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Published on: July 31, 2016
A Phase II Study of Genexol(R) (paclitaxel) in Metastatic Breast Cancer
Purpose:
Paclitaxel is a very effective agent in the treatment of breast cancer. Samyang Corporation has developed its own process to produce paclitaxel in a large volume using plant cell culture technology. To evaluate the efficacy and safety of Genexol(R) in patients with metastatic breast cancer who have failed to respond to standard therapy, we performed a prospective, multi- center phase II clinical trial.
Materials And Methods:
Patients with metastatic breast cancer were included in this study. Enrollees were required to have histologically confirmed breast cancer with bidimensionally measurable metastatic disease. Genexol(R) was administered at 175 mg/m2 as a 3-hour intravenous infusion every 3 weeks. All patients were premedicated with hydrocortisone, pheniramine maleate, and H2 blocker 30 minutes prior to paclitaxel. We planned to administer at least 4 courses of paclitaxel unless there was disease progression or unacceptable toxicity and to continue treatment up to a total of 6 courses in cases of objective response following 4 courses.
Results:
The median duration of follow-up was 8.9 (2.07~13.7) months. Forty-five patients were registered and 43 were eligible. The performance status of patients was ECOG 0~1 in 39 patients (90.7%) and 2 in 4 (9.3%). The location of metastases at the start of the study were the lung (15 patients), liver (8 patients), lymph nodes (22 patients), and other (7 patients). Among the 40 evaluable patients, 15 patients obtained partial responses (PRs) (37.5%, 95% CI: 22.5~52.5%). The median duration of response was 11.67 (4.1~11.7) months and the median time to progression was 7.73 (2.8~11.7) months. The median survival time was not reached at 13.7 months, and the overall survival rate at 13.7 months was 70.1%. The hematologic toxicity was primarily neutropenia with grade 3 or 4 in 10 patients (23.3%). The grade 3 or 4 non-hematologic toxicities included alopecia (17, 39.5%), myalgia (2, 4.7%), neuropathy (2, 4.7%), and pruritus (1, 2.3%). Mild hypersensitivity reaction was observed in 2 patients, although it did not cause withdrawal of the test drug.
Conclusion:
The results suggest that the Genexol injection is an effective anticancer formulation for the treatment of metastatic breast cancer and toxicity is acceptable.
Insights
Genexol (paclitaxel) shows efficacy in treating metastatic breast cancer patients who failed prior therapies. The plant cell culture-derived formulation demonstrated acceptable toxicity profiles in this phase II clinical trial.
Area of Science:
- Oncology
- Pharmacology
- Biotechnology
Background:
- Paclitaxel is a key chemotherapeutic agent for breast cancer.
- Samyang Corporation developed a large-scale paclitaxel production method using plant cell culture technology.
Purpose of the Study:
- To assess the efficacy and safety of Genexol (paclitaxel) in patients with metastatic breast cancer.
- To evaluate Genexol in patients refractory to standard treatments.
Main Methods:
- A prospective, multi-center phase II clinical trial was conducted.
- Genexol was administered intravenously at 175 mg/m2 every 3 weeks.
- Patients received standard premedication to mitigate hypersensitivity reactions.
Main Results:
- Partial responses (PRs) were observed in 37.5% of 40 evaluable patients.
- Median duration of response was 11.67 months; median time to progression was 7.73 months.
- Overall survival rate at 13.7 months was 70.1%; manageable hematologic and non-hematologic toxicities were noted.
Conclusions:
- Genexol injection is an effective anticancer formulation for metastatic breast cancer.
- The toxicity profile of Genexol is considered acceptable for this patient population.
