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JU INSIGHT: Sequential Intravesical Valrubicin and Docetaxel for the Salvage Treatment of Nonmuscle-invasive Bladder Cancer

By: Ian M. McElree, BS, MS; Vignesh T. Packiam, MD; Ryan L. Steinberg, MD; Sarah L. Mott, BA, MS; Paul T. Gellhaus, MD; Kenneth G. Nepple, MD; Michael A. O'Donnell, MD | Posted on: 01 Nov 2022

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. 2022; 208(5):969-977.

Study Need and Importance

Intravesical bacillus Calmette-Guérin is recommended as adjuvant therapy following complete transurethral resection of bladder tumor for high-risk nonmuscle-invasive bladder cancer (NMIBC). Sequential intravesical gemcitabine and docetaxel has recently demonstrated efficacy as a salvage regimen as well as an alternative first-line therapy in this setting. Unfortunately, effective salvage therapies to treat subsequent recurrences are lacking. While radical cystectomy can be offered to some with recurrent NMIBC, this operation is associated with significant morbidity. We evaluated sequential intravesical valrubicin and docetaxel (Val/ Doce) as a salvage treatment.

Figure. High-grade (HG) recurrence-free survival (RFS) and progression-free survival (PFS) following valrubicin and docetaxel (Val/Doce) induction among patients presenting with high-grade disease.

What We Found

We reviewed 75 patients with a median follow-up of 21 months. The cohort was pretreated with a median of 2 prior inductions. In 63 patients presenting with high-grade (HG) disease, the 2-year HG recurrence-free survival (RFS) was 38% (see Figure), and recurrence rates were unaffected by presence of carcinoma in situ (P = .63). There were 11 progression events in the HG group, yielding a 2-year progression-free survival (PFS) of 82% (see Figure). Of these, 9 underwent cystectomy; 1 was node positive. Two patients later developed metastatic disease and died. Of the 12 patients presenting with low-grade disease, 2-year RFS was 73%. Overall survival among the low-grade and HG groups was 90% and 87% at 2 years, respectively. The most commonly reported side effect was bladder spasms occurring during induction.

Limitations

The retrospective nature of this study allows for selection bias and confounding. The modest sample size of 75 patients limits statistical power. Furthermore, these results are from an institution with rigorous NMIBC protocols that may limit generalizability.

Interpretations for Patient Care

While radical cystectomy is curative, it is an overtreatment for a significant minority of patients without effective U.S. Food and Drug Administration–approved alternatives. Our results demonstrate that Val/Doce is a safe and effective salvage treatment for patients with recurrent NMIBC. In light of these promising results, further prospective investigation of Val/Doce is warranted.

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