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The efficacy and safety of preoperative chemotherapy with triweekly abraxane and cyclophosphamide followed by 5-Fluorouracil, epirubicin, and cyclophosphamide therapy for resectable breast cancer: a multicenter clinical trial.

AbstractBACKGROUND:
It has been reported that tri-weekly Abraxane therapy has better outcomes in recurrent breast cancer than tri-weekly Cremophor-based taxol therapy, and that cyclophosphamide combined with taxane shows an enhanced antitumor effect. We conducted a phase II clinical trial of preoperative chemotherapy with a combination of TRI-ABC.
PATIENTS AND METHODS:
From September 2011 to September 2013, 4 cycles of preoperative chemotherapy with TRI-ABC followed by 4 cycles of FEC were administered in patients with resectable breast cancer. In patients with HER2-positive breast cancer, tri-weekly Trastuzumab was administered with TRI-ABC. The primary end point was the pathological complete response (pCR) rate in the breasts and lymph nodes.
RESULTS:
The treatment outcomes and safety were evaluated in 54 patients who received at least 1 dose of chemotherapy. All patients underwent radical surgery, and the overall pCR rate of 37% (20 of 54) was achieved. The pCR rates according to each subtype were 8% (2 of 24) in hormone receptor (HR)-positive HER2-negative breast cancer, 56% (5 of 9) in HR-positive HER2-positive breast cancer, 63% (5 of 8) in HR-negative HER2-positive breast cancer, and 62% (8 of 13) in triple-negative breast cancer. Multivariate analysis revealed that HR negativity and HER2 positivity were predictive factors of pCR. Clinical response was observed in 49 patients (91%). The safety profile was acceptable.
CONCLUSION:
Preoperative chemotherapy with TRI-ABC followed by FEC showed high efficacy and excellent safety. Further clinical studies should be conducted to compare the efficacy of TRI-ABC followed by FEC with conventional taxane-anthracycline regimens.
AuthorsHideo Shigematsu, Takayuki Kadoya, Norio Masumoto, Tatsunari Sasada, Akiko Emi, Masahiro Ohara, Keiko Kajitani, Morihito Okada
JournalClinical breast cancer (Clin Breast Cancer) Vol. 15 Issue 2 Pg. 110-6 (Apr 2015) ISSN: 1938-0666 [Electronic] United States
PMID25454688 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
CopyrightCopyright © 2015 Elsevier Inc. All rights reserved.
Chemical References
  • Albumin-Bound Paclitaxel
  • Epirubicin
  • Cyclophosphamide
  • Fluorouracil
Topics
  • Adult
  • Aged
  • Albumin-Bound Paclitaxel (administration & dosage)
  • Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
  • Breast Neoplasms (drug therapy)
  • Chemotherapy, Adjuvant (methods)
  • Cyclophosphamide (administration & dosage)
  • Epirubicin (administration & dosage)
  • Female
  • Fluorouracil (administration & dosage)
  • Humans
  • Middle Aged
  • Neoadjuvant Therapy (methods)

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