【medical-news】【资讯翻译】卡培他滨可提高乳腺癌新辅助治疗pCR
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Increased pCR With Addition of Capecitabine to Epirubicin/Docetaxel in Neoadjuvant Treatment of Breast Cancer
Ann. Oncol 2013 Dec 16;[EPub Ahead of Print], GG Steger, R Greil, A Lang, M Rudas, F Fitzal, B Mlineritsch, BL Hartmann, R Bartsch, E Melbinger, M Hubalek, H Stoeger, P Dubsky, S Ressler, AL Petzer, CF Singer, C Muss, R Jakesz, SP Gampenrieder, CC Zielinski, C Fesl, M Gnant Research · December 26, 2013 TAKE-HOME MESSAGE
This 536-patient trial included all histologic subtypes of breast cancer and found the overall pCR rate increased from 15% to 23% when capecitabine was added to concurrent epirubicin and docetaxel in the neoadjuvant setting.
However, given the multitude of recently reported trials in this setting, it is unclear where this regimen will fit in the overall treatment paradigm.
- Richard Bambury, MD
http://www.practiceupdate.com/journalscan/7333
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ABSTRACT
BACKGROUND
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 AND METHODS
Patients with invasive breast cancer (except T4d) were randomly assigned to receive six 3-weekly cycles of ED (both 75 mg/m(2)) ± C (1000 mg/m(2), 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.
RESULTS
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.
CONCLUSION
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.
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