilio Francesco Giunta, Nicole Brighi, Giorgia Gurioli, Daniela Montanari, Gema Hernandez Ibarburu, Ugo De Giorgi","doi":"10.1093/oncolo/oyaf243","DOIUrl":"10.1093/oncolo/oyaf243","url":null,"abstract":"<p><strong>Objective: </strong>To estimate the risk of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) secondary to PARP inhibitors (PARPi), based on the line of treatment, in real-world ovarian cancer (OC) patients.</p><p><strong>Methods: </strong>Using the TriNetX platform, we compared a cohort (experimental A) of 3402 OC patients treated with first-line maintenance PARPi to a control cohort of 1653 OC patients treated with platinum-based chemotherapy without PARPi. Experimental group B included 356 OC patients treated with PARPi after a platinum-sensitive relapse and was compared to a control cohort of 1503 patients who had not received PARPi after 2 lines of platinum-based chemotherapy. The cohorts were propensity score matched (PSM) 1:1 (experimental A vs control 1 and experimental B vs control 2) for age, race, bevacizumab treatment, and genetic susceptibility to neoplasms. A hazard ratio (HR) was used to compare the incidence of MDS and AML between the matched cohorts.</p><p><strong>Results: </strong>In the first-line setting, 2 groups of 1346 matched OC patients (mean age 59.8 ± 10.2 SD) were evaluated. The overall incidence of MDS or AML was 1.9% and 0.1% in the experimental A and control groups, respectively (HR = 2.46; 95% CI 1.27-4.75, P = .006). For the platinum--sensitive relapse setting, the HR was 1.76 (95% CI 0.42-7.37, P = .432). No significant differences were observed between the various PARPi used.</p><p><strong>Conclusions: </strong>Our study indicates that PARPi may increase the risk of MDS or AML after first-line maintenance treatment. No significant differences were found across the types of PARPi used.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144838604","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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