Skip to main content
SpringerLink
Log in

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

  • Comment
  • Published:

From Nature Reviews Clinical Oncology

View current issue Sign up to alerts

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, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

References

  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).

    Article  CAS  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).

    Article  CAS  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).

    Article  CAS  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

Acknowledgements

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

  1. Department of Oncology, Queen’s University, Kingston, Ontario, Canada

    Bishal Gyawali & Christopher M. Booth

  2. Cancer Centre of Southeastern Ontario, Kingston, Ontario, Canada

    Bishal Gyawali & Christopher M. Booth

  3. Department of Public Health Sciences, Queen’s University, Kingston, Ontario, Canada

    Bishal Gyawali & Christopher M. Booth

  4. Division of Cancer Care and Epidemiology, Queen’s University Cancer Research Institute, Kingston, Ontario, Canada

    Bishal Gyawali & Christopher M. Booth

Authors
  1. Bishal Gyawali
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Christopher M. Booth
    View author publications

    You can also search for this author in PubMed Google Scholar

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

Check for updates. 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). https://doi.org/10.1038/s41571-022-00667-5

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/s41571-022-00667-5

  • Springer Nature Limited

Search

Navigation