Project Description

Oral Abstract Presentation
Selected by the 2020 Annual Meeting Scientific Program Committee
Type: Oral Abstract Presentation
Presenter: Anna van der Voort, MD
Presented: May 29, 2020
Abstract ref: 501
Subtitles/Captions:
Authors: Anna van der Voort, Mette S. van Ramshorst, Erik D. van Werkhoven, Ingrid A. Mandjes, Inge Kemper, Annelie J. Vulink, Irma M. Oving, Aafke H. Honkoop, Lidwine W. Tick, Agnes J. van de Wouw, Caroline M. Mandigers, Laurence J. C. van Warmerdam, Jelle Wesseling, Marie-Jeanne T.F.D Vrancken Peeters, Sabine C. Linn, Gabe S. Sonke, on behalf of the Dutch Breast Cancer Group (BOOG); Netherlands Cancer Institute, Amsterdam, Netherlands; Reinier de Graaf Hospital, Delft, Netherlands; Ziekenhuisgroep Twente, Almelo, Netherlands; Isala Clinics, Zwolle, Netherlands; Máxima Medical Center, Eindhoven, Netherlands; Viecuri Medical Centre, Venlo, Netherlands; Canisius Wilhelmina Hospital, Nijmegen, Netherlands; Catharina Hospital, Eindhoven, Netherlands; DGOG and Department of Medical Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands

Background: The multicenter phase III TRAIN-2 study showed high pathological complete response (pCR) rates after neoadjuvant chemotherapy with and without anthracylines plus dual HER2-blockade in stage II-III HER2-positive breast cancer patients (67% vs 68%, p = 0.95) (NCT01996267). Here we report 3-year efficacy and safety outcomes.

Methods: Patients were randomly assigned (1:1) to receive 3 cycles 5-fluoruoracil (500mg/m2), epirubicin (90mg/m2), and cyclophosphamide (500mg/m2) followed by 6 cycles paclitaxel (80mg/m2 day 1 and 8) and carboplatin (AUC = 6mg/ml·min) (FEC-PC) or 9 cycles paclitaxel and carboplatin (PC). Both regimens were combined with trastuzumab (T; 6mg/kg, loading dose 8mg/kg) and pertuzumab (Ptz; 420mg, loading dose 840mg). Patients completed one year of trastuzumab, radiotherapy and endocrine therapy as indicated. The primary endpoint pCR was previously reported. Secondary efficacy endpoints reported here are event-free-survival (EFS) defined as time from randomization to first event (disease progression resulting in inoperability, recurrence [contralateral DCIS excluded], secondary primary malignancies, or death) and overall survival (OS), both in the intention-to-treat population. Safety endpoints are reported for patients treated with at least one dose of study medication.

Results: 438 patients were randomized (219/arm) and evaluable for long-term efficacy endpoints. After a median follow-up of 48.8 months 23 EFS events occurred in the FECT-PTC-Ptz-arm and 21 in the PTC-Ptz-arm (HR 0.90; 95% CI 0.50-1.63). Three-year EFS estimates were 92.7% (95% CI: 89.3-96.2) for FECT-PTC-Ptz and 93.6% (95% CI: 90.4-96.9) for PTC-Ptz. Three-year OS estimates were 97.7% (95% CI: 95.7-99.7) for FECT-PTC-Ptz and 98.2% (95% CI: 96.4-100) for PTC-Ptz. These results were irrespective of hormone receptor and nodal status. LVEF decline ≥10% from baseline and < 50% was more common in patients who received anthracyclines than in the PTC-Ptz arm (8.6% vs. 3.2%, p = 0.021). Two patients in the FECT-PTC-Ptz arm developed acute leukemia. No other new safety concerns were seen.

Conclusions: The 3-year follow-up of the TRAIN-2 study confirms the results of the primary outcome that anthracylines do not improve efficacy and are associated with clinically relevant toxicity. A neoadjuvant carboplatin-taxane based regimen with dual HER2-blockade can be considered in all stage II-III breast cancer patients, regardless of hormone receptor and nodal status. Clinical trial information: NCT00954174

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Oral Abstract Presentation
Selected by the 2020 Annual Meeting Scientific Program Committee
Type: Oral Abstract Presentation
Presenter: Anna van der Voort, MD
Presented: May 29, 2020
Abstract ref: 501
Subtitles/Captions: