Skip to main content

Thank you for visiting You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser (or turn off compatibility mode in Internet Explorer). In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript.

Defining clinically important overall survival thresholds: lessons from quality of life


In randomized controlled trials in oncology, changes in quality of life are usually reported together with a description of the differences considered a priori to be clinically important, but overall survival outcomes are rarely provided together with information of what constitutes a clinically meaningful threshold. In this Comment, we propose the benefits that could be derived from reporting overall survival in a similar way to quality of life.

This is a preview of subscription content, access via your institution

Access options

Buy article

Get time limited or full article access on ReadCube.


All prices are NET prices.


  1. Blome, C. & Augustin, M. Measuring change in quality of life: bias in prospective and retrospective evaluation. Value Health 18, 110–115 (2015).

    Article  Google Scholar 

  2. Coleman, R. L. et al. Veliparib with first-line chemotherapy and as maintenance therapy in ovarian cancer. N. Engl. J. Med. 381, 2403–2415 (2019).

    CAS  Article  Google Scholar 

  3. Hubner, R. A. et al. Quality of life in metastatic pancreatic cancer patients receiving liposomal irinotecan plus 5-fluorouracil and leucovorin. Eur. J. Cancer 106, 24–33 (2019).

    CAS  Article  Google Scholar 

  4. Moore, M. J. et al. Erlotinib plus gemcitabine compared with gemcitabine alone in patients with advanced pancreatic cancer: a phase III trial of the National Cancer Institute of Canada Clinical Trials Group. J. Clin. Oncol. 25, 1960–1966 (2007).

    CAS  Article  Google Scholar 

  5. Gyawali, B., Sharma, S. & Booth, C. M. Is the number of cancer drug approvals a surrogate for regulatory success? J. Cancer Policy 22, 100202 (2019).

    Article  Google Scholar 

  6. Del Paggio, J. C. et al. Evolution of the randomized clinical trial in the era of precision oncology. JAMA Oncol. 7, 728–734 (2021).

    Article  Google Scholar 

  7. Gyawali, B. & Kesselheim, A. S. FDA approval standards for anticancer agents — lessons from two recent approvals in breast cancer. Nat. Rev. Clin. Oncol. 18, 397–398 (2021).

    Article  Google Scholar 

  8. Ellis, L. M. et al. American Society of Clinical Oncology perspective: Raising the bar for clinical trials by defining clinically meaningful outcomes. J. Clin. Oncol. 32, 1277–1280 (2014).

    Article  Google Scholar 

  9. Templeton, A. J., Booth, C. M. & Tannock, I. F. Informing patients about expected outcomes: the efficacy–effectiveness gap. J. Clin. Oncol. 38, 1651–1654 (2020).

    Article  Google Scholar 

  10. Samuel, J. N. et al. Association of quality-of-life outcomes in cancer drug trials with survival outcomes and drug class. JAMA Oncol. 8, 879–886 (2022).

    Article  Google Scholar 

Download references


B.G. receives salary support from Ontario Institute for Cancer Research, funded by the government of Ontario. C.M.B. is supported by the Canada Research Chairs programme. The authors would like to thank M. Brundage (Queen’s Cancer Research Institute) for providing valuable comments and feedback on an earlier version of this manuscript.

Author information

Authors and Affiliations


Corresponding author

Correspondence to Bishal Gyawali.

Ethics declarations

Competing interests

B.G. has acted as a consultant for Vivio Health. C.M.B. declares no competing interests.

Rights and permissions

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Gyawali, B., Booth, C.M. Defining clinically important overall survival thresholds: lessons from quality of life. Nat Rev Clin Oncol 19, 613–614 (2022).

Download citation

  • Published:

  • Issue Date:

  • DOI:


Quick links

Nature Briefing: Cancer

Sign up for the Nature Briefing: Cancer newsletter — what matters in cancer research, free to your inbox weekly.

Get what matters in cancer research, free to your inbox weekly. Sign up for Nature Briefing: Cancer