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Treatment of hormonally refractory cancer of the prostate with antineoplaston AS2-1
S R Burzynski1, E Kubove, B Burzynski
1Burzynski Research Institute, Inc., Stafford, TX 77477.
Abstract:
Successful treatment of advanced cancer of the prostate which no longer responds to hormonal manipulation continues to be a difficult task. The present study describes the results of treatment of the first fourteen patients in Phase II clinical trials with Antineoplaston AS2-1 (AS) and low-dose diethylstilbestrol (DES). The study involved thirteen patients diagnosed with stage IV and one patient with stage II adenocarcinoma of the prostate. The ages of the patients were between 54 and 88. The previous therapy included prostatectomy, orchiectomy, radiation therapy and treatment with DES, LHRH agonist (LH), flutamide (FL), aminoglutethimide and immunotherapy. After initial response to such treatments, the disease continued to progress. The majority of patients showed progression of the disease after treatment with LH and FL. The current treatment program consisted of administration of AS and DES. The treatment was given orally daily. The majority of patients received from 97 to 130 mg/kg/24 h of AS and from 0.01 to 0.02 mg/kg/24 h of DES. The treatment was administered from 64 to 425 days and was free from significant side effects due to AS. The dose of DES was lower than usual, and only some patients experienced mild side effects typical for DES. Only two patients showed progression of the disease. Complete remission was obtained in two patients and partial remission in three patients. Stabilization of the disease with objective improvement was determined in seven patients. The first patient enrolled in the program has been in complete remission for 17 months and off the treatment for 16 months.(ABSTRACT TRUNCATED AT 250 WORDS)
Insights
This study shows Antineoplaston AS2-1 (AS) and low-dose diethylstilbestrol (DES) effectively treat advanced prostate cancer. The combination therapy achieved remission or stabilization in most patients with minimal side effects.
Area of Science:
- Oncology
- Pharmacology
Background:
- Advanced prostate cancer resistant to hormonal therapy presents a significant clinical challenge.
- Previous treatments including hormonal manipulation, surgery, and radiation often fail to achieve durable responses.
Purpose of the Study:
- To evaluate the efficacy and safety of Antineoplaston AS2-1 (AS) combined with low-dose diethylstilbestrol (DES) in patients with advanced, hormone-refractory prostate cancer.
Main Methods:
- Phase II clinical trial involving 14 patients with stage II or IV adenocarcinoma of the prostate.
- Oral administration of AS (97-130 mg/kg/24 h) and low-dose DES (0.01-0.02 mg/kg/24 h) daily for 64-425 days.
Main Results:
- Complete remission in 2 patients, partial remission in 3, and disease stabilization with objective improvement in 7 out of 14 patients.
- Only 2 patients showed disease progression.
- The treatment regimen was well-tolerated, with AS showing no significant side effects and DES causing only mild, typical side effects.
Conclusions:
- The combination of Antineoplaston AS2-1 and low-dose diethylstilbestrol demonstrates promising efficacy in advanced prostate cancer refractory to standard hormonal treatments.
- This therapeutic approach offers a viable option with a favorable safety profile for patients with limited treatment alternatives.