Publication: 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
Issued Date
2021-12-01
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14712407
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2-s2.0-85115014004
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Mahidol University
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SCOPUS
Bibliographic Citation
BMC Cancer. Vol.21, No.1 (2021)
Suggested Citation
Erman Mustafa, Biswas Bivas, Danchaivijitr Pongwut, Chen Lingwu, Yoke Fui Wong, Tarek Hashem, Chun Sen Lim, Bulent Karabulut, Hsiao Jen Chung, Chandra Chikatapu, Sara Ingles, Khemaies Slimane, Ravindran Kanesvaran 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. BMC Cancer. Vol.21, No.1 (2021). doi:10.1186/s12885-021-08738-z Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/75922
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Title
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
Other Contributor(s)
Siriraj Hospital
National Yang Ming Chiao Tung University
The First Affiliated Hospital, Sun Yat-sen University
National Cancer Centre, Singapore
Ege Üniversitesi
Hacettepe Üniversitesi
Novartis Pharma S.A.S.
Novartis International AG
Medical Oncology
Radiotherapy and Oncology
Medical Oncology
Novartis Healthcare Pvt. Ltd.
Hospital Sultan Ismail
National Yang Ming Chiao Tung University
The First Affiliated Hospital, Sun Yat-sen University
National Cancer Centre, Singapore
Ege Üniversitesi
Hacettepe Üniversitesi
Novartis Pharma S.A.S.
Novartis International AG
Medical Oncology
Radiotherapy and Oncology
Medical Oncology
Novartis Healthcare Pvt. Ltd.
Hospital Sultan Ismail
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.
