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.
- Author:
In Hae PARK
1
;
Joo Hyuk SOHN
;
Sung Bae KIM
;
Keun Seok LEE
;
Joo Seop CHUNG
;
Soo Hyeon LEE
;
Tae You KIM
;
Kyung Hae JUNG
;
Eun Kyung CHO
;
Yang Soo KIM
;
Hong Suk SONG
;
Jae Hong SEO
;
Hun Mo RYOO
;
Sun Ah LEE
;
So Young YOON
;
Chul Soo KIM
;
Yong Tai KIM
;
Si Young KIM
;
Mi Ryung JIN
;
Jungsil RO
Author Information
- Publication Type:Original Article
- Keywords: Polymeric micelle paclitaxel; Cremophor EL-free; Genexol-PM; Metastatic breast cancer
- MeSH: Breast Neoplasms*; Breast*; Disease-Free Survival; Follow-Up Studies; Humans; Incidence; Neutropenia; Paclitaxel*; Peripheral Nervous System Diseases; Polymers*; Treatment Outcome
- From:Cancer Research and Treatment 2017;49(3):569-577
- CountryRepublic of Korea
- Language:English
- Abstract: PURPOSE: 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). MATERIALS AND METHODS: 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). RESULTS: 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) (p(non-inferiority)=0.021, p(superiority)=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. CONCLUSION: 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.
