Scher R M, Kosierowski R, Lusch C, Alexander R, Fox S, Redei I, Green F, Raskay B, Amfoh K, Engstrom P F, O'Dwyer P J
Fox Chase Cancer Center, Philadelphia, PA 19111, USA.
Invest New Drugs. 1996;13(4):347-54. doi: 10.1007/BF00873143.
A phase II trial of topotecan, an inhibitor of topoisomerase I, was conducted in patients with advanced or metastatic adenocarcinoma of the pancreas to determine the activity and toxicity of topotecan.
35 patients, previously untreated with chemotherapy, received topotecan 1.5 mg/m2/d for five days intravenously and repeated every 21 days. Patients were assessed for response after 3 cycles. Those with either clinical response or stable disease received additional cycles of the drug until toxicity developed or disease progression occurred.
Among 30 patients evaluable for response there were no complete responses and 3 partial responses (10%) for a total response rate of 10% (95% confidence interval = 0-20.6%). Stable disease for at least eight weeks was seen in 11 patients (36%). Median survival was 19 weeks (95% confidence interval 11 to 26 weeks). Therapy was generally well tolerated, with reversible granulocytopenia being the most common toxicity.
Topotecan given on a 5 day, short infusion schedule, demonstrated limited activity in pancreatic carcinoma with minimal toxicity. Further exploration of topotecan in pancreatic carcinoma using different dosing schedules is warranted.
对拓扑替康（一种拓扑异构酶I抑制剂）进行II期试验，以确定其在晚期或转移性胰腺癌患者中的活性和毒性。
35例既往未接受过化疗的患者接受拓扑替康1.5mg/m²/天，静脉输注5天，每21天重复一次。3个周期后评估患者的反应。有临床反应或疾病稳定的患者接受额外周期的药物治疗，直至出现毒性反应或疾病进展。
在30例可评估反应的患者中，无完全缓解，3例部分缓解（10%），总缓解率为10%（95%置信区间=0-20.6%）。11例患者（36%）疾病稳定至少8周。中位生存期为19周（95%置信区间11至26周）。治疗耐受性一般良好，最常见的毒性反应是可逆性粒细胞减少。
按5天短程输注方案给予拓扑替康，在胰腺癌中显示出有限的活性，毒性最小。有必要进一步探索拓扑替康在胰腺癌中不同给药方案的应用。
