Annals of OncologyPub Date : 2025-09-29DOI: 10.1016/j.annonc.2025.09.012
Miguel Zugman, Jennifer R Rider, Diwyanshu Sahu, Robert S Miller, Sumanta K Pal
{"title":"SUNNIFORECAST Trial Design Supported by Real-World Data in Papillary Renal Cell Carcinoma.","authors":"Miguel Zugman, Jennifer R Rider, Diwyanshu Sahu, Robert S Miller, Sumanta K Pal","doi":"10.1016/j.annonc.2025.09.012","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.012","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145205393","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}
Annals of OncologyPub Date : 2025-09-27DOI: 10.1016/j.annonc.2025.09.011
M-O Grimm, K Leucht, A Stenzl
{"title":"Reply to the Letter to the Editor Larcher et al. The opera trial: the active role of the patient in the clinical decision-making process and surgical planning (ANNONC-D-25-00583R1).","authors":"M-O Grimm, K Leucht, A Stenzl","doi":"10.1016/j.annonc.2025.09.011","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.011","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145190778","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}
Annals of OncologyPub Date : 2025-09-26DOI: 10.1016/j.annonc.2025.09.009
J-Y Blay, A Cervantes, F André, S Peters, N Harbeck, E Azambuja, G Curigliano
{"title":"An Unforeseen, Existential Threat to Oncological Research in Europe.","authors":"J-Y Blay, A Cervantes, F André, S Peters, N Harbeck, E Azambuja, G Curigliano","doi":"10.1016/j.annonc.2025.09.009","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.009","url":null,"abstract":"","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184595","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}
Annals of OncologyPub Date : 2025-09-26DOI: 10.1016/j.annonc.2025.09.008
E S M van Aken, B Devnani, A Prelaj, L Castelo-Branco, C A M Marijnen, D Martins-Branco, M A Gambacorta, A Lamarca, K Harrington, G Minniti, M Hecht, D Papamichael, M Krause, R Cathomas, K Lindberg, S M O'Cathail, U Nestle, J Barriuso, S Nowicki, C Rödel, P Boot, C Belka, U Ricardi, F Lordick, D De Ruysscher, G Pentheroudakis, M C de Jong, A K Gandhi
{"title":"ESMO-ESTRO consensus statements on the safety of combining radiotherapy with immune checkpoint inhibitors, VEGF(R) inhibitors, or multitargeted tyrosine kinase inhibitors.","authors":"E S M van Aken, B Devnani, A Prelaj, L Castelo-Branco, C A M Marijnen, D Martins-Branco, M A Gambacorta, A Lamarca, K Harrington, G Minniti, M Hecht, D Papamichael, M Krause, R Cathomas, K Lindberg, S M O'Cathail, U Nestle, J Barriuso, S Nowicki, C Rödel, P Boot, C Belka, U Ricardi, F Lordick, D De Ruysscher, G Pentheroudakis, M C de Jong, A K Gandhi","doi":"10.1016/j.annonc.2025.09.008","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.008","url":null,"abstract":"<p><strong>Background: </strong>The combination of radiotherapy (RT) with targeted agents or immunotherapy may result in improved outcomes, but it can also increase toxicity. However, there is a paucity of high-quality toxicity data, leading to an absence of evidence-based guidelines.</p><p><strong>Design: </strong>To address this, ESMO and ESTRO initiated a series of systematic reviews followed by a Delphi consensus process to develop multidisciplinary, evidence-based consensus statements regarding the safety of combining RT with such agents. The current publication describes the combination of RT with immune checkpoint inhibitors (ICIs), vascular endothelial growth factor (receptor) (VEGF(R)) inhibitors, or multitargeted tyrosine kinase inhibitors (TKIs). By systematically covering different drug classes and irradiated areas, 76 clinical scenarios were evaluated during two Delphi rounds with 20 international experts. Safety statements were developed for each scenario, based on the systematic literature reviews.</p><p><strong>Results: </strong>A total of 5,921 records were screened during the systematic literature review process for ICIs, VEGF(R) inhibitors and multitargeted TKIs, and 159 reports were selected for inclusion in the final literature reviews and the database. During the two Delphi rounds, agreement was reached regarding the safety statements for 74 clinical scenarios.</p><p><strong>Conclusions: </strong>Generally, the expected toxicity of combining RT with ICIs is low, particularly for PD-(L)1 inhibitors. For most combinations with VEGF(R) inhibitors and multitargeted TKIs, exercising caution is recommended. The evidence-based safety statements developed during this comprehensive project, provide practical guidance on combining RT with targeted cancer therapies and immunotherapy.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145184605","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}
Annals of OncologyPub Date : 2025-09-23DOI: 10.1016/j.annonc.2025.09.006
R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios, M Richardet, H Gurney, E R Kessler, Y Tomita, J Bedke, C Scheffold, M Askelson, J Panzica, J Zhang, M van Kooten Losio, T K Choueiri
{"title":"Final analysis of nivolumab plus cabozantinib for advanced renal cell carcinoma from the randomized phase III CheckMate 9ER trial.","authors":"R J Motzer, B Escudier, M Burotto, T Powles, A B Apolo, M T Bourlon, A Y Shah, C Porta, C Suárez, C H Barrios, M Richardet, H Gurney, E R Kessler, Y Tomita, J Bedke, C Scheffold, M Askelson, J Panzica, J Zhang, M van Kooten Losio, T K Choueiri","doi":"10.1016/j.annonc.2025.09.006","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.006","url":null,"abstract":"<p><strong>Background: </strong>Nivolumab plus cabozantinib (NIVO+CABO) showed significant benefits over sunitinib (SUN) in progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) for previously untreated advanced renal cell carcinoma (RCC) in the phase III CheckMate 9ER trial. We report final, updated efficacy and safety results with median follow-up of 5.6 years.</p><p><strong>Patients and methods: </strong>Patients with advanced RCC were randomized to first-line NIVO 240 mg IV every 2 weeks plus CABO 40 mg PO QD or SUN 50 mg PO QD (4 weeks each 6-week cycle) until disease progression or unacceptable toxicity (maximum 2 years of NIVO). The primary endpoint was PFS per RECIST v1.1 by blinded independent central review (BICR). Secondary endpoints included OS, ORR per RECIST v1.1 by BICR, and safety.</p><p><strong>Results: </strong>Median (range) follow-up was 5.6 years (67.6 [60.2-80.2] months). In intent-to-treat patients (NIVO+CABO, n=323; SUN, n=328), PFS favored NIVO+CABO versus SUN (hazard ratio [HR], 0.58 [95% CI, 0.49-0.70]). Median PFS was 16.4 versus 8.3 months, respectively; 60-month PFS rates were 13.6% versus 3.6%. OS favored NIVO+CABO versus SUN (HR, 0.79 [95% CI, 0.65-0.96]). Median OS was 46.5 versus 35.5 months, respectively; 60-month OS rates were 40.9% versus 35.4%. ORR was greater with NIVO+CABO versus SUN (55.7% versus 27.4%; complete response, 13.9% versus 4.6%). The probability of remaining in response through 60 months with NIVO+CABO versus SUN was 22.0% versus 10.0%. In all treated patients (n=320 each arm), any-grade (grade 3-4) treatment-related adverse events occurred in 97.5% (67.8%) versus 93.1% (55.0%) with NIVO+CABO versus SUN, respectively. No new deaths due to study drug toxicity occurred since the 32.9-month median follow-up.</p><p><strong>Conclusions: </strong>Long-term efficacy benefit was observed with NIVO+CABO over SUN in this final follow-up from CheckMate 9ER and safety was consistent with previous reports. These results reaffirm NIVO+CABO as a standard of care for previously untreated advanced RCC.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145147237","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}
Annals of OncologyPub Date : 2025-09-17DOI: 10.1016/j.annonc.2025.09.004
C Lepage, J-M Phelip, L Cany, E Barbier, S Manfredi, P Deguiral, M Laly, M Baconnier, M Jary, J-P Latrive, E Terrebonne, A Lièvre, M Jafari, M Ben Abdelghani, J-F Ain, G Breysacher, I Boillot-Benedetto, A Pelaquier, P Prost, J Ezenfis, Y Rinaldi, C Le Foll, O Berthelet, A Darut-Jouve, L Dahan, T Piche, J-P Lagasse, F Bibeau, P Laurent-Puig, O Bouché
{"title":"Effect of 5 years of CT-scan and CEA follow-up on survival endpoints in patients with colorectal cancer.","authors":"C Lepage, J-M Phelip, L Cany, E Barbier, S Manfredi, P Deguiral, M Laly, M Baconnier, M Jary, J-P Latrive, E Terrebonne, A Lièvre, M Jafari, M Ben Abdelghani, J-F Ain, G Breysacher, I Boillot-Benedetto, A Pelaquier, P Prost, J Ezenfis, Y Rinaldi, C Le Foll, O Berthelet, A Darut-Jouve, L Dahan, T Piche, J-P Lagasse, F Bibeau, P Laurent-Puig, O Bouché","doi":"10.1016/j.annonc.2025.09.004","DOIUrl":"https://doi.org/10.1016/j.annonc.2025.09.004","url":null,"abstract":"<p><strong>Background: </strong>Intensive follow-up of patients after curative surgery for colorectal cancer is recommended by various scientific societies. However, these recommendations are based mainly on expert opinions, while the results of the few clinical trials are controversial. Moreover, no survival benefit has been demonstrated to date.</p><p><strong>Patients and methods: </strong>PRODIGE-13 is a cooperative prospective multicentre controlled phase III trial evaluating by factorial plan the impact of i) intensive radiological monitoring (alternating abdominal ultrasound (US)/CT-scan/3m) versus standard monitoring (US/3m and thoracic radiography/6m) and ii) Carcinoembryonic Antigen (CEA) assessment versus no assessment, in the follow-up of resected stage II or III colorectal cancer with no evidence of residual disease on baseline post-surgical investigation in France and Belgium. The primary endpoint was 5-year overall survival (OS).</p><p><strong>Results: </strong>Altogether, 2009 patients were randomized. Among them, 16% had rectal cancer, and 44% left colon cancer; 75.9% were less than 75 years old. With a median follow-up of 7.8 years, cancer recurred in 22.3% of patients (local 10.5%, metastatic 72.9%, both 16.6%). The 5-year OS rates were 82.1% (95%CI [78.5;85.2]) in group A (intensive imaging + CEA) vs. 84.1% (95%CI [80.5;87.0]) in group B (intensive imaging alone), vs. 83.6%, (95%CI [80.1;86.6]) in group C (standard imaging+ CEA) vs. 79.5% (95%CI [75.7;82.8]) in group D (standard imaging alone) (p(logrank)= 0.170. Median OS was not reached in the four groups, Five-year relapse-free survival (RFS) was 73.8% in the CT-scan surveillance group vs. 69.3% in the no-CT-scan group (HR 0.89 [0.76;1.03]; p=0.108). Five-year RFS was 71.3% in the CEA surveillance group vs. 71.8% in the no-CEA group (HR 1.00 [0.86;1.16]; 0.959).</p><p><strong>Conclusions: </strong>Among patients with stage II or III colorectal cancer, after curative surgery, the implementation of CEA and/or CT-scan surveillance did not provide any benefit in 5-year overall survival for the overall population of the study.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091025","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}
Annals of OncologyPub Date : 2025-09-17DOI: 10.1016/j.annonc.2025.08.002
N Chen, J Q Freeman, S Yarlagadda, A Atmakuri, K Kalinsky, L Pusztai, J A Sparano, D Huo, R Nanda, F M Howard
{"title":"Impact of anthracyclines in genomic high-risk, node-negative, HR-positive/HER2-negative breast cancer.","authors":"N Chen, J Q Freeman, S Yarlagadda, A Atmakuri, K Kalinsky, L Pusztai, J A Sparano, D Huo, R Nanda, F M Howard","doi":"10.1016/j.annonc.2025.08.002","DOIUrl":"10.1016/j.annonc.2025.08.002","url":null,"abstract":"<p><strong>Background: </strong>The benefit of anthracyclines for patients with high 21-gene recurrence score (RS) is unclear, despite the widespread use of RS to guide adjuvant chemotherapy treatment for hormone receptor (HR)-positive /human epidermal growth factor receptor 2 (HER2)-negative breast cancer. This study aimed to assess whether patients with RS ≥ 31 would have improved outcomes with the addition of anthracyclines to taxane-based chemotherapy.</p><p><strong>Patients and methods: </strong>We included patients from TAILORx with RS ≥ 11 who received treatment with either taxanes with cyclophosphamide (TC) or taxane with anthracyclines/cyclophosphamide (T-AC). Distant recurrence-free interval (DRFI), distant recurrence-free survival (DRFS), and overall survival (OS) were compared, controlling for age, tumor size and grade, receptor status, and RS. Spline regression was used to estimate adjusted hazard ratio (aHR) for receipt of T-AC (versus TC) for these endpoints as a function of RS.</p><p><strong>Results: </strong>A total of 2549 patients who received either T-AC or TC were included in the primary analysis. In patients with RS ≥ 31, receipt of T-AC was associated with improved DRFI (5-year rate of 96.1% with T-AC versus 91.0% with TC, aHR 0.31, P = 0.006), DRFS (95.4% versus 89.8%, aHR 0.49, P = 0.032), and a trend toward improved OS (adjusted 5-year rate 97.3% versus 93.6%, aHR 0.67, P = 0.31). Spline regression demonstrated increasing anthracycline benefit with increasing RS.</p><p><strong>Conclusion: </strong>Patients with early-stage, HR-positive/HER2-negative breast cancer with the highest genomic risk disease (RS ≥ 31) may benefit from the addition of an anthracycline to taxane-based adjuvant chemotherapy. Genomic RS testing may predict anthracycline benefit more accurately than clinicopathological factors such as nodal status.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091040","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}
Annals of OncologyPub Date : 2025-09-12DOI: 10.1016/j.annonc.2025.09.003
S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk
{"title":"Randomized phase III trial of adjuvant radiation versus chemoradiation in intermediate-risk, early-stage cervical cancer following radical hysterectomy and lymphadenectomy: results from NRG Oncology/GOG-263/KGOG 1008.","authors":"S Y Ryu, W Deng, K Albuquerque, W-J Koh, J Mayadev, A Heugel, B-J Kim, D-Y Kim, C-H Cho, J-W Kim, J H No, R S Mannel, K Miller, D Fabian, D M Chase, K M Gil, W Small, W Rodgers, C A Leath, B J Monk","doi":"10.1016/j.annonc.2025.09.003","DOIUrl":"10.1016/j.annonc.2025.09.003","url":null,"abstract":"<p><strong>Background: </strong>To determine whether adjuvant chemoradiation (CRT) with weekly cisplatin improves recurrence-free survival (RFS) compared with radiation (RT) in pathologically proven intermediate risk early-stage cervical cancer following radical hysterectomy and lymphadenectomy.</p><p><strong>Methods: </strong>Post-surgical patients with stage I-IIA cervical cancer with pathologically noted intermediate risk factors including combinations of capillary lymphatic space involvement, stromal invasion, and tumor size were randomly assigned in a 1 : 1 ratio to receive either adjuvant CRT or RT (NCT01101451). Patients received conformal RT, or intensity modulated radiation therapy. In the CRT arm, 6 weekly cycles of cisplatin 40 mg/m<sup>2</sup> were administered during RT. RFS was the primary endpoint in randomized and eligible patients. Secondary endpoints included overall survival (OS), quality of life (QoL), and adverse events (AEs).</p><p><strong>Results: </strong>Of the 340 randomized patients, 316 were eligible and most had Federation of Gynecology and Obstetrics (2009) stage IB<sub>1</sub> and squamous cell carcinoma histology. Out of 316 patients, 292 (92.4%) received 28 fractions of RT with a median dose of 50.4 Gy and a median treatment duration of 39 days. Three-year RFS was 88.5% in the CRT arm and 85.4% in the RT arm. Both RFS [hazard ratio (HR) 0.698, 95% confidence interval (CI) 0.408-1.192, P = 0.09], as well as OS [HR 0.586, 95% CI 0.286-1.199, P = 0.07] favored CRT compared with RT alone. Grade 3 or 4 AEs occurred in 43% and 15% in the CRT and RT arms, respectively (P < 0.01). A transient decline in QoL occurred in the CRT arm compared with RT after starting treatments and recovered to pre-treatment level by 36 weeks.</p><p><strong>Conclusion: </strong>Although RFS and OS favored CRT, the addition of cisplatin during RT did not statistically improve RFS or OS in cervical cancer patients with intermediate pathological risk factors following radical hysterectomy and lymphadenectomy. CRT increased grade 3 and 4 AEs with a transient decline in QoL.</p>","PeriodicalId":8000,"journal":{"name":"Annals of Oncology","volume":" ","pages":""},"PeriodicalIF":65.4,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145063360","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}