Patients' preferences for adjuvant sorafenib after resection of renal cell carcinoma in the SORCE trial: what makes it worthwhile?

Background: We sought to determine the survival benefits that patients judged sufficient to warrant adjuvant therapy with sorafenib for 1 year, or for 3 years after resection of renal cell carcinoma in the SORCE trial. Methods: SORCE participants from all sites in Australia and New Zealand, and selected sites in the UK, completed a validated preferences questionnaire at months 0, 3, 15, and 42 to elicit the minimum survival benefits they judged sufficient to warrant adjuvant sorafenib for 1 year (versus observation), or for 3 years (versus 1 year). The questionnaires used reference survival times of 5 and 15 years; and reference survival rates at 5 years of 65% and 85%. Results: The 233 participants had a median age of 57 years (range 29-78) and 71% were male. For 1 year of sorafenib versus no adjuvant therapy, the median benefits in survival times judged sufficient to warrant treatment were an extra 9 months beyond 5 years and an extra 1 year beyond 15 years; the median benefit in survival rates were an extra 4% beyond 65% and an extra 3% beyond 85% at 5 years. For 3 years of sorafenib versus 1 year of sorafenib, the median benefit in survival time judged sufficient to warrant extended treatment was an extra 1 year beyond both 5 and 15 years. Participants randomly allocated to treatment with sorafenib judged larger benefits necessary than those allocated to placebo. Participants' preferences were not associated with their baseline characteristics or the interval from randomisation. Conclusion: Most participants judged an extra year of survival necessary to warrant 1 year of adjuvant sorafenib worthwhile, and an additional year of survival to warrant extending the duration of sorafenib from 1 to 3 years. Patients' preferences are important in shared decision making. SORCE trial clinical trials number: NCT00492258.

The effects of nedocromil sodium on the response to grain dust in West Australian grain workers.

Seasonal grain workers in Western Australia who develop respiratory symptoms after exposure to grain dust develop concomitant changes in lung function and bronchial responsiveness to methacholine. The mechanisms underlying these changes are not known. A detailed study was undertaken of seasonal grain workers in Western Australia to evaluate the effect of nedocromil sodium (Fisons, United Kingdom) on these changes to see if they could be prevented by this drug. Forty seven subjects participated. Symptoms and forced expiratory volume in one second (FEV1) were recorded before the study and before, during, and after each working shift, and bronchial responsiveness to methacholine was measured at the beginning and end of the study. Twenty three subjects received nedocromil and 22 received a placebo in a double blind design; there was no difference in baseline characteristics between the two groups. At the end of the study, no differences were found between the nedocromil and placebo groups in the prevalence of symptoms or development of new symptoms during the study. The drug had no effect on changes in methacholine PD20 or FEV1. As in previous studies, new symptoms developing during the season were more common in atopic subjects and were associated with a fall in methacholine PD20. It is concluded that nedocromil has no effect on the development of new symptoms in grain workers. The mechanisms underlying these symptoms require further study.