Gem in the rough.
Top Line: If intravesical gemcitabine reduces recurrence of non-muscle invasive bladder cancer (NMIBC), what can it do for MIBC?
The Study: Variety in treatment options has been pretty rough for advanced bladder cancer in recent years. The backbone has generally consisted of cisplatin, but there’s room for improvement. This phase 2 trial doesn’t branch out much, but it does assess "dose-dense" cisplatin with gemcitabine. More specifically, 49 patients with MIBC received neoadjuvant dose-dense cisplatin/gemcitabine q2 weeks x 6 weeks prior to radical cystectomy. The primary endpoint was to achieve a rate of pathologic response, defined as conversion to NMIBC (<pT2N0), of at least 35%. Two-thirds of patients were able to complete all 6 cycles of chemo, and over half (n=26) achieved conversion to NMIBC including 7 who converted to pT0. What’s more, an interesting exploratory analysis demonstrated that 8 of 9 patients with DDR gene alterations achieved a “p<T1” (you do the math) response, generating an interesting hypothesis that this may one day make for a useful screening test to identify the best organ preservation candidates.
Bottom Line: Dose-dense cisplatin/gemcitabine is an excellent pre-op treatment for patients who can tolerate it prior to definitive radical cystectomy for MIBC, and it even may one day serve as a route for organ preservation for patients with DDR alterations. | Iyer, J Clin Oncol 2018
The Study: Variety in treatment options has been pretty rough for advanced bladder cancer in recent years. The backbone has generally consisted of cisplatin, but there’s room for improvement. This phase 2 trial doesn’t branch out much, but it does assess "dose-dense" cisplatin with gemcitabine. More specifically, 49 patients with MIBC received neoadjuvant dose-dense cisplatin/gemcitabine q2 weeks x 6 weeks prior to radical cystectomy. The primary endpoint was to achieve a rate of pathologic response, defined as conversion to NMIBC (<pT2N0), of at least 35%. Two-thirds of patients were able to complete all 6 cycles of chemo, and over half (n=26) achieved conversion to NMIBC including 7 who converted to pT0. What’s more, an interesting exploratory analysis demonstrated that 8 of 9 patients with DDR gene alterations achieved a “p<T1” (you do the math) response, generating an interesting hypothesis that this may one day make for a useful screening test to identify the best organ preservation candidates.
Bottom Line: Dose-dense cisplatin/gemcitabine is an excellent pre-op treatment for patients who can tolerate it prior to definitive radical cystectomy for MIBC, and it even may one day serve as a route for organ preservation for patients with DDR alterations. | Iyer, J Clin Oncol 2018
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