• 6/2/2007
  • San Francisco, CA
  • press release
  • BusinessWire.com

Results from a new national survey reveal that the majority (97%) of oral mucositis (OM) sufferers believe there is little or no awareness among the general public of oral mucositis, one of the most common and debilitating complications of cancer treatment. The low level of public awareness may be explained by a perceived lack of effective treatments and information about OM – a problem cited by 85% of the survey respondents. The survey was supported by Cytogen Corporation, which recently licensed and introduced CAPHOSOL®, an advanced electrolyte solution indicated as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy, in the U.S.

The survey, which involved 427 past and present OM sufferers prior to Cytogen’s introduction of CAPHOSOL, also shed light on the difficulties faced by those living with OM, an inflammation of mucous membranes in the mouth that commonly affects patients undergoing cancer chemotherapy and radiation therapy. Only half (52%) of the survey participants reported having received a formal OM diagnosis, and 25% were unable to obtain any treatment that relieved their OM symptoms. The survey results also indicated that OM negatively affects quality of life in an overwhelming majority (90%) of respondents.

“Oral mucositis is one of the most common, debilitating and painful side effects of cancer therapy, and the compelling results of this survey underscore the significant unmet medical need among cancer patients, caregivers and physicians,” said Michael D. Becker, president and CEO of Cytogen. “Given the lack of overall awareness and the need for more effective therapies, it is extremely gratifying to make CAPHOSOL, and information about this condition, more widely available.”

Treatment Options, Awareness and Information Found Lacking

More than half (57%) of the survey respondents stated that historically there has not been adequate treatment options available in the marketplace. A majority (69%) of the patients said they did not receive preventive therapy before the onset of their OM symptoms. Those unmet medical needs may be due to a general perception that OM is not considered a serious condition – a sentiment voiced by 53% of the survey respondents.

“While disappointed, our organization is not surprised by these findings,” said Brian Hill, executive director, The Oral Cancer Foundation, a non-profit entity designed to reduce suffering and save lives through prevention, education, research, advocacy, and support activities. Oral cancer is the largest group of those cancers which fall into the head and neck cancer category. “As a stage four cancer survivor myself, I can testify to the huge implications of mucositis on quality of life issues. I am encouraged to see new products come to market that will help patients deal with this particularly difficult aspect of their treatment process.”

Despite the prevalence of OM as a complication of cancer therapy, 85% of OM sufferers disagreed with the statement that disease information is widely available, and 72% said they did not receive educational materials about the disease and available treatments. Furthermore, two-thirds (66%) of respondents expressed the opinion that physicians need to be educated about OM and its treatments.

“Clearly, the medical community needs to increase their understanding and awareness of oral mucositis,” said Kenneth Miller MD, Associate Professor, Medical Oncology at Harvard Medical School. “Patients need to know that effective treatments, such as CAPHOSOL, are now available for oral mucositis, and that useful resources are available to help them and their caregivers deal with this debilitating condition.”

Oral Mucositis: A Common and Debilitating Condition

Oral complications including mucositis and salivary gland dysfunction are common and often debilitating side effects of cancer therapy. OM is estimated to affect as many as 400,000 cancer patients each year. OM affects approximately 40% of cancer patients who receive chemotherapy, more than 70% of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.

A majority (61%) of survey respondents agreed that OM is one of the most common side effects of chemotherapy and/or radiation. Nearly 20% indicated that they experienced severe or unbearable pain from OM, and more than half (51%) said they took prescription medications to relieve their pain. The five most-frequently mentioned OM symptoms by survey participants were redness and swelling (54%), burning pain (47%), difficulty opening one’s mouth (46%), difficulty speaking (40%), and tooth and/or gum disease (35%).

In terms of quality of life, 8% of respondents indicated they had missed a dose of cancer medication due to OM; of those patients, 31% did not tell their physician about the missed dosage. Eighteen percent of survey participants had missed work because of OM, and nearly 50% of those respondents had missed two to four days of work.

About the Survey

Cytogen Corporation and the Caphosol Relieves Oral Mucositis (CARE OM) educational and support program commissioned an attitude, usage and awareness study of 427 past and present OM sufferers to gain a better understanding of these patients and their experiences with the disease. All survey participants were 18 years or older and were U.S. residents; none had any affiliations with the healthcare industry.

The online survey was conducted by MarketTools, a provider of on-demand market research through innovative approaches based on advanced technology, research expertise, global market reach and an online panel community of over 2.5 million individuals worldwide.

About CAPHOSOL

Cytogen recently established an expanded market presence for CAPHOSOL, an advanced electrolyte solution indicated in the U.S. as an adjunct to standard oral care in treating OM caused by radiation or high dose chemotherapy. CAPHOSOL, a U.S. patented prescription medical device, is also indicated for dryness of the mouth or throat (hyposalivation, xerostomia), regardless of the cause or whether the conditions are temporary or permanent. Patients restricted to a low sodium diet should consult their physician before use.

A prospective, randomized, double-blind, placebo-controlled trial demonstrated CAPHOSOL to be a significant adjunct in the management of mucositis associated with high-dose chemotherapy and radiation therapy. The trial evaluated 95 patients undergoing hematopoietic stem cell transplantation with the duration and severity of mucositis and requirements for opioid medications prospectively evaluated. Data demonstrated significant decreases in days of mucositis (3.72 vs. 7.20, P=0.001), duration of pain (2.86 vs. 7.67, P=0.0001), dose of morphine (30.46 mg vs. 127.96 mg), and days of morphine (1.26 vs. 4.02, P=0.0001) for patients receiving CAPHOSOL as compared to those administered a placebo. The study was conducted at Tufts University School of Medicine, Boston MA and results were published in the April 2003 issue of Bone Marrow Transplantation.

As part of its commitment to advancing the treatment and care of cancer patients, Cytogen recently launched CARE OM (www.careom.com) a web-based education and support center for patients and caregivers seeking to learn more about OM and CAPHOSOL. In addition to oral mucositis educational material and support information, visitors to CARE OM can also download an OM brochure or request a free brochure about OM by mail.