Erman MustafaBiswas BivasDanchaivijitr PongwutChen LingwuYoke Fui WongTarek HashemChun Sen LimBulent KarabulutHsiao Jen ChungChandra ChikatapuSara InglesKhemaies SlimaneRavindran KanesvaranSiriraj HospitalNational Yang Ming Chiao Tung UniversityThe First Affiliated Hospital, Sun Yat-sen UniversityNational Cancer Centre, SingaporeEge ÜniversitesiHacettepe ÜniversitesiNovartis Pharma S.A.S.Novartis International AGMedical OncologyRadiotherapy and OncologyMedical OncologyNovartis Healthcare Pvt. Ltd.Hospital Sultan Ismail2022-08-042022-08-042021-12-01BMC Cancer. Vol.21, No.1 (2021)147124072-s2.0-85115014004https://repository.li.mahidol.ac.th/handle/20.500.14594/75922Background: Clinical effectiveness and safety data of pazopanib in patients with advanced or mRCC in real-world setting from Asia Pacific, North Africa, and Middle East countries are lacking. Methods: PARACHUTE is a phase IV, prospective, non-interventional, observational study. Primary endpoint was the proportion of patients remaining progression free at 12 months. Secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI). Results: Overall, 190 patients with a median age of 61 years (range: 22.0–96.0) were included. Most patients were Asian (70%), clear-cell type RCC was the most common (81%), with a favourable (9%), intermediate (47%), poor (10%), and unknown (34%) MSKCC risk score. At the end of the observational period, 78 patients completed the observational period and 112 discontinued the study; 60% of patients had the starting dose at 800 mg. Median RDI was 82%, with 52% of patients receiving < 85%. Of the 145 evaluable patients, 56 (39%) remained progression free at 12 months, and the median PFS was 10 months (95% CI: 8.48–11.83). 19% of patients (21/109) were long-term responders (on pazopanib for ≥18 months). The best response per RECIST 1.1 was CR/PR in 24%, stable disease in 44%, and PD in 31%. Most frequent (> 10%) TEAEs related to pazopanib included diarrhoea (30%), palmar-plantar erythrodysesthesia syndrome (15%), and hypertension (14%). Conclusions: Results of the PARACHUTE study support the use of pazopanib in patients with advanced or mRCC who are naive to VEGF-TKI therapy. The safety profile is consistent with that previously reported by pivotal and real-world evidence studies.Mahidol UniversityBiochemistry, Genetics and Molecular BiologyMedicineArticleSCOPUS10.1186/s12885-021-08738-z