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Comparative efficacy and safety of talazoparib plus enzalutamide and other first-line treatments for metastatic castration-resistant prostate cancer. 塔拉帕利联合恩杂鲁胺与其他一线治疗转移性耐受性前列腺癌药物的疗效和安全性比较。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae237
Elena Castro, Jenna Ellis, Samantha Craigie, Anja Haltner, Jonathan Nazari, Alexander Niyazov, Imtiaz A Samjoo
{"title":"Comparative efficacy and safety of talazoparib plus enzalutamide and other first-line treatments for metastatic castration-resistant prostate cancer.","authors":"Elena Castro, Jenna Ellis, Samantha Craigie, Anja Haltner, Jonathan Nazari, Alexander Niyazov, Imtiaz A Samjoo","doi":"10.1093/oncolo/oyae237","DOIUrl":"10.1093/oncolo/oyae237","url":null,"abstract":"<p><strong>Background: </strong>Talazoparib plus enzalutamide (TALA + ENZA) has demonstrated antitumor activity in the phase 3 clinical trial (TALAPRO-2; NCT03395197) as first-line (1L) therapy in men with asymptomatic or mildly symptomatic metastatic castration-resistant prostate cancer (mCRPC). Although many active interventions are available, randomized controlled trials (RCTs) involving talazoparib have only been conducted to assess its efficacy and safety compared to enzalutamide. To estimate comparisons between all relevant interventions, indirect comparisons are needed.</p><p><strong>Objective: </strong>To estimate the comparative efficacy and safety of TALA + ENZA in 1L patients with mCRPC by conducting a systematic literature review and network meta-analyses (NMAs).</p><p><strong>Methods: </strong>Databases were searched using Ovid, along with several gray literature sources to identify RCTs evaluating treatments in 1L mCRPC (PROSPERO registration: CRD42021283512). Feasibility assessment evaluated trial suitability for NMA inclusion and Bayesian or frequentist NMAs were conducted for evaluable efficacy and safety outcomes, respectively.</p><p><strong>Results: </strong>Thirty-three RCTs met the eligibility criteria and were feasible for NMAs. Across multiple efficacy outcomes assessed, except for overall survival (OS), TALA + ENZA was ranked the most efficacious treatment. For OS, TALA + ENZA showed the second-highest probability of being the most effective treatment; second to docetaxel 50 mg plus prednisolone 10 mg. With respect to safety outcomes, TALA + ENZA, in general, showed increased rates of hematological adverse events.</p><p><strong>Conclusions: </strong>TALA + ENZA showed favorable results across multiple efficacy endpoints, but not across hematological toxicities compared with other 1L treatments in asymptomatic or mildly symptomatic mCRPC in the all-comers patient population.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954501/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142481136","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
Targeting RAF1 gene fusions with MEK inhibition in metastatic melanoma. 用 MEK 抑制剂靶向转移性黑色素瘤中的 RAF1 基因融合。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae297
Karam Khaddour, Rizwan Haq, Elizabeth I Buchbinder, David Liu, Michael P Manos, Patrick A Ott, F Stephen Hodi, Megan L Insco
{"title":"Targeting RAF1 gene fusions with MEK inhibition in metastatic melanoma.","authors":"Karam Khaddour, Rizwan Haq, Elizabeth I Buchbinder, David Liu, Michael P Manos, Patrick A Ott, F Stephen Hodi, Megan L Insco","doi":"10.1093/oncolo/oyae297","DOIUrl":"10.1093/oncolo/oyae297","url":null,"abstract":"<p><p>The biological and clinical relevance of gene fusions in melanoma is unknown. Reports and preclinical data have suggested that tumor cells with specific rearrangements such as RAF1 gene fusions could be therapeutically targeted. To investigate the relevance of targeted therapy in patients with melanoma harboring RAF1 gene fusions, we reviewed records of 1268 melanoma patients with targeted sequencing data at the Dana-Farber Cancer Institute. We identified 9 cases and report here on their clinicopathologic characteristics. We describe the favorable outcome of 2 patients who received MEK inhibitor therapy, including 1 patient with a durable response. We coalesced our data with published reports of patients with RAF1 gene fusions who were treated with targeted therapy. We find that single-agent MEK inhibition has anti-tumor activity in melanoma patients harboring an RAF1 gene fusion, and we propose that patients with RAF1 gene fusions should be considered for single-agent MEK inhibitor therapy.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954592/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142592241","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 phase I/II trial of avelumab combinations with ivuxolimab, utomilumab, and radiation therapy in patients with advanced gastrointestinal malignancies. 一项针对晚期胃肠道恶性肿瘤患者的 I/II 期试验:阿韦利单抗与伊沃昔单抗、乌妥米单抗和放射治疗的联合疗法。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyaf032
Jibran Ahmed, Anne Knisely, Carlos Torrado, Bettzy Stephen, Yali Yang, Juhee Song, Anas Alshawa, Abdulrazzak Zarifa, Anuja Jhingran, Eugene J Koay, Van Karlyle Morris, Milind Javle, Robert A Wolff, Funda Meric-Bernstam, Shubham Pant, Jordi Rodon, Aung Naing
{"title":"A phase I/II trial of avelumab combinations with ivuxolimab, utomilumab, and radiation therapy in patients with advanced gastrointestinal malignancies.","authors":"Jibran Ahmed, Anne Knisely, Carlos Torrado, Bettzy Stephen, Yali Yang, Juhee Song, Anas Alshawa, Abdulrazzak Zarifa, Anuja Jhingran, Eugene J Koay, Van Karlyle Morris, Milind Javle, Robert A Wolff, Funda Meric-Bernstam, Shubham Pant, Jordi Rodon, Aung Naing","doi":"10.1093/oncolo/oyaf032","DOIUrl":"10.1093/oncolo/oyaf032","url":null,"abstract":"<p><strong>Background: </strong>Checkpoint agonists utomilumab (4-1BB agonist) and ivuxolimab (OX40 agonist) enhance Teffector cell function. Preclinical studies suggest that combining these drugs with avelumab (anti-PD-L1 antibody) can potentially synergize this effect. In addition, tissue abscopal effects of radiation therapy may improve antigen presentation, complementing PD-L1 blockade. We conducted a single institution, open-label, multi-arm, non-randomized, phase 1/2 clinical trial of avelumab in combination with ivuxolimab, with or without utomilumab, and radiation therapy in patients with advanced solid tumors. Herein, we present a subgroup analysis in patients with gastrointestinal (GI) tumors (pancreatic, colon, gastric, and hepatocellular).</p><p><strong>Methods: </strong>The primary objectives of this study were to assess safety, tolerability, and dose-limiting toxicities. The secondary objectives were to evaluate efficacy including response rate, progression free survival (PFS), as determined by immune-related Response Criteria in Solid Tumors (irRECIST) and overall survival (OS).</p><p><strong>Results: </strong>Thirty-one patients with pancreatic (n = 21), colorectal (n = 8), hepatocellular (n = 1), and gastric (n = 1) cancers were included in this study. The most common treatment-related adverse events (TRAEs) were chills (13%), diarrhea (10%), colitis (10%), fatigue (6%), and fever (6%). There were 3 instances of grade 3 diarrhea and colitis (10%) without any other grade ≥ 3 TRAEs Among the 24 patients evaluable for response, 9 (37.5%) had immune-related stable disease (irSD) and 14 (58.3%) had immune-related progressive disease (irPD). One patient had clinical progression without radiological confirmation. The median PFS was 2 months. Median OS was 5.6 months.</p><p><strong>Conclusion: </strong>Combining avelumab with co-stimulatory checkpoint agonists produces modest activity without added safety concerns in patients with advanced GI malignancies (ClinicalTrials.gov Identifier: NCT03217747).</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 3","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11942784/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733057","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
Triage performance of DNA methylation for women with high-risk human papillomavirus infection. 高危人类乳头瘤病毒感染妇女 DNA 甲基化的分流性能。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae324
Linghua Kong, Xiaoping Xiao, Huanwen Wu, Yan You, Xitong Jin, Yuligh Liou, Pei Liu, Jinghe Lang, Lei Li
{"title":"Triage performance of DNA methylation for women with high-risk human papillomavirus infection.","authors":"Linghua Kong, Xiaoping Xiao, Huanwen Wu, Yan You, Xitong Jin, Yuligh Liou, Pei Liu, Jinghe Lang, Lei Li","doi":"10.1093/oncolo/oyae324","DOIUrl":"10.1093/oncolo/oyae324","url":null,"abstract":"<p><strong>Objective: </strong>DNA methylation is a promising biomarker for cervical cancer screening. This study aimed to validate the triage performance of cytological DNA methylation for detecting cervical intraepithelial neoplasia of grade 3 or worse (CIN3+) in women with high-risk human papillomavirus (hrHPV) infection from a large prospective cohort undergoing opportunistic screening in China (METHY3).</p><p><strong>Methods: </strong>The triage performance for detecting CIN3+ lesions was compared between HPV16/18 genotyping, a liquid-based cytology (LBC) test, and the PAX1 and JAM3 methylation (PAX1m/JAM3m) test according to cervical pathologic outcomes. Among the 4394 women infected with hrHPV, 1105 had definitive cervical histological findings that were analyzed.</p><p><strong>Results: </strong>For detecting CIN3+, the specificity of HPV16/18(+), the LBC result of ≥atypical squamous cells of undetermined significance (ASCUS), and PAX1m/JAM3m(+) was 66.4%, 23.9%, and 89.6%, respectively, with odds ratios of 4.24 (95% confidence interval [CI], 2.85-6.40), 4.44 (2.27-10.1), and 18.5 (12.1-28.7) (P < .001), respectively. PAX1m/JAM3m(+) had the highest area under the receiver operating characteristic curve (0.790, 95% CI, 0.747-0.832) in the whole cohort and in women of various ages. PAX1m/JAM3m (+) was detected in all patients with cancer (n = 28). Compared with HPV16/18 genotyping and the LBC test, PAX1m/JAM3m testing reduced referrals to colposcopy by 20.64 percentage points and 61.18 percentage points, respectively.</p><p><strong>Conclusions: </strong>PAX1 m /JAM3 m testing is highly specific for detecting CIN3+. As a triage biomarker, it is superior to HPV 16/18 genotyping and LBC testing for women with hrHPV infection.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954506/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142741405","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 outcomes of recurrent or metastatic head and neck cancer after failure of platinum and nivolumab: a multicenter retrospective study.
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyaf018
Takane Watanabe, Hiroki Oka, Kengo Nagashima, Hideaki Nishi, Yoshihiko Kumai, Hiroaki Iijima, Kenji Okami, Yasushi Shimizu, Satoshi Kano, Kazue Ito, Tomoko Yamazaki, Hideaki Takahashi, Nobuhiko Oridate, Tomoya Yokota, Taiji Koyama, Naomi Kiyota, Yasuyoshi Sato, Shunji Takahashi, Kyoko Kato, Shigenori Kadowaki, Yoshitaka Honma
{"title":"Clinical outcomes of recurrent or metastatic head and neck cancer after failure of platinum and nivolumab: a multicenter retrospective study.","authors":"Takane Watanabe, Hiroki Oka, Kengo Nagashima, Hideaki Nishi, Yoshihiko Kumai, Hiroaki Iijima, Kenji Okami, Yasushi Shimizu, Satoshi Kano, Kazue Ito, Tomoko Yamazaki, Hideaki Takahashi, Nobuhiko Oridate, Tomoya Yokota, Taiji Koyama, Naomi Kiyota, Yasuyoshi Sato, Shunji Takahashi, Kyoko Kato, Shigenori Kadowaki, Yoshitaka Honma","doi":"10.1093/oncolo/oyaf018","DOIUrl":"10.1093/oncolo/oyaf018","url":null,"abstract":"<p><strong>Background: </strong>Platinum and anti-PD-1 antibodies are the front-line systemic therapy for recurrent or metastatic head and neck squamous cell carcinoma (RM-HNSCC). However, limited data are available on clinical outcomes and appropriate regimens for patients with RM-HNSCC following treatment failure with these agents.</p><p><strong>Patients and methods: </strong>We retrospectively analyzed the clinical data of patients with RM-HNSCC from 10 Japanese institutions in whom platinum and nivolumab treatment failed.</p><p><strong>Results: </strong>Of the 480 patients included in the study, 236 were treated with the best supportive care and had a median overall survival of 3.1 months. The remaining 244 patients received salvage-line chemotherapy, which was paclitaxel + cetuximab in 72 (30%), paclitaxel or docetaxel in 89 (36%), and tegafur/gimeracil/oteracil in 48 (20%); the respective objective response rates were 54.9%, 27.9%, and 25.5%, with median progression-free survival of 5.4 months and median overall survival of 13.0 months. Multivariable analysis identified disease stabilization or response on prior nivolumab and paclitaxel + cetuximab as salvage-line chemotherapy to be associated with encouraging progression-free and overall survival.</p><p><strong>Conclusion: </strong>This study sheds light on clinical outcomes and prognostic factors in patients with RM-HNSCC after failure of platinum and anti-PD-1 antibody therapy. The findings provide essential baseline data for future therapeutic development in salvage-line settings.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 3","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11957247/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143756071","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
Emerging molecular testing paradigms in non-small cell lung cancer management-current perspectives and recommendations.
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae357
Frédérique Penault-Llorca, Mark A Socinski
{"title":"Emerging molecular testing paradigms in non-small cell lung cancer management-current perspectives and recommendations.","authors":"Frédérique Penault-Llorca, Mark A Socinski","doi":"10.1093/oncolo/oyae357","DOIUrl":"10.1093/oncolo/oyae357","url":null,"abstract":"<p><p>Advances in molecular testing and precision oncology have transformed the clinical management of lung cancer, especially non-small cell lung cancer, enhancing diagnosis, treatment, and outcomes. Practical guidelines offer insights into selecting appropriate biomarkers and assays, emphasizing the importance of comprehensive testing. However, real-world data reveal the underutilization of biomarker testing and consequently targeted therapies. Molecular testing often occurs late in diagnosis or not at all in clinical practice, leading to delayed or inadequate treatment. Enhancing precision requires adherence to best practices by all health care professionals involved, which can ultimately improve lung cancer patient outcomes. The future of precision oncology for lung cancer will likely involve a more personalized approach, starting increasingly from earlier disease settings, with novel and more complex targeted therapies, immunotherapies, and combination regimens, and relying on liquid biopsies, muti-detection advanced genomic technologies and data integration, with artificial intelligence as a central orchestrator. This review presents the currently known actionable mutations in lung cancer and new upcoming ones that are likely to enter clinical practice soon and provides an overview of established and emerging concepts in testing methodologies. Challenges are discussed and best practice recommendations are made that are relevant today, will continue to be relevant in the future, and are likely to be relevant for other cancer types too.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11966107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143702329","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
Dynamics of hyperglycemia of patients treated with alpelisib: exploratory interim analysis of ITACA trial.
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyaf023
Marija Pancirov, Josipa Flam, Jelena Šuto Pavičić, Dora Čerina Pavlinović, Natalija Dedić Plavetić, Paula Podolski, Žarko Bajić, Mladen Krnić, Eduard Vrdoljak
{"title":"Dynamics of hyperglycemia of patients treated with alpelisib: exploratory interim analysis of ITACA trial.","authors":"Marija Pancirov, Josipa Flam, Jelena Šuto Pavičić, Dora Čerina Pavlinović, Natalija Dedić Plavetić, Paula Podolski, Žarko Bajić, Mladen Krnić, Eduard Vrdoljak","doi":"10.1093/oncolo/oyaf023","DOIUrl":"10.1093/oncolo/oyaf023","url":null,"abstract":"<p><strong>Background: </strong>Alpelisib and fulvestrant combination has improved outcomes in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-)- advanced breast cancer (BC) who relapsed or progressed on prior endocrine therapy. Hyperglycemia, on target toxicity, is a frequent adverse event occurring in over 60% of patients.</p><p><strong>Objectives: </strong>The ITACA trial explores whether low carbohydrate dietary modifications and evening dosing of alpelisib to potentially mitigate impact of food on hyperglycemia. This exploratory interim analysis aimed to quantify the incidence and timing of hyperglycemia in the ITACA trial's pooled sample.</p><p><strong>Methods: </strong>This exploratory interim analysis of the ongoing ITACA trial included 23 patients with HR+, HER2-negative metastatic BC receiving alpelisib and fulvestrant. The exploratory outcomes were grade 2-4 hyperglycemia-free survival and time to onset of hyperglycemia.</p><p><strong>Results: </strong>Most patients, 21 (91.3%), experienced any-grade hyperglycemia (Grade 1: 9 [39.1%], Grade 2: 8 [34.8%], Grade 3: 4 [17.4%], and Grade 4: 0 [0.0%]) within the first week of alpelisib initiation. The median grade 2-4 hyperglycemia-free survival was 6 days (95% CI 3; 44 days).</p><p><strong>Conclusions: </strong>This exploratory interim analysis demonstrated the rapid onset of hyperglycemia in patients receiving alpelisib, even with the ITACA trial's dietary interventions. Proactive monitoring, within the first week after initiation of treatment, and early management of hyperglycemia are crucial in this patient population.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 3","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950915/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733129","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
Geographic disparities in gastrointestinal oncology research: a focus on trial availability in Italy.
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyaf011
Maurizio Polignano, Nicola Carella, Ornella Rotolo, Natalino Vena, Vincenza Lorusso, Giuseppe Dalfino, Gianluigi Giannelli
{"title":"Geographic disparities in gastrointestinal oncology research: a focus on trial availability in Italy.","authors":"Maurizio Polignano, Nicola Carella, Ornella Rotolo, Natalino Vena, Vincenza Lorusso, Giuseppe Dalfino, Gianluigi Giannelli","doi":"10.1093/oncolo/oyaf011","DOIUrl":"10.1093/oncolo/oyaf011","url":null,"abstract":"<p><strong>Background: </strong>Gastrointestinal cancers pose a significant global health burden, bearing as they do high incidence and mortality rates. Clinical trials in oncology offer numerous advantages as helping to develop new treatments and improve existing ones, leading to better patient outcomes, providing patients with access to cutting-edge therapies that might not otherwise be available and enhancing our understanding of cancer biology.</p><p><strong>Methods: </strong>We retrospectively reviewed active interventional clinical trials in Italy in the field of gastrointestinal neoplasms in the period March 1, 2020 and March 1, 2024, by a search on the \"clincaltrials.gov\" database. The search yielded 103 studies active in Italy. For each study, the Centers in Italy at which they are active were extracted. Studies resulted active in a total of 630 locations.</p><p><strong>Results: </strong>The data analysis, by a kernel smoothing for probability density estimation, reveals a pronounced clustering of trials in Northern and Central Italy, while the Southern regions and islands exhibit lower trial availability, highlighting disparities in patient access. The mean number of clinical trials per 100 000 inhabitants was calculated. We found that Northern regions show a much higher concentration compared with the Southern regions and islands (North-east 0.92 CTs/100 000 inhabitants vs Islands 0.53 CTs/100 000 inhabitants).</p><p><strong>Conclusions: </strong>The uneven distribution does not only limit treatment options for patients in less accessible areas but also raises concerns about the representativeness of trial data. This study underscores the need for targeted strategies to enhance trial accessibility, including decentralized trial models and national databases, to ensure equitable patient participation across Italy.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":"30 3","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11950913/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143733154","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 of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population. 顺铂-吉西他滨-德伐卢单抗对晚期胆道癌术后早期复发与晚期复发患者的疗效:一个全球范围内的大型真实人群。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae256
Federica Lo Prinzi, Francesca Salani, Margherita Rimini, Mario Domenico Rizzato, Lorenzo Antonuzzo, Silvia Camera, Tomoyuki Satake, Hanne Vandeputte, Caterina Vivaldi, Tiziana Pressiani, Jessica Lucchetti, Jin Won Kim, Oluseyi Abidoye, Ilario Giovanni Rapposelli, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Alessandro Pastorino, Florian Castet, Emiliano Tamburini, Changhoon Yoo, Alessandro Parisi, Anna Diana, Mario Scartozzi, Gerald W Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Jorge Adeva, Stephen L Chan, Gian Paolo Spinelli, Nicola Personeni, Ingrid Garajova, Maria Grazia Rodriquenz, Silvana Leo, Cecilia Melo Alvim, Ricardo Roque, Lorenzo Fornaro, Antonio De Rosa, Daniele Lavacchi, Federico Rossari, Masafumi Ikeda, Jeroen Dekervel, Monica Niger, Rita Balsano, Giuseppe Tonini, Minsu Kang, Tanios Bekaii-Saab, Massimo Giuseppe Viola, Lucrezia Silvestro, Luca Esposito, Alessandra Boccaccino, Vera Himmelsbach, Matteo Landriscina, Selma Ahcene Djaballah, Valentina Zanuso, Gianluca Masi, Sara Lonardi, Lorenza Rimassa, Andrea Casadei-Gardini
{"title":"Efficacy of cisplatin-gemcitabine-durvalumab in patients with advanced biliary tract cancer experiencing early vs late disease relapse after surgery: a large real-life worldwide population.","authors":"Federica Lo Prinzi, Francesca Salani, Margherita Rimini, Mario Domenico Rizzato, Lorenzo Antonuzzo, Silvia Camera, Tomoyuki Satake, Hanne Vandeputte, Caterina Vivaldi, Tiziana Pressiani, Jessica Lucchetti, Jin Won Kim, Oluseyi Abidoye, Ilario Giovanni Rapposelli, Stefano Tamberi, Fabian Finkelmeier, Guido Giordano, Chiara Pircher, Hong Jae Chon, Chiara Braconi, Alessandro Pastorino, Florian Castet, Emiliano Tamburini, Changhoon Yoo, Alessandro Parisi, Anna Diana, Mario Scartozzi, Gerald W Prager, Antonio Avallone, Marta Schirripa, Il Hwan Kim, Lukas Perkhofer, Ester Oneda, Monica Verrico, Jorge Adeva, Stephen L Chan, Gian Paolo Spinelli, Nicola Personeni, Ingrid Garajova, Maria Grazia Rodriquenz, Silvana Leo, Cecilia Melo Alvim, Ricardo Roque, Lorenzo Fornaro, Antonio De Rosa, Daniele Lavacchi, Federico Rossari, Masafumi Ikeda, Jeroen Dekervel, Monica Niger, Rita Balsano, Giuseppe Tonini, Minsu Kang, Tanios Bekaii-Saab, Massimo Giuseppe Viola, Lucrezia Silvestro, Luca Esposito, Alessandra Boccaccino, Vera Himmelsbach, Matteo Landriscina, Selma Ahcene Djaballah, Valentina Zanuso, Gianluca Masi, Sara Lonardi, Lorenza Rimassa, Andrea Casadei-Gardini","doi":"10.1093/oncolo/oyae256","DOIUrl":"10.1093/oncolo/oyae256","url":null,"abstract":"<p><strong>Background: </strong>In the TOPAZ-1, patients with biliary tract cancers (BTC) and recurrence within 6 months after surgery were excluded, even if this event is frequently observed in clinical practice. Our study aimed to assess if the efficacy of cisplatin-gemcitabine-durvalumab (CGD) in this population is comparable to that reported in the phase 3 trial.</p><p><strong>Methods: </strong>The study cohort included patients with BTC who underwent surgery on the primary tumor, experienced disease recurrence occurring ≤6 months or >6 months after surgery or after the end of adjuvant therapy and started CGD. The primary objectives were overall survival (OS) and progression free survival (PFS).</p><p><strong>Results: </strong>A total of 178 patients were enrolled. No significant differences were observed between early and late relapse groups in OS (23.4 months vs not reached; HR 1.26; 95% CI, 0.67-2.37; P = .45) and PFS [7.0 months vs 9.8 months; HR 1.3(95% CI, 0.9-2.1) P = .13]. Overall response rate and disease control rate (P = .33 and P = .62) were comparable between the 2 groups, as the overall safety profile. In addition, we compared survival outcomes between the selected population and a historical cohort of patients with BTC treated with cisplatin-gemcitabine (CG) and found that despite the absence of statistical significance, CGD showed an outcome trend compared with CG regardless of the time of recurrence after surgery or adjuvant chemotherapy [(CG ≤ 6 vs CGD ≤ 6 months: HR 0.59, 95%CI, 0.35-1.01, P = .05; HR 0.70; 95%CI, 0.46-1.06, P = .09, OS and PFS, respectively) and (CG > 6 vs. CGD > 6 months: HR 0.50; 95%CI, 0.29-0.88, P = 0.0165; HR 0.54; 95%CI, 0.35-0.84, P = .0068, OS and PFS, respectively)].</p><p><strong>Conclusion: </strong>Our analysis suggests that CGD retains its efficacy independently of the timing of relapse after surgery or completion of adjuvant treatment in patients with advanced BTC.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954499/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142481138","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
Opioid use and adverse health effects in breast cancer survivors. 乳腺癌幸存者使用阿片类药物和对健康的不良影响。
IF 4.8 2区 医学
Oncologist Pub Date : 2025-03-10 DOI: 10.1093/oncolo/oyae270
Reina Haque, Lie Hong Chen, Jiaxiao Shi, Zheng Gu, Moira Brady-Rogers, Rowan T Chlebowski, Rulin C Hechter
{"title":"Opioid use and adverse health effects in breast cancer survivors.","authors":"Reina Haque, Lie Hong Chen, Jiaxiao Shi, Zheng Gu, Moira Brady-Rogers, Rowan T Chlebowski, Rulin C Hechter","doi":"10.1093/oncolo/oyae270","DOIUrl":"10.1093/oncolo/oyae270","url":null,"abstract":"<p><strong>Background: </strong>Little information exists on adverse effects related to opioid use in breast cancer survivors following active cancer treatment, and no studies included an age-matched comparison group. Thus, we examined opioid use and risk of falls, fractures, lung problems, and cardiovascular events in breast cancer survivors in the years following active cancer treatment along with a comparison group.</p><p><strong>Methods: </strong>We conducted a longitudinal cohort study 33 989 breast cancer survivors and 157 609 age-matched women without cancer. Rates of adverse events, and multivariable hazards ratios for association between opioid use and the adverse health effects were calculated.</p><p><strong>Results: </strong>Women with breast cancer had greater opioid use (60% vs 48%); longer median opioid duration (18 vs 16 days); and were prescribed stronger opioids than the matched cohort over 5.6 median years of follow-up. In multivariable models, the risk of falls was 12% higher (HR, 95% CI, 1.12 [1.07-1.17]), and fracture risk was 56% (HR = 1.56 [1.48-1.65]) greater in women with breast cancer who used opioids vs the matched cohort unexposed to opioids. In an analysis restricted to women with breast cancer, opioid use was strongly associated with the risk of falls (HR = 1.74 [1.63-1.85]); fractures (HR = 2.10 [1.95-2.27]); lung problems (HR = 1.53 [1.43-1.64]); and cardiovascular events (HR = 1.70 [1.39-2.08]) than opioid non-use.</p><p><strong>Conclusions: </strong>After active cancer treatment, opioid use and high dosage use were common in breast cancer survivors, and were associated with increased risk for falls, lung problems, fractures, and cardiovascular events. Findings underscore the need for careful monitoring of opioid use in these survivors and the exploration of alternative pain management strategies.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8,"publicationDate":"2025-03-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11954500/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142481143","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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