Pazopanib was effective and tolerated among patients with advanced renal cell carcinoma and a poor ECOG performance status, and may serve as a potential treatment option for patients who are unable to tolerate or receive immune checkpoint inhibitor drugs.
Patients diagnosed with advanced renal cell carcinoma (aRCC) exhibit poor Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≥2 and are not considered suitable for receiving immune checkpoint inhibitor treatment. According to this clinical trial, which investigated pazopanib’s safety and efficacy in aRCC patients with PS2, this drug is effective and tolerated in these patients and can be adapted as a suitable treatment for individuals who are not candidates for or who fail to tolerate immune checkpoint inhibitor drugs. These study findings are published in the journal Clinical Genitourinary Cancer.
Baseline Characteristics of the Study Participants
In total, 75 patients were registered for the study, and their baseline characteristics were recorded. The median age of patients was 68.6 years, and 72% were male. All patients were classified as poor-risk, according to the International Metastatic Renal-Cell Carcinoma Database Consortium (IMDC) prognostic model, and 50.6% had undergone previous nephrectomy. All patients had been diagnosed with metastatic disease.
Treatment Duration and Discontinuation of Pazopanib
The median duration of treatment with pazopanib was 5.6 months, with 406 dose modifications being reported by the patients. The underlying reasons for the discontinuation, reduction, or interruption of doses included toxicity, choice of patient or clinician, progression, or a combination of these, with the most frequent being progression alone.
Tolerance and Efficacy of Pazopanib in Advanced Renal Cell Carcinoma Patients
Based on the primary outcome analysis in the study, 46 aRCC patients could tolerate pazopanib treatment, whereas 37 aRCC patients were found to be progression-free and alive at 6 months following the treatment. The median progression-free survival and overall survival (OS) were recorded to be 9.0 and 19.4 months, respectively. The median OS was greater in intermediate-risk patients compared to poor-risk patients in the study.
Safety Profile of Pazopanib in Advanced Renal Cell Carcinoma Patients
A total of 250 adverse events were associated with administering pazopanib in aRCC patients. The most frequent events included fatigue and hypertension, which comprised 27 and 72 adverse occurrences, respectively. A total of 77 serious adverse events were recorded in 49 patients, and only 27 of these SAEs were found to be associated with the trial treatment. One SAE culminated in death, whereas 4 resolved with sequelae, and the remaining 22 resolved without sequelae. The most frequent SAE was vomiting.
These results indicate that the administration of pazopanib is both safe and effective in aRCC patients who exhibit ECOG PS2, and it can be considered a potential treatment option for patients who are unable to tolerate or receive immune checkpoint inhibitor drugs.
Zarkar, A., Pirrie, S., Stubbs, C., Hodgkins, A. M., Farrugia, D., Fife, K., MacDonald-Smith, C., Vasudev, N., & Porfiri, E. (2022). A Study of Pazopanib Safety and Efficacy in Patients With Advanced Clear Cell Renal Cell Carcinoma and ECOG Performance Status 2 (Pazo2): An Open label, Multicentre, Single Arm, Phase II Trial. Clinical Genitourinary Cancer, 20(5), 473-481. https://doi.org/10.1016/j.clgc.2022.06.012