High Levels Of Compliance And Patient/Physician Satisfaction Reported As CAPHOSOL(R) Unveils Positive Final Data

Main Category: Cancer / Oncology
Also Included In: Radiology / Nuclear Medicine;  GastroIntestinal / Gastroenterology;  Clinical Trials / Drug Trials
Article Date: 26 Sep 2008 - 6:00 PDT

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New data show that CAPHOSOL® (http://www.caphosol.com/), an advanced electrolyte solution, significantly limits the occurrence and severity of oral mucositis (OM) in cancer patients undergoing chemotherapy and radiation therapy. The data, which contain the final results from a prospective observational study sponsored by EUSA Pharma, were presented at the 50th annual meeting of the American Society of Therapeutic Radiology and Oncology (ASTRO), and demonstrate that CAPHOSOL use is associated with high levels of medication compliance and patient and physician satisfaction.

The latest findings expand upon the growing body of evidence of the benefits of CAPHOSOL in the management of OM and related symptoms in patients with various types of cancer.

"Oral mucositis is a common, debilitating side effect of chemotherapy and radiation therapy, resulting from erosion of epithelial cells in the oral cavity (cells lining the surface of the throat and esophagus) during therapy," said principal investigator Marilyn L. Haas, PhD, RN, CNS, ANP-C, Nurse Practitioner, Carolina Clinical Consultant. "Patients with oral mucositis often experience severe pain, difficulty eating and swallowing, and greater susceptibility to infection. The registry data suggests that CAPHOSOL, a supersaturated electrolyte oral rinse, has a significant positive impact on the occurrence and severity of oral mucositis, and is highly regarded by patients and physicians."

Dr. Haas and colleagues reported data from 68 patients with head and neck (HN) cancer enrolled in an open-label, observational registry maintained at 26 treatment centers in the U.S. The patients were considered at high risyk of developing OM based on the nature of the cancer treatments they received. Most of the patients were Caucasian (85 percent) and male (74 percent). Twenty-two percent of the patients were receiving radiation therapy, 12 percent were receiving chemotherapy, and 66 percent were receiving the two types of therap in combination. All patients in the study received CAPHOSOL, administered as an oral rinse, four to 10 times daily for 8 weeks for radiation therapy or 2 cycles if receiving chemotherapy, beginning on the first day of either treatment.

CAPHOSOL treatment was associated with low rates of OM. Thirteen percent of the patients did not develop OM, 36 percent had Grade 1 (mild) OM and 33 percent had Grade 2 (moderate) disease. Only 16 percent and two percent of the patients experienced Grades 3 (severe) and 4 (life-threatening or disabling) OM, respectively.

CAPHOSOL use also appeared to benefit patients in terms of incidence of oral pain and dysphagia (difficulty swallowing). Grades 2 (moderate) and 3 (severe) pain were experienced by 38 percent and 18 percent of patients, respectively, with no Grade 4 (disabling) pain reported. Nearly half (46 percent) of the patients did not require opioid pain medication at Week 3 of the study, and more than one-third (36 percent) did not require opioids at Week 8. No dysphagia was reported in 18 percent of the study participants; those who experienced dysphagia had Grade 1 (mild, 21 percent), Grade 2 (moderate, 36 percent) or Grade 3 (severe, 25 percent), with no Grade 4 (disabling) dysphagia reported.

Compliance with CAPHOSOL was very high. Nearly all (96 percent) patients rinsed with CAPHOSOL at least once daily, and 76 percent rinsed four or more times daily. Notably, only four patients (7 percent) experienced an interruption in treatment due to OM, with none of these interruptions lasting longer than seven days. Only two patients discontinued CAPHOSOL treatment, one due to an aversion to the taste and the other due to an increase in the level of pre-existing nausea.

High levels of patient satisfaction were reported among CAPHOSOL users: 79 percent described themselves as "satisfied" or "very satisfied" with this treatment. Similarly, 78 percent of physicians characterized the results with CAPHOSOL as satisfactory or better.

"Most patients treated for head and neck cancer develop oral mucositis, a complication that can cause severe pain and diminished quality of life," said Dr. Haas. "The results of the present study, in which rates of oral mucositis, oral pain and dysphagia were generally of mild to moderate severity, are therefore very encouraging, as are the high ratings of compliance and patient and physician satisfaction with CAPHOSOL treatment."

The estimated incidence of OM among patients with cancers of the head or neck receiving radiation therapy involving the oral cavity is 97%. Severe (grade ¾) OM is a frequent complication.

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 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.

From the initiation of cancer 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.

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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.

As part of its commitment to advancing the treatment and care of cancer patients, EUSA provides CARE OM™ (http://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 http://www.caphosol.com/.

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/.

Source: Anna Brodetsky
Eusa

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