Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3625
Sophia C Kamran,James B Yu,Nirav S Kapadia
{"title":"Prostate-Specific Membrane Antigen PET for Patients With Postoperative Recurrence of Prostate Cancer.","authors":"Sophia C Kamran,James B Yu,Nirav S Kapadia","doi":"10.1001/jamaoncol.2025.3625","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3625","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"28 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203612","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}
Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3760
Alessandro Pastorino,Heshan Liu,Levi Pederson,Valentino Martelli,Timothy Iveson,Aimery de Gramont,Steven R Alberts,Thomas J George,Greg Yothers,Andrea Harkin,Roberto Labianca,Julien Taieb,Hans-Joachim Schmoll,Chris Twelves,Norman Wolmark,Leonard B Saltz,Ioannis Souglakos,Richard M Goldberg,Rachel Kerr,Sara Lonardi,Takayuki Yoshino,Alberto Puccini,Thierry André,Qian Shi,Alberto Sobrero,
ImportanceThe definition of cure in stage II to III colon cancer (CC) remains unclear due to limitations in conventional end points, which include deaths and second primary tumors as events. These can complicate communication with patients regarding long-term outcomes.ObjectiveTo distinguish relapses from competing health-related events to classify long-term outcomes years after surgery and explore when the incidence of true relapses of the initial CC approaches 0% to define cure in this disease.Design, Setting, and ParticipantsThis pooled analysis of individual patient-level data from 15 phase 3 randomized clinical trials assessed time to CC-related relapse using Kaplan-Meier and Aalen-Johansen methods, with death and second primary tumors treated as competing risks. Cox regression models evaluated prognostic associations, stratified by sex, stage, and tumor. Patients with stage II to III CC who underwent adjuvant chemotherapy were included. All patients had undergone radical surgery for CC and received adjuvant chemotherapy with a median follow-up of at least 6 years. The Adjuvant Colon Cancer Endpoints (ACCENT) and the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) databases included adjuvant studies conducted between 1996 and 2015. Data were analyzed from February 2022 to June 2025.ExposuresAdjuvant chemotherapy regimens varied across trials, including fluoropyrimidines alone or in combination with oxaliplatin or biologic agents.Main Outcomes and MeasuresThe primary outcome was time to CC-related recurrence. The predefined threshold for cure was a recurrence risk below 0.5%.ResultsOf 35 213 included patients, 19 346 (54.9%) were male, and the mean (SD) age was 60.2 (10.8) years. The incidence rate of recurrence peaked at 6.4% (1993 of 31 373) between month 6 and month 12 and decreased continuously until year 10 of follow-up never exceeding 0.5%. Recurrence rate appeared to increase again after year 10 and peaked at 2.0% during year 12.5 to year 13, a pattern observed exclusively in the MOSAIC trial. Competing-event analysis revealed that death and second primary tumors inflated the apparent recurrence rate, especially for older patients. The overall cumulative incidence of relapse with death as competing risk was lower among female patients (hazard ratio, 0.58; 95% CI, 0.45-0.76; P < .001).Conclusions and RelevanceIn this pooled analysis of phase 3 randomized clinical trials, a recurrence rate less than 0.5% occurred after 6 years from surgery, supporting a practical definition of cure. Recognizing this milestone may improve patient communication, guide follow-up duration, and reduce unnecessary long-term surveillance.
{"title":"The Definition of Cure in Colon Cancer: A Pooled Analysis of 15 Randomized Clinical Trials.","authors":"Alessandro Pastorino,Heshan Liu,Levi Pederson,Valentino Martelli,Timothy Iveson,Aimery de Gramont,Steven R Alberts,Thomas J George,Greg Yothers,Andrea Harkin,Roberto Labianca,Julien Taieb,Hans-Joachim Schmoll,Chris Twelves,Norman Wolmark,Leonard B Saltz,Ioannis Souglakos,Richard M Goldberg,Rachel Kerr,Sara Lonardi,Takayuki Yoshino,Alberto Puccini,Thierry André,Qian Shi,Alberto Sobrero, ","doi":"10.1001/jamaoncol.2025.3760","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3760","url":null,"abstract":"ImportanceThe definition of cure in stage II to III colon cancer (CC) remains unclear due to limitations in conventional end points, which include deaths and second primary tumors as events. These can complicate communication with patients regarding long-term outcomes.ObjectiveTo distinguish relapses from competing health-related events to classify long-term outcomes years after surgery and explore when the incidence of true relapses of the initial CC approaches 0% to define cure in this disease.Design, Setting, and ParticipantsThis pooled analysis of individual patient-level data from 15 phase 3 randomized clinical trials assessed time to CC-related relapse using Kaplan-Meier and Aalen-Johansen methods, with death and second primary tumors treated as competing risks. Cox regression models evaluated prognostic associations, stratified by sex, stage, and tumor. Patients with stage II to III CC who underwent adjuvant chemotherapy were included. All patients had undergone radical surgery for CC and received adjuvant chemotherapy with a median follow-up of at least 6 years. The Adjuvant Colon Cancer Endpoints (ACCENT) and the International Duration Evaluation of Adjuvant Chemotherapy (IDEA) databases included adjuvant studies conducted between 1996 and 2015. Data were analyzed from February 2022 to June 2025.ExposuresAdjuvant chemotherapy regimens varied across trials, including fluoropyrimidines alone or in combination with oxaliplatin or biologic agents.Main Outcomes and MeasuresThe primary outcome was time to CC-related recurrence. The predefined threshold for cure was a recurrence risk below 0.5%.ResultsOf 35 213 included patients, 19 346 (54.9%) were male, and the mean (SD) age was 60.2 (10.8) years. The incidence rate of recurrence peaked at 6.4% (1993 of 31 373) between month 6 and month 12 and decreased continuously until year 10 of follow-up never exceeding 0.5%. Recurrence rate appeared to increase again after year 10 and peaked at 2.0% during year 12.5 to year 13, a pattern observed exclusively in the MOSAIC trial. Competing-event analysis revealed that death and second primary tumors inflated the apparent recurrence rate, especially for older patients. The overall cumulative incidence of relapse with death as competing risk was lower among female patients (hazard ratio, 0.58; 95% CI, 0.45-0.76; P < .001).Conclusions and RelevanceIn this pooled analysis of phase 3 randomized clinical trials, a recurrence rate less than 0.5% occurred after 6 years from surgery, supporting a practical definition of cure. Recognizing this milestone may improve patient communication, guide follow-up duration, and reduce unnecessary long-term surveillance.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"124 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203614","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}
Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3783
Amar U Kishan,Michael L Steinberg,John Nikitas
{"title":"Concerns Regarding Follow-Up Duration and End Point Validity-Reply.","authors":"Amar U Kishan,Michael L Steinberg,John Nikitas","doi":"10.1001/jamaoncol.2025.3783","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3783","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"7 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203615","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}
ImportanceProstate-specific membrane antigen positron emission tomography (PSMA-PET) offers superior accuracy in detecting prostate cancer lesions leading to intensified radiotherapy (RT), but its impact on patient outcomes is still undefined.ObjectiveTo evaluate whether intensification of salvage RT (SRT) after radical prostatectomy (RP) guided by PSMA-PET (PSMAiSRT) is associated with improved failure-free survival (FFS).Design, Setting, and ParticipantsPSMAiSRT was a stratified cohort within a larger PSMA-guided intensification of radiotherapy (PSMAgRT) trial, a phase 2, two-center, registry-based randomized clinical trial. Patients with biochemical recurrence following RP who were eligible for standard-of-care (SOC) SRT from May 2018 to February 2021, were eligible for randomization in the PSMAiSRT stratum. A total of 130 patients were randomized, with 2 who did not proceed to radiotherapy (RT). The cutoff date for the primary analysis was October 26, 2023.InterventionPatients were randomized in a 1:1 ratio to receive either SOC SRT to the prostate bed, with or without elective pelvic RT, with or without adjuvant hormonal therapy (HT), or PSMA-PET/CT-guided SRT, intensified to detected sites of disease.Main outcome and measuresThe primary end point was FFS, defined as PSA progression (PSA nadir >0.2 ng/mL), radiological progression, next-line therapy initiation, or death.ResultsAmong 128 patients (median [IQR] age, 71 [64-74] years), median (range) PSA at enrollment was 0.3 (0.1-3.0) ng/mL. In the PSMAiSRT group, 33 of 64 patients (52%) received intensified SRT; with addition of pelvic RT (n = 16 [25%]), metastasis-directed RT (n = 2 [3%]), lymph node boost (n = 19 [30%]), or prostate bed boost (n = 15). Adjuvant hormone therapy was equally prevalent in both arms (55 [86%] control vs 54 [84%] PSMAiSRT). At a median (range) follow-up of 37 (7-60) months, PSMAiSRT improved FFS (hazard ratio [HR], 0.50; 95% CI, 0.27-0.94; P = .04) and eugonadal FFS (HR, 0.45; 95% CI, 0.21-0.96; P = .03), with its greatest benefit in the subgroup with PSA of 0.3 ng/mL or more (HR, 0.17; 95% CI, 0.04-0.79; P = .01). Fewer next-line treatment events occurred in the PSMAiSRT arm (4 vs 12; HR, 0.32; 95% CI, 0.11-1.02; P = .04). There were no significant differences in toxic effects or quality of life between arms.Conclusion and RelevanceThis phase 2 trial demonstrated an isotoxic improvement in cancer control with PSMA-PET-guided intensification of SRT after RP. Confirmatory evidence is awaited from a subsequently accrued phase 3 trial.Trial RegistrationClinicalTrials.gov NCT03525288.
{"title":"Prostate-Specific Membrane Antigen PET-Guided Intensification of Salvage Radiotherapy After Radical Prostatectomy: A Phase 2 Randomized Clinical Trial.","authors":"Colin Belliveau,Fred Saad,Danny Duplan,Claire Petit,Guila Delouya,Daniel Taussky,Maroie Barkati,Carole Lambert,Marie-Claude Beauchemin,Sebastien Clavel,Gary Mok,Levon Igidbashian,Anne-Sophie Gauthier-Paré,Thu-van Nguyen,Pierre-Yves McLaughlin,Khun Visith Keu,Jean N DaSilva,Daniel Juneau,Cynthia Ménard","doi":"10.1001/jamaoncol.2025.3746","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3746","url":null,"abstract":"ImportanceProstate-specific membrane antigen positron emission tomography (PSMA-PET) offers superior accuracy in detecting prostate cancer lesions leading to intensified radiotherapy (RT), but its impact on patient outcomes is still undefined.ObjectiveTo evaluate whether intensification of salvage RT (SRT) after radical prostatectomy (RP) guided by PSMA-PET (PSMAiSRT) is associated with improved failure-free survival (FFS).Design, Setting, and ParticipantsPSMAiSRT was a stratified cohort within a larger PSMA-guided intensification of radiotherapy (PSMAgRT) trial, a phase 2, two-center, registry-based randomized clinical trial. Patients with biochemical recurrence following RP who were eligible for standard-of-care (SOC) SRT from May 2018 to February 2021, were eligible for randomization in the PSMAiSRT stratum. A total of 130 patients were randomized, with 2 who did not proceed to radiotherapy (RT). The cutoff date for the primary analysis was October 26, 2023.InterventionPatients were randomized in a 1:1 ratio to receive either SOC SRT to the prostate bed, with or without elective pelvic RT, with or without adjuvant hormonal therapy (HT), or PSMA-PET/CT-guided SRT, intensified to detected sites of disease.Main outcome and measuresThe primary end point was FFS, defined as PSA progression (PSA nadir >0.2 ng/mL), radiological progression, next-line therapy initiation, or death.ResultsAmong 128 patients (median [IQR] age, 71 [64-74] years), median (range) PSA at enrollment was 0.3 (0.1-3.0) ng/mL. In the PSMAiSRT group, 33 of 64 patients (52%) received intensified SRT; with addition of pelvic RT (n = 16 [25%]), metastasis-directed RT (n = 2 [3%]), lymph node boost (n = 19 [30%]), or prostate bed boost (n = 15). Adjuvant hormone therapy was equally prevalent in both arms (55 [86%] control vs 54 [84%] PSMAiSRT). At a median (range) follow-up of 37 (7-60) months, PSMAiSRT improved FFS (hazard ratio [HR], 0.50; 95% CI, 0.27-0.94; P = .04) and eugonadal FFS (HR, 0.45; 95% CI, 0.21-0.96; P = .03), with its greatest benefit in the subgroup with PSA of 0.3 ng/mL or more (HR, 0.17; 95% CI, 0.04-0.79; P = .01). Fewer next-line treatment events occurred in the PSMAiSRT arm (4 vs 12; HR, 0.32; 95% CI, 0.11-1.02; P = .04). There were no significant differences in toxic effects or quality of life between arms.Conclusion and RelevanceThis phase 2 trial demonstrated an isotoxic improvement in cancer control with PSMA-PET-guided intensification of SRT after RP. Confirmatory evidence is awaited from a subsequently accrued phase 3 trial.Trial RegistrationClinicalTrials.gov NCT03525288.","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"39 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203613","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}
Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3780
Michioki Endo,Masahiro Kami
{"title":"Concerns Regarding Follow-Up Duration and End Point Validity.","authors":"Michioki Endo,Masahiro Kami","doi":"10.1001/jamaoncol.2025.3780","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3780","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"54 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203877","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}
Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3743
Meghna Gaddam,Mitchell D Creinin,David Victorson,Seema A Khan
{"title":"Contraceptive Choices for Premenopausal Women and Breast Cancer Risk.","authors":"Meghna Gaddam,Mitchell D Creinin,David Victorson,Seema A Khan","doi":"10.1001/jamaoncol.2025.3743","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3743","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"99 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203624","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}
Pub Date : 2025-10-02DOI: 10.1001/jamaoncol.2025.3768
John K Lin,Ying Xu,Jenny J Xiang,Eric K Singhi,Changchuan Jiang,Mariana Chavez-MacGregor,Ya-Chen Tina Shih
{"title":"Nationwide Response to Carboplatin and Cisplatin Shortages in Lung Cancer.","authors":"John K Lin,Ying Xu,Jenny J Xiang,Eric K Singhi,Changchuan Jiang,Mariana Chavez-MacGregor,Ya-Chen Tina Shih","doi":"10.1001/jamaoncol.2025.3768","DOIUrl":"https://doi.org/10.1001/jamaoncol.2025.3768","url":null,"abstract":"","PeriodicalId":14850,"journal":{"name":"JAMA Oncology","volume":"9 1","pages":""},"PeriodicalIF":28.4,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145203609","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}
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