BACKGROUND.Differences in cancer survival based on race, ethnicity, and socioeconomic status (SES) are a major issue. To identify points of intervention and improve survival, the authors sought to determine the impact of race, ethnicity, and socioeconomic status for patients with cancers of the head and neck (HN).METHODS.HN cancer patients diagnosed between 1998 and 2002 were examined using a linked Florida Cancer Data System and Florida Agency for Health Care Administration data set.RESULTS.A total of 20,915 patients with HN cancers were identified, predominantly in the oral cavity and larynx. Overall, 72% of patients were male, 89.7% were white, 8.4% were African American (AA), and 10.6% were Hispanic. The median survival time (MST) was 37 months. MST varied significantly by race (white, 40 months vs AA, 21 months; P < .001), sex (men, 36 months vs women, 41 months; P = .001), and area poverty level (lowest, 27 months vs highest, 34 months; P < .0001). Only 32% of AA patients underwent surgery in comparison with 45% of white patients (P < .001). On multivariate analysis, independent predictors of poorer outcomes were race, poverty, age, sex, tumor site, stage, grade, treatment modality, and a history of smoking and alcohol consumption.CONCLUSIONS.Carcinomas of the HN have an overall high mortality with a disproportionate impact on AA patients and the poor. Dramatic disparities by race and SES are not explained completely by demographics, comorbid conditions, or undertreatment. Earlier diagnosis and greater access to surgery and adjuvant therapies in these patients would likely yield significant improvement in outcomes. Cancer 2008. © 2008 American Cancer Society.
PGIM occurs most often in the oral-nasopharynx and anal canal. Surgical extirpation is the only identifiable treatment modality that significantly improves survival.
The objective of this study was to define the prognostic significance of surgical center case volume on outcome for head and neck cancer (HNC). Florida cancer registry and inpatient hospital data were queried for HNC diagnosed from 1998 to 2002. Of the 11,160 operative cases of HNC identified, 35.3% were treated at low-volume centers (LVCs), 32.7% in intermediate-volume centers (IVC), and 32.1% at high-volume centers (HVC). A larger proportion of high-grade tumors (27.9%) and lesions over 30 mm (39.7%) were resected at HVC (p < 0.001). Median survival was 61 months for HVC, 52 months for IVC, and 47 months for LVC (p < 0.001). Univariate analysis demonstrated significantly improved survival at HVC for low-, medium-, and high-grade tumors, small tumors (<30 mm), and for cancers of the parotid, larynx, and pharynx. On multivariate analysis, corrected for patient comorbidities, treatment at a HVC was a significant independent predictor of improved survival (HR = 1.25, p = 0.001). We conclude that HNC patients treated at HVC have significantly better long-term survival and cure rates. Where possible, patients with large (>30 mm), high-grade or parotid, larynx, and pharynx tumors should be evaluated and offered care at a high-volume center.
Lumpectomy specimens are commonly divided into six sides: superficial, deep, superior, inferior, medial, and lateral. Orienting stitches are placed on the specimen during surgery to allow reorientation by pathology. Despite those efforts, specimen disorientation may occur. The aim of this study was to assess the correlation in orientation between surgeons and pathologists. Lumpectomy specimens were routinely oriented. An additional Prolene suture was randomly placed by the surgeon on one side to be localized by pathology. The results were recorded and the disorientation rate calculated. Specimen size and presence of skin and/or muscle were also recorded. There were 122 lumpectomy specimens prospectively entered. Average specimen volume was 95.5 cm(3). Twenty-four specimens had segments of skin or muscle. The additional sutures were evenly divided between the six sides. The overall disorientation rate was 31.1% (95% confidence interval, 23.1-40.2).The side-specific disorientation rates were 43%, 40%, 35%, 29%, 28%, and 14% for the deep, superficial, lateral, medial, superior, and inferior surfaces, respectively (no statistical difference). Presence of skin or muscle on the specimen did not contribute to better orientation. Specimen volumes, however, were highly associated with orientation. Specimens of <20 cm(3) had a disorientation rate of 78%, while larger specimen had a disorientation rate of 20% (p < .001). Specimen orientation with stitches placed on two surfaces is associated with a high disorientation rate. Better orientation techniques are necessary to minimize the specimen disorientation.
Purpose:We assessed the safety and efficacy of 2 injections of platelet-rich plasma for treating mild to moderate erectile dysfunction by conducting a prospective, randomized, double-blind, placebo-controlled clinical trial.Materials and Methods:Men with mild to moderate erectile dysfunction (International Index of Erectile Function scores 11-25) were randomized to receive either 2 injections of platelet-rich plasma or placebo separated by 1 month. Primary outcome was percentage of men meeting minimum clinically important difference at 1 month after the second injection. Secondary outcomes were change in International Index of Erectile Function at 1, 3, and 6 months, and changes in penile vascular parameters and adverse events at 6 months.Results:We randomized 61 men: 28 into platelet-rich plasma and 33 into placebo. There was no difference between groups in percentage of men meeting minimum clinically important difference at 1 month: 14 (58.3%) in platelet-rich plasma vs 15 (53.6%) in placebo (P = .730). Mean International Index of Erectile Function–Erectile Function domain changed from 17.4 (95% CI 15.8-19.0) to 21 (17.9-24.0) at 1 month in men receiving platelet-rich plasma, vs 18.6 (17.3-19.8) to 21.6 (19.1-24.1) in the placebo group; however, there was no significant difference between groups (P = .756). There were no major adverse events and only 1 minor adverse event in each group. There were no changes in penile Doppler parameters from baseline to 6 months.Conclusions:The results of our prospective, double-blind, randomized, placebo-controlled clinical trial suggest that 2 injections of intracavernosal platelet-rich plasma separated by 1 month in men with mild to moderate erectile dysfunction is safe, but we found no difference in efficacy between platelet-rich plasma and placebo.
Introduction Men taking testosterone therapy (TT) have potential side effects such as polycythemia, testicular atrophy, and decreased spermatogenesis. Recent evidence has shown that the modality of delivery may affect the prevalence of these side effects. We hypothesized that intranasal short-acting testosterone will have a lower rate of polycythemia than injectable long-acting testosterone because shorter-acting formulations can more closely mimic normal physiology. Objective To compare the effects of Natesto and Testosterone Cypionate (TC) on hematocrit and serum testosterone levels in testosterone deficient men over 4 months. Methods This Phase IV, randomized, open-label clinical trial was performed on 30 symptomatic, testosterone deficient men with at least two serum testosterone levels below 300 ng/dL drawn before 10AM. Men were randomized (1:1) to receive either Natesto three times per day (5.5mg per nostril) and intramuscular TC (200mg) once every two weeks. Hematocrit and serum testosterone were evaluated before and after four months. The primary outcome was changes in hematocrit. Secondary outcomes were changes in E, DHT, PSA and 17-OHP. Data analysis was performed using two-sample and single-sample T tests, and determination of equal or unequal variances was computed using F tests. Results The median participant age was 45 years old. At baseline, serum T of all participants was 239.6 ng/dL and hematocrit of 43.1. Prevalence of participants who screened positive for OSA on STOP-BANG questionnaire for Natesto and TC group were 75% and 78%, respectively. The 4-month change in hematocrit in the Natesto group (-1.1 from baseline) was significantly less than the change in hematocrit seen in the TC group (+5.1 from baseline), (p < 0.001, t = -7.6). Prevalence of polycythemia (HCT > 52%) after 4 months was 0% in Natesto group and 5.5% in TC. Both groups increased testosterone levels above baseline at 1 and 4 months, with a larger increase seen in the TC group compared to Natesto (p = 0.029, t = 1.71), (Figure 1B). In the Natesto group, secondary outcomes E, DHT, PSA, and 17-OHP changed -2.9 (p = 0.54), +4.3 (p = 0.64), +0.34 (p = 0.52), and +1.6 (p = 0.88) from baseline, respectively (Figure 1C). In the TC group, secondary outcomes E, DHT, PSA, and 17-OHP changed +21.2 (p= 0.019), +4.3 (p = 0.64), -0.34 (p = 0.52), and -42.9 (p > 0.001) from baseline, respectively (Figure 1C). Conclusions Short-acting nasal testosterone does not appear to increase serum hematocrit when compared to intramuscular testosterone cypionate, while both modalities returned men to a eugonadal serum testosterone level (>300 ng/dL) in 83% of men. In men who are at risk of developing polycythemia (obstructive sleep apnea, high baseline hematocrit), nasal testosterone gel or other short acting formulations should be strongly considered. Disclosure Yes, this is sponsored by industry/sponsor: Acerus Pharmaceuticals Clarification Industry funding only - investigator initiated and executed study
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