Journal of Clinical Oncology最新文献

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Combined Analyses of Circulating Tumor DNA and Immunoscore in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the PRODIGE-GERCOR IDEA-France/HORG-IDEA-Greece Trials. 合并分析 III 期结肠癌患者的循环肿瘤 DNA 和免疫评分:PRODIGE-GERCOR IDEA-France/HORG-IDEA-Greece 试验的事后分析。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-05-01 Epub Date: 2025-02-04 DOI: 10.1200/JCO.24.00648
Julien Taieb, John Souglakos, Ioannis Boukovinas, Antoine Falcoz, Franck Pages, Ippokratis Messaritakis, Jaafar Bennouna, Pascal Artru, Christophe Louvet, Celine Lepere, Jean Francois Emile, Olivier Bouche, Thibault Mazard, Dewi Vernerey, Konstantinos Vogiatzoglou, Maria Tzardi, Shruti Sharma, Minetta C Liu, Himanshu Sethi, Thierry André, Jérome Galon, Pierre Laurent-Puig
{"title":"Combined Analyses of Circulating Tumor DNA and Immunoscore in Patients With Stage III Colon Cancer: A Post Hoc Analysis of the PRODIGE-GERCOR IDEA-France/HORG-IDEA-Greece Trials.","authors":"Julien Taieb, John Souglakos, Ioannis Boukovinas, Antoine Falcoz, Franck Pages, Ippokratis Messaritakis, Jaafar Bennouna, Pascal Artru, Christophe Louvet, Celine Lepere, Jean Francois Emile, Olivier Bouche, Thibault Mazard, Dewi Vernerey, Konstantinos Vogiatzoglou, Maria Tzardi, Shruti Sharma, Minetta C Liu, Himanshu Sethi, Thierry André, Jérome Galon, Pierre Laurent-Puig","doi":"10.1200/JCO.24.00648","DOIUrl":"10.1200/JCO.24.00648","url":null,"abstract":"<p><strong>Purpose: </strong>Immunoscore (IS) and circulating tumor DNA (ctDNA) are two emerging technologies in improving prognostication and tailoring adjuvant treatments in patients resected from a stage III colon cancer (CC). Here, we analyzed the prognostic value of the two biomarkers in patients who participated in the randomized phase III IDEA-France and HORG trials.</p><p><strong>Methods: </strong>Plasma samples were collected after surgery and before adjuvant chemotherapy. ctDNA analysis was performed using a clinically validated, personalized, tumor-informed 16-plex protein chain reaction assay. Multivariable analyses for time to recurrence (TTR; patients without recurrence or death due to CC) and overall survival (OS) were performed using ctDNA and IS results, along with other parameters including treatment duration and disease risk group.</p><p><strong>Results: </strong>Of the 554 patients with available ctDNA results, 445 were ctDNA-negative (80.3%) and 109 were ctDNA-positive (19.7%); baseline characteristics showed more T4/N2 and venous embolism/lymphatic invasion/perineural invasion+ in ctDNA-positive patients. With a median follow-up of 6.7 years, the 2-year TTR rate was 43.5% (95% CI, 34.1 to 52.6) for ctDNA-positive patients and 88.1% (95% CI, 84.7 to 90.8) for ctDNA-negative patients (<i>P</i> < .0001). ctDNA was confirmed as an independent prognostic marker for both TTR (adjusted hazard ratio [adjHR], 5.21 [95% CI, 3.59 to 7.58]; <i>P</i> < .001) and OS (adjHR, 4.84 [95% CI, 3.40 to 6.89]; <i>P</i> < .001). ctDNA remained the most significant prognostic factor irrespective of disease stage, treatment duration, and IS results. IS was not prognostic in ctDNA-positive patients but remained a significant prognostic tool for ctDNA-negative patients.</p><p><strong>Conclusion: </strong>In this combined analysis of two adjuvant trials dedicated to patients with stage III CC after surgery, ctDNA was detectable in 19.7% of the patients and was confirmed as a major independent prognostic biomarker. IS seems to bring additional prognostic information in the 80.3% of patients who are ctDNA-negative.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1564-1577"},"PeriodicalIF":42.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054978/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189210","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Safety and Efficacy of Neoadjuvant Durvalumab Plus Gemcitabine/Cisplatin or Carboplatin in Patients With Operable High-Risk Upper Tract Urothelial Carcinoma: The iNDUCT-GETUG V08 Trial. 可手术的高风险上尿路上皮癌患者新辅助治疗杜伐单抗加吉西他滨/顺铂或卡铂的安全性和有效性:iNDUCT试验。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-05-01 Epub Date: 2025-02-14 DOI: 10.1200/JCO-25-00179
Nadine Houédé, Thierry Chevallier, François Audenet, Constance Thibault, Yann Neuzillet, Christine Abraham, Alexandra Masson-Lecomte, Hélène Gauthier, Gwenaëlle Gravis, Géraldine Pignot, Sophie Tartas, Alain Ruffion, Damien Pouessel, Mathieu Roumiguié, Brigitte Laguerre, Karim Bensalah, Evanguelos Xylinas, Loïc Jaffrelot, Stéphane Droupy, Guillaume Luquiens, Morgan Rouprêt
{"title":"Safety and Efficacy of Neoadjuvant Durvalumab Plus Gemcitabine/Cisplatin or Carboplatin in Patients With Operable High-Risk Upper Tract Urothelial Carcinoma: The iNDUCT-GETUG V08 Trial.","authors":"Nadine Houédé, Thierry Chevallier, François Audenet, Constance Thibault, Yann Neuzillet, Christine Abraham, Alexandra Masson-Lecomte, Hélène Gauthier, Gwenaëlle Gravis, Géraldine Pignot, Sophie Tartas, Alain Ruffion, Damien Pouessel, Mathieu Roumiguié, Brigitte Laguerre, Karim Bensalah, Evanguelos Xylinas, Loïc Jaffrelot, Stéphane Droupy, Guillaume Luquiens, Morgan Rouprêt","doi":"10.1200/JCO-25-00179","DOIUrl":"10.1200/JCO-25-00179","url":null,"abstract":"<p><strong>Purpose: </strong>After radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC), prognosis is poor for high-risk patients. This study evaluated safety and efficacy of neoadjuvant chemotherapy (cisplatin or carboplatin + gemcitabine) in combination with durvalumab in these patients.</p><p><strong>Patients and methods: </strong>This phase II trial (ClinicalTrials.gov identifier: NCT04617756) included patients with nonmetastatic, high-grade UTUC, on the basis of the ureteroscopic biopsy or urine cytology, and/or infiltrative aspect of the renal pelvis/ureteral wall by computed tomography imaging. Before RNU, patients received durvalumab plus gemcitabine/cisplatin (cohort 1) or durvalumab plus gemcitabine/carboplatin (cohort 2) once every 3 weeks for a total of four cycles (cohort choice on the basis of the glomerular filtration rate). The primary objective was the pathologic complete response (ypT0) rate in each cohort.</p><p><strong>Results: </strong>Fifty patients were enrolled between 2021 and 2024 (31 in cohort 1; 19 in cohort 2). Median age was 68 years (range, 38-79), and 59% were men. Forty-five patients received four cycles of treatment, three patients three cycles, and one patient two cycles. Five patients switched to carboplatin during treatment. At surgery (N = 45 patients), rates of pT0 were 13% (4/29) in cohort 1 and 5% (1/19) in cohort 2. Fifty percent (15/29) of patients were pTa/pT1 in cohort 1, and 42% (8/19) in cohort 2. No severe immunotherapy-mediated toxicity was observed. Four patients had chemotherapy-related grade 3 neutropenia, one grade 4; one patient had grade 3 thrombopenia, one grade 4; and four patients had grade 3 anemia.</p><p><strong>Conclusion: </strong>Although our negative study did not meet its primary end point in either cohort, the combination of durvalumab and platin-based chemotherapy, especially cisplatin, showed promising results in terms of downstaging. The safety profile was good and the surgical risk was not increased.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1578-1586"},"PeriodicalIF":42.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143414339","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}
引用次数: 0
Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047. 来自 RELATIVITY-047 的 Nivolumab 加 Relatlimab 治疗晚期黑色素瘤的三年总生存率。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-05-01 Epub Date: 2024-12-13 DOI: 10.1200/JCO.24.01124
Hussein A Tawbi, F Stephen Hodi, Evan J Lipson, Dirk Schadendorf, Paolo A Ascierto, Luis Matamala, Erika Castillo Gutiérrez, Piotr Rutkowski, Helen Gogas, Christopher D Lao, Juliana Janoski De Menezes, Stéphane Dalle, Ana Maria Arance, Jean-Jacques Grob, Barbara Ratto, Saima Rodriguez, Antonella Mazzei, Sonia Dolfi, Georgina V Long
{"title":"Three-Year Overall Survival With Nivolumab Plus Relatlimab in Advanced Melanoma From RELATIVITY-047.","authors":"Hussein A Tawbi, F Stephen Hodi, Evan J Lipson, Dirk Schadendorf, Paolo A Ascierto, Luis Matamala, Erika Castillo Gutiérrez, Piotr Rutkowski, Helen Gogas, Christopher D Lao, Juliana Janoski De Menezes, Stéphane Dalle, Ana Maria Arance, Jean-Jacques Grob, Barbara Ratto, Saima Rodriguez, Antonella Mazzei, Sonia Dolfi, Georgina V Long","doi":"10.1200/JCO.24.01124","DOIUrl":"10.1200/JCO.24.01124","url":null,"abstract":"<p><p>Nivolumab plus relatlimab demonstrated a statistically significant improvement in progression-free survival (PFS), along with a clinically meaningful, but not statistically significant improvement in overall survival (OS) and a numerically higher objective response rate (ORR) compared with nivolumab in the RELATIVITY-047 trial (ClinicalTrials.gov identifier: NCT03470922). We report updated descriptive efficacy and safety results from RELATIVITY-047 with a median follow-up of 33.8 months. Median PFS was 10.2 months (95% CI, 6.5 to 15.4) with nivolumab plus relatlimab and 4.6 months (95% CI, 3.5 to 6.5) with nivolumab (hazard ratio [HR], 0.79 [95% CI, 0.66 to 0.95]); median OS was 51.0 months (95% CI, 34.0 to not reached) and 34.1 (95% CI, 25.2 to 44.7) months, respectively (HR, 0.80 [95% CI, 0.66 to 0.99]). ORR was 43.7% (95% CI, 38.4 to 49.0) with nivolumab plus relatlimab and 33.7% (95% CI, 28.8 to 38.9) with nivolumab. Efficacy across the majority of prespecified subgroups favored the combination. No new or unexpected safety signals were identified. Overall, at 3-year follow-up, the benefit observed with nivolumab plus relatlimab compared with nivolumab in patients with advanced melanoma was sustained, with the OS HR 95% CI upper bound now <1. This benefit is accompanied by a safety profile consistent with previous reports.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1546-1552"},"PeriodicalIF":42.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054981/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142822268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial. 在EXCLAIM-2 III期临床试验中,Mobocertinib与铂基化疗在EGFR外显子20插入阳性转移性非小细胞肺癌患者中的一线疗效对比
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-05-01 Epub Date: 2025-01-29 DOI: 10.1200/JCO-24-01269
Pasi A Jänne, Bin-Chao Wang, Byoung Chul Cho, Jun Zhao, Juan Li, Maximilian Hochmair, Solange Peters, Benjamin Besse, Nick Pavlakis, Joel W Neal, Terufumi Kato, Yi-Long Wu, Danny Nguyen, Junjing Lin, Jianchang Lin, Florin Vranceanu, Annette Szumski, Huamao M Lin, Robert J Fram, Tony S K Mok
{"title":"First-Line Mobocertinib Versus Platinum-Based Chemotherapy in Patients With <i>EGFR</i> Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer in the Phase III EXCLAIM-2 Trial.","authors":"Pasi A Jänne, Bin-Chao Wang, Byoung Chul Cho, Jun Zhao, Juan Li, Maximilian Hochmair, Solange Peters, Benjamin Besse, Nick Pavlakis, Joel W Neal, Terufumi Kato, Yi-Long Wu, Danny Nguyen, Junjing Lin, Jianchang Lin, Florin Vranceanu, Annette Szumski, Huamao M Lin, Robert J Fram, Tony S K Mok","doi":"10.1200/JCO-24-01269","DOIUrl":"10.1200/JCO-24-01269","url":null,"abstract":"<p><strong>Purpose: </strong>Mobocertinib is an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor that targets <i>EGFR</i> exon 20 insertion (ex20ins) mutations in non-small cell lung cancer (NSCLC). This open-label, phase III trial (EXCLAIM-2, ClinicalTrials.gov identifier: NCT04129502) compared mobocertinib versus platinum-based chemotherapy as first-line treatment of <i>EGFR</i> ex20ins+ advanced/metastatic NSCLC.</p><p><strong>Methods: </strong>Patients with treatment-naive <i>EGFR</i> ex20ins+ locally advanced/metastatic NSCLC were randomly assigned 1:1 to mobocertinib 160 mg once daily or pemetrexed plus cisplatin or carboplatin every 3 weeks for four cycles followed by maintenance pemetrexed. The primary end point was progression-free survival (PFS) by blinded independent central review (BICR), with planned interim analysis (IA) after approximately 70% of 227 expected PFS events.</p><p><strong>Results: </strong>A total of 354 patients were randomly assigned (mobocertinib: n = 179; chemotherapy: n = 175). Baseline characteristics were balanced between arms. At IA (cutoff: April 4, 2023), the median PFS per BICR was 9.6 months in each treatment arm (hazard ratio [HR], 1.04 [95% CI, 0.77 to 1.39]; <i>P</i> = .803). The primary end point crossed the prespecified futility boundary (HR > 1). The confirmed objective response rate (95% CI) per BICR was 32% (26 to 40) with mobocertinib versus 30% (24 to 38) with chemotherapy; the median duration of response was 12.0 versus 8.4 months. Quality-of-life assessments indicated clinically meaningful delays in time to deterioration of lung cancer symptoms, cognitive function, and constipation with mobocertinib versus chemotherapy. Grade ≥3 adverse events in >5% of patients (mobocertinib, chemotherapy) were diarrhea (20%, 1%), anemia (6%, 10%), increased lipase (6%, 0%), and decreased neutrophil count (1%, 7%).</p><p><strong>Conclusion: </strong>The EXCLAIM-2 trial did not meet its primary end point. The efficacy of mobocertinib was not superior to platinum-based chemotherapy for first-line treatment of patients with <i>EGFR</i> ex20ins+ advanced/metastatic NSCLC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1553-1563"},"PeriodicalIF":42.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054980/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143065874","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Fulvestrant Versus Anastrozole in Endocrine Therapy-Naïve Women With Hormone Receptor-Positive Advanced Breast Cancer: Final Overall Survival in the Phase III FALCON Trial. 富维司汀与阿那曲唑治疗内分泌Therapy-Naïve激素受体阳性晚期乳腺癌妇女:III期FALCON试验的最终总生存期
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-05-01 Epub Date: 2025-01-07 DOI: 10.1200/JCO.24.00994
John F R Robertson, Zhimin Shao, Shinzaburo Noguchi, Igor Bondarenko, Lawrence Panasci, Sandeep Singh, Shankar Subramaniam, Matthew J Ellis
{"title":"Fulvestrant Versus Anastrozole in Endocrine Therapy-Naïve Women With Hormone Receptor-Positive Advanced Breast Cancer: Final Overall Survival in the Phase III FALCON Trial.","authors":"John F R Robertson, Zhimin Shao, Shinzaburo Noguchi, Igor Bondarenko, Lawrence Panasci, Sandeep Singh, Shankar Subramaniam, Matthew J Ellis","doi":"10.1200/JCO.24.00994","DOIUrl":"10.1200/JCO.24.00994","url":null,"abstract":"<p><p>The randomized phase III FALCON trial demonstrated significant improvement in progression-free survival (PFS) with fulvestrant versus anastrozole in postmenopausal women with endocrine therapy-naïve, hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Herein, the prespecified final overall survival (OS) analysis is reported. After the primary PFS analysis, data were collected on survival, serious adverse events, and health-related quality of life. The final OS analysis was triggered at ≥65% maturity and ≥8 years since the last patient was enrolled. Analyses were descriptive with nominal <i>P</i> values (one-sided α threshold .01845). At the data cutoff (July 11, 2022), 314 (68.0%) of 462 patients had died (fulvestrant, 157/230 [68.3%], anastrozole, 157/232 [67.7%]). The final OS analysis of FALCON demonstrated no significant difference between fulvestrant and anastrozole (medians, 44.8 and 42.7 months, respectively; hazard ratio [HR], 0.97 [95% CI, 0.77 to 1.21]; <i>P</i> = .7579). Among patients with nonvisceral disease (n = 208), a trend showed a 15% reduction in the relative risk of death with fulvestrant versus anastrozole (median OS, 65.2 <i>v</i> 47.8 months; HR, 0.85 [95% CI, 0.60 to 1.20]). Data from FALCON are consistent with published evidence of long-term clinical benefit with fulvestrant and other endocrine therapies in the subset of patients with nonvisceral disease.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"1539-1545"},"PeriodicalIF":42.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12054979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142949488","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"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
Therapy for Diffuse Astrocytic and Oligodendroglial Tumors in Adults: ASCO-SNO Guideline Rapid Recommendation Update. 成人弥漫性星形细胞和少突胶质肿瘤的治疗:ASCO-SNO指南快速推荐更新
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-04-29 DOI: 10.1200/JCO-25-00250
Jaishri Blakeley, Nimish A Mohile, Hans Messersmith, Andrew B Lassman, David Schiff
{"title":"Therapy for Diffuse Astrocytic and Oligodendroglial Tumors in Adults: ASCO-SNO Guideline Rapid Recommendation Update.","authors":"Jaishri Blakeley, Nimish A Mohile, Hans Messersmith, Andrew B Lassman, David Schiff","doi":"10.1200/JCO-25-00250","DOIUrl":"https://doi.org/10.1200/JCO-25-00250","url":null,"abstract":"<p><p><i>ASCO Rapid Recommendation Updates highlight revisions to select ASCO guideline recommendations as a response to the emergence of new and practice-changing data. The rapid updates are supported by an evidence review and follow the guideline development processes outlined in the</i> <i>ASCO Guideline Methodology Manual</i>. <i>The goal of these articles is to disseminate updated recommendations, in a timely manner, to better inform health practitioners and the public on the best available cancer care options. Guidelines and updates are not intended to substitute for independent professional judgment of the treating clinician and do not account for individual variation among patients. See appendix for disclaimers and other important information (Appendix 1 and Appendix 2, online only).</i></p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2500250"},"PeriodicalIF":42.1,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003516","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}
引用次数: 0
ADAGIO: A Phase IIb, Open-Label, Single-Arm, Multicenter Study Assessing the Efficacy and Safety of Adavosertib (AZD1775) as Treatment for Recurrent or Persistent Uterine Serous Carcinoma. ADAGIO:一项IIb期、开放标签、单臂、多中心研究,评估Adavosertib (AZD1775)治疗复发性或持续性子宫浆液性癌的疗效和安全性。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-04-22 DOI: 10.1200/JCO-24-01606
Joyce F Liu, Nicoletta Colombo, Amit M Oza, Jean-Sebastien Frenel, Bradley R Corr, Maria M Rubinstein, Nicole S Nevadunsky, Stephanie Lheureux, Lydia Gaba, Lucía González Cortijo, Vanda Salutari, Benoit You, Sarah Chiang, Mark J O'Connor, Lenka Oplustil O'Connor, Didier Meulendijks, Mahmuda Khatun, Dana Ghiorghiu, Ana Oaknin
{"title":"ADAGIO: A Phase IIb, Open-Label, Single-Arm, Multicenter Study Assessing the Efficacy and Safety of Adavosertib (AZD1775) as Treatment for Recurrent or Persistent Uterine Serous Carcinoma.","authors":"Joyce F Liu, Nicoletta Colombo, Amit M Oza, Jean-Sebastien Frenel, Bradley R Corr, Maria M Rubinstein, Nicole S Nevadunsky, Stephanie Lheureux, Lydia Gaba, Lucía González Cortijo, Vanda Salutari, Benoit You, Sarah Chiang, Mark J O'Connor, Lenka Oplustil O'Connor, Didier Meulendijks, Mahmuda Khatun, Dana Ghiorghiu, Ana Oaknin","doi":"10.1200/JCO-24-01606","DOIUrl":"https://doi.org/10.1200/JCO-24-01606","url":null,"abstract":"<p><strong>Purpose: </strong>This phase IIb, single-arm, multicenter, global study (ADAGIO; ClinicalTrials.gov identifier: NCT04590248) assessed the efficacy and safety of adavosertib in patients with recurrent/persistent uterine serous carcinoma (USC) who had previously received platinum-based chemotherapy.</p><p><strong>Methods: </strong>Eligible patients were age 18 years and older and had histologically confirmed recurrent/persistent USC, previously treated with at least one platinum-based chemotherapy regimen, and with evidence of measurable disease. Adavosertib was administered orally at 300 mg once daily on days 1-5 and 8-12 of a 21-day cycle until discontinuation criteria were met. The primary end point was objective response rate (ORR) by blinded independent central review (BICR). Secondary end points included duration of response (DoR), progression-free survival (PFS), safety, and tolerability. Biomarkers previously associated with adavosertib response in other settings were assessed in archival tissue samples.</p><p><strong>Results: </strong>In 104 evaluable patients, one complete response and 26 partial responses were observed, for an ORR by BICR of 26.0% (95% CI, 17.9 to 35.5). Median DoR was 4.7 months (95% CI, 3.8 to 8.3); median PFS was 2.8 months (95% CI, 2.6 to 3.9). Biomarker analysis identified no single predictive alteration for adavosertib response, although a trend was observed for <i>CCNE1</i> amplification or high cyclin E1 protein expression. Most patients (97.2%) experienced treatment-related adverse events (TRAEs), most frequently diarrhea (59.6%), nausea (59.6%), and anemia (58.7%). Grade ≥3 TRAEs occurred in 60.6% of patients, with neutropenia (21.1%) and fatigue (13.8%) most common. 17.4% of patients discontinued adavosertib due to AEs (treatment-related in 14.7%).</p><p><strong>Conclusion: </strong>Adavosertib showed some antitumor activity in patients with recurrent/persistent USC. However, at 300 mg once daily dosing, it was not well tolerated in this population. Exploratory biomarker studies suggest <i>CCNE1</i>/cyclin E1 expression may enrich for response to Wee1 inhibition in USC.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2401606"},"PeriodicalIF":42.1,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144020884","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}
引用次数: 0
Writing a Medical Memoir: Lessons From a Long, Steep Road. 写一本医学回忆录:一条漫长而陡峭的道路的教训。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-04-22 DOI: 10.1200/JCO-24-02472
David I Marks
{"title":"Writing a Medical Memoir: Lessons From a Long, Steep Road.","authors":"David I Marks","doi":"10.1200/JCO-24-02472","DOIUrl":"https://doi.org/10.1200/JCO-24-02472","url":null,"abstract":"<p><p>The purpose of this essay is to take readers of the Journal on my challenging journey of writing a memoir describing my patients and career.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402472"},"PeriodicalIF":42.1,"publicationDate":"2025-04-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144020903","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}
引用次数: 0
What I Wish I Had Known: A Pediatric Oncologist's Transition to Survivorship Care. 我希望我知道的:一个儿科肿瘤学家向生存护理的转变。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-04-21 DOI: 10.1200/JCO-24-02821
Ana Carolina Izurieta-Pacheco
{"title":"What I Wish I Had Known: A Pediatric Oncologist's Transition to Survivorship Care.","authors":"Ana Carolina Izurieta-Pacheco","doi":"10.1200/JCO-24-02821","DOIUrl":"https://doi.org/10.1200/JCO-24-02821","url":null,"abstract":"<p><p>This essay explores the often overlooked challenges of survivorship care, reflecting on the journey from pediatric oncology to supporting cancer survivors in navigating life after treatment.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2402821"},"PeriodicalIF":42.1,"publicationDate":"2025-04-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144002426","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}
引用次数: 0
Data, Models, and Visuals: How Data Science Methods Can Augment (Geriatric) Oncology Research. 数据、模型和视觉:数据科学方法如何增强(老年)肿瘤学研究。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-04-20 Epub Date: 2025-03-06 DOI: 10.1200/JCO-25-00053
Erika Ramsdale, Supriya Mohile
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引用次数: 0
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