Prostate cancer management in Southeast Asian countries: a survey of clinical practice patterns.

Background: Prostate cancer (PC) has a serious public health impact, and its incidence is rising due to the aging population. There is limited evidence and consensus to guide the management of PC in Southeast Asia (SEA). We present real-world data on clinical practice patterns in SEA for advanced PC care. Method: A paper-based survey was used to identify clinical practice patterns and obtain consensus among the panelists. The survey included the demographics of the panelists, the use of clinical guidelines, and clinical practice patterns in the management of advanced PC in SEA. Results: Most panelists (81%) voted prostate-specific antigen (PSA) as the most effective test for early PC diagnosis and risk stratification. Nearly 44% of panelists agreed that prostate-specific membrane antigen positron emission tomography-computed tomography imaging for PC diagnostic and staging information aids local and systemic therapy decisions. The majority of the panel preferred abiraterone acetate (67%) or docetaxel (44%) as first-line therapy for symptomatic mCRPC patients. Abiraterone acetate (50%) is preferred over docetaxel as a first-line treatment in metastatic castration-sensitive prostate cancer patients with high-volume disease. However, the panel did not support the use of abiraterone acetate in non-metastatic castration-resistant prostate cancer (nmCRPC) patients. Apalutamide (75%) is the preferred treatment option for patients with nmCRPC. The cost and availability of modern treatments and technologies are important factors influencing therapeutic decisions. All panelists supported the use of generic versions of approved therapies. Conclusion: The survey results reflect real-world management of advanced PC in a SEA country. These findings could be used to guide local clinical practices and highlight the financial challenges of modern healthcare.

Nephrocolocutaneous fistula from a staghorn calculus.

Fistula formation between the kidney, colon and the skin is an extremely rare complication arising from renal infections secondary to renal stone formation. During the 1980s, reports of nephrocolic fistulas, with or without involvement of the skin, were commonly caused by genitourinary tuberculosis. Due to improvements in diagnosis and specifically the development of anti-Koch's therapy, the incidence of nephrocolic or nephrocolocutaneous fistulas has become uncommon especially in developed countries.We report a case of a patient residing in a developing country, presenting with a 20-year history of a left flank lesion extruding minimal purulent output daily. He was seen at the emergency department due to weakness and was managed as a case of urosepsis. Contrast-enhanced CT scan and fistulogram showed a staghorn calculus in the left kidney with connections to the descending colon and skin. The patient eventually underwent a left hemicolectomy with en bloc excision of the kidney and fistula tract.

Incentives for organ donation: proposed standards for an internationally acceptable system.

Incentives for organ donation, currently prohibited in most countries, may increase donation and save lives. Discussion of incentives has focused on two areas: (1) whether or not there are ethical principles that justify the current prohibition and (2) whether incentives would do more good than harm. We herein address the second concern and propose for discussion standards and guidelines for an acceptable system of incentives for donation. We believe that if systems based on these guidelines were developed, harms would be no greater than those to today's conventional donors. Ultimately, until there are trials of incentives, the question of benefits and harms cannot be satisfactorily answered.

Outcomes of Kidney Transplants Under the Philippine Health Insurance Corporation's Z Benefit Package at the University of the Philippines-Philippine General Hospital from 2015 to 2021.

End-stage renal disease is one of the most burdensome diseases, particularly in developing countries such as the Philippines, with dialysis and kidney transplant commonly being a source of out-of-pocket expenditure among patients. To address the burgeoning health inequity, the Philippine Health Insurance Corporation (Philhealth) launched in 2012 its Z Benefit Package for kidney transplantation providing a substantial amount to subsidize the transplant with the aim of increasing financial risk protection of its members, especially the marginalized sector. The University of the Philippines-Philippine General Hospital is a government hospital that was one of the contracted hospitals to provide this benefit package since 2015. Herein we report our initial experience with 29 primary, low immunologic risk, living donor kidney transplants. Recipients mostly had chronic glomerulonephritis with a median discharge creatinine of 1.04 mg/dL. One, 3-, and 5-year graft survival was 100%, 96%, and 85%, respectively, with a median graft survival of 65 months. Donors were mostly male with a median discharge creatinine of 1.0 mg/dL. One, 3-, and 5-year patient survival was 100%, 91%, and 81%, respectively. Complications were mostly urinary tract infections. In conclusion, the Philippine Health Insurance Corporation Z Benefit Package for transplant seems to be achieving its goals of providing quality care particularly for the poor with catastrophic diseases such as end-stage renal disease. Optimal patient selection and management are essential in attaining excellent graft and patient outcomes. Furthermore, it is hoped that with this program, there will be increased awareness of the at-risk population, transplanting them preemptively, ensuring a better overall survival.

ELIGANT: a Phase 4, interventional, safety study of leuprorelin acetate (ELIGARD®) in Asian men with prostate cancer.

Background: The incidence and mortality rate of men with prostate cancer have been increasing in Asia. ELIGARD® is a formulation of leuprorelin acetate whose safety and efficacy have been well-established in Western regions. However, limited safety data are available for Asian populations. Methods: ELIGANT (ELIGard AsiaN sTudy) was a Phase 4, multicenter, prospective, single-arm, interventional study. Men with locally advanced or metastatic prostate cancer without concomitant chemotherapy, or another androgen receptor pathway inhibitor, were enrolled across Asia to receive ELIGARD® (22.5 mg subcutaneous depot injection) every 3 months for 15 months, with a follow-up visit at 18 months. The primary objective was to establish the safety of ELIGARD® in Asian men with hormone-dependent prostate cancer. The secondary objectives were to assess efficacy, via prostate-specific antigen (PSA) progression and testosterone levels, and health-related quality of life (HRQoL). Results: In total, 106 patients were included in the safety analysis set (SAF). The most common treatment-emergent adverse events (TEAEs) included PSA increase, cough, back pain, hot flush, anemia, and upper respiratory tract infection. TEAEs considered related to ELIGARD® were reported in 13.2% of patients (n=14), two of which were serious. In the full analysis set (FAS) (n=105), 81.2% (n=56) and 68.5% (n=61) of patients achieved a PSA reduction of ≥90% from baseline at 12 and 18 months, respectively. At 18 months, the numbers of patients with testosterone levels <20, 20-50, and >50 ng/dL were 65 (61.9%), 17 (16.2%), and two (1.9%), respectively; 20% had missing testosterone measurements. HRQoL remained stable throughout the study with minimal change from baseline at study completion. Conclusions: In conclusion, the safety profile of ELIGARD® (22.5 mg) in Asian men with hormone-dependent prostate cancer is comparable to previous studies in Western regions. Trial Registration: Clinical trial registration number NCT03035032.

Efficacy and tolerability of vardenafil in Asian men with erectile dysfunction.

AIM: To evaluate the efficacy and tolerability of vardenafil, a phosphodiesterase type-5 (PDE-5) inhibitor, in men of Asian ethnicity with erectile dysfunction (ED). METHODS: In this prospective, double-blind, multinational study, Asian men were randomized to receive vardenafil (10 mg) or placebo (4:1 ratio) for 12 weeks. The primary efficacy variables were the International Index of Erectile Function erectile function domain (IIEF-EF), and Sexual Encounter Profile (SEP) questions related to penetration and intercourse completion. Significant mean improvements were required in all three measures to show positive benefits of vardenafil treatment. Secondary efficacy variables included the Global Assessment Question (GAQ) on erection improvement. RESULTS: Least-squares mean baseline IIEF-EF domain scores (vardenafil 14.6, placebo 13.4) were consistent with moderate ED. After 12 weeks, vardenafil treatment was associated with significant increases from the baseline in IIEF-EF domain scores compared with the placebo (22.4 vs. 14.3; P<0.001). Vardenafil was associated with significant improvements from baseline in least squares (LS) mean success rates for SEP-2 (vardenafil 82.2 vs. placebo 43.6; P<0.001) and SEP-3 (vardenafil 66.1 vs. placebo 24.0; P<0.001). Positive GAQ responses were reported by 81.8% of vardenafil recipients vs. 24.3% of placebo recipients. Adverse events were reported by 25.4% of the vardenafil group, the majority mild and transient. CONCLUSION: Vardenafil (10 mg) is a highly effective and well-tolerated treatment for moderate ED in Asian men. These results add to the increasing amount of data demonstrating the safety and efficacy of vardenafil for the treatment of ED in a range of patient populations.