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Paclitaxel in a novel formulation containing less Cremophor EL as first-line therapy for advanced breast cancer: A phase II trial

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Summary

Paclitaxel (Taxol) is formulated in 50% Cremophor EL (CrEL)/absolute ethanol for clinical use. In order to reduce vehicle-related side effects, Genetaxyl was developed to have paclitaxel formulated in a solution containing lesser amounts of CrEL and ethanol plus 2 other solvents. The purpose of the study was to evaluate the efficacy and safety of Genetaxyl as first-line therapy to treat breast cancer patients. Patients with newly diagnosed stage III (N = 8) or IV (N = 10), or recurrent (N = 11) breast cancer received single-agent Genetaxyl at 175 mg/m2 administered in a 3-h infusion every 3 weeks for 3–6 cycles. A total of 148 cycles were delivered to 29 patients. The overall response rate was 41.4% (95% confidence interval, 23.4 to 59.2%), and that of patients with metastatic disease (N = 20) was 30%. Median survival for all patients was 32.4 months and 24.3 months for patients having metastatic disease. The toxicity profile seems favorable, especially regarding myelosuppression and myalgia/arthralgia. No severe hypersensitivity reaction occurred. These phase II trial results demonstrate that a 60% reduction of CrEL by Genetaxyl’s formulation does not affect the activity of paclitaxel and could allow for better control of several CrEL-related toxicities.

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Authors and Affiliations

  1. Division of Medical Oncology, Department of Medicine, Taipei Veteran General Hospital, Taipei, Taiwan, R.O.C.

    Chao Ta-Chung, Chiou Tzeon-Jye, Wang Wei-Shu, Yen Chueh-Chuan, Yang Muh-Hwa, Hsiao Liang-Tsai, Liu Jin-Hwang & Chen Po-Min (M.D., Ph.D.)

  2. Division of General Surgery, Department of Surgery, Taipei Veteran General Hospital, Taipei, Taiwan, R.O.C.

    Tseng Ling-Ming

  3. Genovate Biotechnology Inc., Hsin-Chu, Taiwan, R.O.C.

    Chu Zyting

  4. National Yang-Ming University, Taipei, Taiwan, R.O.C.

    Chao Ta-Chung, Tseng Ling-Ming, Chiou Tzeon-Jye, Wang Wei-Shu, Yen Chueh-Chuan, Yang Muh-Hwa, Hsiao Liang-Tsai, Liu Jin-Hwang & Chen Po-Min (M.D., Ph.D.)

  5. Department of Hematology-Oncology, Mackay Memorial Hospital, Taipei, Taiwan, R.O.C.

    Hsieh Ruey-Kuen

  6. Division of Medical Oncology, Department of Medicine, Taipei Veterans General Hospital, No. 201, Sec. 2, Shih-Pai Rd., Taipei, 112, Taiwan, R.O.C.

    Chen Po-Min (M.D., Ph.D.)

Authors
  1. Chao Ta-Chung
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  2. Chu Zyting
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  3. Tseng Ling-Ming
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  4. Chiou Tzeon-Jye
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  5. Hsieh Ruey-Kuen
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  6. Wang Wei-Shu
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  7. Yen Chueh-Chuan
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  8. Yang Muh-Hwa
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  9. Hsiao Liang-Tsai
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  10. Liu Jin-Hwang
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  11. Chen Po-Min
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Corresponding author

Correspondence to Chen Po-Min.

Additional information

Taxol is a trademark of Bristol-Myers Squibb Company

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Ta-Chung, C., Zyting, C., Ling-Ming, T. et al. Paclitaxel in a novel formulation containing less Cremophor EL as first-line therapy for advanced breast cancer: A phase II trial. Invest New Drugs 23, 171–177 (2005). https://doi.org/10.1007/s10637-005-5863-8

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  • DOI: https://doi.org/10.1007/s10637-005-5863-8

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