Japanese Journal of Clinical Oncology Advance Access originally published online on November 22, 2005
Japanese Journal of Clinical Oncology 2005 35(12):700-706; doi:10.1093/jjco/hyi191
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© 2005 Foundation for Promotion of Cancer Research
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
1 Pulmonary Section, Department of Internal Medicine, Buddhist Dalin Tzu Chi General Hospital, Chiayi and Buddhist Tzu Chi University, Hualien, 2 Section of Thoracic Oncology, Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan, 3 School of Medicine, National Yang-Ming University, Taipei, Taiwan, and 4 Chest Department, Taipei Veterans General Hospital, Taipei, Taiwan
For reprints and all correspondence: Chun-Ming Tsai, Section of Thoracic Oncology, Chest Department of Taipei Veterans General Hospital, Shih-Pai, Taipei 11217, Taiwan. E-mail: cmtsai{at}vghtpe.gov.tw
Received June 21, 2005; accepted October 9, 2005
Background: For orientals, titrating doses of docetaxel (60–66 mg/m2) have 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.
Key Words: chemotherapy • Days 1 and 8 weekly administration • docetaxel • non-small cell lung cancer • tri-weekly administration
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