ABSTRACT
Purpose@#This phase II, open-label, multicenter study aimed to investigate the efficacy and safety of a rituximab intensification for the 1st cycle with every 21-day of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP-21) among patients with previously untreated advanced-stage or bulky diffuse large B-cell lymphoma (DLBCL). @*Materials and Methods@#Ninety-two patients with stage III/IV or bulky DLBCL from 21 institutions were administered 8 cycles of R-CHOP-21 with an additional one dose of rituximab intensification on day 0 of the 1st cycle (RR-CHOP). The primary endpoint was a complete response (CR) rate after 3 cycles of chemotherapy. @*Results@#Among the 92 DLBCL patients assessed herein, the response rate after 3 cycles of chemotherapy was 88.0% (38.0% CR+50.0% partial response [PR]). After the completion of 8 cycles of chemotherapy, the overall response rate was observed for 68.4% (58.7% CR+9.8% PR). The 3-year progression-free survival rate was 64.0%, and the 3-year overall survival rate was 70.4%. Febrile neutropenia was one of the most frequent grade 3 adverse events (40.0%) and 5 treatment-related deaths occurred. Compared with the clinical outcomes of patients who received R-CHOP chemotherapy as a historical control, the interim CR rate was higher in male patients with RR-CHOP (20.5% vs. 48.8%, p=0.016). @*Conclusion@#Rituximab intensification on days 0 to the 1st cycle of the standard 8 cycles R-CHOP-21 for advanced DLBCL yielded favorable response rates after the 3 cycles of chemotherapy and acceptable toxicities, especially for male patients. ClinicalTrials.gov ID: NCT01054781.
ABSTRACT
PURPOSE: Ipilimumab improves survival in advanced melanoma patients. However, the efficacy and safety of ipilimumab has not been evaluated in Asian melanoma patients with a high frequency of mucosal and acral melanoma subtypes. MATERIALS AND METHODS: Advanced melanoma patients treated with 3 mg/kg ipilimumab in a Korean multicenter named-patient program (NPP) were evaluated between September 2014 and July 2015. Baseline characteristics and blood parameters including neutrophil to lymphocyte ratio (NLR) were assessed, and outcome and adverse events were evaluated according to subtypes. RESULTS: A total of 104 advanced melanoma patients were treated. The primary sites were acral (31.7%), mucosal (26%), cutaneous (26%), uveal (9.6%), and unknown (6.7%). Sixty-eight patients (65.4%) experienced adverse events, and the most common toxicity was skin rash (22.1%), 10 patients (9.6%) experienced adverse events of grade 3 or higher. The median progression-free survival (PFS) was 2.73 months (95% confidence interval, 2.67 to 2.85), and there was no difference in PFS according to subtypes. Poor performance status, liver metastasis, and NLR (≥ 5) were independent poor prognostic factors by multivariate analysis. CONCLUSION: In the Korean NPP cohort, ipilimumab showed similar efficacy and tolerability compared to Western patients, regardless of subtypes. All subtypes should benefit from ipilimumab with consideration of performance status, liver metastasis, and NLR.
Subject(s)
Humans , Asian People , Biomarkers , Cohort Studies , Disease-Free Survival , Exanthema , Immunotherapy , Liver , Lymphocytes , Melanoma , Multivariate Analysis , Neoplasm Metastasis , NeutrophilsABSTRACT
PURPOSE: Intracavernous injection (ICI) was once the cornerstone of treatment for erectile dysfunction (ED). This study was designed to investigate how the treatment of ED has changed since introduction of oral sildenafil. MATERIALS AND METHODS: In a total of 574 new ED (mean duration 2.9 years) patients with a mean age of 52.6 11.8 years, associated diseases, the cause and duration of ED, and the treatment used initially and after 6 months were investigated. RESULTS: The ED was psychogenic in 40.7% of the men. The most common cause of organic ED was vascular (18.1%) followed by diabetes (15.9%). The associated diseases were hypertension (19.9%), diabetes mellitus (16.5%), trauma and surgery (5.5%), endocrinologic (4.7%), coronary artery (1.6%), and hypercholesterolemia (1.1%). The initial treatment modality was an oral sildenafil in 68.7%, ICI in 11.3%, testosterone replacement in 2.7%, implantation of penile prostheses in 0.8%, and wait and see in 16.5%. Six months later, excluding the patients lost to follow-up, 73.4% of the patients were using oral sildenafil and 20.5% were using ICI. CONCLUSIONS: Oral sildenafil has largely replaced intracavernous injection for the initial treatment of erectile dysfunction.