Phase II Trial of Intravesical Nanoparticle Albumin Bound Paclitaxel for the Treatment of Nonmuscle Invasive Urothelial Carcinoma of the Bladder after bacillus Calmette-Guérin Treatment Failure

Abstract

Intravesical nab-paclitaxel has minimal toxicity and a 35.7% response rate in patients with nonmuscle invasive bladder cancer and previous bacillus Calmette-Guérin failure. Complete response remained durable at 1 year followup in this heavily pretreated patient population.

Alternative therapies in patients with non-muscle invasive bladder cancer

“…Furthermore, a recent study including 40 patients with BCG refractory or relapsing disease with a primary end point as recurrence-free survival revealed that 35% (14/40) of the patients remained free of HG recurrence at 12 months after the initiation of the treatment. [64] Of 11 patients with long-term (3 years) data, 8 remained free of disease during a period ranging between 15 and ≥36 months. Ninety-seven percent of the patients experienced adverse events, for majority (78%) of them adverse events were transient and classified as either grade 1 or 2.…”

Novel Therapeutic Approaches for Recurrent Nonmuscle Invasive Bladder Cancer

“…9 Results of the phase 2 data were recently reported. 10 A complete response was observed in 10 (35.7%) of 28 patients treated with NAB-paclitaxel with recurrent NMIBC who had failed at least 1 prior BCG regimen. 10 In murine models, the mTOR inhibitor rapamycin was found to potentiate the induction of BCGmediated immune responses in mice.…”

“…10 A complete response was observed in 10 (35.7%) of 28 patients treated with NAB-paclitaxel with recurrent NMIBC who had failed at least 1 prior BCG regimen. 10 In murine models, the mTOR inhibitor rapamycin was found to potentiate the induction of BCGmediated immune responses in mice. 11 In addition, rapamycin demonstrated antitumor activity in preclinical models of bladder cancer.…”

This Month in Adult Urology

“…In this phase II study by McKiernan et al (page 1633) from New York the maximum deliverable dose of nab-paclitaxel was given to 28 patients after BCG failed to treat urothelial carcinoma of the bladder. 6 Nab-paclitaxel has a fivefold higher solubility compared to docetaxel, facilitating drug delivery into tumor cells via albumin receptor mediated transport across epithelial cells.…”