Amodio A, Carpano S, Paoletti G, Gionfra T, Rinaldi M, Manfredi C, Foggi P, Lopez M
Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italia.
Clin Ter. 1998 Mar-Apr;149(2):121-5.
To evaluate the activity and toxicity of docetaxel (TXT) as second line therapy in advanced soft-tissue sarcoma.
Adult patients (pts) with histologically proven locally advanced or metastatic soft tissue sarcoma, were treated with TXT at a dose of 100 mg/m2 in a 1-hour i.v. infusion every 21 days and steroid premedication with oral prednisone 50 mg twice a day for five days starting 24 hours prior to TXT.
From November 1995 to May 1997, 19 pretreated pts entered the trial. Characteristics of the pts: males/females 11/8, median age 58 years (30-74), median WHO performance status 1 (0-2); histotypes: leiomyosarcoma 6 pts, malignant fibrous histiocytoma 6 pts, fibrosarcoma 2 pts, others 5 pts. No objective responses were seen. The disease remained stable in 8 pts (42%). Median time to progression was 3.5 months (range, 2-8), median survival 6 months (range, 2-20). The treatment was well-tolerated: the main side effect was hematological toxicity with G3/4 leukopenia and neutropenia in 58% of the pts; G3 anemia and thrombocytopenia occurred only in 1 case. Other toxicities were alopecia that was universal, G3 emesis in 1 pt, G3 diarrhea in 2 pts, G3 stomatitis in 1 pt. Mild fluid retention was recorded only in 2 pts.
The results of this study do not suggest the use of TXT at this dosage and schedule in advanced soft tissue sarcoma.
评估多西他赛（TXT）作为晚期软组织肉瘤二线治疗的活性和毒性。
组织学确诊为局部晚期或转移性软组织肉瘤的成年患者，接受TXT治疗，剂量为100mg/m²，静脉输注1小时，每21天一次，并从TXT前24小时开始口服泼尼松50mg，每日两次，共五天进行类固醇预处理。
1995年11月至1997年5月，19例经预处理的患者进入试验。患者特征：男性/女性为11/8，中位年龄58岁（30 - 74岁），中位WHO体能状态为1（0 - 2）；组织学类型：平滑肌肉瘤6例，恶性纤维组织细胞瘤6例，纤维肉瘤2例，其他5例。未观察到客观缓解。8例患者（42%）疾病稳定。中位进展时间为3.5个月（范围2 - 8个月），中位生存期6个月（范围2 - 20个月）。治疗耐受性良好：主要副作用是血液学毒性，58%的患者出现3/4级白细胞减少和中性粒细胞减少；仅1例出现3级贫血和血小板减少。其他毒性包括普遍存在的脱发，1例患者出现3级呕吐，2例患者出现3级腹泻，1例患者出现3级口腔炎。仅2例患者记录有轻度液体潴留。
本研究结果不支持在晚期软组织肉瘤中按此剂量和方案使用TXT。
