Richard M. Hoffman

Long-Term Functional Outcomes after Treatment for Localized Prostate Cancer

BACKGROUND The purpose of this analysis was to compare long-term urinary, bowel, and sexual function after radical prostatectomy or external-beam radiation therapy. METHODS The Prostate Cancer Outcomes Study (PCOS) enrolled 3533 men in whom prostate cancer had been diagnosed in 1994 or 1995. The current cohort comprised 1655 men in whom localized prostate cancer had been diagnosed between the ages of 55 and 74 years and who had undergone either surgery (1164 men) or radiotherapy (491 men). Functional status was assessed at baseline and at 2, 5, and 15 years after diagnosis. We used multivariable propensity scoring to compare functional outcomes according to treatment. RESULTS Patients undergoing prostatectomy were more likely to have urinary incontinence than were those undergoing radiotherapy at 2 years (odds ratio, 6.22; 95% confidence interval [CI], 1.92 to 20.29) and 5 years (odds ratio, 5.10; 95% CI, 2.29 to 11.36). However, no significant between-group difference in the odds of urinary incontinence was noted at 15 years. Similarly, although patients undergoing prostatectomy were more likely to have erectile dysfunction at 2 years (odds ratio, 3.46; 95% CI, 1.93 to 6.17) and 5 years (odds ratio, 1.96; 95% CI, 1.05 to 3.63), no significant between-group difference was noted at 15 years. Patients undergoing prostatectomy were less likely to have bowel urgency at 2 years (odds ratio, 0.39; 95% CI, 0.22 to 0.68) and 5 years (odds ratio, 0.47; 95% CI, 0.26 to 0.84), again with no significant between-group difference in the odds of bowel urgency at 15 years. CONCLUSIONS At 15 years, no significant relative differences in disease-specific functional outcomes were observed among men undergoing prostatectomy or radiotherapy. Nonetheless, men treated for localized prostate cancer commonly had declines in all functional domains during 15 years of follow-up. (Funded by the National Cancer Institute.).

Quality-of-life outcomes after primary androgen deprivation therapy: results from the prostate cancer outcomes study

PURPOSE To compare health-related quality-of-life outcomes after primary androgen deprivation (AD) therapy with orchiectomy versus luteinizing hormone-releasing hormone (LHRH) agonists for patients with prostate cancer. PATIENTS AND METHODS Men (n = 431) newly diagnosed with all stages of prostate cancer from six geographic regions who participated in the Prostate Cancer Outcomes Study and who received primary AD therapy but no other treatments within 12 months of initial diagnosis were included in a study of health outcomes. Comparisons were statistically adjusted for patient sociodemographic and clinical characteristics, timing of therapy, and use of combined androgen blockade. RESULTS More than half of the patients receiving primary AD therapy had been initially diagnosed with clinically localized prostate cancer. Among these patients, almost two thirds were at high risk of progression on the basis of prognostic factors. Sexual function outcomes were similar by treatment group both before and after implementation of AD therapy. LHRH patients reported more breast swelling than did orchiectomy patients (24.9% v 9.7%, P <.01). LHRH patients reported more physical discomfort and worry because of cancer or its treatment than did orchiectomy patients. LHRH patients assessed their overall health as fair or poor more frequently than did orchiectomy patients (35.4% v 28.1%, P =.01) and also were less likely to consider themselves free of prostate cancer after treatment. CONCLUSION Most endocrine-related health outcomes are similar after surgical versus medical primary hormonal therapy. Stage at diagnosis had little effect on outcomes. These results provide representative information comparing surgical and medical AD therapy that may be used by physicians and patients to inform treatment decisions.

General Quality of Life 2 Years Following Treatment for Prostate Cancer: What Influences Outcomes? Results From the Prostate Cancer Outcomes Study

PURPOSE The goal of this study was to determine the relationship between primary treatment, urinary dysfunction, sexual dysfunction, and general health-related quality of life (HRQOL) in prostate cancer. METHODS A sample of men with newly diagnosed prostate cancer between 1994 and 1995 was randomly selected from six population-based Surveillance, Epidemiology, and End Results registries. A baseline survey was completed by 2,306 men within 6 to 12 months of diagnosis, and these men also completed a follow-up HRQOL survey 2 years after diagnosis. Logistic regression models were used to determine whether primary treatment, urinary dysfunction, and sexual dysfunction were independently associated with general HRQOL outcomes approximately 2 years after diagnosis as measured by the Medical Outcomes Study 36-item Short Form Health Survey. The magnitude of this effect was estimated using least square means models. RESULTS After adjustment for potential confounders, primary treatment was not associated with 2-year general HRQOL outcomes in men with prostate cancer. Urinary function and bother were independently associated with worse general HRQOL in all domains. Sexual function and bother were also independently associated with worse general HRQOL, although the relationship was not as strong as in the urinary domains. CONCLUSION Primary treatment is not associated with 2-year general HRQOL outcomes in prostate cancer. Although both sexual and urinary function and bother are associated with quality of life, men who are more bothered by their urination or impotence are more likely to report worse quality of life. This implies that future research should be directed toward finding ways to improve treatment-related outcomes or help patients better cope with their posttreatment urinary or sexual dysfunction.

Surgery for herniated lumbar discs: a literature synthesis.

Objective: To assess the risks and benefits of surgery for herniated lumbar discs (discectomy) and to evaluate the methodologic quality of the literature.Design: Literature synthesis.Study selection and data analysis: A structured MEDLINE search identified studies of standard, microsurgical, or percutaneous discectomy. Eligible studies had adult subjects, sample sizes of ≥30, clinical outcome data for ≥75% of patients, and follow-up of ≥1 year. Summary rates of successful outcomes, reoperations, and complications were obtained by a random-effects logistic regression model. Methodologic quality was assessed using established study design criteria.Results: Eighty-one studies met inclusion criteria. Most had substantial design flaws and/or omitted important clinical data. Randomized trials of standard discectomy showed better short-term sciatica relief following surgery; 65% to 85% of patients reported no sciatica one year after surgery, compared with only 36% of conservatively treated patients. No data from randomized trials were available for microdiscectomy or percutaneous discectomy, although most outcomes appeared comparable to those of standard discectomy. Approximately 10% of discectomy patients underwent further back surgery, and rates increased over time. The rate of serious complications, including death and permanent neurologic damage, was less than 1%.Conclusions: Most studies were poorly designed and reported. Standard discectomy appears to offer better short-term outcomes than does conservative treatment, but long-term outcomes are similar. Discectomies are relatively safe procedures, though reoperations are common and increase over time. Decisions for elective surgery must balance faster pain relief against the risks and costs of surgery.Objective: To assess the risks and benefits of surgery for herniated lumbar discs (discectomy) and to evaluate the methodologic quality of the literature. Design: Literature synthesis. Study selection and data analysis: A structured MEDLINE search identified studies of standard, microsurgical, or percutaneous discectomy. Eligible studies had adult subjects, sample sizes of ≥30, clinical outcome data for ≥75% of patients, and follow-up of ≥1 year. Summary rates of successful outcomes, reoperations, and complications were obtained by a random-effects logistic regression model. Methodologic quality was assessed using established study design criteria. Results: Eighty-one studies met inclusion criteria. Most had substantial design flaws and/or omitted important clinical data. Randomized trials of standard discectomy showed better short-term sciatica relief following surgery; 65% to 85% of patients reported no sciatica one year after surgery, compared with only 36% of conservatively treated patients. No data from randomized trials were available for microdiscectomy or percutaneous discectomy, although most outcomes appeared comparable to those of standard discectomy. Approximately 10% of discectomy patients underwent further back surgery, and rates increased over time. The rate of serious complications, including death and permanent neurologic damage, was less than 1%. Conclusions: Most studies were poorly designed and reported. Standard discectomy appears to offer better short-term outcomes than does conservative treatment, but long-term outcomes are similar. Discectomies are relatively safe procedures, though reoperations are common and increase over time. Decisions for elective surgery must balance faster pain relief against the risks and costs of surgery.

Decision-making processes for breast, colorectal, and prostate cancer screening: the DECISIONS survey.

Background Patients should understand the risks and benefits of cancer screening in order to make informed screening decisions. Objectives To evaluate the extent of informed decision making in patient-provider discussions for colorectal (CRC), breast (BrCa), and prostate (PCa) cancer screening. Setting National sample of US adults identified by random-digit dialing. Design Cross-sectional survey conducted between November 2006 and May 2007. Participants English-speaking US adults aged 50 y and older who had discussed cancer screening with a health care provider within the previous 2 y. Measurements Cancer screening survey modules that asked about demographic characteristics, cancer knowledge, the importance of various sources of information, and self-reported cancer screening decision-making processes. Results Overall, 1082 participants completed 1 or more of the 3 cancer modules. Although participants generally considered themselves well informed about screening tests, half or more could not correctly answer even 1 open-ended knowledge question for any given module. Participants consistently overestimated risks for being diagnosed with and dying from each cancer and overestimated the positive predictive values of prostate-specific antigen tests and mammography. Providers were the most highly rated information source, usually initiated screening discussions (64%–84%), and often recommended screening (73%–90%). However, participants reported that providers elicited their screening preferences in only 31% (CRC women) to 57% (PCa) of discussions. Although more than 90% of the discussions addressed the pros of screening, only 19% (BrCa) to 30% (PCa) addressed the cons of screening. Limitations Recall bias is possible because screening process reports were not independently validated. Conclusions Cancer screening decisions reported by patients who discussed screening with their health care providers consistently failed to meet criteria for being informed. Given the high ratings for provider information and frequent recommendations for screening, providers have important opportunities to ensure that informed decision making occurs for cancer screening decisions.

Screening for Prostate Cancer

Current recommendations for prostate-specific antigen testing are reviewed, as well as the initial results of two randomized trials. The potential risks of screening, including morbidity from overdiagnosis and overtreatment, are described.

Health Outcomes After External-Beam Radiation Therapy for Clinically Localized Prostate Cancer: Results From the Prostate Cancer Outcomes Study

PURPOSE Studies reporting effects of radiotherapy for prostate cancer on sexual, bowel, and urinary function have been conducted primarily in referral centers or academic institutions. Effects of external-beam radiotherapy for prostate cancer among a population-based cohort were assessed. PATIENTS AND METHODS The study population included 497 white, Hispanic, and African-American men with localized prostate cancer from six US cancer registries who were diagnosed between October 1, 1994, and October 31, 1995, and treated initially with external-beam radiotherapy. They were interviewed at regular intervals, and medical records were reviewed. Distributions of responses for bowel-, urinary-, and sexual-related functions at 6, 12, and 24 months after diagnosis and adjusted mean composite change scores for each domain were analyzed. RESULTS Declines of 28.9% in the sexual function score and 5.4% in the bowel function score occurred by 24 months, whereas at this time, the urinary function score was relatively unchanged. A total of 43% of those who were potent before diagnosis became impotent after 24 months. More than two thirds of the men were satisfied with their treatment and would make the same decision again. CONCLUSION Sexual function was the most adversely affected quality-of-life domain, with problems continuing to increase between 12 and 24 months. Bowel function problems increased at 6 months, with partial resolution observed by 24 months. Despite the side effects, satisfaction with therapy was high. These results are representative of men in community practice settings and may be of assistance to men and to clinicians when making treatment decisions.

Prostate cancer screening decisions: Results from the National Survey of Medical Decisions (DECISIONS study)

BACKGROUND Guidelines recommend informing patients about the risks and benefits of prostate cancer screening. We evaluated the medical decision-making process for prostate-specific antigen (PSA) testing. METHODS We conducted a telephone survey of a randomly selected national sample of 3010 English-speaking US adults 40 years and older. Included in the survey were 375 men who had either undergone or discussed (with health care providers [HCPs]) PSA testing in the previous 2 years. We asked subjects about sociodemographic characteristics, prostate cancer screening discussion features, prostate cancer knowledge, and the importance of various decision factors and sources of information. RESULTS Overall, 69.9% of subjects discussed screening before making a testing decision, including 14.4% who were not tested. Health care providers most often (64.6%) raised the idea of screening, and 73.4% recommended PSA testing. Health care providers emphasized the pros of testing in 71.4% of discussions but infrequently addressed the cons (32.0%). Although 58.0% of subjects felt well-informed about PSA testing, 47.8% failed to correctly answer any of the 3 knowledge questions. Only 54.8% of subjects reported being asked for their screening preferences. An HCP recommendation (odds ratio, 2.67; 95% confidence interval, 1.08-6.58) was the only discussion characteristic associated with testing. Valuing HCP information was also associated with testing (odds ratio, 1.26; 95% confidence interval, 1.04-1.54). CONCLUSIONS Recommendations and information from HCPs strongly influenced testing decisions. However, most prostate cancer screening decisions did not meet criteria for shared decision making because subjects did not receive balanced discussions of decision consequences, had limited knowledge, and were not routinely asked for their preferences.

Effect of Age, Tumor Risk, and Comorbidity on Competing Risks for Survival in a U.S. Population–Based Cohort of Men With Prostate Cancer

BACKGROUND Accurate estimation of life expectancy is essential to offering appropriate care to men with early-stage prostate cancer, but mortality risks associated with comorbidity are poorly defined. OBJECTIVE To determine the effect of age, comorbidity, and tumor risk on other-cause and prostate cancer-specific mortality in men with early-stage disease. DESIGN Prospective cohort study. SETTING A nationally representative, population-based cohort. PATIENTS 3183 men with nonmetastatic prostate cancer at diagnosis. MEASUREMENTS Baseline self-reported comorbidity (scored as a count of 12 major comorbid conditions), tumor characteristics, initial treatment, and overall and disease-specific mortality through 14 years of follow-up. Survival analyses that accounted for competing risks were performed. RESULTS Fourteen-year cumulative other-cause mortality rates were 24%, 33%, 46%, and 57% for men with 0, 1, 2, and 3 or more comorbid conditions, respectively. For men diagnosed at age 65 years, subhazard ratios for other-cause mortality among those with 1, 2, or 3 or more comorbid conditions (vs. none) were 1.2 (95% CI, 1.0 to 1.4), 1.7 (CI, 1.4 to 2.0), and 2.4 (CI, 2.0 to 2.8), respectively. Among men with 3 or more comorbid conditions, 10-year other-cause mortality rates were 26%, 40%, and 71% for those aged 60 years or younger, 61 to 74 years, and 75 years or older at diagnosis, respectively. Prostate cancer-specific mortality was minimal in patients with low-risk (3%) and intermediate-risk (7%) disease but appreciable in those with high-risk disease (18%) and did not vary by number of comorbid conditions (10% to 11% in all groups). LIMITATION Comorbid conditions were self-reported. CONCLUSION Older men with multiple major comorbid conditions are at high risk for other-cause mortality within 10 years of diagnosis and should consider this information when deciding between conservative management and aggressive treatment for low- or intermediate-risk prostate cancer. PRIMARY FUNDING SOURCE National Cancer Institute.

LASER PROSTATECTOMY VERSUS TRANSURETHRAL RESECTION FOR TREATING BENIGN PROSTATIC OBSTRUCTION: A SYSTEMATIC REVIEW

PURPOSE We conducted a systematic review of randomized controlled trials evaluating the efficacy and safety of laser prostatectomy techniques compared to transurethral resection of the prostate for symptomatic benign prostatic obstruction. MATERIALS AND METHODS We searched MEDLINE, the Cochrane library and reference lists of retrieved studies to identify randomized trials of 6 months or greater in duration with at least 10 subjects in each treatment arm. We extracted data on study design, subject and treatment characteristics, adverse events, urinary symptoms and urinary flow. RESULTS A total of 16 studies involving 1,488 subjects were evaluated, including 8 comparisons of transurethral resection with contact lasers, 7 with noncontact lasers and 4 with hybrid techniques. Study duration ranged from 6 to 36 months. Mean patient age (67.4 years), baseline symptom score (20.2) and peak urinary flow (9.5 ml. per second) did not differ by treatment group. Transurethral resection of the prostate provided slightly greater improvement in urinary symptoms and flow. The pooled mean percentage improvement for urinary symptoms ranged from 59% to 68% with lasers and 63% to 77% with transurethral resection. Improvement for peak urinary flow ranged from 56% to 119% with lasers and 96% to 127% with transurethral resection of the prostate. Laser procedures resulted in fewer transfusions (less than 1% versus 7%) and strictures (0% to 7% versus 8%), and required shorter hospitalizations. Reoperation occurred more often (RR = 5.7) following laser procedures. CONCLUSIONS Laser techniques are a useful alternative to transurethral resection of the prostate for treating benign prostatic obstruction. Small sample sizes and differences in study design limit any definitive conclusions regarding the preferred type of laser technique.