Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology

Abstract While several resources exist that interpret therapeutic significance of genomic alterations in cancer, many regional real-world issues limit access to drugs. There is a need for a pragmatic, evidence-based, context-adapted tool to guide clinical management based on molecular biomarkers. To...

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Autores principales: Frank P. Lin, Subotheni Thavaneswaran, John P. Grady, Mandy Ballinger, Maya Kansara, Samantha R. Oakes, Jayesh Desai, Chee Khoon Lee, John Simes, David M. Thomas
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Publicado: Nature Portfolio 2021
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spelling oai:doaj.org-article:6a749ceadf654e848f7ee68f6d8738172021-12-02T18:02:41ZCriteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology10.1038/s41698-021-00194-z2397-768Xhttps://doaj.org/article/6a749ceadf654e848f7ee68f6d8738172021-06-01T00:00:00Zhttps://doi.org/10.1038/s41698-021-00194-zhttps://doaj.org/toc/2397-768XAbstract While several resources exist that interpret therapeutic significance of genomic alterations in cancer, many regional real-world issues limit access to drugs. There is a need for a pragmatic, evidence-based, context-adapted tool to guide clinical management based on molecular biomarkers. To this end, we have structured a compendium of approved and experimental therapies with associated biomarkers following a survey of drug regulatory databases, existing knowledge bases, and published literature. Each biomarker-disease-therapy triplet was categorised using a tiering system reflective of key therapeutic considerations: approved and reimbursed therapies with respect to a jurisdiction (Tier 1), evidence of efficacy or approval in another jurisdiction (Tier 2), evidence of antitumour activity (Tier 3), and plausible biological rationale (Tier 4). Two resistance categories were defined: lack of efficacy (Tier R1) or antitumor activity (Tier R2). Based on this framework, we curated a digital resource focused on drugs relevant in the Australian healthcare system (TOPOGRAPH: Therapy Oriented Precision Oncology Guidelines for Recommending Anticancer Pharmaceuticals). As of November 2020, TOPOGRAPH comprised 2810 biomarker-disease-therapy triplets in 989 expert-appraised entries, including 373 therapies, 199 biomarkers, and 106 cancer types. In the 345 therapies catalogued, 84 (24%) and 65 (19%) were designated Tiers 1 and 2, respectively, while 271 (79%) therapies were supported by preclinical studies, early clinical trials, retrospective studies, or case series (Tiers 3 and 4). A companion algorithm was also developed to support rational, context-appropriate treatment selection informed by molecular biomarkers. This framework can be readily adapted to build similar resources in other jurisdictions to support therapeutic decision-making.Frank P. LinSubotheni ThavaneswaranJohn P. GradyMandy BallingerMaya KansaraSamantha R. OakesJayesh DesaiChee Khoon LeeJohn SimesDavid M. ThomasNature PortfolioarticleNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENnpj Precision Oncology, Vol 5, Iss 1, Pp 1-10 (2021)
institution DOAJ
collection DOAJ
language EN
topic Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
spellingShingle Neoplasms. Tumors. Oncology. Including cancer and carcinogens
RC254-282
Frank P. Lin
Subotheni Thavaneswaran
John P. Grady
Mandy Ballinger
Maya Kansara
Samantha R. Oakes
Jayesh Desai
Chee Khoon Lee
John Simes
David M. Thomas
Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
description Abstract While several resources exist that interpret therapeutic significance of genomic alterations in cancer, many regional real-world issues limit access to drugs. There is a need for a pragmatic, evidence-based, context-adapted tool to guide clinical management based on molecular biomarkers. To this end, we have structured a compendium of approved and experimental therapies with associated biomarkers following a survey of drug regulatory databases, existing knowledge bases, and published literature. Each biomarker-disease-therapy triplet was categorised using a tiering system reflective of key therapeutic considerations: approved and reimbursed therapies with respect to a jurisdiction (Tier 1), evidence of efficacy or approval in another jurisdiction (Tier 2), evidence of antitumour activity (Tier 3), and plausible biological rationale (Tier 4). Two resistance categories were defined: lack of efficacy (Tier R1) or antitumor activity (Tier R2). Based on this framework, we curated a digital resource focused on drugs relevant in the Australian healthcare system (TOPOGRAPH: Therapy Oriented Precision Oncology Guidelines for Recommending Anticancer Pharmaceuticals). As of November 2020, TOPOGRAPH comprised 2810 biomarker-disease-therapy triplets in 989 expert-appraised entries, including 373 therapies, 199 biomarkers, and 106 cancer types. In the 345 therapies catalogued, 84 (24%) and 65 (19%) were designated Tiers 1 and 2, respectively, while 271 (79%) therapies were supported by preclinical studies, early clinical trials, retrospective studies, or case series (Tiers 3 and 4). A companion algorithm was also developed to support rational, context-appropriate treatment selection informed by molecular biomarkers. This framework can be readily adapted to build similar resources in other jurisdictions to support therapeutic decision-making.
format article
author Frank P. Lin
Subotheni Thavaneswaran
John P. Grady
Mandy Ballinger
Maya Kansara
Samantha R. Oakes
Jayesh Desai
Chee Khoon Lee
John Simes
David M. Thomas
author_facet Frank P. Lin
Subotheni Thavaneswaran
John P. Grady
Mandy Ballinger
Maya Kansara
Samantha R. Oakes
Jayesh Desai
Chee Khoon Lee
John Simes
David M. Thomas
author_sort Frank P. Lin
title Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
title_short Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
title_full Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
title_fullStr Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
title_full_unstemmed Criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
title_sort criteria-based curation of a therapy-focused compendium to support treatment recommendations in precision oncology
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/6a749ceadf654e848f7ee68f6d873817
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