Stathopoulos George P, Boulikas Teni, Vougiouka Maria, Rigatos Sotirios K, Stathopoulos John G
Errikos Dunant Hospital and Medical School of Athens, Greece.
Oncol Rep. 2006 May;15(5):1201-4.
The present trial is a phase I-II study based on a new liposomal cisplatin (lipoplatin). Previous preclinical and clinical data (phase I pharmacokinetics) led to the investigation of a combined treatment modality involving lipoplatin and gemcitabine. The gemcitabine dose was kept standard at 1000 mg/m2 and the lipoplatin dose was escalated from 25 mg/m2 to 125 mg/m2. The treatment was administered to advanced pretreated pancreatic cancer patients who were refractory to previous chemotherapy which included gemcitabine. Lipoplatin at 125 mg/m2 was defined as dose limiting toxicity (DLT) and 100 mg/m2 as the maximum tolerated dose (MTD) in combination with 1000 mg/m2 of gemcitabine. Preliminary objective response rate data showed a partial response in 2/24 patients (8.3%), disease stability in 14 patients (58.3%) for a median duration of 3 months (range 2-7 months) and clinical benefit in 8 patients (33.3%). Liposomal cisplatin is a non-toxic alternative agent to bare cisplatin. In combination with gemcitabine, it has an MTD of 100 mg/m2 and shows promising efficacy in refractory pancreatic cancer.
本试验是一项基于新型脂质体顺铂（脂铂）的I-II期研究。先前的临床前和临床数据（I期药代动力学）促使研究一种涉及脂铂和吉西他滨的联合治疗方式。吉西他滨剂量保持标准的1000mg/m²，脂铂剂量从25mg/m²递增至125mg/m²。该治疗应用于先前接受过包括吉西他滨在内的化疗但难治的晚期预处理胰腺癌患者。125mg/m²的脂铂被定义为剂量限制毒性（DLT），100mg/m²为与1000mg/m²吉西他滨联合使用时的最大耐受剂量（MTD）。初步客观缓解率数据显示，24例患者中有2例部分缓解（8.3%），14例患者疾病稳定（58.3%），中位持续时间3个月（范围2 - 7个月），8例患者有临床获益（33.3%）。脂质体顺铂是一种相对于普通顺铂无毒的替代药物。与吉西他滨联合使用时，其MTD为100mg/m²，在难治性胰腺癌中显示出有前景的疗效。
