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An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer.


ABSTRACT: Genexol-PM is a Cremophor EL-free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol).Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m2 or Genexol 175 mg/m2 intravenously every 3 weeks. The primary outcome was the objective response rate (ORR).The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m2 (95.0%), and that of Genexol was 168.3±10.6 mg/m2 (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (pnon-inferiority=0.021, psuperiority=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments.Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.

SUBMITTER: Park IH 

PROVIDER: S-EPMC5512366 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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An Open-Label, Randomized, Parallel, Phase III Trial Evaluating the Efficacy and Safety of Polymeric Micelle-Formulated Paclitaxel Compared to Conventional Cremophor EL-Based Paclitaxel for Recurrent or Metastatic HER2-Negative Breast Cancer.

Park In Hae IH   Sohn Joo Hyuk JH   Kim Sung Bae SB   Lee Keun Seok KS   Chung Joo Seop JS   Lee Soo Hyeon SH   Kim Tae You TY   Jung Kyung Hae KH   Cho Eun Kyung EK   Kim Yang Soo YS   Song Hong Suk HS   Seo Jae Hong JH   Ryoo Hun Mo HM   Lee Sun Ah SA   Yoon So Young SY   Kim Chul Soo CS   Kim Yong Tai YT   Kim Si Young SY   Jin Mi Ryung MR   Ro Jungsil J  

Cancer research and treatment 20160912 3


<h4>Purpose</h4>Genexol-PM is a Cremophor EL-free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol).<h4>Materials and methods</h4>Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m<sup>2</sup> or Genexol 175 mg/m<sup>2</sup> intravenously every 3 weeks. The primary outcome was the objective response  ...[more]

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