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

Chun Sen Lim¹  Hsiao-Jen Chung²  Ravindran Kanesvaran³  Tarek Hashem⁴  Bulent Karabulut⁵  Mustafa Erman⁶  Pongwut Danchaivijitr⁷  Bivas Biswas⁸  Lingwu Chen⁹  Chandrasekhar Chikatapu^1,10  Sara Ingles^1,11  Khemaies Slimane^1,12  Yoke Fui Wong^1,13 

[1] Clinical Oncology, Sultan Ismail Hospital, Johor Bahru, Malaysia;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;Division of Medical Oncology, National Cancer Centre Singapore, Singapore, Singapore;Medical Oncology, Dr Tarek Hashem’s Clinic, Cairo, Egypt;Medical Oncology, Ege University, Izmir, Turkey;Medical Oncology, Hacettepe University, Ankara, Turkey;Medical Oncology, Siriraj Hospital, Mahidol University, Bangkok, Thailand;Medical Oncology, Tata Medical Center, Kolkata, West Bengal, India;Medical Oncology, The First Affiliated Hospital of Sun Yat-sen, Guangzhou, Guangdong Province, China;Oncology, Novartis Healthcare Pvt Ltd, Hyderabad, Telangana, India;Oncology, Novartis Pharma AG, Basel, Switzerland;Oncology, Novartis Pharma SAS, Rueil-Malmaison, France;Radiotherapy and Oncology, National Cancer Institute, Putrajaya, Malaysia;

关键词: Renal cell carcinoma;    Pazopanib;    Real-world study;    PARACHUTE;   

DOI  :  10.1186/s12885-021-08738-z

来源: Springer

【 摘 要 】

BackgroundClinical 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.MethodsPARACHUTE 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).ResultsOverall, 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%).ConclusionsResults 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.

【 授权许可】

CC BY