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Weekly oral idarubicin in advanced prostatic cancer. A phase II study
E L Madsen1, L Bastholt, K Bertelsen
1Department of Oncology R, Odense University Hospital, Denmark.
Abstract:
Twenty-five patients with advanced prostatic cancer progressing after one course of endocrine treatment entered a phase II study of weekly administration of 30 mg Idarubicin orally. Twenty-two patients were evaluable for response and partial response (PR) was noted in 2 patients and stable disease (NC) in 10 patients. Median survival was 31 weeks and median time to progression was 14 weeks. Twenty-three patients were eligible in a score system combining analgetic consumption and pain reduction measured on a Visual Analogue Scale (VAS) and 30% achieved a subjective response. Fifteen patients fulfilled treatment with the planned dose and 10 patients had dose reduction to a median of 23.8 mg Idarubicin. Haematological toxicity was greater than or equal to grade 3 (WHO) in 20% of the patients. Non-haematological toxicity was dominated by nausea/vomiting with 48% grade 3 (WHO). In conclusion, Idarubicin seems of limited value in the treatment of patients refractory to first line endocrine treatment.
Insights
This study found that oral Idarubicin showed limited effectiveness in advanced prostate cancer patients who did not respond to initial endocrine therapy. Further research is needed for refractory prostate cancer treatment options.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced prostate cancer often progresses despite endocrine therapy.
- Identifying effective salvage treatments for refractory disease is crucial.
Purpose of the Study:
- To evaluate the efficacy and toxicity of oral Idarubicin in patients with advanced prostate cancer progressing after endocrine treatment.
Main Methods:
- A phase II study administered 30 mg of oral Idarubicin weekly.
- Patient response, survival, time to progression, and toxicity were assessed.
- Pain reduction using Visual Analogue Scale (VAS) and analgesic consumption were evaluated.
Main Results:
- Partial response (PR) was observed in 2 of 22 evaluable patients; stable disease (NC) in 10.
- Median survival was 31 weeks; median time to progression was 14 weeks.
- Grade 3 or higher hematological toxicity occurred in 20%, and severe nausea/vomiting in 48%.
Conclusions:
- Oral Idarubicin demonstrated limited clinical benefit in this patient population.
- Significant toxicity, particularly nausea/vomiting, was noted.
- Idarubicin is not recommended for patients refractory to first-line endocrine treatment for advanced prostate cancer.
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