In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 34, No. 2_suppl ( 2016-01-10), p. 120-120
Abstract:
120 Background: Late radiation induced rectal injury remains an issue. Large population based studies indicate an incidence of at least 15%. Statins have been shown to reduce the risk of late radiation injury in animal models. The purpose of this study was to prospectively test lovastatin as a potential protector against radiation induced rectal injury, particularly bleeding. Methods: Eligible patients included men with adenocarcinoma of the prostate who were to be treated with radiation therapy with curative intent. Patients receiving primary radiation therapy (external beam alone, brachytherapy alone, or a combination of both) or post-prostatectomy radiation were eligible, as long as the minimum dose to the rectum was 60 Gy. Patients began lovastatin 20-80 mg/d on day 1 of radiation. Lovastatin was continued for 1 year and patients were followed for an additional year. Patients were seen at 1, 2, 4, 6, 9, 12, 18, 21 and 24 months after treatment. At each follow-up, they were assessed for GI, GU and erectile complications using both patient reported (IIEF, EPIC) and physician reported (CTCAE v3) instruments. The primary endpoint of the study was the incidence of rectal bleeding at 24 months (Grade 2 or higher). Results: From April 2007 through May 2013, 73 patients were enrolled. 21 patients either withdrew or were removed from the study due to noncompliance with the lovastatin regimen or toxicity from the drug. Patients who withdrew or were removed were replaced, in order to achieve the target number of 53 evaluable patients with complete 2-year follow-up. A total of 50 patients are evaluable. All but 2/50 evaluable patients achieved the 24-month follow-up goal. At 24 months, there were a total of 4 patients with rectal bleeding attributable to radiation; 3 were grade 2 and 1 was grade 3 (4/48=8%). Conclusions: The incidence of rectal bleeding at 2 years in this population of patients receiving lovastatin during and after radiation therapy for prostate cancer was less than expected based on historical controls. These data suggest that statins may be useful to protect patients from radiation induced rectal injury. Clinical trial information: NCT00580970.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2016.34.2_suppl.120
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2016
detail.hit.zdb_id:
2005181-5
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