Annals of Oncology最新文献

{"title":"Decaffeinated coffee consumption and risk of total and site-specific cancer.","authors":"Y Zhang, C Ma, L Zhao, L A Mucci, E L Giovannucci","doi":"10.1016/j.annonc.2025.03.018","DOIUrl":"10.1016/j.annonc.2025.03.018","url":null,"abstract":"<p><strong>Background: </strong>Coffee is generally considered safe regarding cancer risk. However, concerns have emerged over methylene chloride, a chemical used in decaffeination, due to its carcinogenic properties. The potential cancer risk from methylene chloride residue in decaffeinated coffee remains unclear.</p><p><strong>Patients and methods: </strong>This prospective cohort study included 75 988 women (Nurses' Health Study, 1984-2020) and 45 349 men (Health Professionals Follow-up Study, 1986-2020). Decaffeinated coffee consumption was assessed at baseline and every 4 years using a validated food frequency questionnaire. Cox proportional hazards models were used to estimate hazard ratios (HRs) and 95% confidence intervals (CIs) of total and 14 site-specific cancers associated with decaffeinated coffee consumption, adjusted for regular coffee intake and other potential confounding variables.</p><p><strong>Results: </strong>During up to 36 years of follow-up, we documented 34 120 incident cancer cases (22 688 in women and 11 432 in men). Overall, decaffeinated coffee intake was not associated with higher total cancer risk [per 1 cup/day higher intake, HR 1.00 (95% CI 0.98-1.01)]. For specific cancer type, an inverse association was observed for colorectal [HR 0.96 (95% CI 0.92-0.99)] and aggressive prostate [HR 0.93 (95% CI 0.87-0.99)] cancer. An observed higher lung cancer risk for decaffeinated coffee attenuated to null when restricted to never smokers. However, we observed elevated bladder cancer risk among male never smokers: compared with nondrinkers, 0.1-0.9, 1-1.9, 2-2.9 and ≥3 cups/day of decaffeinated coffee intake were associated with HRs of 1.30 (95% CI 1.01-1.68), 1.42 (95% CI 1.00-2.03), 1.43 (95% CI 0.91-2.23), and 1.79 (95% CI 0.92-3.50), respectively, with borderline significant linear trends (P_trend = 0.06). This positive association remained robust in various sensitivity analyses and became even stronger with an 8-year lag. No association between decaffeinated coffee and bladder cancer was observed among women (P_{sex-heterogeneity} = 0.03).</p><p><strong>Conclusions: </strong>Higher decaffeinated coffee intake was not associated with total cancer risk. However, the observed significant higher risk of bladder cancer in men warrants further studies.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778789","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":"Prospective randomized phase-II trial of ipilimumab/nivolumab versus standard of care in non-clear cell renal cell cancer - results of the SUNNIFORECAST trial.","authors":"L Bergmann, L Albiges, M Ahrens, M Gross-Goupil, E Boleti, G Gravis, A Fléchon, M-O Grimm, J Bedke, P Barthélémy, D Castellano, B Mellado, P Ivanyi, S Rottey, A Flörcken, C Suarez, P Maroto, V Grünwald, S F Oosting, J Kopecky, S Zschäbitz, M Boegemann, T Buchler, G Niegisch, P J Goebell, T Waddell, F Joly, F Priou, M Retz, S Siemer, U Zimmermann, D Deckbar, I Burkholder, A Hartmann, J B Haanen","doi":"10.1016/j.annonc.2025.03.016","DOIUrl":"10.1016/j.annonc.2025.03.016","url":null,"abstract":"<p><strong>Background: </strong>Non-clear cell renal cell cancers (nccRCCs) are a heterogeneous group of more than 20 different entities, but are rarely included in large, randomized trials. Tyrosine kinase inhibitors with or without immune checkpoint inhibition are considered as a standard of care (SOC), but optimal treatment is not yet defined. We designed the first prospective randomized trial comparing ipilimumab/nivolumab to SOC.</p><p><strong>Patients and methods: </strong>We randomized adult patients with previously untreated advanced or metastatic nccRCC 1:1 to nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for 4 doses followed by fixed dose nivolumab of 240 mg every 2 weeks or 480 mg every 4 weeks or to SOC. Patients were stratified by histology and by IMDC risk score. Central pathology review was mandatory. The primary endpoint was the overall survival (OS) rate at 12 months, secondary endpoints included median OS, response rate, progression-free survival (PFS), safety and quality of life.</p><p><strong>Results: </strong>In total, 157 patients were assigned to receive ipilimumab/nivolumab, and 152 to SOC. The 12-month survival rate was 78% with ipilimumab/nivolumab [95% confidence interval (CI) 71-84%] compared to 68% with SOC (95% CI 60-75%, P = 0.026). Median OS was 33.2 months versus 25.2 months, P = 0.163 [HR 0.81 (0.61-1.099)]. PFS was similar in both arms [HR 0.99 (0.77-1.28)]. The ORR was 32.8% versus 19.3%. No major differences between papillary and non-papillary RCC subtypes were observed for any endpoint. Exploratory analysis showed a significant OS advantage [HR 0.56 (95% CI 0.37-0.86)] associated with a PD-L1 CPS score ≥1. Treatment discontinuation due to toxicity occurred in 27 patients (17%) with ipilimumab/nivolumab and 13 patients (9%) with SOC.</p><p><strong>Conclusions: </strong>Ipilimumab/nivolumab demonstrated a significantly longer OS at the 12-month milestone and an acceptable toxicity profile. Our results therefore underline a relevant clinical benefit of ipilimumab/nivolumab in previously untreated nccRCC entities compared to current SOC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778800","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":"Liquid biopsy in gliomas-are we there yet?","authors":"C Baldini, M Porte, E Rouleau, M Touat","doi":"10.1016/j.annonc.2025.03.017","DOIUrl":"10.1016/j.annonc.2025.03.017","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143778790","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":"ESMO Precision Oncology Working Group recommendations on the structure and quality indicators for molecular tumour boards in clinical practice.","authors":"C B Westphalen, L Boscolo Bielo, P Aftimos, H Beltran, M Benary, D Chakravarty, M Collienne, R Dienstmann, A El Helali, J Gainor, P Horak, C Le Tourneau, C Marchiò, C Massard, F Meric-Bernstam, C Pauli, G Pruneri, F Roitberg, H E G Russnes, D B Solit, N Starling, V Subbiah, D Tamborero, N Tarazona, C Turnbull, J van de Haar, F André, J Mateo, G Curigliano","doi":"10.1016/j.annonc.2025.02.009","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.02.009","url":null,"abstract":"<p><strong>Background: </strong>With an increased uptake of genomic profiling in clinical practice and the evolving complexity of diagnostic modalities, vast amounts of complex data need to be properly interpreted and integrated into an individualised care plan. To address these challenges, molecular tumour boards (MTBs) have been widely established. As of today, no international recommendations regulating the composition and workflows of MTBs have been defined.</p><p><strong>Methods: </strong>ESMO's Precision Oncology Working Group (POWG) established an international expert panel in precision oncology and defined core areas of interest. After several consultations and through an expert consensus process, the group reached a consensus level for each recommendation.</p><p><strong>Results: </strong>The group defined five components in the MTB process that are critical to its function and clinical use: (i) the primary task of MTBs consists in providing genomic-informed clinical recommendations, particularly for cases exhibiting complex genomic alterations; (ii) to achieve this, MTBs should encompass interdisciplinary expertise, with key roles for oncologists with genomic expertise, pathologists with molecular training and clinical geneticists; (iii) MTBs' recommendations should be documented in a structured report that includes genomic-informed treatment strategies, management plans for potential tumour-detected germline alterations and guidance for additional genomic testing; (iv) structured follow-up processes should be implemented for monitoring the clinical effectiveness of MTBs recommendations and (v) finally, the panel proposed quality indicators for operating MTBs, including turnaround times for cases discussion and the proportion of cases for which actionable recommendations and clinical trial enrolments were successfully implemented.</p><p><strong>Conclusions: </strong>These ESMO's POWG recommendations can serve as a guidance and help to define quality standards for MTBs to allow for harmonisation and to further expedite the integration of precision oncology into clinical practice.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143802372","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":"Lessons from TROPiCS-04: ‘safety-first’ for success in late-stage clinical trials","authors":"M. Ong,&nbsp;A.-A. Beltran-Bless","doi":"10.1016/j.annonc.2025.02.008","DOIUrl":"10.1016/j.annonc.2025.02.008","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":"36 5","pages":"Pages 481-483"},"PeriodicalIF":56.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762828","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":"Lung cancer detection by electronic nose analysis of exhaled breath: a multicentre prospective external validation study.","authors":"A I G Buma, M B Muntinghe-Wagenaar, V van der Noort, R de Vries, M M F Schuurbiers, P J Sterk, S P M Schipper, J Meurs, S M Cristescu, T J N Hiltermann, M M van den Heuvel","doi":"10.1016/j.annonc.2025.03.013","DOIUrl":"10.1016/j.annonc.2025.03.013","url":null,"abstract":"<p><strong>Background: </strong>Electronic nose (eNose) analysis of exhaled breath shows potential for accurate and timely lung cancer diagnosis, yet prospective external validation studies are lacking. Our study primarily aimed to prospectively and externally validate a published eNose model for lung cancer detection in chronic obstructive pulmonary disease (COPD) patients and assess its diagnostic performance alongside a new eNose model, specifically tailored to the target population, in a more general outpatient population.</p><p><strong>Patients and methods: </strong>This multicentre prospective external validation study included adults with clinical and/or radiological suspicion of lung cancer who were recruited from thoracic oncology outpatient clinics of two sites in the Netherlands. Breath profiles were collected using a cloud-connected eNose (SpiroNose®). The diagnostic performance of the original and new eNose models was assessed in various population subsets based on receiver operating characteristic-area under the curve (ROC-AUC), specificity, positive predictive value (PPV), and negative predictive value (NPV), targeting 95% sensitivity. For the new eNose model, a training cohort and a validation cohort were used.</p><p><strong>Results: </strong>Between March 2019 and November 2023, 364 participants were included. The original eNose model detected lung cancer with an ROC-AUC of 0.92 [95% confidence interval (CI) 0.85-0.99] in COPD patients (n = 98/116; 84%) and 0.80 (95% CI 0.75-0.85) in all participants (n = 216/364; 59%). At 95% sensitivity, the specificity, PPV, and NPV, were 72% and 51%, 95% and 74%, and 72% and 88%, respectively. In the validation cohort, the new eNose model identified lung cancer across all participants (n = 72/121; 60%) with an ROC-AUC of 0.83 (95% CI 0.75-0.91), sensitivity of 94%, specificity of 63%, PPV of 79%, and NPV of 89%. Notably, accurate detection was consistent across tumour characteristics, disease stage, diagnostic centres, and clinical characteristics.</p><p><strong>Conclusion: </strong>This multicentre prospective external validation study confirms that eNose analysis of exhaled breath enables accurate lung cancer detection at thoracic oncology outpatient clinics, irrespective of tumour characteristics, disease stage, diagnostic centre, and clinical characteristics.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143770922","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":"Response letter re: Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase II trial.","authors":"J J Li, L Chen, Z M Shao","doi":"10.1016/j.annonc.2025.03.015","DOIUrl":"10.1016/j.annonc.2025.03.015","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762834","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":"Letter re: Efficacy and safety of neoadjuvant SHR-A1811 with or without pyrotinib in women with locally advanced or early HER2-positive breast cancer: a randomized, open-label, phase II trial.","authors":"X Zeng, H Sun, Y Wang","doi":"10.1016/j.annonc.2025.03.014","DOIUrl":"10.1016/j.annonc.2025.03.014","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143762830","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":"Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial.","authors":"E Felip, C I Rojas, M Schenker, D M Kowalski, I A Casarini, T Csöszi, M A N Şendur, J Martins, A Calles Blanco, C-C Wang, M Wang, R A L Ramirez Fallas, H Yoshioka, S Nair, X Song, X Deng, M Lala, R Eiras, T Takahashi","doi":"10.1016/j.annonc.2025.03.012","DOIUrl":"10.1016/j.annonc.2025.03.012","url":null,"abstract":"<p><strong>Background: </strong>Pembrolizumab with berahyaluronidase alfa is for subcutaneous (s.c.) administration. The phase III open-label 3475A-D77 study (NCT05722015) assessed s.c. pembrolizumab versus intravenous (i.v.) pembrolizumab, plus chemotherapy, for treatment of metastatic non-small-cell lung cancer (mNSCLC).</p><p><strong>Patients and methods: </strong>Participants with newly diagnosed stage IV squamous or nonsquamous NSCLC without sensitizing EGFR, ALK, or ROS1 alterations were randomized 2 : 1 to pembrolizumab s.c. 790 mg every 6 weeks (q6w) or pembrolizumab i.v. 400 mg q6w (18 cycles), each given with platinum-doublet chemotherapy. Dual primary endpoints were pharmacokinetic exposure measures of cycle 1 area under the curve (AUC_{0-6 weeks}) and steady-state trough concentration (C_trough) of pembrolizumab. The noninferiority margin for AUC_{0-6 weeks} and C_trough geometric mean ratios (GMRs) of pembrolizumab s.c. versus i.v. was specified as 0.8. Secondary endpoints included additional pharmacokinetic exposure measures, pembrolizumab immunogenicity, efficacy, and safety.</p><p><strong>Results: </strong>In total 377 participants were randomized to the pembrolizumab s.c. (n = 251) or i.v. (n = 126) arms. The median time from randomization to data cut-off (12 July 2024) was 9.6 months (range 6.2-16.4 months). The median injection time for pembrolizumab s.c. was 2.0 min (range 1-12 min). The GMR [96% confidence interval (CI)] for cycle 1 AUC_{0-6 weeks} was 1.14 (1.06-1.22); P < 0.0001. The GMR (94% CI) for steady-state C_trough was 1.67 (1.52-1.84); P < 0.0001. Secondary pharmacokinetic endpoints were within established bounds for pembrolizumab. Anti-pembrolizumab antibodies were detected in 1.4% (pembrolizumab s.c. arm) and 0.9% (pembrolizumab i.v. arm) of participants. For the pembrolizumab s.c. versus i.v. arms, objective response rates (ORRs) were 45.4% versus 42.1% (ORR ratio 1.08, 95% CI 0.85-1.37). Other efficacy measures were similar and safety profiles were consistent between treatment arms.</p><p><strong>Conclusions: </strong>Overall exposure and trough concentrations of pembrolizumab s.c. 790 mg q6w were noninferior to those of pembrolizumab i.v. 400 mg q6w given with chemotherapy in participants with treatment-naive mNSCLC. Results support pembrolizumab s.c. as a treatment option in all indications where pembrolizumab i.v. can be used.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143741885","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":"Final survival results from the PENELOPE-B trial investigating palbociclib versus placebo for patients with high-risk HR+/HER2- breast cancer and residual disease after neoadjuvant chemotherapy-PENELOPE-B.","authors":"S Loibl, M Martin, H Bonnefoi, M Untch, S-B Kim, H D Bear, J A García-Sáenz, M Melé Olivé, N Mc Carthy, K Gelmon, C M Kelly, S-A Im, T Reimer, M Martinez-Janez, Z Zhang, M Toi, L Provencher, H S Rugo, M Gnant, A Makris, A Antón Torres, N Hirmas, J Holtschmidt, V Nekljudova, F Marmé","doi":"10.1016/j.annonc.2025.03.010","DOIUrl":"10.1016/j.annonc.2025.03.010","url":null,"abstract":"<p><strong>Background: </strong>The addition of 1 year of palbociclib to endocrine therapy (ET) did not improve invasive disease-free survival (iDFS) compared with placebo in the PENELOPE-B trial. In this article we report the final survival results of the PENELOPE-B trial.</p><p><strong>Patients and methods: </strong>The PENELOPE-B trial investigated whether adding 1 year of palbociclib to ET in hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) breast cancer (BC) patients with residual disease and high relapse risk (clinical and pathological stage + estrogen receptor status and histological grade score ≥3 or 2 and ypN+) after taxane-based neoadjuvant chemotherapy would improve patient survival. Patients (n = 1250) were randomly assigned to receive either palbociclib 125 mg or placebo d1-21 q4w for 13 cycles in addition to ET.</p><p><strong>Results: </strong>After a median follow-up of 77.8 months, we recorded 225 deaths (108 palbociclib; 117 placebo) with a 6-year overall survival (OS) rate of 82.4% in the palbociclib arm versus 80.3% in the placebo arm (hazard ratio 0.87, 95% confidence interval (CI) 0.67-1.14, P = 0.31). No significant improvement was noted for palbociclib versus placebo for iDFS, distant disease-free survival or locoregional relapse rate, even with longer follow-up. Upon stratified analysis, we found no benefits across major subgroups. However, exploratory post hoc analyses of the lobular BC (LBC) subgroup indicated a trend toward better survival outcomes in favor of palbociclib (hazard ratio 0.45, 95% CI 0.19-1.07, P = 0.062 for OS and hazard ratio 0.52, 95% CI 0.28-0.97, P = 0.035 for iDFS).</p><p><strong>Conclusion: </strong>The study concluded that palbociclib did not significantly improve survival outcomes in the overall population. Exploratory post hoc analyses suggested a trend toward better iDFS outcome in patients with LBC receiving palbociclib.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":56.7,"publicationDate":"2025-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143727488","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}