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A Phase II Study to Prevent Radiation-induced Rectal Injury With Lovastatin

Anscher, Mitchell, S., MD*; Chang, Michael, G., MD*,†; Moghanaki, Drew, MD*,†; Rosu, Mihaela, PhD*; Mikkelsen, Ross, B., PhD*; Holdford, Diane, RN; Skinner, Vicki, RN; Grob, Baruch, M., MD§; Sanyal, Arun, MD; Wang, Aiping, MS; Mukhopadhyay, Nitai, D., PhD

American Journal of Clinical Oncology: June 2018 - Volume 41 - Issue 6 - p 544–548
doi: 10.1097/COC.0000000000000320
Original Articles: Genitourinary

Purpose: Physician reported symptomatic late rectal injury occurs in about 5% to 25% of patients treated with radiation therapy for prostate cancer, depending on the treatment technique. Patients, however, report clinically meaningful declines in bowel/rectal function regardless of the technique used. Lovastatin has been shown to protect mice from late radiation injury. This study was designed to determine if lovastatin might reduce the incidence of late rectal injury in patients receiving radiation therapy for prostate cancer.

Materials and Methods: Patients with adenocarcinoma of the prostate receiving radiotherapy with curative intent were eligible. A portion of the rectum had to receive at least 60 Gy. Gastrointestinal functioning was assessed using both physician-reported and patient-reported instruments at baseline and at prescribed intervals during and after treatment. Lovastatin (20 to 80 mg/d) was started on day 1 of radiation and continued for 12 months. Patients were followed for an additional 12 months. The primary endpoint was physician-reported rectal toxicity ≥grade 2 during the first 2 years after treatment.

Results: A total of 20/53 (38%) patients developed grade 2 or higher toxicity during the 2-year follow-up period. Seventeen patients had 1 or more unresolved gastrointestinal symptom at the end of 2 years, 3 (6%) of which were grade 2 and none were of higher grade.

Conclusions: The primary endpoint of the study was not met. Lovastatin, as administered in this trial, did not reduce the incidence of grade 2 or higher rectal toxicity compared with historical controls.

Departments of *Radiation Oncology

§Surgery

Medicine

Biostatistics

The Massey Cancer Center, Virginia Commonwealth University

Hunter Holmes McGuire Veterans Affairs Medical Center, Richmond, VA

Supported by the Department of Radiation Oncology and the Massey Cancer Center (2P30CA016059-31), Virginia Commonwealth University.

The authors declare no conflicts of interest.

Reprints: Mitchell S. Anscher, MD, Department of Radiation Oncology, VCU Medical Center, 401 College Street, P.O. Box 980058, Richmond, VA 23298-0058. E-mail: mitchell.anscher@vcuhealth.org.

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