Literature DB >> 25424854

Sequential intravesical mitomycin plus Bacillus Calmette-Guérin for non-muscle-invasive urothelial bladder carcinoma: translational and phase I clinical trial.

Robert S Svatek1, Xiang Ru Zhao2, Edwin E Morales3, Mithilesh K Jha3, Timothy Y Tseng3, Cory M Hugen3, Vincent Hurez4, Javier Hernandez3, Tyler J Curiel5.   

Abstract

PURPOSE: To determine the safety and toxicities of sequential MMC (mitomycin C) + BCG (bacillus Calmette-Guérin) in patients with non-muscle-invasive bladder cancer (NMIBC) and explore evidence for potentiation of BCG activity by MMC. EXPERIMENTAL
DESIGN: A 3 + 3 phase I dose-escalation trial of six weekly treatments was conducted in patients with NMIBC. MMC (10, 20, or 40 mg) was instilled intravesically for 30 minutes, followed by a 10-minute washout with gentle saline irrigation and then instillation of BCG (half or full strength) for 2 hours. Urine cytokines were monitored and compared with levels in a control cohort receiving BCG only. Murine experiments were carried out as described previously.
RESULTS: Twelve patients completed therapy, including 3 patients receiving full doses. The regimen was well tolerated with no treatment-related dose-limiting toxicities. Urinary frequency and urgency, and fatigue were common. Eleven (91.7%) patients were free of disease at a mean (range) follow-up of 21.4 (8.4-27.0) months. Median posttreatment urine concentrations of IL2, IL8, IL10, and TNFα increased over the 6-week treatment period. A greater increase in posttreatment urinary IL8 during the 6-week period was observed in patients receiving MMC + BCG compared with patients receiving BCG monotherapy. In mice, intravesical MMC + BCG skewed tumor-associated macrophages (TAM) toward a beneficial M1 phenotype.
CONCLUSIONS: Instillation of sequential MMC + BCG is safe tolerable up to 40-mg MMC plus full-strength BCG. This approach could provide improved antitumor activity over BCG monotherapy by augmenting beneficial M1 TAMs. ©2014 American Association for Cancer Research.

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Year:  2014        PMID： 25424854      PMCID： PMC4297588          DOI： 10.1158/1078-0432.CCR-14-1781

Source DB:  PubMed          Journal:  Clin Cancer Res        ISSN： 1078-0432            Impact factor:   12.531


  49 in total

1.  Urinary IL-2 assay for monitoring intravesical bacillus Calmette-Guérin response of superficial bladder cancer during induction course and maintenance therapy.

Authors:  Fabien Saint; Nathalie Kurth; Pascale Maille; Dimitri Vordos; Andre Hoznek; Pascale Soyeux; Jean Jacques Patard; Claude C Abbou; Dominique K Chopin
Journal:  Int J Cancer       Date:  2003-11-10       Impact factor: 7.396

2.  Fibronectin-mediated Calmette-Guerin bacillus attachment to murine bladder mucosa. Requirement for the expression of an antitumor response.

Authors:  L R Kavoussi; E J Brown; J K Ritchey; T L Ratliff
Journal:  J Clin Invest       Date:  1990-01       Impact factor: 14.808

3.  Gemcitabine exerts a selective effect on the humoral immune response: implications for combination chemo-immunotherapy.

Authors:  Anna K Nowak; Bruce W S Robinson; Richard A Lake
Journal:  Cancer Res       Date:  2002-04-15       Impact factor: 12.701

4.  BCG prophylaxis in bladder cancer produces activation of recruited neutrophils.

Authors:  Francesca Vita; Salvatore Siracusano; Rita Abbate; Stefano Ciciliato; Violetta Borelli; Maria Rosa Soranzo; Giuliano Zabucchi
Journal:  Can J Urol       Date:  2011-02       Impact factor: 1.344

5.  Leukocytes in the urine after intravesical BCG treatment for superficial bladder cancer. A flow cytofluorometric analysis.

Authors:  E C de Boer; W H de Jong; A P van der Meijden; P A Steerenberg; F Witjes; P D Vegt; F M Debruyne; E J Ruitenberg
Journal:  Urol Res       Date:  1991

6.  Smac mimetic enables the anticancer action of BCG-stimulated neutrophils through TNF-α but not through TRAIL and FasL.

Authors:  Goodwin Jinesh G; Srinivas Chunduru; Ashish M Kamat
Journal:  J Leukoc Biol       Date:  2012-04-18       Impact factor: 4.962

7.  Effects of local bacillus Calmette-Guerin therapy in patients with bladder carcinoma on immunocompetent cells of the bladder wall.

Authors:  A Böhle; J Gerdes; A J Ulmer; A G Hofstetter; H D Flad
Journal:  J Urol       Date:  1990-07       Impact factor: 7.450

8.  Bladder cancer.

Authors:  Peter E Clark; Neeraj Agarwal; Matthew C Biagioli; Mario A Eisenberger; Richard E Greenberg; Harry W Herr; Brant A Inman; Deborah A Kuban; Timothy M Kuzel; Subodh M Lele; Jeff Michalski; Lance C Pagliaro; Sumanta K Pal; Anthony Patterson; Elizabeth R Plimack; Kamal S Pohar; Michael P Porter; Jerome P Richie; Wade J Sexton; William U Shipley; Eric J Small; Philippe E Spiess; Donald L Trump; Geoffrey Wile; Timothy G Wilson; Mary Dwyer; Maria Ho
Journal:  J Natl Compr Canc Netw       Date:  2013-04-01       Impact factor: 11.908

9.  Phase I trial of intravesical gemcitabine in bacillus Calmette-Guérin-refractory transitional-cell carcinoma of the bladder.

Authors:  Guido Dalbagni; Paul Russo; Joel Sheinfeld; Madhu Mazumdar; William Tong; Farhang Rabbani; Machelle S Donat; Harry W Herr; Pramod Sogani; Dominique dePalma; Dean Bajorin
Journal:  J Clin Oncol       Date:  2002-08-01       Impact factor: 44.544

10.  Side effects of Bacillus Calmette-Guérin (BCG) in the treatment of intermediate- and high-risk Ta, T1 papillary carcinoma of the bladder: results of the EORTC genito-urinary cancers group randomised phase 3 study comparing one-third dose with full dose and 1 year with 3 years of maintenance BCG.

Authors:  Maurizio Brausi; Jorg Oddens; Richard Sylvester; Aldo Bono; Cees van de Beek; George van Andel; Paolo Gontero; Levent Turkeri; Sandrine Marreaud; Sandra Collette; Willem Oosterlinck
Journal:  Eur Urol       Date:  2013-07-24       Impact factor: 20.096
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  18 in total

1.  Rapamycin Prevents Surgery-Induced Immune Dysfunction in Patients with Bladder Cancer.

Authors:  Robert S Svatek; Niannian Ji; Essel de Leon; Neelam Z Mukherjee; Aashish Kabra; Vincent Hurez; Marlo Nicolas; Joel E Michalek; Martin Javors; Karen Wheeler; Z Dave Sharp; Carolina B Livi; Zhen-Ju Shu; David Henkes; Tyler J Curiel
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2.  A Festschrift in Honor of Edward M. Messing, MD, FACS.

Authors:  Jean V Joseph; Ralph Brasacchio; Chunkit Fung; Jay Reeder; Kevin Bylund; Deepak Sahasrabudhe; Shu Yuan Yeh; Ahmed Ghazi; Patrick Fultz; Deborah Rubens; Guan Wu; Eric Singer; Edward Schwarz; Supriya Mohile; James Mohler; Dan Theodorescu; Yi Fen Lee; Paul Okunieff; David McConkey; Hani Rashid; Chawnshang Chang; Yves Fradet; Khurshid Guru; Janet Kukreja; Gerald Sufrin; Yair Lotan; Howard Bailey; Katia Noyes; Seymour Schwartz; Kathy Rideout; Gennady Bratslavsky; Steven C Campbell; Ithaar Derweesh; Per-Anders Abrahamsson; Mark Soloway; Leonard Gomella; Dragan Golijanin; Robert Svatek; Thomas Frye; Seth Lerner; Ganesh Palapattu; George Wilding; Michael Droller; Donald Trump
Journal:  Bladder Cancer       Date:  2018-10-03

3.  Percutaneous BCG enhances innate effector antitumor cytotoxicity during treatment of bladder cancer: a translational clinical trial.

Authors:  Niannian Ji; Neelam Mukherjee; Edwin E Morales; Maggie E Tomasini; Vincent Hurez; Tyler J Curiel; Getahun Abate; Dan F Hoft; Xiang-Ru Zhao; Jon Gelfond; Sourindra Maiti; Laurence J N Cooper; Robert S Svatek
Journal:  Oncoimmunology       Date:  2019-05-25       Impact factor: 8.110

4.  Intravesical BCG Induces CD4+ T-Cell Expansion in an Immune Competent Model of Bladder Cancer.

Authors:  Max Kates; Thomas Nirschl; Nikolai A Sopko; Hotaka Matsui; Christina M Kochel; Leonardo O Reis; George J Netto; Mohammad Hoque; Noah M Hahn; David J McConkey; Alex S Baras; Charles G Drake; Trinity J Bivalacqua
Journal:  Cancer Immunol Res       Date:  2017-06-06       Impact factor: 11.151

5.  Intravesical mitomycin C (MMC) and MMC + cytosine arabinoside for non-muscle-invasive bladder cancer: a randomised clinical trial.

Authors:  Yasuyoshi Miyata; Toshifumi Tsurusaki; Yasushi Hayashida; Yushi Imasato; Kosuke Takehara; Daiyu Aoki; Masaharu Nishikido; Junichi Watanabe; Kensuke Mitsunari; Tomohiro Matsuo; Kojiro Ohba; Keisuke Taniguchi; Hideki Sakai
Journal:  BJU Int       Date:  2021-08-24       Impact factor: 5.969

Review 6.  Much More than M1 and M2 Macrophages, There are also CD169(+) and TCR(+) Macrophages.

Authors:  Leslie Chávez-Galán; Maria L Olleros; Dominique Vesin; Irene Garcia
Journal:  Front Immunol       Date:  2015-05-26       Impact factor: 7.561

7.  Combination of IFNα and poly-I:C reprograms bladder cancer microenvironment for enhanced CTL attraction.

Authors:  Ravikumar Muthuswamy; Liwen Wang; Jamie Pitteroff; Jeffrey R Gingrich; Pawel Kalinski
Journal:  J Immunother Cancer       Date:  2015-03-24       Impact factor: 13.751

8.  NMAAP1 Expressed in BCG-Activated Macrophage Promotes M1 Macrophage Polarization.

Authors:  Qihui Liu; Yuan Tian; Xiangfeng Zhao; Haifeng Jing; Qi Xie; Peng Li; Dong Li; Dongmei Yan; Xun Zhu
Journal:  Mol Cells       Date:  2015-10-02       Impact factor: 5.034

Review 9.  Systematic Review and Cumulative Analysis of the Combination of Mitomycin C plus Bacillus Calmette-Guérin (BCG) for Non-Muscle-Invasive Bladder Cancer.

Authors:  Tuo Deng; Bing Liu; Xiaolu Duan; Tao Zhang; Chao Cai; Guohua Zeng
Journal:  Sci Rep       Date:  2017-06-09       Impact factor: 4.379

Review 10.  Inflammatory microenvironment in the initiation and progression of bladder cancer.

Authors:  Xinbing Sui; Liming Lei; Liuxi Chen; Tian Xie; Xue Li
Journal:  Oncotarget       Date:  2017-10-06
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