14: Real-World Clinical Outcomes of tivozanib as first-line treatment of metastatic renal cell carcinoma in Germany

Karen Rußwurm, Ralf Eckert, Sandra Seseke, Diana Standhaft , Martina Stauch , Monika Schiffer, Jan Dieckhoff, Steffen Baumann, Horst Brenneis, Michael Seidel, Olrik Rau, Silke Schirrmacher-Memmel , Eva Hellmis, Claus F. Fieseler, Christian Doehn, Carsten Ziske , Andrea Distelrath, Norbert Marschner, Philipp Ivanyi, Carsten Lange, Andreas Janitzky, Martin Bögemann

Background
Tivozanib (TIVO) is a standard of care (SOC) in the treatment of mRCC. Here, we investigate the effectiveness of TIVO in a real-world population in Germany.
Methods
T-Rex is a prospective, non-interventional study, which evaluated the effectiveness, tolerability, safety and quality of life in TIVO first-line treatment in patients with mRCC. Incidence of adverse events (AE), treatment-related therapy discontinuations and hospitalizations were considered to evaluate safety. Objective response rate (ORR) according to RECIST 1.1 and/or clinical routine, was utilized to evaluate efficacy. Tumor imaging was performed according to routine practice. The trial was conducted in accordance with the declaration of Helsinki. The study was registered at BfARM #7296.
Results
22 men and 16 women (N = 38) were included and received at least one cycle of treatment. The mean age was 74.24 years (56-89). 18 pts. (47.4%) were ≥75 years old. Mean Charlson Comorbidity Index was 3.21. 92.1% had ECOG 0-1. IMDC risk was favourable/intermediate/poor in 23.7/65.8/10.5%. 84.21% received TIVO in 1st line. ORR of tivozanib treatment was 50% (CR 15.8%, PR 34.2%).
An average of 10.55 treatment cycles was administered. Therapy interruption occurred in a total of 9 (23.68%) and dose reduction in 10 patients (26.32%). 12 patients (31.58%) required hospitalization and 1 patient (2.63%) had treatment discontinuation due to toxicity. All grade AE and severe AE were reported in 15.8% of each patient. The most common adverse events were diarrhoea (G1/2 8.5%, G3/4 1%), nausea (G1/2 3.7%, G3/4 none) and peripheral neuropathy (Grad1/2 2%, G3/4 none).
Conclusions
Tivozanib showed relevant clinical activity and good tolerability in a real-world population in Germany. Our data support the use of tivozanib as a standard of care in patients not suitable for 1st line combinations.