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

Keun Seok Lee, Hyuncheol Chung, Seock Ah Im, Yeon Hee Park, Chul Soo Kim, Sung Bae Kim, SunYoung Rha, Min Young Lee, Jungsil Ro

Research output: Contribution to journalArticle

345 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
Publication statusPublished - 2008 Mar 1

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

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Lee, Keun Seok ; Chung, Hyuncheol ; Im, Seock Ah ; Park, Yeon Hee ; Kim, Chul Soo ; Kim, Sung Bae ; Rha, SunYoung ; 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.
@article{b95b21f5cad14875a9ba202af64c83d5,
title = "Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer",
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.",
author = "Lee, {Keun Seok} and Hyuncheol Chung and Im, {Seock Ah} and Park, {Yeon Hee} and Kim, {Chul Soo} and Kim, {Sung Bae} and SunYoung Rha and Lee, {Min Young} and Jungsil Ro",
year = "2008",
month = "3",
day = "1",
doi = "10.1007/s10549-007-9591-y",
language = "English",
volume = "108",
pages = "241--250",
journal = "Breast Cancer Research and Treatment",
issn = "0167-6806",
publisher = "Springer New York",
number = "2",

}

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, Hyuncheol; Im, Seock Ah; Park, Yeon Hee; Kim, Chul Soo; Kim, Sung Bae; Rha, SunYoung; 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

TY - JOUR

T1 - Multicenter phase II trial of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in patients with metastatic breast cancer

AU - Lee, Keun Seok

AU - Chung, Hyuncheol

AU - Im, Seock Ah

AU - Park, Yeon Hee

AU - Kim, Chul Soo

AU - Kim, Sung Bae

AU - Rha, SunYoung

AU - Lee, Min Young

AU - Ro, Jungsil

PY - 2008/3/1

Y1 - 2008/3/1

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=39749178252&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=39749178252&partnerID=8YFLogxK

U2 - 10.1007/s10549-007-9591-y

DO - 10.1007/s10549-007-9591-y

M3 - Article

VL - 108

SP - 241

EP - 250

JO - Breast Cancer Research and Treatment

JF - Breast Cancer Research and Treatment

SN - 0167-6806

IS - 2

ER -