Randomized Phase II Trial of First-Line Trastuzumab Plus Docetaxel and Capecitabine Compared With Trastuzumab Plus Docetaxel in <i>HER2</i>-Positive Metastatic Breast Cancer

Wardley, Andrew M. ; Pivot, Xavier ; Morales-Vasquez, Flavia ; Zetina, Luis M. ; de Fátima Dias Gaui, Maria ; Reyes, Douglas Otero ; Jassem, Jacek ; Barton, Claire ; Button, Peter ; Hersberger, Veronica ; Antón Torres, Antonio (Universidad de Zaragoza)

Resumen: Purpose To evaluate trastuzumab (H) and docetaxel (T) with or without capecitabine (X) as first-line combination therapy for human epidermal growth factor receptor 2 (HER2) -positive advanced breast cancer. Patients and Methods Patients with HER2-positive locally advanced or metastatic breast cancer were randomly assigned to H (8 mg/kg loading; 6 mg/kg every 3 weeks) plus T (75 mg/m2 in HTX arm, 100 mg/m2 in HT arm, every 3 weeks) with or without X (950 mg/m2 twice per day on days 1 to 14 every 3 weeks). The primary end point was overall response rate (ORR). Results In 222 patients, median follow-up was approximately 24 months. ORR was high with both regimens (70.5% with HTX; 72.7% with HT; P = .717); complete response rate was 23.2% with HTX compared with 16.4% with HT. HTX demonstrated significantly longer progression-free survival: median 17.9 months compared with 12.8 months with HT (hazard ratio, 0.72; P = .045), which translates to a gain of around 5 months. Two-year survival probability was 75% with HTX compared with 66% with HT. Febrile neutropenia (27% v 15%) and grade 3/4 neutropenia (77% v 54%) incidences were higher with HT than HTX. Treatment-related grade 3 hand-foot syndrome (17% v < 1%) and grade 3/4 diarrhea (11% v 4%) occurred more commonly with HTX than HT. One case of congestive heart failure occurred in each arm. Conclusion HTX is an effective and feasible first-line therapy for HER2-positive locally advanced or metastatic breast cancer, although it should be reserved for patients with good performance status who are not receiving long-term steroids.

Idioma: Inglés

DOI: 10.1200/JCO.2008.21.6531

Año: 2009

Publicado en: JOURNAL OF CLINICAL ONCOLOGY 28, 6 (2009), 976-983
ISSN: 0732-183X

Factor impacto JCR: 17.793 (2009)

Categ. JCR: ONCOLOGY rank: 4 / 164 = 0.024 (2009) - Q1 - T1

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)