التفاصيل البيبلوغرافية
| العنوان: |
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. |
| المؤلفون: |
Mustafa, Erman1 (AUTHOR), Bivas, Biswas2 (AUTHOR), Pongwut, Danchaivijitr3 (AUTHOR), Lingwu, Chen4 (AUTHOR), Wong, Yoke Fui5 (AUTHOR), Hashem, Tarek6 (AUTHOR), Lim, Chun Sen7 (AUTHOR), Karabulut, Bulent8 (AUTHOR), Chung, Hsiao-Jen9 (AUTHOR), Chikatapu, Chandra10 (AUTHOR), Ingles, Sara11 (AUTHOR), Slimane, Khemaies12 (AUTHOR), Kanesvaran, Ravindran13 (AUTHOR) ravindran.kanesvaran@singhealth.com.sg |
| المصدر: |
BMC Cancer. 10/8/2021, Vol. 21 Issue 1, p1-10. 10p. |
| مصطلحات موضوعية: |
*RENAL cell carcinoma, *HAND-foot syndrome, *LONGITUDINAL method, *SCIENTIFIC observation, *PARACHUTING |
| مصطلحات جغرافية: |
NORTH Africa, MIDDLE East, PACIFIC Area |
| مستخلص: |
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. [ABSTRACT FROM AUTHOR] |
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