Japanese Journal of Clinical Oncology Advance Access originally published online on October 16, 2006
Japanese Journal of Clinical Oncology 2006 36(12):761-767; doi:10.1093/jjco/hyl106
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© 2006 Foundation for Promotion of Cancer Research
A Phase II Trial of Docetaxel Plus Capecitabine in Patients with Previously Treated Non-Small Cell Lung Cancer
Research Institute and Hospital, National Cancer Center, Goyang, Gyeonggi, Korea
For reprints and all correspondence: Jin Soo Lee, Center for Lung Cancer, National Cancer Center Hospital, 809 Madu 1-dong, Ilsan-gu, Goyang-si, Gyeonggi-do, 411-764, Republic of Korea. E-mail: jslee{at}ncc.re.kr
Received April 17, 2006; accepted July 27, 2006
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 114 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 114 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).
CONCLUSIONS: 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 114 of a 21-day cycle.
Key Words: docetaxel capecitabine non-small cell lung cancer second-line treatment