Does Certificate of Need Minimize Intensity Modulated Radiation Therapy Use in Patients with Low Risk Prostate Cancer?

PURPOSE: Certificate of Need (CON) laws are optional from state to state, and are meant to limit proliferation of certain unnecessary medical facilities. Theoretically, CON should limit the use of IMRT (intensity modulated radiation therapy) in the population who likely would benefit from it the least: older or debilitated men with low risk prostate cancer. We evaluated the effect of CON on IMRT use in these patients in a population-based cohort. METHODS AND MATERIALS: Using the Surveillance, Epidemiology and End Results (SEER) database linked with Medicare files, we identified male residents of SEER regions who were diagnosed in 2004-2009 with low- risk prostate cancer (T1, Gleason≤6, PSA<10) and were either ≥70 years old or ≥65 years old with Charlson comorbidity score ≥ 2. The endpoint was percentage of newly diagnosed patients who were treated with IMRT within 12 month of cancer diagnosis. Logistic regression was used to assess the impact of CON laws on IMRT use. RESULTS: Over 37% (4,491) of the patients came from states with radiation oncology CON laws, whereas 63% (7,572) came from non-CON states. IMRT was performed on 30% of CON patients versus 28% of non-CON patients. Logistic regression analysis revealed that IMRT was utilized more often in CON states than in non-CON states, odds ratio (OR) 1.13 (95% CI 1.04-1.23, p=0.006). CONCLUSIONS: CON laws do not effectively limit use of IMRT in older or debilitated patients with low risk prostate cancer.

Severe genitourinary toxicity following radiation therapy for prostate cancer--how long does it last?

PURPOSE: Radiation therapy is a common treatment for localized prostate cancer but long-term data are sparse on treatment related toxicity compared to observation. We evaluated the time course of grade 2-4 genitourinary toxicities in men treated with primary radiation or observation for T1-T2 prostate cancer. MATERIALS AND METHODS: We performed a population based cohort study using Medicare claims data linked to SEER (Surveillance, Epidemiology and End Results) data. Cumulative incidence functions for time to first genitourinary event were calculated based on the competing risks model with death before any genitourinary event as a competing event. The generalized estimating equation method was used to evaluate the risk ratios of recurrent events. RESULTS: Of the study patients 60,134 received radiation therapy and 25,904 underwent observation. The adjusted risk ratio for genitourinary toxicity was 2.49 (95% CI 2.00-3.11) for 10 years and thereafter. Patients who had required prior procedures for obstruction/stricture, including transurethral prostate resection, before radiation therapy were at significantly increased risk for genitourinary toxicity (risk ratio 2.78, 95% CI 2.56-2.94). CONCLUSIONS: This study demonstrates that the increased risk of grade 2-4 genitourinary toxicities attributable to radiation therapy persists 10 years after treatment and thereafter. Patients who required prior procedures for obstruction/stricture were at higher risk for genitourinary toxicity than those without these preexisting conditions.

Late gastrointestinal toxicities following radiation therapy for prostate cancer.

BACKGROUND: Radiation therapy is commonly used to treat localized prostate cancer; however, representative data regarding treatment-related toxicities compared with conservative management are sparse. OBJECTIVE: To evaluate gastrointestinal (GI) toxicities in men treated with either primary radiation or conservative management for T1-T2 prostate cancer. DESIGN, SETTING, AND PARTICIPANTS: We performed a population-based cohort study, using Medicare claims data linked to the Surveillance Epidemiology and End Results data. Competing risk models were used to evaluate the risks. MEASUREMENTS: GI toxicities requiring interventional procedures occurring at least 6 mo after cancer diagnosis. RESULTS AND LIMITATIONS: Among 41,737 patients in this study, 28,088 patients received radiation therapy. The most common GI toxicity was GI bleeding or ulceration. GI toxicity rates were 9.3 per 1000 person-years after three-dimensional conformal radiotherapy, 8.9 per 1000 person-years after intensity-modulated radiotherapy, 5.3 per 1000 person-years after brachytherapy alone, 20.1 per 1000 person-years after proton therapy, and 2.1 per 1000 person-years for conservative management patients. Radiation therapy is the most significant factor associated with an increased risk of GI toxicities (hazard ratio [HR]: 4.74; 95% confidence interval [CI], 3.97-5.66). Even after 5 yr, the radiation group continued to experience significantly higher rates of new GI toxicities than the conservative management group (HR: 3.01; 95% CI, 2.06-4.39). Because our cohort of patients were between 66 and 85 yr of age, these results may not be applicable to younger patients. CONCLUSIONS: Patients treated with radiation therapy are more likely to have procedural interventions for GI toxicities than patients with conservative management, and the elevated risk persists beyond 5 yr.

Increase of cytosolic calcium induced by trichosanthin suppresses cAMP/PKC levels through the inhibition of adenylyl cyclase activity in HeLa cells.

Increase of cytosolic free calcium played a pivotal role in apoptotic cells induced by trichosanthin. However, little is known about the influence of cytosolic calcium increase on adenylyl cyclase activity and intracellular cAMP signaling pathway in HeLa cells. The present study showed that an influx of extracellular Ca2+ initiated by trichosanthin was required for the suppression of adenylyl cyclase activity and decrease of intracellular cAMP level. Furthermore, this inhibition was abolished by activation of PKC rather than PKA. Therefore, our results suggested that increase of cytosolic calcium induced by trichosanthin inhibits cAMP levels via suppression of adenylyl cyclase activity.

Longitudinal changes in sexual functioning as women transition through menopause: results from the Study of Women's Health Across the Nation.

OBJECTIVE: Sexual functioning is an important component of women's lives. The extent to which the menopausal transition is associated with decreased sexual functioning remains inconclusive. This study seeks to determine if advancing through the menopausal transition is associated with changes in sexual functioning. METHODS: This was a prospective, longitudinal cohort study of women aged 42 to 52 years at baseline recruited at seven US sites (N = 3,302) in the Study of Women's Health Across the Nation (SWAN). Cohort-eligible women had an intact uterus, had at least one ovary, were not currently using exogenous hormones, were either premenopausal or early perimenopausal, and self-identified as one of the study's designated racial/ethnic groups. Data from the baseline interview and six annual follow-up visits are reported. Outcomes are self-reported ratings of importance of sex; frequency of sexual desire, arousal, masturbation, sexual intercourse, and pain during intercourse; and degree of emotional satisfaction and physical pleasure. RESULTS: With adjustment for baseline age, chronological aging, and relevant social, health, and psychological parameters, the odds of reporting vaginal or pelvic pain increased and desire decreased by late perimenopause. Masturbation increased at early perimenopause but declined during postmenopause. The menopausal transition was unrelated to other outcomes. Health, psychological functioning, and importance of sex were related to all sexual function outcomes. Age, race/ethnicity, marital status, change in relationship, and vaginal dryness were also associated with sexual functioning. CONCLUSIONS: Pain during sexual intercourse increases and sexual desire decreases over the menopausal transition. Masturbation increases during the early transition, but then declines in postmenopause. With adjustment for other factors, the menopausal transition was not independently associated with reports of the importance of sex, sexual arousal, frequency of sexual intercourse, emotional satisfaction with partner, or physical pleasure.

The physician's office: can it influence adult immunization rates?

OBJECTIVE: To determine which office and patient factors affect adult influenza and pneumococcal vaccination rates. STUDY DESIGN: Patient interviews and self-administered surveys of office managers. PATIENTS AND METHODS: In a 2-stage random cluster sample, 22 practices in 4 strata (Veterans' Affairs, rural, urban/suburban, and inner city) and 15 patients per physician in each practice (n = 946) were selected. Office managers completed a questionnaire regarding office practices and logistics affecting immunizations. Data were examined using chi2 and regression analyses without and with patient factors in the models. RESULTS: Practice factors significantly related to influenza vaccination status were stratum (VA OR = 2.04; 95% CI = 1.18, 3.53; P < .05 vs inner-city), time allotted for acute care visits (16-20 min vs 10-15 min OR = 2.49; 95% CI = 1.68, 3.09; P < .001), the practice not having a source of free vaccines (OR = .43; 95% CI = .3, .62; P < .001), and the interaction between being an urban/suburban practice and having a source of free flu vaccines (OR = 4.0; 95% CI = 2.63, 6.09; P < .001). Practice factors related to pneumococcal vaccination status were the number of immunization promotion activities (> or = 3 vs 0-2 OR = 1.97; 95% CI = 1.33, 2.94; P = .002) and the time allotted for acute care visits (16-20 min vs 10-15 min OR = 1.94; 95% CI = 1.18, 3.19; P = .011). When practice and patient factors were combined in the analyses, patient factors were more important. CONCLUSION: Although patient factors are more important than practice factors, practices that allot more time for acute care visits and use more immunization promotion activities have higher vaccination rates.

Barriers to pneumococcal and influenza vaccination in older community-dwelling adults (2000-2001).

OBJECTIVES: To identify facilitators of and barriers to vaccination in patients from a range of socioeconomic levels. DESIGN: A survey was conducted in 2001 using computer-assisted telephone interviewing. SETTING: Patients from inner-city health centers and suburban practices were interviewed. PARTICIPANTS: Inclusion criteria were aged 66 and older and an office visit after September 30, 1998. MEASUREMENTS: Self-reported influenza and pneumococcal vaccination status and facilitating conditions, attitudes, social influences, and perceived consequences from the Triandis model were assessed. RESULTS: Overall, 557 interviews were completed with 775 eligible patients (72%). Patients who reported having received pneumococcal vaccine more frequently believed that their physicians recommended the vaccine than did the unvaccinated (97% vs 49%; P=.001). This was also true for influenza vaccine (99% vs 80%; P<.001). More unvaccinated patients than vaccinated patients felt that obtaining either vaccine was more trouble than it is worth (pneumococcal 19% vs 1%; P=.04, influenza 20% vs 1%; P=.004). The vaccinated were more likely to be willing to obtain the influenza and pneumococcal vaccines at the same time (pneumococcal 91% vs 59%; P=.002, influenza 91% vs 55%; P=.014). CONCLUSION: Physicians should take every opportunity to recommend vaccination to their eligible adult patients. Offering influenza and pneumococcal vaccines at the same visit is an acceptable means to ensure that adults are fully vaccinated.