Pre-Surgical Gemcitabine Plus Cisplatin Benefits Bladder Cancer

When used as a neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC), split-dose of gemcitabine and cisplatin has a beneficial response and a high safety profile, according to a study presented at the 2017 American Urological Association Annual Meeting.
BY ARIELA KATZ
PUBLISHED: JUNE 15, 2017
When used as a neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC), split-dose of gemcitabine and cisplatin has a beneficial response and a high safety profile, according to a study presented at the 2017 American Urological Association Annual Meeting.
 
“Our aim was to evaluate our experience with respect to gemcitabine and split-dose cisplatin in terms of safety and efficacy, as well as pathologic downstaging and survival,” said Michael Williams, M.D., a practicing urologist at Urology of Virginia and assistant professor in the Department of Urology at Eastern Virginia Medical School. This is especially significant for patients who are unable to tolerate standard treatment with a combination of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC).
 
A previous randomized phase 3 study investigated the combination of gemcitabine and cisplatin compared to treatment with MVAC in advanced or metastatic bladder cancer. This trial found that gemcitabine and cisplatin provided a similar survival advantage to MVAC, with a better safety profile and tolerability. The investigators even concluded that the standard of care should change for patient in this population from MVAC to gemcitabine and cisplatin.
 
In the large, randomized, multicenter trial, 405 patients were randomized to either receive gemcitabine and cisplatin (203 patients) or MVAC (202 patients). OS was similar in both arms, as were time to disease progression, time to treatment failure, and response rate. More patients completed six cycles of gemcitabine and cisplatin therapy, with fewer dose adjustments. The toxic death rate was 1 percent on the gemcitabine and cisplatin arm and 3 percent on the MVAC arm.
 
In terms of adverse events, more patients in the gemcitabine and cisplatin arm experienced grade 3/4 anemia (27 percent vs 18 percent in the MVAC arm) and thrombocytopenia (57 percent vs 21 percent). More patients in the MVAC arm had grade 3/4 neutropenia (82 percent vs 71 percent in the gemcitabine and cisplatin arm), neutropenic fever (14 percent vs 2 percent), neutropenic sepsis (12 percent vs 1 percent), grade 3/4 mucositis (22 percent vs 1 percent) and alopecia (55 percent vs 11 percent). Patients in the gemcitabine and cisplatin arm also had better improvement in terms of their weight, performance status, and fatigue.
 
A retrospective study investigating the role for neoadjuvant gemcitabine and cisplatin in MIBC similarly concluded that neoadjuvant gemcitabine and cisplatin is feasible and allows for timely drug delivery. Further, the proportion of patients who were treated with the combination of gemcitabine and cisplatin whose primary tumors were downstaged and who had prolonged disease-free survival with minimal or no residual disease, was similar to patients treated with MVAC.
 
With four cycles planned in the study, 39 of 42 patients received all four cycles, with complete responses achieved in 28 percent. Notably, all 15 patients receiving gemcitabine and cisplatin who achieved downstaging of their tumors below pathological stage T2 remained disease-free at a median follow-up of 30 months.
 


Talk about this article with other patients, caregivers, and advocates in the Bladder Cancer CURE discussion group.
x-button
 
CURE wants to hear from you! We are inviting you to Share Your Story with the readers of CURE. Submit your personal experience with cancer by visiting Share Your Story
 
Not yet receiving CURE in your mailbox? Sign up to receive CURE Magazine by visiting GetCureNow.com
x