Radiofrequency-induced thermo-chemotherapy effect plus mitomycin versus a second course of bacillus Calmette-Guérin (BCG) or institutional standard in patients with recurrence of non-muscle invasive bladder cancer following induction or maintenance BCG therapy (HYMN): A phase III, open-label, randomised controlled trial

Intravesical device-assisted therapies for non-muscle-invasive bladder cancer

“…An induction protocol of 6-8 once weekly treatments is administered followed by a maintenance protocol of one treatment every 6 weeks for the first year and one treatment every 8 weeks for the second year. 47 An alternative protocol of six once weekly induction protocol with a maintenance protocol of three once weekly instillations at 3, 6, and 12 months has been reported. 31 No comparisons between the two protocols because they have been used in different patient cohorts.…”

“…To date, 21 reports from 20 studies on the efficacy of RITE for NMIBC have been published (Table 1); five studies report outcomes for RITE delivered in the pre-TURBT ablative setting, 44,48-51 nine studies in the adjuvant setting 47,[52][53][54][55][56][57][58][59][60] and six studies had a mixture of patients treated with adjuvant therapy or pre-TURBT ablative treatment. [61][62][63][64][65][66] Only four randomized controlled trials (RCTs) investigating RITE have been conducted; three as adjuvant treatment 47,53,56,60 and one in the ablative setting. 50 Reported recurrence free survival (RFS) differs between studies , reflecting the heterogenous patient cohorts, follow-up duration, and different treatment regimens and presence of CIS In studies including patients with papillary-only disease, RFS ranges from 53%-91% with 9.6-24-month follow-up duration.…”

“…50 Reported recurrence free survival (RFS) differs between studies , reflecting the heterogenous patient cohorts, follow-up duration, and different treatment regimens and presence of CIS In studies including patients with papillary-only disease, RFS ranges from 53%-91% with 9.6-24-month follow-up duration. 47,53,[58][59][60]65,66 However, in patients who had isolated or concurrent CIS (13-68%), RFS can range from 29%-88.6% at 14-38-months follow-up duration. 47,54,55,57,[61][62][63][64] A substantial number of patients treated with RITE had developed recurrence after previous intravesical therapy and disease progression occurs in 0-38% of patients.…”

“…47,53,[58][59][60]65,66 However, in patients who had isolated or concurrent CIS (13-68%), RFS can range from 29%-88.6% at 14-38-months follow-up duration. 47,54,55,57,[61][62][63][64] A substantial number of patients treated with RITE had developed recurrence after previous intravesical therapy and disease progression occurs in 0-38% of patients. 47,49,52,53,[55][56][57][58][59][60][61][62][63][64][65] In the pre-TURBT ablative setting, data from nine studies reporting outcomes from 211 patients suggest a complete response rate of 65.4%.…”

“…47,54,55,57,[61][62][63][64] A substantial number of patients treated with RITE had developed recurrence after previous intravesical therapy and disease progression occurs in 0-38% of patients. 47,49,52,53,[55][56][57][58][59][60][61][62][63][64][65] In the pre-TURBT ablative setting, data from nine studies reporting outcomes from 211 patients suggest a complete response rate of 65.4%. 44,[48][49][50][51]62,63,65,66 Subsequent studies have used an increased dose of MMC for ablative therapy (two 30-minute cycles of 40 mg MMC vs 20 mg MMC), which might be beneficial for patients with widespread concurrent or isolated carcinoma in situ (CIS) .…”