PRINCETON, NJ, October 16, 2008 – As millions of Americans participate in educational initiatives as part of National Breast Cancer Awareness Month, they should keep in mind an important yet under-recognized consequence of breast cancer therapy: oral mucositis, one of the most common and debilitating side effects of cancer treatment.
Oral mucositis (OM) is a painful inflammation/ulceration of the mucous membranes in the mouth. It results from erosion of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) during cancer treatment. In addition to severe pain, patients with OM often have difficulty eating and swallowing, as well as greater susceptibility to infection. Needless to say, the effects of OM can have a profoundly negative effect on cancer patients' quality of life.
Never heard of oral mucositis? You might be surprised to learn that the condition is estimated to affect more than 400,000 cancer patients each year. OM affects approximately 40 percent of cancer patients who receive chemotherapy, more than 70 percent of those undergoing conditioning therapy for bone marrow transplantation, and virtually all patients receiving radiation therapy for head and neck cancer.
"Given the large numbers of women receiving chemotherapy for breast cancer, oral mucositis is something that every patient, caregiver and family member should be aware of," commented Anne Marie Shaftic, MSN, RN, Oncology Nurse Practitioner in Haskell, N.J. "Yet, although it is a common side effect of chemotherapy, a surprising percentage of the public seems largely unaware of oral mucositis, or that there are medications available to prevent and treat this painful and debilitating condition. Therefore, National Breast Cancer Awareness Month gives us an important opportunity to spread the word about oral mucositis and available treatment options."
Survey Underscores Lack of Awareness of OM
In a recent survey of 427 past and present OM sufferers, nearly all of the respondents – 97 percent – expressed the belief that there is little or no awareness of OM among the general public. 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 percent of the survey participants.
The survey highlighted the difficulties faced by those living with OM. Only half (52 percent) of the respondents reported having received a formal OM diagnosis, and 25 percent were unable to obtain any treatment that relieved their OM symptoms. An overwhelming majority (90 percent) agreed that OM adversely affects their quality of life. Yet more than half (53 percent) of the survey respondents felt that OM is not taken seriously as a condition.
The litany of OM symptoms, as reported by the survey participants, paints a picture of a condition that should be taken seriously. The five most frequently mentioned symptoms were redness and swelling (54 percent), burning pain (47 percent), difficulty opening one's mouth (46 percent), difficulty speaking (40 percent), and tooth and/or gum disease (35 percent).
CAPHOSOL®® Can Limit Occurrence and Severity of OM
Fortunately, women with breast cancer -- as well as other cancer patients – have at their disposal a medication that can treat OM. Recent data suggest that CAPHOSOL® (www.CAPHOSOL.com), an advanced electrolyte solution, has a significant positive impact on the occurrence and severity of OM in cancer patients undergoing chemotherapy and radiation therapy. The data, from an open-label, observational registry maintained at 26 treatment centers in the U.S., reflect findings from 218 patients, including 67 women with breast cancer who were receiving chemotherapy. All patients in the study received CAPHOSOL®, administered as an oral rinse, four to 10 times daily for two cycles if receiving chemotherapy or for eight weeks of radiation therapy, beginning on the first day of either treatment.
In the study, use of CAPHOSOL® resulted in low incidence and severity of OM. Among patients undergoing chemotherapy, OM was rated as mild (Grade 0 or 1) in more than 90 percent, and only one to two percent had severe OM (Grade 3 or 4). Overall, compliance with CAPHOSOL® treatment was very high; patients rinsed at least once on 96 percent of study days, and between two and six times per day on 90 percent of days. Patient satisfaction with CAPHOSOL® was also very high, with 76 percent saying they were "satisfied" or "very satisfied" with the treatment. Similarly, 77 percent of physicians rated CAPHOSOL® treatment as "satisfactory" or better. Additionally, more than half of the patients (54 percent) did not require pain medication for OM.
"The data are consistent with what we have seen in clinical practice, in that CAPHOSOL® can significantly limit the occurrence and severity of oral mucositis; especially in women undergoing chemotherapy for breast cancer, since these treatments can place a woman at high risk for developing mucositis," said James D'Olimpio, M.D. FACP, Assistant Professor of Medicine at New York University School of Medicine and Director of Supportive Oncology/ Pain and Symptom Management at the Monter Cancer Center of North Shore University Hospital in Manhasset, New York. "If you or a loved one has breast cancer, you should be educating yourself about oral mucositis, and asking your physician about medications such as CAPHOSOL® that can prevent or treat this common side effect of chemotherapy."
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. From the initiation of therapy, breakdowns begin to occur below the surface of the skin in the mouth (oral mucosa). Visible signs of oral mucositis can usually be seen within seven to 14 days after initiation of therapy. Initial signs and symptoms include redness, swelling and ulceration of the mucosa. Oral mucositis can cause mouth pain, xerostomia (dryness of the mouth or throat), difficulty eating and drinking, as well as difficulty with speech; these effects can significantly impact a patient's weight, mood and physical functioning. Severe ulceration may cause breaks in the mucosa, which can then become susceptible to oral opportunistic infections, possibly resulting in bacteremia (the presence of bacteria in the blood), sepsis (the presence of pathogenic microorganisms in the blood) or other potentially fatal complications. The economic impact of mucositis can be significant, as the need for prolonged hospital stays, nutritional therapy and treatments for pain and infection can drive up the costs of therapy.
About CAPHOSOL®
CAPHOSOL® is 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. Patients should avoid eating or drinking at least 15 minutes after use.
CAPHOSOL is marketed in the United States by EUSA Pharma Inc. As part of its commitment to advancing the treatment and care of cancer patients, EUSA provides 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 link to patient resource groups. For more information about CAPHOSOL®, visit www.CAPHOSOL.com or call (800) 833-3533.
About EUSA Pharma Inc.
EUSA Pharma is a rapidly growing transatlantic specialty pharmaceutical company focused on in-licensing, developing and marketing late-stage oncology, pain control and critical care products. The company currently has nine products on the global market, including CAPHOSOL® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy, ProstaScint® for imaging the extent and spread of prostate cancer, Quadramet® for the treatment of pain in patients whose cancer has spread to the bones, Erwinase® and Kidrolase® for the treatment of acute lymphoblastic leukemia, the antibiotic surgical implant Collatamp® G, and Rapydan®, a rapid-onset anesthetic patch which recently received Europe-wide approval. EUSA also has several products in late-stage development, notably Collatamp® G topical, a gentamicin impregnated collagen sponge for the prevention and treatment of infected skin ulcers, and CollaRx® bupivacaine implant* for local post-surgical pain control.
Founded in 2006, EUSA Pharma is supported by a consortium of leading life science capital investors, comprising TVM Capital, Essex Woodlands, 3i, Goldman Sachs, Advent Venture Partners, SV Life Sciences, NeoMed and NovaQuest. Since its foundation, the company has raised over $275 million, and completed several significant transactions, including the acquisitions of Cytogen Corporation, Talisker Pharma Ltd, the French biopharmaceutical company OPi SA and the European antibiotic and pain control business of Innocoll Pharmaceuticals Inc. As part of its rapid growth strategy the company has established commercial infrastructure in the US, a pan-European presence covering over 20 countries and a wider distribution network in a further 25 territories. EUSA Pharma plans to continue its aggressive program of acquisitions and in-licensing within its specialist areas of medical and geographic focus, in line with its ambitious target to create a rapidly growing $1 billion company by the beginning of the next decade.
For more information please visit http://www.eusapharma.com.