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Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials.

ABSTRACT:

Background

Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent.

Methods

By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software.

Results

Seventeen trials including a total of 1167 patients (604 and 563 each arm) were analyzed in the meta-analysis. The pooled data showed that the use of amifostine significantly reduce the risk of developing Grade 3-4 mucositis (relative risk [RR],0.72; 95% confidence interval [CI],0.54-0.95; p<0.00001), Grade 2-4 acute xerostomia (RR,0.70; 95%CI,0.52-0.96; p = 0.02), or late xerostomia (RR,0.60; 95%CI,0.49-0.74; p<0.00001) and Grade 3-4 dysphagia (RR,0.39; 95%CI,0.17-0.92; p = 0.03). However, subgroup analysis demonstrated that no statistically significant reduction of Grade 3-4 mucositis (RR,0.97; 95% CI,0.74-1.26; p = 0.80), Grade 2-4 acute xerostomia (RR,0.35; 95%CI,0.02-5.44; p = 0.45), or late xerostomia (RR,0.40; 95%CI,0.13-1.24; p = 0.11) and Grade 3-4 dysphagia (RR,0.23; 95%CI,0.01-4.78; p = 0.35) was observed in patients treated with concomitant chemoradiotherapy. Compared with placebo or observation, amifostine does not show tumor protective effect in complete response (RR,1.02; 95%CI,0.89-1.17; p = 0.76) and partial response (RR,0.90; 95%CI, 0.56-1.44; p = 0.66). For the hematologic side effect, no statistical difference of Grade 3-4 leucopenia (RR,0.60; 95%CI,0.35-1.05; p = 0.07), anemia (RR,0.80; 95%CI, 0.42-1.53; p = 0.50) and thrombocytopenia (RR,0.43; 95%CI,0.16-1.15; p = 0.09) were found between amifostine and control groups. The most common amifostine related side effects were nausea, emesis, hypotension and allergic with an average incidence rate (Grade 3-4) of 5%, 6%, 4% and 4% respectively.

Conclusion

This systematic review showed that amifostine significantly reduce the serious mucositis, acute/late xerastomia and dysphagia without protection of the tumor in HNSCC patients treated with radiotherapy. And the toxicities of amifostine were generally acceptable.

SUBMITTER: Gu J

PROVIDER: S-EPMC4008569 | biostudies-literature | 2014

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials.

Gu Jundong J Zhu Siwei S Li Xuebing X Wu Hua H Li Yang Y Hua Feng F

PloS one 20140502 5

<h4>Background</h4>Amifostine is the most clinical used chemical radioprotector, but its effect in patients treated with radiation is not consistent.<h4>Methods</h4>By searching Medline, CENTRAL, EMBASE, ASCO, ESMO, and CNKI databases, the published randomized controlled trials (RCTs) about the efficacy of amifostine in HNSCC patients treated with radiotherapy were collected. The pooled efficacy and side effects of this drug were calculated by RevMan software.<h4>Results</h4>Seventeen trials inc ...[more]

PMID: 24788761

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Project description:BackgroundCurrent treatment for head and neck cancers (HNCs) have led to an improved survival. However, the sequelae of cancer treatment often result in trismus, or reduced mouth opening. The purpose of this report is to identify interventional studies for trismus management in HNC patients.MethodsA search of PubMed, Embase, Cumulated Index to Nursing and Allied Health Literature, and the Cochrane Library was conducted in March 2020 for randomized controlled trials (RCTs) involving interventions for trismus for head and neck cancer within 10 years. Intervention could involve the use of an exercise regime, jaw rehabilitation device, technological device, medication or massage therapy. The primary outcome was the measurement of mouth opening.ResultsEleven RCTs involving a total of 685 patients with HNC were included. Six RCTs evaluated the effectiveness of a jaw mobilization device with exercises; there was no significant benefit of an exercise regime with a jaw mobilization device either initiated before, during or after treatment compared to no exercise. Two RCTs compared 2 intervention groups that involved exercises only, with 1 study assessing the benefit of weekly supervised physical therapy with gum chewing and another evaluating the benefit of immediate (1-2 days) versus delayed (7-10 days) initiation of exercise post-surgery; there was no significant difference between groups in either study. One RCT that recruited only patients with trismus demonstrated that an exercise regime in combination with low-level laser therapy or low-intensity ultrasound had superior results in mouth opening measurements compared to exercise alone. Two RCTs compared intervention groups with and without follow-up reminders; both studies showed a significant improvement in mouth opening measurements in groups with follow-up reminders.ConclusionThis systematic review did not convey a clear consensus as to optimal intervention for trismus in HNC patients. A variety of exercise regimens and jaw rehabilitation devices appear to have comparable effectiveness. However, efforts focused on increasing adherence to a particular intervention protocol may positively impact mouth opening measures in head and neck cancer patients. Also, low-level laser therapy and low-intensity ultrasound coupled with exercise may be beneficial for patients with trismus.

Project description:BACKGROUND:Cancer cachexia is a prevalent symptom of head and neck neoplasms. The reduction in skeletal muscle mass is one of the main characteristics which can lead to poor physical functioning. The purposes of this pilot randomized controlled trial were to determine the feasibility of progressive resistance training in cachectic head and neck cancer patients during radiotherapy and to explore possible risks and benefits. METHODS:Twenty cachectic participants with head and neck cancer receiving radiation were randomized to obtain either a machine supported progressive resistance training (n =?10) or usual care (n?=?10). The training took place 3 times weekly for 30 min. Intervention included 3 exercises for major muscle groups with 8-12 repetition maximum for 3 sets each. Bioelectrical impedance analysis, hand-held dynamometry, Six-Minute Walk Test and standardized questionnaires for fatigue and quality of life were used for evaluating outcomes at baseline before radiotherapy (t1), after 7 weeks of radiotherapy (t2) and 8 weeks after the end of radiotherapy (t3). RESULTS:All participants (n =?20) completed the trial. No serious adverse events occurred. At the initial assessment the cachectic patients had already lost 7.1?±?5.2% of their body weight. General fatigue (score 10.7?±?3.3) and reduced quality of life (score 71.3?±?20.6) were prevalent in cachectic head and neck cancer patients even before radiotherapy. An average improvement of weight loading for leg press (+?19.0%), chest press (+?29.8%) and latissimus pull-down (+?22.8%) was possible in the intervention group. Participants had at least 13 training sessions. The outcome measures showed nonsignificant changes at t2 and t3, but a trend for a better course of general fatigue and quality of life at t2 in the intervention group. CONCLUSIONS:Despite advanced tumor stage and burdensome treatment the intervention adherence is excellent. Progressive resistance training in cachectic head and neck cancer patients during radiotherapy seems to be safe and feasible and may have beneficial effects of general fatigue and quality of life. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03524755 . Registered 15 May 2018 - Retrospectively registered.

Dataset Information

Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials.

Background

Methods

Results

Conclusion

Publications

Effect of amifostine in head and neck cancer patients treated with radiotherapy: a systematic review and meta-analysis based on randomized controlled trials.

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