Guideline Development
This practice guideline report was developed by the Program in Evidence-based Care (PEBC) of Cancer Care Ontario, using the methods of the Practice Guidelines Development Cycle. Evidence was selected and reviewed by one member of the PEBC's Melanoma Disease Site Group (DSG) and methodologists.
The practice guideline report is a convenient and up-to-date source of the best available evidence on systemic adjuvant therapy for patients at high risk for recurrent melanoma, developed through systematic reviews, evidence synthesis, and input from practitioners in Ontario. The body of evidence in this report is primarily comprised of mature randomized controlled trial data; therefore, recommendations by the DSG are offered. The report is intended to promote evidence-based practice. The PEBC is editorially independent of Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.
A practice guideline report on systemic adjuvant therapy for patients at high risk for recurrent melanoma was originally completed in 1998 and published on the Web site. With the publication of further relevant literature on adjuvant therapy and the adoption of a new staging system for cutaneous melanoma, the Melanoma DSG has rewritten its 1998 report. This document replaces that 1998 report.
Disease Site Group Consensus Process
The members of the Melanoma DSG reviewed the rewritten document at a meeting held in September 2002. The group unanimously agreed that interferon has activity in the adjuvant setting. However, one member of the DSG objected to the word "offered" in the Key Recommendation, pointing out that the issue of adjuvant interferon is controversial and that the use of the word "offered" precludes further clinical trials being undertaken. This member suggested alternate wording for the recommendation: "We recommend that interferon therapy be discussed with the high risk patient. It may be used as adjuvant treatment, provided that each patient has been made aware of the controversies, relative risks, benefits, and costs of this therapy and wishes to proceed." The group noted this objection but decided to let the Key Recommendation stand as currently written, to be reviewed by practitioners in Ontario.
Another issue raised at the meeting of the Melanoma DSG concerned the new American Joint Committee on Cancer (AJCC) staging system, which highlights the presence of ulceration as an important prognostic factor. Under the new staging system, patients with lesions between 2.0 and 4.0 mm with ulceration have the same prognosis as patients with lesions greater than 4.0 mm without ulceration. None of the trials included in this document were conducted under the new staging system. However, the group felt that new trials based on the new staging criteria were unlikely to be undertaken. For this reason, the Target Population has been amended to include patients with shallower, ulcerated lesions. The DSG sought input from Ontario practitioners about the appropriateness of including these new patients when this document was circulated for practitioner feedback.