A Randomized Phase II Study of Weekly Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Weekly Docetaxel in the Treatment of Advanced Non-small Cell Lung Cancer
Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends
in the incidence of lung cancer closely follow the patterns of cigarette smoking, although
other carcinogens have been implicated. Despite intensive treatment over the past several
decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.
Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most
investigators believe that treatment with a combination of two agents is the best first-line
treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using
combinations of agents. Outcomes were improved and these agents were eventually
incorporated into clinical practice.
Weekly docetaxel is being studied in combination with other commonly used NSCLC
chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These
combinations are being studied in both first- and second-line settings. Second line
chemotherapy with docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%).
However, the optimal sequence of chemotherapy was rarely explored. Weekly docetaxel may
offer better tolerability vs. 3-weekly schedule when combining docetaxel to cisplatin. Based
upon these studied, we choose weekly docetaxel in combination with cisplatin as our regimen.
We expected the regimen would be effective and well tolerated.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective of this study is to evaluate the 1-year treatment failure rate of two sequential chemotherapy regimens.
Chih-Hsin Yang, M.D.,Ph.D.
Department of Oncology , National Taiwan University Hospital
Taiwan: Department of Health