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2019 ASCO Annual Meeting!

Session: Breast Cancer—Local/Regional/Adjuvant

Type: Oral Abstract Session

Time: Monday June 3, 9:45 AM to 12:45 PM

Location: Hall D2

Neoadjuvant trastuzumab (H), pertuzumab (P), and chemotherapy versus trastuzumab emtansine (T-DM1) and P in human epidermal growth factor receptor 2 (HER2)-positive breast cancer (BC): Final outcome results from the phase III KRISTINE study.

Adjuvant Therapy

Breast Cancer—Local/Regional/Adjuvant

2019 ASCO Annual Meeting

Abstract No:

J Clin Oncol 37, 2019 (suppl; abstr 500)

Author(s): Sara A. Hurvitz, Miguel Martin, Kyung Hae Jung, Chiun-Sheng Huang, Nadia Harbeck, Vicente Valero, Daniil Stroyakovskiy, Hans Wildiers, Mario Campone, Jean-Francois Boileau, Matthias W. Beckmann, Karen Afenjar, Gonzalo Spera, Vanesa Lopez Valverde, Chunyan Song, Thomas Boulet, Joseph A. Sparano, William Fraser Symmans, Alastair Mark Thompson, Dennis J. Slamon; David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA; Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc, Geicam, Universidad Complutense, Madrid, Spain; Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea; National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Breast Center, University of Munich (LMU), Munich, Germany; University of Texas MD Anderson Cancer Center, Houston, TX; Moscow City Oncology Hospital, Moscow, Russian Federation; University Hospitals Leuven, Leuven, Belgium; Institut de Cancérologie de l'Ouest, René Gauducheau, St Herblain, France; McGill University, Jewish General Segal Cancer Centre, Montreal, QC, Canada; University Hospital Erlangen, Friedrich-Alexander-University Erlangen-Nuremberg, Comprehensive Cancer Center Erlangen-Nuremberg, Erlangen, Germany; Translational Research In Oncology, Paris, France; Translational Research In Oncology, Montevideo, Uruguay; F. Hoffmann-La Roche Ltd., Basel, Switzerland; Genentech, Inc., South San Francisco, CA; Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY; The University of Texas MD Anderson Cancer Center, Houston, TX; Baylor College of Medicine, Houston, TX

Abstract Disclosures


Background: KRISTINE compared neoadjuvant chemotherapy plus dual HER2- blockade (HP) with T-DM1 plus P (T-DM1+P), a targeted regimen that omits standard chemotherapy. T-DM1+P resulted in a lower pathologic complete response (pCR) rate, but a more favorable safety profile. Here we present the final outcomes from KRISTINE. Methods: KRISTINE (NCT02131064) was a randomized study of T-DM1+P versus docetaxel, carboplatin, and H plus P (TCHP). Patients with HER2-positive stage II–III BC received 6 cycles of neoadjuvant T-DM1+P or TCHP q3w. Patients receiving T-DM1+P continued adjuvant T-DM1+P; patients receiving TCHP received adjuvant HP, for 12 cycles in each arm. Patients in the T-DM1+P arm without pCR were encouraged to receive standard adjuvant chemotherapy before adjuvant T-DM1+P. Secondary endpoints, analyzed with descriptive statistics, included event-free survival (EFS; all events pre- and post-surgery), invasive disease-free survival (IDFS; invasive events post-surgery), overall survival and safety. Results: At median follow-up of 37 months, EFS favored TCHP (HR = 2.61 [95% CI: 1.36–4.98]), due to more locoregional progression events in the T-DM1+P arm before surgery (6.7% vs 0; Table). pCR was associated with reduced risk of an IDFS event (HR = 0.24 [95% CI: 0.09– 0.60]) regardless of treatment arm. There were 5 deaths (2.3%) in the TCHP arm and 6 (2.7%) in the T-DM1+P arm. There were more grade ≥3 AEs with TCHP but a higher rate of AEs leading to treatment discontinuation with T-DM1+P. Conclusions: EFS numerically favors TCHP due to locoregional progression events with T-DM1+P prior to surgery. T-DM1+P was associated with fewer grade ≥3 AEs but increased treatment discontinuation. Clinical trial information: NCT02131064

(n = 221)
(n = 223)
EFS events, n (%)13 (5.9)31 (13.9)
Locoregional progression before surgery0 (0)15 (6.7)
Invasive disease recurrence11 (5.0)11 (4.9)
Non-invasive recurrence (DCIS)0 (0)3 (1.3)
Death without prior EFS event2 (0.9)2 (0.9)
3-yr IDFS in patients with pCR (95% CI)97.5%
3-yr IDFS in patients without pCR (95% CI)84.2%
Grade ≥3 AEs, n (%)148 (67.6)71 (31.8)
AEs leading to any treatment discontinuation, n (%)24 (11.0)45 (20.2)

Other Abstracts in this Sub-Category:


1. HER2 heterogeneity as a predictor of response to neoadjuvant T-DM1 plus pertuzumab: Results from a prospective clinical trial.

Meeting: 2019 ASCO Annual Meeting Abstract No: 502 First Author: Otto Metzger Filho
Category: Breast Cancer—Local/Regional/Adjuvant - Adjuvant Therapy


2. Impact of clinical risk category on prognosis and prediction of chemotherapy benefit in early breast cancer (EBC) by age and the 21-gene recurrence score (RS) in TAILORx.

Meeting: 2019 ASCO Annual Meeting Abstract No: 503 First Author: Joseph A. Sparano
Category: Breast Cancer—Local/Regional/Adjuvant - Adjuvant Therapy


3. Benefit from letrozole as extended adjuvant therapy after sequential endocrine therapy: A randomized, phase III study of Gruppo Italiano Mammella (GIM).

Meeting: 2019 ASCO Annual Meeting Abstract No: 504 First Author: Lucia Del Mastro
Category: Breast Cancer—Local/Regional/Adjuvant - Adjuvant Therapy