Περίληψη:
Objective: To determine the efficacy and safety of two different doses
of intravesical mitoxantrone and of recombinant interferon-alpha
(IFNalpha-2b), instilled after transurethral resection ( TUR) of
superficial transitional cell carcinoma (TCC) of the bladder. Material
and Methods: 208 patients (mean age 62.05 years) with primary or
recurrent superficial (TaG1, T1G1, T1G2) bladder cancer were randomly
allocated into four groups, after TUR of all visible tumors. Group A (
45 patients) received no further therapy; group B ( 56 patients)
received 10 mg of mitoxantrone ( 6 weekly and 20 fortnightly
instillations), group C ( 54 patients) 20 mg of mitoxantrone ( 3
fortnightly and 10 monthly instillations) and group D ( 53 patients)
received 100 MU of IFNalpha-2b (8 weekly, 8 fortnightly and 6 monthly
instillations). Results: During the follow-up (mean 21.09 months), 29
(64.44%) patients in group A had recurrence, compared with 19 (33.92%)
in group B, 17 (31.48%) in group C and 15 (28.3%) patients in group D
( p < 0.005). Furthermore, the differences in simple recurrence rates
were statistically more significant (p < 0.05), when group A was
compared with the three other groups in the terms of T1G2, recurrent and
multiple neoplasms. Twenty-nine patients ( 10, 7, 8, and 4 in groups A -
D) experienced tumor progression, and the differences between the four
groups were not statistically significant ( p 1 0.05). The mean
recurrence time was 9.03 months in group A, 13.74 in group B, 14.24 in
group C and 17.4 months in group D ( p < 0.001), and the recurrence rate
per 100 patient-months was 4.39, 1.57, 1.48 and 1.06, respectively ( p <
0.05). Toxicity ( grade 1 - 3) was recorded in 23.21% in group B, in
31.48% in group C and in 9.43% in group D ( p < 0.01). Conclusion: The
two doses of mitoxantrone resulted in similar efficacy for the
prevention of superficial bladder cancer recurrences, with the dose of
10 mg of mitoxantrone being related to fewer side effects. In comparison
with mitoxantrone, the adjuvant intravesical immunotherapy with 100 MU
of IFNα-2b showed a better combination of efficacy and safety.
Copyright (C) 2004 S. Karger AG, Basel.
Συγγραφείς:
Papatsoris, AG
Deliveliotis, C
Giannopoulos, A
Dimopoulos, C
