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Poster display - Cocktail

1154 - Estimation of efficacy and safety of Genexol-PM, a Cremophor-free, polymeric micelle formulation of paclitaxel, in recurrent or metastatic breast cancer patients

Date

24 Nov 2018

Session

Poster display - Cocktail

Presenters

Sung Soo Kang

Citation

Annals of Oncology (2018) 29 (suppl_9): ix13-ix20. 10.1093/annonc/mdy428

Authors

S.S. Kang

Author affiliations

  • Surgery, Cheil General Hospital and women's Healthcare Center, Dankook Univ. College of Medicine, 04619 - Seoul/KR
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Resources

Abstract 1154

Background

Genexol®-PM is a Cremorphor EL (CrEL)-free polymeric micelle formulation of paclitaxel that allows higher-dose administration with less hypersensitivity. This study was conducted to evaluate the response and safety of Genexol®-PM monotherapy in patients with recurrent or metastatic breast cancer (MBC).

Methods

A total of forty-eight patients with recurrent or MBC, ECOG performance status ≤ 2 received Genexol®-PM by intravenous infusion at 300 mg/m2 over 3 h every 3 weeks in the inpatient setting with premedication until disease progression or intolerability. Response to therapy was assessed after every 3 cycles using the Response Evaluation Criteria in Solid tumors (RECIST) guideline (version 1.1) and adverse events were evaluated according to the NCI Common Terminology Criteria for Adverse events, Version 3.0.

Results

A total of 290 chemotherapy cycles were administered, with a median of 6 cycles per patient (range, 1–16). The overall response rate was 52.1% with 1 complete response (CR) and 24 partial responses (PR). Of 11 patients who received Genexol®-PM as a first-line therapy, there were 5 responses (45.5%). Disease control rate (CR + PR + stable disease) was 64.6% (first-line: 72.7%, second-line: 53.8%, respectively). The median time to progression (TTP) was 6.0 months (range, 2.0–36 months). The common grade 3/4 non-hematologic toxicities were peripheral neuropathy (n = 22, 45.8%) and myalgia (n = 5, 10.4%). Hematologic toxicities were grade 3 and 4 neutropenia (n = 15, 31.3% and n = 6, 12.5%, respectively), and grade 1 and 2 thrombocytopenia (n = 7, 14.6%). No febrile neutropenia was observed.

Conclusions

Genexol®-PM, a CrEL-free, polymeric micelle formulation of paclitaxel chemotherapy showed significant antitumor activity with relatively low incidence and severity of toxicity in spite of a high paclitaxel dose in patients with MBC. Although further studies with larger sample size and different dosing schedules are warranted, this study suggests that Genexol®-PM monotherapy may be a candidate as a reasonable treatment for MBC patients.

Editorial acknowledgement

Clinical trial identification

Legal entity responsible for the study

Sung Soo Kang.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.

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