The authors ought to be commended for their diligent follow-up and assessment of long-term outcomes from their original phase I study of docetaxel in patients who were refractory to most other intravesical therapies. Although it is difficult to resist the temptation to assess and report “response” from phase I studies, one has to be cautious about doing so. These data substantiate earlier observations with other chemotherapeutic agents used intravesically in the BCG refractory setting, such as valrubicin 1 Steinberg G. Bahnson R. Brosman S. et al. Efficacy and safety of valrubicin for the treatment of Bacillus Calmette-Guerin refractory carcinoma in situ of the bladder The Valrubicin Study Group. J Urol. 2000; 163: 761-767 Abstract Full Text Full Text PDF Scopus (254) Google Scholar and gemcitabine. 2 Dalbagni G. Russo P. Sheinfeld J. et al. Phase I trial of intravesical gemcitabine in bacillus Calmette–Guérin-refractory transitional-cell carcinoma of the bladder. J Clin Oncol. 2002; 20: 3193-3198 Crossref Scopus (145) Google Scholar Initially, chemotherapy appears to yield an admirable response rate as seen with gemcitabine 3 Dalbagni G. Russo P. Bochner B. et al. Phase II trial of intravesical gemcitabine in bacilli Calmette-Guérin-refractory transitional cell carcinoma of the bladder. J Clin Oncol. 2006; 24: 2729-2734 Crossref Scopus (144) Google Scholar and with docetaxel. 4 McKiernan J.M. Masson P. Murphy A.M. et al. Phase I trial of intravesical docetaxel in the management of superficial bladder cancer refractory to standard intravesical therapy. J Clin Oncol. 2006; 24: 3075-3080 Crossref Scopus (107) Google Scholar However, the response does not appear to be durable. The relatively poor long-term success of single agent intravesical chemotherapy has a familiar ring to it. Single agent systemic chemotherapy for advanced bladder cancer has long been abandoned after it was demonstrated to be comparatively less effective than combination therapy. 5 Brinkley W.M. Torti F.M. Systemic chemotherapy of transitional cell carcinoma of the urothelium. Semin Surg Oncol. 1997; 13: 365-375 Crossref Scopus (7) Google Scholar Therefore, why do we presume it will be any different when the chemotherapy is delivered directly into the bladder? It would be reasonable to expect that a combination of intravesical agents may prove more effective than using a single agent and this indeed appears to be the case based on early reports. 6 Breyer BN, Whitson JM, Carroll PR, et al. Sequential intravesical gemcitabine and mitomycin C chemotherapy regimen in patients with non-muscle invasive bladder cancer. Urol Oncol, in press. Google Scholar We now have at least 3 chemotherapeutic agents (mitomycin, gemcitabine, and docetaxel) that have some demonstrated activity against non–muscle-invasive urothelial cancer. It may behoove us to investigate if any or all of these 3 drugs along with other, yet to be tested agents, can be used to devise a combination regimen that is more effective in these patients who are refractory to BCG or other immunotherapy. Long-term Clinical Outcomes of a Phase I Trial of Intravesical Docetaxel in the Management of Non–muscle-invasive Bladder Cancer Refractory to Standard Intravesical TherapyUrologyVol. 75Issue 1PreviewTo report the long-term clinical outcomes and durability of response after treatment with induction intravesical docetaxel. Most novel agents used to treat bacillus Calmette-Guerin refractory high-grade non–muscle-invasive (NMI) bladder cancer are evaluated only after short follow-up periods. Our previously published phase I trial demonstrated that docetaxel is a safe agent for intravesical therapy with minimal toxicity and no detectable systemic absorption. We sought to determine long-term clinical outcomes after treatment with intravesical docetaxel. Full-Text PDF