FORT LAUDERDALE, Fla--The National Comprehensive Cancer Network (NCCN) continues to fine tune its breast cancer guideline, introduced 2 years ago. Robert Carlson, MD, of Stanford University, and chair of the Breast Cancer Guideline Committee, reviewed the proposed revisions at the NCCNs third conference. The Network is a coalition of 16 US cancer centers.
He reiterated a common note for all the NCCN guidelines: That clinical trial participation is always the preferred treatment, and the guidelines assume that either a clinical trial is not available or the patient has declined to participate.
Most of the changes involve recommendations for primary treatment for stage I, IIa, or IIb breast cancer. Axillary dissection is still recommended whether the patient has mastectomy or breast-conserving surgery with irradiation. However, the new guideline adds a category 2 ("somewhat controversial") recommendation to allow the opportunity for level III axillary dissections. The guideline states: "The axillary dissection should be extended to include level III nodes only if there is gross disease apparent in the level I or II lymph nodes."
Another change is the recognition of sentinel lymph node biopsy as an option in carefully selected women. "The nonrandomized data show very high concordance of the sentinel lymph node pathology versus that found in the rest of the axilla on subsequent axillary dissection," Dr. Carlson said.
The category 2 recommendation is that sentinel node biopsy is an option if the axilla is clinically negative, the lesion is a solitary tumor of less than 3 cm with no large hematoma or seroma in the breast, the patient has not received neoadjuvant chemotherapy, and an experienced sentinel node team is available. Formal axillary dissection is performed if the sentinel node is not identified or if it is positive.
The revised guideline requires post-chemotherapy chest wall and supracla-vicular irradiation in pre- and postmen-opausal women with 4 or more positive axillary lymph nodes. This recommendation is based on studies showing a high risk of recurrence in these women.
The guideline also states that postchemotherapy chest wall and regional node irradiation should be considered in premenopausal women with 1 to 3 positive axillary lymph nodes (in a "controversial" category 3 recommendation). "The disagreement among the committee members was whether the language should be consider or should," he said.
This recommendation is based on two recent trials, one Danish and one Canadian, showing not only decreased probability of local recurrence with such irradiation but also the very surprising result of a survival advantage.
The new guideline also states (in a category 3 recommendation) that inclusion of the internal mammary nodes in the radiation field should be considered for premenopausal women.
For stage I, IIa, and IIb patients, the adjuvant therapy recommendations remain substantially unchanged except for the recognition that ovarian ablation may be considered a treatment option in premenopausal women with hormone-receptor-positive disease.
Dr. Carlson said that he personally had never "ablated an ovary for the adjuvant treatment of breast cancer." However, he said, there is substantial evidence, including a recently published overview analysis by the Early Breast Cancer Trialists Group, that ovarian ablation in receptor-positive premenopausal women under age 45 appears to be as effective as cytotoxic chemotherapy.
In the revised guideline, surveillance for the development of recurrent disease has been limited to regular interval history and physical exam, yearly mammog-raphy of the retained breast(s), and, for women on tamoxifen (Nolvadex), yearly pelvic exam. Absent this year is the use of screening chest x-rays and chemistries.
For the first time, the NCCN has prioritized the first-line chemotherapy options for women with systemic recurrence. "We believe the first-line chemotherapy should be doxorubicin-based, a taxane, or CMF chemotherapy," he said. Further, a footnote has been added for the consideration of the use of the bisphosphate pamidronate (Aredia) in women who have two or more osteolytic lesions, expected survival of 3 months or more, and serum creatinine level of less than 2.5 mg/dL.