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1.
World J Urol ; 42(1): 185, 2024 Mar 21.
Article in English | MEDLINE | ID: mdl-38512511

ABSTRACT

PURPOSE: The International Bladder Cancer Group designated the subgroup that is resistant to Bacillus Calmette-Guérin (BCG) but does not meet the criteria for BCG-unresponsive NMIBC as "BCG-exposed high-risk NMIBC" to guide optimal trial design. We aimed to investigate the treatment patterns and prognoses of patients with BCG-exposed NMIBC. METHODS: We conducted a retrospective chart review of 3283 patients who received intravesical BCG therapy for NMIBC at 14 participating institutions between January 2000 and December 2019. Patients meeting the criteria for BCG-exposed and BCG-unresponsive NMIBC, as defined by the Food and Drug Administration and International Bladder Cancer Group, were selected. To compare treatment patterns and outcomes, high-risk recurrence occurring more than 24 months after the last dose of BCG was defined as "BCG-treated NMIBC." In addition, we compared prognoses between BCG rechallenge and early cystectomy in patients with BCG-exposed NMIBC. RESULTS: Of 3283 patients, 108 (3.3%), 150 (4.6%), and 391 (11.9%) were classified as having BCG-exposed, unresponsive, and treated NMIBC, respectively. BCG-exposed NMIBC demonstrated intermediate survival curves for intravesical recurrence-free and progression-free survival, falling between those of BCG-unresponsive and treated NMIBC. Among patients with BCG-exposed NMIBC, 48 (44.4%) received BCG rechallenge, which was the most commonly performed treatment, and 19 (17.6%) underwent early cystectomy. No significant differences were observed between BCG rechallenge and early cystectomy in patients with BCG-exposed NMIBC. CONCLUSIONS: The newly proposed definition of BCG-exposed NMIBC may serve as a valuable disease subgroup for distinguishing significant gray areas, except in cases of BCG-unresponsive NMIBC.


Subject(s)
Non-Muscle Invasive Bladder Neoplasms , Urinary Bladder Neoplasms , Humans , BCG Vaccine/therapeutic use , Retrospective Studies , Adjuvants, Immunologic/therapeutic use , Prognosis , Urinary Bladder Neoplasms/drug therapy , Data Analysis , Administration, Intravesical , Neoplasm Invasiveness , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/drug therapy
2.
Prev Med ; 180: 107896, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38360151

ABSTRACT

BACKGROUND: Participation in housework and meal preparation are instrumental activity of daily living (IADL) evaluation items that is known to predict prognosis and complications in cancer care. However, these items are often assessed only for females, not for males, in IADL. METHODS: We examined the impact of habit of housework and meal preparation on overall survival (OS) in 1025 Japanese male patients who underwent elective urologic cancer surgery at our institution. The study also used a cohort that was matched by propensity score. RESULTS: We found that patients who did not prepare meals or do housework had significantly shorter OS (hazard ratio [HR] = 3.34, P = 0.005; HR = 5.01, P < 0.001, respectively). Even in the cohort of 448 patients matched by propensity score and adjusted for age, body mass index, comorbidities, performance status, living status, cancer type, stage groups of cancer, and surgical approach, lack of participation in housework was associated with shorter OS (HR = 2.92, P = 0.04) and was an independent predictor of worse OS in multivariable analysis (HR = 5.13, P = 0.008). CONCLUSIONS: Males who did not regularly do household chores before elective cancer surgery had worse life outcomes. Doing more daily physical activities, such as household chores like making the bed and cleaning the room, might have a positive impact on survival when fighting cancer.


Subject(s)
Activities of Daily Living , Neoplasms , Female , Humans , Male , Propensity Score , Japan , Household Work , Prognosis , Neoplasms/surgery
3.
Gerontology ; 70(7): 741-754, 2024.
Article in English | MEDLINE | ID: mdl-38583416

ABSTRACT

INTRODUCTION: The aim of this study was to evaluate the features and benefits of different geriatric screening tools for enhancing the perioperative care of patients who undergo elective cancer surgery using cluster analysis. METHODS: This study was a retrospective, observational analysis of 1,019 consecutive patients who had elective major cancer surgery in the urology department of our hospital from October 2019 to January 2023. Before the surgery, a trained nurse screened the patients using six tools: Eastern Clinical Oncology Group performance status (ECOG-PS), flemish version of the triage risk screening tool (fTRST), geriatric-8 (G8), instrumental activities of daily living, patient health questionnaire-2 (PHQ-2), and simple questionnaire to rapidly diagnose sarcopenia (SARC-F). The study grouped the patients into four clusters based on their scores on these tools and compared their outcomes after the surgery. The outcomes included overall survival, ambulation failure, delirium, and severe complications. The study also examined how each screening tool was associated with the outcomes. RESULTS: Based on their clinical data and screening results, we classified the patients into four groups: Healthy (73%), Depressive (11%), Intermediate (11%), and Unhealthy (5%). The Unhealthy group had the worst outcomes in overall survival (OS), ambulation failure, and delirium, followed by the Intermediate group. In addition, fTRST and SARC-F emerged as significant predictors of OS; ECOG-PS, fTRST, G8, and SARC-F of ambulation failure; ECOG-PS, fTRST, and G8 of delirium; and G8 of severe complications. CONCLUSION: Various geriatric screening tools were found to have the potential to forecast diverse postoperative outcomes.


Subject(s)
Elective Surgical Procedures , Geriatric Assessment , Urologic Neoplasms , Humans , Aged , Male , Female , Retrospective Studies , Urologic Neoplasms/surgery , Urologic Neoplasms/diagnosis , Geriatric Assessment/methods , Cluster Analysis , Aged, 80 and over , Middle Aged , Postoperative Complications/diagnosis , Preoperative Care/methods , Risk Assessment/methods , Sarcopenia/diagnosis , Surveys and Questionnaires , Urologic Surgical Procedures/methods , Activities of Daily Living , Mass Screening/methods
4.
Int J Urol ; 31(6): 607-615, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38402450

ABSTRACT

In urologic oncology, which often involves older patients, it is important to consider how to manage their care appropriately. Geriatric assessment (GA) is a method that can address the specific needs of older cancer patients. The GA encompasses various assessment domains, but these domains exhibit variations across the literature. Some of the common items include functional ability, nutrition, comorbidities, cognitive ability, psychosocial disorders, polypharmacy, social and financial support, falls/imbalance, and vision/hearing. Despite the diversity of domains, there is limited consensus on reliable measurement methods. This review discusses the role of GA in managing urologic cancer in unique scenarios, such as those necessitating temporary or permanent urinary catheters or stomas due to urinary diversion. A comprehensive GA is time and human-resource-intensive in real-world clinical practice. Hence, simpler tools such as the Geriatric-8 (G8), capable of identifying high-risk patients requiring a detailed GA, are also under investigation in various contexts. Therefore, we conducted a systematic literature review on the G8. Our findings indicate that patients with low G8 scores encounter difficulties with stoma self-care after urinary diversion and have higher risks of urinary tract infections and ileus after radical cystectomy. The utilization of G8 as a screening tool for urologic cancer patients may facilitate the delivery of appropriate and personalized treatment and care.


Subject(s)
Geriatric Assessment , Urologic Neoplasms , Humans , Geriatric Assessment/methods , Aged , Urologic Neoplasms/therapy , Urologic Neoplasms/diagnosis , Urinary Diversion/adverse effects , Aged, 80 and over , Comorbidity , Cystectomy/adverse effects
5.
BMC Cancer ; 23(1): 940, 2023 Oct 05.
Article in English | MEDLINE | ID: mdl-37798659

ABSTRACT

BACKGROUND: This study aimed to identify patients with upper urinary tract urothelial carcinoma (UTUC) having potential Lynch syndrome (pLS) by immunohistochemistry (IHC) of DNA mismatch repair gene-related proteins (MMRPs) and Amsterdam criteria II and explore their clinical characteristics. METHODS: We retrospectively collected the clinical data of 150 consecutive patients with UTUC who underwent surgical resection at our institution between February 2012 and December 2020, and immunohistochemistry (IHC) of four MMRPs (MLH1, MSH2, MSH6, and PMS2) on all UTUC specimens was performed. Patients who tested positive for Amsterdam criteria (AMS) II and/or IHC screening were classified as having pLS and others as non-pLS, and their characteristics were explored. RESULTS: In this study, 5 (3%) and 6 (4%) patients were positive for AMS II and IHC screening, respectively. Two patient were positive for both AMS II and IHC screening, resulting in 9 (6%) patients with pLS. The pLS group was predominantly female (67% vs. 36%; p = 0.0093) and had more right-sided tumors (100% vs. 43%; p = 0.0009) than the non-pLS group. Of the 6 patients who were positive for IHC screening, 4 showed a combined loss of MSH2/MSH6 (n = 3) and MLH1/PMS2 (n = 1). Other two patients showed single loss of MSH6 and PSM2. CONCLUSIONS: AMS II and IHC screening identified pLS in 6% of patients with UTUC. The IHC screening-positive group tends to have relatively high rate of combined loss, but some patients have single loss. AMS II may overlook patients with LS, and a universal screening may be required for patients with UTUC as well as those with colorectal and endometrial cancer.


Subject(s)
Carcinoma, Transitional Cell , Colorectal Neoplasms, Hereditary Nonpolyposis , Kidney Neoplasms , Ureteral Neoplasms , Urinary Bladder Neoplasms , Urinary Tract , Humans , Female , Male , Carcinoma, Transitional Cell/diagnosis , Carcinoma, Transitional Cell/epidemiology , Carcinoma, Transitional Cell/genetics , Colorectal Neoplasms, Hereditary Nonpolyposis/diagnosis , Colorectal Neoplasms, Hereditary Nonpolyposis/epidemiology , Colorectal Neoplasms, Hereditary Nonpolyposis/genetics , Mismatch Repair Endonuclease PMS2/genetics , Mismatch Repair Endonuclease PMS2/metabolism , Retrospective Studies , Prevalence , MutS Homolog 2 Protein/genetics , MutS Homolog 2 Protein/metabolism , MutL Protein Homolog 1/genetics , MutL Protein Homolog 1/metabolism , Ureteral Neoplasms/diagnosis , Ureteral Neoplasms/epidemiology , Urinary Tract/metabolism , Urinary Tract/pathology , DNA Mismatch Repair
6.
J Surg Oncol ; 127(6): 1071-1078, 2023 May.
Article in English | MEDLINE | ID: mdl-36695780

ABSTRACT

OBJECTIVES: The purpose of this study was to develop a new composite score to accurately predict postoperative delirium (POD) after major urological cancer surgery. METHODS: Our retrospective analysis included, in total, 449 consecutive patients who experienced major urological cancer surgery and a preoperative geriatric functional assessment at our institution (development cohort). Geriatric functional assessments included Geriatric 8, Instrumental Activities of Daily Living, and mini-cognitive assessment instrument (Mini-Cog). Multivariate analysis was used to identify factors related to POD and combined to create a predictive score. The composite score was externally validated using a cohort of 92 consecutive pancreatic cancer patients who underwent pancreaticoduodenectomy and a preoperative geriatric functional assessment (validation cohort). The predictive accuracy and performance of the composite score were evaluated using the area under the receiver operating characteristic curves (AUC) and calibration plots. RESULTS: In multivariate analysis of a development cohort, the following factors were significantly associated with POD: a Mini-Cog score of <3 (odds ratio [OR] = 9.5; p < 0.001), disability in the responsibility for medication (OR = 4.1; p = 0.03), and the preoperative use of benzodiazepine (OR = 6.4; p < 0.001). The composite score of these three factors showed excellent discrimination in predicting POD, with AUC values of 0.819 and 0.804 in development and validation cohorts, respectively. Calibration plots showing predicted probability and actual observation in both cohorts showed good agreement. CONCLUSIONS: A combined model of Mini-Cog, a disability in the responsibility for medication, and preoperative benzodiazepine use showed excellent discriminative power in predicting POD.


Subject(s)
Delirium , Emergence Delirium , Humans , Aged , Retrospective Studies , Activities of Daily Living , Postoperative Complications/prevention & control , Delirium/diagnosis , Geriatric Assessment , Risk Factors
7.
Int J Urol ; 30(2): 128-138, 2023 02.
Article in English | MEDLINE | ID: mdl-36375037

ABSTRACT

This Asia-Pacific (AP) AMS 800™ artificial urinary sphincter (AUS) consensus statement aims to provide a set of practical recommendations to assist surgeons with the AMS 800 device surgery. The AP consensus committee consisted of key opinion leaders with extensive experience with AMS 800 surgery across several AP countries. The panel reviewed and discussed relevant findings with emphasis on locoregional and specific clinical challenges relevant to the AP region. Recommendations were made in key areas namely (1) patient selection and informed consent process; (2) preoperative assessment; (3) dealing with co-existing urological disorders; (4) surgical principles and intraoperative troubleshooting; (5) postoperative care; (6) special populations; and (7) cost analysis and comparative review. The AMS 800 device should be offered to males with moderate to severe stress urinary incontinence (SUI). Full informed consent should be undertaken, and emphasis is placed on surgical contraindications and high-risk candidates. The presence of a surgical mentor or referral to experts is recommended in complex AUS candidates. Preoperative cystoscopy with or without multichannel urodynamic study is necessary and patients with pre-existing urological disorders should be treated adequately and clinically stable before surgery. Adherence to strict patient selection and safe surgical principles are critical to ensure excellent clinical outcomes and minimize complications. Given that InhibiZone-coated device is not available in many AP countries, the use of prophylactic antibiotics pre-and post-operatively are recommended. The AMS 800 device should be prepared according to the manufacturer's guidelines and remains a cost-effective treatment for male SUI. The AMS 800 device remains the surgical benchmark for male SUI but is associated with certain mechanical limitations and a unique set of complications.


Subject(s)
Urinary Incontinence, Stress , Urinary Sphincter, Artificial , Humans , Male , Urinary Incontinence, Stress/surgery , Treatment Outcome , Postoperative Care , Asia
8.
BMC Urol ; 22(1): 145, 2022 Sep 07.
Article in English | MEDLINE | ID: mdl-36071427

ABSTRACT

BACKGROUND: We assess whether short-term recovery of urinary incontinence following robot-assisted laparoscopic radical prostatectomy (RARP) is associated with postoperative membranous urethral length (MUL) and position of vesico-urethral anastomosis (PVUA). METHODS: Clinical variables including PVUA and pre-and postoperative MUL were evaluated in 251 patients who underwent RARP from August 2019 to February 2021. Continence recovery was defined as no pad or one security liner per day assessed by patient interview at least 6 months follow-up. Univariate and multivariate logistic regression analyses were used to assess variables associated with continence recovery at 3 months after the operation. RESULTS: Continence recovery rates at 3 and 6 months were 75% and 84%, respectively. Lower BMI (< 25 kg/m2) (p = 0.040), longer preoperative MUL (≥ 9.5 mm) (p = 0.013), longer postoperative MUL (≥ 9 mm) (p < 0.001), higher PVUA (< 14.5 mm) (p = 0.019) and shorter operating time (< 170 min) (p = 0.013) were significantly associated with continence recovery at 3 months in univariate analysis. Multivariate analysis revealed that postoperative MUL (OR 3.75, 95% CI 1.90-7.40, p < 0.001) and higher PVUA (OR 2.02, 95% CI 1.07-3.82, p = 0.032) were independent factors for continence recovery. Patients were divided into 3 groups based on the multivariate analysis, with urinary continence recovery rates found to have increased in turn with rates of 43.7% versus 68.2% versus 85.0% (p < 0.001) at 3 months. CONCLUSIONS: PVUA and postoperative MUL were significant factors for short-term continence recovery. Preservation of urethral length might contribute to continence recovery after RARP.


Subject(s)
Laparoscopy , Robotics , Anastomosis, Surgical , Humans , Male , Prostatectomy/adverse effects , Recovery of Function
9.
Int J Urol ; 29(12): 1498-1504, 2022 12.
Article in English | MEDLINE | ID: mdl-36102589

ABSTRACT

OBJECTIVES: To estimate the surgical and quality-of-life outcomes of artificial urinary sphincter implantation in patients with diabetes mellitus (DM). Subanalyses were performed using the same population as that in our previous multicenter, prospective, observational study. METHODS: A total of 135 male patients who underwent primary artificial urinary sphincter implantation were divided into two groups: those with and without DM. The revision-free rates, that is, the percentage of patients who did not require revision surgery, were compared between patients with and without DM. The number of urinary pads required per day, International Consultation on Incontinence Questionnaire-Short Form, and King's Health Questionnaire were used to compare the continence status and quality of life (QOL) between the two groups preoperatively and at 1, 3, and 12 months after surgery. RESULTS: Revision-free rates were significantly lower in the DM group (83.9%, 77.4%, and 67.8% at 1, 2, and 3 years after implantation, respectively) than in the non-DM group (95.5%, 92.5%, and 85.5% at 1, 2, and 3 years after implantation, respectively). Both continence status and QOL, assessed by questionnaires, markedly improved after surgery in patients with and without DM. CONCLUSIONS: Despite differences in the durability of the artificial urinary sphincters, patients with DM can obtain as much benefit from artificial urinary sphincter implantation regarding continence and quality-of-life improvement as patients without DM. Therefore, DM was not considered a comorbidity that contraindicated artificial urinary sphincter implantation. Additional large-scale studies are required to verify our findings.


Subject(s)
Diabetes Mellitus , Urinary Incontinence, Stress , Urinary Sphincter, Artificial , Humans , Male , Urinary Sphincter, Artificial/adverse effects , Quality of Life , Prospective Studies , Treatment Outcome , Diabetes Mellitus/epidemiology , Urinary Incontinence, Stress/surgery , Retrospective Studies , Prosthesis Implantation/adverse effects
10.
Int J Urol ; 29(3): 242-249, 2022 Mar.
Article in English | MEDLINE | ID: mdl-34902876

ABSTRACT

OBJECTIVES: The US Food and Drug Administration recently defined the clinical term "bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer" as a disease state resistant to adequate bacillus Calmette-Guérin therapy. There is a significant lack of prognostication for this disease even in patients who have undergone early radical cystectomy. This study aimed to identify the clinical outcomes and prognostic factors in Japanese patients with bacillus Calmette-Guérin-unresponsive non-muscle-invasive bladder cancer who underwent early radical cystectomy. METHODS: Data from a large-scale multicenter retrospective study included 2879 patients with highest-risk or high-risk non-muscle-invasive bladder cancer who received intravesical bacillus Calmette-Guérin induction therapy between January 2000 and December 2019. A total of 141 patients (4.3%) met the criteria for bacillus Calmette-Guérin-unresponsive disease, of whom 47 (33.3%) underwent early radical cystectomy. Prognostic factors for three clinical endpoints, namely, unresectable lesion-free survival, cancer-specific survival, and overall survival, were identified. RESULTS: The highest-risk status at induction bacillus Calmette-Guérin was associated with short unresectable lesion-free survival (hazard ratio 7.85; P < 0.05), cancer-specific survival (hazard ratio 12.24; P < 0.05), and overall survival (hazard ratio 9.25; P < 0.01). Moreover, extravesical tumors (pathological T3 or T4) on the radical cystectomy specimens were associated with poor prognosis and were found at a higher rate in patients with the highest-risk status at induction bacillus Calmette-Guérin than in those with high-risk status (35.7% vs 21.2%). CONCLUSIONS: The highest-risk status among the pre-bacillus Calmette-Guérin factors was associated with upstaging to extravesical tumors and poor prognosis despite early radical cystectomy procedures. Appropriate decision-making and the correct timing of radical cystectomy are vital to avoid treatment delays and improve outcomes.


Subject(s)
BCG Vaccine , Urinary Bladder Neoplasms , Adjuvants, Immunologic/therapeutic use , Administration, Intravesical , BCG Vaccine/therapeutic use , Cystectomy/methods , Humans , Japan/epidemiology , Neoplasm Invasiveness , Neoplasm Recurrence, Local/drug therapy , Neoplasm Recurrence, Local/epidemiology , Neoplasm Recurrence, Local/prevention & control , Retrospective Studies , Urinary Bladder Neoplasms/drug therapy , Urinary Bladder Neoplasms/pathology , Urinary Bladder Neoplasms/surgery
11.
Cancer Immunol Immunother ; 70(3): 657-665, 2021 Mar.
Article in English | MEDLINE | ID: mdl-32876736

ABSTRACT

OBJECTIVE: To assess the prognostic and predictive ability of early C-reactive protein (CRP) kinetics, dynamic changes in CRP levels, in patients with advanced urothelial cancer treated with pembrolizumab. PATIENTS AND METHODS: We retrospectively evaluated 97 patients with advanced urothelial cancer treated with pembrolizumab in second-line or later settings. Patients were divided into three early CRP kinetics groups: non-elevated (baseline CRP < 5 mg/L), responder (baseline CRP ≥ 5 mg/L and CRP decreased below baseline at least once within 30 days), and non-responder (baseline CRP ≥ 5 mg/L and CRP never decreased to baseline within 30 days). Association between early CRP kinetics and pembrolizumab efficacy including objective response rate (ORR), disease control rate (DCR), and overall survival (OS) were evaluated. RESULTS: Based on early CRP kinetics, 40, 27, and 30 patients were classified as non-elevated, responder, and non-responder, respectively. ORR and DCR were 33% and 60% in non-elevated, 30% and 48% in responder, and 17% and 40% in non-responder; without a statistically significant difference. OS was significantly different among the non-elevated, responder, and non-responder groups (p < 0.01), with 1-year survival rates of 69%, 61%, and 31%, respectively. Early CRP kinetics could discriminate the OS of patients without objective response. Non-responder was an independent predictor for OS (HR 3.65, p < 0.01), as well as liver metastasis and ECOG PS ≥ 2. CONCLUSION: Early CRP kinetics is associated with survival of advanced urothelial cancer patients treated with pembrolizumab and could be a potential biomarker for clinical benefit from immune checkpoint inhibitors.


Subject(s)
Biomarkers , C-Reactive Protein/metabolism , Urologic Neoplasms/blood , Urologic Neoplasms/mortality , Adult , Aged , Aged, 80 and over , Antibodies, Monoclonal, Humanized/pharmacology , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents, Immunological/pharmacology , Antineoplastic Agents, Immunological/therapeutic use , Female , Humans , Kinetics , Male , Middle Aged , Molecular Targeted Therapy , Prognosis , Treatment Outcome , Urologic Neoplasms/drug therapy
12.
Colorectal Dis ; 23(7): 1745-1754, 2021 07.
Article in English | MEDLINE | ID: mdl-33715303

ABSTRACT

AIM: The aim of this retrospective study was to evaluate the incidence of male sexual dysfunction after mid to low rectal cancer surgery and to identify factors associated with postoperative erectile and ejaculatory dysfunction. METHODS: The subjects were 410 consecutive male patients who underwent surgery for mid to low rectal cancer from 2009 to 2015. Two questionnaires on sexual function were administered: the International Index of Erectile Function, and an original questionnaire on ejaculatory status. Erectile and ejaculatory dysfunction were examined before and 3, 6, 12 months after surgery. In patients without preoperative dysfunction, multivariate regression analyses were performed to identify factors associated with the incidence of erectile and ejaculatory dysfunction at 12 months after surgery. RESULTS: Of 410 patients, 234 (57%) gave complete responses to the questionnaires, of whom 108 (46%) and 155 (66%) had severe erectile dysfunction, while 115 (49%) and 168 (72%) had severe ejaculatory dysfunction before and 12 months after surgery, respectively. Of the patients who maintained sexual function preoperatively, the incidence of erectile and ejaculatory dysfunction at 12 months after surgery was 51% (64/126) and 49% (58/119), respectively. In multivariate analysis, age >60 years (P = 0.02), laparotomy (P = 0.002), and creation of a diverting ileostomy (P = 0.003) were independent factors associated with postoperative erectile dysfunction, while age >60 years (P = 0.005), laparotomy (P = 0.04), and lateral lymph node dissection (P = 0.001) were independent factors associated with postoperative ejaculatory dysfunction. CONCLUSION: Sexual dysfunction occurred in almost half of patients after rectal cancer surgery, and was independently associated with several factors, including laparotomy.


Subject(s)
Erectile Dysfunction , Laparoscopy , Rectal Neoplasms , Erectile Dysfunction/epidemiology , Erectile Dysfunction/etiology , Humans , Male , Middle Aged , Rectal Neoplasms/surgery , Rectum , Retrospective Studies , Surveys and Questionnaires
13.
Int J Clin Oncol ; 25(1): 151-157, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31522314

ABSTRACT

BACKGROUND: Nivolumab, which has a promising anti-tumor efficacy and a manageable safety profile, has being rapidly introduced in metastatic renal cell cancer therapy in Japan. We evaluated the efficacy and adverse events of nivolumab in real world clinical practice in Japan. METHODS: The medical records of 45 consecutive patients who started treatment with nivolumab, up to September 2018, were reviewed and statistically analyzed. RESULTS: The median follow-up period was 22.3 months. The best responses were a complete response in three patients (8%), a partial response in 14 patients (36%), stable disease in 14 patients (36%), and progressive disease in eight patients (20%). The median progression-free survival period and 1 year progression-free survival rate were 14.9 months and 54.5%, respectively. The estimated overall survival period and 1-year and 2-year overall survival rates from initiation of nivolumab were not reached, and 91.1%, and 86.2%, respectively. Twenty-seven patients (60%) experienced adverse events including four (10%) severe adverse events (Grade 3 or 4). The most common adverse event was rash (n = 9, 20%). Five patients discontinued nivolumab therapy, because of an adverse event (Grade 3 diarrhea, one patient; Grade 2 fatigue, one patient; Grade 3 uveitis, two patients; and Grade 3 adrenal insufficiency, one patient). CONCLUSIONS: Nivolumab has a relatively favorable efficacy and safety profile for Japanese metastatic renal cell cancer patients in clinical practice.


Subject(s)
Antineoplastic Agents, Immunological/therapeutic use , Carcinoma, Renal Cell/drug therapy , Kidney Neoplasms/drug therapy , Nivolumab/therapeutic use , Aged , Antineoplastic Agents, Immunological/adverse effects , B7-H1 Antigen/metabolism , Carcinoma, Renal Cell/pathology , Diarrhea/chemically induced , Exanthema/chemically induced , Humans , Japan , Kidney Neoplasms/pathology , Middle Aged , Nivolumab/adverse effects , Survival Analysis , Survival Rate , Treatment Outcome
14.
Urol Int ; 104(1-2): 16-21, 2020.
Article in English | MEDLINE | ID: mdl-31461724

ABSTRACT

OBJECTIVES: To analyze the incidence and predictors of deep vein thrombosis (DVT) in patients with elevated D-dimer prior to surgery for urologic malignancy. METHODS: Between January 2015 and September 2017, 987 consecutive patients underwent surgery for urologic malignancy under general anesthesia in our institution. Of these, 191 patients underwent preoperative venous ultrasonography of the lower extremities for DVT due to elevated D-dimer. We analyzed the incidence and predictors of DVT in these patients. RESULTS: The median age was 69 years. DVT was detected in 18% of patients (35/191). Multivariate analysis showed that the primary site of urologic malignancy (p < 0.01) and older age (p < 0.01) were independent predictors of DVT. Patients with bladder cancer had the highest incidence of DVT. When bladder cancer and age of 70 or older were defined as predictors for DVT, the incidence of DVT in zero, 1, and 2 predictors was 3.4% (3/89), 29% (22/77), and 44% (11/25), respectively. CONCLUSIONS: DVT was found in 18% of patients with elevated D-dimer prior to surgery for urologic malignancy. Bladder cancer patients and older patients in whom D-dimer has been elevated should undergo careful early examination for DVT.


Subject(s)
Fibrin Fibrinogen Degradation Products/analysis , Urologic Neoplasms/epidemiology , Urologic Neoplasms/surgery , Venous Thrombosis/complications , Venous Thrombosis/epidemiology , Aged , Female , Humans , Incidence , Leg/diagnostic imaging , Male , Middle Aged , Multivariate Analysis , Postoperative Complications , Regression Analysis , Risk Factors , Ultrasonography , Urologic Neoplasms/blood , Veins/diagnostic imaging , Venous Thrombosis/blood
15.
BJU Int ; 124(2): 242-250, 2019 08.
Article in English | MEDLINE | ID: mdl-30811784

ABSTRACT

OBJECTIVES: To evaluate the oncological and functional outcomes associated with selective tetramodal bladder-sparing therapy, comprising maximal transurethral resection of bladder tumour (TURBT), induction chemoradiotherapy (CRT), and consolidative partial cystectomy (PC) with pelvic lymph node dissection (PLND). MATERIALS AND METHODS: In the present study, 154 patients with non-metastatic muscle-invasive bladder cancer (MIBC), prospectively enrolled in the tetramodal bladder-preservation protocol, were analysed. After TURBT and induction CRT, patients showing complete remission were offered consolidative PC with PLND for the achievement of bladder preservation. Pathological response to induction CRT was evaluated using PC specimens. Oncological and functional outcomes after bladder preservation were evaluated using the following endpoints: MIBC-recurrence-free survival (RFS); cancer-specific survival (CSS); overall survival (OS), and cross-sectional assessments of preserved bladder function and quality of life (QoL) including uroflowmetry, bladder diary, International Prostate Symptom Score, Overactive Bladder Symptom Score and the 36-item Short-Form Health Survey (SF-36) score. RESULTS: The median follow-up period was 48 months. Complete MIBC remission was achieved in 121 patients (79%) after CRT, and 107 patients (69%) completed the tetramodal bladder-preservation protocol comprising consolidative PC with PLND. Pathological examination in these 107 patients revealed residual invasive cancer (≥pT1) that was surgically removed in 11 patients (10%) and lymph node metastases in two patients (2%). The 5-year MIBC-RFS, CSS and OS rates in the 107 patients who completed the protocol were 97%, 93% and 91%, respectively. As for preserved bladder function, the median maximum voided volume, post-void residual urine volume, and nighttime frequency were 350 mL, 25 mL, and two voids, respectively. In the SF-36, patients had favourable scores, equivalent to the age-matched references in all the QoL scales. CONCLUSION: Selective tetramodal bladder-preservation therapy, incorporating consolidative PC with PLND, yielded favourable oncological and functional outcomes in patients with MIBC. Consolidative PC may have contributed to the low rate of MIBC recurrence in patients treated according to this protocol.


Subject(s)
Organ Sparing Treatments , Urinary Bladder Neoplasms/therapy , Aged , Chemoradiotherapy , Cohort Studies , Cystectomy , Female , Humans , Induction Chemotherapy , Lymph Node Excision , Male , Middle Aged , Neoplasm Invasiveness , Treatment Outcome , Urinary Bladder Neoplasms/pathology
16.
J Urol ; 199(1): 245-250, 2018 01.
Article in English | MEDLINE | ID: mdl-28823767

ABSTRACT

PURPOSE: We performed a multicenter, prospective, observational study to assess outcomes, including changes in continence status and quality of life, after artificial urinary sphincter implantation. MATERIALS AND METHODS: Prospectively enrolled in this study were 135 patients who underwent primary AMS 800™ implantation between 2011 and 2014 at 1 of 5 institutions. Perioperative complications were categorized according to the Clavien-Dindo classification. We estimated the revision-free rate, that is the incidence of patients who did not undergo artificial urinary sphincter revision surgery. Cox regression analysis was performed to identify patient risk factors for revision surgery. The number of pads needed per day, ICIQ-SF (International Consultation on Incontinence Questionnaire-Short Form) and KHQ (King's Health Questionnaire) were used to estimate continence status and quality of life preoperatively, and 1, 3 and 12 months postoperatively. RESULTS: The artificial urinary sphincter was implanted without major complications. The revision-free rate 1, 2 and 3 years after implantation was 94%, 88% and 81%, respectively. Diabetes mellitus and poor preoperative American Society of Anesthesiologists® physical status were significant risk factors for revision surgery. Continence status and quality of life were markedly improved after surgery. However, ICIQ-SF and some KHQ items showed slight but significant deterioration at 12 months compared with scores 1 month after surgery. CONCLUSIONS: Artificial urinary sphincter implantation is a safe and durable procedure that substantially improves patient continence status and quality of life soon after surgery. Our results indicate that patients start to experience slight but noticeable deterioration in continence status and quality of life relatively early (within 1 year) after surgery. This finding might be helpful with appropriately counseling patients who undergo artificial urinary sphincter implantation.


Subject(s)
Intraoperative Complications/epidemiology , Patient Reported Outcome Measures , Postoperative Complications/epidemiology , Urinary Incontinence, Stress/surgery , Urinary Sphincter, Artificial/adverse effects , Urologic Surgical Procedures/instrumentation , Aged , Humans , Incidence , Incontinence Pads/statistics & numerical data , Male , Patient Satisfaction , Perioperative Period , Postoperative Complications/etiology , Prospective Studies , Quality of Life , Reoperation/statistics & numerical data , Time Factors , Treatment Outcome , Urologic Surgical Procedures/adverse effects , Urologic Surgical Procedures/methods
17.
Pathol Int ; 67(11): 575-579, 2017 Nov.
Article in English | MEDLINE | ID: mdl-28872768

ABSTRACT

Adenocarcinoma of Skene's gland (the female homolog to the male prostate) is extremely rare, with only a few cases reported. We present a case of Skene's gland adenocarcinoma with intestinal differentiation. The patient was a 69-year-old Japanese woman who was operated on for a recurrent tumor of the external ostium of the urethra. Histopathologically, the tumor showed glandular and cribriform patterns with a signet-ring cell component in a mucus lake. Immunohistochemically, the tumor cells were positive for prostate specific acid phosphatase (PSAP), and AMACR, and negative for Nkx3.1 or prostate specific antigen (PSA). Although in situ lesion could not be discovered, positive immunostainings for Nkx3.1, PSAP, and androgen receptor in the remaining paraurethral glands around the tumor indirectly but strongly suggest that the tumor had originated from Skene's gland. This tumor also showed intestinal differentiation as suggested histologically and by positive immunostainings for CDX2, MUC2, and CK20, along with negative immunostaining for CK7. It is often very difficult to identify the origin of a female urethral carcinoma. In such cases, immunohistochemical features can be an essential clue to the origin. We therefore present this instructive case with a literature review.


Subject(s)
Adenocarcinoma/pathology , Urethral Neoplasms/pathology , Aged , Biomarkers, Tumor/analysis , Cell Differentiation , Female , Humans , Intestines
18.
Int J Clin Oncol ; 22(4): 629-634, 2017 Aug.
Article in English | MEDLINE | ID: mdl-28382562

ABSTRACT

Nivolumab is a fully human immunoglobulin (Ig) G4 antibody that selectively inhibits the programmed death 1 (PD-1) immune checkpoint molecule, and has recently been launched for the treatment of renal cell cancer (RCC) in Japan. Based on its promising anti-tumor efficacy and manageable safety profile demonstrated in the phase III Checkmate 025 trial, nivolumab therapy is rapidly being introduced in metastatic RCC clinical practice. The phase Ia study of atezolizumab, which is a humanized anti-PD-ligand 1 (PD-L1) monoclonal IgG1 antibody, also demonstrated excellent treatment results. The identification of biomarkers to predict the response and side-effects of checkpoint inhibitor therapy is thus urgently needed. In this review, we introduce the current candidate biomarkers of immune checkpoint inhibitor therapy. Based on the mechanism of efficacy, the number of neoantigens and expression of major histocompatibility complex molecules are strong candidate biomarkers. Despite the various interference factors, PD-L1 expression can be considered a potential biomarker. In terms of clinical factors, serum clinical factors and severity of adverse events are examined. Although further implementation in prospective studies is necessary, if validated, these biomarkers can be utilized to measure therapeutic response and design treatment strategies for metastatic RCC.


Subject(s)
Antineoplastic Agents/therapeutic use , Biomarkers, Tumor/analysis , Carcinoma, Renal Cell/drug therapy , Kidney Neoplasms/drug therapy , Tumor Microenvironment/immunology , Antibodies, Monoclonal/pharmacology , Antibodies, Monoclonal/therapeutic use , Antineoplastic Agents/pharmacology , B7-H1 Antigen/immunology , B7-H1 Antigen/metabolism , Biomarkers, Tumor/metabolism , Carcinoma, Renal Cell/immunology , Carcinoma, Renal Cell/pathology , Genes, MHC Class I/immunology , Humans , Japan , Kidney Neoplasms/immunology , Kidney Neoplasms/pathology , Nivolumab , Prognosis , Prospective Studies , Treatment Outcome
19.
Int J Urol ; 24(7): 511-517, 2017 07.
Article in English | MEDLINE | ID: mdl-28600877

ABSTRACT

OBJECTIVES: To develop a stepwise diagnostic algorithm for fat-poor angiomyolipoma in small renal masses. METHODS: Two cohorts of small renal masses <4 cm without an apparent fat component that was pathologically diagnosed were included: 153 cases (18 fat-poor angiomyolipomas/135 renal cell carcinomas) for model development and 71 cases (seven fat-poor angiomyolipomas/59 renal cell carcinomas/5 oncocytomas) for validation. Dynamic contrast-enhanced computed tomography, magnetic resonance imaging and clinical findings were analyzed. Based on multivariate analysis, we developed two prediction models for fat-poor angiomyolipoma, the computed tomography model and the computed tomography + magnetic resonance imaging model, and a stepwise algorithm that proposes the sequential use of computed tomography and magnetic resonance imaging. RESULTS: The computed tomography model, which was composed of female aged <50 years, high attenuation on unenhanced computed tomography, less enhancement than the normal renal cortex and homogeneity in the corticomedullary phase, differentiated tumors with none of the factors as the low angiomyolipoma-probability group, and the others were candidates for the computed tomography + magnetic resonance imaging model. The computed tomography + magnetic resonance imaging model, consisting of the first three factors of the computed tomography model, low signal intensity and absence of pseudocapsule on T2-weighted magnetic resonance imaging, re-stratified the tumors into low, intermediate and high angiomyolipoma-probability groups. The incidence of fat-poor angiomyolipoma in each group was 0%, 26% and 93%, respectively (area under the curve 0.981). External validation by two readers showed a high area under the curve (0.912 and 0.924) for each. The interobserver agreement was good (kappa score 0.77). CONCLUSIONS: The present algorithm differentiates fat-poor angiomyolipoma in small renal masses with high accuracy by adding magnetic resonance imaging to computed tomography in selected patients.


Subject(s)
Adenoma, Oxyphilic/diagnostic imaging , Angiomyolipoma/diagnostic imaging , Carcinoma, Renal Cell/diagnostic imaging , Kidney Neoplasms/diagnostic imaging , Multimodal Imaging/methods , Adult , Aged , Aged, 80 and over , Algorithms , Diagnosis, Differential , Female , Humans , Magnetic Resonance Imaging/methods , Male , Middle Aged , Models, Biological , Patient Selection , Prognosis , Tomography, X-Ray Computed/methods
20.
BJU Int ; 117(1): 94-101, 2016 Jan.
Article in English | MEDLINE | ID: mdl-25124332

ABSTRACT

OBJECTIVES: To identify prostatic quadrants that could be preserved without intervention, using diffusion-weighted magnetic resonance imaging (DWI) and extended core biopsy, as a step toward implementation of quadrant-based focal ablation with potential preservation of erectile and ejaculatory functions, based on comparisons with unilateral hemi-gland ablation. PATIENTS AND METHODS: We conducted a prebiopsy DWI study including 648 quadrants in 162 men who underwent 14-core biopsy including anterior sampling and radical prostatectomy (RP) for localised cancer. Imaging and pathology were analysed on a quadrant basis. Each quadrant was assessed through four-core sampling. Predictive performance of DWI and biopsy for quadrant status was analysed. RESULTS: On RP specimens, 170 anterior (52.5%) and 172 posterior quadrants (53.1%) harboured significant cancer. Negative predictive values of DWI, biopsy, and their combination for significant cancer were 79.7%, 70.6%, and 91.1%, respectively, in anterior quadrants, and 78.5%, 81.3%, and 91.7%, respectively, in posterior quadrants. DWI incrementally improved the negative predictive values of biopsy in anterior (P < 0.001) and posterior quadrants (P = 0.025), without untoward impacts on positive predictive values. Negative findings on both DWI and biopsy were identified in posterior quadrants of 109 sides (33.6%), but in entire hemi-glands of 54 sides (16.7%). CONCLUSIONS: The combination of DWI and 14-core biopsy including anterior sampling efficiently identifies quadrants without significant cancer in men with localised prostate cancer; the remaining quadrants, therefore, could be potential candidate areas for focal ablation. Focal therapy designed based on quadrant-based assessment could be superior to unilateral hemi-gland ablation for preservation of posterior quadrants and retaining of sexual function in more sides.


Subject(s)
Biopsy/methods , Diffusion Magnetic Resonance Imaging/methods , Prostate/pathology , Prostate/surgery , Prostatic Neoplasms/pathology , Prostatic Neoplasms/surgery , Ablation Techniques/methods , Aged , Aged, 80 and over , Humans , Image Interpretation, Computer-Assisted , Male , Middle Aged , Prostatectomy/methods , Prostatic Neoplasms/epidemiology
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