Docetaxel followed by fluorouracil/epirubicin/cyclophosphamide as neoadjuvant chemotherapy for patients with primary breast cancer

Hiroji Iwata, Nobuaki Sato, Norikazu Masuda, Seigo Nakamura, Naohito Yamamoto, Katsumasa Kuroi, Masafumi Kurosumi, Hitoshi Tsuda, Futoshi Akiyama, Yasuo Ohashi, Masakazu Toi
Japanese Journal of Clinical Oncology 2011, 41 (7): 867-75

OBJECTIVE: This multicenter, open-label, single-arm, Phase II study assessed the efficacy of a neoadjuvant chemotherapy with docetaxel (75 mg/m(2) q3w) followed by 5-fluorouracil 500 mg/m(2), epirubicin 100 mg/m(2) and cyclophosphamide 500 mg/m(2) q3w in patients with early-stage breast cancer.

METHODS: Women with resectable breast cancer (T1c-3 N0 M0 or T1-3 N1 M0) were enrolled. Before surgery, patients received four cycles of docetaxel followed by four cycles of 5-fluorouracil, epirubicin, and cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate defined for the breast alone, assessed by a central review committee. Secondary endpoints included clinical response and safety.

RESULTS: One hundred and thirty-seven patients were enrolled. Of the 132 patients assessable for pathologic response, 23% (95% confidence interval, 16-31%) experienced a pathological complete response and 6% (95% confidence interval, 3-12%) had a near pathological complete response (few remaining cancer cells), resulting in a quasi-pathological complete response of 29% (95% confidence interval, 21-37%). Clinical response rate following the initial docetaxel regimen was 64%. The overall clinical response rate after completion of 5-fluorouracil, epirubicin, and cyclophosphamide was 79%; breast-conserving surgery was performed in 79% of patients. More patients with triple-negative disease (estrogen/progesterone receptors negative; human epidermal growth factor 2 negative) experienced a pathological complete response [14/29, (48%); 95% confidence interval, 29-68%] versus those with other molecular subtypes. The safety profile was acceptable.

CONCLUSIONS: Eight cycles of neoadjuvant chemotherapy-docetaxel followed by 5-fluorouracil, epirubicin, and cyclophosphamide-are tolerable and conferred high rates of pathological complete response and breast-conserving surgery. Patients with triple-negative disease were more likely to achieve pathological complete response versus other subtypes, suggesting that selecting appropriate neoadjuvant chemotherapy based on molecular subtype could be possible.

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