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Comparative study of sequential intravesical chemotherapy using gemcitabine and mitomycin C with mitomycin C alone for non-muscle invasive bladder carcinoma- a randomized trial

  • 1,
  • 1,
  • 1,
  • 1 and
  • 1
Journal for ImmunoTherapy of Cancer20153 (Suppl 2) :P136

https://doi.org/10.1186/2051-1426-3-S2-P136

  • Published:

Keywords

  • Gemcitabine
  • Partial Response
  • Mitomycin
  • Viable Option
  • Gentamycin

Introduction

This study was conducted to investigate the ablative efficacy and safety of sequential intravesical gemcitabine and mitomycin C with mitomycin C alone in refractory non-muscle invasive bladder cancer (NMIBC).

Methods

A total of 219 patients with refractory NMIBC were prospectively enrolled at tertiary academic center over period of Feb 2009-Jan 2012 & followed for next 3 yrs. They were randomly assigned to either of treatment arms: Gentamycin & mitomycin C (group A) or mitomycin C (group B). All patients underwent a 6-week induction regimen followed by a monthly maintenance regimen for one year if they responded to the induction course.

Results

In Group A 98 of 102 & in group B 94 of 96 patients completed the therapy and were evaluated for response while 6 patient left the therapy in between. The therapy was well tolerated in the rest of patients. In group‘A’ i.e Gentamycin & mitomycin C a total, 82 patients (83.67%) exhibited a complete response to intravesical therapy. In 12.2% (12) patients had biopsy proven recurrence (22±6.16 months). In group ‘B’ (mitomycin C), 63 (65.60%) patients exhibited a complete response to intravesical therapy, 22 patients (22.9%) showed a partial response. During follow-up, 16 patients (25.3%) developed recurrence within this period. (14.5 +/- 8.26 months).

Conclusions

Chemoresection with sequential intravesical gemcitabine and mitomycin C administration may be a viable option for BCG refractory non-muscle invasive bladder cancer (NMIBC).

Figure 2

Table 1

Detail parameters of both groups.

Parameters

Group A

Group B

P value

 

(MMC+Gemcitabine)

(MMC)

 

Total patients

102

96

NS+

Male

81

78

NS+

Female

21

19

NS+

Age

65.7±9.8 yrs

63.9±8.9 yrs

NS+

Mean Duration of follow up

36 months

36 months

 

Mean size of tumor <2cm

63

58

NS+

Mean sixe of tume >2 cm

39

38

NS+

Stage Ta

60

58

NS+

Stage T1

42

38

NS+

Grade 1

19

17

NS+

Grade 2

63

61

NS+

Grade 3

20

18

NS+

Previous treatment with BCG

All

All

 

Aim of complete response

100%

100%

 

Actual complete response

83.67% (82)

65.6% (63)

0.001*

Recurrence %

12.2% (12)

25.3% (16)

0.001*

Recurrence

22±6.16 months

14.5±8.26 months

0.001*

Recurrence range in months

8-36 months

4-14 months

 

Values are presented as mean (+/- standard devitation)

Group A: Gemcitabine & Mitomycin (MMC+Gentamycin)

Group B: Mitomycin C(MMS)

*Statistical significance was analyzed by student t-test

+Statistical significance was analyzed by the chi-square test.

Table 2

Details of adverse effects of therapy in both groups.

Parameters

Group A

Group B

P value

 

Gemcitabine + MMC

Mitomycin C(MMC)

 

Dysuria

11.7% (12)

7.2% (7)

NS+

Suprapubic pain

11.7% (12)

9.3% (9)

NS+

Hematuria

3.9% (4)

3.1% (3)

NS+

Chemical Cystitis

7.8% (8)

6.25% (6)

NS+

Local reaction

6.8% (7)

4.16% (4)

NS+

Skin reaction

5.8% (6)

4.16% (4)

NS+

Group A: Gemcitabine & Mitomycin (MMC+Gentamycin)

Group B: Mitomycin C(MMS)

*Statistical significance was analyzed by student t-test

+Statistical significance was analyzed by the chi-square test.

Figure 2
Figure 2

CONSORT diagram showing the participants through each stage of a randomized trial.

Authors’ Affiliations

(1)
SHMRC/PGIMER, Kota, India

Copyright

© Jayant et al. 2015

This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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