ASCO Clinical Practice Guideline Focused Update: Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer


As reported by Neelima Denduluri, MD, of US Oncology Network, Virginia Cancer Specialists, and colleagues in the Journal of Clinical Oncology, ASCO has issued a focused update on the clinical practice guideline on optimal chemotherapy and targeted therapy in early breast cancer.

To develop the updated recommendations, an expert panel conducted targeted systematic literature reviews to identify potentially practice-changing data that might prompt revision of clinical practice. In particular, the panel reviewed phase III trials assessing adjuvant capecitabine after completion of standard preoperative anthracycline- and taxane-based combination chemotherapy in early HER2-negative breast cancer with residual invasive disease at surgery; the addition of 1 year of adjuvant pertuzumab (Perjeta) to combination chemotherapy and trastuzumab (Herceptin) for patients with early HER2-positive breast cancer; and the use of neratinib (Nerlynx) in extended adjuvant therapy after combination chemotherapy and trastuzumab-based adjuvant therapy in early HER2-positive breast cancer.

The panel was co-chaired by Dr. Denduluri and Sharon H. Giordano, MD, of The University of Texas MD Anderson Cancer Center. The focused update recommendations are summarized/reproduced below.

Focused Update Recommendations

  • Patients with early-stage HER2-negative breast cancer with pathologic invasive residual disease at surgery following standard anthracycline- and taxane-based preoperative therapy may be offered up to six to eight cycles of adjuvant capecitabine.

Qualifying statements: If clinicians decide to use capecitabine, then the expert panel preferentially supports the use of adjuvant capecitabine in the subgroup of patients with hormone receptor–negative, HER2-negative disease. The capecitabine dosage used in the CREATE-X study (1,250 mg/m2 twice daily) is associated with higher toxicity in patients ≥ 65 years old.

  • Clinicians may add 1 year of adjuvant pertuzumab to trastuzumab-based combination chemotherapy in patients with high-risk, early-stage, HER2-positive breast cancer.

Qualifying statements: The panel preferentially supports pertuzumab in patients with node-positive, HER2-positive breast cancer in view of the clinically insignificant absolute benefit observed among node-negative patients. After a median follow-up of 3.8 years, pertuzumab offered a modest disease-free survival benefit. The first planned interim analysis did not show an overall survival benefit in the trial population. There are no data to guide the duration of pertuzumab in patients who received neoadjuvant pertuzumab and achieved a pathologic complete response.

  • Clinicians may use extended adjuvant therapy with neratinib to follow trastuzumab in patients with early-stage, HER2-positive breast cancer. (Neratinib causes substantial diarrhea, and diarrhea prophylaxis must be used.)

Qualifying statements: The panel preferentially favors use of neratinib in patients with HER2-positive, hormone receptor–positive, and node-positive disease. At a median follow-up of 5.2 years, no overall survival benefit has been observed. Patients who began neratinib within 1 year of trastuzumab completion appeared to derive the greatest benefit. There are no data on the added benefit of neratinib in patients who also received pertuzumab in the neoadjuvant or adjuvant setting.

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The corresponding author for the Journal of Clinical Oncology article is ASCO; e-mail

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.