Stevenson J P, Scher R M, Kosierowski R, Fox S C, Simmonds M, Yao K S, Green F, Broom C, Fields S Z, Krebs J B, O'Dwyer P J
Thomas Jefferson University, Kimmel Cancer Center, Philadelphia, PA 19107, USA.
Eur J Cancer. 1998 Aug;34(9):1358-62. doi: 10.1016/s0959-8049(98)00053-7.
The aim of this study was to determine the efficacy and toxicity of topotecan administered as a 21-day continuous intravenous infusion in patients with advanced or metastatic adenocarcinoma of the pancreas. 26 previously untreated patients with advanced or metastatic pancreatic adenocarcinoma received topotecan at a dose of 0.5 mg/m2/day or 0.6 mg/m2/day as a continuous intravenous infusion for 21 days. Courses were repeated every 28 days. 26 patients were assessable for response and toxicity on an intent-to-treat basis. The initial 8 patients at a starting dose of 0.6 mg/m2/day experienced unacceptable myelosuppression and dose delays. The subsequent 18 patients, therefore began therapy at a dose of 0.5 mg/m2/day. The major toxicity of topotecan at this dose and schedule was myelosuppression, which was reversible and non-cumulative. There were no complete responses and two partial responses for a total response rate of 8% (95% confidence interval, 1-25%). Response durations were 17 and 45 weeks. Stable disease was seen in 3 patients. The median time to progression for all patients was 8 weeks and the median survival was 20 weeks. Topotecan given as a 21-day continuous intravenous infusion has a similar response rate and median survival to our previously reported study of the 5-day short infusion regimen in pancreatic carcinoma.
本研究的目的是确定拓扑替康以21天持续静脉输注方式给药对晚期或转移性胰腺腺癌患者的疗效和毒性。26例先前未接受过治疗的晚期或转移性胰腺腺癌患者接受拓扑替康治疗，剂量为0.5mg/m²/天或0.6mg/m²/天，持续静脉输注21天。疗程每28天重复一次。26例患者可根据意向性治疗原则评估疗效和毒性。最初8例起始剂量为0.6mg/m²/天的患者出现了不可接受的骨髓抑制和剂量延迟。因此，随后的18例患者开始以0.5mg/m²/天的剂量进行治疗。该剂量和给药方案下拓扑替康的主要毒性是骨髓抑制，其具有可逆性且无累积性。无完全缓解，有2例部分缓解，总缓解率为8%（95%置信区间，1%-25%）。缓解持续时间分别为17周和45周。3例患者病情稳定。所有患者的中位进展时间为8周，中位生存期为20周。拓扑替康以21天持续静脉输注方式给药，其缓解率和中位生存期与我们之前报道的胰腺癌5天短程输注方案研究相似。
