The complete response rate at the end of the intensive phase was 75.0% [95% CI: 50.90 to 91.34], while at month 3 of the maintenance therapy (6 months after treatment start) was 65.0% [95% CI: 40.78 to 84.61] and at the end of the maintenance phase (15 months after treatment start) was 40.0% [95% CI: 19.12 to 63.95]. The combination of paclitaxel and HA revealed an excellent safety and tolerability profile, with a good compliance rate and without systemic absorption, when administered at a dose of 600 mg weekly for 12 consecutive weeks followed by 12 monthly administrations. Unfortunately, those results are limited to phase I and limit their clinical use.
The BCG shortage, the FDA not approval of Vicinium for BCG-unresponsive NMIBC, and the poor safety/efficacy profile of Keytruda prompt a confirmatory larger phase III study for Oncofid-P-B to allow patients receiving innovative “bladder sparing” treatment for high-risk NMIBC.
Very high-risk group, risk factors: age>70, multiple papillary tumors, tumor diameter > 3 cm.
- Ta HG/G3 and CIS with all 3 risk factors
- T1 G2 and CIS with at least 2 risk factors
- T1 HG/G3 and CIS with at least 1 risk factor
- T1 HG/G3 no CIS with all 3 risk factors
- All T1 HG/G3 without CIS, EXCEPT those included in the very high-risk group
- All CIS patients, EXCEPT those included in the very high-risk group
- Ta LG/G2 or T1 G1, no CIS with all 3 risk factors
- Ta HG/G3 or T1 LG, no CIS with at least 2 risk factors
Written by: Rodolfo Hurle, Roberto Contieri, Massimo Lazzeri, Department of Urology, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy
References:
- Hurle R, Guazzoni G, Colombo P, et al. Oncofid-P-B: a novel treatment for BCG unresponsive carcinoma in situ (CIS) of the bladder: Results of a prospective European Multicentre study at 15 months from treatment start. Urol Oncol. 2021 Oct 11:S1078-1439(21)00308-2. doi: 10.1016/j.urolonc.2021.07.007.
- Redorta JP, Sanguedolce F, Pardo GS, et al. Multicentre International Study for the Prevention with iAluRil of Radio-induced Cystitis (MISTIC): A Randomised Controlled Study. Eur Urol Open Sci. 2021 Feb 23;26:45-54. doi: 10.1016/j.euros.2021.01.016.
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