Clinical Practice Guidelines for Bladder Cancer 2019 edition by the Japanese Urological Association: Revision working position paper

Abstract

The Clinical Practice Guidelines for Bladder Cancer edited by the Japanese Urological Association were first published in 2009 and a revised edition was released in 2015. Four years has passed since the 2015 edition, and the clinical practice environment surrounding bladder cancer has drastically changed during that time. The main changes include: (i) insurance coverage of a new diagnostic method for nonmuscle-invasive bladder cancer; (ii) insurance coverage of an immune checkpoint inhibitor in advanced and metastatic bladder cancer; and (iii) advances in robot-assisted radical cystectomy as a minimally invasive treatment for muscle-invasive bladder cancer. A paradigm shift in bladder cancer diagnosis and treatment is occurring day by day. Therefore, in this 2019 edition, while dealing with the above changes, we carefully selected clinical questions with clear evidence and included other clinically important points in the general statement. We also added a new chapter on rare cancers of the urinary tract. As a new method for the evaluation of study evidence level, we introduce "The Grading of Recommendations Assessment, Development and Evaluation" system modified to Japanese by the Medical Information Network Distribution Service.

Japanese subgroup analysis of EV‐301: An open‐label, randomized phase 3 study to evaluate enfortumab vedotin versus chemotherapy in subjects with previously treated locally advanced or metastatic urothelial carcinoma

“…The lack of evidence‐based, effective, third‐line treatments remained a concern until Japan's Ministry of Health, Labour, and Welfare approved EV for unresectable UC that has progressed after cancer treatments. 12 , 15 , 16 , 25 , 26 In a real‐world study of patients in Japan with metastatic UC undergoing second‐line chemotherapy (per physician decision and predominantly with a taxane‐based regimen [paclitaxel, ifosphamide, and nedaplatin] but also including platinum‐based regimens), median PFS was 4 months and OS was 9 months. 7 It is known that the efficacy with PD‐1/L1 inhibitors is limited by their low (~20%) ORRs.…”

Clinical Practice Guidelines for Bladder Cancer 2019 update by the Japanese Urological Association: Summary of the revision

“…Details of those processes have been described previously. 1 The basic stance regarding the revision was as follows.…”

“…Basic stance regarding the revision 1 The previous style of the guidelines and basic CQs were to be, for the most part, kept as is.…”

Combination therapy with paclitaxel and gemcitabine after platinum‐based chemotherapy in patients with advanced urothelial cancer

“…5 According to the recent guidelines for BC or UTUC, pembrolizumab is recommended as the second-line therapy for patients who received previous platinum-based combination chemotherapy. [6][7][8] However, there are some patients who are unfit to undergo treatment with ICI because of comorbidities, such as immune-related diseases. Therefore, the establishment of subsequent chemotherapy for patients with platinum-refractory UC is still valuable.…”