J Korean Cancer Assoc.  2000 Jun;32(3):545-552.

Phase II Multicenter Trial of Paclitaxel for Metastatic Breast Cancer

• Byun JH
• Yoon SS
• Park CH
• Kim SR
• Kim SY
• Kim HJ
• Bang SM
• Chang HM
• Heo DS
• Bang YJ
• Kim NK

Abstract

PURPOSE: To evaluate the efficacy and safety of paclitaxel for metastatic breast cancer patients who had received previous chemotherapy, we have performed phase II multicenter trial between December 1997 and December 1998. MATERIALS AND METHOD: Thirty patients were accrued to this study and paclitaxel was administered at 175 mg/m2 as a 3-hour intravenous infusion every 3 weeks until the progression of the disease.
RESULTS
Objective response were observed in 13 of 30 patients (43.3%). There were 1 complete response (3.3%) and 12 partial responses (40%). Especially, 50% (11/22) of patients who had received prior anthracycline-containing regimens for adjuvant or metastatic disease responded to paclitaxel. Responses were observed in all sites of metastatic disease. One hundred forty-nine cycles of treatment were administered, with a median of six cycles per patient. Grade III and IV toxicities included neutropenia (24%), elevated liver enzyme (10%), peripheral neuropathy (10%), arthralgia/myalgia (23%), and alopecia (87%). No significant hypersensitivity type reaction or cardiac arrhythmia were seen. Median duration of response was 7.2 months.
CONCLUSIONS
These results suggested that paclitaxel is active therapeutic agent in metastatic breast cancer patients and it can be safely administered by 3-hour intravenous infusion with premedication.

Keyword

Breast neoplasm; Chemotherapy; Paclitaxel; Phase II

MeSH Terms

Alopecia
Arrhythmias, Cardiac
Breast Neoplasms*
Breast*
Drug Therapy
Humans
Hypersensitivity
Infusions, Intravenous
Liver
Neutropenia
Paclitaxel*
Peripheral Nervous System Diseases
Premedication
Paclitaxel