Background: about 25% of patients newly diagnosed with bladder cancer have muscle-invasive bladder cancer (MIBC). Patients with MIBC have a worse prognosis than those with non-MIBC. Radical cystectomy with pelvic lymphadenectomy has been shown to be effective against MIBC. The pathologic stage of the primary tumor and regional lymph nodes status has been shown to be the most accurate predictors of disease recurrence after radical cystectomy.
Aim of the Work: to evaluate the toxicity profile related to the adjuvant chemotherapy cisplatin, gemcitabine when added to radical cystectomy as primary treatment, and to estimate disease free survival (DFS) and overall survival (OS).
Patients and Methods: during the period between December 2013 and October, 2017, a total number of 42 patients were included in this study at Clinical Oncology and Nuclear Medicine Department, Al-Hussein University Hospital with a provisional diagnosis of invasive type bladder cancer. The cutoff date for the analysis of overall survival was 31st April, 2018 corresponding to 6 months of follow-up for the last patient enrolled in the study. All patients were subjected to radical cystectomy and pelvic lymphadenectomy and received four cycles of adjuvant chemotherapy cisplatin 70mg/m2 D1, gemcitabine 1000mg/m2 D1,8, every three weeks.
Results: the most common grade 3 and 4 adverse events of hematological and non-hematological toxicities recorded during adjuvant chemotherapy were neutropenia (18.8%), grade 3 anemia (9.5%), grade 3 thrombocytopenia (2.3%), grade 3 nausea (28.5%), grade 3 and 4 vomiting (9.4%), grade 3 diarrhea (9.4%) while grade 3 renal toxicities observed in two patients (4.7%). As regard the survival analysis, the median disease-free survival (DFS) rate was not reached due to a relatively short follow up period and DFS was 82.9% at 1 year, 74% at 2 years, and 70.1% at 3 years. Concerning overall survival analysis, the median overall survival in our study was not reached due to a relatively short follow up period. Overall Survival rate at 1 year was 90.4%; at 2 years was 77.3% and 73.4% at 3 years.
Conclusion: for patients with bladder cancer who were not treated with neoadjuvant chemotherapy, we suggest not routinely administering chemotherapy following cystectomy. However, for patients with high-risk (T3 or higher, pathologic node involvement) urothelial carcinomas who are candidates for cisplatin -based combination chemotherapy and are willing to accept the risk for treatment-related toxicities in the absence of high level of evidence, adjuvant chemotherapy is a reasonable option. If administered, we prefer to use a cisplatin-based combination.