Abstract | OBJECTIVES: PATIENTS AND METHODS: A total of 64 invasive breast cancer patients were recruited in the N001 Phase II, multicenter, open-label, single-arm study to receive four cycles of FEC (500, 100, 500 mg/m(2)) followed by four cycles of T (100 mg/m(2)) with concurrent CXB (200 mg b.i.d.) as neoadjuvant therapy ( NAT). The combined chemotherapies were administered on day 1 of each cycle every 3 weeks. Primary endpoints were pathologic complete response (pCR) rate and objective response rate (ORR). Quasi-pCR (QpCR), pCR and near pCR (npCR) were discussed considering their similar survival outcomes. ORR included clinical complete response (cCR) and clinical partial response ( cPR). Secondary endpoints included safety, breast conservation rate and disease-free survival. RESULTS: Between February 2006 and January 2010, 57 of 64 evaluable patients with luminal A (n = 35, 61.4%), luminal B (n = 12, 21.1%), HER-2 positive (n = 8, 14%) and triple-negative (n = 2, 3.5%) breast cancer completed NAT and surgery. QpCR rate was observed in 18 (31.6%) patients. Exclusive of triple-negative subtype, pCR (p = 0.761) did not differ compared to other subtypes, while npCR (p = 0.043) exhibited a difference. Patients with HER-2 overexpression had a significantly higher QpCR than those of the disease attribute (10/20 vs 8/37, p = 0.029). After NAT, 43 (75.4%) and 13 (22.8%) patients achieved cCR and cPR, respectively. Patients responding to FEC were more likely to achieve a better ORR after subsequent T (p = 0.004). Over 80% of all patients received breast-conserving therapy (BCT) after receiving NAT, and 11 of 14 (78.6%) patients with T3 tumor at diagnosis became eligible for BCT after NAT. A total of 60 patients completed ≥ 6 cycles of NAT, followed by surgery; at a median follow-up of 50 months, 80% of the patients are disease-free. Neither drug-induced life-threatening toxicity nor cardiotoxicity was observed. CONCLUSIONS: Neoadjuvant use of FEC-T with concurrent CXB is active and safe for treatment of operable invasive breast cancer. The ORR was higher, but QpCR was comparable to other studies. Most patients are still disease-free, and BCT became an option for the females. Further clinical and translational studies on the use of cyclooxygenase-2 inhibitors with neoadjuvant chemotherapy are warranted.
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Authors | Louis W C Chow, Stewart Y Tung, Ting-Ying Ng, Seock-Ah Im, Min-Hyuk Lee, Adrian Y S Yip, Masakazu Toi, Stefan Glück |
Journal | Expert opinion on investigational drugs
(Expert Opin Investig Drugs)
Vol. 22
Issue 3
Pg. 299-307
(Mar 2013)
ISSN: 1744-7658 [Electronic] England |
PMID | 23394482
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Chemical References |
- Pyrazoles
- Sulfonamides
- Taxoids
- Docetaxel
- Epirubicin
- Cyclophosphamide
- Receptor, ErbB-2
- Celecoxib
- Fluorouracil
- Phenobarbital
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Topics |
- Adult
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, metabolism, pathology)
- Celecoxib
- Cyclophosphamide
(administration & dosage)
- Disease-Free Survival
- Docetaxel
- Epirubicin
(administration & dosage)
- Female
- Fluorouracil
(administration & dosage)
- Follow-Up Studies
- Humans
- Middle Aged
- Neoadjuvant Therapy
- Neoplasm Invasiveness
- Neoplasm Staging
- Phenobarbital
(metabolism)
- Prospective Studies
- Pyrazoles
(administration & dosage)
- Receptor, ErbB-2
(metabolism)
- Sulfonamides
(administration & dosage)
- Taxoids
(administration & dosage)
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