Approvals in 2016: questioning the clinical benefit of anticancer therapies

Approvals in 2016: questioning the clinical benefit of anticancer therapies

Play all audios:

Loading...

Patients with cancer expect to derive a meaningful clinical benefit from anticancer treatments, especially considering that such therapies are associated with adverse events and, often, substantial financial costs. We have evaluated new anticancer agents approved by the FDA in 2015 and 2016 using the ESMO Magnitude of Clinical Benefit Scale and ASCO Value Framework, and conclude that many agents only offer marginal value. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS Access through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $32.99 / 30 days cancel any time Learn more Subscribe to this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full article PDF Buy now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs * Contact customer support REFERENCES * Saltz, L. B. Progress in cancer care: the hope, the hype, and the gap between reality and perception. _J. Clin. Oncol._ 26, 5020–5021 (2008). Article  Google Scholar  * Booth, C. M. & Eisenhauer, E. A. Progression-free survival: meaningful or simply measurable? _J. Clin. Oncol._ 30, 1030–1033 (2012). Article  Google Scholar  * Booth, C. M. & Tannock, I. Reflections on medical oncology: 25 years of clinical trials — where have we come and where are we going? _J. Clin. Oncol._ 26, 6–8 (2008). Article  Google Scholar  * Booth, C. M. _ et al_. Evolution of the randomized controlled trial in oncology over three decades. _J. Clin. Oncol._ 26, 5458–5464 (2008). Article  Google Scholar  * Seruga, B. _ et al_. Absolute benefits of medical therapies in phase III clinical trials for breast and colorectal cancer. _Ann. Oncol._ 21, 1411–1418 (2010). Article  CAS  Google Scholar  * Cherny, N. I. _ et al_. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS). _Ann. Oncol._ 26, 1547–1573 (2015). Article  CAS  Google Scholar  * Schnipper, L. E. _ et al_. Updating the American Society of Clinical Oncology value framework: revisions and reflections in response to comments received. _J. Clin. Oncol._ 34, 2925–2934 (2016). Article  Google Scholar  * Del Paggio, J. C. _ et al_. Do contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit? _Ann. Oncol._ http://dx.doi.org/10.1093/annonc/mdw538 (2016). * Tap, W. D. _ et al_. Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. _Lancet_ 388, 488–497 (2016). Article  CAS  Google Scholar  * Schlumberger, M. _ et al_. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. _N. Engl. J. Med._ 372, 621–630 (2015). Article  Google Scholar  * Truven Health Analytics. RED BOOK: a comprehensive, consistent drug pricing resource. _Micromedex_ http://micromedex.com/products/product-suites/clinical-knowledge/redbook (2017). Download references ACKNOWLEDGEMENTS C.M.B. is supported as the Canada Research Chair in Population Cancer Care. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Departments of Oncology and Public Health Sciences, Queen's University, University Avenue, Kingston, K7L 3N6, Ontario, Canada Christopher M. Booth * Department of Medicine, Division of Medical Oncology, University of Toronto, King's College Circus, Toronto, M5S, Ontario, Canada Joseph C. Del Paggio Authors * Christopher M. Booth View author publications You can also search for this author inPubMed Google Scholar * Joseph C. Del Paggio View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Christopher M. Booth. ETHICS DECLARATIONS COMPETING INTERESTS The authors declare no competing financial interests. SUPPLEMENTARY INFORMATION SUPPLEMENTARY INFORMATION S1 (TABLE) Clinical benefit of anticancer agents approved by the FDA in 2015–2016 (PDF 228 kb) POWERPOINT SLIDES POWERPOINT SLIDE FOR TABLE 1 RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Booth, C., Del Paggio, J. Approvals in 2016: questioning the clinical benefit of anticancer therapies. _Nat Rev Clin Oncol_ 14, 135–136 (2017). https://doi.org/10.1038/nrclinonc.2017.18 Download citation * Published: 20 February 2017 * Issue Date: March 2017 * DOI: https://doi.org/10.1038/nrclinonc.2017.18 SHARE THIS ARTICLE Anyone you share the following link with will be able to read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing initiative

Patients with cancer expect to derive a meaningful clinical benefit from anticancer treatments, especially considering that such therapies are associated with adverse events and, often,


substantial financial costs. We have evaluated new anticancer agents approved by the FDA in 2015 and 2016 using the ESMO Magnitude of Clinical Benefit Scale and ASCO Value Framework, and


conclude that many agents only offer marginal value. Access through your institution Buy or subscribe This is a preview of subscription content, access via your institution ACCESS OPTIONS


Access through your institution Access Nature and 54 other Nature Portfolio journals Get Nature+, our best-value online-access subscription $32.99 / 30 days cancel any time Learn more


Subscribe to this journal Receive 12 print issues and online access $209.00 per year only $17.42 per issue Learn more Buy this article * Purchase on SpringerLink * Instant access to full


article PDF Buy now Prices may be subject to local taxes which are calculated during checkout ADDITIONAL ACCESS OPTIONS: * Log in * Learn about institutional subscriptions * Read our FAQs *


Contact customer support REFERENCES * Saltz, L. B. Progress in cancer care: the hope, the hype, and the gap between reality and perception. _J. Clin. Oncol._ 26, 5020–5021 (2008). Article 


Google Scholar  * Booth, C. M. & Eisenhauer, E. A. Progression-free survival: meaningful or simply measurable? _J. Clin. Oncol._ 30, 1030–1033 (2012). Article  Google Scholar  * Booth,


C. M. & Tannock, I. Reflections on medical oncology: 25 years of clinical trials — where have we come and where are we going? _J. Clin. Oncol._ 26, 6–8 (2008). Article  Google Scholar  *


Booth, C. M. _ et al_. Evolution of the randomized controlled trial in oncology over three decades. _J. Clin. Oncol._ 26, 5458–5464 (2008). Article  Google Scholar  * Seruga, B. _ et al_.


Absolute benefits of medical therapies in phase III clinical trials for breast and colorectal cancer. _Ann. Oncol._ 21, 1411–1418 (2010). Article  CAS  Google Scholar  * Cherny, N. I. _ et


al_. A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology


Magnitude of Clinical Benefit Scale (ESMO-MCBS). _Ann. Oncol._ 26, 1547–1573 (2015). Article  CAS  Google Scholar  * Schnipper, L. E. _ et al_. Updating the American Society of Clinical


Oncology value framework: revisions and reflections in response to comments received. _J. Clin. Oncol._ 34, 2925–2934 (2016). Article  Google Scholar  * Del Paggio, J. C. _ et al_. Do


contemporary randomized controlled trials meet ESMO thresholds for meaningful clinical benefit? _Ann. Oncol._ http://dx.doi.org/10.1093/annonc/mdw538 (2016). * Tap, W. D. _ et al_.


Olaratumab and doxorubicin versus doxorubicin alone for treatment of soft-tissue sarcoma: an open-label phase 1b and randomised phase 2 trial. _Lancet_ 388, 488–497 (2016). Article  CAS 


Google Scholar  * Schlumberger, M. _ et al_. Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. _N. Engl. J. Med._ 372, 621–630 (2015). Article  Google Scholar  * Truven


Health Analytics. RED BOOK: a comprehensive, consistent drug pricing resource. _Micromedex_ http://micromedex.com/products/product-suites/clinical-knowledge/redbook (2017). Download


references ACKNOWLEDGEMENTS C.M.B. is supported as the Canada Research Chair in Population Cancer Care. AUTHOR INFORMATION AUTHORS AND AFFILIATIONS * Departments of Oncology and Public


Health Sciences, Queen's University, University Avenue, Kingston, K7L 3N6, Ontario, Canada Christopher M. Booth * Department of Medicine, Division of Medical Oncology, University of


Toronto, King's College Circus, Toronto, M5S, Ontario, Canada Joseph C. Del Paggio Authors * Christopher M. Booth View author publications You can also search for this author inPubMed 


Google Scholar * Joseph C. Del Paggio View author publications You can also search for this author inPubMed Google Scholar CORRESPONDING AUTHOR Correspondence to Christopher M. Booth. ETHICS


DECLARATIONS COMPETING INTERESTS The authors declare no competing financial interests. SUPPLEMENTARY INFORMATION SUPPLEMENTARY INFORMATION S1 (TABLE) Clinical benefit of anticancer agents


approved by the FDA in 2015–2016 (PDF 228 kb) POWERPOINT SLIDES POWERPOINT SLIDE FOR TABLE 1 RIGHTS AND PERMISSIONS Reprints and permissions ABOUT THIS ARTICLE CITE THIS ARTICLE Booth, C.,


Del Paggio, J. Approvals in 2016: questioning the clinical benefit of anticancer therapies. _Nat Rev Clin Oncol_ 14, 135–136 (2017). https://doi.org/10.1038/nrclinonc.2017.18 Download


citation * Published: 20 February 2017 * Issue Date: March 2017 * DOI: https://doi.org/10.1038/nrclinonc.2017.18 SHARE THIS ARTICLE Anyone you share the following link with will be able to


read this content: Get shareable link Sorry, a shareable link is not currently available for this article. Copy to clipboard Provided by the Springer Nature SharedIt content-sharing


initiative