摘要
No AccessJournal of UrologyAdult Urology1 May 2020Multi-Institution Evaluation of Sequential Gemcitabine and Docetaxel as Rescue Therapy for Nonmuscle Invasive Bladder CancerThis article is commented on by the following:Editorial Comment Ryan L. Steinberg, Lewis J. Thomas, Nathan Brooks, Sarah L. Mott, Andrew Vitale, Trafford Crump, Mounica Y. Rao, Marcus J. Daniels, Jonathan Wang, Supriya Nagaraju, William C. DeWolf, Donald L. Lamm, Max Kates, M. Eric Hyndman, Ashish M. Kamat, Trinity J. Bivalacqua, Kenneth G. Nepple, and Michael A. O’Donnell Ryan L. SteinbergRyan L. Steinberg Department of Urology, University of Texas Southwestern, Dallas, Texas More articles by this author , Lewis J. ThomasLewis J. Thomas Department of Urology, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author , Nathan BrooksNathan Brooks MD Anderson Cancer Center, Houston, Texas More articles by this author , Sarah L. MottSarah L. Mott Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa More articles by this author , Andrew VitaleAndrew Vitale Department of Urology, University of Iowa, Iowa City, Iowa More articles by this author , Trafford CrumpTrafford Crump Department of Urology, University of Calgary, Calgary, Alberta, Canada More articles by this author , Mounica Y. RaoMounica Y. Rao University of Arizona School of Medicine, Phoenix, Arizona More articles by this author , Marcus J. DanielsMarcus J. Daniels Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author , Jonathan WangJonathan Wang Beth Israel Deaconess Medical Center, Boston, Massachusetts More articles by this author , Supriya NagarajuSupriya Nagaraju MD Anderson Cancer Center, Houston, Texas More articles by this author , William C. DeWolfWilliam C. DeWolf Beth Israel Deaconess Medical Center, Boston, Massachusetts More articles by this author , Donald L. LammDonald L. Lamm University of Arizona School of Medicine, Phoenix, Arizona BCG Oncology, Phoenix, Arizona More articles by this author , Max KatesMax Kates Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author , M. Eric HyndmanM. Eric Hyndman Department of Urology, University of Calgary, Calgary, Alberta, Canada More articles by this author , Ashish M. KamatAshish M. Kamat MD Anderson Cancer Center, Houston, Texas Financial interest and/or other relationship with Merck, BMS, Arquer, MDxHealth, Photocure, Theralase, Medac, Asieris, Abbott Molecular and US Biotest. More articles by this author , Trinity J. BivalacquaTrinity J. Bivalacqua Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author , Kenneth G. NeppleKenneth G. Nepple Department of Urology, University of Iowa, Iowa City, Iowa Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa More articles by this author , and Michael A. O’DonnellMichael A. O’Donnell †Correspondence: Department of Urology, University of Iowa Hospitals and Clinics, 3 RCP, 200 Hawkins Drive, Iowa City, Iowa 52242 telephone: 319-353-8939; FAX: 319-356-3900; E-mail Address: [email protected] Department of Urology, University of Iowa, Iowa City, Iowa Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa Financial interest and/or other relationship with Abbott Molecular, Photocure, UroGen, Tocogen, Cold Genesis, Medical Enterprises, Fidia Pharmaceuticals, Vaxiion Pharmaceuticals, Ferring Pharmaceuticals, Sesen Bio, Urovant and Theralase. More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000688AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Rescue intravesical therapies for patients with bacillus Calmette-Guérin failure nonmuscle invasive bladder cancer remain a critical focus of ongoing research. Sequential intravesical gemcitabine and docetaxel therapy has shown safety and efficacy in 2 retrospective, single institution cohorts. This doublet has since been adopted as an intravesical salvage option at multiple institutions. We report the results of a multi-institutional evaluation of gemcitabine and docetaxel. Materials and Methods: Each institution retrospectively reviewed all records of patients treated with intravesical gemcitabine and docetaxel for nonmuscle invasive bladder cancer between June 2009 and May 2018. Only patients with recurrent nonmuscle invasive bladder cancer and a history of bacillus Calmette-Guérin treatment were included in the analysis. If patients were disease-free after induction, maintenance was instituted at the treating physician’s discretion. Posttreatment surveillance followed American Urological Association guidelines. Survival analysis was performed using the Kaplan-Meier method and risk factors for treatment failure were assessed with Cox regression models. Results: Overall 276 patients (median age 73 years, median followup 22.9 months) received treatment. Nine patients were unable to tolerate a full induction course. One and 2-year recurrence-free survival rates were 60% and 46%, and high grade recurrence-free survival rates were 65% and 52%, respectively. Ten patients (3.6%) had disease progression on transurethral resection. Forty-three patients (15.6%) went on to cystectomy (median 11.3 months from induction), of whom 11 (4.0%) had progression to muscle invasion. Analysis identified no patient, disease or prior treatment related factors associated with gemcitabine and docetaxel failure. Conclusions: Intravesical gemcitabine and docetaxel therapy is well tolerated and effective, providing a durable response in patients with recurrent nonmuscle invasive bladder cancer after bacillus Calmette-Guérin therapy. Further prospective study is warranted. References 1. : Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline. J Urol 2016; 196: 1021. Link, Google Scholar 2. : Clarification of bladder cancer disease states following treatment of patients with intravesical BCG. Bladder Cancer 2015; 1: 29. Google Scholar 3. : Definitions, end points, and clinical trial designs for non-muscle-invasive bladder cancer: recommendations from the International Bladder Cancer Group. J Clin Oncol 2016; 34: 1935. Google Scholar 4. : Radical cystectomy in the treatment of invasive bladder cancer: long-term results in 1,054 patients. J Clin Oncol 2001; 19: 666. Google Scholar 5. American Urological Association: Policy Blog: Important Updates on BCG Availability. Linthicum, Maryland: American Urological Association 2014. Google Scholar 6. : Bacillus Calmette-Guérin with or without interferon alpha-2b and megadose versus recommended daily allowance vitamins during induction and maintenance intravesical treatment of nonmuscle invasive bladder cancer. J Urol 2010; 184: 1915. Link, Google Scholar 7. : Long-term survival outcomes with intravesical docetaxel for recurrent nonmuscle invasive bladder cancer after previous bacillus Calmette-Guérin therapy. J Urol 2013; 189: 834. Link, Google Scholar 8. : Randomized intergroup comparison of bacillus Calmette-Guerin immunotherapy and mitomycin C chemotherapy prophylaxis in superficial transitional cell carcinoma of the bladder a Southwest Oncology Group study. Urol Oncol 1995; 1: 119. Google Scholar 9. : Phase II trial of intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus Calmette-Guérin treatment failure. J Urol 2014; 192: 1633. Link, Google Scholar 10. : SWOG S0353: phase II trial of intravesical gemcitabine in patients with nonmuscle invasive bladder cancer and recurrence after 2 prior courses of intravesical bacillus Calmette-Guérin. J Urol 2013; 190: 1200. Link, Google Scholar 11. : Intravesical valrubicin in patients with bladder carcinoma in situ and contraindication to or failure after bacillus Calmette-Guerin. Urol Oncol 2013; 31: 1635. Google Scholar 12. : Intravesical electromotive mitomycin C versus passive transport mitomycin C for high risk superficial bladder cancer: a prospective randomized study. J Urol 2003; 170: 777. Link, Google Scholar 13. : Combined local bladder hyperthermia and intravesical chemotherapy for the treatment of high-grade superficial bladder cancer. Urology 2004; 63: 466. Google Scholar 14. : A cocktail regimen of intravesical mitomycin-C, doxorubicin, and cisplatin (MDP) for non-muscle-invasive bladder cancer. Urol Oncol 2012; 30: 421. Google Scholar 15. : Multi-institutional analysis of sequential intravesical gemcitabine and mitomycin C chemotherapy for non-muscle invasive bladder cancer. Urol Oncol 2014; 32: 35. Google Scholar 16. : Phase 2 KEYNOTE-057 study: pembrolizumab for patients with high-risk non–muscle invasive bladder cancer unresponsive to bacillus Calmette-Guerin (abstract MP43-01). J Urol, suppl., 2019; 201: e616. Google Scholar 17. : Bacillus Calmette-Guerin (BCG) treatment failures in non-muscle invasive bladder cancer: what truly constitutes unresponsive disease. Bladder Cancer 2015; 1: 105. Google Scholar 18. : Sequential intravesical gemcitabine and docetaxel for the salvage treatment of non-muscle invasive bladder cancer. Bladder Cancer 2015; 1: 65. Google Scholar 19. : Oncological outcomes of sequential intravesical gemcitabine and docetaxel in patients with non-muscle invasive bladder cancer. Bladder Cancer 2017; 3: 293. Google Scholar 20. : Maintenance bacillus Calmette-Guérin immunotherapy for recurrent Ta, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group study. J Urol 2000; 163: 1124. Link, Google Scholar 21. : Bacillus Calmette-Guerin (BCG) treatment failures with non-muscle invasive bladder cancer: a data-driven definition for BCG unresponsive disease. Bladder Cancer 2016; 2: 215. Google Scholar 22. : Treatment options for BCG failures. World J Urol 2006; 24: 481. Google Scholar 23. : Does early cystectomy improve the survival of patients with high risk superficial bladder tumors?J Urol 2001; 166: 1296. Link, Google Scholar 24. : Primary superficial bladder cancer risk groups according to progression, mortality and recurrence. J Urol 2000; 164: 680. Link, Google Scholar 25. : Residual tumor discovered in routine second transurethral resection in patients with stage T1 transitional cell carcinoma of the bladder. J Urol 1991; 146: 316. Link, Google Scholar 26. : An evaluation of morphological and functional multi-parametric MRI sequences in classifying non-muscle and muscle invasive bladder cancer. Eur Radiol 2017; 27: 3759. Google Scholar 27. : Validation of the BCG unresponsive definition. Presented at the 18th Annual Meeting of the Society of Urologic Oncology, Washington, DC, November 20-December 1, 2017. Google Scholar 28. : Celecoxib plus hormone therapy versus hormone therapy alone for hormone-sensitive prostate cancer: first results from the STAMPEDE multiarm, multistage, randomised controlled trial. Lancet Oncol 2012; 13: 549. Google Scholar 29. : Clinical trial design for the development of new therapies for nonmuscle-invasive bladder cancer: report of a Food and Drug Administration and American Urological Association public workshop. Urology 2014; 83: 262. Google Scholar Supported by the John & Carol Walter Family Foundation. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsRelated articlesJournal of UrologyJan 27, 2020, 12:00:00 AMEditorial Comment Volume 203Issue 5May 2020Page: 902-909Supplementary Materials Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.Keywordsgemcitabinedocetaxeladministrationintravesicalurinary bladder neoplasmssalvage therapyMetricsAuthor Information Ryan L. Steinberg Department of Urology, University of Texas Southwestern, Dallas, Texas More articles by this author Lewis J. Thomas Department of Urology, Cleveland Clinic Foundation, Cleveland, Ohio More articles by this author Nathan Brooks MD Anderson Cancer Center, Houston, Texas More articles by this author Sarah L. Mott Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa More articles by this author Andrew Vitale Department of Urology, University of Iowa, Iowa City, Iowa More articles by this author Trafford Crump Department of Urology, University of Calgary, Calgary, Alberta, Canada More articles by this author Mounica Y. Rao University of Arizona School of Medicine, Phoenix, Arizona More articles by this author Marcus J. Daniels Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author Jonathan Wang Beth Israel Deaconess Medical Center, Boston, Massachusetts More articles by this author Supriya Nagaraju MD Anderson Cancer Center, Houston, Texas More articles by this author William C. DeWolf Beth Israel Deaconess Medical Center, Boston, Massachusetts More articles by this author Donald L. Lamm University of Arizona School of Medicine, Phoenix, Arizona BCG Oncology, Phoenix, Arizona More articles by this author Max Kates Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author M. Eric Hyndman Department of Urology, University of Calgary, Calgary, Alberta, Canada More articles by this author Ashish M. Kamat MD Anderson Cancer Center, Houston, Texas Financial interest and/or other relationship with Merck, BMS, Arquer, MDxHealth, Photocure, Theralase, Medac, Asieris, Abbott Molecular and US Biotest. More articles by this author Trinity J. Bivalacqua Department of Urology, Johns Hopkins University, Baltimore, Maryland More articles by this author Kenneth G. Nepple Department of Urology, University of Iowa, Iowa City, Iowa Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa More articles by this author Michael A. O’Donnell Department of Urology, University of Iowa, Iowa City, Iowa Holden Comprehensive Cancer Center, University of Iowa, Iowa City, Iowa †Correspondence: Department of Urology, University of Iowa Hospitals and Clinics, 3 RCP, 200 Hawkins Drive, Iowa City, Iowa 52242 telephone: 319-353-8939; FAX: 319-356-3900; E-mail Address: [email protected] Financial interest and/or other relationship with Abbott Molecular, Photocure, UroGen, Tocogen, Cold Genesis, Medical Enterprises, Fidia Pharmaceuticals, Vaxiion Pharmaceuticals, Ferring Pharmaceuticals, Sesen Bio, Urovant and Theralase. More articles by this author Expand All Supported by the John & Carol Walter Family Foundation. No direct or indirect commercial, personal, academic, political, religious or ethical incentive is associated with publishing this article. Advertisement PDF DownloadLoading ...