Subcutaneous compared with intravenous administration of amifostine in patients with head and neck cancer receiving radiotherapy: final results of the GORTEC2000-02 phase III randomized trial.
Details
Serval ID
serval:BIB_F5C74FCB1B42
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Subcutaneous compared with intravenous administration of amifostine in patients with head and neck cancer receiving radiotherapy: final results of the GORTEC2000-02 phase III randomized trial.
Journal
Journal of Clinical Oncology
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Publication state
Published
Issued date
2011
Peer-reviewed
Oui
Volume
29
Number
2
Pages
127-133
Language
english
Notes
Publication types: Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov'tPublication Status: ppublish
Abstract
PURPOSE: To compare compliance with and efficacy of intravenous (IV) and subcutaneous (SC) amifostine for the treatment of patients undergoing radiotherapy for head and neck cancer.
PATIENTS AND METHODS: Patients with newly diagnosed squamous cell carcinoma of the head and neck, who were eligible for radiotherapy and who were not receiving concurrent chemotherapy, were randomly assigned to receive either IV amifostine (200 mg/m(2) daily for 3 minutes, 15 to 30 minutes before irradiation) or SC amifostine (500 mg; two sites; 20 to 60 minutes before irradiation). The primary end point was late xerostomia at 1 year as indicated by unstimulated and stimulated salivary flow rates, a patient benefit questionnaire score, and Radiation Therapy Oncology Group (RTOG) late toxicity grade.
RESULTS: Results for IV (n = 143) versus SC (n = 148) administration were as follows. There was no significant difference in compliance (69% for IV v 71% for SC) in patients receiving a full dose of amifostine. Reasons for dose reduction were acute toxicity (25% for IV v 27% for SC; P = .51) and logistics (18% for IV v 9% for SC administration; P = .09). Acute toxicity differed significantly in terms of grade 1 to 2 hypotension (19% for IV v 8% for SC; P = .01), grade 1 to 2 skin rash (9% for IV v 21% for SC; P = .01), and local pain (0% for IV v 8% for SC; P = .003). The incidence of grade 2 or greater xerostomia was significantly higher for patients who received amifostine via SC administration (37% for IV v 62% for SC; P = .005) in the 127 patients (n = 67, IV; n = 60, SC) evaluable at 1 year but not at 2 or 3 years (36% for IV v 51% for SC administration; P = .19; 32% for IV v 41% for SC; P = .63). A generalized linear mixed-model analysis of all data revealed no significant difference in patient self-assessment of salivary function (P = .25), unstimulated or stimulated salivary flow rates (P = .054 and .82, respectively), or grade 2 or greater xerostomia (P = .23).
CONCLUSION: SC amifostine administration was not significantly superior to IV amifostine administration in terms of patient compliance or efficacy.
PATIENTS AND METHODS: Patients with newly diagnosed squamous cell carcinoma of the head and neck, who were eligible for radiotherapy and who were not receiving concurrent chemotherapy, were randomly assigned to receive either IV amifostine (200 mg/m(2) daily for 3 minutes, 15 to 30 minutes before irradiation) or SC amifostine (500 mg; two sites; 20 to 60 minutes before irradiation). The primary end point was late xerostomia at 1 year as indicated by unstimulated and stimulated salivary flow rates, a patient benefit questionnaire score, and Radiation Therapy Oncology Group (RTOG) late toxicity grade.
RESULTS: Results for IV (n = 143) versus SC (n = 148) administration were as follows. There was no significant difference in compliance (69% for IV v 71% for SC) in patients receiving a full dose of amifostine. Reasons for dose reduction were acute toxicity (25% for IV v 27% for SC; P = .51) and logistics (18% for IV v 9% for SC administration; P = .09). Acute toxicity differed significantly in terms of grade 1 to 2 hypotension (19% for IV v 8% for SC; P = .01), grade 1 to 2 skin rash (9% for IV v 21% for SC; P = .01), and local pain (0% for IV v 8% for SC; P = .003). The incidence of grade 2 or greater xerostomia was significantly higher for patients who received amifostine via SC administration (37% for IV v 62% for SC; P = .005) in the 127 patients (n = 67, IV; n = 60, SC) evaluable at 1 year but not at 2 or 3 years (36% for IV v 51% for SC administration; P = .19; 32% for IV v 41% for SC; P = .63). A generalized linear mixed-model analysis of all data revealed no significant difference in patient self-assessment of salivary function (P = .25), unstimulated or stimulated salivary flow rates (P = .054 and .82, respectively), or grade 2 or greater xerostomia (P = .23).
CONCLUSION: SC amifostine administration was not significantly superior to IV amifostine administration in terms of patient compliance or efficacy.
Keywords
Adult, Aged, Amifostine/administration & dosage, Amifostine/adverse effects, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/radiotherapy, Combined Modality Therapy, Female, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/radiotherapy, Humans, Infusions, Intravenous, Infusions, Subcutaneous, Male, Middle Aged, Patient Compliance, Radiation-Protective Agents/administration & dosage, Radiation-Protective Agents/adverse effects
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Web of science
Create date
01/12/2014 18:06
Last modification date
20/08/2019 17:22
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