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

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.

Demographic Characteristics and Treatment Outcomes of Advanced Renal Cell Carcinoma With Clear Cell Histology: A Single-Center Experience From India

“…Due to financial constraints and a limited access program, it was a major challenge to offer TKI plus ICI or double ICI in combination to our patients. Despite this limitation, the clinical benefit rate (81%) in our study was quite impressive and even higher than published data from Asia Pacific countries [ 10 , 16 - 18 ].…”

Lenvatinib plus pembrolizumab in Japanese patients with endometrial cancer: Results from Study 309/KEYNOTE‐775

“…Hypothyroidism and proteinuria were also among the most common treatment‐related AEs observed in a phase 1 study of lenvatinib plus pembrolizumab in Japanese patients with advanced solid tumors, although no data on outcomes in patients with endometrial cancer were available 10 . Increased incidences of these AEs have been previously reported in Asian patients receiving VEGF or VEGF receptor inhibitors 11–15 . A number of hypotheses have been proposed to explain the higher incidence of such events among Asian patients receiving VEGF receptor inhibitors, including lower body weight/body surface area and/or genetic differences; evidence supporting these hypotheses has been equivocal 12,16 .…”

“…10 Increased incidences of these AEs have been previously reported in Asian patients receiving VEGF or VEGF receptor inhibitors. [11][12][13][14][15] A number of hypotheses have been proposed to explain the higher incidence of such events among Asian patients receiving VEGF receptor inhibitors, including lower body weight/body surface area and/ or genetic differences; evidence supporting these hypotheses has been equivocal. 12,16 Although the incidence of these events was in-…”

Correction to: 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

“…Following publication of the original article [ 1 ], the authors identified an error in the author names of Mustafa Erman, Bivas Biswas, Pongwut Danchaivijitr, Lingwu Chen and Chandrasekhar Chikatapu. The given names and family names were erroneously transposed.…”