Retrospective analysis of the efficacy and safety of neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer.

BACKGROUND: Neoadjuvant cisplatin-based combination chemotherapy for muscle-invasive bladder cancer (MIBC) improves overall and disease-free survival. However, there is much debate over the optimal neoadjuvant regimen. Gemcitabine plus cisplatin (GC) has been the neoadjuvant regimen of choice for many institutions for patients with MIBC based on data extrapolated from the metastatic setting. Based on recent data, many institutions are transitioning to variations of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) as the neoadjuvant regimen of choice.

OBJECTIVE: To assess the effectiveness and safety of neoadjuvant chemotherapy with gemcitabine plus cisplatin in patients with muscle-invasive bladder cancer prior to cystectomy.

METHODS: This is a single-center, retrospective, cohort study at Duke University Hospital (DUH). Patients included had MIBC and received gemcitabine plus cisplatin chemotherapy prior to a cystectomy. The primary endpoint was to assess the pathologic complete response (pCR) rate in MIBC after treatment with gemcitabine and cisplatin. Patients were split into two groups, those who received their chemotherapy at DUH, and those who received their chemotherapy at an outside facility.

RESULTS: Overall pCR rate for all patients (n = 36) was 14%. The pCR rates for patients in the Duke Chemotherapy Group (n = 17) and in the Community Chemotherapy Group (n = 19) were 24% and 5%, respectively. GC was overall well tolerated in most patients with few adverse events ≥ grade 3.

CONCLUSIONS: This retrospective study demonstrates a consistent pCR rate (24% in Duke Chemotherapy Group) for neoadjuvant GC in MIBC compared with other literature. The overall pCR rate for all patients was 14%.