Appropriate endpoints for superficial bladder cancer clinical trials.

1987 ◽  
Vol 5 (12) ◽  
pp. 2004-2008 ◽  
Author(s):  
L A Kalish ◽  
M B Garnick ◽  
J P Richie
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Clinical Outcome ◽  
Superficial Bladder Cancer ◽  
Invasive Disease ◽  
Actual Data ◽  
Cancer Clinical Trials ◽  
Data Sets ◽  
End Points

Many protocols for treatment of superficial bladder cancer include periodic cystoscopic examinations with resection of visible lesions. This allows pathological restaging of the disease at each examination. For example, this type of follow-up is common in clinical trials evaluating intravesical therapies. In such trials, clinical outcome is typically summarized using end-points that measure failure to control superficial disease. Alternative endpoints measuring failure to prevent progression to invasive disease are often ignored. In this report, the rationale for ignoring the invasive disease endpoints is given and flaws in the rationale are described. Evidence from actual data sets support the view that superficial disease endpoints may not be appropriate surrogates for invasive disease endpoints. It is recommended that time to invasive disease should be considered a major endpoint when designing and analyzing trials in superficial bladder cancer.

832: Optimized Intravesical Mitomycin C Treatment for Superficial Bladder Cancer: Long-Term Follow-Up

2006 ◽  
Vol 175 (4S) ◽  
pp. 268-269 ◽  
Author(s):  
Jessie L. Au ◽  
Robert A. Badalament ◽  
M. Guillaume Wientjes ◽  
Donn C. Young ◽  
Tong Shen ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Mitomycin C ◽  
Superficial Bladder Cancer ◽  
Long Term Follow Up

scholarly journals Intratumoral CD103+ CD8+ T cells predict response to PD-L1 blockade

2021 ◽  
Vol 9 (4) ◽  
pp. e002231
Author(s):  
Romain Banchereau ◽  
Avantika S. Chitre ◽  
Alexis Scherl ◽  
Thomas D. Wu ◽  
Namrata S. Patil ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Clinical Trials ◽  
Cancer Progression ◽  
Cd8 T Cells ◽  
Clonal Expansion ◽  
T Cell Response ◽  
High Dimensional ◽  
Cancer Clinical Trials ◽  
Complex Phenotype ◽  
Cytotoxic Proteins

BackgroundCD8+ tissue-resident memory T (TRM) cells, marked by CD103 (ITGAE) expression, are thought to actively suppress cancer progression, leading to the hypothesis that their presence in tumors may predict response to immunotherapy.MethodsHere, we test this by combining high-dimensional single-cell modalities with bulk tumor transcriptomics from 1868 patients enrolled in lung and bladder cancer clinical trials of atezolizumab (anti-programmed cell death ligand 1 (PD-L1)).ResultsITGAE was identified as the most significantly upregulated gene in inflamed tumors. Tumor CD103+ CD8+ TRM cells exhibited a complex phenotype defined by the expression of checkpoint regulators, cytotoxic proteins, and increased clonal expansion.ConclusionsOur analyses indeed demonstrate that the presence of CD103+ CD8+ TRM cells, quantified by tracking intratumoral CD103 expression, can predict treatment outcome, suggesting that patients who respond to PD-1/PD-L1 blockade are those who exhibit an ongoing antitumor T-cell response.

596 UROVYSION© VS TRADITIONAL SURVEILLANCE FOR FOLLOW–UP OF PATIENTS WITH SUPERFICIAL BLADDER CANCER

2007 ◽  
Vol 6 (2) ◽  
pp. 171 ◽  
Author(s):  
S. Gudjonsson ◽  
B.L. Isfoss ◽  
K. Hansson ◽  
A.M. Domanski ◽  
J. Warenholt ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Superficial Bladder Cancer ◽  
Traditional Surveillance

scholarly journals Evaluation of End Points in Cancer Clinical Trials

2018 ◽  
Vol 13 (6) ◽  
pp. 745-747 ◽  
Author(s):  
Jun Yin ◽  
Suzanne E. Dahlberg ◽  
Sumithra J. Mandrekar
Keyword(s):  
Clinical Trials ◽  
Cancer Clinical Trials ◽  
End Points

Adjuvant Intravesical Chemotherapy in Patients with Primary T1 G3 Transitional Cell Carcinoma of the Bladder

1993 ◽  
Vol 60 (4) ◽  
pp. 345-348
Author(s):  
V. Serretta ◽  
S. Piazza ◽  
C. Pavone ◽  
G. Corselli ◽  
B. Piazza ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Transitional Cell Carcinoma ◽  
Carcinoma In Situ ◽  
Transitional Cell ◽  
Invasive Disease ◽  
Intravesical Chemotherapy ◽  
Carcinoma Of The Bladder ◽  
Bladder Tumours

The Authors present their experience with TUR plus adjuvant intravesical chemotherapy in 50 patients affected by primary T1 G3 bladder tumours without previous or concomitant carcinoma in situ. At a mean follow-up of 36 months, 84% of the patients are alive and tumour-free. Cystectomy was performed in three patients due to locally invasive disease. Five patients (10%) died of bladder cancer.

scholarly journals The value of the NMP22 test for superficial bladder cancer diagnosis and follow-up

2014 ◽  
Vol 39 (3) ◽  
pp. 137-142 ◽  
Author(s):  
Caner Dogan ◽  
Eyyüp Sabri Pelit ◽  
Asif Yildirim ◽  
Itir Ebru Zemheri ◽  
Cengiz Canakci ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Cancer Diagnosis ◽  
Superficial Bladder Cancer

Espressione di oncogeni di proliferazione e morte cellulare nel carcinoma superficiale della vescica: Expression of oncogenes in relation to cell proliferation and death in superficial bladder carcinoma

1995 ◽  
Vol 62 (2) ◽  
pp. 216-228
Author(s):  
G. Ferrari ◽  
G. Castagnetti ◽  
A. Dotti ◽  
G. Galizia ◽  
P. Ferrari ◽  
...  
Keyword(s):  
Bladder Cancer ◽  
Superficial Bladder Cancer ◽  
Neoplastic Progression ◽  
P53 Expression ◽  
Proliferation Indices ◽  
Superficial Bladder Carcinoma ◽  
Progression Of Disease ◽  
The One ◽  
Definition Of

Although superficial bladder cancer may be considered “benign”, it is still today a many-sided neoplasm with a prognosis that cannot be well-defined with known traditional parameters. Proliferation indices Ki67 and AgNOR associated with the expression of some oncogenes (p53, Rb, c-myc, BCL2, c-erbB-2) in relation to traditional parameters could help in the prognosis definition of individual patients. 111 patients with superficial bladder cancer were studied for this purpose, relating the grade, stage, follow-up and morphotype to the proliferation indices. Significant correlations were found with AgNOR, but only for grade with Ki67. The study of the oncoproteins and their different expression showed that those alterations typical of infiltration are already present in the superficial forms, with a significant correlation between oncogenic alterations and grade and stage of disease (p53, Rb) on the one hand, and above all of disease-free interval and progression (c-erbB-2) on the other. Lastly, assessment of the oncoproteins c-myc and BCL2, oncogenes connected with the programmed cell death mechanism (apoptosis), showed important correlations with the neoplastic progression of disease in relation to the p53 expression and proliferative activity.

Results after two years of follow up after intravesical thermochemotherapy with heated mitomycin 40 in patients with high-risk superficial bladder cancer.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 512-512
Author(s):  
Thomas Alexander Voegeli ◽  
Eric Frank ◽  
Christian Bach ◽  
Catejan Nzeh
Keyword(s):  
Bladder Cancer ◽  
High Risk ◽  
Alternative Treatment ◽  
Superficial Bladder Cancer ◽  
Treatment Options ◽  
High Rate ◽  
Intravesical Therapy ◽  
Bladder Irrigation ◽  
Metastatic Prostate Carcinoma

512 Background: Standard management of high risk TCC is either BCG or radical cystectomy, alternative treatment options are limited. It is known that the anti-tumor effect of heated mitomycin is 10 fold higher than at room temperature, which is the standard of intravesical therapy. We herein report the first 2 year follow up (FU) after intravesical therapy with heated mitomycin in a cohort of patients with high risk superficial bladder cancer (TCC). Methods: Treatment was performed for 1 hour with machine bladder irrigation (COMBAT) which maintaines temperature of mitomycin (40 mg) exactly at 43 C. Patients underwent therapy with a 6 week course of weekly treatment and were than followed by cystoscopy every 3 month and if necessary biopsy. Results: We identified 62 patients out of a total group of 108 patients who met the inclusion criteria for high risk TCC according to the EAU Guidelines and who got the complete 6 courses of treatment. 2 were lost of follow up, 1 died due to cardiac problems and 1 from metastatic prostate carcinoma. The remaining 58 patients had a mean FU of 26 month (16-54 m) and included 20 non-responders to BCG. 48/58 patients had CIS or pT1 Tumors or both, 10 patients had pTa+CIS. There were 5 recurrences, all superficial stage pTa, one in the rigth ureter, all could be managed without cystectomy. 8 patients had progressive or recurrent CIS/pT1 or were progressive to pT2 after therapy and underwent cystectomy. Conclusions: In this high risk cohort of 58 patients with a high rate of BCG non-responders only 8 patients had to undergo cystectomy during a 2 year follow up. Intravesical therapy with heated mitomycin is safe and well tolerated and may be an additional alternative treatment before cystectomy is performed in high risk patients with high risk TCC or BCG non responders.

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