Neoadjuvant Trastuzumab Emtansine and Pertuzumab in Human Epidermal Growth Factor Receptor 2–Positive Breast Cancer: Three-Year Outcomes From the Phase III KRISTINE Study

Author:

Hurvitz Sara A.1,Martin Miguel2,Jung Kyung Hae3,Huang Chiun-Sheng4,Harbeck Nadia5,Valero Vicente6,Stroyakovskiy Daniil7,Wildiers Hans8,Campone Mario9,Boileau Jean-François10,Fasching Peter A.11,Afenjar Karen12,Spera Gonzalo13,Lopez-Valverde Vanesa14,Song Chunyan15,Trask Peter15,Boulet Thomas14,Sparano Joseph A.16,Symmans W. Fraser6,Thompson Alastair M.17,Slamon Dennis1

Affiliation:

1. University of California, Los Angeles, Los Angeles, CA

2. Universidad Complutense, CUBERONC, GEICAM, Madrid, Spain

3. Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea

4. National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Republic of China

5. University of Munich, Munich, Germany

6. The University of Texas MD Anderson Cancer Center, Houston, TX

7. Moscow City Oncology Hospital 62, Moscow, Russia

8. University Hospitals Leuven, Leuven, Belgium

9. Centre René Gauducheau, Saint-Herblain, France

10. McGill University, Jewish General Hospital Segal Cancer Centre, Montréal, Québec, Canada

11. University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Erlangen, Germany

12. Translational Research in Oncology, Paris, France

13. Translational Research in Oncology, Montevideo, Uruguay

14. PAREXEL International GmbH, Berlin, Germany

15. Genentech, South San Francisco, CA

16. Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY

17. Baylor College of Medicine, Houston, TX

Abstract

PURPOSE The KRISTINE study compared neoadjuvant trastuzumab emtansine plus pertuzumab (T-DM1+P) with docetaxel, carboplatin, trastuzumab plus P (TCH+P) for the treatment human epidermal growth factor receptor 2–positive stage II to III breast cancer. T-DM1+P led to a lower pathologic complete response rate (44.4% v 55.7%; P = .016), but fewer grade 3 or greater and serious adverse events (AEs). Here, we present 3-year outcomes from KRISTINE. METHODS Patients were randomly assigned to neoadjuvant T-DM1+P or TCH+P every 3 weeks for six cycles. Patients who received T-DM1+P continued adjuvant T-DM1+P, and patients who received TCH+P received adjuvant trastuzumab plus pertuzumab. Secondary end points included event-free survival (EFS), overall survival, patient-reported outcomes (measured from random assignment), and invasive disease-free survival (IDFS; measured from surgery). RESULTS Of patients, 444 were randomly assigned (T-DM1+P, n = 223; TCH+P, n = 221). Median follow-up was 37 months. Risk of an EFS event was higher with TDM-1+P (hazard ratio [HR], 2.61 [95% CI, 1.36 to 4.98]) with more locoregional progression events before surgery (15 [6.7%] v 0). Risk of an IDFS event after surgery was similar between arms (HR, 1.11 [95% CI, 0.52 to 2.40]). Pathologic complete response was associated with a reduced risk of an IDFS event (HR, 0.24 [95% CI, 0.09 to 0.60]) regardless of treatment arm. Overall, grade 3 or greater AEs (31.8% v 67.7%) were less common with T-DM1+P. During adjuvant treatment, grade 3 or greater AEs (24.5% v 9.9%) and AEs leading to treatment discontinuation (18.4% v 3.8%) were more common with T-DM1+P. Patient-reported outcomes favored T-DM1+P during neoadjuvant treatment and were similar to trastuzumab plus pertuzumab during adjuvant treatment. CONCLUSION Compared with TCH+P, T-DM1+P resulted in a higher risk of an EFS event owing to locoregional progression events before surgery, a similar risk of an IDFS event, fewer grade 3 or greater AEs during neoadjuvant treatment, and more AEs leading to treatment discontinuation during adjuvant treatment.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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