{"title":"Expanding Indications for Stereotactic Radiosurgery in Small Cell Lung Cancer With Brain Metastases.","authors":"Masamune Noguchi,Kenta Nimura,Yutaro Koide","doi":"10.1200/jco-25-01867","DOIUrl":"https://doi.org/10.1200/jco-25-01867","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"1 1","pages":"JCO2501867"},"PeriodicalIF":45.3,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146005568","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 : 2026-01-20Epub Date: 2025-12-09DOI: 10.1200/JCO-25-01650
Alice Cusick
A connection to a cancer patient manifested as a scent.
与癌症病人的联系表现为一种气味。
{"title":"Smell.","authors":"Alice Cusick","doi":"10.1200/JCO-25-01650","DOIUrl":"10.1200/JCO-25-01650","url":null,"abstract":"<p><p>A connection to a cancer patient manifested as a scent.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"252-253"},"PeriodicalIF":41.9,"publicationDate":"2026-01-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145714641","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}
Aryana Sepassi,Scott D Ramsey,A Mark Fendrick,Nico Gabriel,Jason A Zell,Dana B Mukamel,Sean D Sullivan
PURPOSETo address high out-of-pocket (OOP) medication costs among Medicare Part D beneficiaries, the 2022 Inflation Reduction Act introduced the Medicare Prescription Payment Plan (M3P), a voluntary program that allows beneficiaries to spread OOP costs over the calendar year. We examined M3P's potential impact among beneficiaries with cancer, who frequently incur substantial early-year Part D medication costs.MATERIALS AND METHODSWe evaluated a 2022 5% random sample of Medicare beneficiaries with a cancer diagnosis and ≥1 fill for a cancer-indicated Part D medication. We estimated 2025-adjusted annual true OOP spending and median monthly beneficiary OOP payment obligations with and without M3P enrollment. Subgroup analyses were performed by demographics, nonadherence status in 2022, and Part D benefit phase.RESULTSAmong 168,480 beneficiaries with cancer, most were diagnosed with breast (47.6%), dermatologic (17.6%), or prostate (13.3%) cancers. Overall, 46.7% were projected to reach catastrophic coverage in 2025, with 32.4% doing so in January. Breast (29.7%), prostate (21.20%), and hematologic (20.0%) cancers were most common among those reaching catastrophic coverage. Overall, 43.0% were nonadherent to cancer-indicated Part D medications, with 31.5% reaching catastrophic coverage in January 2025. M3P reduced beneficiary payment obligation variability, especially among those reaching the catastrophic phase in January (IQR, $1,798 US dollars [USD] no M3P v $118 USD M3P). Of those reaching catastrophic coverage with a cancer-indicated drug (58.6% overall), 89.2% did so in January.CONCLUSIONEarly-year entry into catastrophic coverage is common among beneficiaries with certain high-cost cancers. M3P may most effectively reduce financial burden when enrollment occurs before January. Targeted outreach from cancer care teams and Part D plans to nonadherent patients and those considering costly therapies could maximize program impact and improve treatment outcomes.
目的：为了解决医疗保险D部分受益人自付高额（OOP）药物费用问题，《2022年通货膨胀减少法案》引入了医疗保险处方支付计划（M3P），这是一个自愿计划，允许受益人在日历年内分摊OOP费用。我们检查了M3P对癌症受益人的潜在影响，他们经常在早期产生大量的D部分药物费用。材料和方法我们评估了2022个5%的医疗保险受益人的随机样本，这些受益人被诊断为癌症，并且在癌症指示的D部分药物中填充≥1。我们估计了2025年调整后的年度真实OOP支出和有或没有M3P登记的受益人每月OOP支付义务的中位数。亚组分析按人口统计学、2022年的不依从状态和D部分获益阶段进行。结果在168,480名患有癌症的受益人中，大多数被诊断为乳腺癌（47.6%）、皮肤病（17.6%）或前列腺癌（13.3%）。总体而言，46.7%的人预计在2025年达到灾难性覆盖范围，1月份达到32.4%。乳腺癌（29.7%）、前列腺癌（21.20%）和血液癌（20.0%）在达到灾难性覆盖率的患者中最为常见。总体而言，43.0%的患者不坚持癌症指示的D部分药物治疗，其中31.5%的患者在2025年1月达到灾难性覆盖。M3P降低了受益人支付义务的可变性，特别是在1月份达到灾难性阶段的受益人中（IQR， 1798美元的M3P vs 118美元的M3P）。在那些使用癌症适应症药物达到灾难性覆盖率的人中（58.6%），89.2%是在1月份达到的。结论在某些高成本癌症患者中，早期加入巨灾保险是常见的。M3P可能最有效地减轻经济负担，当注册在1月之前。癌症护理团队和D部分计划针对非依从性患者和那些考虑昂贵治疗的患者进行有针对性的推广，可以最大限度地发挥项目影响并改善治疗结果。
{"title":"Potential Impact of the Medicare Prescription Payment Plan for Medicare Part D Beneficiaries With a Cancer Diagnosis.","authors":"Aryana Sepassi,Scott D Ramsey,A Mark Fendrick,Nico Gabriel,Jason A Zell,Dana B Mukamel,Sean D Sullivan","doi":"10.1200/jco-25-01788","DOIUrl":"https://doi.org/10.1200/jco-25-01788","url":null,"abstract":"PURPOSETo address high out-of-pocket (OOP) medication costs among Medicare Part D beneficiaries, the 2022 Inflation Reduction Act introduced the Medicare Prescription Payment Plan (M3P), a voluntary program that allows beneficiaries to spread OOP costs over the calendar year. We examined M3P's potential impact among beneficiaries with cancer, who frequently incur substantial early-year Part D medication costs.MATERIALS AND METHODSWe evaluated a 2022 5% random sample of Medicare beneficiaries with a cancer diagnosis and ≥1 fill for a cancer-indicated Part D medication. We estimated 2025-adjusted annual true OOP spending and median monthly beneficiary OOP payment obligations with and without M3P enrollment. Subgroup analyses were performed by demographics, nonadherence status in 2022, and Part D benefit phase.RESULTSAmong 168,480 beneficiaries with cancer, most were diagnosed with breast (47.6%), dermatologic (17.6%), or prostate (13.3%) cancers. Overall, 46.7% were projected to reach catastrophic coverage in 2025, with 32.4% doing so in January. Breast (29.7%), prostate (21.20%), and hematologic (20.0%) cancers were most common among those reaching catastrophic coverage. Overall, 43.0% were nonadherent to cancer-indicated Part D medications, with 31.5% reaching catastrophic coverage in January 2025. M3P reduced beneficiary payment obligation variability, especially among those reaching the catastrophic phase in January (IQR, $1,798 US dollars [USD] no M3P v $118 USD M3P). Of those reaching catastrophic coverage with a cancer-indicated drug (58.6% overall), 89.2% did so in January.CONCLUSIONEarly-year entry into catastrophic coverage is common among beneficiaries with certain high-cost cancers. M3P may most effectively reduce financial burden when enrollment occurs before January. Targeted outreach from cancer care teams and Part D plans to nonadherent patients and those considering costly therapies could maximize program impact and improve treatment outcomes.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"56 1","pages":"JCO2501788"},"PeriodicalIF":45.3,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145971771","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}
Carmine Valenza,Yue Zheng,Monica Milano,Dario Trapani,Elisa Giordano,Lorenzo Guidi,Pier Paolo Maria Berton Giachetti,Laura Boldrini,Grazia Castellano,Jalissa Katrini,Bianca Malagutti,Gabriele Antonarelli,Fabio Conforti,Eleonora Pagan,Vincenzo Bagnardi,Gregory J Kirkner,Claudia Sangalli,Kate E Dibble,Marco Colleoni,Meredith M Regan,Elisabetta Munzone,Giuseppe Curigliano,Ann H Partridge
PURPOSETo evaluate the clinical benefit of extended endocrine therapy (eET) after 5 years of adjuvant treatment with luteinizing hormone-releasing hormone agonists (LHRHa) in premenopausal women with node-positive, hormone receptor-positive early breast cancer (eBC).METHODSWe conducted a cohort study analysis on two prospectively collected data sets (the Young Women's Breast Cancer Study and IEO Breast Cancer Cohort). Eligible patients were diagnosed with eBC at age ≤40 years (between 2005 and 2016), had node-positive, hormone receptor-positive disease, and remained premenopausal after 5 years of adjuvant LHRHa with no evidence of recurrence. The primary end point was invasive breast cancer-free survival (IBCFS), calculated from the sixth year after the initiation of adjuvant endocrine therapy (ET; study baseline), and adjusted through the propensity score (PS) weighting analysis.RESULTSA total of 501 patients were included in the analysis: 287 received eET for a median duration of 3.7 years (IQR, 2.3-5.0), including 48% tamoxifen monotherapy and 52% LHRHa plus tamoxifen or aromatase inhibitor. After a median follow-up of 7.3 years from the study baseline, the PS weighted IBCFS rates at 5 years were 85% in the eET group and 78% in the non-eET group (hazard ratio [HR], 0.63 [95% CI, 0.44 to 0.89]; P = .0135). The PS weighted distant recurrence-free survival rates at 5 years were 91% and 83% in the eET and non-eET group, respectively (cause-specific HR, 0.49 [95% CI, 0.31 to 0.79]). In both groups, bone fractures and major cardiovascular events were reported in 1% of patients.CONCLUSIONIn this cohort study analysis, extending ET in premenopausal patients with node-positive eBC after 5 years of LHRHa treatment was associated with a clinically meaningful reduction in both invasive and distant breast cancer recurrences.
{"title":"Extended Endocrine Therapy Following 5 Years of Adjuvant Luteinizing Hormone-Releasing Hormone Agonist in Premenopausal Patients With Node-Positive, Hormone Receptor-Positive Breast Cancer: A Cohort Study.","authors":"Carmine Valenza,Yue Zheng,Monica Milano,Dario Trapani,Elisa Giordano,Lorenzo Guidi,Pier Paolo Maria Berton Giachetti,Laura Boldrini,Grazia Castellano,Jalissa Katrini,Bianca Malagutti,Gabriele Antonarelli,Fabio Conforti,Eleonora Pagan,Vincenzo Bagnardi,Gregory J Kirkner,Claudia Sangalli,Kate E Dibble,Marco Colleoni,Meredith M Regan,Elisabetta Munzone,Giuseppe Curigliano,Ann H Partridge","doi":"10.1200/jco-25-01660","DOIUrl":"https://doi.org/10.1200/jco-25-01660","url":null,"abstract":"PURPOSETo evaluate the clinical benefit of extended endocrine therapy (eET) after 5 years of adjuvant treatment with luteinizing hormone-releasing hormone agonists (LHRHa) in premenopausal women with node-positive, hormone receptor-positive early breast cancer (eBC).METHODSWe conducted a cohort study analysis on two prospectively collected data sets (the Young Women's Breast Cancer Study and IEO Breast Cancer Cohort). Eligible patients were diagnosed with eBC at age ≤40 years (between 2005 and 2016), had node-positive, hormone receptor-positive disease, and remained premenopausal after 5 years of adjuvant LHRHa with no evidence of recurrence. The primary end point was invasive breast cancer-free survival (IBCFS), calculated from the sixth year after the initiation of adjuvant endocrine therapy (ET; study baseline), and adjusted through the propensity score (PS) weighting analysis.RESULTSA total of 501 patients were included in the analysis: 287 received eET for a median duration of 3.7 years (IQR, 2.3-5.0), including 48% tamoxifen monotherapy and 52% LHRHa plus tamoxifen or aromatase inhibitor. After a median follow-up of 7.3 years from the study baseline, the PS weighted IBCFS rates at 5 years were 85% in the eET group and 78% in the non-eET group (hazard ratio [HR], 0.63 [95% CI, 0.44 to 0.89]; P = .0135). The PS weighted distant recurrence-free survival rates at 5 years were 91% and 83% in the eET and non-eET group, respectively (cause-specific HR, 0.49 [95% CI, 0.31 to 0.79]). In both groups, bone fractures and major cardiovascular events were reported in 1% of patients.CONCLUSIONIn this cohort study analysis, extending ET in premenopausal patients with node-positive eBC after 5 years of LHRHa treatment was associated with a clinically meaningful reduction in both invasive and distant breast cancer recurrences.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"22 1","pages":"JCO2501660"},"PeriodicalIF":45.3,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145971773","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}
Yohann Loriot,Thomas Powles,Victor Moreno,Taek Won Kang,Irfan Cicin,Angela Girvin,Sydney Akapame,Anne O'Hagan,Wei Zhu,Meggan Tammaro,Shibu Thomas,Spyros Triantos,Arlene O Siefker-Radtke
PURPOSEFirst-line treatment options for cisplatin-ineligible patients with metastatic urothelial cancer (mUC) are limited. We conducted a phase II study of erdafitinib, alone or with cetrelimab, in FGFR-altered mUC.METHODSAdults with mUC and select FGFR alterations who are ineligible for cisplatin were randomly assigned 1:1 in a noncomparative design to once-daily erdafitinib 8 mg (with pharmacodynamically guided uptitration to 9 mg) or erdafitinib 8 mg plus intravenous cetrelimab 240 mg once every 2 weeks at cycles 1-4 and 480 mg once every 4 weeks thereafter. Primary end points were investigator-assessed confirmed overall response rate (ORR) and safety; secondary end points included duration of response (DOR), progression-free survival, and overall survival (OS). No statistical hypotheses were tested.RESULTSAt data cutoff, 87 patients were randomly assigned and treated (erdafitinib, n = 43; erdafitinib plus cetrelimab, n = 44). Of 64 patients with PD-L1 expression data, 56 (87.5%) had low levels of PD-L1 expression (combined positive score <10). Median survival follow-up was 14.2 months. Investigator-assessed confirmed ORR for erdafitinib was 44.2% (95% CI, 29.1 to 60.1) with one complete response (CR); median DOR and median OS were 9.7 months (95% CI, 4.6 to not estimable [NE]) and 16.2 months (95% CI, 8.3 to NE), respectively. Investigator-assessed confirmed ORR for erdafitinib plus cetrelimab was 54.5% (95% CI, 38.8 to 69.6), with six (13.6%) CRs; median DOR and median OS were 11.1 months (95% CI, 8.8 to NE) and 20.8 months (95% CI, 12.0 to NE), respectively. The most frequent treatment-related adverse events (TRAEs) were hyperphosphatemia (83.7% and 68.2% in erdafitinib and erdafitinib plus cetrelimab groups, respectively), stomatitis (69.8% and 56.8%), and dry mouth (37.2% and 56.8%). Grade ≥3 TRAEs occurred in 46.5% and 45.5% of patients receiving erdafitinib and erdafitinib plus cetrelimab, respectively.CONCLUSIONFirst-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.
{"title":"Erdafitinib or Erdafitinib Plus Cetrelimab for Patients With Metastatic Urothelial Carcinoma and FGFR Alterations: Final Results From the Phase II NORSE Study.","authors":"Yohann Loriot,Thomas Powles,Victor Moreno,Taek Won Kang,Irfan Cicin,Angela Girvin,Sydney Akapame,Anne O'Hagan,Wei Zhu,Meggan Tammaro,Shibu Thomas,Spyros Triantos,Arlene O Siefker-Radtke","doi":"10.1200/jco-25-00826","DOIUrl":"https://doi.org/10.1200/jco-25-00826","url":null,"abstract":"PURPOSEFirst-line treatment options for cisplatin-ineligible patients with metastatic urothelial cancer (mUC) are limited. We conducted a phase II study of erdafitinib, alone or with cetrelimab, in FGFR-altered mUC.METHODSAdults with mUC and select FGFR alterations who are ineligible for cisplatin were randomly assigned 1:1 in a noncomparative design to once-daily erdafitinib 8 mg (with pharmacodynamically guided uptitration to 9 mg) or erdafitinib 8 mg plus intravenous cetrelimab 240 mg once every 2 weeks at cycles 1-4 and 480 mg once every 4 weeks thereafter. Primary end points were investigator-assessed confirmed overall response rate (ORR) and safety; secondary end points included duration of response (DOR), progression-free survival, and overall survival (OS). No statistical hypotheses were tested.RESULTSAt data cutoff, 87 patients were randomly assigned and treated (erdafitinib, n = 43; erdafitinib plus cetrelimab, n = 44). Of 64 patients with PD-L1 expression data, 56 (87.5%) had low levels of PD-L1 expression (combined positive score <10). Median survival follow-up was 14.2 months. Investigator-assessed confirmed ORR for erdafitinib was 44.2% (95% CI, 29.1 to 60.1) with one complete response (CR); median DOR and median OS were 9.7 months (95% CI, 4.6 to not estimable [NE]) and 16.2 months (95% CI, 8.3 to NE), respectively. Investigator-assessed confirmed ORR for erdafitinib plus cetrelimab was 54.5% (95% CI, 38.8 to 69.6), with six (13.6%) CRs; median DOR and median OS were 11.1 months (95% CI, 8.8 to NE) and 20.8 months (95% CI, 12.0 to NE), respectively. The most frequent treatment-related adverse events (TRAEs) were hyperphosphatemia (83.7% and 68.2% in erdafitinib and erdafitinib plus cetrelimab groups, respectively), stomatitis (69.8% and 56.8%), and dry mouth (37.2% and 56.8%). Grade ≥3 TRAEs occurred in 46.5% and 45.5% of patients receiving erdafitinib and erdafitinib plus cetrelimab, respectively.CONCLUSIONFirst-line erdafitinib monotherapy and erdafitinib plus cetrelimab demonstrated antitumor activity and a manageable safety profile in cisplatin-ineligible patients with mUC.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"82 1","pages":"JCO2500826"},"PeriodicalIF":45.3,"publicationDate":"2026-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145971768","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}
Kristin A Higgins,Chen Hu,Helen J Ross,Salma K Jabbour,David E Kozono,Taofeek K Owonikoko,Timothy A Ritter,Terence M Williams,James Welsh,Jeffry P Simko,B Movsas,Canhua Xiao,Kyoichi Kaira,Amit K Gupta,Pranshu Mohindra,Elie G Dib,Jeremy Brownstein,Stephen Chun,Charles S Kuzma,Rupesh Kotecha,Adedayo A Onitilo,Yuhchyau Chen,Thomas E Stinchcombe,Xiaofei Wang,Rebecca Paulus,Jeffrey D Bradley
PURPOSENRG Oncology/Alliance LU005 (ClinicalTrials.gov identifier: NCT03811002) tested the addition of atezolizumab to concurrent chemoradiation (CRT) in this open-label, phase III international trial.METHODSPatients with limited-stage small cell lung cancer (LS-SCLC), stage Tx-IV, N0-3, and M0 with Eastern Cooperative Group performance status (PS) 0-2 received one cycle of chemotherapy (platinum/etoposide) before study registration and were randomly assigned to CRT alone versus CRT plus concurrent and adjuvant atezolizumab, 1,200 mg once daily, every 3 weeks until investigator-assessed progression or intolerable side effects for a maximum of 17 cycles. Patients were stratified by choice of chemotherapy (cisplatin v carboplatin), radiation fractionation schedule (66 Gy once daily v 45 Gy twice daily), sex, and PS (0/1 v 2). The primary end point was overall survival (OS). Secondary end points included investigator-assessed progression-free survival (PFS), objective response rate, local control, and distant-metastasis-free survival (DMFS).RESULTSpatients were randomly assigned from May 2019 to December 2023. The median OS was 36.1 months (95% CI, 28.1 to 42.5) for the CRT-alone arm and 31.1 months (95% CI, 28.5 to 44.7) for the CRT + atezolizumab arm, respectively (hazard ratio [HR], 1.03 [95% CI, 0.80 to 1.32]). The median PFS was 11.4 months (95% CI, 10.3 to 13.2) for the CRT-alone arm and 12.1 months (95% CI, 10.9 to 15.2) for the CRT + atezolizumab arm, respectively (HR, 0.98 [95% CI, 0.79 to 1.22]). The median DMFS was 13.0 months (95% CI, 11.3 to 18.2) for the CRT-alone arm and 16.8 months (95% CI, 12.1 to 21.6) for the CRT + atezolizumab arm (HR, 0.96 [95% CI, 0.76 to 1.21]). No unexpected safety signals with concurrent atezolizumab were observed.CONCLUSIONConcurrent and adjuvant atezolizumab with chemoradiation did not improve survival in patients with LS-SCLC.
{"title":"Chemoradiation ± Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005.","authors":"Kristin A Higgins,Chen Hu,Helen J Ross,Salma K Jabbour,David E Kozono,Taofeek K Owonikoko,Timothy A Ritter,Terence M Williams,James Welsh,Jeffry P Simko,B Movsas,Canhua Xiao,Kyoichi Kaira,Amit K Gupta,Pranshu Mohindra,Elie G Dib,Jeremy Brownstein,Stephen Chun,Charles S Kuzma,Rupesh Kotecha,Adedayo A Onitilo,Yuhchyau Chen,Thomas E Stinchcombe,Xiaofei Wang,Rebecca Paulus,Jeffrey D Bradley","doi":"10.1200/jco-25-01569","DOIUrl":"https://doi.org/10.1200/jco-25-01569","url":null,"abstract":"PURPOSENRG Oncology/Alliance LU005 (ClinicalTrials.gov identifier: NCT03811002) tested the addition of atezolizumab to concurrent chemoradiation (CRT) in this open-label, phase III international trial.METHODSPatients with limited-stage small cell lung cancer (LS-SCLC), stage Tx-IV, N0-3, and M0 with Eastern Cooperative Group performance status (PS) 0-2 received one cycle of chemotherapy (platinum/etoposide) before study registration and were randomly assigned to CRT alone versus CRT plus concurrent and adjuvant atezolizumab, 1,200 mg once daily, every 3 weeks until investigator-assessed progression or intolerable side effects for a maximum of 17 cycles. Patients were stratified by choice of chemotherapy (cisplatin v carboplatin), radiation fractionation schedule (66 Gy once daily v 45 Gy twice daily), sex, and PS (0/1 v 2). The primary end point was overall survival (OS). Secondary end points included investigator-assessed progression-free survival (PFS), objective response rate, local control, and distant-metastasis-free survival (DMFS).RESULTSpatients were randomly assigned from May 2019 to December 2023. The median OS was 36.1 months (95% CI, 28.1 to 42.5) for the CRT-alone arm and 31.1 months (95% CI, 28.5 to 44.7) for the CRT + atezolizumab arm, respectively (hazard ratio [HR], 1.03 [95% CI, 0.80 to 1.32]). The median PFS was 11.4 months (95% CI, 10.3 to 13.2) for the CRT-alone arm and 12.1 months (95% CI, 10.9 to 15.2) for the CRT + atezolizumab arm, respectively (HR, 0.98 [95% CI, 0.79 to 1.22]). The median DMFS was 13.0 months (95% CI, 11.3 to 18.2) for the CRT-alone arm and 16.8 months (95% CI, 12.1 to 21.6) for the CRT + atezolizumab arm (HR, 0.96 [95% CI, 0.76 to 1.21]). No unexpected safety signals with concurrent atezolizumab were observed.CONCLUSIONConcurrent and adjuvant atezolizumab with chemoradiation did not improve survival in patients with LS-SCLC.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"35 1","pages":"JCO2501569"},"PeriodicalIF":45.3,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145961324","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}
PURPOSENeoadjuvant chemoradiotherapy (nCRT) is the standard treatment for patients with locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates and long-term outcomes remain suboptimal. This study evaluated the safety and efficacy of atezolizumab (Atezo) with or without tiragolumab (Tira) after nCRT in patients with LARC.METHODSThis randomized, parallel-group, phase II study included a safety run-in and a subsequent randomized phase. Eligible patients (cT3N+M0 or cT4NanyM0) received long-course nCRT (45-50.4 Gy in 25-28 fractions with concurrent capecitabine), followed by three 21-day cycles of Atezo (1,200 mg once on day 1 of each cycle), either combined with Tira (600 mg; Atezo + Tira arm) or alone (Atezo arm). Radical surgery was performed 2 weeks after final dose. The primary end point was pCR rate. Secondary end points included 1-year event-free survival (EFS) rate and safety. Outcomes were compared with historical controls.RESULTSAt data cutoff (January 6, 2025), three patients were enrolled in safety run-in and received Atezo + Tira. In randomized phase, 55 patients were assigned 1:1 to Atezo + Tira arm (n = 28) or Atezo arm (n = 27). pCR rate was 35.7% (95% CI, 18.6 to 55.9; v historical control [15%] P = .002) in Atezo + Tira arm and 22.2% (95% CI, 8.6 to 42.3; v historical control [15%] P = .293) in Atezo arm. After a median follow-up of 21.55 months (range, 20.67-22.24), 1-year EFS rates were 96.3% (95% CI, 76.5 to 99.5) in Atezo + Tira arm and 92.1% (95% CI, 72.1 to 98.0) in Atezo arm. Grade 3 to 4 treatment-related adverse events occurred in 31.0% and 26.9%. Grade 3 to 4 AEs related to Atezo or Tira were 10.3% and 11.5%, respectively. No treatment-emergent deaths were reported.CONCLUSIONIn patients with LARC, Atezo + Tira after nCRT statistically improved the pCR rate compared with historical controls, with an acceptable safety profile.
{"title":"Randomized Parallel-Group Phase II Study (NEOTERIC) of Atezolizumab With or Without Tiragolumab After Neoadjuvant Chemoradiotherapy in Locally Advanced Rectal Cancer.","authors":"Wentao Tang,Aiwen Wu,Ping Lan,Kefeng Ding,Zhenning Wang,Jian Wang,Nan Chen,Xianrui Wu,Yurong Jiao,Funan Liu,Lin Tong,Yanjun Shi,Jianmin Xu","doi":"10.1200/jco-25-01883","DOIUrl":"https://doi.org/10.1200/jco-25-01883","url":null,"abstract":"PURPOSENeoadjuvant chemoradiotherapy (nCRT) is the standard treatment for patients with locally advanced rectal cancer (LARC); however, pathologic complete response (pCR) rates and long-term outcomes remain suboptimal. This study evaluated the safety and efficacy of atezolizumab (Atezo) with or without tiragolumab (Tira) after nCRT in patients with LARC.METHODSThis randomized, parallel-group, phase II study included a safety run-in and a subsequent randomized phase. Eligible patients (cT3N+M0 or cT4NanyM0) received long-course nCRT (45-50.4 Gy in 25-28 fractions with concurrent capecitabine), followed by three 21-day cycles of Atezo (1,200 mg once on day 1 of each cycle), either combined with Tira (600 mg; Atezo + Tira arm) or alone (Atezo arm). Radical surgery was performed 2 weeks after final dose. The primary end point was pCR rate. Secondary end points included 1-year event-free survival (EFS) rate and safety. Outcomes were compared with historical controls.RESULTSAt data cutoff (January 6, 2025), three patients were enrolled in safety run-in and received Atezo + Tira. In randomized phase, 55 patients were assigned 1:1 to Atezo + Tira arm (n = 28) or Atezo arm (n = 27). pCR rate was 35.7% (95% CI, 18.6 to 55.9; v historical control [15%] P = .002) in Atezo + Tira arm and 22.2% (95% CI, 8.6 to 42.3; v historical control [15%] P = .293) in Atezo arm. After a median follow-up of 21.55 months (range, 20.67-22.24), 1-year EFS rates were 96.3% (95% CI, 76.5 to 99.5) in Atezo + Tira arm and 92.1% (95% CI, 72.1 to 98.0) in Atezo arm. Grade 3 to 4 treatment-related adverse events occurred in 31.0% and 26.9%. Grade 3 to 4 AEs related to Atezo or Tira were 10.3% and 11.5%, respectively. No treatment-emergent deaths were reported.CONCLUSIONIn patients with LARC, Atezo + Tira after nCRT statistically improved the pCR rate compared with historical controls, with an acceptable safety profile.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"15 1","pages":"JCO2501883"},"PeriodicalIF":45.3,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145961321","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}
An ophthalmology resident discovers how vision care can honor end-of-life goals, helping a cancer patient with failing sight write to his children while considering how and when such letters should be read.
{"title":"Quiet Work of Clarity.","authors":"Henry Bair","doi":"10.1200/JCO-25-02215","DOIUrl":"https://doi.org/10.1200/JCO-25-02215","url":null,"abstract":"<p><p>An ophthalmology resident discovers how vision care can honor end-of-life goals, helping a cancer patient with failing sight write to his children while considering how and when such letters should be read.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2502215"},"PeriodicalIF":41.9,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145965961","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}
Glenwood D Goss,Gail E Darling,Virginie Westeel,Kazuhiko Nakagawa,Bartomeu Massutí,Francesco Perrone,Sue-Anne McLachlan,Jin Hyoung Kang,Yi-Long Wu,Anne-Marie C Dingemans,Rafal Dziadziuszko,Laurent Greillier,Morihito Okada,Clarisse Audigier-Valette,Shunichi Sugawara,Ernest Nadal,Annamaria Catino,Anne-Claire Toffart,Tetsuya Mitsudomi,Renaud Whittom,Manuel Domine,Nobuyuki Yamamoto,Olivier Molinier,Franck Morin,Penelope A Bradbury,Martin R Stockler,Keyue Ding,Christopher J O'Callaghan
PURPOSEAdjuvant immunotherapy improved patient outcomes in two trials in completely resected non-small cell lung cancer (NSCLC), but with conflicting primary end point results. The Canadian Cancer Trials Group BR.31 trial evaluated adjuvant durvalumab in completely resected early-stage NSCLC.METHODSFollowing resection of stage IB (≥4 cm) to IIIA NSCLC (American Joint Committee on Cancer 7th Edition) and optional adjuvant chemotherapy, patients were randomly assigned 2:1 to durvalumab 20 mg/kg or placebo 20 mg/kg once every 4 weeks for 12 cycles. Random assignment was stratified by stage, extent of nodal dissection, tumor cell (TC) PD-L1 expression, adjuvant chemotherapy use, and center. The primary end point was investigator-assessed disease-free survival (DFS). Secondary outcomes included overall survival (OS), adverse events, and quality of life. The primary analysis was in the subgroup with cancers that had a PD-L1 TC expression ≥25%, no common activating EGFR mutations (EGFR-), and no ALK gene rearrangements (ALK-). Secondary analyses in hierarchical order included DFS in the subgroup whose tumors were EGFR-/ALK- with PD-L1 TC ≥1%, followed by all patients whose tumors were EGFR-/ALK-, followed by OS in the same primary and secondary subgroups in the same hierarchical order.RESULTSOf 1,415 patients randomly assigned, 1,219 (86%) had EGFR-/ALK- tumors: 815 randomly assigned to durvalumab and 404 to placebo. With a median follow-up of 60 months, there were no differences in DFS between patients assigned durvalumab (316) versus placebo (161) in the primary population (stratified hazard ratio [HR], 0.93 [95% CI, 0.71 to 1.25]; P = .64) or in the secondary populations. Grade 3 to 4 adverse events were higher in durvalumab-treated patients (D = 26% v P = 20%).CONCLUSIONAdjuvant durvalumab following complete resection was not associated with improvement in DFS compared with placebo in EGFR-/ALK- NSCLC, regardless of PD-L1 status.
{"title":"Adjuvant Durvalumab in Completely Resected Early-Stage Non-Small Cell Lung Cancer.","authors":"Glenwood D Goss,Gail E Darling,Virginie Westeel,Kazuhiko Nakagawa,Bartomeu Massutí,Francesco Perrone,Sue-Anne McLachlan,Jin Hyoung Kang,Yi-Long Wu,Anne-Marie C Dingemans,Rafal Dziadziuszko,Laurent Greillier,Morihito Okada,Clarisse Audigier-Valette,Shunichi Sugawara,Ernest Nadal,Annamaria Catino,Anne-Claire Toffart,Tetsuya Mitsudomi,Renaud Whittom,Manuel Domine,Nobuyuki Yamamoto,Olivier Molinier,Franck Morin,Penelope A Bradbury,Martin R Stockler,Keyue Ding,Christopher J O'Callaghan","doi":"10.1200/jco-25-01828","DOIUrl":"https://doi.org/10.1200/jco-25-01828","url":null,"abstract":"PURPOSEAdjuvant immunotherapy improved patient outcomes in two trials in completely resected non-small cell lung cancer (NSCLC), but with conflicting primary end point results. The Canadian Cancer Trials Group BR.31 trial evaluated adjuvant durvalumab in completely resected early-stage NSCLC.METHODSFollowing resection of stage IB (≥4 cm) to IIIA NSCLC (American Joint Committee on Cancer 7th Edition) and optional adjuvant chemotherapy, patients were randomly assigned 2:1 to durvalumab 20 mg/kg or placebo 20 mg/kg once every 4 weeks for 12 cycles. Random assignment was stratified by stage, extent of nodal dissection, tumor cell (TC) PD-L1 expression, adjuvant chemotherapy use, and center. The primary end point was investigator-assessed disease-free survival (DFS). Secondary outcomes included overall survival (OS), adverse events, and quality of life. The primary analysis was in the subgroup with cancers that had a PD-L1 TC expression ≥25%, no common activating EGFR mutations (EGFR-), and no ALK gene rearrangements (ALK-). Secondary analyses in hierarchical order included DFS in the subgroup whose tumors were EGFR-/ALK- with PD-L1 TC ≥1%, followed by all patients whose tumors were EGFR-/ALK-, followed by OS in the same primary and secondary subgroups in the same hierarchical order.RESULTSOf 1,415 patients randomly assigned, 1,219 (86%) had EGFR-/ALK- tumors: 815 randomly assigned to durvalumab and 404 to placebo. With a median follow-up of 60 months, there were no differences in DFS between patients assigned durvalumab (316) versus placebo (161) in the primary population (stratified hazard ratio [HR], 0.93 [95% CI, 0.71 to 1.25]; P = .64) or in the secondary populations. Grade 3 to 4 adverse events were higher in durvalumab-treated patients (D = 26% v P = 20%).CONCLUSIONAdjuvant durvalumab following complete resection was not associated with improvement in DFS compared with placebo in EGFR-/ALK- NSCLC, regardless of PD-L1 status.","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"37 1","pages":"JCO2501828"},"PeriodicalIF":45.3,"publicationDate":"2026-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145961322","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":"Focal Boosting in Localized Prostate Cancer in the Era of Systemic Therapy and Prostate-Specific Membrane Antigen Imaging.","authors":"Yunfeng Zhang,Xing Wang,Honglin Hu","doi":"10.1200/jco-25-02107","DOIUrl":"https://doi.org/10.1200/jco-25-02107","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":"29 1","pages":"JCO2502107"},"PeriodicalIF":45.3,"publicationDate":"2026-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145955498","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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