Clinical Abstracts From Overseas

By Stanton R. Mehr
Published: Friday, May 21, 2010


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MULTIPLE SITES FROM AROUND THE WORLD


Effects of Preoperative Radiotherapy on Quality of Life

A randomized trial of 1350 patients with rectal cancer from Canada, New Zealand, South Africa, and the United Kingdom found that preoperative radiotherapy reduced the risk of recurrence but increased sexual dysfunction and bowel leakage.

Patients received either 1 week of radiation (25 Gy) prior to surgery or surgery followed by selective chemoradiation (45 Gy, 25 exposures over 5 wk) in patients with positive margins. The study noted a 4% reduction in the 3-year rate of recurrence for patients in the preoperative radiation arm compared with 11% for patients undergoing chemoradiation postoperatively. Additionally, the 5-year recurrence-free survival rate was higher in patients who underwent preoperative radiation.

Using questionnaires, researchers assessed patients’ quality of life over a 3-year period following completion of treatment. They obtained a baseline score at initiation of therapy and administered additional surveys every 3 months following treatment in the first year, then every 6 months for the remaining 2 years. Higher scores correlated to worse functioning.

At 3 months’ follow-up, both groups reported decreased physical functioning and male sexual function. At 6 months, men in the preoperative radiotherapy group reported poorer sexual function than men who underwent postoperative chemoradiation, and this trend persisted for the remainder of the study period. Although overall ratings of bowel function remained the same between both groups, patients who had preoperative radiotherapy reported a higher incidence of bowel incontinence, with 16.4% reporting that they had experienced “quite a bit” or “very much” unintentional release of stools, compared with 6.5% in the postoperative group (P = .003). Although the rate dropped at 24 months’ assessment, it remained higher for the preoperative therapy group.

Results may be affected by declining participation; 87% of patients participated at baseline, dropping to 43% by the end of the 3-year period. The study’s results indicate, however, that patients and their physicians must weigh the benefits of improved rate of recurrence- free survival associated with preoperative radiotherapy against the increased risks of diminished sexual and bowel function postoperatively.


Sebag-Montefiore D, et al. The impact of short course pre-operative radiotherapy on patients’ quality of life: data from the MRC CR07/NCIC CO16 randomised clinical trial in patients with rectal cancer. In: Proceedings from the 50th Annual Meeting of the American Society for Therapeutic Radiology and Oncology; September 22, 2008; Boston, MA; Abstract 61.




SWEDEN

How Countries in the European Union Rate on Uptake of New Oncology Agents

The speed at which member countries of the European Union approve marketing of the newest oncology agents—which are usually biologics—varies from country to country. Researchers from the Karolinska Institute, Stockholm, Sweden, used sales data from IMS Health Inc to track the uptake of newer agents across 27 countries over a 10-year period. The United Kingdom appeared to be the slowest in introducing new oncology drugs and consequently had the lowest use. The study suggests this is probably because of a provision that requires the National Institute for Cost Effectiveness to qualify the agent for coverage first.

Austria, Switzerland, and France demonstrated relatively quick access to the newest oncology products. The study observed the greatest use of new agents in France. At the start of the decade being evaluated, Spain appeared to introduce new products promptly, but over time, researchers report, this trend slowed somewhat. The study notes that although one might intuitively link the introduction of new products to improved clinical status and better cancer outcomes, a separate study that included detailed epidemiologic data would be needed to determine whether any correlation existed.


Wilking N. European disparities in access to cancer drugs. Paper presented at: 33rd European Society for Medical Oncology Congress; the annual meeting of the European Society for Medical Oncology; September 2008; Stockholm, Sweden.




CANADA

Undiagnosed Cancer in Patients with Unprovoked Thromboembolism

We know that patients with malignant tumors are at high risk for experiencing a venous thromboembolism (VTE). Is the reverse also true? Could an undiagnosed tumor be the cause of an unprovoked VTE? Researchers from the University of Ottawa conducted a retrospective review to quantify the risk of cancer in seemingly cancer-free patients who suffer a VTE. They also wanted to determine whether a VTE should be viewed as an indication that intensive cancer screening is warranted.

Researchers evaluated 36 studies concerning patients with a newly diagnosed unprovoked VTE and the prevalence of occult cancer diagnosed at baseline and at 6 and 12 months following VTE. The literature review also encompassed 14 articles and 1 abstract that met inclusion criteria for evaluating the benefit of limited cancer screening versus comprehensive testing in individuals with a VTE.


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