Rofecoxib Fails to Improve Outcomes After Colorectal Cancer Surgery: Presented at ESMO

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Title: Rofecoxib Fails to Improve Outcomes After Colorectal Cancer Surgery: Presented at ESMO
URL: http://www.pslgroup.com/dg/22C7FE.htm
Doctor's Guide
September 16, 2008

By Ed Susman

STOCKHOLM, Sweden -- September 16, 2008 -- Results of a truncated trial of rofecoxib show that treatment with the cyclooxygenase 2 inhibitor failed to make a difference in outcomes among patients treated with surgery for colorectal cancer, researchers reported here at the 33rd European Society for Medical Oncology Congress (ESMO).

The Vioxx in Colorectal Cancer Therapy: Definition of Optimal Regime (VICTOR) study was stopped early, based on concerns about the cardiovascular risks of rofecoxib.

The study was an international randomised, double-blind, placebo-controlled, multicentre evaluation of rofecoxib in 7,000 patients with colorectal cancer that started in April 2002 and ceased on September 30, 2004, after Merck voluntarily recalled rofecoxib.

The study recruited patients who had undergone surgical resection of stage II/III colorectal carcinoma and had completed adjuvant therapy less than 12 weeks previously. Patients with active ulcers or gastrointestinal bleeding were excluded. Patients were an average of 65 years old at enrolment, and 36% of subjects were women.

Although the trial recruited 2,433 patients instead of the 7,000 originally sought, said Rachel SJ Midgely, MD, Oncology Clinical Trials Office, Oxford University, Oxford, United Kingdom, enough patients were randomised to detect a reduction of risk of recurrent colorectal cancer among the high-risk patients.

"We found no clear benefit for rofecoxib across intent-to-treat populations," added Dr. Midgely in a presentation on September 15.

There were 177 deaths (14.5%) among the rofecoxib patients and 191 (15.7%) among the placebo patients. The difference failed to approach significance (P = .57).

Overall, 291 recurrences (23.9%) occurred among the 1,217 patients who were assigned to treatment with rofecoxib and 316 recurrences (26%) among the 1,216 placebo patients (P = .25).

According to Dr. Midgely, there was an increase in the risk of thrombotic events among the patients taking rofecoxib.

Confirmed cardiovascular thrombotic events occurred in the treatment period or within 14 days of cessation -- 16 in the rofecoxib arm and 7 occurred in the placebo arm. Dr. Midgely said the difference was significant (P = .04) and translated to a 2.66 times increased risk of a thrombotic event if the patient was on placebo.

Funding for this study was provided by Merck & Co.

[Presentation title: VICTOR: A Phase III Placebo-Controlled Trial of Rofecoxib in Colorectal Cancer Patients Following Surgical Resection. Abstract LBA3]

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