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Gene Test Receives Lukewarm Endorsement Into Breast Cancer Guidelines: Presented at NCCN

By Ed Susman

HOLLYWOOD, Fla -- March 14, 2010 -- A genetic test that can give patients and clinicians an idea of what the risk of recurrence may be has been added to the treatment and management algorithm for breast cancer, physicians said here at the 15th Annual National Comprehensive Cancer Network (NCCN) Conference on Clinical Practice Guidelines and Quality Cancer Care.

However, the use of the 21-gene reverse transcription polymerase chain reaction test was given a lukewarm endorsement (Level 2B - low level evidence and a lack of consensus on the guideline panel), according to Robert Carlson, MD, Stanford University, Stanford, California.

"Many of us do not think that use of the test provides information that would not be unexpected," said Dr. Carlson. "Level 2B evidence means we disagreed about including it in the guidelines, but no one thought the proponents of its use were crazy."

In the guidelines, the use of the commercially available test is limited to use among breast cancer patients who have hormone receptor positive tumours that are also human epidermal growth factor receptor 2 (HER2)-gene receptor negative.

The use of the test is also limited to use in tumours that are 0.6 to 1.0 cm (or >1 cm), are grade 2 or 3, or have unfavourable features.

In presenting the wide-ranging breast cancer treatment guidelines on March 11, Dr. Carlson said the guidelines suggests that clinicians "consider" the use of the assay when considering treatment options:
· If the test is not performed, patients would be placed on adjuvant endocrine therapy with or without adjuvant chemotherapy. This recommendation has Level 1 evidence, meaning it is supported by results from randomised clinical trials.
· If the test is employed and comes up with a low recurrence score, patients would be treated with adjuvant endocrine therapy.
· If the test revealed an intermediate recurrence score, the guidelines suggest adjuvant endocrine therapy with or without adjuvant chemotherapy.
· If the test revealed a high recurrence score, the guidelines suggest adjuvant endocrine therapy plus adjuvant chemotherapy.

The guideline writers noted that all the treatment suggestions based on recurrence scores are considered Level 2B recommendations.

Dr. Carlson noted that the test has been "validated only in tamoxifen-treated patients with first generation chemotherapy. Since most HER2-positive tumours have high recurrence scores, the major use of the test would be in oestrogen receptor-positive, HER2-negative, node-negative disease."

[Presentation title: NCCN Breast Cancer Guidelines Update]

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