Oral Relugolix for Androgen-Deprivation Therapy in Advanced Prostate Cancer.

BACKGROUND: Injectable luteinizing hormone-releasing hormone agonists (e.g., leuprolide) are the standard agents for achieving androgen deprivation for prostate cancer despite the initial testosterone surge and delay in therapeutic effect. The efficacy and safety of relugolix, an oral gonadotropin-releasing hormone antagonist, as compared with those of leuprolide are not known. METHODS: In this phase 3 trial, we randomly assigned patients with advanced prostate cancer, in a 2:1 ratio, to receive relugolix (120 mg orally once daily) or leuprolide (injections every 3 months) for 48 weeks. The primary end point was sustained testosterone suppression to castrate levels (<50 ng per deciliter) through 48 weeks. Secondary end points included noninferiority with respect to the primary end point, castrate levels of testosterone on day 4, and profound castrate levels (<20 ng per deciliter) on day 15. Testosterone recovery was evaluated in a subgroup of patients. RESULTS: A total of 622 patients received relugolix and 308 received leuprolide. Of men who received relugolix, 96.7% (95% confidence interval [CI], 94.9 to 97.9) maintained castration through 48 weeks, as compared with 88.8% (95% CI, 84.6 to 91.8) of men receiving leuprolide. The difference of 7.9 percentage points (95% CI, 4.1 to 11.8) showed noninferiority and superiority of relugolix (P<0.001 for superiority). All other key secondary end points showed superiority of relugolix over leuprolide (P<0.001). The percentage of patients with castrate levels of testosterone on day 4 was 56.0% with relugolix and 0% with leuprolide. In the subgroup of 184 patients followed for testosterone recovery, the mean testosterone levels 90 days after treatment discontinuation were 288.4 ng per deciliter in the relugolix group and 58.6 ng per deciliter in the leuprolide group. Among all the patients, the incidence of major adverse cardiovascular events was 2.9% in the relugolix group and 6.2% in the leuprolide group (hazard ratio, 0.46; 95% CI, 0.24 to 0.88). CONCLUSIONS: In this trial involving men with advanced prostate cancer, relugolix achieved rapid, sustained suppression of testosterone levels that was superior to that with leuprolide, with a 54% lower risk of major adverse cardiovascular events. (Funded by Myovant Sciences; HERO ClinicalTrials.gov number, NCT03085095.).

Evaluating Autologous Lipofilling for Parry-Romberg Syndrome-Associated Defects: A Systematic Literature Review and Case Report.

BACKGROUND: Parry-Romberg syndrome (PRS) is a rare craniofacial disease that causes progressive hemifacial atrophy of the soft tissue before spontaneously entering remission. Autologous fat grafting may provide a less invasive alternative, producing aesthetically pleasing results while avoiding the need for traditional microsurgical free flap coverage. METHODS: A systematic review of the literature was conducted. Inclusion and exclusion criteria were applied. The case report highlights the technique using two-dimensional and three-dimensional photography. RESULTS: Our review yielded 31 articles in addition to our case describing 147 cases of lipofilling to correct PRS soft-tissue defects. Patients underwent an average of 2.2 procedures, receiving on average 95 mL of grafted fat. Disease severity was classified into mild (41%), moderate (42%), and severe (17%) in the identified patients. Increasing disease severity correlated with an increasing number of procedures and fat-grafting volumes to achieve adequate aesthetic outcomes (mean, 1.5 and 38 mL; 2.3 and 81 mL; 3.7 and 129 mL, respectively). Reported benefits over flap-based reconstructions included reductions in cost (40%), operative time (50%), donor-site morbidity (52%), and rate of complications (33%). Aesthetic benefits cited included improved skin quality (65%), more natural contours (1%), and more natural facial expressions (10%). CONCLUSION: Fat grafting for correction of PRS-associated soft-tissue defects is receiving heightened acceptance for its ability to restore natural facial contours. While additional fat-grafting procedures may be required with increased disease severity, autologous fat grafting may be a beneficial option as a sole modality to correct PRS-associated soft-tissue atrophy.

Component Restoration in the Bilateral Intermediate Cleft Tip Rhinoplasty.

SUMMARY: The intermediate cleft tip rhinoplasty is frequently performed during childhood to address nasal tip anomalies in cleft patients before the most critical period of psychosocial development. The authors previously described the component restoration intermediate cleft tip rhinoplasty technique for the unilateral cleft nose, which was developed to systematically address the lining deficiency, cleft lower lateral cartilage malpositioning, and cleft lateral cartilage weakness using a combination of lower lateral cartilage release, lateral cartilage repositioning, and placement of an auricular composite chondrocutaneous graft. In this work, the authors evaluate the utility of this technique to the bilateral cleft nose. Preoperative and postoperative (mean ± SD, 18.6 ± 10.8 months) photographs of bilateral cleft patients treated with the component restoration intermediate cleft tip rhinoplasty (n = 7) were evaluated using photogrammetric measurements and aesthetic assessments. From preoperatively to postoperatively, the columella length-to-alar width ratio on basal photographs increased (0.19 ± 0.05 versus 0.28 ± 0.05; p = 0.001). On lateral view, the columella-labial angle decreased from preoperatively to postoperatively [138 degrees (interquartile range, 132 to 144 degrees) versus 123 degrees (interquartile range, 122 to 139 degrees); p = 0.04]. Aesthetic ratings performed by four blinded observers also improved from preoperatively to postoperatively (1.6 ± 0.8 versus 2.4 ± 0.7; p = 0.004). As a comparison, bilateral cleft nose patients who did not undergo intermediate cleft tip rhinoplasty (n = 3) of similar ages were subjected to the same photogrammetric and aesthetic analyses, which showed no differences from preoperatively to postoperatively. In combination, the current work suggests that the component restoration technique in the bilateral intermediate cleft tip rhinoplasty improves nasal tip support and aesthetic outcomes.

Scar Management After Surgical Repair of Lateral Facial Clefts.

The prevention of scar contracture after surgery is an important aspect of lateral facial cleft repair. Maintaining adequate mouth opening is essential for speech, expression, chewing, oral hygiene and psychosocial well-being. Although there have been extensive reviews of non-surgical microstomia management in patients with oral electrical burns, there have been no reports on the use of oral commissure splints to manage the surgical scar in patients with lateral facial clefts. The case study presented here will demonstrate the clinical use of cheek retractors to provide physical resistance to scar contracture. We recommend early rehabilitation with cheek retractors to minimize scar contracture and the negative sequelae of scarred tissues on the dentition after lateral facial cleft repair.

Physical Activity in an Underserved Population: Identifying Technology Preferences.

BACKGROUND: This study aims to identify patterns of use and preferences related to technology platforms that could support physical activity (PA) programs in an underserved population. METHODS: A 29-item questionnaire was administered at 5 health and wellness sites targeting low income communities in Chicago. Frequency tables were generated for Internet, cell phone, and social media use and preferences. Chi-squared analysis was used to evaluate differences across age and income groups. RESULTS: A total of 291 individuals participated and were predominantly female (69.0%). Majority reported incomes less than $30,000 (72.9%) and identified as African American/Black/Caribbean (49.3%) or Mexican/Mexican American (34.3%). Most participants regularly used smartphones (63.2%) and the Internet (75.9%). Respondents frequently used Facebook (84.8%), and less commonly used Instagram (43.6%), and Twitter (20.0%). Free Internet-based exercise programs were the most preferred method to increase PA levels (31.6%), while some respondents (21.0%) thought none of the surveyed technology applications would help. CONCLUSION: Cell phone, Internet, and social media use is common among the surveyed underserved population. Technology preferences to increase PA levels varied, with a considerable number of respondents not preferring the surveyed technology platforms. Creating educational opportunities to increase awareness may maximize the effectiveness of technology-based PA interventions.