Pub Date : 2024-08-01Epub Date: 2024-07-01DOI: 10.1016/S1470-2045(24)00327-9
Andrew Toyin Olagunju
{"title":"Cancer and premature mortality-pushing the frontiers of cancer care.","authors":"Andrew Toyin Olagunju","doi":"10.1016/S1470-2045(24)00327-9","DOIUrl":"10.1016/S1470-2045(24)00327-9","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"946-947"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141534679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-18DOI: 10.1016/S1470-2045(24)00400-5
Priya Venkatesan
{"title":"Impact of pharmacy benefit managers on cancer health care.","authors":"Priya Venkatesan","doi":"10.1016/S1470-2045(24)00400-5","DOIUrl":"10.1016/S1470-2045(24)00400-5","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"e339"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734511","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01DOI: 10.1016/S1470-2045(24)00134-7
Catharina J P Op 't Hoog, Niven Mehra, Marc Maliepaard, Kalijn Bol, Hans Gelderblom, Gabe S Sonke, Adrianus J de Langen, Niels W C J van de Donk, Jeroen J W M Janssen, Monique C Minnema, Nielka P van Erp, Emmy Boerrigter
Historically, dose selection of anticancer drugs has mainly been based on establishing the maximum tolerated dose in phase 1 clinical trials with a traditional 3 plus 3 design. In the era of targeted therapies and immune-modulating agents, this approach does not necessarily lead to selection of the most favourable dose. This strategy can introduce potentially avoidable toxicity or inconvenience for patients. Multiple changes in drug development could lead to more rational dose selection, such as use of better predictive preclinical models, adaptive and randomised trial design, evaluation of multiple dose levels in late-phase development, assessment of target activity and saturation, and early biomarker use for efficacy and safety evaluation. In this Review, we evaluate the rationale and validation of dose selection in each phase of drug development for anticancer drugs approved by the European Medicines Agency and US Food and Drug Administration from Jan 1, 2020, to June 30, 2023, and give recommendations for dose optimisation to improve safety and patient convenience. In our evaluation, we classified 20 (65%) of the 31 recently registered anticancer agents as potential candidates for dose optimisation, which could be achieved either by reducing the dose (n=10 [32%]) or adjusting the dosage regimen (n=10 [32%]). Dose selection seemed to be adequately justified for nine (29%) of the drugs, whereas the reviewed data were inconclusive for formulating a recommendation on dose optimisation for two (6%) of the drugs.
{"title":"Dose selection of novel anticancer drugs: exposing the gap between selected and required doses.","authors":"Catharina J P Op 't Hoog, Niven Mehra, Marc Maliepaard, Kalijn Bol, Hans Gelderblom, Gabe S Sonke, Adrianus J de Langen, Niels W C J van de Donk, Jeroen J W M Janssen, Monique C Minnema, Nielka P van Erp, Emmy Boerrigter","doi":"10.1016/S1470-2045(24)00134-7","DOIUrl":"https://doi.org/10.1016/S1470-2045(24)00134-7","url":null,"abstract":"<p><p>Historically, dose selection of anticancer drugs has mainly been based on establishing the maximum tolerated dose in phase 1 clinical trials with a traditional 3 plus 3 design. In the era of targeted therapies and immune-modulating agents, this approach does not necessarily lead to selection of the most favourable dose. This strategy can introduce potentially avoidable toxicity or inconvenience for patients. Multiple changes in drug development could lead to more rational dose selection, such as use of better predictive preclinical models, adaptive and randomised trial design, evaluation of multiple dose levels in late-phase development, assessment of target activity and saturation, and early biomarker use for efficacy and safety evaluation. In this Review, we evaluate the rationale and validation of dose selection in each phase of drug development for anticancer drugs approved by the European Medicines Agency and US Food and Drug Administration from Jan 1, 2020, to June 30, 2023, and give recommendations for dose optimisation to improve safety and patient convenience. In our evaluation, we classified 20 (65%) of the 31 recently registered anticancer agents as potential candidates for dose optimisation, which could be achieved either by reducing the dose (n=10 [32%]) or adjusting the dosage regimen (n=10 [32%]). Dose selection seemed to be adequately justified for nine (29%) of the drugs, whereas the reviewed data were inconclusive for formulating a recommendation on dose optimisation for two (6%) of the drugs.</p>","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":"25 8","pages":"e340-e351"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-18DOI: 10.1016/S1470-2045(24)00398-X
Karl Gruber
{"title":"Lifestyle factors driving cancer cases and mortality in the USA.","authors":"Karl Gruber","doi":"10.1016/S1470-2045(24)00398-X","DOIUrl":"10.1016/S1470-2045(24)00398-X","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"e337"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141734512","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01DOI: 10.1016/S1470-2045(24)00325-5
Joshua M Peterson, Adam Gonzalez, Juan P Olano, Suimin Qiu, Tejo Musunuru, Kirill A Lyapichev
{"title":"Primary cardiac angiosarcoma presenting as restrictive cardiomyopathy.","authors":"Joshua M Peterson, Adam Gonzalez, Juan P Olano, Suimin Qiu, Tejo Musunuru, Kirill A Lyapichev","doi":"10.1016/S1470-2045(24)00325-5","DOIUrl":"10.1016/S1470-2045(24)00325-5","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":"25 8","pages":"e396"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875174","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01DOI: 10.1016/S1470-2045(24)00370-X
Abigail P Sneider, Valerie Gutmann Koch, Andrew Hantel, Peter Angelos
{"title":"Two-physician certification in end-of-life decision making.","authors":"Abigail P Sneider, Valerie Gutmann Koch, Andrew Hantel, Peter Angelos","doi":"10.1016/S1470-2045(24)00370-X","DOIUrl":"10.1016/S1470-2045(24)00370-X","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":"25 8","pages":"966-968"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141875178","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-04DOI: 10.1016/S1470-2045(24)00381-4
Paul Adepoju
{"title":"Nigeria mandates reporting of all cancer diagnoses.","authors":"Paul Adepoju","doi":"10.1016/S1470-2045(24)00381-4","DOIUrl":"10.1016/S1470-2045(24)00381-4","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"959"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141555148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-08-01Epub Date: 2024-07-05DOI: 10.1016/S1470-2045(24)00384-X
Leslie T Stayner, Tania Carreón-Valencia, Paul A Demers, Jason M Fritz, Malcolm R Sim, Patricia Stewart, Hiroyuki Tsuda, Andres Cardenas, Dario Consonni, Laurie Davies, Sara De Matteis, Emanuela Felley-Bosco, Andrew J Ghio, Thomas Göen, Yann Grosse, Alessandro F Gualtieri, P David Josephy, Stella Koutros, Igor Linhart, Henriqueta Louro, Katie M O'Brien, Simona Panzacchi, Laura Peña, Pavel Rössner, Joellen M Schildkraut, Aleksandr B Stefaniak, Nicolas Wentzensen, Pascal Wild, Yuanyuan Xu, Aline de Conti, Caterina Facchin, Roland Wedekind, Ayat Ahmadi, Jessica Blanco, Shirisha Chittiboyina, Shalini Kulasingam, Richard MacLehose, Melitah Motlhale, Sanam Shah, Eero Suonio, Heidi Mattock, Andrew Kunzmann, Federica Madia, Elisa Pasqual, Lamia Benbrahim-Tallaa, Mary K Schubauer-Berigan
{"title":"Carcinogenicity of talc and acrylonitrile.","authors":"Leslie T Stayner, Tania Carreón-Valencia, Paul A Demers, Jason M Fritz, Malcolm R Sim, Patricia Stewart, Hiroyuki Tsuda, Andres Cardenas, Dario Consonni, Laurie Davies, Sara De Matteis, Emanuela Felley-Bosco, Andrew J Ghio, Thomas Göen, Yann Grosse, Alessandro F Gualtieri, P David Josephy, Stella Koutros, Igor Linhart, Henriqueta Louro, Katie M O'Brien, Simona Panzacchi, Laura Peña, Pavel Rössner, Joellen M Schildkraut, Aleksandr B Stefaniak, Nicolas Wentzensen, Pascal Wild, Yuanyuan Xu, Aline de Conti, Caterina Facchin, Roland Wedekind, Ayat Ahmadi, Jessica Blanco, Shirisha Chittiboyina, Shalini Kulasingam, Richard MacLehose, Melitah Motlhale, Sanam Shah, Eero Suonio, Heidi Mattock, Andrew Kunzmann, Federica Madia, Elisa Pasqual, Lamia Benbrahim-Tallaa, Mary K Schubauer-Berigan","doi":"10.1016/S1470-2045(24)00384-X","DOIUrl":"10.1016/S1470-2045(24)00384-X","url":null,"abstract":"","PeriodicalId":17942,"journal":{"name":"Lancet Oncology","volume":" ","pages":"962-963"},"PeriodicalIF":41.6,"publicationDate":"2024-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141559068","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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