Journal of Clinical Oncology最新文献

{"title":"Reply to: Afatinib, Dose Reduction, and Pseudo-Acute Kidney Injury.","authors":"Derek De-Rui Huang,James Chih-Hsin Yang","doi":"10.1200/jco-25-01341","DOIUrl":"https://doi.org/10.1200/jco-25-01341","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"214 1","pages":"JCO2501341"},"PeriodicalIF":45.3,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701279","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to: Afatinib, Dose Reduction, and Pseudo-Acute Kidney Injury.","authors":"Satoru Miura","doi":"10.1200/jco-25-01429","DOIUrl":"https://doi.org/10.1200/jco-25-01429","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"23 1","pages":"JCO2501429"},"PeriodicalIF":45.3,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701280","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Afatinib, Dose Reduction, and Pseudo-Acute Kidney Injury.","authors":"Jacqueline Nguyen,Devika Das,Chintan V Shah","doi":"10.1200/jco-25-01219","DOIUrl":"https://doi.org/10.1200/jco-25-01219","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"52 1","pages":"JCO2501219"},"PeriodicalIF":45.3,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701285","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas.","authors":"Martin Wermke,Valentina Gambardella,Yasutoshi Kuboki,Enriqueta Felip,Miguel F Sanmamed,Olatunji B Alese,Cyrus M Sayehli,Edurne Arriola,Jürgen Wolf,Liza C Villaruz,Julia Bertulis,Matus Studeny,Mohamed Bouzaggou,Xiaoyan Fang,Daniel Morgensztern","doi":"10.1200/jco-25-00363","DOIUrl":"https://doi.org/10.1200/jco-25-00363","url":null,"abstract":"PURPOSEWe report phase I results for obrixtamig (BI 764532), a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager, in patients with previously treated DLL3-positive small cell lung cancer (SCLC), extrapulmonary neuroendocrine carcinomas (epNECs), or large cell neuroendocrine carcinoma of the lung (LCNEC-L).METHODSPatients received escalating intravenous obrixtamig doses using four regimens: a fixed dose once every 3 weeks (A); a fixed dose once weekly (B1); a step-up dose once weekly for two weeks and target dose once weekly (B2); and a step-up dose once weekly for 3 weeks, target dose once weekly for 3 weeks, and once every 3 weeks thereafter (B3). The primary objective was maximum tolerated dose (MTD). Secondary objectives included safety, pharmacokinetics, and tumor response (RECIST v1.1).RESULTSAs of February 21, 2024, 168 patients received obrixtamig, 72% received ≥2 lines of previous anticancer therapy, and 51% received previous anti-PD-1/PD-L1 therapy. Seven dose-limiting toxicities occurred during MTD evaluation (Regimen A, n = 1; Regimen B2, n = 6). MTD was not reached. The most common treatment-related adverse event was cytokine release syndrome (any grade: 57%; grade ≥3: 3%); most cases occurred early and were reversible. Across all doses, regimens, and tumor types, the overall response rate (ORR) was 23% (95% CI, 17.4% to 30.2%), the median duration of response (DoR) was 8.5 months (95% CI, 6.2 to not reached), and the 6-month DoR rate was 70% (95% CI, 53% to 88%). All patients in Regimens B2/B3 received the minimum effective dose (≥90 μg/kg once weekly or once every 3 weeks), achieving an ORR of 28% (95% CI, 20.7% to 35.9%). With Regimens B2/B3, ORRs were 21% (95% CI, 12.9% to 33.1%), 27% (95% CI, 17.4% to 39.6%), and 70% (95% CI, 39.7% to 89.2%) for SCLC, epNECs, and LCNEC-L, respectively.CONCLUSIONThe demonstrated tolerability and efficacy of obrixtamig regimens, administered as step-up followed by target doses of 90-1,080 μg/kg (once weekly or once every 3 weeks), in patients with heavily pretreated DLL3-positive tumors support further exploration in SCLC, epNEC, and LCNEC-L.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"25 1","pages":"JCO2500363"},"PeriodicalIF":45.3,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701062","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Totality of the Evidence: Optimizing Dosage Selection Strategies in Oncology.","authors":"Laura A Levit,Mirat Shah,Mark J Ratain,Elizabeth Garrett-Mayer,Atiqur Rahman,Marc Theoret,R Donald Harvey","doi":"10.1200/jco-25-00488","DOIUrl":"https://doi.org/10.1200/jco-25-00488","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"27 1","pages":"JCO2500488"},"PeriodicalIF":45.3,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144701070","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: BO-112 Plus Pembrolizumab for Patients With Anti-PD-1-Resistant Advanced Melanoma: Phase II Clinical Trial SPOTLIGHT-203.","authors":"Iván Márquez-Rodas, Caroline Dutriaux, Philippe Saiag, Luis de la Cruz Merino, Eduardo Castañón Álvarez, Caroline Robert, Juan F Rodríguez-Moreno, Ana Arance, Pablo Cerezuela-Fuentes, Henri Montaudié, Miguel F Sanmamed, María González-Cao, Julie Charles, María Pilar López Criado, Alfonso Berrocal, Enrique de Miguel, Elisa Funck-Brentano, Sorilla Prey, Mᵃ Carmen Álamo de la Gala, Ignacio Melero, Jose Antonio Avilés-Izquierdo, Ruth Roman, Beatriz Garcia-Pelaez, Sonia Rodriguez, Zuzana Jirakova Trnkova, Marisol Quintero, Sonia Maciá, Marya F Chaney, Stephane Dalle","doi":"10.1200/JCO-25-01680","DOIUrl":"https://doi.org/10.1200/JCO-25-01680","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2501680"},"PeriodicalIF":42.1,"publicationDate":"2025-07-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144707644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Primary Analysis of EPIK-O/ENGOT-ov61: Alpelisib Plus Olaparib Versus Chemotherapy in Platinum-Resistant or Platinum-Refractory High-Grade Serous Ovarian Cancer Without BRCA Mutation.","authors":"Panagiotis A Konstantinopoulos,Jae Weon Kim,Gilles Freyer,Jung Yun Lee,Lydia Gaba,Rachel N Grisham,Nicoletta Colombo,Xiaohua Wu,Jalid Sehouli,Felipe Cruz,David Cibula,Bradley J Monk,Gitte-Bettina Nyvang,Michael Friedlander,Domenica Lorusso,Els Van Nieuwenhuysen,Rozita Malik,Rosalind Glasspool,Christian Marth,Alexandra Leary,Alfonso Cortés-Salgado,Claudio Zamagni,Frederik Marmé,Jozef Sufliarsky,Patsy Hinson,Monica Zuradelli,Craig Wang,Fei Su,Ines Paule,Michelle Miller,Ursula A Matulonis,Antonio González-Martín","doi":"10.1200/jco-25-00225","DOIUrl":"https://doi.org/10.1200/jco-25-00225","url":null,"abstract":"PURPOSEPatients with platinum-resistant/platinum-refractory high-grade serous ovarian cancer (HGSOC) without a BRCA mutation have poor prognosis and limited treatment options. We report efficacy and biomarker data from EPIK-O, which investigated alpelisib + olaparib versus single-agent chemotherapy in these patients.PATIENTS AND METHODSEPIK-O was an open-label, phase III trial that randomly assigned patients with platinum-resistant/platinum-refractory HGSOC with no germline or known somatic BRCA mutation 1:1 to alpelisib 200 mg once daily + olaparib 200 mg twice daily or treatment of physician's choice (TPC; paclitaxel 80 mg/m2 once weekly or pegylated liposomal doxorubicin 40-50 mg/m2 once every 28 days). Patients had 1-3 previous systemic therapies. Previous bevacizumab was required (unless contraindicated); previous poly(adenosine diphosphate-ribose) polymerase inhibitors were allowed. Primary end point was progression-free survival (PFS) per RECIST 1.1 (blinded independent review committee [BIRC]). Secondary efficacy end points included overall response rate (ORR; per BIRC), duration of response (per BIRC), and overall survival (OS; key secondary end point).RESULTSA total of 358 patients (alpelisib + olaparib [n = 180], TPC [n = 178]) were included. The median follow-up time was 9.3 months. At data cutoff (April 21, 2023), 33 (18.3%) and 30 (16.9%) patients remained on treatment with alpelisib + olaparib and TPC, respectively. The median PFS (BIRC) was 3.6 versus 3.9 months (hazard ratio [HR], 1.14 [95% CI, 0.88 to 1.48]; one-sided P = .84) for alpelisib + olaparib versus TPC. The ORR was 15.6% (95% CI, 10.6% to 21.7%) versus 13.5% (95% CI, 8.8% to 19.4%). The median OS was 10.0 versus 10.6 months (HR, 1.22; 95% CI, 0.87 to 1.71). The safety profile of alpelisib + olaparib was consistent with that observed for the individual agents.CONCLUSIONThe primary objective, PFS improvement, was not met in EPIK-O. No new or unexpected adverse events were observed. Biomarker analyses provided new insights for responders to alpelisib + olaparib.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"13 1","pages":"JCO2500225"},"PeriodicalIF":45.3,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144693301","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Erratum: Randomized Phase II Study of Nab-Paclitaxel and Gemcitabine With or Without Tocilizumab as First-Line Treatment in Advanced Pancreatic Cancer: Survival and Cachexia.","authors":"Inna M Chen, Julia S Johansen, Susann Theile, Libbie M Silverman, Katherine R Pelz, Kasper Madsen, Olav Dajani, Kevin Z M Lim, Torben Lorentzen, Omnia Gaafer, Leonidas G Koniaris, Anna C Ferreira, Brian Neelon, Denis C Guttridge, Michael C Ostrowski, Teresa A Zimmers, Dorte Nielsen","doi":"10.1200/JCO-25-01631","DOIUrl":"https://doi.org/10.1200/JCO-25-01631","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2501631"},"PeriodicalIF":42.1,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144698679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Caution Needed Before Adopting Reduced-Dose Elective Neck Irradiation in Head and Neck Cancer: A Response to UPGRADE-RT.","authors":"Naomi Kiyota,Junki Mizusawa,Sadamoto Zenda,Tomoya Yokota,Yasushi Fujimoto,Koichiro Wasano,Takeshi Kodaira","doi":"10.1200/jco-25-00928","DOIUrl":"https://doi.org/10.1200/jco-25-00928","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"20 1","pages":"JCO2500928"},"PeriodicalIF":45.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144684082","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reply to: Caution Needed Before Adopting Reduced-Dose Elective Neck Irradiation in Head and Neck Cancer: A Response to UPGRADE-RT.","authors":"Sven van den Bosch,Gerjon Hannink,Johannes H A M Kaanders","doi":"10.1200/jco-25-01390","DOIUrl":"https://doi.org/10.1200/jco-25-01390","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"17 1","pages":"JCO2501390"},"PeriodicalIF":45.3,"publicationDate":"2025-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144684080","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}