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Sodium Phenylbutyrate Shows Potential in Treatment of Malignant Mesothelioma: Presented at ICACT

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 11^th at the 15^th 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]

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