BACKGROUND:Bacillus Calmette-Guérin (BCG) instillation is regarded as the most effective bladder-sparing treatment for patients with high-grade T1 tumours and carcinoma in situ (CIS). The major problem with this therapy is the side-effects, making maintenance therapy difficult, even impossible, in a proportion of patients. Thus, alternative schedules and drugs have been proposed. OBJECTIVE: To compare BCG to the combination of epirubicin and interferon-alpha2b as adjuvant therapy of T1 tumours. DESIGN, SETTING, AND PARTICIPANTS: This is a Nordic multicenter, prospective, randomised trial in patients with primary T1 G2-G3 bladder cancer. Initial transurethral resection (TUR) was followed by a second-look resection. Patients were randomised to receive either regimen, given as induction for 6 wk followed by maintenance therapy for 2 yr. MEASUREMENTS: The drugs were compared with respect to time to recurrence and progression. Also, side-effects were documented. RESULTS AND LIMITATIONS: A total of 250 patients were randomised. At the primary end point, 62% were disease free in the combination arm as opposed to 73% in the BCG arm (p=0.065). At 24 mo, there was a significant difference in favour of the BCG-treated patients (p=0.012) regarding recurrence, although there was no difference regarding progression. The subgroup analysis showed that the superiority of BCG was mainly in those with concomitant CIS. In a multivariate analysis of association with recurrence/progression status, significant variables for outcome were type of drug, tumour size, multiplicity, status at second-look resection, and grade. A corresponding analysis was performed separately in the two treatment arms. Tumour size was the only significant variable for BCG-treated patients, while multiplicity, status at second-look resection, and grade were significant for patients treated with the combination. CONCLUSIONS: For prophylaxis of recurrence, BCG was more effective than the combination. There were no differences regarding progression and adverse events between the two treatments.
RCT Entities:
BACKGROUND: Bacillus Calmette-Guérin (BCG) instillation is regarded as the most effective bladder-sparing treatment for patients with high-grade T1 tumours and carcinoma in situ (CIS). The major problem with this therapy is the side-effects, making maintenance therapy difficult, even impossible, in a proportion of patients. Thus, alternative schedules and drugs have been proposed. OBJECTIVE: To compare BCG to the combination of epirubicin and interferon-alpha2b as adjuvant therapy of T1 tumours. DESIGN, SETTING, AND PARTICIPANTS: This is a Nordic multicenter, prospective, randomised trial in patients with primary T1 G2-G3 bladder cancer. Initial transurethral resection (TUR) was followed by a second-look resection. Patients were randomised to receive either regimen, given as induction for 6 wk followed by maintenance therapy for 2 yr. MEASUREMENTS: The drugs were compared with respect to time to recurrence and progression. Also, side-effects were documented. RESULTS AND LIMITATIONS: A total of 250 patients were randomised. At the primary end point, 62% were disease free in the combination arm as opposed to 73% in the BCG arm (p=0.065). At 24 mo, there was a significant difference in favour of the BCG-treated patients (p=0.012) regarding recurrence, although there was no difference regarding progression. The subgroup analysis showed that the superiority of BCG was mainly in those with concomitant CIS. In a multivariate analysis of association with recurrence/progression status, significant variables for outcome were type of drug, tumour size, multiplicity, status at second-look resection, and grade. A corresponding analysis was performed separately in the two treatment arms. Tumour size was the only significant variable for BCG-treated patients, while multiplicity, status at second-look resection, and grade were significant for patients treated with the combination. CONCLUSIONS: For prophylaxis of recurrence, BCG was more effective than the combination. There were no differences regarding progression and adverse events between the two treatments.
Authors: Niannian Ji; Neelam Mukherjee; Edwin E Morales; Maggie E Tomasini; Vincent Hurez; Tyler J Curiel; Getahun Abate; Dan F Hoft; Xiang-Ru Zhao; Jon Gelfond; Sourindra Maiti; Laurence J N Cooper; Robert S Svatek Journal: Oncoimmunology Date: 2019-05-25 Impact factor: 8.110
Authors: Ashish M Kamat; Thomas W Flaig; H Barton Grossman; Badrinath Konety; Donald Lamm; Michael A O'Donnell; Edward Uchio; Jason A Efstathiou; John A Taylor Journal: Nat Rev Urol Date: 2015-03-24 Impact factor: 14.432
Authors: Peter E Clark; Philippe E Spiess; Neeraj Agarwal; Rick Bangs; Stephen A Boorjian; Mark K Buyyounouski; Jason A Efstathiou; Thomas W Flaig; Terence Friedlander; Richard E Greenberg; Khurshid A Guru; Noah Hahn; Harry W Herr; Christopher Hoimes; Brant A Inman; A Karim Kader; Adam S Kibel; Timothy M Kuzel; Subodh M Lele; Joshua J Meeks; Jeff Michalski; Jeffrey S Montgomery; Lance C Pagliaro; Sumanta K Pal; Anthony Patterson; Daniel Petrylak; Elizabeth R Plimack; Kamal S Pohar; Michael P Porter; Wade J Sexton; Arlene O Siefker-Radtke; Guru Sonpavde; Jonathan Tward; Geoffrey Wile; Mary A Dwyer; Courtney Smith Journal: J Natl Compr Canc Netw Date: 2016-10 Impact factor: 11.908
Authors: Richard J Sylvester; Maurizio A Brausi; Wim J Kirkels; Wolfgang Hoeltl; Fernando Calais Da Silva; Philip H Powell; Stephen Prescott; Ziya Kirkali; Cees van de Beek; Thierry Gorlia; Theo M de Reijke Journal: Eur Urol Date: 2009-12-18 Impact factor: 20.096