Source: Kardiologiia  |  Posted 7 years ago

By Paula Moyer

PARIS, FRANCE -- February 16, 2004 -- Sodium phenylbutyrate, an investigative agent, produces responses and prolongs survival in patients with malignant mesothelioma, say researchers.

"[Sodium phenylbutyrate] may be of value in the management of this cancer, either as a single palliative agent or in combination with cytotoxic chemotherapy," according to principal investigator Stanislaw R. Burzynski, MD, PhD. These findings were presented here February 11th at the 15th International Congress of Anti-Cancer Therapy. Dr. Burzynski, the director of the Burzynski Clinic in Houston, Texas, United States, noted that he and his co-investigators are continuing to study this investigative agent in combination with antineoplastons (ANP), a class of cancer therapies for which sodium phenylbutyrate is a prodrug.

He said that they were motivated to study the treatment drug and conduct a small initial trial because of the aggressive nature of mesothelioma and because of the inoperable nature of the disease.

Eleven patients with stage IV mesothelioma were studied: 8 men and 3 women, with a median age of 66 years, with a range from 37 to 72 years. Two patients had metastases to lymph nodes and 9 had metastatic sites in distant organs. One patient had had prior surgery; 1 had had a combination of surgery, chemotherapy, and radiation; and 1 had had chemotherapy only. The others had had no previous treatment.

The patients received an average of 180 mg/kg daily of the investigative therapy, with the dose divided and taken approximately 6 times daily. The duration of treatment ranged from 25 days to 622 days.

The investigators observed a complete response to treatment in 1 patient, a 61-year-old woman with multiple metastases to organs and lymph nodes who had had several previous treatments. Another 4 patients had stable disease. Two had disease progression, and 4 discontinued treatment against medical advice before they were evaluated. One patient died during treatment. No myelosuppressive events were reported.

The investigators reported no Grade 3-4 toxicities. Grade 2 toxicities included fatigue, indigestion, tongue soreness, and vertigo. The median survival for those who continued in the trial was 13.2 months, compared to 6 months for those who discontinued. Previous research had shown that patients receiving a combination of pemetrexed (Alimta) and cisplatin (Platinol) had a survival of 12.1 months.

These results show a promising efficacy and safety profile for sodium phenylbutyrate and suggest it may have a role either as a monotherapy or in combination with ANP agents or with conventional chemotherapeutic agents, noted Dr. Burzynski.

[Study title: "Treatment of Malignant Mesotheloma (MM) With Sodium Phenylbutyrate." Abstract P10]