ETHYOL Use in Head and Neck Cancer

Efficacy Benefits

  • Sparing of the parotid glands translates into1
    • Objective and subjective improvement of xerostomia in patients with head and neck cancers receiving radiation therapy (RT)
  • Only ETHYOL provides timely radioprotection1-3
    • Administration of ETHYOL® before each fraction of RT can significantly reduce the incidence of moderate to severe xerostomia
    • ETHYOL administration during head and neck RT reduces the incidence of moderate to severe xerostomia 2 years after treatment

ETHYOL is indicated to reduce the incidence of moderate to severe xerostomia in patients undergoing postoperative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands (see Clinical Studies, in full Prescribing Information).

For the approved indication, the clinical data do not suggest that the effectiveness of radiation therapy is altered by ETHYOL. There are at present only limited data on the effects of ETHYOL on the efficacy of radiotherapy in other settings. ETHYOL should not be administered to patients receiving definitive radiotherapy, except in the context of a clinical study (see WARNINGS in full Prescribing Information).

  • ETHYOL Helps Protect for Today1,2

    Incidence of Grade 2 or higher xerostomia versus time
    Results were from an open-label, randomized, controlled, multicenter trial using standard fractionated RT in patients with head and neck cancer, as assessed by RTOG Acute and Late Morbidity Scoring Criteria.1,2

  • ETHYOL Helps Preserve for Tomorrow3

    Incidence of Grade 2 or higher xerostomia versus time
    Results were from an open-label, randomized, controlled, multicenter trial using standard fractionated RT in patients with head and neck cancer, as assessed by RTOG Acute and Late Morbidity Scoring Criteria.3

  • Clinical data do not suggest that the effectiveness of RT in head and neck cancer is altered by ETHYOL1-3
    • ETHYOL did not compromise locoregional tumor control, disease-free survival, or overall survival 24 months after RT3*

    Overall survival (%) versus time
    * Results were from an open-label, randomized, controlled, multicenter trial using standard fractionated RT in patients with head and neck cancer.3
    † Survival rates were based on Kaplan-Meier estimates.
    ‡ Based on Wilcoxon test.

The American Society of Clinical Oncology (ASCO) Clinical Practice Guidelines recommend4,5

  • ETHYOL use may be considered to decrease the incidence of acute and late xerostomia in patients receiving fractionated RT for head and neck cancer based upon a 1A level of clinical evidence4,5††

†† Level I type of evidence on scale of I-V, Grade A for recommendation on scale of A-D. Level I: Evidence obtained from meta-analysis of multiple, well-designed, controlled studies; or from randomized trials with low false-positive and low false-negative errors (high power). Grade A: Evidence of type I for consistent findings from multiple studies of type II, III, or IV.

Please see important safety information and full Prescribing Information.

References
1. ETHYOL (amifostine for injection) [Package Insert]. Gaithersburg, MD: MedImmune, LLC, 2007.
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;18:3339-3345.
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;63:985-990.
4. Schuchter LM, Hensley ML, Meropol NJ, Winer EP; American Society of Clinical Oncology Chemotherapy and Radiotherapy Expert Panel. 2002 update of recommendations for the use of chemotherapy and radiotherapy protectants: clinical practice guidelines of the American Society of Clinical Oncology. J Clin Oncol. 2002;20:2895-2903.
5. Hensley ML, Schuchter LM, Lindley C, et al; American Society of Clinical Oncology. American Society of Clinical Oncology clinical practice guidelines for the use of chemotherapy and radiotherapy protectants. J Clin Oncol. 1999;17:3333-3355.