1. Prospective observational study on Pazopanib in patients treated for advanced or metastatic renal cell carcinoma in countries in Asia Pacific, North Africa, and Middle East regions: PARACHUTE study.
- Author
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Erman M, Biswas B, Danchaivijitr P, Chen L, Wong YF, Hashem T, Lim CS, Karabulut B, Chung HJ, Chikatapu C, Ingles S, Slimane K, and Kanesvaran R
- Subjects
- Adult, Africa, Northern, Aged, Aged, 80 and over, Angiogenesis Inhibitors administration & dosage, Angiogenesis Inhibitors adverse effects, Asia, Carcinoma, Renal Cell ethnology, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell pathology, Female, Humans, Indazoles administration & dosage, Indazoles adverse effects, Kidney Neoplasms ethnology, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Male, Middle Aged, Middle East, Progression-Free Survival, Prospective Studies, Pyrimidines administration & dosage, Pyrimidines adverse effects, Response Evaluation Criteria in Solid Tumors, Risk Factors, Sulfonamides administration & dosage, Sulfonamides adverse effects, Time Factors, Treatment Outcome, Young Adult, Angiogenesis Inhibitors therapeutic use, Antineoplastic Agents therapeutic use, Carcinoma, Renal Cell drug therapy, Indazoles therapeutic use, Kidney Neoplasms drug therapy, Pyrimidines therapeutic use, Sulfonamides therapeutic use
- Abstract
Background: 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., (© 2021. The Author(s).)
- Published
- 2021
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