Journal of Clinical Oncology最新文献

{"title":"National Cancer Institute's Working Group on Biochemically Recurrent Prostate Cancer: Clinical Trial Design Considerations.","authors":"David J Einstein,Melissa L Abel,Jeanny B Aragon-Ching,Philip M Arlen,Karen A Autio,Marijo Bilusic,Michael A Carducci,Peter L Choyke,Deborah E Citrin,William D Figg,Julie N Graff,James L Gulley,Susan Halabi,Fatima Karzai,Liza Lindenberg,Mark C Markowski,Catherine H Marshall,Douglas G McNeel,Esther Mena,Helen Moon,Russell K Pachynski,Channing J Paller,Krishnan R Patel,Edwin M Posadas,Kenneth J Pienta,Meredith M Regan,Laura A Sena,Charlotte S Walmsley,Xiao X Wei,Evan Y Yu,Phuoc T Tran,Ravi A Madan","doi":"10.1200/jco-25-01693","DOIUrl":"https://doi.org/10.1200/jco-25-01693","url":null,"abstract":"PURPOSEBiochemical recurrence (BCR) of prostate cancer (PCa) after definitive surgery and/or radiation (including salvage strategies) is a burgeoning area of clinical research inspired by ultrasensitive next-generation imaging. Most phase III trials in PCa have focused on metastatic disease, defined by conventional imaging. Despite the emergence of new imaging, clinical trial principles from metastatic studies will not optimize future BCR trials.METHODSA Working Group convened at the National Cancer Institute on November 13, 2024 (NCI BCR WG). Key areas of discussion included nomenclature, baseline criteria for data capture, imaging considerations, delineation of high-risk populations to be targeted for trial development, requirements of metastasis-directed therapy (MDT) or hormonal therapy, quality-of-life considerations, and potential study end points.RESULTSThe NCI BCR WG defined the novel term \"prostate-specific membrane antigen (PSMA)+BCR\" to identify the emerging concept of recurrent PCa identifiable only on PSMA positron emission tomography (PET), overlapping with BCR and distinct from metastatic hormone-sensitive PCa as traditionally defined by conventional imaging. The WG suggested defining high-risk BCR with a prostate-specific antigen doubling time of ≤6 months, regardless of PET findings. The WG provided recommendations for baseline data capture and imaging requirements. Neither systemic therapy nor MDT were considered mandatory for control arms. The WG also discussed novel end points and quality-of-life metrics in this disease space.CONCLUSIONThese discussions should inform future clinical BCR trials in this distinct disease space relative to metastatic disease defined by conventional imaging. The NCI BCR WG strongly advocates that future trials explore deintensification of treatment to minimize toxicity in this relatively indolent disease state.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"101 1","pages":"JCO2501693"},"PeriodicalIF":45.3,"publicationDate":"2025-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145351591","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":"Single-Arm Pivotal Studies in Bacillus Calmette-Guérin-Unresponsive Non-Muscle-Invasive Bladder Cancer.","authors":"Jathin Bandari,Edward M Messing","doi":"10.1200/jco-25-01893","DOIUrl":"https://doi.org/10.1200/jco-25-01893","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"78 1","pages":"JCO2501893"},"PeriodicalIF":45.3,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145338653","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":"Cost-Utility of Geriatric Assessment and Management in Older Adults With Cancer: Model-Based Economic Evaluation.","authors":"Selai Akseer,Shant Torkom Yeretzian,Lusine Abrahamyan,Martine Puts,Mostafa Mohamed,Wee Kheng Soo,Shabbir M H Alibhai,Yeva Sahakyan","doi":"10.1200/jco-25-00248","DOIUrl":"https://doi.org/10.1200/jco-25-00248","url":null,"abstract":"PURPOSEGeriatric assessment and management (GAM) is a guideline-recommended strategy for optimizing cancer management among older adults. A recent cost-utility analysis of the Canadian 5C randomized controlled trial (RCT) found GAM to be cost effective for selected groups. This study aimed to assess the cost-utility of GAM plus usual care (UC) versus UC alone in older adults with cancer using a decision model and best available evidence from four international RCTs-GAIN, GAP70, INTEGERATE, and 5C.METHODSFor the model, we used pooled data from four RCTs and peer-reviewed literature. Deterministic and probabilistic analyses were performed from the Canadian health care payer perspective, applying a 6-month time horizon. Sensitivity analyses included per-trial scenario analyses, 1-year time horizon, and US health care payer perspective. We reported costs per quality-adjusted life year (QALY) and incremental net monetary benefit (INMB).RESULTSThe base-case analysis indicated that GAM had an INMB of $599 in Canadian dollars (CAD; 95% credibility interval, -$3,428 to $4,742) with 60.9% probability of being cost effective at a threshold of $50,000 (CAD) per QALY. Trial-specific results varied, with the GAP70 and INTEGERATE trials yielding positive INMB ($2,231 [CAD] and $2,104 [CAD], respectively), suggesting cost-effectiveness, whereas 5C and GAIN resulted in negative INMB (-$489 [CAD] and -$234 [CAD], respectively). Chemotherapy and hospitalization costs were the main driver of costs in both strategies.CONCLUSIONGAM is overall cost effective, with results varying across trial scenarios due to differences in chemotherapy dose intensity, hospitalization rates, and associated costs. Future research should prioritize identifying optimal core GAM components, delivery mode, and patient selection criteria to enhance its effectiveness and cost-effectiveness.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"39 1","pages":"JCO2500248"},"PeriodicalIF":45.3,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145338654","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: \"Rethinking Treatment Priorities in Estrogen Receptor-Low Breast Cancer\" and \"CDK4/6 Inhibitors in Estrogen Receptor-Low Breast Cancer\".","authors":"Matthew P Goetz, Grace M Choong, Tanya L Hoskin, Judy C Boughey, Sameera R Wijayawardana, James N Ingle","doi":"10.1200/JCO-25-01688","DOIUrl":"10.1200/JCO-25-01688","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3323-3324"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955866","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":"Novel Systemic Anticancer Treatments and Health Services Use at the End of Life Among Adults With Cancer.","authors":"Javaid Iqbal, Rahim Moineddin, Kieran L Quinn, Christopher M Booth, Craig C Earle, Stephanie Lheureux, Robert Grant, Jenny Lau, Lisa W Le, Peter Tanuseputro, James Downar, Gary Rodin, Hsien Seow, Jillian Tsai, Robert A Fowler, Breffni Hannon, Monika K Krzyzanowska, Camilla Zimmermann","doi":"10.1200/JCO-24-02816","DOIUrl":"10.1200/JCO-24-02816","url":null,"abstract":"<p><strong>Purpose: </strong>Use of chemotherapy at the end of life (EOL) is discouraged, but evidence to guide decisions on the use of novel systemic anticancer treatment (SACT) agents is lacking. We examined trends of use among SACT types and association with health services use at the EOL.</p><p><strong>Materials and methods: </strong>We analyzed Canadian Ontario Cancer Registry data for adults diagnosed with solid tumors or hematologic malignancies within 5 years of death who received SACT between March 2015 and March 2021. Receipt of SACT in the last 30 days of life was categorized as chemotherapy alone, chemotherapy and immunotherapy, immunotherapy alone, and targeted therapy alone. Outcomes included high health services use, including multiple (≥2) emergency department (ED) visits, multiple (≥2) hospitalizations, or any (≥1) intensive care unit admission, and hospital deaths. Segmented linear regression estimated monthly trends; multivariable logistic regression estimated adjusted odds ratios (aORs) of outcomes for various SACT types.</p><p><strong>Results: </strong>Among 68,963 patients, 18,337 (26.6%) received SACT at the EOL. From March 2015 to March 2020, use of SACT at the EOL increased (0.072% per month; <i>P</i> < .001), mainly driven by increased use of immunotherapy alone (0.064% per month; <i>P</i> < .001). Adjusted odds of high health services use and hospital death were more than two-fold greater among patients receiving SACT at the EOL (vs. none); individual aORs of high health services use and hospital death were 2.20 and 2.72 for chemotherapy alone, 2.36 and 3.10 for chemotherapy and immunotherapy, 1.92 and 2.27 for immunotherapy alone, and 1.75 and 2.37 for targeted therapy alone, respectively.</p><p><strong>Conclusion: </strong>Use of SACT at the EOL increased significantly over time, driven by increased use of immunotherapy. SACT use at the EOL, regardless of its type, was associated with high health services use and hospital death. Guidelines on the use of SACT at the EOL should include novel cancer treatments.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3279-3291"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144225601","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}

{"title":"Benefit of Chemoradiotherapy Versus Chemotherapy After Induction Therapy for Conversion of Unresectable Into Resectable Pancreatic Cancer: The Randomized CONKO-007 Trial.","authors":"Rainer Fietkau, Michael Ghadimi, Robert Grützmann, Uwe A Wittel, Lutz Jacobasch, Waldemar Uhl, Roland S Croner, Wolf Otto Bechstein, Ulf Peter Neumann, Dirk Waldschmidt, Stefan Boeck, Nicolas Moosmann, Anke C Reinacher-Schick, Henriette Golcher, Werner Adler, Sabine Semrau, Dorota Lubgan, Annett Kallies, Markus Hecht, Iris Tischoff, Andrea Tannapfel, Benjamin Frey, Helmut Oettle","doi":"10.1200/JCO-24-01502","DOIUrl":"10.1200/JCO-24-01502","url":null,"abstract":"<p><strong>Purpose: </strong>To determine the benefit, measured as complete removal of a tumor so that no tumor cells are detectable during histopathologic examination of the resection margin (R0 resection rate), of induction chemotherapy plus chemoradiotherapy (CRT) compared with chemotherapy alone for unresectable pancreatic tumors.</p><p><strong>Patients and methods: </strong>CONKO-007, an investigator-initiated open-label, multicentric, phase III randomized clinical trial, enrolled 525 patients with unresectable tumors, and 495 patients received induction chemotherapy (402 with fluorouracil, irinotecan, and oxaliplatin [FOLFIRINOX] and 93 with gemcitabine). Patients without progression after 3 months of induction chemotherapy (n = 336) were randomly assigned for continuation of the same chemotherapy (n = 167) or CRT (n = 169; 50.4Gy concurrently with gemcitabine). Resectability was centrally reassessed by a panel of surgeons. Surgery was recommended if possible. After an interim analysis, the primary end point was changed from overall survival (OS) to overall R0 resection rate because of slow recruitment. The median follow-up was 76 months. Important planned secondary end points were R0 resection rate in the surgically treated population and OS.</p><p><strong>Results: </strong>The primary end point (overall R0 resection rate) was not significantly different between treatment arms with 25% (43 of 169) in the CRT arm versus 18% in the chemotherapy arm (30 of 167; <i>P</i> = .113). Secondary end point analysis showed that surgery was performed equally often (<i>P</i> = .91); R0 resection rate in patients who underwent surgery was higher after CRT, 69.4% (43 of 62) compared with chemotherapy alone: 50.0% (30 of 60 patients, <i>P</i> = .04). Other parameters of resection (ratio of R0/R1/R2/no resection) also favored CRT (<i>P</i> = .02). No difference in OS was seen between treatment arms (hazard ratio [HR], 0.937 [95% CI, 0.747 to 1.174]; <i>P</i> = .57; randomly assigned intention-to-treat patients). Surgery was associated with longer OS (<i>P</i> < .001, HR, 0.525 [95% CI, 0.408 to 0.676]).</p><p><strong>Conclusion: </strong>Although not improving overall R0 resection rate or survival, CRT enables a R0 resection in surgically treated patients more often than chemotherapy alone.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3266-3278"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144846652","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":"Addition of Carboplatin to Sequential Taxane-Anthracycline Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer: A Phase III Randomized Controlled Trial.","authors":"Sudeep Gupta,Nita Nair,Rohini W Hawaldar,Shalaka Joshi,Seema Gulia,Tanuja Shet,Rajiv Sarin,Vani Parmar,Sangeeta Desai,Jaya Ghosh,Tabassum Wadasadawala,Vaibhav Vanmali,Tejal Panhale,Pallavi Parab,Asawari Patil,Garvit Chitkara,Sushmita Rath,Jyoti Bajpai,Rima Pathak,Palak Popat,Meenakshi Thakur,Rajendra A Badwe","doi":"10.1200/jco-25-01023","DOIUrl":"https://doi.org/10.1200/jco-25-01023","url":null,"abstract":"PURPOSEWe evaluated the survival impact of adding platinum to standard taxane-anthracycline neoadjuvant chemotherapy in triple-negative breast cancer (TNBC).METHODSIn this phase III trial, patients with TNBC were randomly assigned, after stratification by stage and menopausal status, to receive neoadjuvant chemotherapy comprising once-per-week carboplatin (AUC-2) plus paclitaxel (100 mg/m2) for 8 weeks, followed by four cycles of anthracycline plus cyclophosphamide, or same chemotherapy without carboplatin. The primary end point was event-free survival (EFS), and secondary end points were overall survival (OS) and pathologic complete response. This is the prespecified primary analysis of this study.RESULTSOf 720 patients randomly assigned between April 2010 and January 2020, 717 (platinum 361, control 356) were included in modified intention-to-treat analysis. At median follow-up of 67.6 months, in platinum and control arms, there were 111/361 and 131/356 EFS events (hazard ratio [HR], 0.80 [95% CI, 0.62 to 1.03]; two-sided unstratified P = .081), with 5-year EFS of 70.7% (95% CI, 65.8% to 75.6%) and 64.1% (95% CI, 59.0% to 69.2%), respectively, and 94/361 and 121/356 deaths (HR, 0.74 [95% CI, 0.57 to 0.97]; nominal P = .029), with 5-year OS of 74.4% and 66.8%, respectively. In premenopausal patients, EFS (HR, 0.61 [95% CI, 0.43 to 0.84]; nominal P = .003; 5-year EFS 75.0% v 59.6%) and OS (HR, 0.57 [95% CI, 0.40 to 0.82]; nominal P = .002; 5-year OS 78.2% v 64.6%) were significantly higher, while in postmenopausal patients, EFS (HR, 1.19 [95% CI, 0.80 to 1.78]; nominal P = .386) and OS (HR, 1.06 [95% CI, 0.70 to 1.61]; nominal P = .772) were not significantly different, in platinum versus control arm. There was statistically significant interaction between study intervention and menopausal status for EFS and OS, with a benefit of adding platinum in premenopausal but not in postmenopausal patients. There was more grade ≥3 myelosuppression in carboplatin arm, but there was no difference in nonhematologic toxicities.CONCLUSIONCarboplatin did not significantly increase EFS but significantly increased the OS in patients with TNBC, with benefits confined to premenopausal patients.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"134 1","pages":"JCO2501023"},"PeriodicalIF":45.3,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145331635","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":"Investigating Racial and Ethnic Disparities Along the Care Cascade for Older Adults Newly Diagnosed With Metastatic Cancer.","authors":"Jennifer L Lund, Vanessa E Slater, Allison Magnuson","doi":"10.1200/JCO-25-01613","DOIUrl":"10.1200/JCO-25-01613","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3233-3236"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955877","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: PASS-01: Randomized Phase II Trial of Modified FOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel and Molecular Correlatives for Previously Untreated Metastatic Pancreatic Cancer.","authors":"Jennifer J Knox, Grainne O'Kane, Daniel King, Daniel Laheru, Amber N Habowski, Kenneth Yu, Kimberly Perez, Andrew J Aguirre, Zachary Coyne, Harry Harvey, Ronan A McLaughlin, Raymond W Jang, Robert C Grant, Elena C Elimova, Daniel J Renouf, Sandra Fischer, Kai Duan, Stephanie Ramotar, Gun Ho Jang, Amy Zhang, Craig E Devoe, Harshabad Singh, Michael J Pishvaian, Fieke E M Froeling, Muhammad W Saif, Eileen M O'Reilly, Erica S Tsang, Brian M Wolpin, Julie M Wilson, Anna Dodd, Trevor J Pugh, Xiang Y Ye, Steven Gallinger, David A Tuveson, Faiyaz Notta, Elizabeth M Jaffee","doi":"10.1200/JCO-25-02195","DOIUrl":"10.1200/JCO-25-02195","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3325"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137512","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":"Rethinking Treatment Priorities in Estrogen Receptor-Low Breast Cancer.","authors":"Jincong Q Freeman, Rita Nanda, Frederick M Howard","doi":"10.1200/JCO-25-01176","DOIUrl":"10.1200/JCO-25-01176","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"3322-3323"},"PeriodicalIF":41.9,"publicationDate":"2025-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12527746/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144955794","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}