Sequential intravesical valrubicin and docetaxel may be a suitable salvage therapy for recurrent non-muscle invasive bladder cancer (NMIBC) following the failure of intravesical bacillus Calmette-Guérin (BCG) and/or gemcitabine-docetaxel, according to a pilot study.

In the retrospective study, investigators identified 75 patients with recurrent NMIBC treated with weekly sequential intravesical instillations of 800 mg valrubicin and 37.5 mg docetaxel for 6 weeks. Of 54 patients who were disease free at 3 months, 49 received maintenance valrubicin and docetaxel. For prior intravesical therapy, 70 patients had received gemcitabine-docetaxel, 54 had received BCG, and 51 had received both.

Of the 75 patients treated with valrubicin and docetaxel, 63 had high-grade and 12 had low-grade disease. Among patients with low-grade disease, the recurrence-free survival rate at 2 years was 73%, Michael A. O’Donnell, MD, and colleagues from the University of Iowa Hospitals and Clinics in Iowa City, reported in The Journal of Urology. Among the patients with high-grade disease, the recurrence-free survival rate at 2 years was 38%. Recurrence-free survival did not differ among the 42 patients with and the 33 patients without carcinoma in situ. The elapsed time since gemcitabine-docetaxel failure did not influence efficacy, the investigators noted.

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For patients with high-grade disease, overall, cancer-specific, and cystectomy-free survival rates were 87%, 96%, and 84% at 2 years, respectively, the investigators reported.

Of the full cohort, 10 patients eventually underwent cystectomy and 2 patients died of metastatic bladder cancer. Adverse events of valrubicin and docetaxel salvage therapy included bladder-spasms, urinary frequency, dysuria, and intolerance.

“Our findings suggest that a trial of Val/Doce following treatment failure is reasonable and may allow some patients to achieve a disease-free state with intact bladders,” Dr O’Donnell’s team wrote. “Ultimately, the decision to proceed with rescue therapy is a circumstance of competing risks which is best managed through shared decision.”

As with all retrospective studies, selection bias and confounding could not be ruled out. Further longitudinal, multi-arm, prospective trials on sequential salvage valrubicin and docetaxel for NMIBC are needed.


McElree IM, Packiam VT, Steinberg RL, et al. Sequential intravesical valrubicin and docetaxel for the salvage treatment of non-muscle invasive bladder cancer. J Urol. In press. Abstract published online July 5, 2022. doi:10.1097/JU.0000000000002848