Moving Beyond Guidelines to Improve the Quality of Care for Men With Prostate Cancer

Androgen deprivation therapy (ADT) was described more than 60 years ago as an effective treatment for reducing morbidity in men with metastatic prostate cancer. Over time, the increasing proportion of newly diagnosed men with localized disease (a consequence of ad hoc screening) motivated research into possible benefits of ADT for these men. Urologic oncologists now have robust data supporting specific indications for the use of ADT in men with localized disease. Men with high-risk disease undergoing radiation therapy derive a survival benefit from neoadjuvant ADT, whereas men undergoing radical prostatectomy do not. No robust data support ADT as being beneficial in primary therapy for localized prostate cancer, compared with other available modalities including watchful waiting. These observations have been codified into national practice guidelines, such as those promulgated by the National Comprehensive Cancer Network, to promote evidence-based oncologic care. As inquiries into ADT’s potential for benefit have delivered some answers, data have also accumulated describing the potential harms of ADT. Men receiving ADT as primary therapy for prostate cancer have lowered vitality scores, increased physical discomfort, and diminished sexual function compared with watchful waiting. Generally, ADT is associated with fatigue, hot flashes, decreased libido, decreased muscle mass, increased adiposity, and decreased quality of life scores. Other significant health effects include osteoporosis with a subsequent increased risk for fracture as well as a likely increased risk of diabetes and heart disease. Given these potential morbidities, ADT as primary treatment of low-risk prostate cancer may increase overall mortality in some men. In light of the documented risks of ADT, it seems logical that its use should be restricted to clinical settings in which a clear benefit has been demonstrated. However, in a previous study, Shahinian and colleagues used linked Surveillance, Epidemiology and End Results (SEER)Medicare data to demonstrate that the identity of the particular urologist who treats a patient with prostate cancer is a more important determinant of that patient’s likelihood of receiving ADT in the clinical setting. In this issue of the Journal, Shahinian and colleagues further characterize one element of the quality problem documented in their initial article. They ask the question, “If the identity of the urologist is a critical determinant of this form of cancer treatment, are particular urologists delivering care that has no basis in evidence?” They again turn to linked SEER-Medicare data in a retrospective, observational cohort study. Using the American Medical Association Physician Masterfile, Shahinian et al identified a cohort of men with incident prostate cancer in the SEER-Medicare linked data set and identified a variety of urologist characteristics that might predict practice consonant with evidence-based use of ADT. The primary hypothesis was that urologists who are strongly academically affiliated and those who are board certified would provide more evidence-based cancer care. In the overall cohort, patients of nonacademically affiliated urologists were more likely to receive ADT as part of their care. To bring the quality issue into focus, they divided the cohort of men into two groups: those with a clear, evidence-based indication for ADT use (locally advanced or high grade tumors in men undergoing radiation therapy) and those with no evidence-based indication (use of ADT as primary therapy for moderateor lowgrade localized disease). They found that urologists lacking academic affiliation were 1.7 times more likely to use ADT in a clinical scenario where harm may well outweigh benefit. Lack of board certification was not significantly associated with nonevidencebased usage, potentially due to problems with the statistical power of the study (only approximately 6% of urologists in the sample were not board certified). Reassuringly, board certification and academic affiliation did not change odds for receipt of ADT in the setting for which good evidence supports its use. Interestingly, in a time trend analysis, nonacademically affiliated urologists were more likely to use ADT in the evidence-based setting at the end of the time period under study. This may be due to financial incentives to use ADT, which was well-reimbursed at the time and could have had higher impact on nonacademic practices. Several hypotheses could be forwarded to explain some of the differences seen in this study, but it is important to note that even among academically affiliated or board-certified urologists, nearly one in three patients received ADT in the setting for which there was no proven benefit. Only about four in 10 patients of these urologists got ADT when it would likely have improved their survival. Shahinian et al cannot account for patient preferences for treatment with this data set; some patients may simply refuse ADT or, conversely, demand it for reasons of their own. However, other community-based work has documented widespread use of ADT in settings for which no benefit has been demonstrated, such as JOURNAL OF CLINICAL ONCOLOGY E D I T O R I A L VOLUME 25 NUMBER 34 DECEMBER 1 2007