Phase II trial of arsenic trioxide in patients with metastatic renal cell carcinoma
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Published on: August 11, 2017
Jacqueline Vuky1, Richard Yu, Lawrence Schwartz
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.
Abstract:
Fourteen patients with metastatic renal cell carcinoma (RCC) were treated on a Phase II trial with arsenic trioxide (As2O3). Eligible patients had metastatic renal cell carcinoma with bidimensionally measurable disease, a Karnofsky performance status of at least 70%, life expectancy of greater than three months, and no evidence of brain metastases. Arsenic trioxide was given intravenously at a dose of 0.3 mg/kg/day for five consecutive days every four weeks. The most common toxicity observed was grade II elevation in liver function tests (36%), anemia (21%), renal insufficiency (14%), rash (7%), and diarrhea (7%). Best response was stable disease in 3 patients with one patient remaining on study at 8+ months At the dose and schedule used in this trial, arsenic trioxide did not achieve a complete or partial response in metastatic renal cell carcinoma.
Insights
Arsenic trioxide (As2O3) showed limited efficacy in treating metastatic renal cell carcinoma (RCC). While some patients experienced stable disease, no complete or partial responses were observed in this Phase II trial.
Area of Science:
- Oncology
- Pharmacology
Background:
- Metastatic renal cell carcinoma (RCC) presents a significant clinical challenge.
- Novel therapeutic agents are continuously investigated for advanced RCC.
- Arsenic trioxide (As2O3) has shown activity in other cancers.
Purpose of the Study:
- To evaluate the efficacy and safety of arsenic trioxide (As2O3) in patients with metastatic renal cell carcinoma (RCC).
Main Methods:
- A Phase II clinical trial was conducted involving 14 patients with metastatic RCC.
- Patients received intravenous arsenic trioxide at 0.3 mg/kg/day for five consecutive days every four weeks.
- Eligibility criteria included measurable disease and adequate performance status.
Main Results:
- The most frequent toxicities included elevated liver function tests (36%), anemia (21%), and renal insufficiency (14%).
- Three patients achieved stable disease, with one remaining on study for over 8 months.
- No complete or partial responses were observed.
Conclusions:
- Arsenic trioxide (As2O3), at the tested dose and schedule, did not demonstrate significant anti-tumor activity in metastatic renal cell carcinoma (RCC).
- Further investigation into different dosing or combinations may be warranted, but current results suggest limited utility as a monotherapy.
