Midterm follow-up (3 years) confirms and extends short-term results of intravesical gemcitabine as bladder-preserving treatment for non-muscle-invasive bladder cancer after BCG failure

被引:14
|
作者
Hurle, Rodolfo [1 ]
Contieri, Roberto [1 ]
Casale, Paolo [1 ]
Morenghi, Emanuela [2 ]
Saita, Alberto [1 ]
Buffi, Nicolomaria [1 ,2 ,3 ]
Lughezzani, Giovanni [1 ,3 ]
Colombo, Piergiuseppe [4 ]
Frego, Nicola [1 ]
Fasulo, Vittorio [1 ]
Paciotti, Marco [1 ]
Guazzoni, Giorgio [1 ,3 ]
Lazzeri, Massimo [1 ]
机构
[1] Humanitas Clin & Res Ctr IRCCS, Dept Urol, Milan, Italy
[2] Humanitas Clin & Res Ctr IRCCS, Dept Med Stat, Milan, Italy
[3] Dept Biomed Sci, Dept Urol, Pieve Emanuele Milano, Italy
[4] Humanitas Clin & Res Ctr IRCCS, Dept Pathol, Milan, Italy
关键词
Bladder cancer; BCG; Gemcitabine; Intravesical therapy; BACILLUS-CALMETTE-GUERIN; CARCINOMA IN-SITU; UROTHELIAL CANCER; TRIAL; VALRUBICIN; RECURRENCE; CISPLATIN; THERAPIES; EFFICACY;
D O I
10.1016/j.urolonc.2020.09.017
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Background: There is a high demand for bladder sparing therapies in patients who do not respond to bacillus Calmette-Guerin (BCG). Objective: To report the mid-term results of intravesical gemcitabine in non-muscle-invasive bladder cancer (NMIBC) patients, who failed BCG and who were unwilling to undergo radical cystectomy (RC). Material & methods: This is an extended confirmatory open-label, single-arm study, which enrolled consecutive patients who failed BCG or were BCG intolerant and unwilling to undergo the RC (histologically confirmed Tis (CIS), T1 high grade or multifocal Ta high grade of the urinary bladder). Intravesical gemcitabine was administered once a week for 6 consecutive weeks and once a month for 12 months. The primary outcome was disease-free survival (DFS) defined as the lack of tumor on cystoscopy and negative urine cytology. The secondary endpoint was safety, defined according a grading of side effects. overall survival, progression-free survival and DFS were described with Kaplan-Meier method at 12, 24, and 36 months. Results and limitations: Overall 46 patients were enrolled. The mean follow-up was 40 months. The DFS was 69.05% at the end of induction phase and 32.69% at 36 months. The progression-free survival at 36 months was 65.38%. The overall survival and cancer specific survival were 66.97% (95% confidence interval 47.25%-80.70%) and 78.71% (95% confidence interval 59.16%-89.66%), respectively. There was no life-threatening event or treatment related death (grade 4 or 5). The most common mild and moderate adverse events reported were urinary symptoms (lower urinary tract symptoms) and fatigue (G1-G2). Conclusion: Intravesical gemcitabine seemed to represent a valid and safe alternative at 3 years follow-up for patients who failed BCG and were unwilling to undergo RC. (C) 2020 Elsevier Inc. All rights reserved.
引用
收藏
页码:195.e7 / 195.e13
页数:7
相关论文
共 50 条
  • [41] Long-term Follow-up and Factors Associated with Active Surveillance Failure for Patients with Non-muscle-invasive Bladder Cancer: The Bladder Cancer Italian Active Surveillance (BIAS) Experience
    Contieri, Roberto
    Paciotti, Marco
    Lughezzani, Giovanni
    Buffi, Nicolo M.
    Frego, Nicola
    Diana, Pietro
    Fasulo, Vittorio
    Saita, Alberto
    Casale, Paolo
    Lazzeri, Massimo
    Guazzoni, Giorgio
    Hurle, Rodolfo
    EUROPEAN UROLOGY ONCOLOGY, 2022, 5 (02): : 251 - 255
  • [42] Efficacy of hyperthermic intravesical chemotherapy (HIVEC) in patients with non-muscle invasive bladder cancer after BCG failure
    Géraldine Pignot
    Michael Baboudjian
    Cédric Lebacle
    Alexandre Chamouni
    Eric Lechevallier
    Jacques Irani
    Xavier Tillou
    Thibaut Waeckel
    Arnaud Monges
    Laure Doisy
    Jochen Walz
    Gwenaelle Gravis
    Eric Mourey
    Céline Duperron
    Alexandra Masson-Lecomte
    World Journal of Urology, 2023, 41 : 3195 - 3203
  • [43] Efficacy of hyperthermic intravesical chemotherapy (HIVEC) in patients with non-muscle invasive bladder cancer after BCG failure
    Pignot, Geraldine
    Baboudjian, Michael
    Lebacle, Cedric
    Chamouni, Alexandre
    Lechevallier, Eric
    Irani, Jacques
    Tillou, Xavier
    Waeckel, Thibaut
    Monges, Arnaud
    Doisy, Laure
    Walz, Jochen
    Gravis, Gwenaelle
    Mourey, Eric
    Duperron, Celine
    Masson-Lecomte, Alexandra
    WORLD JOURNAL OF UROLOGY, 2023, 41 (11) : 3195 - 3203
  • [44] LONG-TERM SURVIVAL OUTCOMES WITH INTRAVESICAL DOCETAXEL IN THE MANAGEMENT OF NON-MUSCLE-INVASIVE BLADDER CANCER (NMIBC) REFRACTORY TO BCG THERAPY
    Barlow, LaMont
    McKiernan, James
    Benson, Mitchell
    JOURNAL OF UROLOGY, 2012, 187 (04): : E677 - E677
  • [45] Long-term Follow-up After En Bloc Transurethral Resection of Non-muscle-invasive Bladder Cancer: Results from a Single-center Experience
    Paciotti, Marco
    Casale, Paolo
    Colombo, Piergiuseppe
    Fasulo, Vittorio
    Saita, Alberto
    Lughezzani, Giovanni
    Contieri, Roberto
    Buffi, Nicolo Maria
    Lazzeri, Massimo
    Guazzoni, Giorgio
    Hurle, Rodolfo
    EUROPEAN UROLOGY OPEN SCIENCE, 2021, 26 : 64 - 71
  • [46] Sequential Gemcitabine plus Docetaxel Is the Standard Second-line Intravesical Therapy for BCG-unresponsive Non-muscle-invasive bladder cancer: Pro
    Roumiguie, Mathieu
    Black, Peter C.
    EUROPEAN UROLOGY FOCUS, 2022, 8 (04): : 1117 - 1120
  • [47] Long-term follow-up of intravesical gemcitabine and docetaxel as rescue therapy for nonmuscle-invasive bladder cancer.
    Chevuru, Phani T.
    McElree, Ian Mitchell
    Martin, Alexander C.
    Richards, Jordan
    Mott, Sarah L.
    Gellhaus, Paul T.
    Nepple, Kenneth G.
    Steinberg, Ryan L.
    O'Donnell, Michael A.
    Packiam, Vignesh T.
    JOURNAL OF CLINICAL ONCOLOGY, 2022, 40 (06)
  • [48] Carcinogenesis and Bacillus Calmette-Guerin (BCG) Intravesical Treatment of Non-Muscle-Invasive Bladder Cancer under Tryptophan and Thymine Supplementation
    Ossick, Marina, V
    Assalin, Heloisa B.
    Kiehl, Isis G. A.
    Salustiano, Ana C. C.
    Rocha, Guilherme Zweig
    Ferrari, Karen L.
    Linarelli, Maria C. B.
    Degasperi, Giovanna
    Reis, Leonardo O.
    NUTRITION AND CANCER-AN INTERNATIONAL JOURNAL, 2021, 73 (11-12): : 2687 - 2694
  • [49] Long-term intravesical adjuvant chemotherapy further reduces recurrence rate compared with short-term intravesical chemotherapy and short-term therapy with bacillus Calmette-Guerin (BCG) in patients with non-muscle-invasive bladder carcinoma
    Friedrich, Martin G.
    Pichlmeier, Uwe
    Schwaibold, Hartwig
    Conrad, Stefan
    Huland, Hartwig
    EUROPEAN UROLOGY, 2007, 52 (04) : 1123 - 1130
  • [50] Diminished Short-Term Efficacy of Reduced-Dose Induction BCG in the Treatment of Non-Muscle Invasive Bladder Cancer
    Ostrowski, David A.
    Chelluri, Raju R.
    Herzig, Matthew
    Xia, Leilei
    Cortese, Brian D.
    Roberson, Daniel S.
    Guzzo, Thomas J.
    Lee, Daniel H. J.
    Malkowicz, S. Bruce
    CANCERS, 2023, 15 (14)