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The Cochrane Database of Systematic... Feb 2011Cisplatin and several related antineoplastic agents used to treat many types of solid tumors are neurotoxic, and most patients completing a full course of cisplatin... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cisplatin and several related antineoplastic agents used to treat many types of solid tumors are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.
OBJECTIVES
To examine the efficacy of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related agents.
SEARCH STRATEGY
We searched the Cochrane Neuromuscular Disease Group Specialized Register (25 August 2010), the Cochrane Central Register of Controlled Trials (Issue 3, 2010 in The Cochrane Library), MEDLINE (January 1966 to August 2010), EMBASE (January 1980 to August 2010), LILACS (January 1982 to August 2010), CINAHL (January 1982 to August 2010) for randomized trials designed to evaluate neuroprotective agents used to prevent or limit neurotoxicity of cisplatin and related agents among human patients.
SELECTION CRITERIA
Quasi-randomized or randomized controlled trials whose participants received cisplatin (or related compounds) chemotherapy with or without a potential chemoprotectant (acetylcysteine, amifostine, ACTH, BNP7787, calcium and magnesium, diethyldithiocarbamate, glutathione, Org 2766, oxcarbazepine, or vitamin E) and were evaluated zero to six months after completing chemotherapy using quantitative sensory testing (primary) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary).
DATA COLLECTION AND ANALYSIS
We identified 16 randomized trials involving five possible chemoprotective agents in the initial 2006 review. Each study was reviewed by two authors who extracted the data and reached consensus. The 2010 update identified 11 additional randomized trials consisting of nine possible chemoprotective agents, including three treatments (acetylcysteine, calcium and magnesium, and oxcarbazepine) not among those described in the 2006 review. The included trials in the updated review involved eight unrelated treatments and included many disparate measures of neuropathy, resulting in insufficient data for any one measure to combine the results in most instances.
MAIN RESULTS
One of four eligible amifostine trials (541 total participants in all four trials) used quantitative sensory testing and demonstrated a favorable outcome in terms of amifostine neuroprotection, but the vibration perception threshold result was based on data from only 14 participants receiving amifostine who completed the post-treatment evaluation and should be regarded with caution. Of the six eligible glutathione trials (354 participants), one used quantitative sensory testing but reported only qualitative analyses. Four eligible Org 2766 trials (311 participants) employed quantitative sensory testing reported disparate results; meta-analyses of three trials using comparable measures showed no significant vibration perception threshold neuroprotection. The remaining trial reported only descriptive analyses. The single eligible trials involving acetylcysteine (14 participants), diethyldithiocarbamate (195 participants), calcium and magnesium (33 participants), and oxcarbazepine (32 participants) and the two eligible trials involving vitamin E (57 participants) did not perform quantitative sensory testing. In all, data from 1,537 participants were included.
AUTHORS' CONCLUSIONS
At present, the data are insufficient to conclude that any of the purported chemoprotective agents (acetylcysteine, amifostine, calcium and magnesium, diethyldithiocarbamate, glutathione, Org 2766, oxycarbazepine, or Vitamin E) prevent or limit the neurotoxicity of platin drugs among human patients.
Topics: Antineoplastic Agents; Cisplatin; Humans; Neuroprotective Agents; Peptide Fragments; Peripheral Nervous System Diseases
PubMed: 21328275
DOI: 10.1002/14651858.CD005228.pub3 -
The Cochrane Database of Systematic... Dec 2010Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers).
OBJECTIVES
To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment.
SEARCH STRATEGY
Electronic searches of Cochrane Oral Health Group and PaPaS Trials Registers (to 1 June 2010), CENTRAL (The Cochrane Library 2010, Issue 2), MEDLINE via OVID (1950 to 1 June 2010), EMBASE via OVID (1980 to 1 June 2010), CINAHL via EBSCO (1980 to 1 June 2010), CANCERLIT via PubMed (1950 to 1 June 2010), OpenSIGLE (1980 to 2005) and LILACS via the Virtual Health Library (1980 to 1 June 2010) were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information.
SELECTION CRITERIA
Randomised controlled trials of interventions to prevent oral mucositis in patients receiving treatment for cancer.
DATA COLLECTION AND ANALYSIS
Information regarding methods, participants, interventions, outcome measures, results and risk of bias were independently extracted, in duplicate, by two review authors. Authors were contacted for further details where these were unclear. The Cochrane Collaboration statistical guidelines were followed and risk ratios calculated using random-effects models.
MAIN RESULTS
A total of 131 studies with 10,514 randomised participants are now included. Nine interventions, where there was more than one trial in the meta-analysis, showed some statistically significant evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis, compared to either a placebo or no treatment. These nine interventions were: allopurinol, aloe vera, amifostine, cryotherapy, glutamine (intravenous), honey, keratinocyte growth factor, laser, and polymixin/tobramycin/amphotericin (PTA) antibiotic pastille/paste.
AUTHORS' CONCLUSIONS
Nine interventions were found to have some benefit with regard to preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for further well designed, and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.
Topics: Antineoplastic Agents; Candidiasis, Oral; Humans; Mouth Mucosa; Neoplasms; Oral Ulcer; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 21154347
DOI: 10.1002/14651858.CD000978.pub3 -
Current Oncology (Toronto, Ont.) Aug 2010Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges...
Radiation therapy is a common treatment for cancer patients. One of the most common side effects of radiation is acute skin reaction (radiation dermatitis) that ranges from a mild rash to severe ulceration. Approximately 85% of patients treated with radiation therapy will experience a moderate-to-severe skin reaction. Acute radiation-induced skin reactions often lead to itching and pain, delays in treatment, and diminished aesthetic appearance-and subsequently to a decrease in quality of life. Surveys have demonstrated that a wide variety of topical, oral, and intravenous agents are used to prevent or to treat radiation-induced skin reactions. We conducted a literature review to identify trials that investigated products for the prophylaxis and management of acute radiation dermatitis. Thirty-nine studies met the pre-defined criteria, with thirty-three being categorized as prophylactic trials and six as management trials.For objective evaluation of skin reactions, the Radiation Therapy Oncology Group criteria and the U.S. National Cancer Institute Common Toxicity Criteria were the most commonly used tools (65% of the studies). Topical corticosteroid agents were found to significantly reduce the severity of skin reactions; however, the trials of corticosteroids evaluated various agents, and no clear indication about a preferred corticosteroid has emerged. Amifostine and oral enzymes were somewhat effective in preventing radiation-induced skin reactions in phase II and phase III trials respectively; further large randomized controlled trials should be undertaken to better investigate those products. Biafine cream (Ortho-McNeil Pharmaceuticals, Titusville, NJ, U.S.A.) was found not to be superior to standard regimes in the prevention of radiation-induced skin reactions (n = 6).In conclusion, the evidence is insufficient to support the use of a particular agent for the prevention and management of acute radiation-induced skin reactions. Future trials should focus on comparing agents and approaches that, in phase I and II trials, suggest efficacy. These future phase III randomized controlled trials must clearly distinguish between preventive and management strategies for radiation-induced dermatitis. Only then can evidence-based guidelines be developed, with the hope of standardizing the approach across centres and of improving the prevention and management of radiation-induced dermatitis.
PubMed: 20697521
DOI: 10.3747/co.v17i4.493 -
Supportive Care in Cancer : Official... Aug 2010The purpose was to review relevant scientific papers written since 1989 which focused on the prevalence and management of dysgeusia as an oral side effect of cancer... (Review)
Review
PURPOSE
The purpose was to review relevant scientific papers written since 1989 which focused on the prevalence and management of dysgeusia as an oral side effect of cancer treatment.
METHODS
Our literature search was limited to English language papers published between 1990 and 2008. A total of 30 papers were reviewed; the results of 26 of these papers were included in the present systematic review. A structured assessment form was used by two reviewers for each paper. Studies were weighted as to the quality of the study design, and treatment recommendations were based on the relative strength of each paper.
RESULTS
A wide range in reported prevalence of dysgeusia was identified with the weighted prevalence from 56-76%, depending on the type of cancer treatment. Attempts to prevent dysgeusia through the prophylactic use of zinc sulfate or amifostine have been of limited benefit. Nutritional counseling may be helpful to some patients in minimizing the symptoms of dysgeusia.
CONCLUSIONS
Dysgeusia is a common oral side effect of cancer therapy (radiotherapy, chemotherapy, or combined modality therapy) and often impacts negatively on quality of life. From the current literature, there does not appear to be a predictable way of preventing or treating dysgeusia.
Topics: Amifostine; Dysgeusia; Humans; Neoplasms; Prevalence; Quality of Life; Zinc Sulfate
PubMed: 20495984
DOI: 10.1007/s00520-010-0902-1 -
Supportive Care in Cancer : Official... Aug 2010This systematic review aimed to assess the literature for management strategies and economic impact of salivary gland hypofunction and xerostomia induced by cancer... (Review)
Review
PURPOSE
This systematic review aimed to assess the literature for management strategies and economic impact of salivary gland hypofunction and xerostomia induced by cancer therapies and to determine the quality of evidence-based management recommendations.
METHODS
The electronic databases of MEDLINE/PubMed and EMBASE were searched for articles published in English since the 1989 NIH Development Consensus Conference on the Oral Complications of Cancer Therapies until 2008 inclusive. For each article, two independent reviewers extracted information regarding study design, study population, interventions, outcome measures, results, and conclusions.
RESULTS
Seventy-two interventional studies met the inclusion criteria. In addition, 49 intensity-modulated radiation therapy (IMRT) studies were included as a management strategy aiming for less salivary gland damage. Management guideline recommendations were drawn up for IMRT, amifostine, muscarinic agonist stimulation, oral mucosal lubricants, acupuncture, and submandibular gland transfer.
CONCLUSIONS
There is evidence that salivary gland hypofunction and xerostomia induced by cancer therapies can be prevented or symptoms be minimized to some degree, depending on the type of cancer treatment. Management guideline recommendations are provided for IMRT, amifostine, muscarinic agonist stimulation, oral mucosal lubricants, acupuncture, and submandibular gland transfer. Fields of sparse literature identified included effects of gustatory and masticatory stimulation, specific oral mucosal lubricant formulas, submandibular gland transfer, acupuncture, hyperbaric oxygen treatment, management strategies in pediatric cancer populations, and the economic consequences of salivary gland hypofunction and xerostomia.
Topics: Humans; Neoplasms; Practice Guidelines as Topic; Radiotherapy, Intensity-Modulated; Salivary Gland Diseases; Xerostomia
PubMed: 20333412
DOI: 10.1007/s00520-010-0837-6 -
The Cochrane Database of Systematic... Oct 2009Radioactive iodine treatment for differentiated thyroid cancer possibly results in xerostomia. Amifostine has been used to prevent the effects of irradiation to salivary... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Radioactive iodine treatment for differentiated thyroid cancer possibly results in xerostomia. Amifostine has been used to prevent the effects of irradiation to salivary glands. To date, the effects of amifostine on salivary glands in radioactive iodine treated differentiated thyroid cancer remain uncertain.
OBJECTIVES
To assess the effects of amifostine on salivary glands in high-dose radioactive iodine treated differentiated thyroid cancer.
SEARCH STRATEGY
Studies were obtained from computerized searches of MEDLINE, EMBASE, The Cochrane Library and paper collections of conferences held in Chinese.
SELECTION CRITERIA
Randomised controlled clinical trials and quasi-randomised controlled clinical trials comparing the effects of amifostine on salivary glands after radioactive iodine treatment for differentiated thyroid cancer with placebo and a duration of follow up of at least three months.
DATA COLLECTION AND ANALYSIS
Two authors independently assessed risk of bias and extracted data.
MAIN RESULTS
Two trials with 130 patients (67 and 63 patients randomised to intervention versus control) were included. Both studies had a low risk of bias. Amifostine versus placebo showed no statistically significant differences in the incidence of xerostomia (130 patients, two studies), the decrease of scintigraphically measured uptake of technetium-99m by salivary or submandibular glands at twelve months (80 patients, one study), and the reduction of blood pressure (130 patients, two studies). Two patients in one study collapsed after initiation of amifostine therapy and had to be treated by withdrawing the infusion and volume substitution. Both patients recovered without sequelae. Meta-analysis was not performed on the function of salivary glands measured by technetium-99m scintigraphy at three months after high dose radioactive iodine treatment due to the highly inconsistent findings across studies (I(2) statistic 99%). None of the included trials investigated death from any cause, morbidity, health-related quality of life or costs.
AUTHORS' CONCLUSIONS
Results from two randomised controlled clinical trials suggest that the amifostine has no significant radioprotective effects on salivary glands in high-dose radioactive iodine treated differentiated thyroid cancer patients. Moreover, no health-related quality of life and other patient-oriented outcomes were evaluated in the two included trials. Randomised controlled clinical trials with low risk of bias investigating patient-oriented outcomes are needed to guide treatment choice.
Topics: Adenocarcinoma, Follicular; Amifostine; Carcinoma, Papillary; Humans; Iodine Radioisotopes; Radiation Injuries; Radiation-Protective Agents; Radionuclide Imaging; Randomized Controlled Trials as Topic; Salivary Glands; Thyroid Neoplasms; Xerostomia
PubMed: 19821441
DOI: 10.1002/14651858.CD007956.pub2 -
The Cochrane Database of Systematic... Oct 2007Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Treatment of cancer is increasingly more effective but is associated with short and long term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers).
OBJECTIVES
To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment.
SEARCH STRATEGY
The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted to identify trials and obtain additional information. Date of most recent searches: June 2006: CENTRAL (The Cochrane Library 2006, Issue 2).
SELECTION CRITERIA
Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with cancer receiving chemotherapy or radiotherapy treatment for cancer; interventions - agents prescribed to prevent oral mucositis; outcomes - prevention of mucositis, pain, amount of analgesia, dysphagia, systemic infection, length of hospitalisation, cost and patient quality of life.
DATA COLLECTION AND ANALYSIS
Information regarding methods, participants, interventions and outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Collaboration statistical guidelines were followed and risk ratios (RR) calculated using random-effects models.
MAIN RESULTS
Two hundred and seventy-seven studies were eligible. One hundred and eighty-eight were excluded for various reasons, usually as there was no useable information on mucositis. Of the 89 useable studies all had data for mucositis comprising 7523 randomised patients. Interventions evaluated were: acyclovir, allopurinol mouthrinse, aloe vera, antibiotic pastille or paste, benzydamine, beta carotene, calcium phosphate, camomile, Chinese medicine, chlorhexidine, etoposide, folinic acid, glutamine, granulocyte/macrophage colony-stimulating factor (GM-CSF), histamine gel, honey, hydrolytic enzymes, ice chips, iseganan, keratinocyte GF, misonidazole, pilocarpine, pentoxifylline, povidone, prednisone, propantheline anticholinergic, prostaglandin, sucralfate, systemic antibiotic clarithromycin, traumeel, zinc sulphate. Of the 33 interventions included in trials, 12 showed some evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis. Interventions where there was more than one trial in the meta-analysis finding a significant difference when compared with a placebo or no treatment were: amifostine which provided minimal benefit in preventing mild and moderate mucositis RRs = 0.95 (95% confidence interval (CI) 0.92 to 0.98) and 0.88 (95% CI 0.80 to 0.98); Chinese medicine showed a benefit at all three dichotomies of mucositis with RR values of 0.44 (95% CI 0.20 to 0.96), 0.44 (95% CI 0.33 to 0.59) and 0.16 (95% CI 0.07 to 0.35) for increasing levels of mucositis severity; hydrolytic enzymes reduced moderate and severe mucositis with RRs = 0.52 (95% CI 0.36 to 0.74) and 0.17 (95% CI 0.06 to 0.52); and ice chips prevented mucositis at all levels RRs = 0.64 (95% CI 0.50 to 0.82), 0.38 (95% CI 0.23 to 0.62), and 0.24 (95% CI 0.12 to 0.48). Other interventions showing some benefit with only one study were: benzydamine, calcium phosphate, etoposide bolus, honey, iseganan, oral care, zinc sulphate. The general reporting of RCTs, especially concealment of randomisation, was poor. However, the assessments of the quality of the randomisation improved when the authors provided additional information.
AUTHORS' CONCLUSIONS
Several of the interventions were found to have some benefit at preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for well designed and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.
Topics: Antifungal Agents; Antineoplastic Agents; Candidiasis, Oral; Cryotherapy; Drugs, Chinese Herbal; Humans; Ice; Mouth Mucosa; Neoplasms; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 17943748
DOI: 10.1002/14651858.CD000978.pub3 -
The Cochrane Database of Systematic... Jan 2007Cisplatin and several related antineoplastic agents used to treat many types of solid tumors are neurotoxic, and most patients completing a full course of cisplatin... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cisplatin and several related antineoplastic agents used to treat many types of solid tumors are neurotoxic, and most patients completing a full course of cisplatin chemotherapy develop a clinically detectable sensory neuropathy. Effective neuroprotective therapies have been sought.
OBJECTIVES
To examine the efficacy of purported chemoprotective agents to prevent or limit the neurotoxicity of cisplatin and related agents among human patients.
SEARCH STRATEGY
We searched the Cochrane Neuromuscular Disease Group Register (January 2005), the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 1 2005), MEDLINE from (January 1966 to March 2005), EMBASE (from January 1980 to March 2005), LILACS (from January 1982 to March 2005), CINAHL (from January 1982 to March 2005) for randomized trials designed to evaluate neuroprotective agents used to prevent or limit neurotoxicity of cisplatin and related agents among human patients.
SELECTION CRITERIA
Quasi-randomized or randomized controlled trials whose participants received cisplatin (or related compounds) chemotherapy with or without a potential neuroprotectant (amifostine, diethyldithiocarbamate, glutathione, Org 2766, or vitamin E) and were evaluated zero to six months after completing chemotherapy using quantitative sensory testing (primary) or other measures including nerve conduction studies or neurological impairment rating using validated scales (secondary).
DATA COLLECTION AND ANALYSIS
We identified 16 randomized trials involving five possible chemoprotective agents. Each study was reviewed by two authors who extracted the data and reached consensus. The included trials involved five unrelated treatments and included many disparate measures of neuropathy, resulting in insufficient data for any one measure to combine the results in most instances.
MAIN RESULTS
The one of five eligible amifostine trials (541 participants) using quantitative sensory testing demonstrated a favorable outcome in terms of amifostine neuroprotection, but the subclinical result was based on 14 participants receiving amifostine. Of the five eligible glutathione trials (327 participants), one used quantitative sensory testing but reported only qualitative analyses. Four eligible Org 2766 trials (311 participants) employed quantitative sensory testing reported disparate results; meta-analyses of three trials using comparable measures showed no significant vibration perception threshold neuroprotection. The remaining trial reported only descriptive analyses. The one eligible diethyldithiocarbamate trial (214 participants) and the one eligible vitamin E trial (27 participants) did not perform quantitative sensory testing.
AUTHORS' CONCLUSIONS
At present, the data are insufficient to conclude if any of the purported neuroprotective agents (amifostine, diethyldithiocarbamate, glutathione, Org 2766, or Vitamin E) prevent or limit the neurotoxicity of platin drugs among human patients.
Topics: Adrenocorticotropic Hormone; Amifostine; Antineoplastic Agents; Cisplatin; Ditiocarb; Glutathione; Humans; Neuroprotective Agents; Peptide Fragments; Peripheral Nervous System Diseases; Randomized Controlled Trials as Topic; Vitamin E
PubMed: 17253547
DOI: 10.1002/14651858.CD005228.pub2 -
The Cochrane Database of Systematic... Apr 2006Treatment of cancer is increasingly more effective but is associated with short and long-term side effects. Oral side effects remain a major source of illness despite... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Treatment of cancer is increasingly more effective but is associated with short and long-term side effects. Oral side effects remain a major source of illness despite the use of a variety of agents to prevent them. One of these side effects is oral mucositis (mouth ulcers).
OBJECTIVES
To evaluate the effectiveness of prophylactic agents for oral mucositis in patients with cancer receiving treatment, compared with other potentially active interventions, placebo or no treatment.
SEARCH STRATEGY
The Cochrane Oral Health Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE were searched. Reference lists from relevant articles were scanned and the authors of eligible studies were contacted to identify trials and obtain additional information. Date of most recent searches: April 2004.
SELECTION CRITERIA
Trials were selected if they met the following criteria: design - random allocation of participants; participants - anyone with cancer receiving chemotherapy or radiotherapy treatment for cancer; interventions - agents prescribed to prevent oral mucositis; outcomes - prevention of mucositis, pain, amount of analgesia, dysphagia, systemic infection, length of hospitalisation, cost and patient quality of life.
DATA COLLECTION AND ANALYSIS
Information regarding methods, participants, interventions and outcome measures and results were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation and withdrawals and a quality assessment was carried out. The Cochrane Oral Health Group statistical guidelines were followed and risk ratios (RR) calculated using random-effects models.
MAIN RESULTS
Two hundred and two studies were eligible. One hundred and thirty two were excluded for various reasons, usually as there was no useable information on mucositis. Of the 71 useable studies all had data for mucositis comprising 5217 randomised patients. Interventions evaluated were: acyclovir, allopurinol mouthrinse, aloe vera, amifostine, antibiotic pastille or paste, benzydamine, beta carotene, calcium phosphate, camomile, chlorhexidine, clarithromycin, folinic acid, glutamine, GM-CSF, honey, hydrolytic enzymes, ice chips, iseganan, keratinocyte GF, misonidazole, oral care, pentoxifylline, povidone, prednisone, propantheline, prostaglandin, sucralfate, traumeel and zinc sulphate. Of the 29 interventions included in trials, 10 showed some evidence of a benefit (albeit sometimes weak) for either preventing or reducing the severity of mucositis. Interventions where there was more than one trial in the meta-analysis finding a significant difference when compared with a placebo or no treatment were: amifostine which provided minimal benefit in preventing moderate and severe mucositis RR = 0.84 (95% confidence interval (CI) 0.75 to 0.95) and 0.60 (95% CI 0.37 to 0.97), antibiotic paste or pastille demonstrated a moderate benefit in preventing mucositis RR = 0.87 (95% CI 0.79 to 0.97), hydrolytic enzymes reduced moderate and severe mucositis with RRs = 0.52 (95% CI 0.36 to 0.74) and 0.17 (95% CI 0.06 to 0.52), and ice chips prevented mucositis at all levels RR = 0.63 (95% CI 0.44 to 0.91), 0.43 (95% CI 0.23 to 0.81), 0.27 (95% CI 0.11 to 0.68). Other interventions showing some benefit with only one study were: benzydamine, calcium phosphate, honey, oral care protocols, povidone and zinc sulphate. The number needed to treat (NNT) to prevent one patient experiencing moderate or severe mucositis over a baseline incidence of 60% for amifostine is 10 (95% CI 7 to 33), antibiotic paste or pastille 13 (95% CI 8 to 56), hydrolytic enzyme 4 (95% CI 3 to 6) and ice chips 5 (95% CI 3 to 19). When the baseline incidence is 40%/90% the NNTs for amifostine are 16/7, for antibiotic paste or pastille 19/7, for hydrolytic enzyme 5/3 and for ice chips 7/3. The general reporting of RCTs was poor. However, the assessments of the quality of the randomisation improved when the authors provided additional information.
AUTHORS' CONCLUSIONS
Several of the interventions were found to have some benefit at preventing or reducing the severity of mucositis associated with cancer treatment. The strength of the evidence was variable and implications for practice include consideration that benefits may be specific for certain cancer types and treatment. There is a need for well designed and conducted trials with sufficient numbers of participants to perform subgroup analyses by type of disease and chemotherapeutic agent.
Topics: Antifungal Agents; Antineoplastic Agents; Candidiasis, Oral; Cryotherapy; Humans; Ice; Mouth Mucosa; Neoplasms; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 16625538
DOI: 10.1002/14651858.CD000978.pub2 -
International Journal of Radiation... Mar 2006To evaluate the efficacy of amifostine in diminishing radiotherapy side effects and whether or not it protects the tumor. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To evaluate the efficacy of amifostine in diminishing radiotherapy side effects and whether or not it protects the tumor.
METHODS AND MATERIALS
We performed a systematic review and meta-analysis of 14 included randomized controlled trials, comprising 1451 patients, comparing the use of radiotherapy vs. radiotherapy plus amifostine for cancer treatment.
RESULTS
The use of amifostine significantly reduced the risk of developing mucositis (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29-0.48; p < 0.00001), esophagitis (OR, 0.38; CI, 0.26-0.54; p < 0.00001), acute xerostomia (OR, 0.24; CI, 0.15-0.36; p < 0.00001), late xerostomia (OR, 0.33; CI, 0.21-0.51; p < 0.00001), dysphagia (OR, 0.26; CI, 0.07-0.92; p = 0.04), acute pneumonitis (OR, 0.15; CI, 0.07-0.31; p < 0.00001) and cystitis (OR, 0.17; CI, 0.09-0.32; p < 0.00001). There was no difference in overall response rate between the groups. However, complete response rate was superior for patients using amifostine (OR, 1.81; CI, 1.10-2.96; p = 0.02).
CONCLUSIONS
This systematic review shows that amifostine significantly reduces the side effects of radiation therapy. The efficacy of radiotherapy was not itself affected by the use of this drug and patients receiving amifostine were able to achieve higher rates of complete response.
Topics: Amifostine; Cystitis; Deglutition Disorders; Esophagitis; Humans; Neoplasms; Radiation Injuries; Radiation Pneumonitis; Radiation-Protective Agents; Radiodermatitis; Randomized Controlled Trials as Topic; Stomatitis; Xerostomia
PubMed: 16198504
DOI: 10.1016/j.ijrobp.2005.06.023