High-dose paclitaxel in combination with doxorubicin, cyclophosphamide and peripheral blood progenitor cell rescue in patients with high-risk primary and responding metastatic breast carcinoma: Toxicity profile, relationship to paclitaxel pharmacokinetics and short-term outcome

G. Somlo, J. H. Doroshow, T. Synold, J. Longmate, D. Reardon, W. Chow, S. J. Forman, L. A. Leong, K. A. Margolin, Jr J. Morgan, J. W. Raschko, S. I. Shibata, M. L. Tetef, Y. Yen, N. Kogut, J. Schriber, J. Alvarnas

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27 引文 斯高帕斯(Scopus)

摘要

We assessed the feasibility and pharmacokinetics of high-dose infusional paclitaxel in combination with doxorubicin, cyclophosphamide, and peripheral blood progenitor cell rescue. Between October 1995 and June 1998, 63 patients with high-risk primary [stage II with ≥ 10 axillary nodes involved, stage IIIA or stage IIIB inflammatory carcinoma (n = 53)] or with stage IV responsive breast cancer (n = 10) received paclitaxel 150-775mg/m2 infused over 24 hours, doxorubicin 165mg/m2 as a continuous infusion over 96 hours, and cyclophosphamide 100 mg kg-1. There were no treatment-related deaths. Dose-limiting toxicity was reversible, predominantly sensory neuropathy following administration of paclitaxel at the 775 mg/m2 dose level. Paclitaxel pharmacokinetics were non-linear at higher dose levels; higher paclitaxel dose level, AUC, and peak concentrations were associated with increased incidence of paraesthesias. No correlation between stomatitis, haematopoietic toxicities, and paclitaxel dose or pharmacokinetics was found. Kaplan-Meier estimates of 30-month event-free and overall survival for patients with primary breast carcinoma are 65% (95% CI; 51-83%) and 77% (95% CI; 64-93%). Paclitaxel up to 725 mg/m2 infused over 24 hours in combination with with doxorubicin 165 mg/m2 and cyclophosphamide 100 mg kg-1 is tolerable. A randomized study testing this regimen against high-dose carboplatin, thiotepa and cyclophosphamide (STAMP V) is currently ongoing.

原文英語
頁(從 - 到)1591-1598
頁數8
期刊British Journal of Cancer
84
發行號12
DOIs
出版狀態已發佈 - 六月 15 2001
對外發佈Yes

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Somlo, G., Doroshow, J. H., Synold, T., Longmate, J., Reardon, D., Chow, W., Forman, S. J., Leong, L. A., Margolin, K. A., Morgan, J. J., Raschko, J. W., Shibata, S. I., Tetef, M. L., Yen, Y., Kogut, N., Schriber, J., & Alvarnas, J. (2001). High-dose paclitaxel in combination with doxorubicin, cyclophosphamide and peripheral blood progenitor cell rescue in patients with high-risk primary and responding metastatic breast carcinoma: Toxicity profile, relationship to paclitaxel pharmacokinetics and short-term outcome. British Journal of Cancer, 84(12), 1591-1598. https://doi.org/10.1054/bjoc.2001.1835