Introduction: The recommended treatment of muscle invasive bladder cancer (MIBC) is radical cystectomy with cisplatin based neoadjuvant chemotherapy (NAC) as per latest guidelines. Report from National cancer database in 2014 showed that only 16.9 % of patients with MIBC have received Cisplatin-based NAC. We initiated NAC (Gemcitabine + Cisplatin regime) in MIBC patients and reviewed the radiological and pathological downgrading and the toxicity profile.
Material and methods: The duration of study is from Oct-2015 to Oct-2017. The study is still undergoing. Patients of MIBC on initial TURBT are staged with CECT thorax, abdomen and pelvis. Patients of clinical stage T2-T4a, N0-N1, M0 are given 4 cycles of NAC (Gemcitabine + Cisplatin regime). After completion of chemotherapy, patients undergo repeat CECT thorax, abdomen and pelvis to note radiological downgrading. If patient are found operable on imaging (T0-T4a, N0-N1, M0), radical cystectomy and pelvic lymphadenectomy with urinary diversion (ileal conduit/ neobladder) is done within 6 weeks after the last course. Primary endpoint of this trial is radiological and pathological response rate with the GC regime used in the neoadjuvant setting. Secondary endpoints are tolerability of the combination using CTCAE criteria version 4.0, and intra-operative and post-operative outcome of definitive surgery (radical cystectomy) after GC regimen.
Results: We have enrolled 25 patients till now and still recruiting. The mean age of patients are 53.42 years. There are 22 males and 3 females. Mean BMI is 19.9. ECOG status ranged from 0 to 2. Of 25 patients, 12 have completed NAC, of which 5 underwent definitive surgery, 2 patients refused further treatment after achieving complete clinical response. Total 4 patients have expired of which 2 had completed chemotherapy regime and died at home. Definitive cause of death could not be assessed as autopsy was not carried out in these patients. Thirteen patients are under mid-chemotherapy regime. 3/5 patients achieved complete pathological response. 3/12 patients who completed chemotherapy regime suffered myelosuppression and were recovered successfully on conservative management.
Discussion: NAC (Gemcitabine + cisplatin regime) has good tolerability and efficacy. 3/5 patients achieved complete pathological response on definitive surgery after completing NAC. Long term results of our study is still awaited.
