Oncologist最新文献

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Equipoise lost in pancreatic cancer: reimagining crossover for promising cancer therapies. 失去平衡:通过重新设想交叉,在临床试验设计中优先考虑患者安全性和早期获得有希望的癌症治疗。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag347
Kruti B Vora, Susan E Bates
{"title":"Equipoise lost in pancreatic cancer: reimagining crossover for promising cancer therapies.","authors":"Kruti B Vora, Susan E Bates","doi":"10.1093/oncolo/oyag347","DOIUrl":"10.1093/oncolo/oyag347","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13628384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148852108","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
Central nervous system symptom burden and clinical implications for antiemetic management with olanzapine in AC chemotherapy. AC化疗中中枢神经系统症状负担及奥氮平止吐管理的临床意义。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag351
Ryoko Udagawa, Mototsugu Shimokawa, Hirotoshi Iihara, Rie Ozeki, Michiko Tsuneizumi, Manabu Futamura, Tomoyuki Fujita, Hideaki Ogata, Hiroko Bando, Toshitaka Uomori, Hironobu Hashimoto, Ryosuke Hayami, Yoshihisa Tokumaru, Goro Kutomi, Kan Yonemori, Ryoichi Matsunuma, Mika Kitahora, Naotake Yanagisawa, Tatsunori Shimoi, Mitsue Saito
{"title":"Central nervous system symptom burden and clinical implications for antiemetic management with olanzapine in AC chemotherapy.","authors":"Ryoko Udagawa, Mototsugu Shimokawa, Hirotoshi Iihara, Rie Ozeki, Michiko Tsuneizumi, Manabu Futamura, Tomoyuki Fujita, Hideaki Ogata, Hiroko Bando, Toshitaka Uomori, Hironobu Hashimoto, Ryosuke Hayami, Yoshihisa Tokumaru, Goro Kutomi, Kan Yonemori, Ryoichi Matsunuma, Mika Kitahora, Naotake Yanagisawa, Tatsunori Shimoi, Mitsue Saito","doi":"10.1093/oncolo/oyag351","DOIUrl":"10.1093/oncolo/oyag351","url":null,"abstract":"<p><strong>Background: </strong>Olanzapine 5 mg improves chemotherapy-induced nausea and vomiting (CINV) control in patients receiving anthracycline-cyclophosphamide (AC) chemotherapy, but sedation remains a concern. We evaluated whether central nervous system (CNS) symptom burden identifies patients at higher risk of poor CINV control.</p><p><strong>Patients and methods: </strong>This secondary analysis of the phase III JTOP-B trial included women with breast cancer receiving AC chemotherapy. Patients were randomized to olanzapine 5 mg or placebo plus standard triplet antiemetic therapy. Daily patient-reported sedation and concentration impairment were assessed for 5 days. CNS burden was evaluated using recurrent \"Bad Days\" (concurrent moderate/severe sedation and concentration impairment) and cumulative CNS burden scores. Associations between CNS symptom patterns and complete response (CR; no emesis and no rescue medication) during 0-120 hours were analyzed.</p><p><strong>Results: </strong>Among 480 patients, CR rates decreased with increasing CNS symptom severity in both groups. In the olanzapine group, CR rates decreased across increasing sedation (75.0%-51.6%) and concentration impairment (78.1%-48.6%). Concentration impairment more strongly identified patients with poor CINV control than sedation alone. Higher cumulative CNS burden and recurrent Bad Days were associated with lower CR rates, identifying a clinically vulnerable population. Olanzapine maintained higher CR rates than placebo across CNS symptom strata.</p><p><strong>Conclusions: </strong>CNS symptom burden was associated with suboptimal CINV control, while 5 mg of olanzapine maintained superior antiemetic efficacy across CNS symptom strata. Monitoring day-to-day CNS symptoms may help identify patients requiring closer observation or additional supportive care.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials Identifier: jRCT1031200134.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13599778/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148914367","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
Real-world characteristics of trastuzumab deruxtecan-related interstitial lung disease in Japanese patients with breast cancer and gastric cancer. 日本乳腺癌和胃癌患者曲妥珠单抗相关间质性肺病的真实世界特征
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag340
Yutaka Fujiwara, Katsunori Oikado, Tomohisa Baba, Masahiko Kusumoto, Shinichi Sasaki, Masahiro Endo, Terufumi Kato, Yasuyuki Kurihara, Yoshinobu Saito, Kunihiro Yagihashi, Masafumi Sata, Yoshinao Sato, Hirotsugu Kenmotsu, Taiki Fukuda, Teppei Yamaguchi, Saiko Isshiki, Hiroshi Wakui, Haruki Kobayashi, Satoshi Ikeda, Motoyasu Kato, Ou Yamaguchi, Toshimi Takano, Ken Kato, Yoshiharu Hiruma, Koji Hirata, Wataru Hashimoto, Kazuyoshi Kuwano
{"title":"Real-world characteristics of trastuzumab deruxtecan-related interstitial lung disease in Japanese patients with breast cancer and gastric cancer.","authors":"Yutaka Fujiwara, Katsunori Oikado, Tomohisa Baba, Masahiko Kusumoto, Shinichi Sasaki, Masahiro Endo, Terufumi Kato, Yasuyuki Kurihara, Yoshinobu Saito, Kunihiro Yagihashi, Masafumi Sata, Yoshinao Sato, Hirotsugu Kenmotsu, Taiki Fukuda, Teppei Yamaguchi, Saiko Isshiki, Hiroshi Wakui, Haruki Kobayashi, Satoshi Ikeda, Motoyasu Kato, Ou Yamaguchi, Toshimi Takano, Ken Kato, Yoshiharu Hiruma, Koji Hirata, Wataru Hashimoto, Kazuyoshi Kuwano","doi":"10.1093/oncolo/oyag340","DOIUrl":"10.1093/oncolo/oyag340","url":null,"abstract":"<p><strong>Background: </strong>Interstitial lung disease (ILD)/pneumonitis is an important adverse drug reaction associated with trastuzumab deruxtecan (T-DXd). This report comprehensively characterized clinical and imaging features of T-DXd-related ILD, systematically evaluated by an independent ILD Adjudication Committee (AC), in Japanese patients with breast/gastric cancer from all-patient post-marketing surveillance studies.</p><p><strong>Patients and methods: </strong>This post hoc analysis evaluated independent ILD AC-adjudicated T-DXd-related ILD cases. Demographics, clinical/radiological features, time to onset, treatment interventions, and outcomes (followed up to 12 months from onset) were analyzed.</p><p><strong>Results: </strong>Among 2801 T-DXd-treated patients (breast cancer: 1731; gastric cancer: 1070), 421 potential cases were reviewed: 381 were adjudicated as T-DXd-related ILD (breast cancer: 278; gastric cancer: 103). Median age was 65.0 years, 75.1% were female, and 28.3% had a smoking history. ILD occurred throughout observation (including fatal cases ≥12 months post-initiation) with no specific onset window. Time to onset did not differ across CTCAE grades. Organizing pneumonia was the predominant imaging pattern (67.7%), followed by hypersensitivity pneumonitis (14.2%) and diffuse alveolar damage (DAD, 12.6%). Most cases (78.2%) were worst CTCAE Grade 1-2. Grade 5 ILD occurred in 30 patients (7.9%), with DAD the most common pattern (26 patients). Overall recovery was 83.5%. Corticosteroids were used in 54.6% of cases, with 79.3% responding. High-dose corticosteroids and additional immunosuppressants were ineffective in seven DAD cases.</p><p><strong>Conclusions: </strong>Most T-DXd-related ILD cases were mild/moderate and corticosteroid-responsive; DAD pattern was associated with higher mortality. These findings underscore the importance of vigilant monitoring, early recognition, and prompt corticosteroid treatment to mitigate fatal T-DXd-related ILD.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653604/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148908136","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
Linking early and late endpoints in adjuvant immunotherapy trials: an evaluation of multiple clinical outcomes. 连接辅助免疫治疗试验的早期和晚期终点:多种临床结果的评估。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag342
Sirui Tang, Huiran Zang, Linhan Mao, Xingyu Liu, Xinyu Li
{"title":"Linking early and late endpoints in adjuvant immunotherapy trials: an evaluation of multiple clinical outcomes.","authors":"Sirui Tang, Huiran Zang, Linhan Mao, Xingyu Liu, Xinyu Li","doi":"10.1093/oncolo/oyag342","DOIUrl":"10.1093/oncolo/oyag342","url":null,"abstract":"<p><strong>Background: </strong>Overall survival (OS) in adjuvant and perioperative immunotherapy trials requires prolonged follow-up. We examined whether treatment effects on disease-free survival (DFS) and recurrence-free survival (RFS) were associated with OS at matched 2-, 3-, and 5-year windows.</p><p><strong>Methods: </strong>The main analysis included 23 strict-primary randomized trials. DFS and RFS were modeled separately across 6 paired time windows using 2 co-primary trial-level approaches: a conventional OS-variance-weighted regression and a conditional errors-in-variables model accounting for uncertainty in both log-HRs. Because within-trial correlations were unavailable, ρ was varied from 0 to 0.75. Eligibility-sensitivity studies were supplementary; broad-taxonomy evidence was excluded. EFS was descriptive, PFS and PFS2 were analyzed separately, and QoL regression required at least 5 verified contrasts.</p><p><strong>Results: </strong>Nineteen trials contributed 2-year same-window pairs (12 DFS; 7 RFS), 8 contributed 3-year pairs, and 5 contributed 5-year pairs. For 2-year early endpoints vs 2-year OS, weighted slopes were 0.014 (95% CI, -0.286 to 0.314) for DFS and 0.630 (95% CI, -1.243 to 2.502) for RFS. Eight of 9 fitted weighted-regression intervals included zero; the only nominally positive result involved 4 RFS trials. In errors-in-variables analyses, slopes for the largest DFS and RFS comparisons ranged from 0.011 to 0.264 and from 0.758 to 0.885, respectively, and all profile CIs included zero. Six strict-primary QoL contrasts were verified, but no window reached n = 5.</p><p><strong>Conclusion: </strong>Strict-primary analyses did not demonstrate a consistent or precise early-endpoint-OS relationship. Sparse later windows and uncertainty in both treatment-effect estimates preclude surrogate validation.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584216/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148801760","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
Computed tomography-derived body composition and early changes predict outcomes of first-line chemo-immunotherapy in recurrent/metastatic nasopharyngeal carcinoma. ct来源的体成分和早期变化预测复发/转移鼻咽癌一线化疗免疫治疗的预后
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag355
Xia Gan, Zhengzheng Yu, Yaning Tang, Lin Zhang, Wenji Xie, Xiaowen Sun, Yue Li, Jianing Fang, Yating Liu, Zhongjie Liu, Can Zhou, Zhuolong Xie, Wen Yao, Shuyu Ouyang, Jing Zhang, Jingyu Wang, Hua Li, Pan Chen, Hui Wang, Yanxian Li, Huai Liu
{"title":"Computed tomography-derived body composition and early changes predict outcomes of first-line chemo-immunotherapy in recurrent/metastatic nasopharyngeal carcinoma.","authors":"Xia Gan, Zhengzheng Yu, Yaning Tang, Lin Zhang, Wenji Xie, Xiaowen Sun, Yue Li, Jianing Fang, Yating Liu, Zhongjie Liu, Can Zhou, Zhuolong Xie, Wen Yao, Shuyu Ouyang, Jing Zhang, Jingyu Wang, Hua Li, Pan Chen, Hui Wang, Yanxian Li, Huai Liu","doi":"10.1093/oncolo/oyag355","DOIUrl":"10.1093/oncolo/oyag355","url":null,"abstract":"<p><strong>Background: </strong>Reliable biomarkers for risk stratification and treatment monitoring in recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) treated with first-line chemo-immunotherapy remain limited. This study evaluated the prognostic value of baseline computed tomography (CT)-derived body composition parameters and their early dynamic changes.</p><p><strong>Methods: </strong>In this single-center retrospective cohort study, patients with R/M NPC receiving first-line chemo-immunotherapy were included. The primary endpoint was progression-free survival (PFS), and secondary endpoints included overall survival (OS), objective response rate (ORR), and disease control rate (DCR). Associations between body composition and outcomes were analyzed.</p><p><strong>Results: </strong>A total of 199 patients were included, and 99 with post-treatment CT after 2 cycles were further analyzed for dynamic changes. Higher baseline skeletal muscle area (SMA) was independently associated with longer PFS (HR = 0.56; 95% CI, 0.37-0.85; P = 0.006) and OS (HR = 0.46; 95% CI, 0.23-0.93; P = 0.03), and with higher ORR (82.8% vs 70.0%; P = 0.033) and DCR (98.0% vs 91.0%; P = .031). During early treatment, a ≤1.3% decrease or an increase in SMA was independently associated with longer PFS (HR = 0.53; P = 0.045) and OS (HR = 0.27; P = 0.018). A greater decline in visceral adipose tissue density (ΔVATD < -0.9%) was also associated with more favorable PFS and OS, whereas no significant difference in ORR was observed.</p><p><strong>Conclusion: </strong>Baseline SMA and early changes in SMA and VATD have prognostic value in R/M NPC treated with first-line chemo-immunotherapy. CT-based body composition assessment may serve as a practical imaging biomarker for risk re-stratification and individualized management.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13600379/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148889383","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 HIF-2α inhibition in Von Hippel-Lindau disease: a multicenter real-world study. HIF-2α抑制在Von Hippel-Lindau病中的临床结果:一项多中心真实世界研究
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag331
Mousab Al Abbas, Jabra Zarka, Alvin C Silva, Filippo Cingolani, Muhammed Uzair Sarfraz, Albert Jang, Muhammad Ali Khan, Fouad Nahhat, Winston Tan, Brian A Costello, Haidar Abdul-Muhsin, Irbaz Bin Riaz, Yousef Zakharia
{"title":"Clinical outcomes of HIF-2α inhibition in Von Hippel-Lindau disease: a multicenter real-world study.","authors":"Mousab Al Abbas, Jabra Zarka, Alvin C Silva, Filippo Cingolani, Muhammed Uzair Sarfraz, Albert Jang, Muhammad Ali Khan, Fouad Nahhat, Winston Tan, Brian A Costello, Haidar Abdul-Muhsin, Irbaz Bin Riaz, Yousef Zakharia","doi":"10.1093/oncolo/oyag331","DOIUrl":"10.1093/oncolo/oyag331","url":null,"abstract":"<p><strong>Background and objective: </strong>Management of von Hippel-Lindau (VHL) disease is challenging due to multisystem involvement and limited systemic treatment options. Belzutifan has shown promising efficacy in clinical trials; however, real-world data remain limited. We aimed to evaluate its effectiveness and safety in a real-world cohort.</p><p><strong>Methods: </strong>We conducted a retrospective study of 59 patients with VHL disease treated with belzutifan between August 2021 and January 2026. Objective response rates (ORR) for renal cell carcinoma (RCC), central nervous system hemangioblastomas (CNS HB), and pancreatic neuroendocrine tumors (pNET) were assessed by an independent radiologist. Retinal hemangioblastoma outcomes were evaluated through ophthalmology records by chart review.</p><p><strong>Results: </strong>Median follow-up was 29 months. ORR was 27.6%, 39.6%, and 85.7% for RCC, CNS HB, and pNET, respectively. Among 13 patients with retinal hemangioblastomas (20 eyes), 17 eyes (85%) showed improvement. At data cutoff, 47 patients (79.6%) remained on treatment, while 12 (20.3%) discontinued (7 due to adverse events, 3 to disease progression, and 2 to other reasons). The most common adverse event was anemia (86.4%). Grade ≥3 adverse events occurred in 10 patients (16.9%). The procedure rate per patient-year decreased from 0.35 in the 3 years prior to treatment to 0.08 during follow-up (Incidence Rate Ratio, 0.23; 95% CI, 0.12-0.47; P < .001).</p><p><strong>Conclusions: </strong>Belzutifan demonstrated efficacy across VHL-associated lesions, with a favorable safety profile. Most adverse events were grade 1-2. A reduction in procedure rate was observed after treatment initiation.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570587/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148801714","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 view from the periphery: trial design, commercial competition, and the access gap in multiple myeloma. 从外围看:多发性骨髓瘤的试验设计、商业竞争和准入差距。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag364
Mehmet Baysal, Seval Akpınar
{"title":"A view from the periphery: trial design, commercial competition, and the access gap in multiple myeloma.","authors":"Mehmet Baysal, Seval Akpınar","doi":"10.1093/oncolo/oyag364","DOIUrl":"10.1093/oncolo/oyag364","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623524/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148931959","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
Oral toxicities secondary to TROP2 and HER2-directed antibody drug conjugates: a multicenter retrospective cohort study. TROP2和her2导向抗体药物偶联物继发的口服毒性。一项多中心回顾性队列研究。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag359
Paolo J Fantozzi, Stephen Sonis, Andrea Botticelli, Simone Scagnoli, Monica Verrico, Giulia Bianchini, Maria Vittoria Bonomo, Chiara Bonadonna, Mathilde Casagrande, Lucia Borghetti, Gianluca Tenore, Sankalp Das, John P Diaz, Umberto Romeo, Alessandro Villa
{"title":"Oral toxicities secondary to TROP2 and HER2-directed antibody drug conjugates: a multicenter retrospective cohort study.","authors":"Paolo J Fantozzi, Stephen Sonis, Andrea Botticelli, Simone Scagnoli, Monica Verrico, Giulia Bianchini, Maria Vittoria Bonomo, Chiara Bonadonna, Mathilde Casagrande, Lucia Borghetti, Gianluca Tenore, Sankalp Das, John P Diaz, Umberto Romeo, Alessandro Villa","doi":"10.1093/oncolo/oyag359","DOIUrl":"10.1093/oncolo/oyag359","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this multicenter retrospective cohort study was to characterize the incidence, clinical presentation, timing, severity, and management of oral toxicities (OTs) associated with TROP2-directed (datopotamab deruxtecan and sacituzumab govitecan) and HER2-directed (trastuzumab deruxtecan) antibody-drug conjugates in patients with advanced-stage cancers.</p><p><strong>Methods: </strong>A retrospective medical-records review of 207 patients was conducted to characterize antibody-drug conjugate (ADC)-associated OTs. Patients had been treated for advanced-stage cancers treated with TROP2 (sacituzumab govitecan and datopotamab deruxtecan) and HER2-directed ADCs (trastuzumab deruxtecan) at the Sapienza University-Hospital and Miami Cancer Institute between 2024 and 2025. Multivariate logistic regressions were performed to evaluate any correlation between the ADC type and prevalence, type, severity, time of onset, and time to resolution of OTs.</p><p><strong>Results: </strong>Overall, 47 patients (22.7%) developed OTs, with a median onset time of 7.5 days (range: 1-358). The OT prevalence was similar between TROP2 (n = 27, 23.5%) and HER2-directed (n = 20, 21.7%) ADCs, however, oral mucositis (OM) was more frequent with TROP2-directed ADCs (14.8% vs 5.4%, P = .04), whereas xerostomia (10.9% vs 6.1%, P = .31) and dysgeusia (9.8% vs 5.2%, P = .28) were more common and more severe with HER2-directed ADCs, although not reaching statistical significance. Patients receiving TROP2-directed ADCs had a 3.02-fold higher-risk of developing OM compared to those receiving HER2-directed ADCs (95% CI: 1.07-8.52, P = .040). In cases of OM, the trajectory of TROP2-associated OM was more acute than with HER-2-associated OM with earlier onset (P = .035) and quicker resolution (P = .045). Management of OTs was provided for 29 (14.0%) patients with the majority of them receiving TROP2-directed ADCs (n = 21, 17.3%). With regard to OTs, patients developing OM were associated with a greater need for management (n = 19/22; P = .001), compared to xerostomia (n = 8/17; P = .471) and dysgeusia (n = 2/15; P = .196). Ultimately, ADC dose reduction (DR) was required in 43 patients (20.8%) and was significantly more frequent with TROP2-directed ADCs (26.1% vs 14.1%, P = .039).</p><p><strong>Conclusion: </strong>TROP2-directed ADCs are associated with a higher-risk of OM (P = .040) with earlier onset of toxicities (P = .035), and greater DR requirements (P = .039). In contrast, HER2-directed ADCs are associated with more prevalent xerostomia and dysgeusia, a higher overall severity, and later onset but potentially longer duration.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13616048/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149018922","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
The role of adjuvant chemotherapy in small bowel adenocarcinomas. 辅助化疗在小肠腺癌中的作用。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag262
Kruti Vora, Ryan H Moy, Alfred I Neugut
{"title":"The role of adjuvant chemotherapy in small bowel adenocarcinomas.","authors":"Kruti Vora, Ryan H Moy, Alfred I Neugut","doi":"10.1093/oncolo/oyag262","DOIUrl":"10.1093/oncolo/oyag262","url":null,"abstract":"","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13591055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148426517","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
The insufficient publication of early-phase clinical trials in oncology. 肿瘤早期临床试验发表不足。
IF 4.7 2区 医学
Oncologist Pub Date : 2026-09-09 DOI: 10.1093/oncolo/oyag361
Merel J J Lucassen, Tim Schutte, Alwin D R Huitema, Neeltje Steeghs
{"title":"The insufficient publication of early-phase clinical trials in oncology.","authors":"Merel J J Lucassen, Tim Schutte, Alwin D R Huitema, Neeltje Steeghs","doi":"10.1093/oncolo/oyag361","DOIUrl":"10.1093/oncolo/oyag361","url":null,"abstract":"<p><strong>Introduction: </strong>Early-phase oncology clinical trials are often underrepresented in studies regarding publication of trial results. This study investigated the publication status of early-phase clinical trials, focusing on trials of compounds discontinued in clinical development.</p><p><strong>Methods: </strong>Two retrospective cohorts were formed: one included early-phase trials supporting European Medicines Agency marketing authorization applications (2017-2020), while the second cohort included early-phase trials of discontinued compounds. Trials were matched with database registry and their corresponding publications.</p><p><strong>Results: </strong>The first cohort consisted of 73 trials. Nine ongoing trials were excluded. No full publication or full report was found for 11% (n = 7/64) of trials. Median time from registered closure date to publication of trial results as full publication or full report was 109 days (IQR -733 to 597). Trials sponsored by large-size firms (HR 2.25 [95% CI, 1.23-4.1]), with >100 patients (HR 2.15 [95% CI, 1.19-3.88]) and duration >2 years (HR 6.83 [95% CI, 3.03-14.38]) were more likely to be published. The cohort with discontinued compounds consisted of 66 clinical trials. After exclusion of 9 ongoing trials, 39% (n = 22/57) lacked full publication or full report. Median time from registered closure date to publication of trial results as full publication or full report was 693 days (IQR 406-963). No covariates influencing publication status were found.</p><p><strong>Conclusions: </strong>Timely and complete publication of early-phase clinical trial results remains inadequate. Forty percent of trials with discontinued drugs are not publicly reported, and even among approved compounds, 11% of early-phase trial results cannot be found in the public domain.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13623515/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148957221","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}
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