Annals of Oncology最新文献

{"title":"What is in a name? A call to retire negative nomenclature in oncology.","authors":"V Subbiah, C Nabhan","doi":"10.1016/j.annonc.2026.09.007","DOIUrl":"10.1016/j.annonc.2026.09.007","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149023764","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":"Navigating uncertainties and evidence gaps in adjuvant therapy for premenopausal women with HR+/HER2- breast cancer.","authors":"L Licata, M Mariani, A Chiavassa, A H Partridge, C Zanibelli, K Jhaveri, K Kalinsky, F Patanè, C Criscitiello, M Lambertini, H S Rugo, M M Naldini, G Notini, G Viale, L Pusztai, G Bianchini","doi":"10.1016/j.annonc.2026.09.005","DOIUrl":"https://doi.org/10.1016/j.annonc.2026.09.005","url":null,"abstract":"<p><p>Premenopausal women with hormone receptor-positive (HR+)/HER2-negative early breast cancer represent a clinically distinct population, characterized by more aggressive tumor biology, unique survivorship concerns, and complex treatment decision-making. Although evidence from dedicated trials and subgroup analyses is available, management remains challenging because data are heterogeneous, evolving, and often extrapolated from broader populations that include predominantly postmenopausal women. Adjuvant endocrine therapy, with the addition of CDK4/6 inhibitors in selected higher-risk patients, remains the cornerstone of treatment; however major uncertainties persist regarding the optimal use of ovarian function suppression, the interpretation of genomic assays to inform chemotherapy decisions, the selection of candidates for extended endocrine therapy, and the management of adherence, treatment-related toxicities, pregnancy-related issues, and survivorship concerns. Here, we synthesize current evidence across these domains and propose a pragmatic clinical framework to support individualized treatment strategies and optimize care for this population in the contemporary therapeutic landscape.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987741","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":"Adjuvant olaparib in germline BRCA carriers: new certainties and remaining open questions from the updated OlympiA results.","authors":"L Arecco, M Lambertini","doi":"10.1016/j.annonc.2026.09.006","DOIUrl":"10.1016/j.annonc.2026.09.006","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987709","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":"Is it time to reassess standard toxicity and patient-reported outcomes methodologies for the adjuvant use of immune checkpoint inhibitors (ICIs)?","authors":"E Nally, J Lyon, M M Regan, B I Rini, M H Voss, M B Atkins, T B Powles, D F McDermott","doi":"10.1016/j.annonc.2026.09.003","DOIUrl":"10.1016/j.annonc.2026.09.003","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975239","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":"Safety and antitumor activity of the first-in-class EGFR-HER3 bispecific antibody-drug conjugate iza-bren (BL-B01D1) in patients with pretreated locally advanced or metastatic breast cancer: a phase Ib study.","authors":"J Zhang, Y Meng, Y Du, T Sun, J Cui, Y Chen, Y Sun, Y Wang, W Chen, F Xu, Y Shi, Y Chen, K Wang, G Jin, H Zhou, Z Zhuang, W Xie, Z Wang, M Sun, Q Wen, X Wang, C Wang, S Xiao, H Zhu, Y Zhu, J Wu","doi":"10.1016/j.annonc.2026.09.002","DOIUrl":"10.1016/j.annonc.2026.09.002","url":null,"abstract":"<p><strong>Background: </strong>Bispecific antibody-drug conjugates (ADCs) may overcome limitations of monospecific ADCs. We report results from a phase Ib study of iza-bren, a first-in-class epidermal growth factor receptor-human epidermal growth factor receptor 3 bispecific ADC, in patients with heavily pretreated locally advanced or metastatic breast cancer (MBC).</p><p><strong>Patients and methods: </strong>This multicenter study enrolled pretreated patients into three groups: human epidermal growth factor receptor 2 (HER2)-positive (n = 41), hormone receptor (HR)-positive/HER2-negative (n = 75), and triple-negative breast cancer (TNBC; n = 46). Patients received iza-bren 2.5 mg/kg i.v. on days 1 and 8 of each 21-day cycle. The primary endpoint was safety.</p><p><strong>Results: </strong>All 162 enrolled patients were heavily pretreated (69.8% had ≥3 prior lines of therapy). Treatment-related adverse events occurred in 99.4% of patients, with grade ≥3 events observed in 77.8%, primarily hematological toxicities (neutropenia 55.6% and anemia 42.0%). Two treatment-related deaths occurred (febrile neutropenia and intracranial hemorrhage). No interstitial lung disease was reported. Confirmed objective response rates were 46.3% [95% confidence interval (CI) 30.7% to 62.6%] in HER2-positive, 37.3% (95% CI 26.4% to 49.3%) in HR-positive/HER2-negative, and 34.8% (95% CI 21.4% to 50.2%) in TNBC groups, with median progression-free survival of 5.8, 7.0, and 5.8 months, respectively.</p><p><strong>Conclusions: </strong>Iza-bren exhibited a generally tolerable safety profile and demonstrated clinically meaningful antitumor activity across three major subtypes of heavily pretreated MBC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944141","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":"TIGIT at a crossroads: lessons from SKYSCRAPER-03 in unresectable stage III NSCLC.","authors":"Y Zenke","doi":"10.1016/j.annonc.2026.09.004","DOIUrl":"10.1016/j.annonc.2026.09.004","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148928796","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":"Overall survival with abemaciclib in early breast cancer.","authors":"F Poggio, D Generali","doi":"10.1016/j.annonc.2026.08.008","DOIUrl":"10.1016/j.annonc.2026.08.008","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148872716","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":"Adjuvant pembrolizumab for the treatment of clear cell renal cell carcinoma: five-year results from the phase III KEYNOTE-564 study.","authors":"N B Haas, T B Powles, P Tomczak, S H Park, B Venugopal, S N Symeonides, T Ferguson, Y-H Chang, J-L Lee, P Sawrycki, N Sarwar, H Gurney, M Gross-Goupil, J M Burke, G Doshi, J Cornell, J E Burgents, R F Perini, T K Choueiri","doi":"10.1016/j.annonc.2026.08.006","DOIUrl":"10.1016/j.annonc.2026.08.006","url":null,"abstract":"<p><strong>Background: </strong>The randomized phase III study KEYNOTE-564 (NCT03142334) established pembrolizumab after surgery as the standard of care for patients with clear cell renal cell carcinoma (ccRCC) at increased risk of recurrence. Prior analyses showed significantly improved disease-free survival (DFS) and overall survival (OS) with adjuvant pembrolizumab versus placebo. We present results from the fourth prespecified interim analysis, with a minimum follow-up of 5 years.</p><p><strong>Patients and methods: </strong>Eligible adults with ccRCC at increased risk of recurrence were randomly assigned 1 : 1 to receive adjuvant pembrolizumab 200 mg or placebo every 3 weeks following nephrectomy or following nephrectomy and metastasectomy. Study treatment continued for ≤17 cycles (∼1 year), until recurrence, or until treatment discontinuation criteria were met. The primary endpoint was DFS per investigator assessment, and the key secondary endpoint was OS. Safety was a secondary endpoint.</p><p><strong>Results: </strong>Overall, 994 participants were randomly assigned to pembrolizumab (n = 496) or placebo (n = 498). Median time from randomization to data cut-off (25 September 2024) was 70 months (range, 60-87). Pembrolizumab improved DFS versus placebo [hazard ratio (HR) 0.71, 95% confidence interval (CI) 0.59-0.86]; median DFS was not reached (NR) versus 68 months, and estimated 5-year DFS rates were 60.9% versus 52.2%, respectively. OS was improved with pembrolizumab over placebo (HR 0.66, 95% CI 0.48-0.90); median OS was NR for both arms with an estimated 5-year OS rate of 87.7% and 82.3%, respectively. DFS and OS benefits were consistent across key subgroups. Safety was largely unchanged since last analysis.</p><p><strong>Conclusions: </strong>After a median follow-up of 70 months, adjuvant pembrolizumab demonstrated sustained DFS and OS benefit and a safety profile consistent with prior analyses. These findings continue to support the use of adjuvant pembrolizumab in ccRCC at increased risk of recurrence.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-08-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148824293","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":"Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2-associated high-risk HER2-negative early breast cancer: updated results from the OlympiA phase III trial.","authors":"J E Garber, D Cameron, C Campbell, G Yothers, M Taboada, S El-Abed, P Rastogi, R McConnell, A Correa, S Delaloge, W T Liu, P Sharma, J Bergh, W Janni, J Balmaña, N Loman, T Španić, S Friedman, T Freeman, A Armstrong, L Korde, S Im, Y Sagara, G Viale, J Bliss, L Gianni, Ó Jóhannsson, G Zoppoli, E Martinez De Dueñas, F Marmé, L Fein, M Arnedos, J Ford, R Schmutzler, S Loibl, B Linderholm, S R Lakhani, M Gnant, K Gelmon, S M Domchek, E Senkus, A Eisen, A Jager, M Piccart, K A Phillips, T Traina, E Stickeler, C F Singer, Z Shao, X Liu, H Tipping, G Aktan, M Martinez, J L Canon, M Takahashi, H Yasojima, K Middleton, G Pristauz-Telsnigg, G Pfeiler, S Virani, F Valdes-Albini, N Wolmark, I Diaz Mesa, V Paterson, R D Gelber, C E Geyer, A N J Tutt","doi":"10.1016/j.annonc.2026.08.002","DOIUrl":"10.1016/j.annonc.2026.08.002","url":null,"abstract":"<p><strong>Background: </strong>The randomised phase III OlympiA trial (NCT02032823) compared 1 year of adjuvant olaparib [oral poly (ADP-ribose) polymerase inhibitor] with placebo in 1836 patients with pathogenic/likely pathogenic BRCA1 or BRCA2 [germline BRCA pathogenic variants (gBRCApvs)] germline variants and high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (BC). Previous interim analyses (IAs) demonstrated statistically significant improvements in invasive disease-free survival (IDFS), distant disease-free survival (DDFS) and overall survival (OS), irrespective of hormone receptor status, prior platinum administration, timing of prior chemotherapy or type of gBRCApv. Herein are the results of the third prespecified IA with a median follow-up (MFU) of 6.1 years.</p><p><strong>Patients and methods: </strong>Descriptive analyses are presented for the primary endpoint IDFS and key secondary endpoints of DDFS and OS. Estimates of the hazard ratio (HR) based on the stratified Cox's proportional hazards model and 95% confidence intervals (CIs) are presented with yearly event rates at an MFU of ≤6.1 years. Safety analyses included adverse events of special interest (AESIs).</p><p><strong>Results: </strong>Olaparib benefits were maintained in IDFS (HR 0.65, 95% CI 0.53-0.78), DDFS (HR 0.65, 95% CI 0.53-0.81) and OS (HR 0.72, 95% CI 0.56-0.93). The 6-year OS for olaparib versus placebo was 87.5% versus 83.2% (difference 4.4%, 95% CI 0.9% to 6.7%). Olaparib benefit was consistent across all key subgroups, including patients with high-risk hormone receptor-positive disease. There were fewer BRCA-associated new BC and ovarian/fallopian tube cancer cases and there was no increase in AESI risks (6.3% versus 9.3%), including myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) (0.4% versus 0.7%), with olaparib versus placebo.</p><p><strong>Conclusions: </strong>At an MFU of 6.1 years, 1 year of adjuvant olaparib after (neo)adjuvant chemotherapy demonstrated ongoing clinically meaningful improvements in IDFS, DDFS and OS in patients with gBRCApvs and high-risk, HER2-negative early BC, with acceptable toxicity and without increased risk of MDS/AML. These data continue to provide support for adjuvant olaparib in the treatment of gBRCApv-associated high-risk, HER2-negative early BC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148811805","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":"Atezolizumab with or without tiragolumab in unresectable esophageal squamous-cell carcinoma following definitive concurrent chemoradiotherapy (SKYSCRAPER-07): a randomised, phase III study.","authors":"R H Xu, B C Cho, M Chen, K Muro, L Wyrwicz, B Li, S Gao, C Hsu, A Turpin, F Lordick, E Cha, Q Wu, S Kim, J Cai, L Zhang, J Fan, L Wang, K Sully, L Wang, K Goodman, M A Shah, I Chau","doi":"10.1016/j.annonc.2026.07.413","DOIUrl":"10.1016/j.annonc.2026.07.413","url":null,"abstract":"<p><strong>Background: </strong>New therapies are needed to improve survival in unresectable esophageal squamous cell carcinoma (ESCC) following definitive chemoradiotherapy (dCRT). We investigated the efficacy and safety of atezolizumab with or without tiragolumab versus placebo in this setting.</p><p><strong>Patients and methods: </strong>SKYSCRAPER-07 (ClinicalTrials.gov: NCT04543617) is a global, randomised, placebo-controlled, phase III trial carried out at 166 centres in 28 countries. Adult patients with stage II-IVA locally advanced and selected stage IVB ESCC who had received dCRT were randomly assigned (1 : 1 : 1) to receive atezolizumab 1200 mg plus tiragolumab 600 mg, atezolizumab 1200 mg plus placebo, or placebo plus placebo (hereafter placebo) intravenously every 3 weeks for 17 cycles. Hierarchically tested primary endpoints are investigator-assessed progression-free survival (INV-PFS) then overall survival (OS) with atezolizumab plus tiragolumab versus placebo, followed by OS with atezolizumab plus placebo versus placebo.</p><p><strong>Results: </strong>Between 28 September 2020 and 31 August 2023, 760 patients were assigned to receive atezolizumab plus tiragolumab (n = 257), atezolizumab plus placebo (n = 250), or placebo (n = 253). Overall, 564 (74.2%) patients were male and 477 (62.8%) were Asian. At a median survival follow-up of 25.0 months, atezolizumab plus tiragolumab versus placebo did not statistically improve INV-PFS [hazard ratio (HR) 0.82, 95% confidence interval (CI) 0.65-1.03, P = 0.0947] or OS (HR 0.91, 95% CI 0.70-1.18, descriptive P = 0.4772). However, OS was significantly improved with atezolizumab plus placebo versus placebo (HR 0.69, 95% CI 0.52-0.91, descriptive P = 0.0085), as was INV-PFS (HR 0.74, 95% CI 0.58-0.93). Treatment-related adverse events occurred in 74.8%, 65.2%, and 55.4% of patients in the atezolizumab plus tiragolumab, atezolizumab plus placebo, and placebo groups, respectively, with treatment-related deaths occurring in 1.2%, 0.8%, and 1.6%, respectively.</p><p><strong>Conclusions: </strong>The SKYSCRAPER-07 study did not meet the primary endpoint. Clinically meaningful improvements in OS and PFS were demonstrated with atezolizumab plus placebo versus placebo following dCRT for patients with unresectable ESCC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":80.4,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787464","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}