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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

Erman M 1 , Biswas B 2 , Danchaivijitr P 3 , Chen L 4 , Wong YF 5 , Hashem T 6 Show all authors , Lim CS 7 , Karabulut B 8 , Chung HJ 9 , Chikatapu C 10 , Ingles S 11 , Slimane K 12 , Kanesvaran R 13

Affiliations 

  • 1 Medical Oncology, Hacettepe University, Ankara, Turkey
  • 2 Medical Oncology, Tata Medical Center, Kolkata, West Bengal, India
  • 3 Medical Oncology, Siriraj Hospital, Mahidol University, Bangkok, Thailand
  • 4 Medical Oncology, The First Affiliated Hospital of Sun Yat-sen, Guangzhou, Guangdong Province, China
  • 5 Radiotherapy and Oncology, National Cancer Institute, Putrajaya, Malaysia
  • 6 Medical Oncology, Dr Tarek Hashem's Clinic, Cairo, Egypt
  • 7 Clinical Oncology, Sultan Ismail Hospital, Johor Bahru, Malaysia
  • 8 Medical Oncology, Ege University, Izmir, Turkey
  • 9 Department of Urology, Taipei Veterans General Hospital and Department of Urology, College of Medicine and Shu-Tien Urological Research Cente, National Yang Ming Chiao Tung University, Taipei, Taiwan
  • 10 Oncology, Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, India
  • 11 Oncology, Novartis Pharma AG, Basel, Switzerland
  • 12 Oncology, Novartis Pharma SAS, Rueil-Malmaison, France
  • 13 Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore. [email protected]
BMC Cancer, 2021 Sep 14;21(1):1021.
PMID: 34521387 DOI: 10.1186/s12885-021-08738-z

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  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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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