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Southwest Oncology Group phase II study of arsenic trioxide in patients with refractory germ cell malignancies
Tomasz M Beer1, Catherine M Tangen, Craig R Nichols
1Department of Medicine, Division of Hematology and Medical Oncology, Oregon Health and Science University, Portland, Oregon 97239, USA. beert@ohsu.edu
Background:
To the authors' knowledge, no satisfactory therapy is available for patients with refractory germ cell neoplasms. The activity and safety of arsenic trioxide in refractory germ cell tumors was assessed.
Methods:
Twenty patients were treated with arsenic trioxide at a dose of 0.25 mg/kg/day and administered intravenously over 1 to 2 hours on Days 1-5 and repeated every 28 days.
Results:
There were no complete or partial responses. The median progression-free survival was 1 month and the median overall survival was 2 months. Three patients died as a result of adverse events believed to be possibly related to treatment: ventricular arrhythmia, adult respiratory distress syndrome, and pneumonitis.
Conclusions:
In the current study, arsenic trioxide in the dose regimen and schedule employed was found to have no activity in men with refractory germ cell malignancies. Treatment was associated with severe toxicity. Dismal overall survival reflects the poor outcome in this patient group and highlights the acute need for new agents with activity in refractory germ cell neoplasms.
Insights
Arsenic trioxide showed no effectiveness for refractory germ cell tumors and was linked to severe toxicity, including fatal adverse events. This highlights the urgent need for novel therapeutic agents for this patient population.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Refractory germ cell neoplasms lack effective treatment options.
- Investigating arsenic trioxide as a potential therapy for these malignancies.
Purpose of the Study:
- To assess the activity and safety of arsenic trioxide in patients with refractory germ cell tumors.
Main Methods:
- Twenty patients received arsenic trioxide (0.25 mg/kg/day IV) on a 5-day schedule, repeated every 28 days.
- Evaluation of treatment response, progression-free survival, and overall survival.
Main Results:
- No complete or partial responses were observed.
- Median progression-free survival was 1 month; median overall survival was 2 months.
- Three treatment-related deaths occurred due to adverse events (ventricular arrhythmia, ARDS, pneumonitis).
Conclusions:
- Arsenic trioxide demonstrated no activity in refractory germ cell malignancies at the tested dose and schedule.
- Treatment was associated with significant toxicity and poor survival outcomes.
- There is a critical need for new, effective agents for refractory germ cell neoplasms.