Midgley, Rachel S. J., McConkey, Christopher C., Langman, Michael J., Smith, Justine L., Julier, Patrick, Iveson, Claire, Johnstone, Elaine, Chen, Xiao-he, Dunn, Janet A. and Kerr, David J. (2008) VICTOR : a phase III placebo-controlled trial of rofecoxib in colorectal cancer patients following surgical resection. In: 33rd European Society for Medical Oncology Congress, Stockholm, Sweden, 12-16 Sept 2008. Published in: Annals of Oncology, Vol.19 (No.19 ). p. 1. ISSN 0923-7534.

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Abstract

Background: The cyclo-oxygenase-2 inhibitor, rofecoxib (R) was hypothesised to improve survival in cancer patients who had undergone surgery for colorectal cancer (CRC). This trial recruited from April 2002 until September 2004 when R was withdrawn over concerns about its cardiovascular safety (CVS). This report provides preliminary efficacy results. Methods: Recruited patients had undergone Ro resection of a stage II/III CRC and completion of adjuvant therapy (radiotherapy/chemotherapy/both/neither) less than 12 weeks previously. Excluded patients were those with active peptic ulceration, gastro-intestinal bleeding and those receiving long-term NSAID therapy (except low dose aspirin). 7,000 patients were planned to receive 25mg R daily or an identical placebo (P) for 2 or 5 years, with the goal of detecting a reduction in risk of death - hazard ratio (HR) 0.82. After the trial's premature closure, a modified protocol of the post- treatment follow-up phase and revised statistical analysis plan permitted the detection of a reduction (HR=0.75) in risk of death with 87% power, type I error 0.05, with one pre-planned event-driven interim analysis. Overall survival (OS) and disease-free survival (DFS) were both measured from randomisation, with DFS defined as the time to recurrence or death from any cause. Results: 1,167 of 1,217 patients randomised to R and 1,160 0f 1,217 randomised to P received treatment with median durations of 7.4 months and 8.2 months respectively. Median follow-up was 3.0 and 3.1 years in the two arms (R vs P), with 177 vs 191 deaths and 291 vs 316 DFS events. This pre-planned Kaplan-Meier and log- rank analysis demonstrated that the R patients had slightly longer OS than the P patients, HR 0.94 (95% CI 0.77-1.16; p=0.57). Similarly DFS was slightly higher in the R patients, HR 0.91 (95% CI 0.78-1.07; p=0.25). 19 patients in each arm died without recurrence of CRC. Conclusions: In this study of short treatment duration treatment with R is unlikely to result in a substantial improvement in OS but a small protective effect against recurrence is suggested.

Item Type:	Conference Item (Paper)
Subjects:	R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) R Medicine > RM Therapeutics. Pharmacology
Divisions:	Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH):	Rofecoxib -- Testing, Placebos (Medicine) -- Testing, Colon (Anatomy) -- Cancer, Rectum -- Cancer
Journal or Publication Title:	Annals of Oncology
Publisher:	Oxford University Press
ISSN:	0923-7534
Official Date:	September 2008
Dates:	Date Event September 2008 Completion
Volume:	Vol.19
Number:	No.19
Number of Pages:	1
Page Range:	p. 1
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Conference Paper Type:	Paper
Title of Event:	33rd European Society for Medical Oncology Congress
Type of Event:	Conference
Location of Event:	Stockholm, Sweden
Date(s) of Event:	12-16 Sept 2008

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