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Annals of Oncology Advance Access originally published online on September 13, 2006
Annals of Oncology 2006 17(12):1810-1817; doi:10.1093/annonc/mdl301
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© 2006 European Society for Medical Oncology

gastrointestinal tumors

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

S Popat1,*, Z Chen2, D Zhao3, H Pan2, N Hearle1, I Chandler1, Y Shao3, W Aherne4 and RS Houlston1

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

* Correspondence to: Dr S. Popat, Section of Cancer Genetics, Institute of Cancer Research, Sutton, SM2 5NG, UK. Tel: +44-(0)-208-642-6011; Fax: +44-(0)-208-643-0373. E-mail: sanjay.popat{at}icr.ac.uk

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.

Key words: colorectal cancer, p53, prognosis, thymidylate synthase


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