Purpose Ipilimumab increases antitumor T-cell responses by binding to cytotoxic T-lymphocyte antigen 4. We evaluated treatment with ipilimumab in asymptomatic or minimally symptomatic patients with chemotherapy-naive metastatic castration-resistant prostate cancer without visceral metastases. Patients and Methods In this multicenter, double-blind, phase III trial, patients were randomly assigned (2:1) to ipilimumab 10 mg/kg or placebo every 3 weeks for up to four doses. Ipilimumab 10 mg/kg or placebo maintenance therapy was administered to nonprogressing patients every 3 months. The primary end point was overall survival (OS). Results Four hundred patients were randomly assigned to ipilimumab and 202 to placebo; 399 were treated with ipilimumab and 199 with placebo. Median OS was 28.7 months (95% CI, 24.5 to 32.5 months) in the ipilimumab arm versus 29.7 months (95% CI, 26.1 to 34.2 months) in the placebo arm (hazard ratio, 1.11; 95.87% CI, 0.88 to 1.39; P = .3667). Median progression-free survival was 5.6 months in the ipilimumab arm versus 3.8 with placebo arm (hazard ratio, 0.67; 95.87% CI, 0.55 to 0.81). Exploratory analyses showed a higher prostate-specific antigen response rate with ipilimumab (23%) than with placebo (8%). Diarrhea (15%) was the only grade 3 to 4 treatment-related adverse event (AE) reported in ≥ 10% of ipilimumab-treated patients. Nine (2%) deaths occurred in the ipilimumab arm due to treatment-related AEs; no deaths occurred in the placebo arm. Immune-related grade 3 to 4 AEs occurred in 31% and 2% of patients, respectively. Conclusion Ipilimumab did not improve OS in patients with metastatic castration-resistant prostate cancer. The observed increases in progression-free survival and prostate-specific antigen response rates suggest antitumor activity in a patient subset.
Background: Conventional surgeries of the nasal septum improve the nasal airway but recent development and advancement of the knowledge about the endoscopic septoplasty has significantly changed the treatment modality and had brought focus over several aspects of possible advantages. This study aims to see the advantages, complications and limitations of endoscopic septoplasty.
Methods: It was an observational prospective study conducted over 90 patients of symptomatic deviated nasal septum. It evaluated symptoms, anterior rhinoscopy and nasal endoscopy findings, objective and subjective improvement of symptoms using the nasal obstruction symptom evaluaiton (NOSE) score, post-operative pain using the visual analogue scale (VAS) and complication following the surgery.
Results: Deviated nasal septum (DNS) either left or right side was the most common examination finding 97.78%. Post-operatively there was a good symptom relief and significant subjective improvement in NOSE scores with average decline in the score by 96.26%. Objective assessment of all patients showed improved airway. The complication rate was minimum 7.78%.
Conclusion: Endoscopic septoplasty (ES) was found to have distinct advantages with good subjective and objective improvement of symptoms and lesser rate of complications. It should be an option offered to all patients requiring septoplasty. We also found that it helps in improving the learning curve and surgical skill of the trainees.
Bangladesh J Otorhinolaryngol 2021; 27(2): 170-176
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