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Is It Time to Retire the Unified Cancer of Unknown Primary Concept in the Precision Oncology Era? 精准肿瘤学时代,是时候让原初概念未知的统一癌症退场了吗?
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-12 DOI: 10.1200/jco-25-02189
Vivek Subbiah,F Anthony Greco
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引用次数: 0
Reply to: Focal Boosting in Localized Prostate Cancer in the Era of Systemic Therapy and Prostate-Specific Membrane Antigen Imaging. 回复:在系统治疗和前列腺特异性膜抗原成像时代,局部前列腺癌的局灶性增强。
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-12 DOI: 10.1200/jco-25-02744
Floris J Pos,Karolína Menne Guricová,Jochem R N van der Voort van der Zyp,Robert J Smeenk,Uulke A van der Heide,Karin Haustermans,Cédric Draulans
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引用次数: 0
Can Pathologic Complete Response Serve as a Valid Surrogate End Point? 病理完全缓解可以作为有效的替代终点吗?
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-12 DOI: 10.1200/jco-25-02070
Doga Kahramangil,Ilyas Sahin
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引用次数: 0
Erratum: Quizartinib for Newly Diagnosed FLT3-Internal Tandem Duplication-Negative AML: The Randomized, Double-Blind, Placebo-Controlled, Phase II QUIWI Study. Quizartinib用于新诊断的flt3 -内部串联重复阴性AML:随机,双盲,安慰剂对照,II期QUIWI研究。
IF 41.9 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-10 Epub Date: 2025-12-01 DOI: 10.1200/JCO-25-02762
Pau Montesinos, Rebeca Rodríguez-Veiga, Juan Miguel Bergua, Jesús Lorenzo Algarra Algarra, Carmen Botella, Eduardo Rodríguez-Arbolí, Teresa Bernal, Mar Tormo, Maria Calbacho, Olga Salamero, Josefina Serrano, Victor Noriega, Juan Antonio López-López, Susana Vives, Jose Luis López-Lorenzo, Mercedes Colorado, Maria-Belén Vidriales, Raimundo García Boyero, Maria Teresa Olave, Pilar Herrera, Olga Arce, Manuel Barrios, Maria Jose Sayas, Marta Polo, Maria Isabel Gómez-Roncero, Eva Barragán, Rosa Ayala, Carmen Chillón, Maria José Calasanz, Bruno Paiva, Blanca Boluda, Ignacio Casas-Avilés, Pilar Lloret, Maria-José Sánchez, Carlos Rodríguez-Medina, Laida Cuevas, José Ángel Raposo-Puglia, M Carmen Mateos, Matxalen Olivares, Carmen Martínez-Chamorro, Natalia Alonso, Sandra Suárez, Irene Sánchez-Vadillo, María Solé Rodríguez, Bernardo Javier González, Antonio Martínez-Francés, Rebeca Cuello, Alfonso Fernández, David Martínez-Cuadrón, Jorge Labrador
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引用次数: 0
Precision Oncology 2.0: Guiding Magic Bullets With Expression-Based Liquid Biopsy. 精确肿瘤学2.0:用基于表达的液体活检引导魔弹。
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-09 DOI: 10.1200/jco-25-01983
Gunsagar S Gulati,Toni K Choueiri,Matthew L Freedman,Sylvan C Baca
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引用次数: 0
Three-Year Follow-Up of Nivolumab-AVD Versus Brentuximab Vedotin-AVD in Adolescents With Advanced-Stage Classic Hodgkin Lymphoma on S1826. Nivolumab-AVD与Brentuximab - Vedotin-AVD在S1826上对晚期经典霍奇金淋巴瘤青少年的三年随访
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-09 DOI: 10.1200/jco-25-00203
Sharon M Castellino,Hongli Li,Alex F Herrera,Michael LeBlanc,Susan K Parsons,Joseph M Unger,Angela Punnett,David Hodgson,Frank G Keller,Richard A Drachtman,Adam Lamble,Christopher J Forlenza,Andrew Doan,Sarah C Rutherford,Andrew M Evens,Richard F Little,Malcolm A Smith,Bradford S Hoppe,Joo Y Song,Sonali M Smith,Jonathan W Friedberg,Kara M Kelly
We present a subset analysis on the adolescent cohort of the S1826 randomized phase three trial, comparing nivolumab, doxorubicin, vinblastine, dacarbazine (N-AVD) to brentuximab vedotin-AVD (BV-AVD) in newly diagnosed advanced-stage (AS, stages III and IV) classic Hodgkin lymphoma (cHL). Among 994 patients enrolled, 24% (n = 240) were age 12-17 years. The 3-year progression-free survival (PFS) was significantly higher in the N-AVD group (93% [95% CI, 87 to 96]) compared with the BV-AVD group (82% [95% CI, 73 to 88]; hazard ratio, 0.37 [95% CI, 0.17 to 0.80]). One N-AVD and two BV-AVD patients received protocol-specified residual site radiotherapy (RT). Rates of febrile neutropenia and sepsis were low in both groups. Severe immune-related adverse events were infrequent, although thyroid dysfunction was seen in 7% with N-AVD. Sensory neuropathy (grade ≥2) was more frequent with BV-AVD (14% v 7%) by clinician report. Although premature discontinuation of therapy was reported in 12 N-AVD patients and four BV-AVD patients, no PFS events were noted in the N-AVD group. Patient-reported outcomes indicated less toxicity with N-AVD. N-AVD demonstrated high 3-year PFS in adolescents with AS cHL, with minimal RT use. S1826 exemplifies the benefits of harmonized clinical trial protocols, resulting in timely access to novel agents for adolescents.
我们对S1826随机三期试验的青少年队列进行了一项亚组分析,比较了纳武单抗、阿霉素、长春碱、达卡巴嗪(N-AVD)和布伦妥昔单抗维多汀- avd (BV-AVD)在新诊断的晚期(AS, III期和IV期)经典霍奇金淋巴瘤(cHL)中的疗效。在纳入的994例患者中,24% (n = 240)的年龄为12-17岁。N-AVD组的3年无进展生存期(PFS) (93% [95% CI, 87 - 96])明显高于BV-AVD组(82% [95% CI, 73 - 88];风险比,0.37 [95% CI, 0.17 - 0.80])。1例N-AVD和2例BV-AVD患者接受了方案规定的残余部位放疗(RT)。两组发热性中性粒细胞减少症和败血症发生率均较低。严重的免疫相关不良事件很少发生,尽管7%的N-AVD患者出现甲状腺功能障碍。根据临床报告,感觉神经病变(≥2级)在BV-AVD中更为常见(14% vs 7%)。虽然在12例N-AVD患者和4例BV-AVD患者中报告了过早停药,但N-AVD组没有发现PFS事件。患者报告的结果表明,N-AVD的毒性较小。N-AVD在青少年AS - cHL患者中显示出较高的3年PFS,并且很少使用RT。S1826举例说明了统一临床试验方案的好处,导致及时获得青少年的新药物。
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引用次数: 0
Three Versus 6 Months of Adjuvant Oxaliplatin-Fluoropyrimidine Chemotherapy for Colorectal Cancer: Final Results of SCOT-An International, Randomized, Phase III, Noninferiority Trial. 3个月与6个月奥沙利铂-氟嘧啶辅助化疗治疗结直肠癌:scot的最终结果-一项国际,随机,III期,非劣效性试验
IF 45.3 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-09 DOI: 10.1200/jco-25-00621
Timothy Iveson,Mark P Saunders,Caroline Kelly,Rachel S Kerr,Jim Cassidy,Niels Henrik Hollander,Josep Tabernero,Andrew Haydon,Bengt Glimelius,Andrea Harkin,Karen Allan,John McQueen,Sarah Pearson,Kathleen A Boyd,Andrew H Briggs,Ashita Waterston,Louise Medley,Richard Ellis,Amandeep S Dhadda,Mark Harrison,Stephen Falk,Charlotte Rees,Rene K Olesen,David Propper,John Bridgewater,Ashraf Azzabi,David Cunningham,Tamas Hickish,Simon Gollins,Harpreet S Wasan,David Church,Enric Domingo
Adjuvant chemotherapy for colorectal cancer (CRC) with oxaliplatin and fluoropyrimidine was traditionally given for 6 months but is associated with cumulative peripheral neuropathy. The SCOT study (ISRCTN59757862) was an international, randomized, phase III, noninferiority trial investigating treatment reduction from 6 to 3 months. It originally reported noninferior disease-free survival with reduced toxicity and improved quality of life for 3 months of treatment in 6,088 patients. Here, we report overall survival (OS) with 38 months of additional follow-up. Patients with high-risk stage II and stage III CRC were assigned (1:1) to receive 3 or 6 months of either capecitabine and oxaliplatin (CAPOX) or infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX; bolus and infused fluorouracil with oxaliplatin) that were selected before random assignment. With a median of 113 months follow-up and 1,255 OS events, 5-year OS for 3 versus 6 months of treatment was 82.4% in both groups (hazard ratio, 0.96; 95% CI, 0.8 to 1.07), proving noninferiority of 3 months of treatment. Noninferiority of 3 months of treatment for OS was also shown in 1,087 patients with rectal cancer. The duration effect is regimen-dependent with noninferiority shown for CAPOX but not for FOLFOX. In summary, SCOT has shown noninferiority for OS with 3 months of adjuvant chemotherapy treatment, which should be recommended for most patients.
传统上,奥沙利铂和氟嘧啶对结直肠癌(CRC)的辅助化疗疗程为6个月,但与周围神经病变相关。SCOT研究(ISRCTN59757862)是一项国际、随机、III期、非劣效性试验,研究治疗时间从6个月减少到3个月。它最初报道了6088例患者在3个月的治疗中无病生存,毒性降低,生活质量提高。在这里,我们报告了38个月的额外随访后的总生存期(OS)。高危II期和III期CRC患者按1:1分配,接受3个月或6个月卡培他滨和奥沙利铂(CAPOX)或氟尿嘧啶、亚叶酸钙和奥沙利铂输注(FOLFOX;氟尿嘧啶和奥沙利铂输注),随机分配前选择。中位随访113个月,1255个OS事件,两组治疗3个月和6个月的5年OS为82.4%(风险比,0.96;95% CI, 0.8 - 1.07),证明治疗3个月的非劣效性。在1087例直肠癌患者中也显示了3个月治疗OS的非劣效性。持续时间效应是方案依赖的,CAPOX显示出非劣效性,而FOLFOX没有。综上所述,SCOT对3个月辅助化疗的OS无劣效性,应推荐大多数患者使用。
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引用次数: 0
Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT) N-of-1 Precision Oncology Study: Molecular Profiling to Match Individually Dosed, Personalized Drug Combinations. 确定个体化癌症治疗(I-PREDICT) N-of-1精确肿瘤学研究:分子谱匹配个体化剂量、个体化药物组合
IF 41.9 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1200/JCO-25-01453
Jason K Sicklick, Daisuke Nishizaki, Hirotaka Miyashita, Ryosuke Okamura, Michael E Hahn, Mina Nikanjam, Paul T Fanta, David E Piccioni, Hitendra Patel, Ramez N Eskander, Rana R McKay, Jeffrey S Ross, J Jack Lee, Scott M Lippman, Shumei Kato, Razelle Kurzrock

Purpose: Malignancies have complex and distinct molecular profiles that may not segregate by tumor type. However, most precision oncology treatments are matched to a single biomarker. We aimed to optimize therapy for advanced cancers using individually dosed drug regimens customized to cotarget multiple molecular alterations.

Methods: Investigation of Profile-Related Evidence Determining Individualized Cancer Therapy (I-PREDICT; NCT02534675) is a prospective, investigator-initiated, multidepartment/pan-cancer trial for aggressive advanced/metastatic malignancies. Patients had tissue and/or blood next-generation sequencing (NGS; Foundation Medicine). A molecular tumor board made suggestions. Degree of biomarker matching to drugs given was calculated by a matching score (MS; broadly, number of pathogenic alterations targeted divided by total pathogenic alterations).

Results: Overall, 210 evaluable patients (n = 456 consented) received ≥1 US Food and Drug Administration-approved drug (mostly off label) after NGS. Median number of pathogenic alterations/tumor was five (range, 0-20); approximately 95% of patients had unique molecular landscapes. Consistent with I-PREDICT's objective to optimize/tailor treatment for each patient, we administered 157 different regimens (including 103 personalized combinations without established safety/dosing data). For previously unstudied combinations, starting doses were reduced and titrated to tolerance (intrapatient dose-finding); only 6.5% experienced Grade 3/4 drug-related toxicities (v 15.5% of those receiving established regimens). Higher disease control rate (stable disease ≥6 months/objective response), and longer progression-free survival and overall survival correlated significantly/independently/linearly with greater degrees of drug matching to alterations (higher MS), but did not vary by drug number or dosages.

Conclusion: The I-PREDICT strategy of maximizing personalized biomarker matching with individually dosed customized drug combinations enabled safe and active N-of-1 matched treatment, including regimens previously unstudied in Phase I trials. I-PREDICT represents a blueprint for a new personalized precision oncology paradigm, which merits validation via additional prospective trials.

目的:恶性肿瘤具有复杂而独特的分子特征,可能不会因肿瘤类型而分离。然而,大多数精确的肿瘤治疗都与单一的生物标志物相匹配。我们的目标是优化晚期癌症的治疗方法,使用定制的单独剂量的药物方案来共同靶向多种分子改变。I-PREDICT (NCT02534675)是一项针对侵袭性晚期/转移性恶性肿瘤的前瞻性、研究者发起的、多部门/泛癌症试验。患者进行了组织和/或血液下一代测序(NGS;基础医学)。一个分子肿瘤委员会提出了建议。生物标志物与所给药物的匹配程度通过匹配评分(MS;广义上,目标致病性改变的数量除以总致病性改变)来计算。结果:总体而言,210名可评估患者(n = 456名同意)在NGS后接受了≥1种美国食品和药物管理局批准的药物(大多数为标签外药物)。致病性改变/肿瘤的中位数为5(范围0-20);大约95%的患者具有独特的分子景观。与I-PREDICT为每位患者优化/定制治疗的目标一致,我们实施了157种不同的方案(包括103种个性化组合,没有建立安全性/剂量数据)。对于以前未研究的组合,减少起始剂量并滴定到耐受性(患者内剂量测定);只有6.5%经历了3/4级药物相关毒性(接受既定方案的患者为15.5%)。更高的疾病控制率(病情稳定≥6个月/客观缓解)、更长的无进展生存期和总生存期与更大程度的药物匹配改变(更高的MS)显著/独立/线性相关,但不受药物数量或剂量的影响。结论:I- predict策略最大化个性化生物标志物匹配与单独剂量定制药物组合,实现安全有效的N-of-1匹配治疗,包括以前未在I期试验中研究的方案。I-PREDICT代表了一种新的个性化精准肿瘤学范式的蓝图,值得通过额外的前瞻性试验进行验证。
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引用次数: 0
Reply to: Enhancing Representation and Reporting of Body Mass Index in Cancer Randomized Clinical Trials. 回复:加强癌症随机临床试验中身体质量指数的代表性和报告。
IF 41.9 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1200/JCO-25-02689
Stephanie B Wheeler
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引用次数: 0
Enhancing Representation and Reporting of Body Mass Index in Cancer Randomized Clinical Trials. 增强肿瘤随机临床试验中身体质量指数的代表性和报告。
IF 41.9 1区 医学 Q1 ONCOLOGY Pub Date : 2026-01-08 DOI: 10.1200/JCO-25-02077
Mei-An Nolan, Ludovic Trinquart
{"title":"Enhancing Representation and Reporting of Body Mass Index in Cancer Randomized Clinical Trials.","authors":"Mei-An Nolan, Ludovic Trinquart","doi":"10.1200/JCO-25-02077","DOIUrl":"https://doi.org/10.1200/JCO-25-02077","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2502077"},"PeriodicalIF":41.9,"publicationDate":"2026-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145933480","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
期刊
Journal of Clinical Oncology
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