Fossella F V, Lee J S, Berille J, Hong W K
Department of Thoracic/Head and Neck Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston 77030, USA.
Semin Oncol. 1995 Apr;22(2 Suppl 4):22-9.
Six phase II studies have been conducted in the United States and Europe using docetaxel (Taxotere; Rhone-Poulenc Rorer, Antony, France) for advanced non-small cell lung cancer. One hundred eighty chemotherapy-naive patients in four studies and 88 patients who failed prior platinum-containing chemotherapy in two studies were treated with docetaxel 75 to 100 mg/m2 intravenously over 1 hour every 3 weeks. Fifty-nine percent of patients had adenocarcinoma and 82% had stage IV disease. At a dose of 100 mg/m2, 30% of evaluable chemotherapy-naive patients (27% of the intent-to-treat population) and 20% of evaluable platinum-refractory/resistant patients (17% of the intent-to-treat population) achieved a partial response; projected median survival is 9 months in both studies. Neutropenia was the primary dose-limiting acute side effect. Fluid retention, which occurred in patients who received multiple courses of treatment, was common but rarely dose-limiting, and may be ameliorated with prophylactic corticosteroids. Other toxic effects were relatively mild. Docetaxel has significant activity against advanced non-small cell lung cancer, producing a major response in both chemotherapy-naive patients and patients who had failed prior platinum-containing chemotherapy.
在美国和欧洲开展了六项II期研究，使用多西他赛（泰索帝；法国罗纳普朗克乐安公司，安东尼）治疗晚期非小细胞肺癌。四项研究中的180例初治化疗患者以及两项研究中的88例铂类化疗失败患者，每3周接受一次静脉输注多西他赛治疗，剂量为75至100mg/m²，输注时间1小时。59%的患者为腺癌，82%的患者为IV期疾病。在100mg/m²剂量下，30%的可评估初治化疗患者（意向性治疗人群的27%）以及20%的可评估铂类难治/耐药患者（意向性治疗人群的17%）达到部分缓解；两项研究中预计的中位生存期均为9个月。中性粒细胞减少是主要的剂量限制性急性副作用。接受多疗程治疗的患者出现的液体潴留很常见，但很少成为剂量限制性因素，预防性使用皮质类固醇可能会改善这种情况。其他毒性作用相对较轻。多西他赛对晚期非小细胞肺癌具有显著活性，在初治化疗患者和铂类化疗失败患者中均产生了主要缓解。
