ETHYOL SUMMARY
ETHYOL® (amifostine) is an organic thiophosphate cytoprotective agent.
ETHYOL® (amifostine) is indicated to reduce the cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer or non-small cell lung 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 (Clinical Studies).
For the approved indications, the clinical data do not suggest that the effectiveness of cisplatin based chemotherapy regimens or radiation therapy is altered by ETHYOL® . There are at present only limited data on the effects of ETHYOL® on the efficacy of chemotherapy or radiotherapy in other settings. ETHYOL® should not be administered to patients in other settings where chemotherapy can produce a significant survival benefit or cure, or in patients receiving definitive radiotherapy, except in the context of a clinical study (see WARNINGS).
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NEWS HIGHLIGHTS
Published Studies Related to Ethyol (Amifostine)
Amifostine has the potential to induce haematologic responses and decelerate disease progression in individual patients with low- and intermediate-1-risk myelodysplastic syndromes. [2009.09]
Myelodysplastic syndromes (MDS) are characterized by hypercellular bone marrow, peripheral cytopenia and an increased rate of intramedullary apoptosis. Oxidative stress is known as an important factor that leads to apoptosis in MDS.
Randomized phase 2 study of subcutaneous amifostine versus epoetin-alpha given 3 times weekly during concurrent chemotherapy and hyperfractionated radiotherapy for limited-disease small cell lung cancer. [2008.10.01]
BACKGROUND: The purpose of the current study was to investigate the role of amifostine and epoetin-alpha in reducing severe toxicities during concurrent chemo-hyperfractionated radiotherapy (CCRT) for limited disease small cell lung cancer (LD-SCLC)... CONCLUSIONS: Although amifostine administered 3 times weekly during CCRT did not significantly reduce severe toxicities, epoetin-alpha was effective in preventing severe anemia during CCRT in patients with LD-SCLC. Other radioprotective strategies to minimize severe toxicities should be investigated.
Toxicity prevention with amifostine in pediatric osteosarcoma patients treated with cisplatin and doxorubicin. [2007.09]
Amifostine has emerged as a pancytoprotectant shown protection against nephrotoxicity, neurotoxicity and ototoxicity in preclinical studies... CONCLUSION: amifostine did not reduce the ototoxicity and nephrotoxicity of our treatment regime. It was not well tolerated due to emesis. It is a selective cytoprotectant without reducing the effect of chemotherapy.
Radiotherapy alone, versus radiotherapy with amifostine 3 times weekly, versus radiotherapy with amifostine 5 times weekly: A prospective randomized study in squamous cell head and neck cancer. [2006.08.01]
BACKGROUND: The main objective of this study was to investigate whether nondaily intravenous administration of amifostine was as effective as daily intravenous administration with regard to the reduction of the incidence of Grade 2 or greater xerostomia in patients with head and neck cancer... CONCLUSIONS: Long-term, patient-rated xerostomia was less for the AMI-3 and AMI-5 groups through 2-year follow-up, but no difference was noted between the AMI-3 and AMI-5 groups. For late xerostomia according to the Radiation Therapy Oncology Group criteria, the same effect was observed at 6 months, but not thereafter. Copyright 2006 American Cancer Society.
Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study. [2006.03.01]
CONCLUSIONS: The used amifostine doses were not able to reduce the toxicity of simultaneous radiochemotherapy for head-and-neck cancer. The safety of amifostine and the lack of tumor protection were consistent with previous studies.
Clinical Trials Related to Ethyol (Amifostine)
Toxicities Associated With Subcutaneous Administration of Ethyol (Amifostine) for the Prevention of Radiation-Induced Toxicities [Completed]
Dry mouth occurs very often in patients who receive radiation treatment. Amifostine is a
drug approved to reduce the short and long-term occurrence of dry mouth when patients receive
radiation treatment for head and neck cancer. Some studies have shown that Amifostine
reduces the side effects of radiation treatment for lung cancer. The use of Amifostine is
still being investigated in lung malignancies. Amifostine is found to be a protectant from
radiation side effects of such normal tissues as bone marrow, skin, oral mucosal, esophagus,
kidney and testes. Patients that receive radiation treatments for lung cancer may experience
side effects involving the esophagus. It is hoped that patients will benefit from the
protection of their esophagus and avoid delays in radiation treatment due to side effects of
the radiation.
Study Evaluating the Addition of Amifostine (Ethyol®) to Idarubicin and Cytosine Arabinoside in Older Patients With Acute Myeloid Leukemia [Active, not recruiting]
The primary objectives of this study are:
1. To evaluate whether the addition of amifostine will allow for the safe administration of
idarubicin at a dose of 21 mg/m² in combination with standard-dose ara-C in older
patients with newly diagnosed, previously untreated acute myeloid leukemia (AML); and
2. To estimate the complete remission rate of induction therapy with amifostine, idarubicin
(21 mg/m²), plus ara-C or induction therapy with idarubicin (12 mg/m²) plus ara-C in
this patient population.
Amifostine for Head and Neck Irradiation in Lymphoma [Active, not recruiting]
Determination of Amifostine Levels During Radiation Therapy [Completed]
Currently, there are no published methods for easily determining the level of amifostine in
the blood or saliva. A method has been developed within the Department of Radiation Oncology
by Drs. Douglas Spitz and Gurminder Sidhu, within the Spitz Lab. This method has been tested
using both animal sampling and expired blood (obtained from DeGowin blood center) mixed with
amifostine.
If the method proves successful, it could then be used as a tool to quantify blood and
salivary amifostine levels and possibly correlate them to treatment efficacy or limiting
adverse events using amifostine. A better method of treatment, either increasing the efficacy
of amifostine or reducing its unwanted side effects, could then be developed.
Subcutaneous Amifostine Safety Study [Completed]
Amifostine is a radioprotective drug which is approved by the US FDA for administration prior
to each radiation treatment using the intravenous route. The study evaluated the safety of
amifostine administered subcutaneously. The four targeted toxicities were nausea/vomiting,
hypotension, generalized skin rash, and injection-site skin reactions.
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