Original Guideline: May 2003
The literature was searched using the MEDLINE (1966 through January 2003), CANCERLIT (1983 through October 2002), and Cochrane Library (Issue 4, 2002) databases. In addition, the Physician Data Query clinical trials database, and abstracts published in the conference proceedings from the meetings of the American Society of Clinical Oncology (1998-2002), the American Society for Therapeutic Radiology and Oncology (1999-2002), and the European Society for Medical Oncology (1998, 2000) were searched for reports of new or ongoing trials. The Canadian Medical Association Infobase and the National Guideline Clearinghouse databases were searched for clinical practice guidelines. Reference lists from relevant articles and reviews were searched for additional trials. In the event of incomplete or missing data, authors were contacted for further information.
The literature search combined disease-specific terms (head and neck neoplasms/ or carcinoma, squamous cell/ or head and neck cancer.tw.) with treatment-specific terms (amifostine/ or amifostine.tw. or ethyol.tw. or wr-2721.tw.) and (radiotherapy/ or combined modality therapy/) with search-specific terms for the following study designs: practice guidelines, systematic reviews or meta-analyses, reviews, randomized controlled trials, and clinical trials.
Update
The original literature search has been updated using MEDLINE (January 2003 through March 2004), EMBASE (1980 through March 2004), the Cochrane Library (Issue 1, 2004), the Physician Data Query database, the Canadian Medical Association Infobase, and the National Guideline Clearinghouse, as well as abstracts published in the proceedings of the meetings of the American Society of Clinical Oncology (2003), the American Society for Therapeutic Radiology and Oncology (2003), and the European Society for Medical Oncology (2002). Article bibliographies and personal files were also searched to March 2004 for evidence relevant to this practice guideline report. Please note that CANCERLIT is no longer included in update searches: results from an internal PGI project indicated that the overlap with MEDLINE is 100%, making CANCERLIT database searches redundant.
Original Guideline: May 2003
Inclusion Criteria
Articles were selected for inclusion in this systematic review of the evidence if they were fully published reports or published abstracts that met the following criteria:
- Randomized trials comparing conventionally fractionated radical radiotherapy or concurrent radiochemotherapy, encompassing at least 75% of the parotid glands, with or without amifostine in adult patients with any stage squamous cell head and neck cancer. Conventionally fractionated radiotherapy was defined as single daily fractions ranging from 1.8 to 2.5 Gy to a total of 5,000 to 7,400 cGy.
- Practice guidelines, meta-analyses, or systematic reviews related to the guideline question
- Outcomes related to radiation-induced side effects, quality of life, or survival differences were reported. Xerostomia, mucositis, and the anti-tumour effects of amifostine were the main outcomes of interest. Tumour protection was inferred from differences in rates of response, local recurrence, and/or survival between the intervention group (with amifostine) and the control group (without amifostine).
Update
Through the editorial process the second bullet was revised as a separate paragraph to read:
Practice guidelines, meta-analyses, or systematic reviews explicitly based on randomized trials to the guideline question were also eligible for inclusion.
Original Guideline: May 2003
Exclusion Criteria
- Phase I and II studies were not considered.
- Letters and editorials were not considered.
- Papers published in a language other than English were not considered.
Update
Through the editorial process the document was modified to reflect the removal of the following two exclusion criteria:
- Phase I and II studies were not considered.
- Letters and editorials were not considered.