Phase II study of single-agent vinflunine in platinum-refractory transitional cell carcinoma of the urothelium (TCCU)

• DOI: 10.1200/jco.2007.25.18_suppl.15543
• Publication Date: 2020-03-06T21:05:21Z
• Authors: D. J. Vaughn; S. Srinivas; W. M. Stadler; R. Pili; D. Petrylak; S. De Marco; D. C. Smith; S. Nason; E. De Wit; C. George
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

15543 Background: Vinflunine (VFL) is a new microtubule inhibitor of the vinca alkaloid class with clinical activity in TCCU (S. Culine, BJC 2006). This trial was conducted to define VFL activity in platinum-refractory TCCU patients (pts). Methods: Multicenter, single-arm study. Primary endpoint: Objective response rate (Independent Review; WHO criteria). Planned sample size: 150 pts. Main pt eligibility: at least one measurable lesion; documented progression within 12 months of last dose of platinum-containing regimen; calculated creatinine clearance (Cr Cl) = 20 mL/min. VFL 320 mg/m2 IV infusion over 20 minutes was administered every 3 weeks. In pts with poor performance status, prior pelvic irradiation, or renal impairment (Cr Cl 20–60 mL/min), initial dose (ID) was 280 mg/m2, escalated to 320 mg/m2 if well tolerated. Results: Enrollment of 150 pts complete. Baseline pt characteristics (first 118 pts treated): Gender: male 78%, female 22%. Median age: 66 years (range 40–83). Renal impairment: 32%. Prior chemotherapy: cisplatin: 69%; carboplatin: 47%, gemcitabine: 94%. Total of 402 VFL cycles administered (range: 1–12). 320 mg/m2 ID: 35 pts; 280 mg/m2 ID: 83 pts. Main toxicity was hematologic (Grade (G) 3/4): neutropenia: 19%/37%; thrombocytopenia: 3%/0%; anemia: 13%/0%; febrile neutropenia: 320 mg/m2 ID: 5 pts; 280 mg/m2 ID: 3 pts. Main non-hematologic toxicities: constipation: 320 mg/m2 ID: 63% (G3/4: 14%/3%); 280 mg/m2 ID: 59% (G3/4: 12%/1%); fatigue: 320 mg/m2 ID: 43% (G3/4: 6%/0%); 280 mg/m2 ID: 35% (G3/4: 7%/0%). Severe diarrhea or vomiting was infrequent. No G3/4 peripheral neuropathy was noted. Responses have been observed by the investigators, but independent review is on-going. Conclusions: VFL has a manageable toxicity profile in pts with platinum-refractory TCCU. Independently reviewed response rate and other efficacy endpoints of the entire cohort will be presented. No significant financial relationships to disclose.