6 Final report of a phase III randomized trial of amifostine as a radioprotectant in head and neck cancer

Brizel, D.M.; Wasserman, Todd H.; Strnad, Vratislav; Wannemacher, M.; Henke, Michael; Monnier, Alain; Eschwège, F.; Zhang, J.; Russell, Lindy; Sauer, Rolf

doi:10.1016/s0360-3016(99)90024-x

Cited by 12 publications

(5 citation statements)

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“…Whole saliva collection 1 year following radiation therapy showed better saliva production in the amifostine group. 16 At 2 year follow-up, patients treated with amifostine had lesser subjective feeling of dry mouth and had more meaningful unstimulated salivary flow. 17 But, the inconvenience of daily administration of the drug minutes before radiotherapy and the risk of potentially life-threatening adverse reactions like severe hypotension have limited the popularity of the drug.…”

Section: Xerostomiamentioning

confidence: 91%

“…The subjects received standard fractionated radiation with or without amifostine (Ethyol), administered at 200 mg per square metres as a 3-minute IV infusion 15 to 30 minutes before each fraction of radiation. 16 Patient eligibility criteria included that the radiation field encompassed at least 75% of both parotid glands. The incidence of acute xerostomia (90 days from the start of radiotherapy) and late xerostomia (9 to 12 months after radiotherapy) was significantly reduced in patients receiving amifostine.…”

Section: Xerostomiamentioning

confidence: 99%

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Addressing Quality of Life Issues in Long Term Survivors of Head & Neck Cancer treated with Radiation Therapy

Basu

2015

BJOHNS

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The rapid advancement of curative treatment modalities has resulted in improvement of cure rates of head neck cancer leaving us with a larger number of long term survivors from the disease. Unfortunately, long term complications of therapy continue to hurt patients even after cure, compromising their quality of life. This is particularly true for the patients treated with primary radiation/chemo-radiation therapy, where so called organ preservation does not necessarily translate into preservation of organ function. Long term sequelae of treatment, particularly xerostomia and swallowing difficulties compromise the survivors’ quality of life. More studies, particularly suited to our clinical scenario, are warranted to address the quality of life issues in these patients, so that better evidence-based guidelines may be developed for their benefit.

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Section: Xerostomiamentioning

confidence: 91%

Section: Xerostomiamentioning

confidence: 99%

Addressing Quality of Life Issues in Long Term Survivors of Head & Neck Cancer treated with Radiation Therapy

Basu

2015

BJOHNS

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“…The dose of amifostine used for this trial (200 mg/m 2 ) was based on that delivered by Brizel et al . and recommended by both the American Society of Clinical Oncology and the manufacturer (Product Information, Schering‐Plough Ltd, Australia: TGA, 31 March 2000).…”

Section: Methodsmentioning

confidence: 99%

“…Based on an anticipated accrual rate of 40 patients per year, and the rates of acute and late salivary gland toxicity reported by Brizel et al ,. a sample size of 200 patients was estimated to detect a 22% (acute) and 20% (late) difference between the arms using the relevant statistical tests with 80% power and two‐sided significance level of 2.5%.…”

Section: Methodsmentioning

confidence: 99%

“…At the time of trial development in 2001, only one prospective, randomized study addressing the use of amifostine in patients receiving RT for the treatment of H&N cancer had been published. This demonstrated the effectiveness of amifostine in protecting against xerostomia . Using a similar design, our broad objective was to determine whether pretreatment with amifostine reduced the incidence of acute and late xerostomia in patients receiving RT for HNSCC without reducing tumour control or survival.…”

Section: Introductionmentioning

confidence: 97%

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Randomized double‐blind trial of amifostine versus placebo for radiation‐induced xerostomia in patients with head and neck cancer

et al. 2018

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Introduction: The role of the radioprotector amifostine in ameliorating radiotherapy side effects in head and neck squamous cell carcinoma (HNSCC) is controversial. This trial aimed to determine whether pretreatment with amifostine reduced the incidence of Radiation Therapy Oncology Group grade ≥2 acute and late xerostomia in patients receiving definitive or adjuvant radiotherapy for HNSCC, without reducing tumour control or survival. Methods: Between 14 September 2001 and 8 November 2004, 44 Royal Adelaide Hospital patients were randomized double-blind to receive amifostine (200 mg/m 2 IV) or placebo (normal saline IV) 5 days/week, prior to standard radiotherapy (60-70 Gy), each having ≥75% of the parotids treated to ≥40 Gy. Side effects were assessed weekly during treatment, at 3 and 5 months after radiotherapy, then every 6 months until disease progression or death. Results: The accrual target was 200 patients over 4-5 years, but the trial closed prematurely when only 44 patients had been randomized after 3 years. Of 41 evaluable patients, 80% (16/20) in the amifostine arm had grade ≥2 acute radiation salivary toxicity versus 76% (16/21) in the placebo arm (P = 1.00). The rate of grade ≥2 late radiation salivary toxicity at 12 months was 66% in the amifostine arm and 82% in the placebo arm (estimated hazard ratio 1.61, 95% confidence interval 0.74-3.49, P = 0.22). Other toxicities tended to be worse in the amifostine arm: acute grade 3-4 skin 35% vs 5% and mucous membrane 40% vs 5%; grade ≥2 vomiting 35% vs 5%, hypocalcaemia 25% vs 5% and fatigue 85% vs 33%, with only the latter retaining statistical significance after adjusting for multiple comparisons. There were no significant differences in failure-free (P = 0.70) or overall survival (P = 0.86), with estimated 4-year rates of 48% vs 54% and 49% vs 59% for the amifostine vs placebo arms respectively. Conclusion: There was no clear evidence that pretreatment with amifostine made any difference to the incidence of grade ≥2 acute or late xerostomia. Other toxicity tended to be more severe with amifostine. There was no effect on failure-free or overall survival. Acknowledging the low statistical power, these results do not support the use of IV amifostine pre-radiotherapy in HNSCC.

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Novel Substances in the Treatment of Lung Cancer for the Radiation Oncologist

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Medical Radiology Radiation Oncology

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6 Final report of a phase III randomized trial of amifostine as a radioprotectant in head and neck cancer

Cited by 12 publications

References 0 publications

Addressing Quality of Life Issues in Long Term Survivors of Head & Neck Cancer treated with Radiation Therapy

Addressing Quality of Life Issues in Long Term Survivors of Head & Neck Cancer treated with Radiation Therapy

Randomized double‐blind trial of amifostine versus placebo for radiation‐induced xerostomia in patients with head and neck cancer

Novel Substances in the Treatment of Lung Cancer for the Radiation Oncologist

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