NCCN BREAST CANCER GUIDELINES

March 23, 2012 (Hollywood, Florida) — The breast cancer guidelines from the National Comprehensive Cancer Network (NCCN) have had a "major change" in the past year with regard to axillary lymph node dissection, according to a presenter here at the NCCN 17th Annual Conference.

The guidelines also feature a "major shift" in systemic staging in early disease.

"From the surgical standpoint, the major change...has to do with the management of the axilla," said Benjamin Anderson, MD, from the University of Washington and the Seattle Cancer Care Alliance, who presented the surgery section of the guidelines.

Currently, the NCCN recommends that surgeons forgo sentinel lymph node biopsy whenever the initial findings are negative, Dr. Anderson noted. In other words, if there is no disease in the sentinel node, then no further surgery in the axilla is needed. This recommendation stays the same.

In the past, axillary completion dissection was advised when any disease was found in sentinel nodes. The new guidance says that — for a certain set of early breast cancer patients with minimal lymph node involvement — the axillary completion dissection can now be skipped.

The reason is simple — to avoid a "lifelong problem" associated with axillary completion dissection. Lymphedema of the arm occurs in a "significant" number of patients and can become a "serious quality-of-life issue" with this more extensive lymph node surgery, said Dr. Anderson.

Forgoing axillary dissection is now acceptable in some patients because a major clinical trial from the American College of Surgeons Oncology Group (ACOSOG) found that outcomes in patients with minimal sentinel lymph node involvement (1 or 2 positive nodes) who did not receive axillary dissection were similar to outcomes in those who did. In other words, there is no price to pay, evidently, for skipping the more extensive surgery when there is minimal disease in the axilla, and there is a benefit in terms of lymphedema.

Exactly Which Patients Can Forgo Surgery?

The ACOSOG Z11 trial addressed a "big question," according to Dr. Anderson: When a patient has a positive sentinel node, "do we need to do complete axillary dissection?"

The answer of course is a conditional no. However, clinicians can only subscribe to this recommendation if a patient meets "all of the criteria" in the guidelines, Dr. Anderson explained.

Namely, patients can be considered for sentinel lymph node biopsy alone if they have early-stage disease (T1 or T2 tumor), if they have 1 or 2 positive nodes on biopsy, if they have been treated with breast-conserving surgery, if they have undergone whole-breast radiation therapy, and if they have not received neoadjuvant chemotherapy.

These proscriptions arise from the particulars of the patient population in the practice-changing Z11 trial.

The women in that trial all met the above criteria, and about 96% had received adjuvant systemic therapy (chemotherapy and/or hormone therapy). This was of "great importance," said Dr. Anderson, because between the systemic and the radiation therapy, the axilla are being treated — just not with surgery.

The 5-year overall survival was 91.8% for axillary lymph node dissection (ALND) and 92.5% for sentinel lymph node dissection (SLND) alone, with a median follow-up of 6.3 years. The results were first presented at the 2010 meeting of the American Society of Clinical Oncology, and were reported at that time as practice-changing byMedscape Medical News.

There was also no benefit of ALND in terms of local control or disease-free survival.

The median number of nodes removed was 17 in the ALND group and 2 in the SLND-alone group. The 5-year disease-free survival was 83.9% with SLND alone and 82.2% with ALND. The locoregional recurrence rates were also similar in the ALND and SLND groups (4.1% vs 2.8%).

Reducing Testing in Early Disease

In the breast cancer guidelines, the section on patient work-up (early-stage disease) after mammography and sentinel node biopsy also featured important changes.

The recommendations in the section are mostly unchanged. Among other things, clinicians are advised to take a history, perform a physical exam, do complete blood and platelet counts, perform liver function tests, review the pathology, and determine receptor status.

In the past, the breast cancer panel told clinicians to "consider" additional studies. Now, for clinical stage I to IIB patients, the panel recommends considering "additional studies only if directed by signs or symptoms."

"The major shift is that...routine systemic staging is not recommended in early-stage disease in the absence of signs and symptoms," explained Dr. Anderson.

"We are moving away from the idea in early-stage disease that one just routinely gets a battery of tests," he continued.

In summary, clinicians should only order the following tests for patients with early-stage disease if they are warranted clinically:

• bone scan, for localized bone pain or elevated alkaline phosphatase
• abdominal and/or pelvic diagnostic computed tomography (CT) or magnetic resonance imaging, for elevated alkaline phosphatase, abnormal liver function tests, abdominal symptoms, or abnormal physical examination of the abdomen or pelvis
• chest diagnostic CT, if pulmonary symptoms are present.

Dr. Anderson reports being a consultant to Navidea Biopharmaceuticals.

National Comprehensive Cancer Network (NCCN) 17th Annual Conference. Presented March 16, 2011