Abstract
PurposeThe sequence of taxanes (T) followed by anthracyclines (A) as neoadjuvant chemotherapy has been the standard of care for almost 20 years for locally advanced breast cancer (LABC). Sequential administration of eribulin (E) following A/T could provide a greater response rate for women with LABC.MethodsIn this single-arm, multicenter, Phase II prospective study, the patients received 4 cycles of the FEC regimen and 4 cycles of taxane. After the A/T-regimen, 4 cycles of E were administered followed by surgical resection. The primary endpoint was the clinical response rate. Eligible patients were women aged 20 years or older, with histologically confirmed invasive breast cancer, clinical Stage IIIA (T2–3 and N2 only), Stage IIIB, and Stage IIIC, HER2-negative.ResultsA preplanned interim analysis aimed to validate the trial assumptions was conducted after treatment of 20 patients and demonstrated that clinical progressive disease rates in the E phase were significantly higher (30%) than assumed. Therefore, the Independent Data Monitoring Committee recommended stopping the study. Finally, 53 patients were enrolled, and 26 patients received the A/T/E-regimen. The overall observed clinical response rate (RR) was 73% (19/26); RRs were 77% (20/26) in the AT phase and 23% (6/26) in the E phase. Thirty percent (8/26) of patients had PD in the E phase, 6 of whom had achieved cCR/PR in the AT phase. Reported grade ≥ 3 AEs related to E were neutropenia (42%), white blood cell count decrease (27%), febrile neutropenia (7.6%), weight gain (3.8%), and weight loss (3.8%).ConclusionSequential administration of eribulin after the A/T-regimen provided no additional effect for LABC patients. Future research should continue to focus on identifying specific molecular biomarkers that can improve response rates.
Highlights
Neoadjuvant chemotherapy (NAC) for breast cancer has been used mainly for locally advanced cancer aiming at down-staging
A phase II study of eribulin in Japan was conducted in subjects in whom the median number of previous chemotherapeutic regimens involving A and T preparations was 3 (1–5), of which 2 (0–3) were following progression/ recurrence
Key exclusion criteria were the presence of breast cancer in bilateral breasts, other malignant conditions or synchronic multiple cancers, other concurrent serious disease that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or uncontrolled hypertension, pregnant or lactating, hypersensitivity to any of the study medications, and chronic immunosuppressive therapies, including systemic corticosteroids
Summary
Neoadjuvant chemotherapy (NAC) for breast cancer has been used mainly for locally advanced cancer aiming at down-staging. Preoperative docetaxel administration increased the pathological complete response (pCR) rate by Extended author information available on the last page of the article. In patients in whom pCR was obtained after NAC, both the OS and DFS rates were good [1]. The pCR rate is used as an important parameter to assess the therapeutic effects of preoperative chemotherapy. No improvement in DFS or OS was seen, despite an improvement in the pCR rate. In NSABP B-27, AC and AC-DTX improved the pCR rate by 13%, but there was no improvement in the prognosis [6]. According to reviews of preoperative chemotherapy in Japan, the pCR rate for FEC administration after PTX therapy was 27.7%, and the response rate was 85.1% [7]. After FEC therapy, that for DTX administration was 25%, and the
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