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Annals of Oncology Advance Access published online on November 9, 2009
Annals of Oncology, doi:10.1093/annonc/mdp523
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

review

Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature

E. D. Saad1,*, A. Katz2, P. M. Hoff2 and M. Buyse3

1 Dendrix Research, Rua Joaquim Floriano
2 Oncology Center, Hospital Sírio-Libanês, Sao Paulo, Brazil
3 International Drug Development Institute, Louvain-la-Neuve, Belgium

* Correspondence to: Dr E. D. Saad, Dendrix Research, Rua Joaquim Floriano 72/24, 04534-000 Sao Paulo, Brazil. Tel: +55-11-3168-7088; Fax: +55-11-3167-1148; E-mail: everardo{at}dendrix.com.br

Significant achievements in the systemic treatment of both advanced breast cancer and advanced colorectal cancer over the past 10 years have led to a growing number of drugs, combinations, and sequences to be tested. The choice of surrogate and true end points has become a critical issue and one that is currently the subject of much debate. Many recent randomized trials in solid tumor oncology have used progression-free survival (PFS) as the primary end point. PFS is an attractive end point because it is available earlier than overall survival (OS) and is not influenced by second-line treatments. PFS is now undergoing validation as a surrogate end point in various disease settings. The question of whether PFS can be considered an acceptable surrogate end point depends not only on formal validation studies but also on a standardized definition and unbiased ascertainment of disease progression in clinical trials. In advanced breast cancer, formal validation of PFS as a surrogate for OS has so far been unsuccessful. In advanced colorectal cancer, in contrast, current evidence indicates that PFS is a valid surrogate for OS after first-line treatment with chemotherapy. The other question is whether PFS sufficiently reflects clinical benefit to be considered a true end point in and of itself.

breast neoplasms, colorectal neoplasms, disease-free survival, end point determination, survival analysis

Received for publication July 28, 2009. Accepted for publication October 14, 2009.


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