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J Korean Cancer Assoc > Volume 32(3); 2000 > Article
Journal of the Korean Cancer Association 2000;32(3): 545-552.
Phase II Multicenter Trial of Paclitaxel for Metastatic Breast Cancer
Jae Ho Byun, Sung Soo Yoon, Chan Hyung Park, Sung Rok Kim, Si Young Kim, Hyo Jin Kim, Soo Mee Bang, Heung Moon Chang, Dae Seog Heo, Yung Jue Bang, Noe Kyeong Kim
1Department of Internal Medicine, Seoul National University College of Medicine, Seoul.
2Department of Internal Medicine, Sung Kyun Kwan University College of Medicine, Seoul.
3Department of Internal Medicine, In Je University College of Medicine, Seoul.
4Department of Internal Medicine, Kyung Hee University College of Medicine, Seoul.
5Department of Internal Medicine, Dong-A University College of Medicine, Pusan, Korea.
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.
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.
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.
Key words: Breast neoplasm;Chemotherapy;Paclitaxel;Phase II
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