Breast Cancer Research and Treatment

, Volume 108, Issue 2, pp 241–250

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

  • Keun Seok Lee
  • Hyun Cheol Chung
  • Seock Ah Im
  • Yeon Hee Park
  • Chul Soo Kim
  • Sung-Bae Kim
  • Sun Young Rha
  • Min Young Lee
  • Jungsil Ro
Clinical Trial

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.

Keywords

Breast cancer Clinical trial Genexol-PM Phase II 

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Copyright information

© Springer Science+Business Media, LLC 2007

Authors and Affiliations

  • Keun Seok Lee
    • 1
    • 8
  • Hyun Cheol Chung
    • 2
    • 8
  • Seock Ah Im
    • 3
    • 8
  • Yeon Hee Park
    • 4
    • 8
  • Chul Soo Kim
    • 5
    • 8
  • Sung-Bae Kim
    • 6
    • 8
  • Sun Young Rha
    • 2
    • 8
  • Min Young Lee
    • 7
  • Jungsil Ro
    • 1
    • 8
  1. 1.Center for Breast Cancer, Research Institute and Hospital, National Cancer CenterIlsan-gu, Goyang-siRepublic of Korea
  2. 2.Yonsei Cancer Center, Yonsei University College of MedicineSeoulRepublic of Korea
  3. 3.Department of Internal MedicineSeoul National University College of MedicineSeoulRepublic of Korea
  4. 4.Department of Internal MedicineKorea Cancer Center HospitalSeoulRepublic of Korea
  5. 5.Comprehensive Cancer Center, Inha University Hospital and College of MedicineInchonRepublic of Korea
  6. 6.Department of Internal MedicineAsan Medical Center, University of Ulsan College of MedicineSeoulRepublic of Korea
  7. 7.Samyang CorporationSeoulRepublic of Korea
  8. 8.Korean Cancer Study GroupSeoulRepublic of Korea

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