Ogawara Daiki, Nakamura Yoichi, Fukuda Minoru, Nakatomi Katsumi, Yamaguchi Hiroyuki, Motoshima Kohei, Mizoguchi Kosuke, Nakano Hirofumi, Takemoto Shinnosuke, Gyotoku Hiroshi, Nagashima Seiji, Kohno Shigeru
Second Department of Internal Medicine, Nagasaki University Hospital; Unit of Molecular Microbiology and Immunology, Department of Infectious Diseases, Nagasaki University Graduate School of Biomedical Sciences, Japan.
Chemotherapy. 2014;60(3):180-4. doi: 10.1159/000371870. Epub 2015 Mar 25.
A phase I/II study of combination chemotherapy with amrubicin and nedaplatin for patients with untreated, advanced, non-small cell lung cancer (NSCLC) was conducted. Amrubicin was given on days 1-3, with nedaplatin given on day 1. The treatment was repeated every 3 weeks. In the phase I trial, the initial amrubicin dose of 25 mg/m(2) was escalated in 5-mg/m(2) increments until the maximum tolerated dose was reached, with the dose of nedaplatin fixed at 100 mg/m(2). In the phase II trial, the primary endpoint was the overall response rate (ORR), assuming 20% for a standard therapy and 40% for a target therapy (α = 0.05 and β = 0.20), and the estimated required total number of patients was 35. In the phase I study, nedaplatin 100 mg/m(2) and amrubicin 25 mg/m(2) was recommended. In the phase II study, 17 out of 35 patients achieved a partial response, and the ORR was 48.6%. Grade 3/4 neutropenia, grade 3 anemia and grade 3/4 thrombocytopenia occurred in 62.9, 11.4 and 11.4% of cycles, respectively. Febrile neutropenia occurred in 5 cycles (3.9%) and all cases were manageable. The recommended dose of this combination is well tolerated and effective in patients with advanced NSCLC.
开展了一项针对未经治疗的晚期非小细胞肺癌（NSCLC）患者的阿柔比星与奈达铂联合化疗的I/II期研究。阿柔比星于第1 - 3天给药，奈达铂于第1天给药。每3周重复一次治疗。在I期试验中，阿柔比星初始剂量为25mg/m²，以5mg/m²的增量逐步递增，直至达到最大耐受剂量，奈达铂剂量固定为100mg/m²。在II期试验中，主要终点为总缓解率（ORR），假设标准治疗为20%，目标治疗为40%（α = 0.05，β = 0.20），估计所需患者总数为35例。在I期研究中，推荐使用奈达铂100mg/m²和阿柔比星25mg/m²。在II期研究中，35例患者中有17例获得部分缓解，ORR为48.6%。3/4级中性粒细胞减少、3级贫血和3/4级血小板减少分别发生在62.9%、11.4%和11.4%的周期中。发热性中性粒细胞减少发生在5个周期（3.9%），所有病例均可控制。该联合方案的推荐剂量耐受性良好，对晚期NSCLC患者有效。
