PARACHUTE, a phase IV, observational study of treatment patterns and outcomes planned to describe the clinical effectiveness and safety of pazopanib in patients (pts) with advanced or mRCC who are naïve to VEGF-TKI therapy in the real-life setting from Asia Pacific, North Africa, and the Middle East countries where data from the registration trials are lacking.
Eligible pts were ≥18y with advanced or mRCC and clinical decision to initiate pazopanib treatment or had already started new treatment with pazopanib within 15 days prior to study entry and naïve to any prior anti-VEGF therapy. Primary endpoint was the proportion of pts remaining progression free at 12 months (mo). The secondary endpoints were ORR, PFS, safety and tolerability, and relative dose intensity (RDI).
Between Jun 2017 and Dec 2018, 200 pts were enrolled from 15 countries in Asia, North Africa and Middle East. A total of 190 pts with a median age of 61y (range, 22.0-96.0) were included in this final analysis. Majority of the pts were Asian (70%), clear-cell type RCC was the most common (80%), with a favourable (9%), intermediate (47%), poor (10%) and unknown (34%) MSKCC risk score. At end of observation period, 78 pts completed the observational period and 112 discontinued the study. 60% of pts had the starting dose at 800mg. Median RDI was 82% with 52% pts received <85%. 56 of 145 evaluable pts (39%) remained progression-free at 12 mo and median PFS was 10 mo (95% CI, 8.48-11.83). 19% of pts (21/109) were long-term responders (on pazopanib for ≥18mo). The best ORR per RECIST 1.1 was CR/PR in 24%, SD in 44% and PD in 31%. The major reason for switching to other treatment was disease progression with 86%. 73% pts reported ≥1 treatment related adverse event (TRAE). Most frequent (>10%) TRAEs include, diarrhea (30%), palmar-plantar erythrodysaesthesia syndrome (15%) and hypertension (14%).
The final analysis results of the PARACHUTE study support the use of pazopanib in pts with advanced or mRCC who are naïve to VEGF-TKI therapy. The safety profile is consistent with the previously reported pivotal and real-world evidence studies.
Medical writing and editorial support was provided by Anuradha Bandaru, Novartis Healthcare Pvt Ltd (Hyderabad, India).
Novartis.
Has not received any funding.
R. Kanesvaran: Research grant/Funding (self): Eisai; Research grant/Funding (self): Ipsen; Research grant/Funding (self): BMS; Research grant/Funding (self): MSD; Research grant/Funding (self): Pfizer. P. Danchaivijitr: Speaker Bureau/Expert testimony: Novartis; Speaker Bureau/Expert testimony: Pfizer. T. Hashem: Advisory/Consultancy, Speaker Bureau/Expert testimony: Hoffman-La Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Advisory/Consultancy, Speaker Bureau/Expert testimony: Janssen Cilag; Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Serono; Advisory/Consultancy, Speaker Bureau/Expert testimony: Mundi Pharma. B. Karabulut: Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Merck Sereno; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Bayer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Pfizer; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Novartis; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: MSD; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: BMS; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: J&J; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Astellas; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Amgen; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Sanofi; Honoraria (self), Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche. C. Chikatapu: Full/Part-time employment: Novartis. S. Ingles: Full/Part-time employment: Stamford Consultants AG; Full/Part-time employment: Novartis Pharma AG; Shareholder/Stockholder/Stock options: Novartis Pharma AG. K. Silmane: Shareholder/Stockholder/Stock options, Full/Part-time employment: Novartis Pharma S.A.S. M. Erman: Honoraria (self), Advisory/Consultancy: Novartis; Honoraria (self), Advisory/Consultancy: Roche; Honoraria (self), Advisory/Consultancy: Astellas; Honoraria (self), Advisory/Consultancy: MSD; Honoraria (self), Advisory/Consultancy: Pfizer; Honoraria (self), Advisory/Consultancy: Janssen; Honoraria (self), Advisory/Consultancy: Gen Ilac; Honoraria (self), Advisory/Consultancy: Nobel Ilac; Honoraria (self), Advisory/Consultancy: BMS; Honoraria (self), Advisory/Consultancy: Takeda; Honoraria (self), Advisory/Consultancy: Beigene; Honoraria (self), Advisory/Consultancy: AstraZeneca; Honoraria (self), Advisory/Consultancy: Merck; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy: Lilly. All other authors have declared no conflicts of interest.