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Efficacy and Safety of Tailored and Dose-Dense Adjuvant Chemotherapy and Trastuzumab for Resected HER2-Positive Breast Cancer: Results From the Phase 3 PANTHER Trial
Karolinska Inst, Sweden; Univ Hosp, Sweden.
Karolinska Inst, Sweden; Univ Hosp, Sweden.
Univ Hosp Umea, Sweden.
Lund Univ, Sweden; Skane Univ Hosp, Sweden.
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(English)In: Cancer, ISSN 0008-543X, E-ISSN 1097-0142Article in journal (Refereed) Epub ahead of print
Abstract [en]

BACKGROUND Dose-dense (DD) adjuvant chemotherapy improves outcomes in early breast cancer (BC). However, there are no phase 3 randomized data to inform on its combination with trastuzumab for patients with human epidermal growth factor receptor 2 (HER2)-positive disease. METHODS This was a protocol-predefined secondary analysis of the randomized phase 3 Pan-European Tailored Chemotherapy (PANTHER) trial. Women 65 years old or younger with node-positive or high-risk, node-negative BC were randomized 1:1 to either tailored (according to hematologic nadirs) and DD epirubicin and cyclophosphamide followed by docetaxel or standard 5-fluorouracil, epirubicin, and cyclophosphamide plus docetaxel every 3 weeks. Patients with HER2-positive disease received 1 year of adjuvant trastuzumab. The primary endpoint was BC relapse-free survival. In addition, HER2-positive patients and an equal number of HER2-negative patients matched for age, treatment group, and institution who were enrolled at Swedish sites were asked to participate in a predefined study of cardiac safety and underwent echocardiography or multigated acquisition scanning and electrocardiography at the baseline and at 4 and 6 years of follow-up. RESULTS There were 342 HER2-positive patients; 335 received at least 1 dose of trastuzumab, and 29 patients discontinued trastuzumab prematurely. Relapse-free survival was not statistically significantly in favor of the tailored and DD group (hazard ratio, 0.68; 95% confidence interval, 0.37-1.27; P = .231). Cardiac outcomes after 4 and 6 years of follow-up did not differ significantly between HER2-positive and HER2-negative patients or between the 2 treatment groups. CONCLUSIONS The combination of DD chemotherapy and trastuzumab decreased the relative risk for relapse by 32% in comparison with standard treatment, a statistically nonsignificant difference. Its efficacy and safety merit further evaluation as part of both escalation and de-escalation strategies.

Place, publisher, year, edition, pages
WILEY.
Keywords [en]
adjuvant chemotherapy; breast cancer; cardiotoxicity; dose-dense; human epidermal growth factor receptor 2 (HER2); trastuzumab
National Category
Urology and Nephrology
Identifiers
URN: urn:nbn:se:liu:diva-162919DOI: 10.1002/cncr.32653ISI: 000503104800001PubMedID: 31851385OAI: oai:DiVA.org:liu-162919DiVA, id: diva2:1382387
Note

Funding Agencies|Swedish Cancer SocietySwedish Cancer Society [CAN 2017/1043, CAN 2016/791]; Swedish Breast Cancer Association; Radiumhemmet [164003, 174113]; AmgenAmgen; RocheRoche Holding; Sanofi-AventisSanofi-Aventis; Stockholm County CouncilStockholm County Council

Available from: 2020-01-02 Created: 2020-01-02 Last updated: 2020-01-02

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Hübbert, Laila
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Division of Cardiovascular MedicineFaculty of Medicine and Health SciencesDepartment of Cardiology in Norrköping
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