Efficacy of oral Etoposide in pretreated metastatic breast cancer: a multicenter phase 2 study.
No standard chemotherapy has been defined for metastatic breast cancer (MBC) patients pretreated with anthracyclines and taxanes. A multicenter phase 2 study was conducted to evaluate the safety and efficacy of oral etoposide in patients with MBC.Eligible patients were treated with repeated cycles of oral etoposide (60 mg/m/d on days 1-10, followed by 11 days of rest). The primary endpoint was progression-free survival (PFS). The secondary endpoints were objective response rate, clinical benefit rate (CBR), and toxicity profiles.Seventy-five women with MBC were enrolled at 10 centers in China. Seven (9.3%) patients achieved partial response (PR) and 29 (38.7%) had stable disease (SD). Nine patients (12%) had SD for >24 weeks and the CBR was 21.3% (16/75). The median PFS was 4.5 (range, 1.3-7.7) months. Of the 38 patients who received ≥3 regimens prior to this study, 2 (5.3%) had PR and 3 (7.9%) had SD for >24 weeks, with a CBR of 13.2%. The reported grade 3/4 adverse events included leukopenia (13.3%, n = 10), neutropenia (17.9%, n = 14), anemia (2.7%, n = 2), vomiting (2.6%, n = 2), and alopecia (1.3%, n = 1).Oral etoposide was effective and well tolerated in Chinese women with pretreated MBC.
From the Department of Medical Oncology (PY, RH, BX), Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Peking University Cancer Hospital (LD); Peking Union Medical College Hospital (XZ), Beijing; Henan Cancer Hospital (MY), Zhengzhou; China-Japan Friendship Hospital (DW), Beijing; First Affiliated Hospital of Dalian Medical University (LL), Dalian; Beijing Hospital of the Ministry of Health (YZ); Zhejiang Cancer Hospital (JC); Beijing ChaoYang Hospital (HD), Beijing; and Shanghai Putuo District People's Hospital (QZ), Shanghai, China.
Peng
P
Yuan
Lijun
L
Di
Xiaohui
X
Zhang
Min
M
Yan
Donggui
D
Wan
Li
L
Li
Yongqiang
Y
Zhang
Jufen
J
Cai
Hong
H
Dai
Qi
Q
Zhu
Ruoxi
R
Hong
Binghe
B
Xu
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D002681:China; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008875:Middle Aged; D016879:Salvage Therapy; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome
D018943:Anthracyclines; D043823:Taxoids; D005047:Etoposide