Abstract
Vinflunine is the only cytotoxic agent tested as a second line therapy in transitional cell carcinoma of the urothelium in a phase III trial. It is not largely employed in clinical practice because of the high incidence of grade 3–4 toxicity. We evaluated efficacy and safety of Vinflunine at the dose of 280 mg/m2 every 3 weeks associated with primary prophylaxis with granulocyte growth factors and laxatives for patients progressed after platinum + Gemcitabine. Overall survival was 8.5 months, progression-free survival 4.33 months and response rate 25%, with disease control rate 57.2%. Grade III-IV neutropenia occurred in 10.7% of the patients, grade III-IV anemia and grade III thrombocytopenia in 10.7% and 7.2%, respectively. Among non haematological toxicity, grade I-II constipation was reported in 14.2% of the patients, without grade III-IV adverse events. No discontinuation for toxicity was observed. This study underlines that Vinfluinine at a dose of 280 mg/m2 associated with primary prophylaxis for neutropenia and constipation is effective and with a favorable toxicity profile.
Highlights
Vinflunine is the only cytotoxic agent tested as a second line therapy in transitional cell carcinoma of the urothelium in a phase III trial
We evaluated efficacy and safety of Vinflunine at the dose of 280 mg/m2 every 3 weeks associated with primary prophylaxis with granulocyte growth factors and laxatives for patients progressed after platinum + Gemcitabine
This study underlines that Vinfluinine at a dose of 280 mg/m2 associated with primary prophylaxis for neutropenia and constipation is effective and with a favorable toxicity profile
Summary
Transitional cell carcinomas of the urothelium (TCCU) represent more than 90% of all cancers of the urinary tract, among which 90% are localized in the bladder. [1,2]. Cisplatin-based regimens (Gemcitabine + Cisplatin: GC or Cisplatin + Methotrexate + Doxorubicin + Vinblastine: MVAC) are the cornerstone of first line treatment with a median survival of 13–15 months [6,7]. Prognosis is dismal at the time of progression after first line chemotherapy or recurrence after neoadjuvant/ adjuvant treatment. When performance status is adequate and relapse occurs later than 12 months after neoadjuvant/ adjuvant therapy, change of platinum based regimen could be considered [9]. In case of patients unfit for Cisplatin because of a poor performance status (up to 50% of patients) or impaired renal function, other options – e.g. alternative platinum agents (Oxaliplatin or Carboplatin) or the combination of Paclitaxel and Gemcitabine – have been proposed, less effective [11,12,13]. Limited treatment options are available after an early relapse following platinum based neoadjuvant/adjuvant chemotherapy or after palliative first-line chemotherapy. The activity of agents, such as taxanes [15] and Pemetrexed [16], has been reported despite not being tested in randomized phase III trials
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