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SHR Neuro Cancer Cardio Lipid Metab Microb
Steger, GG; Greil, R; Lang, A; Rudas, M; Fitzal, F; Mlineritsch, B; Hartmann, BL; Bartsch, R; Melbinger, E; Hubalek, M; Stoeger, H; Dubsky, P; Ressler, S; Petzer, AL; Singer, CF; Muss, C; Jakesz, R; Gampenrieder, SP; Zielinski, CC; Fesl, C; Gnant, M.
Epirubicin and docetaxel with or without capecitabine as neoadjuvant treatment for early breast cancer: final results of a randomized phase III study (ABCSG-24)
ANN ONCOL. 2014; 25(2): 366-371.
Doi: 10.1093/annonc/mdt508
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- Co-authors Med Uni Graz
- Stöger Herbert
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- Abstract:
- This randomized phase III trial compared pathologic complete response (pCR) rates of early breast cancer (EBC) following neoadjuvant epirubicin-docetaxel (ED)±capecitabine (C), and evaluated the addition of trastuzumab in HER2-positive tumors. Patients with invasive breast cancer (except T4d) were randomly assigned to receive six 3-weekly cycles of ED (both 75 mg/m2)±C (1000 mg/m2, twice daily, days 1-14). Patients with HER2-positive disease were further randomized to receive trastuzumab (8 mg/kg, then 6 mg/kg every 3 weeks) or not. Primary end point: pCR rate at the time of surgery. Five hundred thirty-six patients were randomized to ED (n=266) or EDC (n=270); 93 patients were further randomized to trastuzumab (n=44) or not (n=49). pCR rate was significantly increased with EDC (23.0% versus 15.4% ED, P=0.027), and nonsignificantly further increased with trastuzumab (38.6% EDC versus 26.5% ED, P=0.212). Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED, but not significantly; the addition of trastuzumab had no further impact. Hormone receptor status, tumor size, grade, and C (all P≤0.035) were independent prognostic factors for pCR. Trastuzumab added to ED±C significantly increased the number of serious adverse events (35 versus 18; P=0.020), mainly due to infusion-related reactions. These findings show that the integration of C into a neoadjuvant taxane-/anthracycline-based regimen is a feasible, safe, and effective treatment option, with incorporation of trastuzumab in HER2-positive disease. NCT00309556, www.clinicaltrials.gov.
- Find related publications in this database (using NLM MeSH Indexing)
- Adolescent -
- Adult -
- Aged -
- Antineoplastic Combined Chemotherapy Protocols - adverse effects
- Antineoplastic Combined Chemotherapy Protocols - therapeutic use
- Breast Neoplasms - drug therapy
- Capecitabine -
- Carcinoma, Ductal, Breast - drug therapy
- Chemotherapy, Adjuvant -
- Deoxycytidine - administration & dosage
- Deoxycytidine - analogs & derivatives
- Epirubicin - administration & dosage
- Female -
- Fluorouracil - administration & dosage
- Fluorouracil - analogs & derivatives
- Humans -
- Middle Aged -
- Neoadjuvant Therapy -
- Prospective Studies -
- Taxoids - administration & dosage
- Treatment Outcome -
- Young Adult -
- Find related publications in this database (Keywords)
- capecitabine
- docetaxel
- early breast cancer
- epirubicin
- neoadjuvant treatment