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According to a recent article published in the International Journal of Radiation Oncology, Biology and Physics, the agent Ethyol® (amifostine) protects against xerostomia (abnormally dry mouth) while not affecting long-term outcomes in patients with head and neck cancer who undergo radiation therapy. Over the past 50 years, many drugs called radiation protectors have been tested in the laboratory for prevention of radiation damage to normal cells and tissues. In order for such drugs to effectively treat cancer, they must protect only normal cells—not the cancer cells—from radiation.

Ethyol is a radiation protector and the only drug that has been approved by the U.S. Food and Drug Administration (FDA) for use in patients receiving radiation therapy for cancers of the head and neck. There has been worry, however, that the use of Ethyol may result in worse outcomes for patients.

The researchers concluded that Ethyol significantly improves xerostomia in patients with head and neck cancer who are treated with radiation therapy. Furthermore, Ethyol does not compromise outcomes in these patients, as overall survival, progression-free survival, and local control was similar to patients who did not receive Ethyol in this trial. Patients diagnosed with head and neck cancer may wish to speak with their physician regarding their individual risks and benefits of receiving treatment with Ethyol.

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NEW YORK FEB 28, 2006 (Reuters Health) - The use of subcutaneous amifostine to reduce the toxic effects of radiation therapy and chemotherapy is feasible in patients with head and neck cancer, Swiss physicians report. However, nausea and vomiting and hypotension are relatively common adverse events associated with the drug.

Dr. Ozsahin's group concludes that subcutaneous amifostine administration is feasible for patients undergoing treatment for head and neck cancer.

In a related editorial, Dr. David I. Rosenthal, from the University of Texas M. D. Anderson Cancer Center in Houston, notes that well-designed, prospective phase III clinical trials will be needed to see if amifostine benefits patients undergoing radiation for head and neck cancer.

He adds: "if Ozsahin and colleagues had used adequate premedication, hydration prior to amifostine administration, and therapy for breakthrough symptoms, then the impact of adverse events on the rate of study completion might have been mitigated."

SOURCE:
Arch Otolaryngol Head Neck Surg 2006;132:129-130,141-145.

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Standard treatment for head and neck cancer is largely determined by the stage (extent to which the cancer has spread) and by the specific locations within the head or neck area where the cancer has spread.

For head and neck cancer patients treated with radiation therapy, xerostomia is a potential side effect of treatment. Xerostomia refers to a condition of an abnormally dry mouth. Patients with severe xerostomia have very limited or virtually no saliva production. This results in difficulty eating, speaking, and swallowing. These symptoms make xerostomia is extremely uncomfortable, and patients who suffer from the condition have a drastically reduced quality of life. Xerostomia can last long after treatment is completed.

Over the past 50 years, drugs called radiation protectors have been tested in the laboratory for prevention of radiation damage to normal cells and tissues. In order for such drugs to effectively treat cancer, they must protect only normal cells—not the cancer cells—from radiation. Ethyol is a radiation protector.

In order to explore the effects of Ethyol administered on two different schedules—either three days per week or five days per week during radiation therapy—researchers conducted a phase II clinical trial among 91 with patients with Stage III-IVB head and neck cancer. One third of the patients did not receive Ethyol, one third of the patients received Ethyol three times per week, and one third of the patients received Ethyol five times per week.

• Six months after radiation therapy, grade 2 or worse dry mouth was observed in 74% of patients who did not receive Ethyol, 67% of patients who received Ethyol three times per week, and 52% of patients who received Ethyol five times per week.
  
• When considering patient-reported symptoms, patients treated with Ethyol (either three times per week or five times per week) reported less dry mouth than patients who were not treated with Ethyol.
  
• Nausea and vomiting were the most common adverse effects of Ethyol. Twenty-eight percent of patients chose to discontinue use of Ethyol before the end of radiation therapy.

These results suggest that treatment with Ethyol reduces dry mouth among patients undergoing radiation therapy for advanced head and neck cancer.

Reference: Jellema AP, Slotman BJ, Muller MJ et al. Radiotherapy Alone, versus Radiotherapy with Amifostine 3 Times Weekly, versus Radiotherapy with Amifostine 5 Times Weekly. Cancer. 2006;107:544-53.

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Guideline Question
For patients with squamous cell head and neck cancer, does amifostine safely and effectively ameliorate important side effects of radiotherapy with acceptable toxicity and no tumour protection? Xerostomia, mucositis, and the anti-tumour effects of amifostine were the main outcomes of interest.

Target Population
These recommendations apply to adult patients with any stage of squamous cell head and neck cancer who are receiving radical radiotherapy, encompassing at least 75% of the parotid glands, with or without concurrent chemotherapy.

Recommendations
• On the basis of the available data, amifostine is recommended as an effective treatment option for the reduction of acute and chronic xerostomia associated with radical conventionally fractionated radiotherapy, given to patients in the head and neck region encompassing at least 75% of the parotid glands, with or without standard dose carboplatin.
• The recommended dose and administration of amifostine is an intravenous infusion 15 to 30 minutes prior to radiation, with standard doses of 500mg or doses ranging from 200mg/m2 to 300 mg/m2. The Head and Neck Cancer Disease Site Group would be supportive of randomized trials designed to compare amifostine delivered subcutaneously versus intravenously.
• Data on the protective effect of amifostine from mucositis are inconclusive at this time.

Qualifying Statements
• For suitable patients with stage III/IV squamous cell carcinoma, a common practice in Ontario is a conventionally fractionated course of radiotherapy delivered concurrently with low-dose cisplatin or carboplatin. No trials of amifostine added to concurrent low-dose radiochemotherapy were identified in our literature search. While it is reasonable to extrapolate that the radioprotection of acute and chronic xerostomia with amifostine may extend to patients treated with low-dose concurrent chemoradiotherapy, there is the theoretical possibility that amifostine may compromise the anti-tumour effectiveness of low-dose daily cisplatin or carboplatin.
• The data on tumour control and survival outcomes support the conclusion that amifostine does not confer tumour protection; however, long-term data beyond 24 months are not yet available for this population of patients.
• Nausea, vomiting, hypotension, and allergic reactions were reported as the most common side effects of amifostine, but they were rarely severe (≥ grade