Intra vesical gemcitabine (G) single agent as adjuvant chemotherapy in superficial transitional cell carcinoma (TCC) of the bladder: Final results

Abstract

5078 Background: Systemic intravenous G is usually used in advanced bladder carcinoma. A phase I study of intravesical G has shown safety profile in pts refractory to BCG therapy (Dalbani G et al JCO 2002; 20:3193–98). In this study we evaluate the toxicity and the efficacy of intravesical G in patients (pts) with superficial bladder carcinoma. Methods: The study population criteria were: age = 18 years old, histological diagnosis of transitional cell carcinoma (TCC) of bladder (Cis and pT1) confirmed by transurethral resection (TUR), no prior chemotherapy, a performance status (PS) < 2, good bone marrow reserve, adequate renal and liver function and informed consent. Three weeks after a total TUR, pts receive intravesical instillation of 2,000 mg G every wk for 6 wks, than every month for six months. Evaluation is performed 3–4 wks after the last instillation (CT scan and/or US pelvis, urinary cytology and cystoscopy with biopsy). Results: From February 2003 to June 2004, 60 pts (57M/3F) were enrolled in the study (M/F = 57/3). The median age was 59,5 years old (24–84). Nine pts had a carcinoma in situ (Cis) and 51 had pT1 lesions. They received a total of 720 instillations. All pts were evaluable for toxicity and response Toxicity (CTC/NCI scale) is evaluated over the 720 instillations. Non haematological toxicity was grade 1: irritate bladder reaction (4.7%), asthenia (2.9%), nausea and vomiting (1.8%) and hot flashes (2%). Grade 1 haematological toxicity: anaemia (6.8%), leucopenia (4.5%) and thrombocytopenia (0.4%). After a follow-up time of 30 to 48 months, all pts were evaluable for tumor response: 53 patient had a persistant complete remission after TUR. Five patients (8.3%) had a superficial relapse of TCC (one at six months, 2 at 9 months and 2 others at 12 months). Two patients had progressive disease at 18 months and 27 months. Conclusion: Intravesical G is an active and well tolerated treatment even after repeated instillation in pts with superficial TCC carcinoma of the bladder. No significant financial relationships to disclose.