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Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial

Summary Background The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical p... Full description

Journal Title: The lancet oncology 2011, Vol.12 (9), p.871-879
Main Author: Di Stasi, Savino M, Prof
Other Authors: Valenti, Marco, Prof , Verri, Cristian, MD , Liberati, Emanuele, MD , Giurioli, Arcangelo, MD , Leprini, Gioia, BSc , Masedu, Francesco, PhD , Ricci, Antonio R, MD , Micali, Francesco, Prof , Vespasiani, Giuseppe, Prof
Format: Electronic Article Electronic Article
Language: English
Subjects:
Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 1470-2045
Link: https://www.ncbi.nlm.nih.gov/pubmed/21831711
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title: Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial
format: Article
creator:
  • Di Stasi, Savino M, Prof
  • Valenti, Marco, Prof
  • Verri, Cristian, MD
  • Liberati, Emanuele, MD
  • Giurioli, Arcangelo, MD
  • Leprini, Gioia, BSc
  • Masedu, Francesco, PhD
  • Ricci, Antonio R, MD
  • Micali, Francesco, Prof
  • Vespasiani, Giuseppe, Prof
subjects:
  • Adjuvant
  • Administration
  • Administration, Intravesical
  • Aged
  • Antibiotics
  • Antibiotics, Antineoplastic - administration & dosage
  • Antibiotics, Antineoplastic - adverse effects
  • Antimitotic agents
  • Antineoplastic
  • Antineoplastic agents
  • Bladder cancer
  • Cancer
  • Carcinoma
  • Carcinoma - drug therapy
  • Carcinoma - mortality
  • Carcinoma - secondary
  • Carcinoma - surgery
  • Care and treatment
  • Chemotherapy
  • Chemotherapy, Adjuvant
  • Cystectomy
  • Cystectomy - adverse effects
  • Disease
  • Disease-Free Survival
  • Electrochemotherapy
  • Female
  • Free Survival
  • Hematology, Oncology and Palliative Medicine
  • Humans
  • Intravesical
  • Italy
  • Local
  • Male
  • Middle Aged
  • Mitomycin
  • Mitomycin - administration & dosage
  • Mitomycin - adverse effects
  • Neoadjuvant Therapy
  • Neoplasm Invasiveness
  • Neoplasm Recurrence
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Proportional Hazards Models
  • Risk Assessment
  • Risk Factors
  • Settore MED
  • Surgery
  • Survival Analysis
  • Survival Rate
  • Time Factors
  • Treatment Outcome
  • Urinary Bladder
  • Urinary Bladder - drug effects
  • Urinary Bladder - pathology
  • Urinary Bladder - surgery
  • Urinary Bladder Neoplasms
  • Urinary Bladder Neoplasms - drug therapy
  • Urinary Bladder Neoplasms - mortality
  • Urinary Bladder Neoplasms - pathology
  • Urinary Bladder Neoplasms - surgery
  • Urologia
  • Urothelium
  • Urothelium - drug effects
  • Urothelium - pathology
  • Urothelium - surgery
ispartof: The lancet oncology, 2011, Vol.12 (9), p.871-879
description: Summary Background The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer. Methods We did a multicentre, randomised, parallel-group study in patients with primary non-muscle invasive bladder cancer in three centres in Italy between Jan 1, 1994, and Dec 31, 2003. Patients were randomly assigned to receive treatment by means of stratified blocked randomisation across six strata. Patients and physicians giving the interventions were aware of assignment, but it was masked from outcome assessors and data analysts. Patients were randomly assigned to receive TURBT alone, immediate post-TURBT instillation of 40 mg PD mitomycin dissolved in 50 mL sterile water infused over 60 min, or immediate pre-TURBT instillation of 40 mg EMDA mitomycin dissolved in 100 mL sterile water with intravesical 20 mA pulsed electric current for 30 min. Our primary endpoints were recurrence rate and disease-free interval. Analyses were done by intention to treat. Follow-up for our trial is complete. This study is registered with ClinicalTrials.gov , number NCT01149174. Findings 124 patients were randomly assigned to receive TURBT alone, 126 to receive immediate post-TURBT PD mitomycin, and 124 to receive immediate pre-TURBT EMDA mitomycin. 22 patients were excluded from our analyses because they did meet our eligibility criteria after TURBT: 11 had stage pT2 disease and 11 had carcinoma in situ. Median follow-up was 86 months (IQR 57–125). Patients assigned to receive EMDA mitomycin before TURBT had a lower rate of recurrence (44 [38%] of 117) than those assigned to receive PD mitomycin after TURBT (70 [59%] of 119) and TURBT alone (74 [64%] of 116; log-rank p
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 1470-2045
fulltext: fulltext
issn:
  • 1470-2045
  • 1474-5488
url: Link


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titleElectromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial
sourceAlma/SFX Local Collection
creatorDi Stasi, Savino M, Prof ; Valenti, Marco, Prof ; Verri, Cristian, MD ; Liberati, Emanuele, MD ; Giurioli, Arcangelo, MD ; Leprini, Gioia, BSc ; Masedu, Francesco, PhD ; Ricci, Antonio R, MD ; Micali, Francesco, Prof ; Vespasiani, Giuseppe, Prof
creatorcontribDi Stasi, Savino M, Prof ; Valenti, Marco, Prof ; Verri, Cristian, MD ; Liberati, Emanuele, MD ; Giurioli, Arcangelo, MD ; Leprini, Gioia, BSc ; Masedu, Francesco, PhD ; Ricci, Antonio R, MD ; Micali, Francesco, Prof ; Vespasiani, Giuseppe, Prof
descriptionSummary Background The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer. Methods We did a multicentre, randomised, parallel-group study in patients with primary non-muscle invasive bladder cancer in three centres in Italy between Jan 1, 1994, and Dec 31, 2003. Patients were randomly assigned to receive treatment by means of stratified blocked randomisation across six strata. Patients and physicians giving the interventions were aware of assignment, but it was masked from outcome assessors and data analysts. Patients were randomly assigned to receive TURBT alone, immediate post-TURBT instillation of 40 mg PD mitomycin dissolved in 50 mL sterile water infused over 60 min, or immediate pre-TURBT instillation of 40 mg EMDA mitomycin dissolved in 100 mL sterile water with intravesical 20 mA pulsed electric current for 30 min. Our primary endpoints were recurrence rate and disease-free interval. Analyses were done by intention to treat. Follow-up for our trial is complete. This study is registered with ClinicalTrials.gov , number NCT01149174. Findings 124 patients were randomly assigned to receive TURBT alone, 126 to receive immediate post-TURBT PD mitomycin, and 124 to receive immediate pre-TURBT EMDA mitomycin. 22 patients were excluded from our analyses because they did meet our eligibility criteria after TURBT: 11 had stage pT2 disease and 11 had carcinoma in situ. Median follow-up was 86 months (IQR 57–125). Patients assigned to receive EMDA mitomycin before TURBT had a lower rate of recurrence (44 [38%] of 117) than those assigned to receive PD mitomycin after TURBT (70 [59%] of 119) and TURBT alone (74 [64%] of 116; log-rank p<0·0001). Patients assigned to receive EMDA mitomycin before TURBT also had a higher disease-free interval (52 months, IQR 32–184) than those assigned to receive PD mitomycin after TURBT (16 months, 12–168) and TURBT alone (12 months, 12–37; log-rank p<0·0001). We recorded persistent bladder symptoms after TURBT in 18 (16%) of 116 patients in the TURBT-alone group (duration 3–7 days), 37 (31%) of 119 in the PD mitomycin post-TURBT group (duration 20–30 days), and 24 (21%) of 117 in the EMDA mitomycin pre-TURBT group (duration 7–12 days); haematuria after TURBT in eight (7%) of 116 patients in the TURBT-alone group, 16 (13%) of 119 in the PD mitomycin post-TURBT group, and 11 (9%) of 117 in the EMDA mitomycin pre-TURBT group; and bladder perforation after TURBT in five (4%) of 116 patients in the TURBT-alone group, nine (8%) of 119 in the PD mitomycin post-TURBT group, and seven (6%) of 117 in the EMDA mitomycin pre-TURBT group. Interpretation Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. Funding None.
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0ISSN: 1470-2045
1EISSN: 1474-5488
2DOI: 10.1016/S1470-2045(11)70190-5
3PMID: 21831711
4CODEN: LANCAO
languageeng
publisherEngland: Elsevier Ltd
subjectAdjuvant ; Administration ; Administration, Intravesical ; Aged ; Antibiotics ; Antibiotics, Antineoplastic - administration & dosage ; Antibiotics, Antineoplastic - adverse effects ; Antimitotic agents ; Antineoplastic ; Antineoplastic agents ; Bladder cancer ; Cancer ; Carcinoma ; Carcinoma - drug therapy ; Carcinoma - mortality ; Carcinoma - secondary ; Carcinoma - surgery ; Care and treatment ; Chemotherapy ; Chemotherapy, Adjuvant ; Cystectomy ; Cystectomy - adverse effects ; Disease ; Disease-Free Survival ; Electrochemotherapy ; Female ; Free Survival ; Hematology, Oncology and Palliative Medicine ; Humans ; Intravesical ; Italy ; Local ; Male ; Middle Aged ; Mitomycin ; Mitomycin - administration & dosage ; Mitomycin - adverse effects ; Neoadjuvant Therapy ; Neoplasm Invasiveness ; Neoplasm Recurrence ; Neoplasm Recurrence, Local ; Neoplasm Staging ; Proportional Hazards Models ; Risk Assessment ; Risk Factors ; Settore MED ; Surgery ; Survival Analysis ; Survival Rate ; Time Factors ; Treatment Outcome ; Urinary Bladder ; Urinary Bladder - drug effects ; Urinary Bladder - pathology ; Urinary Bladder - surgery ; Urinary Bladder Neoplasms ; Urinary Bladder Neoplasms - drug therapy ; Urinary Bladder Neoplasms - mortality ; Urinary Bladder Neoplasms - pathology ; Urinary Bladder Neoplasms - surgery ; Urologia ; Urothelium ; Urothelium - drug effects ; Urothelium - pathology ; Urothelium - surgery
ispartofThe lancet oncology, 2011, Vol.12 (9), p.871-879
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0Di Stasi, Savino M, Prof
1Valenti, Marco, Prof
2Verri, Cristian, MD
3Liberati, Emanuele, MD
4Giurioli, Arcangelo, MD
5Leprini, Gioia, BSc
6Masedu, Francesco, PhD
7Ricci, Antonio R, MD
8Micali, Francesco, Prof
9Vespasiani, Giuseppe, Prof
title
0Electromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial
1The lancet oncology
addtitleLancet Oncol
descriptionSummary Background The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer. Methods We did a multicentre, randomised, parallel-group study in patients with primary non-muscle invasive bladder cancer in three centres in Italy between Jan 1, 1994, and Dec 31, 2003. Patients were randomly assigned to receive treatment by means of stratified blocked randomisation across six strata. Patients and physicians giving the interventions were aware of assignment, but it was masked from outcome assessors and data analysts. Patients were randomly assigned to receive TURBT alone, immediate post-TURBT instillation of 40 mg PD mitomycin dissolved in 50 mL sterile water infused over 60 min, or immediate pre-TURBT instillation of 40 mg EMDA mitomycin dissolved in 100 mL sterile water with intravesical 20 mA pulsed electric current for 30 min. Our primary endpoints were recurrence rate and disease-free interval. Analyses were done by intention to treat. Follow-up for our trial is complete. This study is registered with ClinicalTrials.gov , number NCT01149174. Findings 124 patients were randomly assigned to receive TURBT alone, 126 to receive immediate post-TURBT PD mitomycin, and 124 to receive immediate pre-TURBT EMDA mitomycin. 22 patients were excluded from our analyses because they did meet our eligibility criteria after TURBT: 11 had stage pT2 disease and 11 had carcinoma in situ. Median follow-up was 86 months (IQR 57–125). Patients assigned to receive EMDA mitomycin before TURBT had a lower rate of recurrence (44 [38%] of 117) than those assigned to receive PD mitomycin after TURBT (70 [59%] of 119) and TURBT alone (74 [64%] of 116; log-rank p<0·0001). Patients assigned to receive EMDA mitomycin before TURBT also had a higher disease-free interval (52 months, IQR 32–184) than those assigned to receive PD mitomycin after TURBT (16 months, 12–168) and TURBT alone (12 months, 12–37; log-rank p<0·0001). We recorded persistent bladder symptoms after TURBT in 18 (16%) of 116 patients in the TURBT-alone group (duration 3–7 days), 37 (31%) of 119 in the PD mitomycin post-TURBT group (duration 20–30 days), and 24 (21%) of 117 in the EMDA mitomycin pre-TURBT group (duration 7–12 days); haematuria after TURBT in eight (7%) of 116 patients in the TURBT-alone group, 16 (13%) of 119 in the PD mitomycin post-TURBT group, and 11 (9%) of 117 in the EMDA mitomycin pre-TURBT group; and bladder perforation after TURBT in five (4%) of 116 patients in the TURBT-alone group, nine (8%) of 119 in the PD mitomycin post-TURBT group, and seven (6%) of 117 in the EMDA mitomycin pre-TURBT group. Interpretation Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. Funding None.
subject
0Adjuvant
1Administration
2Administration, Intravesical
3Aged
4Antibiotics
5Antibiotics, Antineoplastic - administration & dosage
6Antibiotics, Antineoplastic - adverse effects
7Antimitotic agents
8Antineoplastic
9Antineoplastic agents
10Bladder cancer
11Cancer
12Carcinoma
13Carcinoma - drug therapy
14Carcinoma - mortality
15Carcinoma - secondary
16Carcinoma - surgery
17Care and treatment
18Chemotherapy
19Chemotherapy, Adjuvant
20Cystectomy
21Cystectomy - adverse effects
22Disease
23Disease-Free Survival
24Electrochemotherapy
25Female
26Free Survival
27Hematology, Oncology and Palliative Medicine
28Humans
29Intravesical
30Italy
31Local
32Male
33Middle Aged
34Mitomycin
35Mitomycin - administration & dosage
36Mitomycin - adverse effects
37Neoadjuvant Therapy
38Neoplasm Invasiveness
39Neoplasm Recurrence
40Neoplasm Recurrence, Local
41Neoplasm Staging
42Proportional Hazards Models
43Risk Assessment
44Risk Factors
45Settore MED
46Surgery
47Survival Analysis
48Survival Rate
49Time Factors
50Treatment Outcome
51Urinary Bladder
52Urinary Bladder - drug effects
53Urinary Bladder - pathology
54Urinary Bladder - surgery
55Urinary Bladder Neoplasms
56Urinary Bladder Neoplasms - drug therapy
57Urinary Bladder Neoplasms - mortality
58Urinary Bladder Neoplasms - pathology
59Urinary Bladder Neoplasms - surgery
60Urologia
61Urothelium
62Urothelium - drug effects
63Urothelium - pathology
64Urothelium - surgery
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4Giurioli, Arcangelo, MD
5Leprini, Gioia, BSc
6Masedu, Francesco, PhD
7Ricci, Antonio R, MD
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titleElectromotive instillation of mitomycin immediately before transurethral resection for patients with primary urothelial non-muscle invasive bladder cancer: a randomised controlled trial
authorDi Stasi, Savino M, Prof ; Valenti, Marco, Prof ; Verri, Cristian, MD ; Liberati, Emanuele, MD ; Giurioli, Arcangelo, MD ; Leprini, Gioia, BSc ; Masedu, Francesco, PhD ; Ricci, Antonio R, MD ; Micali, Francesco, Prof ; Vespasiani, Giuseppe, Prof
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1Administration
2Administration, Intravesical
3Aged
4Antibiotics
5Antibiotics, Antineoplastic - administration & dosage
6Antibiotics, Antineoplastic - adverse effects
7Antimitotic agents
8Antineoplastic
9Antineoplastic agents
10Bladder cancer
11Cancer
12Carcinoma
13Carcinoma - drug therapy
14Carcinoma - mortality
15Carcinoma - secondary
16Carcinoma - surgery
17Care and treatment
18Chemotherapy
19Chemotherapy, Adjuvant
20Cystectomy
21Cystectomy - adverse effects
22Disease
23Disease-Free Survival
24Electrochemotherapy
25Female
26Free Survival
27Hematology, Oncology and Palliative Medicine
28Humans
29Intravesical
30Italy
31Local
32Male
33Middle Aged
34Mitomycin
35Mitomycin - administration & dosage
36Mitomycin - adverse effects
37Neoadjuvant Therapy
38Neoplasm Invasiveness
39Neoplasm Recurrence
40Neoplasm Recurrence, Local
41Neoplasm Staging
42Proportional Hazards Models
43Risk Assessment
44Risk Factors
45Settore MED
46Surgery
47Survival Analysis
48Survival Rate
49Time Factors
50Treatment Outcome
51Urinary Bladder
52Urinary Bladder - drug effects
53Urinary Bladder - pathology
54Urinary Bladder - surgery
55Urinary Bladder Neoplasms
56Urinary Bladder Neoplasms - drug therapy
57Urinary Bladder Neoplasms - mortality
58Urinary Bladder Neoplasms - pathology
59Urinary Bladder Neoplasms - surgery
60Urologia
61Urothelium
62Urothelium - drug effects
63Urothelium - pathology
64Urothelium - surgery
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6Masedu, Francesco, PhD
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eissn1474-5488
codenLANCAO
abstractSummary Background The clinical effect of intravesical instillation of chemotherapy immediately after transurethral resection of bladder tumours (TURBT) has recently been questioned, despite its recommendation in guidelines. Our aim was to compare TURBT alone with immediate post-TURBT intravesical passive diffusion (PD) of mitomycin and immediate pre-TURBT intravesical electromotive drug administration (EMDA) of mitomycin in non-muscle invasive bladder cancer. Methods We did a multicentre, randomised, parallel-group study in patients with primary non-muscle invasive bladder cancer in three centres in Italy between Jan 1, 1994, and Dec 31, 2003. Patients were randomly assigned to receive treatment by means of stratified blocked randomisation across six strata. Patients and physicians giving the interventions were aware of assignment, but it was masked from outcome assessors and data analysts. Patients were randomly assigned to receive TURBT alone, immediate post-TURBT instillation of 40 mg PD mitomycin dissolved in 50 mL sterile water infused over 60 min, or immediate pre-TURBT instillation of 40 mg EMDA mitomycin dissolved in 100 mL sterile water with intravesical 20 mA pulsed electric current for 30 min. Our primary endpoints were recurrence rate and disease-free interval. Analyses were done by intention to treat. Follow-up for our trial is complete. This study is registered with ClinicalTrials.gov , number NCT01149174. Findings 124 patients were randomly assigned to receive TURBT alone, 126 to receive immediate post-TURBT PD mitomycin, and 124 to receive immediate pre-TURBT EMDA mitomycin. 22 patients were excluded from our analyses because they did meet our eligibility criteria after TURBT: 11 had stage pT2 disease and 11 had carcinoma in situ. Median follow-up was 86 months (IQR 57–125). Patients assigned to receive EMDA mitomycin before TURBT had a lower rate of recurrence (44 [38%] of 117) than those assigned to receive PD mitomycin after TURBT (70 [59%] of 119) and TURBT alone (74 [64%] of 116; log-rank p<0·0001). Patients assigned to receive EMDA mitomycin before TURBT also had a higher disease-free interval (52 months, IQR 32–184) than those assigned to receive PD mitomycin after TURBT (16 months, 12–168) and TURBT alone (12 months, 12–37; log-rank p<0·0001). We recorded persistent bladder symptoms after TURBT in 18 (16%) of 116 patients in the TURBT-alone group (duration 3–7 days), 37 (31%) of 119 in the PD mitomycin post-TURBT group (duration 20–30 days), and 24 (21%) of 117 in the EMDA mitomycin pre-TURBT group (duration 7–12 days); haematuria after TURBT in eight (7%) of 116 patients in the TURBT-alone group, 16 (13%) of 119 in the PD mitomycin post-TURBT group, and 11 (9%) of 117 in the EMDA mitomycin pre-TURBT group; and bladder perforation after TURBT in five (4%) of 116 patients in the TURBT-alone group, nine (8%) of 119 in the PD mitomycin post-TURBT group, and seven (6%) of 117 in the EMDA mitomycin pre-TURBT group. Interpretation Intravesical EMDA mitomycin before TURBT is feasible and safe; moreover, it reduces recurrence rates and enhances the disease-free interval compared with intravesical PD mitomycin after TURBT and TURBT alone. Funding None.
copEngland
pubElsevier Ltd
pmid21831711
doi10.1016/S1470-2045(11)70190-5
oafree_for_read