Low dose capecitabine plus weekly paclitaxel in patients with metastatic breast cancer: a multicenter phase II study KBCSG-0609.

Abstract:

PURPOSE:The combination of capecitabine and paclitaxel (XP) has demonstrated synergistic antitumor activity in preclinical models. The purpose of this phase II study was to evaluate the efficacy and safety of a monthly XP regimen in patients with metastatic breast cancer (MBC). METHODS:Eligible patients had received one or fewer prior chemotherapy regimens for MBC. Patients received oral capecitabine of low dose (828 mg/m(2) twice daily, days 1-21) plus paclitaxel (80 mg/m(2), i.v., over 60 min, days 1, 8 and 15) every 28 days until disease progression or unacceptable toxicity. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival (OS) and safety were secondary endpoints. An exploratory analysis of efficacy according to hormone receptor (HR) status was performed. RESULTS:Forty-four patients were enrolled, and 43 patients were evaluable. ORR was 46.5%. PFS and OS were 8.3 and 22.9 months, respectively. ORR was 45.5% in patients with HR-positive tumors and 50% in HR-negative cases. The most frequently observed grade 3/4 adverse events were neutropenia (27.9%), leukopenia (11.6%), hand-foot syndrome (HFS, 9.3%) and fatigue (7.0%). There were no discontinuations due to HFS. CONCLUSIONS:Monthly XP was an effective and well-tolerated regimen for the first- or second-line treatment for MBC.

authors

Taguchi T,Yamamoto D,Masuda N,Oba K,Nakayama T,Nagata T,Nomura M,Yoshidome K,Yoshino H,Matsunami N,Miyashita M,Furuya Y,Ishida T,Wakita K,Sakamoto J,Noguchi S,Kinki Breast Cancer Study Group (KBCSG).

doi

10.1007/s00280-012-2068-7

subject

Has Abstract

pub_date

2013-03-01 00:00:00

pages

741-7

issue

3

eissn

0344-5704

issn

1432-0843

journal_volume

71

pub_type

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