Safety and tolerability of lapatinib ditosylate given concurrently with docetaxel, carboplatin, and trastuzumab (TCHL) as part of adjuvant therapy for patients with HER2+ …

Abstract:

565 Background: The nonanthracycline regimen of docetaxel (T), carboplatin (C), and trastuzumab (H) is available for patients with early HER2+ breast cancer. We sought to evaluate the tolerability of adding L to adjuvant TCH, in anticipation of allowing such regimen in the ALTTO adjuvant study. Methods: A single-arm phase II safety study of T (75 mg/m2 d1), C (AUC 6 d1), H (4 mg/kg loading dose, then 2 mg/kg d1, d8, d15), and L (1,000 mg PO qd) q 21d × 6 cycles, followed by H (6 mg/kg, q 21d × 12) and L (1,000 mg PO qd × 34 weeks) for a total of 52 weeks of treatment was conducted. Filgrastrim or pegfilgrastrim was administered as part of cycles 1-6. Primary endpoint was cardiac safety and overall tolerability. Results: The study completed accrual of 30 pts from March to November 2009. We report safety data available for the first 24 pts. Median follow up of 2.7 months. Median pt age 51.8 …

Año de publicación:

2010

Keywords:

Fuente:

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