Clinical utility of multigene profiling assays in early-stage breast cancer.

BACKGROUND: This clinical practice guideline was developed to determine the level of evidence supporting the clinical utility of commercially available multigene profiling assays and to provide guidance about whether certain breast cancer patient populations in Ontario would benefit from alternative tests in addition to Oncotype dx (Genomic Health, Redwood City, CA, U.S.A.). METHODS: A systematic electronic Ovid search of the medline and embase databases sought out systematic reviews and primary literature. A systematic review and practice guideline was written by a working group and was then reviewed and approved by Cancer Care Ontario's Molecular Oncology Advisory Committee. RESULTS: Twenty-four studies assessing the clinical utility of Oncotype dx, Prosigna (NanoString Technologies, Seattle, WA, U.S.A.), EndoPredict (Myriad Genetics, Salt Lake City, U.S.A.), and MammaPrint (Agendia, Irvine, CA, U.S.A.) were included in the evidence base. CONCLUSIONS: The clinical utility of multigene profiling assays is currently established for an appropriate subset of patients with estrogen receptor-positive, her2-negative, node-negative breast cancer for whom a decision to give chemotherapy is difficult to make. For patients with estrogen receptor-positive tumours who receive tamoxifen alone, Oncotype dx, Prosigna, and EndoPredict validly identify a low-risk population with favourable outcomes, indicating that a low-risk assay result is actionable and the decision to withhold chemotherapy is supported. Clinical evidence indicates that a high Oncotype dx recurrence score can predict for chemotherapy benefit, but a high Prosigna or EndoPredict score, although prognostic, is not, based on clinical trial evidence, directly actionable. Prosigna and EndoPredict are statistically more likely to identify a population at risk for recurrence beyond 5 years, but that information is currently not actionable because of a lack of interventional studies.

Primary excision margins, sentinel lymph node biopsy, and completion lymph node dissection in cutaneous melanoma: a clinical practice guideline.

Background: For patients who are diagnosed with early-stage cutaneous melanoma, the principal therapy is wide surgical excision of the primary tumour and assessment of lymph nodes. The purpose of the present guideline was to update the 2010 Cancer Care Ontario guideline on wide local excision margins and sentinel lymph node biopsy (slnb), including treatment of the positive sentinel node, for melanomas of the trunk, extremities, and head and neck. Methods: Using Ovid, the medline and embase electronic databases were systematically searched for systematic reviews and primary literature evaluating narrow compared with wide excision margins and the use of slnb for melanoma of the truck and extremities and of the head and neck. Search timelines ran from 2010 through week 25 of 2017. Results: Four systematic reviews were chosen for inclusion in the evidence base. Where systematic reviews were available, the search of the primary literature was conducted starting from the end date of the search in the reviews. Where systematic reviews were absent, the search for primary literature ran from 2010 forward. Of 1213 primary studies identified, 8 met the inclusion criteria. Two randomized controlled trials were used to inform the recommendation on completion lymph node dissection.Key updated recommendations include:■ Wide local excision margins should be 2 cm for melanomas of the trunk, extremities, and head and neck that exceed 2 mm in depth.■ slnb should be offered to patients with melanomas of the trunk, extremities, and head and neck that exceed 0.8 mm in depth.■ Patients with sentinel node metastasis should be considered for nodal observation with ultrasonography rather than for completion lymph node dissection. Conclusions: Recommendations for primary excision margins, sentinel lymph node biopsy, and completion lymph node dissection in patients with cutaneous melanoma have been updated based on the current literature.

Follow-up Care for Survivors of Prostate Cancer - Clinical Management: a Program in Evidence-Based Care Systematic Review and Clinical Practice Guideline.

AIMS: This clinical practice guideline was developed to provide evidence-based guidance on the frequency by which prostate-specific antigen (PSA) levels should be tested in men after curative-intent treatment for prostate cancer and to define the most appropriate diagnostic testing if biochemical recurrence occurs. MATERIALS AND METHODS: An electronic search using OVID was used to systematically search the MEDLINE and EMBASE databases for systematic reviews and primary literature. A systematic review and practice guideline was written, reviewed and approved by the Guideline Development Group (GDG) and Program in Evidence-Based Care Report Approval Panel. External review by three prostate experts was completed, as well as an online consultation with healthcare professionals who were intended users of the guideline. RESULTS: Three systematic reviews and seven primary studies were included in the evidence base. All identified literature reported on diagnostic imaging properties of diagnostic tests following biochemical recurrence. CONCLUSIONS: Due to a lack of empirical research, few evidenced-based recommendations could be made with respect to a follow-up schedule of PSA testing for prostate cancer survivors following curative-intent treatment, or detailing diagnostic testing upon detection of biochemical recurrence. Accordingly, the GDG focused substantial effort on critical examination of the identified evidence, existing clinical practice guidelines and on obtaining clinical expertise consensus using a modified Delphi method. Overall, the recommendations embedded in this guideline reflect the best practice to date for the efficient and effective clinical follow-up care of prostate cancer survivors.