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Japanese Journal of Clinical Oncology Advance Access published online on October 16, 2006
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyl106
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© 2006 Foundation for Promotion of Cancer Research
Received April 17, 2006
Accepted July 27, 2006

Original Article

A Phase II Trial of Docetaxel Plus Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer

Jae Jin Lee 1, Ji-Youn Han 1, Dae Ho Lee 1, Hyae Young Kim 1, Jong Ho Chun 1, Hong Gi Lee 1, Seong Min Yoon 1, Sung Young Lee 1, and Jin Soo Lee 2 *

1 Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea
2 Research Institute and Hospital, Center for Lung Cancer, National Cancer Center, 809 Madu 1-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, 411-764, Republic of Korea

* To whom correspondence should be addressed.
Jin Soo Lee, E-mail: jslee{at}ncc.re.kr


  Abstract

Background: A combination of docetaxel (T) and capecitabine (X) showed synergistic effects in preclinical studies and phase III randomized trials of metastatic breast cancer. We conducted this phase II study to examine its efficacy in previously treated non-small cell lung cancer (NSCLC) patients.

Methods: Patient eligibility required advanced NSCLC with measurable lesion(s), at least one prior regimen failure and Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Treatment consisted of T 36 mg/m2 i.v. on days 1 and 8 plus X 1000 mg/m2 p.o. b.i.d. on days 1-14 of a 21-day cycle (level I) or T 30 mg/m2 i.v. on days 1 and 8 plus X 625 mg/m2 p.o. b.i.d. on days 1-14 of a 21-day cycle (level II).

Results: A total of 35 patients (M/F=24/11) were enrolled; 29 had received one prior regimen and 19 had received platinum-based regimens. Significant non-hematologic toxicities were observed after the treatment given at level I, including one treatment-related death. Subsequently 29 patients were treated at level II. The treatment at level II was well tolerated with grade 3 or 4 neutropenia only in 10%, grade 3 asthenia in 21% and stomatitis in 14% of patients. Four (15%) of 27 evaluable patients had partial response (PR) at level II and eight (30%) had stable disease (SD).

Conclustions: The TX regimen showed modest antitumor effects in patients with previously treated NSCLC. For further studies, we recommend T 30 mg/m2 i.v. on days 1 and 8 plus X 625 mg/m2 p.o. b.i.d. on days 1-14 of a 21-day cycle.

Keywords: docetaxel; capecitabine; non-small cell lung cancer; second-line treatment.
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