Keizer H J, Crowther D, Nielsen O S, Oosterom A T, Muguiro J H, Pottelberghe C V, Somers R, Tursz T
Leiden University Hospital The Netherlands.
Sarcoma. 1997;1(2):99-101. doi: 10.1080/13577149778371.
Purpose. This study investigates the efficacy and toxicity of daily oral etoposide in chemotherapy for non-heavily pretreated advanced and metastatic soft tissue sarcoma (STS).Subjects. Twenty-seven patients with progressive and measurable disease were treated. Median age was 53 years (range 20-71 years) and performance status WHO 0 or 1. Histologies included mainly leiomyosarcoma (8), malignant fibrous histiocytoma (4), rhabdomyosarcoma (4), liposarcoma (2) and synovial sarcoma (2). Fifteen patients had received prior radiotherapy, of whom three included sites with haematopoiesis. All patients had received prior chemotherapy, including adjuvant therapy (7) and mostly consisted of one two-drug schedule (ifosfamide and doxorubicin) or two single-drug regimens.Methods. Chemotherapy consisted of etoposide (VP16-213), 50 mg m(-2) day(-1) x 21 q 4 weeks. Blood cell counts were done weekly. Dose reductions and a maximum delay of 2 weeks was allowed depending on cell counts during treatment and at the start of a new 4-week treatment cycle.Results. No objective response was observed. Progressive disease was observed after two treatment cycles in 17/27 patients (68%) and after three cycles in 22/27 patients (81%). The other patients received three to five cycles. Twenty-four patients went off study due to progressive disease. Grade 3 and 4 neutropenia was observed in eight and one patients, respectively. Thrombocytopenia grade 3 was seen in two patients. Non-haematological toxicity grade 3 (nausea, diarrhoea or alopecia) was observed in three patients, and grade 4 (dyspnea, hypotension or haemorrhage) in three patients.Discussion. No objective response was obtained. Oral etoposide at a dose of 50 mg m(-2) day(-1) x 21 q 4 weeks is inactive in chemotherapy of pretreated STS. Disease progression occurred within three cycles in the majority (81%) of patients. Toxicity of this regimen in non-heavily pretreated patients is low.
目的。本研究调查每日口服依托泊苷用于非重度预处理的晚期和转移性软组织肉瘤（STS）化疗的疗效和毒性。
对象。27例病情进展且可测量的患者接受了治疗。中位年龄为53岁（范围20 - 71岁），世界卫生组织（WHO）体能状态为0或1。组织学类型主要包括平滑肌肉瘤（8例）、恶性纤维组织细胞瘤（4例）、横纹肌肉瘤（4例）、脂肪肉瘤（2例）和滑膜肉瘤（2例）。15例患者曾接受过放疗，其中3例放疗部位包括造血部位。所有患者均接受过先前的化疗，包括辅助治疗（7例），且大多由一种两药方案（异环磷酰胺和多柔比星）或两种单药方案组成。
方法。化疗方案为依托泊苷（VP16 - 213），50 mg/m²/天×21天，每4周重复。每周进行血细胞计数。根据治疗期间及新的4周治疗周期开始时的血细胞计数情况，允许剂量减少及最长延迟2周。
结果。未观察到客观缓解。17/27例患者（68%）在两个治疗周期后出现病情进展，22/27例患者（81%）在三个周期后出现病情进展。其他患者接受了三至五个周期的治疗。24例患者因病情进展退出研究。分别有8例和1例患者出现3级和4级中性粒细胞减少。2例患者出现3级血小板减少。3例患者出现3级非血液学毒性（恶心、腹泻或脱发），3例患者出现4级非血液学毒性（呼吸困难、低血压或出血）。
讨论。未获得客观缓解。剂量为50 mg/m²/天×21天、每4周重复的口服依托泊苷在预处理的STS化疗中无活性。大多数（81%）患者在三个周期内病情进展。该方案在非重度预处理患者中的毒性较低。
