EFFECTS OF LEVOFLOXACIN ON BACILLUS CALMETTE-GUERIN-INDUCED TOXICITY IN PATIENTS WITH NONMUSCLE INVASIVE BLADDER CANCER: RESULTS OF A RANDOMIZED, PROSPECTIVE, MULTICENTER STUDY

You have accessJournal of UrologyBladder Cancer: Non-invasive I (PD03)1 Apr 2020PD03-06 EFFECTS OF LEVOFLOXACIN ON BACILLUS CALMETTE-GUERIN-INDUCED TOXICITY IN PATIENTS WITH NONMUSCLE INVASIVE BLADDER CANCER: RESULTS OF A RANDOMIZED, PROSPECTIVE, MULTICENTER STUDY Kazuyuki Numakura*, Mizuki Kobayashi, Toshiya Ishida, Katsumi Okane, Kazumasa Suzuki, Naotake Shimoda, Takehiro Suzuki, Teruaki Kumazawa, Ryusei Sasaki, Hisami Fukuda, Taketoshi Nara, Sohei Kanda, Huang Mingguo, Mitsuru Saito, Shintaro Narita, Takamitsu Inoue, Norihiko Tsuchiya, and Tomonori Habuchi Kazuyuki Numakura*Kazuyuki Numakura* More articles by this author , Mizuki KobayashiMizuki Kobayashi More articles by this author , Toshiya IshidaToshiya Ishida More articles by this author , Katsumi OkaneKatsumi Okane More articles by this author , Kazumasa SuzukiKazumasa Suzuki More articles by this author , Naotake ShimodaNaotake Shimoda More articles by this author , Takehiro SuzukiTakehiro Suzuki More articles by this author , Teruaki KumazawaTeruaki Kumazawa More articles by this author , Ryusei SasakiRyusei Sasaki More articles by this author , Hisami Fukuda Hisami Fukuda More articles by this author , Taketoshi Nara Taketoshi Nara More articles by this author , Sohei KandaSohei Kanda More articles by this author , Huang MingguoHuang Mingguo More articles by this author , Mitsuru SaitoMitsuru Saito More articles by this author , Shintaro NaritaShintaro Narita More articles by this author , Takamitsu InoueTakamitsu Inoue More articles by this author , Norihiko Tsuchiya Norihiko Tsuchiya More articles by this author , and Tomonori HabuchiTomonori Habuchi More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000823.06AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Although bacillus Calmette-Guerin (BCG) is a standard of care for especially high-risk nonmuscle-invasive bladder cancer (NMIBC), a high rate of adverse events (AEs) remains a major problem. In this randomized, prospective, multicenter study, we examined whether levofloxacin (LVFX) given after each intravesical instillation of BCG could improve its tolerance in patients with intermediate- to high-risk urothelial carcinoma of the bladder. We also investigated the impact of LVFX on the antitumor efficacy of BCG. METHODS: In this study, 100 patients with primary or recurrent NMIBC (Ta/T1, CIS, G1-G3) were randomized to induction treatment with intravesical BCG plus LVFX in group 1 (n=52) or BCG alone in group 2 (n=48). AEs were assessed using a National Cancer Institute-Common Toxicity Criteria Version 3.0. The median patient ages were 69.5 years (46 – 80) and the median follow up period was 36 months (12 – 128). All patients were Japanese, consisting of 80 men and 20 women. RESULTS: There was no significant difference in baseline characteristics and symptoms between the groups. Overall, there were no significant differences decreases in the rate of patients having with pollakisuria, miction pain, gross hematuria, fever elevation, and others between the group 1 and group 2. The rate of BCG discontinuation was not different between the groups (24.5% vs 13.7%, p = 0.207). However, the incidence of AEs with grade II or more pollakisuria and fever elevation was significantly lower (5.9% vs 28.2%, p = 0.016; 0% vs 8.2%, p=0.034) in the group 1 (Table 1). The 5-year progression-free and cancer-specific survival rates were better in the group I (HR 0.26, 95%CI 0.57-0.81, p = 0.011; 1 HR 0.13, 95%CI 0.01-0.74, p = 0.006) (Figure 1). CONCLUSIONS: Prophylactic LVFX may reduce the severity of AEs and can contribute to better outcomes from BCG intravesical therapy in patients with NMIBC, improving compliance with the BCG course. Source of Funding: none © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e74-e74 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kazuyuki Numakura* More articles by this author Mizuki Kobayashi More articles by this author Toshiya Ishida More articles by this author Katsumi Okane More articles by this author Kazumasa Suzuki More articles by this author Naotake Shimoda More articles by this author Takehiro Suzuki More articles by this author Teruaki Kumazawa More articles by this author Ryusei Sasaki More articles by this author Hisami Fukuda More articles by this author Taketoshi Nara More articles by this author Sohei Kanda More articles by this author Huang Mingguo More articles by this author Mitsuru Saito More articles by this author Shintaro Narita More articles by this author Takamitsu Inoue More articles by this author Norihiko Tsuchiya More articles by this author Tomonori Habuchi More articles by this author Expand All Advertisement PDF downloadLoading ...