Cecilia Brown

GU Oncology Now

<p>Gemcitabine plus docetaxel is an &ldquo;effective and readily available alternative&rdquo; to bacillus Calmette-Gu&eacute;rin (BCG) therapy for patients with high-risk non-muscle-invasive bladder cancer (NMIBC), according to a retrospective analysis.<p>While BCG has been the &ldquo;gold-standard&rdquo; adjuvant therapy for patients with high-risk NMIBC, the ongoing shortage &ldquo;has forced many urological practices to re-evaluate alternative regimens,&rdquo; authors of the analysis wrote.</p><p>The results of the analysis led by Ian McElree, MS, a medical student at the University of Iowa, and principal investigator Vignesh Packiam, MD, of University of Iowa Hospitals and Clinics, were published in The Journal of Urology.</p><p>Investigators retrospectively reviewed data from BCG-na&iuml;ve patients with NMIBC who were treated with gemcitabine plus docetaxel between May 2013 and April 2021. The analysis included 107 high-risk NMIBC patients who were assessed at a median follow-up of 15 months.</p><p>Patients received six weekly intravesical instillations of gemcitabine 1 gm and docetaxel 37.5 mg after complete transurethral resection of a bladder tumor. Monthly maintenance continued for two years if patients were disease-free at the first follow-up. The primary endpoint of the study was recurrence-free survival (RFS).</p><h2>Survival Rates and Disease Progression</h2><p>The two-year RFS was 82%, while the one-year RFS was 85% and the six-month RFS was 89%. The recurrence rates were not significantly different between patients with or without carcinoma in situ. The two-year overall survival was 84%. Bladder cancer recurrence at follow-up was reported in 19 (17.8%) of patients. None of the patients had disease progression or died of bladder cancer, the authors reported.</p><h2>Adverse Events and Side Effects</h2><p>At least one adverse event throughout the course of treatment was reported in 60 (56%) patients. A total of 92 adverse events were reported, including one grade-3 adverse event. Most adverse events were grade 2 (60) or grade 1 (31). Urinary frequency/urgency was the most reported side effect. Most patients (96%) were able to complete a full induction course.</p><h2>Limitations and Future Directions</h2><p>While the study is limited by its retrospective nature and lack of direct comparison groups, the &ldquo;excellent&rdquo; two-year RFS for patients treated with gemcitabine plus docetaxel was similar to RFS reported in patients treated with BCG in other studies, the authors reported.</p><p>The findings of this analysis &ldquo;may serve as a benchmark for future prospective trial design assessing [gemcitabine plus docetaxel] as a first-line treatment for NMIBC,&rdquo; investigators concluded.</p><p><strong>Reference</strong></p><p><a href="https://pubmed.ncbi.nlm.nih.gov/35892270/" target="_blank" rel="noopener">Sequential intravesical gemcitabine and docetaxel for bacillus calmette-Gu&eacute;rin&ndash;na&iuml;ve high-risk nonmuscle-invasive bladder cancer.</a></p></p>


Gemcitabine Plus Docetaxel: An Effective Alternative to BCG Therapy for High-Risk NMIBC

Non-Muscle Invasive Urothelial Carcinoma

While BCG has been the standard adjuvant therapy for patients with high-risk NMIBC, a shortage has led to other regimens.

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