The study covered in this summary was published on researchsquare.com as a preprint and has not yet been peer reviewed.
Key Takeaway
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Neuropathy was less frequent and severe when women with invasive breast cancer received eribulin (Havalen) instead of paclitaxel as neoadjuvant chemotherapy.
Why This Matters
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Neoadjuvant chemotherapy is essential for surgical downstaging, but some women cannot tolerate paclitaxel’s neurotoxicity.
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Eribulin is a good alternative for these patients.
Study Design
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The investigators randomized 60 women with invasive breast cancer to four cycles of eribulin on days 1 and 8 of a 21-day cycle, followed by four cycles of fluorouracil, eribulin, and cyclophosphamide (FEC).
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Another 58 patients received paclitaxel weekly for 12 weeks followed by FEC.
Key Results
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The incidence of sensory peripheral neuropathy was significantly lower in the eribulin group after week 6 and remained lower throughout the neoadjuvant chemotherapy period.
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Peripheral motor neuropathy was significantly lower with eribulin at weeks 9 (20% vs 36.2%), 12 (25% vs 36.2%), and 15 (21.7% vs 36.2%).
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The pathologic complete response rate was 20.7% with eribulin and 29.8% with paclitaxel (P = .289).
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The clinical response rate was 55.2% with eribulin and 77.2% with paclitaxel (P = .017).
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Three-year disease-free survival was 89.7% with eribulin and 86.0% with paclitaxel (P = .561).
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Neutropenia and other hematologic adverse events were more frequent and severe with eribulin.
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At 4 years, sensory neurotoxicity was lower in the eribulin group.
Limitations
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The trial was stopped early after a similar study at MD Anderson closed early owing to lower pathologic complete response rates with eribulin.
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Enrollment fell short, so analyses of the prespecified endpoints were underpowered.
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There is potential to introduce bias because neuropathy is subjective, and the study was not blinded.
Disclosures
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There was no industry funding.
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The investigators did not report any conflicts of interest.
This is a summary of a preprint research study, “A Randomised, Controlled Phase 2 Study of Neoadjuvant Eribulin Versus Paclitaxel in Women With Operable Breast Cancer: The JONIE-3 Study,” led by Kazutaka Narui of Yokohama City University Medical Center, Japan. The study has not been peer reviewed. The full text can be found at researchsquare.com.
M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news outlets before joining Medscape and also an MIT Knight Science Journalism fellow. Email: [email protected]. Email: [email protected].
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