If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Sunitinib Shows Promise in Patients With Advanced Renal Cancer, Poor Prognosis NEW YORK -- July 15, 2009 -- Sunitinib prolongs progression-free and overall survival, and is safe and well tolerated in patients with advanced/metastatic renal cell carcinoma who have a poor prognosis such as the elderly and those whose cancer has spread to the brain, according to a study published online first and in the August edition of The Lancet Oncology. In previous trials sunitinib has shown clear benefit in patients with advanced renal cell carcinoma. However, certain patients with renal cancer -- often those with a poor prognosis such as those whose cancer has spread to the brain, those with a poor performance status (PS), and the elderly -- are often excluded or inadequately represented in clinical trials. Thus, little is known about the activity, safety, and tolerability of sunitinib in these patients. To resolve this uncertainty, Martin Gore, MD, Royal Marsden Hospital, Fulham Road, London, United Kingdom, and colleagues conducted an international expanded-access trial including subgroups of patients with advanced renal cancer not usually entered into clinical trials, or those being treated in countries where the drug is not yet approved who would not normally receive the drug. In total, 4,564 patients from 52 countries were recruited between June 2005 and December 2007. These included 4 subgroups of patients with brain metastases (n = 321), poor performance status (n = 582), non-clear-cell renal cell carcinoma (n = 588), and patients aged 65 years or older (n = 1,418). Patients received sunitinib 50 mg once daily in repeated 6-week cycles of 4 weeks of treatment followed by 2 weeks off. Tumour response, toxicity, and adverse events were assessed at regular intervals. Overall, findings showed that sunitinib can be given safely and is well tolerated in all 4 subgroups of patients that might be expected to have a lower tolerance to therapy than the broader advanced renal cancer patient population. The safety profile was found to be very similar to that reported in previous trials and the overall incidence of adverse events (AEs) was slightly less. The most common treatment-related AEs were diarrhoea (44%) and fatigue (37%). Importantly, there were no differences in incidences of grade 3 and 4 AEs between the overall population and patients with brain metastases, poor PS, non-clear RCC, and the elderly, with fatigue (8%) and thrombocytopenia (8%) reported as the most common. Median progression-free and overall survival were 10.9 and 18.4 months respectively, an improvement on historical data. The overall objective response rate (ORR) was 17%, with all 4 subgroups showing clear evidence of response; brain metastases (12%), non-clear RCC (11%), poor PS (9%), and the elderly (17%). The authors said that these results should "encourage the study of targeted agents in subgroups of patients otherwise excluded from trials and therefore potentially disadvantaged." In an accompanying editorial, Joaquim Bellmunt, MD, Hospital del Mar, Barcelona, Spain, and Toni K Choueiri, MD, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts, said: "As with sorafenib, the safety and efficacy of sunitinib in an older population are confirmed and evidence shows that age alone should not be a deterrent from attempting therapy." "However, patients with brain metastases, non-clear-cell histology, and poor performance status benefit less from sunitinib, despite good drug tolerance, suggesting the need for prospective studies in these subpopulations," they continued. "Thus, claiming sunitinib as a 'standard' in these subgroups remains controversial. An oncologist might not have access to such trials in practice, however, and based on available information the use of sunitinib may be justified in these subpopulations." SOURCE: The Lancet Oncology
|
