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    JAMA oncology. 2018 Jan 11. pii: 2668528. doi: 10.1001/jamaoncol.2017.4612
    Comparing Neoadjuvant Nab-paclitaxel vs Paclitaxel Both Followed by Anthracycline Regimens in Women With ERBB2/HER2-Negative Breast Cancer-the Evaluating Treatment With Neoadjuvant Abraxane (ETNA) Trial: A Randomized Phase 3 Clinical Trial.
    Gianni L1,  Mansutti M2,  Anton A3,  Calvo L4,  Bisagni G5,  Bermejo B6,  Semiglazov V7,  Thill M8,  Chacon JI9,  Chan A10,  Morales S11,  Alvarez I12,  Plazaola A13,  Zambetti M14,  Redfern AD15,  Dittrich C16,  Dent RA17,  Magazzù D18,  De Fato R19,  Valagussa P20,  Tusquets I21
    Author information
    1Department of Medical Oncology, San Raffaele Scientific Institute, Milano, Italy.
    2Department of Oncology, Azienda Sanitaria Universitaria Integrata, Udine, Italy.
    3Department of Medical Oncology, Miguel Servet University Hospital, Aragón Health Research Institute, Zaragoza, Spain.
    4Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
    5IRCCS Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia, Reggio Emilia, Italy.
    6Department of Medical Oncology, Hospital Clinico Universitario Valencia, Valencia, Spain.
    7NN Petrov Research Institute of Oncology, St Petersburg, Russia.
    8Agaplesion Markus Krankenhaus, Klinik für Gynäkologie und Geburtshilfe, Frankfurt am Main, Germany.
    9Department of Medical Oncology, Hospital Virgen de la Salud, Toledo, Spain.
    10Breast Cancer Research Centre, Western Australia & Curtin University, Perth, Australia.
    11Department of Medical Oncology, Hospital Universitario Arnau de Vilanova de Lleida, Lleida, Spain.
    12Department of Oncology, Hospital Universitario Donostia, San Sebastian, Spain.
    13Onkologikoa, Hospital Donostia, San Sebastián, Spain.
    14Department of Medical Oncology, San Raffaele Scientific Institute, Milano, Italy.
    15Department of Medical Oncology, Royal Perth Hospital, Perth, Australia.
    16Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna) & Kaiser Franz Josef-Spital, Vienna, Austria.
    17Department of Medical Oncology, National Cancer Center Singapore, Singapore.
    18Fondazione Michelangelo, Milano, Italy.
    19Fondazione Michelangelo, Milano, Italy.
    20Fondazione Michelangelo, Milano, Italy.
    21Department of Medical Oncology, Hospital del Mar, Barcelona, Spain.
    Abstract

    IMPORTANCE: Studies of neoadjuvant chemotherapy regimens using anthracyclines followed by taxanes have reported a doubling of pathological complete remission (pCR) rates compared with anthracycline-based regimens alone. A reverse sequence did not reduce activity. Nab-paclitaxel is an albumin-bound nanoparticle of paclitaxel that allows for safe infusion without premedication, and its use led to a significantly higher rate of pCR in the GeparSepto trial.

    OBJECTIVE: To determine whether nab-paclitaxel improves the outcomes of early and locally advanced human epidermal growth factor receptor 2 (ERBB2/HER2)-negative breast cancer compared with paclitaxel when delivered in a neoadjuvant setting.

    DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, open-label study, in collaboration with Grupo Español de Investigación en Cáncer de Mama (GEICAM) and Breast Cancer Research Center-Western Australia (BCRC-WA), patients with newly diagnosed and centrally confirmed ERBB2/HER2-negative breast cancer were recruited. Participants were randomly allocated to paclitaxel, 90 mg/m2 (349 patients), or nab-paclitaxel, 125 mg/m2 (346 patients). The 2 drugs were given on weeks 1, 2, and 3 followed by 1 week of rest for 4 cycles before 4 cycles of an anthracycline regimen per investigator choice.

    MAIN OUTCOMES AND MEASURES: The primary end point was the rate of pCR, defined as absence of invasive cells in the breast and axillary nodes (ie, ypT0/is ypN0) at the time of surgery. A secondary end point was to assess tolerability and safety of the 2 regimens.

    RESULTS: From May 2013 to March 2015, 814 patients were registered to the study; 695 patients met central confirmation eligibility and were randomly allocated to receive either paclitaxel (349), or nab-paclitaxel (346) (median age, 50 years; range, 25-79 years). The intention-to-treat analysis of the primary end point pCR revealed that the improved pCR rate after nab-paclitaxel (22.5%) was not statistically significant compared with paclitaxel (18.6%; odds ratio [OR], 0.77; 95% CI, 0.52-1.13; P = .19). Overall, 38 of 335 patients (11.3%) 11.3% of patients had at least 1 serious adverse event in the paclitaxel arm and 54 of 337 patient (16.0%) in the nab-paclitaxel arm. Peripheral neuropathy of grade 3 or higher occurred in 6 of 335 patients (1.8%) and in 15 of 337 (4.5%), respectively.

    CONCLUSIONS AND RELEVANCE: The improved rate of pCR after nab-paclitaxel was not statistically significant. The multivariate analysis revealed that tumor subtype (triple-negative vs luminal B-like) was the most significant factor (OR, 4.85; 95% CI, 3.28-7.18) influencing treatment outcome.

    TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01822314.


    Publikations ID: 29327055
    Quelle: öffnen
     
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