NCCN Guidelines and Compendium Updated
NCCN Flash Update sent March 13, 2013
NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Breast Cancer. These NCCN Guidelines® are currently available as Version 2.2013.
- Page BINV-21
- Systemic treatment of recurrent or stage IV disease, ER- and PR-negative; or ER- and/or PR-positive and endocrine refractory; and HER2-positive
Ado-trastuzumab emtansine was added as a preferred therapeutic option in the treatment of HER2-positive, metastatic breast cancer.
- Page BINV-O (1 of 7)
- Added ado-trastuzumab emtansine as a preferred agent for trastuzumab-exposed HER2-positive disease
- Page BINV-O (7 of 7)
- Added the following reference: Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med 2012;367:1783-1791.
- The Discussion section has been updated to reflect the changes in the algorithm.
*For your reference, the announcement of the previous update (Version 1.2013) to the NCCN Guidelines for Breast Cancer, distributed on February 6, 2013, is included below:
NCCN has published updates to the NCCN Guidelines and NCCN Compendium for Breast Cancer. These NCCN Guidelines are currently available as Version 1.2013.
- Lobular Carcinoma in Situ (LCIS):
- Added a new footnote "Multifocal/extensive LCIS involving >4 terminal ductal lobular units on a core biopsy may be associated with increased risk of invasive cancer on surgical excision." (LCIS-1)
- Ductal Carcinoma in Situ (DCIS):
- Breast MRI was added as optional test for work-up (DCIS-1)
- Invasive Breast Cancer:
- In the preoperative chemotherapy guideline,
- The option of alternative chemotherapy prior to surgery for those with partial response to preoperative chemotherapy or with progressive disease was removed.
- After mastectomy or lumpectomy, the option of "chemotherapy in the context of a clinical trial" was taken off and a new bullet was added stating "complete planned chemotherapy regimen course if not completed preoperatively plus endocrine treatment if ER-positive and/or PR-positive (sequential chemotherapy followed by endocrine therapy)." (BINV-13)
- Principles of HER2 Testing (BINV-A)
- Two new footnotes were added to the page: Footnote 1, "NCCN endorses the ASCO CAP recommendations for quality control performance of HER2 testing and interpretation of IHC and ISH results"; and Footnote 5, "In those circumstances if both IHC and ISH are performed, if one or the other or both are positive, then consider HER2 positive."
- The HER2 status on the basis of ISH testing results are classified as
- HER2 negative if ISH (-) <2
- HER2 positive if ISH (+) ≥ 2
- The Borderline result is discussed in the modified footnote 7: "Borderline in situ hybridization (ISH) samples (eg, an average HER2 gene/chromosome 17 ratio of 1.8- < 2 or an average HER2 gene copy number of > 4 - < 6) should undergo: counting of additional cells; retesting by ISH; or reflex testing by a validated IHC method.
- Surgical Axillary Staging
- For sentinel node-positive disease that meets all the criteria listed on page BINV-D, the panel added axillary level I/II dissection as an option in addition the option of considering no further surgery.
- For sentinel node-negative disease, the panel recommends no further surgery
- Axillary Lymph Node Staging
- The panel added the following statement "In the absence of gross disease in level II nodes, lymph node dissection should include tissue inferior to the axillary vein from the latissimus dorsi muscle laterally to the medial border of the pectoralis minor muscle (Level I/II). Level III dissection to the thoracic inlet should be performed only in cases with gross disease in level II."(BINV-E)
- Neoadjuvant/Adjuvant Chemotherapy (BINV-K)
- Moved TAC (docetaxel/doxorubicin/cyclophosphamide) from "Preferred Regimens" to "Other Regimens".
- Removed the following regimens from the Guidelines:
- AC (doxorubicin/cyclophosphamide) followed by weekly paclitaxel
- A followed by T followed by C (doxorubicin followed by paclitaxel followed by cyclophosphamide)
- Added dose-dense AC (doxorubicin/cyclophosphamide) followed by weekly paclitaxel to "Preferred Regimens".
- Added FAC followed by T (fluorouracil/doxorubicin/cyclophosphamide followed by weekly paclitaxel) to the list of "Other Regimens".
- Updated dosing schedules and references.
- Chemotherapy Regimens for Recurrent or Metastatic Breast Cancer (BINV-O)
- Moved the following to the list of "Other single agents" :
- Albumin-bound paclitaxel
- Added carboplatin to the list of "Other Single Agents".
- Removed the following from the Guidelines
- Etoposide (PO)
- Fluorouracil Cl
- Added the following to the list of chemotherapy combinations:
- Removed the following combination therapies from the Guidelines:
- AT (doxorubicin/docetaxel; doxorubicin/paclitaxel)
- Ixabepilone + capecitabine
- Updated dosing schedules and references.
- The Discussion section and references have been updated to reflect the changes in the algorithm
For the complete updated versions of the NCCN Guidelines, the NCCN Compendium®, and the NCCN Chemotherapy Order Templates (NCCN Templates®), please visit NCCN.org.
To view the NCCN Guidelines for Patients®, please visit NCCN.com.
To access free NCCN Guidelines mobile apps for iPhone and Android, visit NCCN.org/mobile.
Now Available! The Virtual Library of NCCN Guidelines are now formatted for iPad and Android. Visit NCCN.org/mobile/tablet.asp.