Japanese Journal of Clinical Oncology Advance Access published online on November 22, 2005
Japanese Journal of Clinical Oncology, doi:10.1093/jjco/hyi191
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1 Pulmonary Section, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi and Buddhist Tzu Chi University, Hualien, Taiwan
* To whom correspondence should be addressed. Background: For oriental, titrating doses of docetaxel (60-66 mg/m2) have been shown equal effectiveness and fewer side effects as a second-line chemotherapy for patients with advanced non-small cell lung cancer (NSCLC). Under such doses, there were no comparative data between classic tri-weekly and Days 1 and 8 weekly schedules. Methods: This Phase II randomized prospective study was designed to compare the toxicity profile, efficacy and quality-of-life (QOL) between these two schedules of docetaxel in the treatment of previously treated patients with advanced NSCLC. Fifty patients were randomized to docetaxel arm A (66 mg/m2 Day 1) and B (33 mg/m2 Days 1 and 8) given every 3 weeks. Results: The overall response rates (ORRs) were 12 and 24% in arm A and B, respectively (P = 0.46), and disease control rates were 52 and 48%. The median time-to-progression (TTP) was 11.3 and 12.7 weeks and median survivals were 33.4 and 27.6 weeks, respectively. Both arms have same 1 year (36%) and 2 year survivals (12%). Arm A had significantly higher neutropenia but less compromised QOL. In this study, the response of second-line chemotherapy was significantly better in the group that was response to front-line chemotherapy (P = 0.032). Conclusions: While Days 1 and 8 weekly docetaxel schedules show higher ORR and less hematological toxicity, there is no advantage to tri-week schedule in terms of TTP and survival, but more compromised QOL.
Received June 21, 2005
Accepted October 9, 2005
Original Article
Phase II Randomized Trial of Tri-weekly Versus Days 1 and 8 Weekly Docetaxel as a Second-line Treatment of Advanced Non-small Cell Lung Cancer
Chun-Liang Lai 1,
Chun-Ming Tsai 2 *,
Chao-Hua Chiu 3,
Gwo-Shu Wang 4,
Wei-Juin Su 4,
Yuh-Min Chen 3,
and
Reury-Perng Perng 3
2 Section of Thoracic Oncology, Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan; School of Medicine, National Yang-Ming University, Taipei, Taiwan
3 Section of Thoracic Oncology, Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan
4 Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan
Chun-Ming Tsai, E-mail: cmtsai{at}vghtpe.gov.tw
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