Real-Life Experience with Neo-Adjuvant Chemotherapy in Muscle Invasive Bladder Cancer and Its Outcome

Abstract

Objectives : Muscle-invasive bladder cancer (MIBC) has a poor prognosis with a 5-year overall survival rate of 50%. Current guidelines recommend the use of neoadjuvant chemotherapy (NAC) followed by radical cystectomy in these patients. However, its application remains limited and underutilized in clinical practice. This study aims to delineate, in real-life practice, the clinical characteristics and outcomes of patients with muscle-invasive bladder cancer (MIBC) who received NAC and were subsequently candidates for cystectomy. Methods: This study is a retrospective observational analysis of patients with muscle-invasive bladder cancer (stages T2-T4aN0M0 and T1-T4aN1M0) who received neoadjuvant chemotherapy prior to total cystectomy. The data, collected over a six-year period from 2018 to 2024, originates from Hotel Dieu de France University Hospital in Beirut. Various factors were analyzed, including age, sex, history of smoking, stage of disease at diagnosis, presence of carcinoma in situ (CIS), and any prior history of Bacillus Calmette-Guérin (BCG) treatment or T1 or Ta disease. Additionally, the study evaluates renal function prior to neoadjuvant chemotherapy (NAC), specifies the type and number of chemotherapy cycles administered, the pathological complete response (pCR) following cystectomy and calculate both overall survival and disease-free survival rates. Results: A total of 36 patients were analyzed, with a median age of 71.6 years. 77.7% were male, 22.2% were female, and 77.8% were smokers. 55.6% of the patients presented with de novo muscle-invasive bladder cancer (MIBC), 44.4% had a history of Ta or T1 stage tumors and 100% had urothelial histology and lower tract location. Among these 36 patients, 27.8% had received intravesical Bacillus Calmette-Guérin (BCG) treatment, while 72.2% did not. 86.1% of patients had a creatinine clearance greater than 60, whereas 13.9% had a clearance below 60 but still above 50. At the time of diagnosis, 61.1% were at stage II, 13.9% were at stage IIIa, and 25.0% were at stage IIIb. All the patients received the combination of gemcitabine and cisplatin with a median number of 3.9 cycles per patient. Out of the 36 patients, 5 experienced disease progression and did not undergo radical cystectomy, while another 5 opted for trimodal therapy (TMT) after evaluation by cystoscopy showing no residual lesion. The remaining 26 patients proceeded with radical cystectomy. Among these 26 cystectomized, 30.8% demonstrated a complete pathological response. During the follow-up period, 75% of these 36 patients did not experience disease progression, with a median disease-free survival of 9.5 months and a mean disease-free survival of 19.72 months. No deaths were recorded in this study, and overall survival data could not be determined. Conclusion : In our real-world experience, approximately one-third of patients who received gemcitabine and cisplatin NAC followed by radical cystectomy achieved a pathological complete response. Extended follow-up is necessary to assess long-term outcomes, including median overall survival. Future research should focus on investigating and comparing between triple modality therapy and cystectomy, both after neoadjuvant chemotherapy.