Skip to content

Advertisement

  • Poster presentation
  • Open Access

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

Advertisement