Patients' self-management of adverse events and patient-reported outcomes in advanced renal cell carcinoma treated with targeted therapies: A prospective, longitudinal, observational study.

BACKGROUND: Early intervention to reduce the impact of adverse events (AEs) may improve patients' quality of life and enable optimal treatment duration. METHODS: This nationwide, multicenter, prospective, longitudinal, 1-year observational study investigated patients' self-management of AEs associated with targeted therapy for advanced renal cell carcinoma (RCC) and explored corresponding outcomes, including treatment duration and patient-reported outcomes (PROs). RESULTS: We enrolled 77 advanced RCC patients (mean age 62 years) treated with a first targeted therapy. 210 cases of seven AEs of interest (fatigue, hand-foot syndrome, oral mucosal inflammation, diarrhea, gastrointestinal symptoms, hypertension, and anorexia) were observed. Most AEs were mild to moderate. Overall, 63.4% of patients were identified as managing their AEs well, reporting numerically longer treatment duration and significantly higher PRO scores than patients identified as poor managers. CONCLUSIONS: Longer treatment duration and improved PROs were observed when advanced RCC patients managed targeted therapy-associated AEs well. Repeated education for consolidating AE self-management could be considered to enhance overall treatment outcomes.

Endoscopic Suturing for the Prevention and Treatment of Complications Associated with Endoscopic Mucosal Resection of Large Duodenal Adenomas.

BACKGROUND/AIMS: Endoscopic mucosal resection (EMR) is the primary treatment for duodenal adenomas; however, it is associated with a high risk of perforation and bleeding, especially with larger lesions. The goal of this study was to demonstrate the feasibility and safety of endoscopic suturing (ES) for the closure of mucosal defects after duodenal EMR. METHODS: Consecutive adult patients who underwent ES of large mucosal defects after EMR of large (>2 cm) duodenal adenomas were retrospectively enrolled. The OverStitch ES system was employed for closing mucosal defects after EMR. Clinical outcomes and complications, including delayed bleeding and perforation, were documented. RESULTS: During the study period, ES of mucosal defects was performed in seven patients in eight sessions (six for prophylaxis and two for the treatment of perforation). All ES sessions were technically successful. No early or delayed post-EMR bleeding was recorded. In addition, no clinically obvious duodenal stricture or recurrence was encountered on endoscopic follow-up evaluation, and no patients required subsequent surgical intervention. CONCLUSION: ES for the prevention and treatment of duodenal perforation after EMR is technically feasible, safe, and effective. ES should be considered an option for preventing or treating perforations associated with EMR of large duodenal adenomas.

Factors Associated with Rebleeding in Patients with Peptic Ulcer Bleeding: Analysis of the Korean Peptic Ulcer Bleeding (K-PUB) Study.

BACKGROUND/AIMS: Rebleeding is associated with mortality in patients with peptic ulcer bleeding (PUB), and risk stratification is important for the management of these patients. The purpose of our study was to examine the risk factors associated with rebleeding in patients with PUB. METHODS: The Korean Peptic Ulcer Bleeding registry is a large prospectively collected database of patients with PUB who were hospitalized between 2014 and 2015 at 28 medical centers in Korea. We examined the basic characteristics and clinical outcomes of patients in this registry. Univariate and multivariate analyses were performed to identify the factors associated with rebleeding. RESULTS: In total, 904 patients with PUB were registered, and 897 patients were analyzed. Rebleeding occurred in 7.1% of the patients (64), and the 30-day mortality was 1.0% (nine patients). According to the multivariate analysis, the risk factors for rebleeding were the presence of co-morbidities, use of multiple drugs, albumin levels, and hematemesis/hematochezia as initial presentations. CONCLUSIONS: The presence of co-morbidities, use of multiple drugs, albumin levels, and initial presentations with hematemesis/hematochezia can be indicators of rebleeding in patients with PUB. The wide use of proton pump inhibitors and prompt endoscopic interventions may explain the low incidence of rebleeding and low mortality rates in Korea.

Primary androgen deprivation therapy for prostate cancer in koreans: a retrospective multicenter study.

PURPOSE: To evaluate the characteristics of patients who received primary androgen deprivation therapy (PADT) for prostate cancer and the clinical efficacy of this treatment. MATERIALS AND METHODS: Two hundred forty patients treated by PADT were reviewed. These patients could not receive definitive therapy owing to old age, patient need, and medical comorbidity. The patients were divided into three groups according to the extent of prostate cancer: localized, locally advanced, and metastatic. Then, prostate-specific antigen (PSA) progression in these groups was analyzed. RESULTS: The median age of the patients was 73.0 years, and the median pretreatment PSA level was 47.0 ng/mL. Of the patients, 91.7% were treated with combined androgen blockade, and 8.3% were treated with monotherapy. Clinical factors for PSA progression were a PSA nadir and a high clinical stage. Estimated PSA recurrence-free median survival time in each group was 57, 24, and 12 months, respectively. A PSA nadir of >0.2 ng/mL and metastatic stage were independent factors for expecting a poor response to PADT (hazard ratio 4.26, p<0.001; and 2.60, p<0.001). CONCLUSIONS: Patients with localized or locally advanced prostate cancer who did not receive definitive therapy had lower PSA progression rates than those at metastatic stage during PADT. Further, a PSA nadir of ≤0.2 ng/mL showed better progression-free survival. Therefore, PADT can be another therapeutic option in well-selected patients with localized or locally advanced prostate cancer and PSA change should be checked carefully.

Clinical Significance of Wnt/ß-Catenin Signalling and Androgen Receptor Expression in Prostate Cancer.

PURPOSE: To investigate the relationships among the Wnt/ß-catenin pathway, androgen receptor (AR), and clinicopathological factors in hormone-naïve prostate cancer. MATERIALS AND METHODS: This study was conducted with132 cases of hormone-naïve prostate cancer treated by prostatectomy and prostate needle biopsy. An immunohistochemical study using antibodies against ß-catenin, matrix metalloproteinase-7 (MMP-7), and the AR was performed. For the in vitro study, PC-3, LNCaP, 22Rv1, and DU145 cell lines were used. RESULTS: The clinical or pathological stage ware a localized cancer in 36 patients (27.3%), locally advanced cancer in 31 (23.5%), and metastatic cancer in 65 (49.2%). We detected increased ß-catenin, AR, and MMP-7 expression with a high Gleason grade, disease progression, and increasing serum prostate-specific antigen (PSA) levels (p<0.01). In Spearman's rank correlations, the expression of cytoplasmic ß-catenin, MMP-7, and the AR were found to be significantly positively correlated. In addition, the expression of ß-catenin, MMP-7, and the AR were significantly correlated with clinicopathological variables indicative of a poor prognosis. Forty-nine patients with primary androgen deprivation had short response durations from hormone therapy to PSA progression with elevated MMP-7 expression on the Kaplan-Meier curve (p=0.0036). CONCLUSIONS: These data show that an activated Wnt/ß-catenin pathway and AR expression in prostate cancer are correlated with metastasis and aggressiveness. In addition, the expression of MMP-7 protein, a target of the Wnt/ß-catenin pathway, is associated with PSA progression in prostate cancer patients undergoing primary hormone therapy.

Urothelial carcinoma arising from a large ureteral polyp.

We report an unusual case of a urothelial tumor on a ureteral polyp without hydronephrosis. The patient was a 50-year-old male. He had experienced several episodes of gross hematuria. Cystoscopy revealed a tumor that periodically prolapsed into the bladder. The tumor had a smooth-surfaced stalk with an erythematous, edematous lesion at the end. Tomography showed a mass and filling defect at the left ureterovesical junction. The results of urine cytology tests were negative. After the tumor was identified as a urothelial carcinoma by frozen biopsy analysis, a ureteroscopic resection was performed. The final pathological diagnosis was urothelial carcinoma arising in a ureteral polyp. No recurrence of the tumor or polyp was observed at the 3-month follow-up. To our knowledge, this is the first report in the Korean population of a urothelial tumor arising from a ureteral polyp.

Prognostic significance of perirenal infiltration in renal cell carcinoma (<7 cm).

PURPOSE: Pathologic stage is the most accurate prognostic factor of renal cell carcinoma. We evaluated whether perirenal fat infiltration is a significant factor in tumors 7 cm or less in size. MATERIALS AND METHODS: We retrospectively reviewed the record of 164 cases of tumors 7 cm or less in size. We divided the patients into two groups according to the presence of perirenal fat infiltration (group A, pT1; group B, pT3a). We evaluated relationships, recurrence-free survival and disease-specific survival according to clinicopathologic parameters. Statistical differences were calculated by log-rank test. RESULTS: A total 131 patients were included in group A, with a mean age of 55.8 years, average tumor size was 4.2 cm, and a mean follow-up period of 43 months. Group B included 33 patients, with a mean age of 55.9 years, an average tumor size of 4.1 cm, and a mean follow-up period of 38 months. There was no significant difference in disease-specific survival; however, recurrence-free survival showed significantly different between two groups (group A: 95.5%, group B: 84.4%). CONCLUSION: In this study, perirenal fat infiltration proved to be an independent prognostic factor for predicting disease-free survival in patients with tumors of 7 cm or less in size. Therefore, as this study showed, the presence of perirenal fat infiltration requires stricter follow-up planning, even in small renal cell carcinoma.

Peripheral blood gene expression of B7 and CD28 family members associated with tumor progression and microscopic lymphovascular invasion in colon cancer patients.

PURPOSE: To associate the global gene expression of B7/CD28 family transcripts with pathologic features of colon cancer, we determined the B7/CD28 family transcripts in peripheral blood mononuclear cells (PBMCs) from normal subjects and patients with adenomatous polyps and colon cancer, and correlated the results with pathologic features of colon cancer. METHODS: PBMCs from age-matched normal subjects and patients with adenomatous polyps and colon cancer were analyzed for peripheral blood transcripts (PBTs) of B7/CD28 family using real-time PCR. Differences in expression levels of B7/CD28 PBTs across all cancer stages and between colon cancer patients with or without microscopic lymphovascular invasion (LVI) were analyzed. RESULTS: The results showed a significant upregulation of PBTs of co-inhibitory molecules such as B7-H3 and PD-1 and a significant PBT downregulation of co-stimulatory molecules including CD28 and ICOS in colon cancer patients. Furthermore, the increase of B7-H3 PBT was strongly associated with tumor invasion (P = 0.025) and advanced TNM stages (P = 0.019), whereas the decline of co-stimulatory ligand B7-H2 PBT was related to regional lymph node metastasis (P = 0.028) and aggressive tumor invasion (P = 0.031). In addition, the ratios of PBT expression of CD28 family to B7 family such as CTLA-4 to B7-H2 and PD-1 to B7-H2 were significantly higher in colon cancer patients with microscopic LVI than in those without LVI (P = 0.001 and P = 0.016, respectively). CONCLUSIONS: Our results suggest that B7/CD28 family PBTs may serve as valuable markers reflecting the pathological features of colon cancer.