Early Phase II Study Of Combination Chemotherapy of Docetaxel and Carboplatin in Patients With Postoperative Recurrent Adenocarcinoma of the Lung.

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Objective. Efficacy and safety of combination chemotherapy with Docetaxel (D) and Carboplatin (C) were evaluated in this early phase II study in patients with postoperative recurrent adenocarcinoma of the lung. Study design. D (60mg/m2, day 1) and C (5 area under the concentration-time curve, day 1) were given every 3 weeks to patients with aged under 70 years old and a Performance Status of 2 or less. Subsequently, D and C were given every 2 months until PD. This early phase II study was based on the Fleming method with two steps, was stopped early if significant efficacy was recognized in interim analysis. Result. The total of number courses was 66, the median was 4 courses (range 2-9 courses), follow up period 10.6-23.1 months (median 20.3 months). The overall response rate was 26.7%(95% CI: 4.2-49.0%), with 1 CR, 3 PR, 9 NC and 2 PD. Median time to response was 4 weeks (range: 3.6-8 weeks), and median response duration was 43.6 weeks (range: 9.4-68.7 weeks). Grade 3 or more toxicity consisted of 2 cases of anemia (13.3%), 7 cases of leucocytopenia (46.7%), 10 cases of neutrocytepenia (66.7%) and 2 cases of thrombocytopenia (13.3%). There was one treatment-related death (6.7%). One-year survival Is 51.9%(95% CI: 25.9-77.8%) and median survival has not yet been reached. Conculusion. This combinatin chemotherapy shows efficacy and warrants further investigation in future.
特定非営利活動法人日本肺癌学会の論文