AIM: To investigate the development of a safer chemotherapeutic regimen with better compliance, a total of 67 patients were enrolled as a single arm in a twostage multi-center phase Ⅱ study.METHODS: The patients rece...AIM: To investigate the development of a safer chemotherapeutic regimen with better compliance, a total of 67 patients were enrolled as a single arm in a twostage multi-center phase Ⅱ study.METHODS: The patients received chemotherapy with carboplatin(CBDCA) with an area under the curve(AUC) of 5, and docetaxel(DTX) at 60 mg/m2 tri-weekly for three cycles after surgery. The primary endpoint of this study was compliance, while the secondary endpoints were the adverse events(AE) and recurrencefree survival(RFS).RESULTS: Sixty-one patients were treated in this study arm. The patients were 43 males and 18 females, with a median age of 64.6 years. Fifty-one patients(83.6%)completed all three cycles of therapy. The presence of Grade 3 and 4 neutropenia was noted in 25% and 66%of the patients, respectively. The non-hematological AE were less frequently reported, and no treatmentrelated death was registered. The two-year RFS and OS rates of the 61 patients were 69.8% and 88.3%,respectively.CONCLUSION: A tri-weekly schedule of CBDCA and DTX as adjuvant chemotherapy showed a favorable feasibility.展开更多
基金Supported by JPJS KAKENHI,No.25462202A UOEH Research Grant for Promotion of Occupational HealthUramoto H,Hanagiri T and Tanaka F received a research grant that belongs to the institute from Sanofi-Aventis,Inc
文摘AIM: To investigate the development of a safer chemotherapeutic regimen with better compliance, a total of 67 patients were enrolled as a single arm in a twostage multi-center phase Ⅱ study.METHODS: The patients received chemotherapy with carboplatin(CBDCA) with an area under the curve(AUC) of 5, and docetaxel(DTX) at 60 mg/m2 tri-weekly for three cycles after surgery. The primary endpoint of this study was compliance, while the secondary endpoints were the adverse events(AE) and recurrencefree survival(RFS).RESULTS: Sixty-one patients were treated in this study arm. The patients were 43 males and 18 females, with a median age of 64.6 years. Fifty-one patients(83.6%)completed all three cycles of therapy. The presence of Grade 3 and 4 neutropenia was noted in 25% and 66%of the patients, respectively. The non-hematological AE were less frequently reported, and no treatmentrelated death was registered. The two-year RFS and OS rates of the 61 patients were 69.8% and 88.3%,respectively.CONCLUSION: A tri-weekly schedule of CBDCA and DTX as adjuvant chemotherapy showed a favorable feasibility.
