Sahmoud T, Postmus P E, van Pottelsberghe C, Mattson K, Tammilehto L, Splinter T A, Planting A S, Sutedja T, van Pawel J, van Zandwijk N, Baas P, Roozendaal K J, Schrijver M, Kirkpatrick A, Van Glabbeke M, Ardizzoni A, Giaccone G
EORTC Data Center, Brussels, Belgium.
Eur J Cancer. 1997 Nov;33(13):2211-5. doi: 10.1016/s0959-8049(97)00183-4.
Intravenous and oral etoposide (VP 16-213) were tested in two sequential phase II trials in chemotherapy-naive patients with malignant pleural mesothelioma. In the first trial, etoposide was given intravenously (i.v.) at a dose of 150 mg/m2 on days 1, 3 and 5 every 3 weeks. The second trial investigated a daily oral dose of 100 mg for 21 days followed by a 2-week treatment-free period, and then recycling. In both trials, the treatment was given until disease progression, intolerable toxicity or patient refusal. In the i.v. trial, 49 patients were included, 2 patients were ineligible. The oral trial recruited 45 patients, 4 patients were not eligible. In both trials, the main side-effects were moderate leucopenia, alopecia, nausea and vomiting. Two partial responses (4%) and three partial responses (7%) were reported in the i.v. and oral trials, respectively. The median survival was 29 weeks and 38 weeks in the i.v. and oral trials, respectively. In conclusion, further investigation of etoposide in malignant mesothelioma is not recommended.
在两项针对初治恶性胸膜间皮瘤患者的序贯II期试验中，对静脉注射和口服依托泊苷（VP 16 - 213）进行了测试。在第一项试验中，依托泊苷每3周在第1、3和5天静脉注射，剂量为150 mg/m²。第二项试验研究了每日口服剂量100 mg，持续21天，随后为2周无治疗期，然后循环给药。在两项试验中，治疗持续进行直至疾病进展、出现无法耐受的毒性或患者拒绝。在静脉注射试验中，纳入了49例患者，2例不符合纳入标准。口服试验招募了45例患者，4例不符合标准。在两项试验中，主要副作用为中度白细胞减少、脱发、恶心和呕吐。静脉注射试验和口服试验分别报告了2例部分缓解（4%）和3例部分缓解（7%）。静脉注射试验和口服试验的中位生存期分别为29周和38周。总之，不建议对恶性间皮瘤患者进一步研究依托泊苷。
