Pub Date : 2025-02-06DOI: 10.1016/s1470-2045(25)00069-5
Barbara Casassus
No Abstract
{"title":"Law to extend free medical treatment for breast cancer in France","authors":"Barbara Casassus","doi":"10.1016/s1470-2045(25)00069-5","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00069-5","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"9 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143258401","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-06DOI: 10.1016/s1470-2045(25)00068-3
Elizabeth Gourd
No Abstract
{"title":"More than three in five kidney cancer diagnoses in the UK are incidental","authors":"Elizabeth Gourd","doi":"10.1016/s1470-2045(25)00068-3","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00068-3","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143258584","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-05DOI: 10.1016/s1470-2045(24)00731-9
Ryan S Huang, Ronald Chow, Ali Benour, David Chen, Gabriel Boldt, Christopher J D Wallis, Anand Swaminath, Charles B Simone, Michael Lock, Srinivas Raman
<h3>Background</h3>Non-invasive and minimally invasive ablative treatments, including stereotactic body radiotherapy (SBRT), radiofrequency ablation, microwave ablation, and cryoablation, have emerged as key treatment options for managing renal cell carcinoma, especially for patients who are unsuitable for surgery. We aimed to compare the clinical efficacy and safety of these emerging treatment methods in patients with localised renal cell carcinoma.<h3>Methods</h3>In this systematic review and meta-analysis, we searched PubMed (MEDLINE), Embase, and the Cochrane Library for publications between Jan 1, 2000, and March 1, 2024. Eligible articles were observational studies and randomised controlled trials including at least five adult patients (age ≥18 years) with primary and localised renal cell carcinoma treated with SBRT, radiofrequency ablation, microwave ablation, or cryoablation and that reported on local control outcomes. Two reviewers independently screened titles and abstracts and then full texts of eligible studies were independently evaluated by the same reviewers, with disagreements resolved via discussion or consultation with a third reviewer. Summary estimates were extracted from published reports manually using a standardised data extraction form. The primary endpoint was local control rate at 1 year, 2 years, and 5 years after start of treatment. A meta-analysis was conducted using a DerSimonian and Laird model to summarise local control rates. Publication bias was evaluated using funnel plots and Egger's test. We also recorded the frequency and severity of adverse events after treatment on the basis of the Common Terminology Criteria for Adverse Events (version 5.0) and Clavien-Dindo complication index. The study protocol was prospectively registered with PROSPERO, CRD42024511840.<h3>Findings</h3>We identified 6668 records, of which 330 were assessed via full-text review, and 133 were included in our systematic review and meta-analysis. The eligible studies included data for 8910 patients (mean age 67·9 years [SD 7·3], 2518 [31·4%] of 8018 patients with available data were female and 5500 [68·6%] were male). Local control rates for SBRT were 99% (95% CI 97–100; <em>I</em><sup>2</sup>=6%) at 1 year, 97% (95–99; <em>I</em><sup>2</sup>=0%) at 2 years, and 95% (89–98; <em>I</em><sup>2</sup>=42%) at 5 years; for radiofrequency ablation were 96% (94–98; <em>I</em><sup>2</sup>=73%) at 1 year, 95% (92–98; <em>I</em><sup>2</sup>=77%) at 2 years, and 92% (88–96; <em>I</em><sup>2</sup>=78%) at 5 years; for microwave ablation were 97% (95–99; <em>I</em><sup>2</sup>=74%) at 1 year, 95% (92–98; <em>I</em><sup>2</sup>=77%) at 2 years, and 86% (75–94; <em>I</em><sup>2</sup>=66%) at 5 years; and for cryoablation were 95% (93–96; <em>I</em><sup>2</sup>=61%) at 1 year, 94% (91–96; <em>I</em><sup>2</sup>=69%) at 2 years, and 90% (87–93; <em>I</em><sup>2</sup>=74%) at 5 years. The proportion of patients who reported grade 3–4 adverse events was 3% (121
{"title":"Comparative efficacy and safety of ablative therapies in the management of primary localised renal cell carcinoma: a systematic review and meta-analysis","authors":"Ryan S Huang, Ronald Chow, Ali Benour, David Chen, Gabriel Boldt, Christopher J D Wallis, Anand Swaminath, Charles B Simone, Michael Lock, Srinivas Raman","doi":"10.1016/s1470-2045(24)00731-9","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00731-9","url":null,"abstract":"<h3>Background</h3>Non-invasive and minimally invasive ablative treatments, including stereotactic body radiotherapy (SBRT), radiofrequency ablation, microwave ablation, and cryoablation, have emerged as key treatment options for managing renal cell carcinoma, especially for patients who are unsuitable for surgery. We aimed to compare the clinical efficacy and safety of these emerging treatment methods in patients with localised renal cell carcinoma.<h3>Methods</h3>In this systematic review and meta-analysis, we searched PubMed (MEDLINE), Embase, and the Cochrane Library for publications between Jan 1, 2000, and March 1, 2024. Eligible articles were observational studies and randomised controlled trials including at least five adult patients (age ≥18 years) with primary and localised renal cell carcinoma treated with SBRT, radiofrequency ablation, microwave ablation, or cryoablation and that reported on local control outcomes. Two reviewers independently screened titles and abstracts and then full texts of eligible studies were independently evaluated by the same reviewers, with disagreements resolved via discussion or consultation with a third reviewer. Summary estimates were extracted from published reports manually using a standardised data extraction form. The primary endpoint was local control rate at 1 year, 2 years, and 5 years after start of treatment. A meta-analysis was conducted using a DerSimonian and Laird model to summarise local control rates. Publication bias was evaluated using funnel plots and Egger's test. We also recorded the frequency and severity of adverse events after treatment on the basis of the Common Terminology Criteria for Adverse Events (version 5.0) and Clavien-Dindo complication index. The study protocol was prospectively registered with PROSPERO, CRD42024511840.<h3>Findings</h3>We identified 6668 records, of which 330 were assessed via full-text review, and 133 were included in our systematic review and meta-analysis. The eligible studies included data for 8910 patients (mean age 67·9 years [SD 7·3], 2518 [31·4%] of 8018 patients with available data were female and 5500 [68·6%] were male). Local control rates for SBRT were 99% (95% CI 97–100; <em>I</em><sup>2</sup>=6%) at 1 year, 97% (95–99; <em>I</em><sup>2</sup>=0%) at 2 years, and 95% (89–98; <em>I</em><sup>2</sup>=42%) at 5 years; for radiofrequency ablation were 96% (94–98; <em>I</em><sup>2</sup>=73%) at 1 year, 95% (92–98; <em>I</em><sup>2</sup>=77%) at 2 years, and 92% (88–96; <em>I</em><sup>2</sup>=78%) at 5 years; for microwave ablation were 97% (95–99; <em>I</em><sup>2</sup>=74%) at 1 year, 95% (92–98; <em>I</em><sup>2</sup>=77%) at 2 years, and 86% (75–94; <em>I</em><sup>2</sup>=66%) at 5 years; and for cryoablation were 95% (93–96; <em>I</em><sup>2</sup>=61%) at 1 year, 94% (91–96; <em>I</em><sup>2</sup>=69%) at 2 years, and 90% (87–93; <em>I</em><sup>2</sup>=74%) at 5 years. The proportion of patients who reported grade 3–4 adverse events was 3% (121","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"7 2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143192493","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(24)00681-8
Fabio Y Moraes, Michael Yan, Ada Muellner, Hedvig Hricak
No Abstract
{"title":"Transforming oncology care in Latin America: artificial intelligence-driven solutions to bridge workforce gaps","authors":"Fabio Y Moraes, Michael Yan, Ada Muellner, Hedvig Hricak","doi":"10.1016/s1470-2045(24)00681-8","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00681-8","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"25 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083257","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(24)00451-0
Bishal Gyawali, Elizabeth A Eisenhauer, Winette van der Graaf, Christopher M Booth, Nathan I Cherny, Aaron M Goodman, Rachel Koven, Madeline L Pe, Bernard L Marini, Ghulam Rehman Mohyuddin, Gregory R Pond, Manju Sengar, Enrique Soto-Perez-de-Celis, Dario Trapani, Michelle Tregear, Brooke E Wilson, Ian F Tannock
Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of randomised, controlled, phase 3 clinical trials evaluating cancer treatments. These principles include: (1) control treatment should be the best current standard of care; (2) the preferred primary endpoint is overall survival or a validated surrogate; (3) an absolute measure of benefit should be provided, such as the difference between groups in median overall survival times or the proportion of surviving patients at a prespecified time; (4) health-related quality of life should be at least a secondary endpoint; (5) toxicity should be described objectively without subjective language diminishing its importance; (6) trials should be designed to show or rule out clinically meaningful differences in outcomes, rather than a statistically significant difference alone; (7) censoring should be detailed, and sensitivity analyses done to determine its possible effects; (8) experimental treatments known to improve overall survival at later disease stages should be offered and funded for patients progressing in the control group; and (9) reports of trials should include a lay-language summary. We include checklists to guide compliance with these principles. By encouraging adherence, CSO aims to ensure that clinical trials yield results that are scientifically robust and meaningful to patients.
{"title":"Common Sense Oncology principles for the design, analysis, and reporting of phase 3 randomised clinical trials","authors":"Bishal Gyawali, Elizabeth A Eisenhauer, Winette van der Graaf, Christopher M Booth, Nathan I Cherny, Aaron M Goodman, Rachel Koven, Madeline L Pe, Bernard L Marini, Ghulam Rehman Mohyuddin, Gregory R Pond, Manju Sengar, Enrique Soto-Perez-de-Celis, Dario Trapani, Michelle Tregear, Brooke E Wilson, Ian F Tannock","doi":"10.1016/s1470-2045(24)00451-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00451-0","url":null,"abstract":"Common Sense Oncology (CSO) prioritises treatments providing meaningful benefits for people with cancer. Here, we describe CSO principles aimed at improving the design, analysis, and reporting of randomised, controlled, phase 3 clinical trials evaluating cancer treatments. These principles include: (1) control treatment should be the best current standard of care; (2) the preferred primary endpoint is overall survival or a validated surrogate; (3) an absolute measure of benefit should be provided, such as the difference between groups in median overall survival times or the proportion of surviving patients at a prespecified time; (4) health-related quality of life should be at least a secondary endpoint; (5) toxicity should be described objectively without subjective language diminishing its importance; (6) trials should be designed to show or rule out clinically meaningful differences in outcomes, rather than a statistically significant difference alone; (7) censoring should be detailed, and sensitivity analyses done to determine its possible effects; (8) experimental treatments known to improve overall survival at later disease stages should be offered and funded for patients progressing in the control group; and (9) reports of trials should include a lay-language summary. We include checklists to guide compliance with these principles. By encouraging adherence, CSO aims to ensure that clinical trials yield results that are scientifically robust and meaningful to patients.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"81 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(24)00674-0
Amit M Oza, Alla Lisyanskaya, Alexander Fedenko, Andreia Cristina de Melo, Yaroslav Shparyk, Irina Rakhmatullina, Igor Bondarenko, Nicoletta Colombo, Valentyn Svintsitskiy, Luciano Biela, Marina Nechaeva, Domenica Lorusso, Giovanni Scambia, David Cibula, Róbert Póka, Ana Oaknin, Tamar Safra, Beata Mackowiak-Matejczyk, Ling Ma, Daleen Thomas, Rebecca Kristeleit
<h3>Background</h3>In the ARIEL4 trial of rucaparib versus standard-of-care chemotherapy in patients with relapsed <em>BRCA</em>-mutated ovarian carcinoma, the primary endpoint was met, showing improved investigator-assessed progression-free survival with rucaparib. Here, we present the final overall survival analysis of the trial and other post-progression outcomes.<h3>Methods</h3>This open-label, randomised, controlled phase 3 trial was done at 64 hospitals and cancer centres in 12 countries, including Brazil, Canada, Czech Republic, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, the UK, and the USA. Eligible patients were women aged 18 or older with <em>BRCA1</em> or <em>BRCA2</em>-mutated ovarian carcinoma and had received at least two previous chemotherapy regimens. Patients had to have evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) criteria and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (2:1) using an interactive response technology and block randomisation (block size of six) and stratified by progression-free interval after the most recent platinum-containing therapy to receive oral rucaparib (600 mg twice daily administered in 28-day cycles) or chemotherapy on the basis of platinum-sensitivity status. In the chemotherapy group, patients with platinum-resistant disease (progression-free interval ≥1 to <6 months) or partially platinum-sensitive disease (progression-free interval ≥6 to <12 months) received weekly paclitaxel (starting dose 60–80 mg/m<sup>2</sup> on days 1, 8, and 15). Patients with fully platinum-sensitive disease (progression-free interval ≥12 months) received the investigator's choice of platinum-based chemotherapy (single-agent cisplatin or carboplatin, or platinum-doublet chemotherapy), in 21-day or 28-day cycles. The primary endpoint (previously reported) was investigator-assessed progression-free survival, assessed in the efficacy population (all randomly assigned patients with deleterious <em>BRCA1</em> or <em>BRCA2</em> mutations without reversion mutations) and in the intention-to-treat population (all randomly assigned patients). Overall survival was a prespecified secondary endpoint and was analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of assigned study treatment. The cutoff date was April 10, 2022. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>, <span><span>NCT02855944</span><svg aria-label="Opens in new window" focusable="false" height="20" viewbox="0 0 8 8"><path d="M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z"></path></svg></span>; enrolment is complete and the stu
{"title":"Rucaparib versus chemotherapy for treatment of relapsed ovarian cancer with deleterious BRCA1 or BRCA2 mutation (ARIEL4): final results of an international, open-label, randomised, phase 3 trial","authors":"Amit M Oza, Alla Lisyanskaya, Alexander Fedenko, Andreia Cristina de Melo, Yaroslav Shparyk, Irina Rakhmatullina, Igor Bondarenko, Nicoletta Colombo, Valentyn Svintsitskiy, Luciano Biela, Marina Nechaeva, Domenica Lorusso, Giovanni Scambia, David Cibula, Róbert Póka, Ana Oaknin, Tamar Safra, Beata Mackowiak-Matejczyk, Ling Ma, Daleen Thomas, Rebecca Kristeleit","doi":"10.1016/s1470-2045(24)00674-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00674-0","url":null,"abstract":"<h3>Background</h3>In the ARIEL4 trial of rucaparib versus standard-of-care chemotherapy in patients with relapsed <em>BRCA</em>-mutated ovarian carcinoma, the primary endpoint was met, showing improved investigator-assessed progression-free survival with rucaparib. Here, we present the final overall survival analysis of the trial and other post-progression outcomes.<h3>Methods</h3>This open-label, randomised, controlled phase 3 trial was done at 64 hospitals and cancer centres in 12 countries, including Brazil, Canada, Czech Republic, Hungary, Israel, Italy, Poland, Russia, Spain, Ukraine, the UK, and the USA. Eligible patients were women aged 18 or older with <em>BRCA1</em> or <em>BRCA2</em>-mutated ovarian carcinoma and had received at least two previous chemotherapy regimens. Patients had to have evaluable disease as per Response Evaluation Criteria in Solid Tumors (RECIST; version 1.1) criteria and an Eastern Cooperative Oncology Group performance status of 0 or 1. Patients were randomly assigned (2:1) using an interactive response technology and block randomisation (block size of six) and stratified by progression-free interval after the most recent platinum-containing therapy to receive oral rucaparib (600 mg twice daily administered in 28-day cycles) or chemotherapy on the basis of platinum-sensitivity status. In the chemotherapy group, patients with platinum-resistant disease (progression-free interval ≥1 to <6 months) or partially platinum-sensitive disease (progression-free interval ≥6 to <12 months) received weekly paclitaxel (starting dose 60–80 mg/m<sup>2</sup> on days 1, 8, and 15). Patients with fully platinum-sensitive disease (progression-free interval ≥12 months) received the investigator's choice of platinum-based chemotherapy (single-agent cisplatin or carboplatin, or platinum-doublet chemotherapy), in 21-day or 28-day cycles. The primary endpoint (previously reported) was investigator-assessed progression-free survival, assessed in the efficacy population (all randomly assigned patients with deleterious <em>BRCA1</em> or <em>BRCA2</em> mutations without reversion mutations) and in the intention-to-treat population (all randomly assigned patients). Overall survival was a prespecified secondary endpoint and was analysed in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of assigned study treatment. The cutoff date was April 10, 2022. This study is registered with <span><span>ClinicalTrials.gov</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>, <span><span>NCT02855944</span><svg aria-label=\"Opens in new window\" focusable=\"false\" height=\"20\" viewbox=\"0 0 8 8\"><path d=\"M1.12949 2.1072V1H7V6.85795H5.89111V2.90281L0.784057 8L0 7.21635L5.11902 2.1072H1.12949Z\"></path></svg></span>; enrolment is complete and the stu","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"12 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083313","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(25)00033-6
Mark Lawler, Pat Price
No Abstract
{"title":"UK's National Cancer Plan needs to be radical, accountable, and deliverable","authors":"Mark Lawler, Pat Price","doi":"10.1016/s1470-2045(25)00033-6","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00033-6","url":null,"abstract":"No Abstract","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"13 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083448","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(25)00015-4
Zhang X, Liang H, Li Z, et al. Perioperative or postoperative adjuvant oxaliplatin with S-1 versus adjuvant oxaliplatin with capecitabine in patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma undergoing D2 gastrectomy (RESOLVE): an open-label, superiority and non-inferiority, phase 3 randomised controlled trial. Lancet Oncol 2021; 22: 1081–92—In this Article, in the Summary Methods, this sentence should have read as follows: “The primary endpoint, assessed in the modified intention-to-treat population, is 3-year disease-free survival to assess the superiority of perioperative-SOX compared with adjuvant-CapOx and the non-inferiority (hazard ratio non-inferiority margin of 1·33) of adjuvant-SOX compared with adjuvant-CapOx.” This correction has been made to the online version as of Feb 3, 2025.
{"title":"Correction to Lancet Oncol 2021; 22: 1081–92","authors":"","doi":"10.1016/s1470-2045(25)00015-4","DOIUrl":"https://doi.org/10.1016/s1470-2045(25)00015-4","url":null,"abstract":"<em>Zhang X, Liang H, Li Z, et al. Perioperative or postoperative adjuvant oxaliplatin with S-1 versus adjuvant oxaliplatin with capecitabine in patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma undergoing D2 gastrectomy (RESOLVE): an open-label, superiority and non-inferiority, phase 3 randomised controlled trial.</em> Lancet Oncol <em>2021; <strong>22:</strong> 1081–92—</em>In this Article, in the Summary Methods, this sentence should have read as follows: “The primary endpoint, assessed in the modified intention-to-treat population, is 3-year disease-free survival to assess the superiority of perioperative-SOX compared with adjuvant-CapOx and the non-inferiority (hazard ratio non-inferiority margin of 1·33) of adjuvant-SOX compared with adjuvant-CapOx.” This correction has been made to the online version as of Feb 3, 2025.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"63 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083309","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-02-03DOI: 10.1016/s1470-2045(24)00434-0
Martina Perini, Beatrice Castiglioni, Elisabetta Galai, Dario Trapani, Armando A Genazzani, Gianluca Miglio
The definition of a therapeutic indication formulated by regulatory agencies is a decisive element for the marketing authorisation of medicinal products and for patient access. Trotta and colleagues found that oncological indications granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the period between 1999 and 2008 were clinically different in about 10% of cases. In this Policy Review, we compared the 162 therapeutic indications of 80 medicinal products for solid tumours and blood cancers authorised by the EMA between January, 2015, and September, 2022, with the corresponding labels approved by the FDA. Clinically relevant discrepancies in the EMA summary of product characteristics and FDA labels were identified for 51·9% of the evaluated indications. Differences arise in the place in therapy, in the need for patients to be refractory to previous therapies, in biomarker requirement for eligibility, in concomitant treatments, or in patient characteristics. These differences lead to a different population for which drugs can be prescribed on label, with the FDA granting broader indications more often than the EMA. Therapeutic indications are a legal basis that define the eligible population to specific treatments. The fact that about half of the indications are different between the USA and Europe affect patient access to medications and should stimulate a debate on the weight that uncertainty plays in regulatory decisions.
{"title":"Differences in the on-label cancer indications of medicinal products between Europe and the USA","authors":"Martina Perini, Beatrice Castiglioni, Elisabetta Galai, Dario Trapani, Armando A Genazzani, Gianluca Miglio","doi":"10.1016/s1470-2045(24)00434-0","DOIUrl":"https://doi.org/10.1016/s1470-2045(24)00434-0","url":null,"abstract":"The definition of a therapeutic indication formulated by regulatory agencies is a decisive element for the marketing authorisation of medicinal products and for patient access. Trotta and colleagues found that oncological indications granted by the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the period between 1999 and 2008 were clinically different in about 10% of cases. In this Policy Review, we compared the 162 therapeutic indications of 80 medicinal products for solid tumours and blood cancers authorised by the EMA between January, 2015, and September, 2022, with the corresponding labels approved by the FDA. Clinically relevant discrepancies in the EMA summary of product characteristics and FDA labels were identified for 51·9% of the evaluated indications. Differences arise in the place in therapy, in the need for patients to be refractory to previous therapies, in biomarker requirement for eligibility, in concomitant treatments, or in patient characteristics. These differences lead to a different population for which drugs can be prescribed on label, with the FDA granting broader indications more often than the EMA. Therapeutic indications are a legal basis that define the eligible population to specific treatments. The fact that about half of the indications are different between the USA and Europe affect patient access to medications and should stimulate a debate on the weight that uncertainty plays in regulatory decisions.","PeriodicalId":22865,"journal":{"name":"The Lancet Oncology","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2025-02-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143083315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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