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Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up.

Publication ,  Journal Article
Piccart, M; Procter, M; Fumagalli, D; de Azambuja, E; Clark, E; Ewer, MS; Restuccia, E; Jerusalem, G; Dent, S; Reaby, L; Bonnefoi, H; Krop, I ...
Published in: J Clin Oncol
May 1, 2021

PURPOSE: APHINITY, at 45 months median follow-up, showed that pertuzumab added to adjuvant trastuzumab and chemotherapy significantly improved invasive disease-free survival (IDFS) (hazard ratio 0.81 [95% CI, 0.66 to 1.00], P = .045) for patients with early human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC), specifically those with node-positive or hormone receptor (HR)-negative disease. We now report the preplanned second interim overall survival (OS) and descriptive updated IDFS analysis with 74 months median follow-up. METHODS: After surgery and central HER2-positive confirmation, 4,805 patients with node-positive or high-risk node-negative BC were randomly assigned (1:1) to either 1-year pertuzumab or placebo added to standard adjuvant chemotherapy and 1-year trastuzumab. RESULTS: This interim OS analysis comparing pertuzumab versus placebo did not reach the P = .0012 level required for statistical significance (P = .17, hazard ratio 0.85). Six-year OS were 95% versus 94% with 125 deaths (5.2%) versus 147 (6.1%), respectively. IDFS analysis based on 508 events (intent-to-treat population) showed a hazard ratio of 0.76 (95% CI, 0.64 to 0.91) and 6-year IDFS of 91% and 88% for pertuzumab and placebo groups, respectively. The node-positive cohort continues to derive clear IDFS benefit from pertuzumab (hazard ratio 0.72 [95% CI, 0.59 to 0.87]), 6-year IDFS being 88% and 83%, respectively. Benefit was not seen in the node-negative cohort. In a subset analysis, IDFS benefit from pertuzumab showed a hazard ratio of 0.73 (95% CI, 0.59 to 0.92) for HR-positive disease and a hazard ratio of 0.83 (95% CI, 0.63 to 1.10) for HR-negative disease. Primary cardiac events remain < 1% in both the treatment groups. No new safety signals were seen. CONCLUSION: This analysis confirms the IDFS benefit from adding pertuzumab to standard adjuvant therapy for patients with node-positive HER2-positive early BC. Longer follow-up is needed to fully assess OS benefit.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 1, 2021

Volume

39

Issue

13

Start / End Page

1448 / 1457

Location

United States

Related Subject Headings

  • Trastuzumab
  • Survival Rate
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Follow-Up Studies
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Piccart, M., Procter, M., Fumagalli, D., de Azambuja, E., Clark, E., Ewer, M. S., … APHINITY Steering Committee and Investigators, . (2021). Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol, 39(13), 1448–1457. https://doi.org/10.1200/JCO.20.01204
Piccart, Martine, Marion Procter, Debora Fumagalli, Evandro de Azambuja, Emma Clark, Michael S. Ewer, Eleonora Restuccia, et al. “Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up.J Clin Oncol 39, no. 13 (May 1, 2021): 1448–57. https://doi.org/10.1200/JCO.20.01204.
Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, et al. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448–57.
Piccart, Martine, et al. “Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up.J Clin Oncol, vol. 39, no. 13, May 2021, pp. 1448–57. Pubmed, doi:10.1200/JCO.20.01204.
Piccart M, Procter M, Fumagalli D, de Azambuja E, Clark E, Ewer MS, Restuccia E, Jerusalem G, Dent S, Reaby L, Bonnefoi H, Krop I, Liu T-W, Pieńkowski T, Toi M, Wilcken N, Andersson M, Im Y-H, Tseng LM, Lueck H-J, Colleoni M, Monturus E, Sicoe M, Guillaume S, Bines J, Gelber RD, Viale G, Thomssen C, APHINITY Steering Committee and Investigators. Adjuvant Pertuzumab and Trastuzumab in Early HER2-Positive Breast Cancer in the APHINITY Trial: 6 Years' Follow-Up. J Clin Oncol. 2021 May 1;39(13):1448–1457.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

May 1, 2021

Volume

39

Issue

13

Start / End Page

1448 / 1457

Location

United States

Related Subject Headings

  • Trastuzumab
  • Survival Rate
  • Receptor, erbB-2
  • Receptor, ErbB-2
  • Prognosis
  • Oncology & Carcinogenesis
  • Middle Aged
  • Humans
  • Follow-Up Studies
  • Female