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Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer

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Abstract

Genexol-PM is a novel Cremophor EL-free polymeric micelle formulation of paclitaxel. This single arm, multicenter phase II study was designed to evaluate the efficacy and safety of Genexol-PM in patients with histologically confirmed metastatic breast cancer (MBC). Forty-one women received Genexol-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks without premedication until disease progression or intolerability. A total of 331 chemotherapy cycles were administered, with a median of 8 cycles per patient (range, 1–16). Overall response rate was 58.5% (95% CI: 43.5–72.3) with 5 complete responses and 19 partial responses. Thirty-seven patients who received Genexol-PM as a first-line therapy for their metastatic disease showed a response rate of 59.5% (95% CI: 43.5–73.7), and two responses were reported in four patients treated in the second-line setting for their metastatic disease. The median time to progression (TTP) for all patients was 9.0 months (range, 1.0–17.0+ months). Grade 3 non-hematologic toxicities included sensory peripheral neuropathy (51.2%), and myalgia (2.4%). Eight patients (19.5%) experienced hypersensitivity reactions, with grade 3 in two patients. Hematologic toxicities were grade 3 and 4 neutropenia (51.2 and 17.1%, respectively), and grade 1 and 2 thrombocytopenia (22.0%). Notably, no febrile neutropenia was observed. Genexol-PM appears a promising new paclitaxel in view of significant efficacies. Further trials with different dosing schedules, durations of delivery, or in combination with other drugs are warranted.

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Acknowledgements

Supported in part by NCC grant 0610240-1, the Korean Health 21 R&D Project Grant, Ministry of Heath & Welfare, Republic of Korea (0412-CR01-0704-0001), and Samyang Co.

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Authors and Affiliations

  1. Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu-1-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, 410-769, Republic of Korea

    Keun Seok Lee & Jungsil Ro

  2. Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea

    Hyun Cheol Chung & Sun Young Rha

  3. Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

    Seock Ah Im

  4. Department of Internal Medicine, Korea Cancer Center Hospital, Seoul, Republic of Korea

    Yeon Hee Park

  5. Comprehensive Cancer Center, Inha University Hospital and College of Medicine, Inchon, Republic of Korea

    Chul Soo Kim

  6. Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea

    Sung-Bae Kim

  7. Samyang Corporation, Seoul, Republic of Korea

    Min Young Lee

  8. Korean Cancer Study Group, Seoul, Republic of Korea

    Keun Seok Lee, Hyun Cheol Chung, Seock Ah Im, Yeon Hee Park, Chul Soo Kim, Sung-Bae Kim, Sun Young Rha & Jungsil Ro

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  1. Keun Seok Lee
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Correspondence to Jungsil Ro.

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Lee, K.S., Chung, H.C., Im, S.A. et al. Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer. Breast Cancer Res Treat 108, 241–250 (2008). https://doi.org/10.1007/s10549-007-9591-y

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