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Phase I study of nanoparticle albumin-bound paclitaxel, carboplatin and trastuzumab in women with human epidermal growth factor receptor 2-overexpressing breast cancer. | LitMetric

AI Article Synopsis

  • - The combination of anthracycline-containing chemotherapy and trastuzumab is the standard treatment for HER2-positive early breast cancer, but a non-anthracycline regimen with docetaxel, carboplatin, and trastuzumab has shown similar effectiveness.
  • - A phase I study tested a new regimen combining nab-paclitaxel, carboplatin, and trastuzumab for HER2-positive locally advanced breast cancer, starting with a nab-paclitaxel dose of 220 mg/m, which was increased to 260 mg/m, administered tri-weekly.
  • - While no dose-limiting toxicities were reported, the trial revealed severe hematological issues in some patients, leading to the conclusion

Article Abstract

Although the concurrent use of anthracycline-containing chemotherapy and taxane with trastuzumab are considered the treatment of choice for the primary systemic therapy of human epidermal growth factor receptor 2 (HER2)-overexpressing early breast cancer, non-anthracycline regimens, such as concurrent administration of docetaxel and carboplatin with trastuzumab, exhibited similar efficacies in a previous study. In addition, tri-weekly treatment with nanoparticle albumin-bound paclitaxel (nab-paclitaxel) resulted in significantly higher response rates and a favorable safety profile compared with standard paclitaxel for metastatic breast cancer patients in another phase III study. Based on these results, a phase I study of combination therapy with nab-paclitaxel, carboplatin and trastuzumab was planned, in order to estimate its efficacy and safety for HER2-overexpressing locally advanced breast cancer. The present study was designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose and recommended dose of this combination treatment in women with HER2-overexpressing locally advanced breast cancer. The starting dose of nab-paclitaxel was 220 mg/m (level 1), and the dose was escalated to 260 mg/m (level 2). Nab-paclitaxel was administered with carboplatin (area under the curve, 6 mg/ml/min) and trastuzumab tri-weekly. A total of 6 patients were enrolled. Although no DLT was observed during the first cycle, 4 patients developed grade 4 thrombocytopenia, 2 had grade 4 neutropenia and 3 exhibited a grade 4 decrease in hemoglobin levels. In the present phase I study, although no patients experienced DLTs, this regimen was associated with severe hematological toxicities and it was not well tolerated. However, considering the high efficacy and lower risk of cardiotoxicity and secondary carcinogenesis with taxane, platinum and trastuzumab combination therapy, further evaluation of another regimen including weekly administration or a more accurate dose setting should be conducted.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5374931PMC
http://dx.doi.org/10.3892/mco.2017.1176DOI Listing

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