Ethyol

Impact on Antitumor Efficacy

ETHYOL® (amifostine) does not compromise the antitumor efficacy of radiotherapy

  • Overall survival was 81% in patients pretreated with ETHYOL compared with 73% in patients who received radiotherapy alone (not statistically significant)2
Brizel study overview: An open-label, phase 3, multi-institutional, randomized trial of 303 patients with newly diagnosed, previously untreated squamous cell head and neck cancer. ETHYOL 200 mg/m2 was administered 15 to 30 minutes before radiotherapy daily as a 3-minute IV infusion. The mean dose of irradiation delivered was 64 ± 8 Gy in the ETHYOL + radiation patients and 65 ± 5 Gy in the radiotherapy alone patients. The primary end points included the incidence of grade ≥2 acute and late xerostomia (1 year after the initiation of treatment).2

  • No significant differences in 2-year loco-regional control rates, progression-free survival rates, and overall survival rates were observed between treatment groups3
  • This proof-of-principle study demonstrates that pretreatment with ETHYOL protects against xerostomia without compromising the antitumor activity of radiotherapy2,3

Wasserman study overview: Two-year follow-up study to the open-label, phase 3 study conducted by Brizel et al (2000), that evaluated the effects of ETHYOL on chronic xerostomia and tumor control 18 and 24 months after initial radiotherapy. The objectives were to evaluate the magnitude of xerostomia improvement and the potential to compromise the antitumor efficacy of radiotherapy over a longer, more clinically relevant follow-up time. Analyses were performed at 18 and 24 months.3
References:
1. ETHYOL [prescribing information]. Nashville, TN; Cumberland Pharmaceuticals Inc.; May 2017. 2. Brizel DM, Wasserman TH, Henke M, et al. Phase III randomized trial of amifostine as a radioprotector in head and neck cancer. J Clin Oncol. 2000;18(19):3339-3345. 3. Wasserman TH, Brizel DM, Henke M, et al. Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and-neck cancer: 2-year follow-up of a prospective, randomized, phase III trial. Int J Radiat Oncol Biol Phys. 2005;63(4):985-990.

Indication: ETHYOL (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer.

ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.

IMPORTANT DOSAGE AND ADMINISTRATION INSTRUCTIONS
Patients should be adequately hydrated prior to ETHYOL infusion. Blood pressure should be monitored prior to, during and immediately after infusion. Antiemetic medication should be administered prior to and in conjunction with ETHYOL.

IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS

ETHYOL is contraindicated in patients with known hypersensitivity to aminothiol compounds.

WARNINGS AND PRECAUTIONS
ETHYOL should not be administered in patients receiving chemotherapy for other malignancies in which chemotherapy can produce a significant survival benefit or cure. ETHYOL should not be administered in patients receiving definitive radiotherapy, since there are at present insufficient data to exclude a tumor-protective effect in this setting.

Patients who are hypotensive or in a state of dehydration should not receive ETHYOL. Patients should have antihypertensive therapy interrupted 24 hours preceding administration of ETHYOL. Patients should not receive ETHYOL where therapy cannot be stopped for 24 hours preceding treatment.

The fluid balance of the patient should be carefully monitored when ETHYOL is administered with highly emetogenic chemotherapy.

Fatal and serious cutaneous reactions such as Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, toxicoderma, exfoliative dermatitis and drug reaction with biopsy-confirmed eosinophilia and systemic symptoms (DRESS) have been reported with ETHYOL treatment. These reactions is higher in patients receiving ETHYOL as a radioprotectant. Serious cutaneous reactions may develop weeks after initiation of ETHYOL administration. Discontinue Ethyol for cutaneous reactions or mucosal lesions appearing outside the injection site or radiation port and for erythematous, edematous or bullous lesions on the palms or soles. Monitor patients carefully prior to, during and after ETHYOL administration. In case of severe acute allergic reactions ETHYOL should be immediately and permanently discontinued. Epinephrine and other appropriate measures should be available for treatment of serious allergic events such as anaphylaxis.

ADVERSE REACTIONS
In a randomized study of patients with ovarian cancer given ETHYOL, the most common adverse events included transient hypotension, nausea, vomiting, and a decrease in serum calcium concentrations. Other adverse events reported in clinical studies involving patients with ovarian or head and neck cancers include hypersensitivity and anaphylactic reactions, flushing, chills, malaise, pyrexia, diplopia, blurred vision, rash, dizziness, somnolence, hiccups, diarrhea, and sneezing. Injection site reactions including pruritus and urticaria were also observed.

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