Efficacy of escalating doses of intravesical interferon alpha-2b in reducing recurrence rate and progression in superficial transitional cell carcinoma

• Published in: British journal of urology 1998-12, Vol.82 (6), p.829-834
• Main Authors: Giannakopoulos, S, Gekas, A, Alivizatos, G, Sofras, F, Becopoulos, T, Dimopoulos, C
• Format: Article
• Language: English
• Subjects: Administration, Intravesical; Adult; Aged; Antineoplastic Agents - administration & dosage; Carcinoma, Transitional Cell - therapy; Disease Progression; Disease-Free Survival; Female; Follow-Up Studies; Hematuria - etiology; Humans; Interferon alpha-2; Interferon-alpha - administration & dosage; Male; Middle Aged; Neoplasm Recurrence, Local; Prospective Studies; Recombinant Proteins; Treatment Outcome; Urinary Bladder Neoplasms - therapy
• ISSN: 0007-1331

To compare the efficacy of three different doses of intravesical interferon alpha-2b (IFN alpha-2b) in reducing recurrence and progression rates in superficial grade II, transitional cell carcinoma (TCC). Eighty-nine patients with primary or recurrent TCC stage Ta/T1, grade II, were randomly allocated into four groups after transurethral resection (TUR) of the tumour. Group A (20 patients) received no further treatment, serving as the control group; group B (22 patients) received 40 MU of IFN alpha-2b, group C (24 patients) 60 MU and group D (23 patients) 80 MU. The instillations started within 48-72 h after TUR and were performed weekly for 2 months, bimonthly for the next 4 months and thereafter monthly for 6 months. The patients were followed for 36 months. The four groups were compared for the number of recurrences (simple recurrence rate), progression in stage, disease-free interval and recurrence rate per 100 patient-months. During the follow-up, 33 patients had recurrence (13, eight, seven and five in groups A to D, respectively). The simple recurrence rate was 65% for group A, compared with 36% (P = 0.06), 29% (P < 0.05) and 22% (P < 0.01) for groups B, C and D, respectively. The differences in simple recurrence rates between the groups treated with IFN alpha-2b were not statistically significant. Eleven patients experienced progression in stage, with six, there, one and one in groups A to D, respectively. The differences were statistically significant only between groups A and C (P < 0.05) and groups A and D (P < 0.05). The disease-free interval was 15 months for group A, compared with 21.4 (P < 0.05), 26.1 (P < 0.001) and 30 months (P < 0.001) for groups C to D, respectively. The disease-free intervals of the groups treated with IFN alpha-2b were significantly different between all patients in groups B and D (P < 0.01) and only for those with stage T1 between groups C and D (P < 0.01). Finally the recurrence rate per 100 patient-months was 2.91, 1.19, 0.88 and 0.63 for groups A to D, respectively (all P < 0.001). The results were always in favour of the patients treated with the high dose, the only exception being the difference between groups C and D (P = 0.026). No side-effects of the drug were noted, nor was any adverse reaction reported from any patient. These results show a significant advantage for adjuvant intravesical IFN alpha-2b treatment over TUR alone for the 36 months of follow up and indicate that IFN alpha-2b can modify the clinica