title: A Phase II Study of Genexol(R) (paclitaxel) in Metastatic Breast Cancer.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  The results suggest that the Genexol injection is an effective anticancer formulation for the treatment of metastatic breast cancer and toxicity is acceptable.
authors.forename: J Y
authors.initials: JY
authors.lastname: Jung
authors.forename: H C
authors.initials: HC
authors.lastname: Jeong
authors.forename: S S
authors.initials: SS
authors.lastname: Yoon
authors.forename: J H
authors.initials: JH
authors.lastname: Lee
authors.forename: J S
authors.initials: JS
authors.lastname: Kim
authors.forename: H J
authors.initials: HJ
authors.lastname: Kim
authors.forename: K H
authors.initials: KH
authors.lastname: Kim
authors.forename: J O
authors.initials: JO
authors.lastname: Park
authors.forename: W S
authors.initials: WS
authors.lastname: Lee
authors.forename: D S
authors.initials: DS
authors.lastname: Heo
authors.forename: Y J
authors.initials: YJ
authors.lastname: Bang
authors.forename: N K
authors.initials: NK
authors.lastname: Kim
keywords: Breast neoplasm; Chemotherapy; Genexol; Phase II study