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Investigational Oral Solution Reduces Breast Cancer Chemotherapy-Related Mucositis: Presented at SABCS

By Ed Susman

SAN ANTONIO, TX -- December 13, 2004 -- An investigative liquid solution that transports saliva-dependent L-glutamine into glands in the mouth appears to reduce occurrence of oral mucositis associated with chemotherapy regimens frequently used in breast cancer therapy.

"To our knowledge this study represents the first phase 3 randomized clinical trial to meet a primary end point of reducing oral mucositis incidence in the largest population at risk -- patients with solid tumor undergoing nonmyeloablative, combination chemotherapy," said Douglas Peterson, DMD, PhD, head, department of oral diagnosis, School of Dental Medicine, and associate director, Cancer Center, University of Connecticut Health Center, Farmington, Connecticut.

Dr. Peterson presented the findings here during at his poster presentation on December 11th at the 27th San Antonio Breast Cancer Symposium.

In the trial, 326 patients were randomized to receive 5 mL of placebo suspension or 5 mL of AES-14 (Saforis) in a crossover trial design. After they were diagnosed with mucositis according to World Health Organization criteria, patients were randomized equally into 1 of 2 groups: anthracycline-based regimen plus either Saforis or placebo. After 1 cycle of treatment patients were crossed over to either placebo or Saforis and received another chemotherapy cycle. They were then assessed for mucositis.

About 49.7% of placebo patients developed grade 2 mucositis compared with 38.7% on Saforis, a difference that reached statistical significance at the P =.026 level, Dr. Peterson reported. Grade 3 mucositis occurred in 2 patients in the Saforis arm and 11 on placebo, a difference that was also significant at the P=.012 level.

In the second cycle, placebo patients had a mucositis rate of 18.4%, indicating a significant (P =.027) carryover, preventive impact of previous Saforis use, he said.

Patients rinsed their mouths for about 30 seconds then swallowed 5 mL of either placebo liquid or Saforis, 3 times per day. They were asked to refrain from eating for 30 minutes after taking the drug.

Saforis is a suspension of L-glutamine in a proprietary delivery vehicle that enhances transport of 100 times more L-glutamine into cells than conventional L-glutamine in as little as 10 seconds.

"As with most drugs for treatment of these conditions, Saforis is not a home run," Dr. Peterson said. "I would anticipate it will be used with other medications in these patients."

The study was supported by Aesgen, Inc., which was acquired by MGI Pharma Inc., Princeton, New Jersey, in September 2004.


[Presentation title: AES-14 (Saforis™) Treatment Reduces the Severity and Duration of Oral Mucositis in Three Common Breast Cancer Chemotherapy Regimens. Abstract 6029]

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