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Annals of Oncology Advance Access published online on September 13, 2006
Annals of Oncology, doi:10.1093/annonc/mdl301
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© 2006 European Society for Medical Oncology
Received May 9, 2006
Revised July 9, 2006
Accepted July 10, 2006

original article

A prospective, blinded analysis of thymidylate synthase and p53 expression as prognostic markers in the adjuvant treatment of colorectal cancer

S. Popat 1 *, Z. Chen 2, D. Zhao 3, H. Pan 2, N. Hearle 1, I. Chandler 1, Y. Shao 3, W. Aherne 4, and R. S. Houlston 1

1 Section of Cancer Genetics, Institute of Cancer Research, Sutton, UK
2 Clinical Trial Service Unit, Richard Doll Building, Oxford, UK
3 Department of Abdominal Surgery, Tumour Hospital, Chinese Academy of Medical Sciences, Beijing, People's Republic of China
4 Cancer Research UK Centre for Cancer Therapeutics, Institute of Cancer Research, Sutton, UK

* To whom correspondence should be addressed.
S. Popat, E-mail: sanjay.popat{at}icr.ac.uk


  Abstract

Background: Despite previous studies, uncertainty has persisted about the role of thymidylate synthase (TS) and p53 status as markers of prognosis in colorectal cancer (CRC).

Patients and methods: A total of 967 patients accrued to a large adjuvant trial in CRC were included in a prospectively planned molecular substudy, and of them, 59% had rectal cancer and about 90% received adjuvant chemotherapy (either systemically or randomly allocated to intraportal 5-fluorouracil infusion or both). TS and p53 status were determined, blinded to any clinical data, by immunohistochemistry using a validated polyclonal antibody or the DO-7 clone, respectively, and their relationships with overall survival were examined.

Results: High TS expression was observed in 58% and overexpression of p53 in 60% of tumours. TS expression correlated with tumour stage, and p53 overexpression, with rectal cancers. There was no evidence that either marker was significantly associated with survival by either univariate (TS hazard ratio (HR) = 0.94, 95% CI 0.76-1.18 and P = 0.6 and p53 HR = 0.98, 95% CI 0.78-1.23 and P = 0.9) or multivariate analyses (TS HR = 0.99, 95% CI 0.79-1.25 and P = 0.9 and p53 HR = 0.98, 95% CI 0.78-1.23 and P = 0.8).

Conclusions: Neither TS nor p53 expression has significant prognostic value in the adjuvant setting of CRC.

Keywords: colorectal cancer; p53; prognosis; thymidylate synthase.
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