Chemoablation with Intensive Intravesical Mitomycin C Treatment: A New Approach for Non–muscle-invasive Bladder Cancer

Babjuk, 2017, EAU guidelines on non-muscle-invasive urothelial carcinoma of the bladder: update 2016, Eur Urol, 71, 447, 10.1016/j.eururo.2016.05.041 Antoni, 2017, Bladder cancer incidence and mortality: a global overview and recent trends, Eur Urol, 71, 96, 10.1016/j.eururo.2016.06.010 Messing, 1998, Urothelial tumors of the urinary tract, 2327 Fleshner, 1996, The National Cancer Data Base report on bladder carcinoma, Cancer, 78, 1505, 10.1002/(SICI)1097-0142(19961001)78:7<1505::AID-CNCR19>3.0.CO;2-3 Smith, 1999, Bladder Cancer Clinical Guidelines Panel summary report on the management of nonmuscle invasive bladder cancer (stages Ta, T1 and TIS), J Urol, 162, 1697, 10.1016/S0022-5347(05)68208-0 Holmang, 2001, Stage progression in Ta papillary urothelial tumors: relationship to grade, immunohistochemical expression of tumor markers, mitotic frequency and DNA ploidy, J Urol, 165, 1124, 10.1016/S0022-5347(05)66443-9 Maffezzini, 2007, Short-schedule intravesical gemcitabine with ablative intent in recurrent Ta–T1, G1-G2, low- or intermediate-risk, transitional cell carcinoma of the bladder, Eur Urol, 51, 956, 10.1016/j.eururo.2006.08.038 Popert, 1994, Superficial bladder cancer: the response of a marker tumour to a single intravesical instillation of epirubicin, Br J Urol, 74, 195, 10.1111/j.1464-410X.1994.tb16585.x van der Heijden, 2006, Phase II marker lesion study with intravesical instillation of apaziquone for superficial bladder cancer: toxicity and marker response, J Urol, 176, 1349, 10.1016/j.juro.2006.06.007 van der Meijden, 1996, Phase II trials in Ta, T1 bladder cancer. The marker tumour concept, Br J Urol, 77, 634, 10.1046/j.1464-410X.1996.09002.x Calais da Silva, 1988, Intravesical chemoresection with 40-epi-doxorubicin in patients with superficial bladder tumors, Eur Urol, 14, 207, 10.1159/000472938 Dalton, 1991, Pharmacokinetics of intravesical mitomycin C in superficial bladder cancer patients, Cancer Res, 51, 5144 Elliott, 1974, Characterization of a cell line from human transitional cell cancer of the urinary tract, J Natl Cancer Inst, 53, 1341, 10.1093/jnci/53.5.1341 Fujiyama, 2001, Human bladder cancer invasion model using rat bladder in vitro and its use to test mechanisms and therapeutic inhibitors of invasion, Br J Cancer, 84, 558, 10.1054/bjoc.2000.1641 Hu, 2010, Bladder tissue pharmacokinetics of intravesical mitomycin C and suramin in dogs, AAPS J, 12, 586, 10.1208/s12248-010-9219-8 Oshinsky, 1995, A model of bladder tumor xenografts in the nude rat, J Urol, 154, 1925, 10.1016/S0022-5347(01)66827-7 US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf Pasin, 2008, Superficial bladder cancer: an update on etiology, molecular development, classification, and natural history, Rev Urol, 10, 31 Solsona, 1999, Effectiveness of a single immediate mitomycin C instillation in patients with low risk superficial bladder cancer: short and longterm followup, J Urol, 161, 1120, 10.1016/S0022-5347(01)61606-9 Gudjónsson, 2009, Should all patients with non–muscle-invasive bladder cancer receive early intravesical chemotherapy after transurethral resection? The results of a prospective randomised multicentre study, Eur Urol, 55, 773, 10.1016/j.eururo.2009.01.006 Di Stasi, 2011, Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial, Lancet Oncol, 12, 871, 10.1016/S1470-2045(11)70190-5 Oosterlinck, 2001, 9 Logan, 2012, Intravesical therapies for bladder cancer—indications and limitations, BJU Int, 110, 12, 10.1111/j.1464-410X.2012.11619.x Au, 2001, Methods to improve efficacy of intravesical mitomycin C: results of a randomized phase III trial, J Natl Cancer Inst, 93, 597, 10.1093/jnci/93.8.597 Racioppi, 2010, Intensive intravesical mitomycin C therapy in non-muscle-invasive bladder cancer: a dose intensity approach, Urol Int, 85, 266, 10.1159/000315492 Colombo, 2012, Neoadjuvant short-term intensive intravesical mitomycin C regimen compared with weekly schedule for low grade recurrent non-muscle-invasive bladder cancer: preliminary results of a randomized phase 2 study, Eur Urol, 62, 797, 10.1016/j.eururo.2012.05.032 Divrik, 2006, The effect of repeat transurethral resection on recurrence and progression rates in patients with T1 tumors of the bladder who received intravesical mitomycin: a prospective, randomized clinical trial, J Urol, 175, 1641, 10.1016/S0022-5347(05)01002-5 Herr, 2007, Management of low grade papillary bladder tumors, J Urol, 178, 1201, 10.1016/j.juro.2007.05.148 Malmström, 2002, A randomized comparative dose-ranging study of interferon-alpha and mitomycin-C as an internal control in primary or recurrent superficial transitional cell carcinoma of the bladder, BJU Int, 89, 681, 10.1046/j.1464-410X.2002.02734.x Gerace, 2017, Cost of illness of urothelial bladder cancer in Italy, Clinicoecon Outcomes Res, 9, 433, 10.2147/CEOR.S135065 Soloway, 2003, Expectant management of small, recurrent, noninvasive papillary bladder tumors, J Urol, 170, 438, 10.1097/01.ju.0000076621.71247.6c Pruthi, 2008, Conservative management of low risk superficial bladder tumors, J Urol, 179, 87, 10.1016/j.juro.2007.08.171 Stadler, 1997, Phase II study of single-agent gemcitabine in previously untreated patients with metastatic urothelial cancer, J Clin Oncol, 15, 3394, 10.1200/JCO.1997.15.11.3394 Shelley, 2012, Intravesical gemcitabine therapy for non-muscle invasive bladder cancer (NMIBC): a systematic review, BJU Int, 109, 496, 10.1111/j.1464-410X.2011.10880.x Gontero, 2004, Phase II study to investigate the ablative efficacy of intravesical administration of gemcitabine in intermediate-risk superficial bladder cancer (SBC), Eur Urol, 46, 339, 10.1016/j.eururo.2004.05.001 Serretta, 2005, Gemcitabine in intravesical treatment of Ta–T1 transitional cell carcinoma of bladder: phase I–II study on marker lesions, Urology, 65, 65, 10.1016/j.urology.2004.08.027 De Berardinis, 2004, Intravesical administration of gemcitabine for the chemoresection of superficial bladder cancer: a marker lesion study, Eur Urol Suppl, 3, 123, 10.1016/S1569-9056(04)90480-0 Calais da Silva, 2005, Phase 2 study 2000mg of intravesical gemcitabine in marker lesions, Eur Urol Suppl, 4, 222, 10.1016/S1569-9056(05)80881-4 Brausi, 2007, Phase II marker lesion study of 6-week intravesical gemcitabine instillation in patients with low risk non muscle invasive bladder tumours, Eur Urol Suppl, 6, 59, 10.1016/S1569-9056(07)60147-X Böhle, 2009, Single postoperative instillation of gemcitabine in patients with non-muscle-invasive transitional cell carcinoma of the bladder: a randomised, double-blind, placebo-controlled phase III multicenter study, Eur Urol, 56, 495, 10.1016/j.eururo.2009.06.010 Addeo, 2010, Randomized phase III trial on gemcitabine versus mitomycin in recurrent superficial bladder cancer: evaluation of efficacy and tolerance, J Clin Oncol, 28, 543, 10.1200/JCO.2008.20.8199