Safety and efficacy Gemcitabine-Cisplatin split dose as a neoaduvant chemotherapy for muscle invasive bladder cancer
Sources of Funding: None
Introduction
Neoadjuvant chemotherapy (NAC) (Cisplatin based) and radical cystectomy are currently level 1 recommendation for muscle invasive bladder cancer. Gemcitabine-Cisplatin regimens are gaining popularity as (NAC). Only few data at present about splitting the doses in order to decrease toxicity, used with patients with lower renal function and achieve more patient compliance. The objective of this study is to study the effectiveness and safety of split dose Gemcitabine and Cisplatine as a NAC for muscle invasive bladder cancer.
Methods
All consecutive patients from 2004 to 2015 that received Gemcitabine and Cisplatine split doses and followed by open radical cystectomy for T2-T4 bladder cancer were included in the study. All patients administered 1,000 mg/m2 of gemcitabine and 35 mg/m2 of Cisplatin given on days 1 and 8 of a 21 days cycle for 4 cycles. Preoperative patients` clinical parameters, need for dose reduction, number of cycles complications of NAC and pathologic response were recorded. Patients with unavailable follow up data were excluded from the study. Fisher exact test was used for univariate analysis to detect preoperative factors affecting pathologic response.
Results
Eighty two patients met the inclusion criteria. Only 10 patents (12 %) couldn't complete 4 cycles because of complications. 38 patients (46%) were down staged (pT≤ 1) and 32 achieved complete response (pT0). Median follow up time was 29 months. Univariate analysis for detecting factors affect pathologic response showed no significant effect of Gender (p=0.742), race (p=0.783), Age (p=0.377), BMI (p=0.821), T stage (0.982), N stage (0.615), presence of Cis (0.096), squamous differentiation (p=0.229) and presence of lymphovasular invasion (p=0.749).
Conclusions
Splitting the dose of Gemcitabine and Cisplatine as a NAC for muscle invasive bladder cancer has a good pathologic response with high safety profile. Patients with different preoperative characters can get benefit from this regimen.
Funding
None
Michael Williams