A Phase II Study of Gemcitabine Monotherapy in Breast Cancer Patients Refractory to Anthracycline and Taxane

Park, Jun Yong; Kim, Chul; Sohn, Joo Hyuk; Kim, Yong Tae; Rha, Sun Young; Jang, Woo Ick; Kim, Gwi Eon; Chung, Hyun Cheol

doi:2002.34.4.274

Cancer Research and Treatment > Volume 34(4); 2002 > Article

Original Article

Cancer Research and Treatment 2002;34(4): 274-279. doi: https://doi.org/10.4143/crt.2002.34.4.274

A Phase II Study of Gemcitabine Monotherapy in Breast Cancer Patients Refractory to Anthracycline and Taxane

Jun Yong Park, Chul Kim, Joo Hyuk Sohn, Yong Tae Kim, Sun Young Rha, Woo Ick Jang, Gwi Eon Kim, Hyun Cheol Chung

¹Department of Internal Medicine, Yonsei University Collegeof Medicine, Korea.
²Yonsei Cancer Center, Yonsei University College of Medicine,Korea.
³Cancer Metastasis Research Center, Yonsei University Collegeof Medicine, Korea.
⁴Brain Korea 21 Project for Medical Science, YonseiUniversity College of Medicine, Korea.
⁵Department of Lilly Korea Ltd., Seoul, Korea.

Published online: August 31, 2002.

ABSTRACT

We performed a phase II trial to evaluate the efficacy and the safety of gemcitabine monotherapy, a pyrimidine antimetabolite, in patients, who had previously failed anthracycline and taxane-based chemotherapy for the treatment of metastatic breast cancer.
MATERIALS AND METHODS:
Twenty-one patients with metastatic breast cancer, which was unresponsive to previous chemotherapy, were entered into this study. Gemcitabine was administered at 850 mg/m2, as a 60- minute intravenous infusion on days 1, 8 and 15. This regimen was repeated every 28 days with G-CSF support, but without dose reduction.
RESULTS:
Objective responses were seen in 6 of the 20 patients who were able to be evaluated (1 complete response and 5 partial responses), with an objective response rate of 30%. The median time to progression was 5 (1~20) months, and the median overall survival duration was 11 (2~21) months. The actual dose intensity was 566.7 mg/m2/wk (range; 340~637.5 mg/m2/wk) and the relative dose intensity was 0.89 (range; 0.40~1.00). Toxicity was mainly hematological. Toxicities included: grade 3 neutropenia in 20% and anemia in 5%. Grades 3 and 4 thrombocytopenia occurred in 15% of the patients.
CONCLUSION:
Gemcitabine monotherapy is an effective and safe treatment for refractory breast cancer patients heavily treated with the anthracycline and taxane- based regimen.

Key words: Metastatic breast neoplasm;Chemotherapy;Gemcitabine