mucositis – Page 3 – Oral Cancer News

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 [...]

Oral Cancer Foundation News Team - A2011-07-03T09:08:28-07:00July, 2011|Oral Cancer News|

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 [...]

Oral Cancer Foundation News Team - A2011-06-14T10:16:17-07:00June, 2011|Oral Cancer News|

Palifermin Decreases Severe Oral Mucositis of Patients Undergoing Postoperative Radiochemotherapy for Head and Neck Cancer: A Randomized, Placebo-Controlled Trial

Source: Journal of Clinical Oncology Purpose: Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela. Methods: We conducted a multicenter, double-blind, randomized, placebo-controlled trial in 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received 60 or 66 Gy after complete (R0) or incomplete resection (R1), respectively, at 2 Gy/fraction and five fractions per week. Cisplatin 100 mg/m2 was administered on days 1 and 22 (and on day 43 with R1). Patients were randomly assigned to receive weekly palifermin 120 μg/kg or placebo from 3 days before and continuing throughout radiochemotherapy. Trained evaluators performed oral assessments twice weekly. The primary end point was the incidence of severe oral mucositis (WHO grades 3 to 4). Overall survival and time to locoregional progression were also assessed. Analysis was by intention to treat. Results: Severe oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). Palifermin decreased the duration (median, 4.5 v 22.0 days) and prolonged the time to develop (median, 45 v 32 days) severe mucositis. Neither patient-reported mouth and throat soreness scores nor treatment breaks differed between treatment arms. After median follow-up of 32.8 months, 23 deaths (25%) had occurred in both treatment arms, and disease had recurred in 25 (27%) and 22 (24%) of palifermin- and placebo-treated patients, respectively. Conclusion: Palifermin reduced the occurrence of severe oral mucositis in [...]

Oral Cancer Foundation News Team - A2011-06-14T09:57:52-07:00June, 2011|Oral Cancer News|

Age is not a limiting factor for brachytherapy for carcinoma of the node negative oral tongue in patients aged eighty or older

Source: 7thspace.com Author: Hideya Yamazaki et al Purpose: To examine the role of brachytherapy for aged patients 80 or more in the trend of rapidly increasing number. Methods: We examined the outcomes for elderly patients with node negative oral tongue cancer (T1-3N0M0) treated with brachytherapy. The 21 patients (2 T1, 14 T2, and 5 T3 cases) ranged in age from 80 to 89 years (median 81), and their cancer was pathologically confirmed. All patients underwent definitive radiation therapy, with low dose rate (LDR) Ra-226 brachytherapy (n=4; median 70Gy), with Ir-192 (n=12; 70Gy), with Au-198 (n=1) or with high dose rate (HDR) Ir-192 brachytherapy (n=4; 60 Gy). Eight patients also underwent external radiotherapy (median 30 Gy). The period of observation ranged from 13 months to 14 years (median 2.5 years). We selected 226 population matched younger counterpart from our medical chart. Results: Definitive radiation therapy was completed for all 21 patients (100%), and acute grade 2-3 mucositis related to the therapy was tolerable for patients with good performance status. Local control (initial complete response) was attained in 19 of 21 patients (90%). The 2-year and 5-year local control rates were both 91%, (100% for T1, 83% for T2 and 80% for T3 tumors after 2 years). The cause-specific survival rate was 83% and the regional control rate 84% at the 2-years follow-up. However, 12 patients died because of intercurrent diseases or senility, resulting in overall survival rates of 55% at 2 years and 34% at 5 years. Conclusion: Age is not [...]

Oral Cancer Foundation News Team - A2010-12-10T09:00:06-07:00December, 2010|Oral Cancer News|

Avaxia Biologics awarded phase I SBIR grant to develop antibody therapeutic for oral mucositis

Source: www.reuters.com Author: press release Avaxia Biologics, Inc., a biotechnology company developing oral antibodies for disease targets accessible via the GI tract, announced today that it has been awarded a Phase I SBIR grant from the National Institute of Dental and Craniofacial Research to support the development of a novel antibody therapeutic for oral mucositis. Avaxia is developing a polyclonal anti-TNF antibody to be administered to the oral cavity of patients suffering from mucositis. The antibody is designed to reduce the pain and ulceration associated with this serious side effect of cancer treatment. The grant will fund key pre-clinical studies of the antibody in a well-established animal model of radiation-induced oral mucositis. "We are delighted to have been awarded this grant from the NIH," said Barbara S. Fox, Avaxia's founder and CEO. "Our preliminary data indicate that an anti-TNF antibody, delivered topically to a damaged mucosal membrane, will limit the severity of the inflammatory response induced by ionizing radiation. The support of the NIH provides both the funding we need to advance the development of this much needed therapeutic, and critical scientific validation of our approach." Avaxia is carrying out the grant-funded research in collaboration with Biomodels LLC, a Watertown-based pre-clinical drug research organization. Biomodels specializes in animal models of toxicities associated with chemotherapy and radiation therapy used for the treatment of cancer and is a world leader in the study of cancer treatment-related mucosal injury (mucositis). "We are looking forward to working closely with Avaxia Biologics scientists in developing [...]

Oral Cancer Foundation News Team - A2009-10-08T21:22:07-07:00October, 2009|Oral Cancer News|

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 [...]

Oral Cancer Foundation News Team - A2009-07-08T05:12:37-07:00July, 2009|Oral Cancer News|

Mucositis versus tumor control: the therapeutic index of adding chemotherapy to irradiation of head and neck cancer

Source: Int J Radiat Oncol Biol Phys, March 20, 2009 Authors: Irwin H Lee and Avraham Eisbruch Purpose: To determine whether the addition of concurrent chemotherapy to radiation for head and neck cancer (HNSCC) improves the therapeutic ratio regarding tumor control vs. mucositis. Methods and Materials: Data were taken from 14 randomized trials of radiation with or without concurrent chemotherapy for HNSCC. Mucositis-bioequivalent dose (mBED) was computed for each study using mBED = D [1 + d/(alpha/beta)] - 0.693(T - Tk)/Tp. An "S-value," relating the increase in the rate of Grade 3 (confluent) mucositis to the increase in mBED with radiation alone, was determined using data from trials of radiation alone with altered fractionation. We then determined the difference in the rate of mucositis and used the S-value to estimate the apparent difference in mBED in the chemoradiation and radiation alone arms for each trial. After accounting for differences in the radiation schedules, we estimated the mBED attributable to adding chemotherapy and compared it with previously published estimates of increases in tumor BED. Results: Computed S-values ranged from 0.4 to 1.7. For S = 1, the mean increase in mBED attributable to chemotherapy was 8.3 Gy(10) (SD = 6.4). The average difference between tumor-BED and mBED was 2.8 Gy(10) (SD = 6.0). Increasing the S-value decreases the estimated increase in mBED due to chemotherapy. Conclusions: Concurrent chemotherapy improves the therapeutic index for radiation of HNSCC. Further refinements are needed in quantifying the therapeutic gain attributable to specific radiosensitizing agents in [...]

Oral Cancer Foundation News Team - A2009-04-02T13:38:55-07:00April, 2009|Oral Cancer News|

ASCO updates guideline on chemotherapy and radiation protectants

Source: www.medscape.com Author: Nick Mulcahy In its first issuance since 2002, the American Society of Clinical Oncology (ASCO) has released an updated guideline on the use of protectants for chemotherapy and radiation therapy. The update provides new guidance on the use of palifermin, the only new protectant approved by the US Food and Drug Administration since 2002, as well as new or deleted recommendations for amifostine and dexrazoxane. The updated guideline, published online November 17 in the Journal of Clinical Oncology, also addresses the concern that protectant agents could compromise tumor response and survival. Palifermin, a recombinant keratinocyte growth factor, was approved for prophylaxis against severe mucositis associated with hematopoietic stem-cell transplantation in hematologic malignancies. It represents "an advance for the field," write the guideline authors, cochaired by Martee L Hensley, MD, from Memorial Sloan-Kettering Cancer Center, in New York City, and Lynn M. Schuchter, MD, from the University of Pennsylvania, in Philadelphia. Because of the growing body of evidence on amifostine use in the prevention of esophagitis, the ASCO panel of experts decided to add a new section on this topic in the chemoradiotherapy setting for non–small-cell lung cancer. Updates on amifostine also include guidance on its use for both chemotherapy and radiation-therapy toxicities. With regard to dexrazoxane, the panel made only 1 change from the previous guidelines: guidance on its use in patients receiving high-dose anthracycline therapy has been deleted because of insufficient data. However, the panel highlighted its previous and ongoing recommendation that this agent not be [...]

Oral Cancer Foundation News Team - A2008-11-25T22:27:09-07:00November, 2008|Oral Cancer News|

Favourable impact of intensity-modulated radiation therapy on chronic dysphagia in patients with head and neck cancer

Source: British Journal of Radiology (2008) 81, 865-871 Authors: A. K. Anand, MD et al. The aim of this study was to evaluate the impact of intensity-modulated radiation therapy (IMRT) on the incidence and severity of chronic dysphagia in patients with head and neck cancer. 62 evaluable patients with head and neck cancer who were treated with IMRT with or without concurrent chemotherapy were analysed. The majority of the patients (77.4%) had advanced locoregional disease. 45 patients underwent definitive IMRT and 17 received post-operative IMRT. Concurrent chemotherapy was given to 29 of the 45 patients treated with definitive IMRT. The average prescribed dose to clinical target volume (CTV)1 was 66–70 Gy (definitive IMRT) and 56–62 Gy (post-operative IMRT); 60 Gy to CTV2; 54 Gy to CTV3; and 50–52 Gy to the supraclavicular area. At a median follow-up of 19 months, 2-year actuarial locoregional control and survival was 77% and 74%, respectively. At 6 months after IMRT, chronic dysphagia was Grade 0 in 77.1% of patients, Grade 1 in 10.5% and Grade 2 in 12.3%. Acute mucositis showed no correlation with long-term dysphagia. The percutaneous endoscopic gastrostomy or nasogastric tube was removed in all of the patients within 8 weeks of completion of treatment. Xerostomia was Grade 0 in 61.4% of patients, Grade 1 in 31.5% and Grade 2 in 7% of patients. In conclusion, IMRT conferred a major favourable impact on chronic dysphagia in patients with locally advanced head and neck cancers, with satisfactory locoregional control. Authors: A. K. Anand, [...]

Oral Cancer Foundation News Team - A2008-10-24T06:49:50-07:00October, 2008|Oral Cancer News|

Radiation treatment breaks and ulcerative mucositis in head and neck cancer

Source: The Oncologist, Vol. 13, No. 8, 886-898, August 2008 Authors: Gregory Russo et al. Unplanned radiation treatment breaks and prolongation of the radiation treatment time are associated with lower survival and locoregional control rates when radiotherapy or concurrent chemoradiotherapy is used in the curative treatment of head and neck cancer. Treatment of head and neck cancer is intense, involving high-dose, continuous radiotherapy, and often adding chemotherapy to radiotherapy. As the intensity of treatment regimens has escalated in recent years, clinical outcomes generally have improved. However, more intensive therapy also increases the incidence of treatment-related toxicities, particularly those impacting the mucosal lining of the oral cavity, pharynx, and cervical esophagus, and results in varying degrees of ulcerative mucositis. Ulcerative mucositis is a root cause of unscheduled radiation treatment breaks, which prolongs the total radiation treatment time. Alterations in radiotherapy and chemotherapy, including the use of continuous (i.e., 7 days/week) radiotherapy to ensure constant negative proliferative pressure, may improve efficacy outcomes. However, these approaches also increase the incidence of ulcerative mucositis, thereby increasing the incidence of unplanned radiation treatment breaks. Conversely, the reduction of ulcerative mucositis to minimize unplanned breaks in radiotherapy may enhance not only tolerability, but also efficacy outcomes. Several strategies to prevent ulcerative mucositis in radiotherapy for head and neck cancer have been evaluated, but none have demonstrated strong efficacy. Continued investigation is needed to identify superior radiation treatment regimens, technology, and supportive care that reduce unplanned radiation treatment breaks with the goal of improving clinical outcomes in [...]

Oral Cancer Foundation News Team - A2008-09-01T09:36:49-07:00September, 2008|Oral Cancer News|