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Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study.
Int J Radiat Oncol Biol Phys. 2006 Mar 01; 64(3):684-91.IJ

Abstract

PURPOSE

Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer.

METHODS AND MATERIALS

Patients from European and American study centers received i.v. amifostine 300 mg/m2 (n = 67) or placebo (n = 65) before carboplatin 70 mg/m2 and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m2 or placebo before radiotherapy on other days.

RESULTS

Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39%, 34%, 0.715), Grade 3 or higher acute mucositis (39%, 22%, 0.055), Grade 2 or higher late xerostomia (37%, 24%, 0.235), and Grade 3 or higher treatment-related adverse events (42%, 20%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments.

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.

Authors+Show Affiliations

Department of Otolaryngology, Head & Neck Surgery, Suedharzkrankenhaus Nodhausen, Nordhausen, Germany. jens.buentzel@shk-ndh.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16243440

Citation

Buentzel, Jens, et al. "Intravenous Amifostine During Chemoradiotherapy for Head-and-neck Cancer: a Randomized Placebo-controlled Phase III Study." International Journal of Radiation Oncology, Biology, Physics, vol. 64, no. 3, 2006, pp. 684-91.
Buentzel J, Micke O, Adamietz IA, et al. Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study. Int J Radiat Oncol Biol Phys. 2006;64(3):684-91.
Buentzel, J., Micke, O., Adamietz, I. A., Monnier, A., Glatzel, M., & de Vries, A. (2006). Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study. International Journal of Radiation Oncology, Biology, Physics, 64(3), 684-91.
Buentzel J, et al. Intravenous Amifostine During Chemoradiotherapy for Head-and-neck Cancer: a Randomized Placebo-controlled Phase III Study. Int J Radiat Oncol Biol Phys. 2006 Mar 1;64(3):684-91. PubMed PMID: 16243440.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: a randomized placebo-controlled phase III study. AU - Buentzel,Jens, AU - Micke,Oliver, AU - Adamietz,Irenaus A, AU - Monnier,Alain, AU - Glatzel,Michael, AU - de Vries,Alexander, Y1 - 2005/10/21/ PY - 2005/05/08/received PY - 2005/08/05/revised PY - 2005/08/09/accepted PY - 2005/10/26/pubmed PY - 2006/4/14/medline PY - 2005/10/26/entrez SP - 684 EP - 91 JF - International journal of radiation oncology, biology, physics JO - Int. J. Radiat. Oncol. Biol. Phys. VL - 64 IS - 3 N2 - PURPOSE: Clinical trials demonstrated the efficacy and safety of intravenous (i.v.) or subcutaneous (s.c.) amifostine for reducing xerostomia and mucositis after radiotherapy or radiochemotherapy for head-and-neck cancer. This randomized, double-blinded, placebo-controlled, phase III study evaluated the efficacy and safety of i.v. amifostine during radiochemotherapy for head-and-neck cancer. METHODS AND MATERIALS: Patients from European and American study centers received i.v. amifostine 300 mg/m2 (n = 67) or placebo (n = 65) before carboplatin 70 mg/m2 and radiotherapy on Days 1 to 5 and 21 to 25, and i.v. amifostine 200 mg/m2 or placebo before radiotherapy on other days. RESULTS: Toxicity incidences were (amifostine, placebo, p value): Grade 2 or higher acute xerostomia (39%, 34%, 0.715), Grade 3 or higher acute mucositis (39%, 22%, 0.055), Grade 2 or higher late xerostomia (37%, 24%, 0.235), and Grade 3 or higher treatment-related adverse events (42%, 20%, 0.008). One-year rates of locoregional failure, progression-free survival, and overall survival were not significantly different between treatments. 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. SN - 0360-3016 UR - https://www.unboundmedicine.com/medline/citation/16243440/Intravenous_amifostine_during_chemoradiotherapy_for_head_and_neck_cancer:_a_randomized_placebo_controlled_phase_III_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0360-3016(05)02366-7 DB - PRIME DP - Unbound Medicine ER -