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

Research output: Contribution to journalArticle

352 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)241-250
Number of pages10
JournalBreast Cancer Research and Treatment
Volume108
Issue number2
DOIs
StatePublished - 1 Mar 2008

Fingerprint

Micelles
Paclitaxel
Breast Neoplasms
Febrile Neutropenia
Premedication
Myalgia
Peripheral Nervous System Diseases
cremophor
Neutropenia
Intravenous Infusions
Disease Progression
Appointments and Schedules
Hypersensitivity
Safety
Drug Therapy
Pharmaceutical Preparations

Keywords

  • Breast cancer
  • Clinical trial
  • Genexol-PM
  • Phase II

Cite this

Lee, Keun Seok ; Chung, Hyun Cheol ; Im, Seock Ah ; Park, Yeon Hee ; Kim, Chul Soo ; Kim, Sung Bae ; Rha, Sun Young ; Lee, Min Young ; Ro, Jungsil. / Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer. In: Breast Cancer Research and Treatment. 2008 ; Vol. 108, No. 2. pp. 241-250.
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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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Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer. / Lee, Keun Seok; Chung, Hyun Cheol; Im, Seock Ah; Park, Yeon Hee; Kim, Chul Soo; Kim, Sung Bae; Rha, Sun Young; Lee, Min Young; Ro, Jungsil.

In: Breast Cancer Research and Treatment, Vol. 108, No. 2, 01.03.2008, p. 241-250.

Research output: Contribution to journalArticle

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T1 - 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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AU - Chung, Hyun Cheol

AU - Im, Seock Ah

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AU - Lee, Min Young

AU - Ro, Jungsil

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