Palifermin reduces severe mucositis in head and neck cancer

Source: http://www.medscape.com/ Author: Janis C. Kelly Palifermin (Kepivance), which is currently approved for preventing mucositis associated with total-body irradiation and stem-cell transplantation in hematologic malignancies, also prevents oral mucositis in patients with head and neck cancer undergoing radiation and chemotherapy, according to 2 randomized trials published online June 13 in the Journal of Clinical Oncology. Michael Henke, MD, who led both studies, told Medscape Medical News that "this shows for the first time that radiation-induced mucositis can be ameliorated — and this in a phase 2/3 design!" Dr. Henke is from the Department of Radiation Oncology at University Clinic in Freiburg, Germany. The multicenter studies included researchers from Austria, France, Germany, Hungary, Italy, Poland, Spain, the United Kingdom, and the United States. The first study was a double-blind randomized placebo-controlled trial of 186 patients with stage II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Treatment included radiation, 60 or 66 Gy, after complete or incomplete resection, delivered at 2 Gy per fraction and 5 fractions per week. Treatment also included cisplatin 100 mg/m2 on days 1 and 22 (and on day 43 with incomplete resection). Patients were randomized to weekly palifermin 120 μg/kg or placebo from 3 days before and throughout radiochemotherapy. The primary end point was the incidence of severe oral mucositis (World Health Organization [WHO] grades 3 to 4). Palifermin reduced oral mucositis incidence to 51% (41 of 92), compared with 67% (63 of 94) with placebo (P = .027), shortened median mucositis from [...]

Palifermin decreases severe oral mucositis after radiotherapy

Source: www.drbicuspid.com Author: Will Boggs, MD Palifermin (Kepivance) helps reduce the rate, severity, and duration of severe oral mucositis in head and neck cancer patients receiving chemoradiotherapy, two new studies show. "Combined data from both studies consistently indicated that palifermin has activities against radiochemotherapy-induced mucositis," said Dr. Quynh-Thu Le, who led one of the studies, in email to Reuters Health. "However, the lack of improvement in some of the secondary end points suggests that the doses and schedules tested were inadequate to overcome the severe mucositis brought on by concurrent radiochemotherapy." The recombinant keratinocyte growth factor palifermin is FDA-approved to treat severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. But Dr. Le said that unlike the mucositis related to chemotherapy for bone marrow transplant, mucositis from chemoradiotherapy is more severe and persistent and "may require more drug administered at a higher frequency." Dr. Le, from Stanford University, California, and colleagues tested palifermin, 180 mcg/kg IV once weekly, in 188 patients with locally advanced head and neck cancer receiving definitive chemoradiotherapy. The incidence of severe oral mucositis (grade 3 or 4) was significantly lower with palifermin versus placebo (54% versus 69%; p = 0.041). In addition, the median duration of severe oral mucositis was shorter in the palifermin group (5 versus 26 days), according to a report published online June 13 in the Journal of Clinical Oncology. But mouth and throat soreness (MTS) scores averaged only slightly lower in the palifermin arm, and [...]

Topical EGF may decrease severe mucositis in patients with head and neck cancer receiving radiotherapy

Source: professional.cancerconsultants.com Author: staff Researchers from Korea have reported that recombinant epidermal growth factor (EGF) delivered as a spray twice daily may decrease the severity of severe mucositis in patients undergoing radiotherapy with or without chemotherapy for head and neck cancer. The details of this study appeared in an early online publication on June 9, 2009 in Cancer.[1] Oral mucositis is a frequent clinical problem in patients receiving chemotherapy and/or radiation therapy. Mucositis can be a severe dose-limiting toxicity, especially in patients receiving high-dose chemotherapy. Keritonocyte growth factor (Kepivance®) has been approved for prevention of mucositis in patients undergoing autologous stem cell transplantation. Other methods of treating or preventing oral mucositis include oral antiseptics, cryotherapy, laser therapy, L-glutamine (Saforis® and velafermin). Previous studies of antiseptic, antibiotic, and antifungal mouth washes and lozenges have revealed no dramatic effects, but two recent randomized trials suggested a limited role for topical antibiotic and antifungal treatment of mucositis. This multicenter trial enrolled 113 patients who were receiving definitive chemoradiotherapy or adjuvant radiotherapy. Patients were randomly allocated to a placebo group or to a group receiving three doses of EGF. Responders were defined as patients who had an RTOG grade of 2 or lower at the fourth- and fifth-week examinations. By this criteria 64% of patients receiving a 50-microgram dose of EGF responded compared with 37% in the control group. These authors concluded: “The EGF spray may have potential benefit for oral mucositis in patients undergoing RT for head and neck cancer. Phase 3 studies [...]

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