Hirose Takashi, Sugiyama Tomohide, Kusumoto Sojiro, Shirai Takao, Nakashima Masanao, Yamaoka Toshimitsu, Okuda Kentaro, Ogura Keiichi, Ohnishi Tsukasa, Ohmori Tohru, Adachi Mitsuru
Division of Respiratory and Allergy, Department of Internal Medicine, Showa University School of Medicine, 1-5-8 Hatanodai, Shinagawa, Tokyo 142-8666, Japan.
Anticancer Res. 2009 May;29(5):1733-8.
To date, no phase II trial of nedaplatin and weekly paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) has been published. The safety and efficacy of the combination of nedaplatin and weekly paclitaxel in patients with NSCLC was examined.
Patients with previously untreated NSCLC, either stage IIIB with pleural effusion or stage IV, were eligible if they had a performance status of 0 to 2, were 75 years or younger and had adequate organ function. Patients were treated with nedaplatin (80 mg/m(2) on day 1) and weekly paclitaxel (90 mg/m(2) on days 1, 8 and 15).
From March 2005 through March 2008, 47 patients (31 men and 16 women; median age, 66 years; age range, 38 to 75 years) were enrolled. The overall response rate was 53.2% (95% confidence interval, 38.1% to 67.9%). The median survival time was 13 months (range, 1 to 36 months), the 1-year survival rate was 62% and the median time to disease progression was 5 months (range, 1 to 19 months). Grade 3 to 4 hematologic toxicities included neutropenia in 38.3% of patients, thrombocytopenia in 2.1% and anemia in 23.4% . Although frequent non-hematologic toxicities were nausea, hepatic dysfunction and peripheral neuropathy, all cases were of only mild to moderate severity. Although 1 patient had grade 3 pulmonary toxicity due to drug-induced pneumonia, this patient recovered after receiving steroid therapy.
This combination chemotherapy is effective and well tolerated and is an acceptable therapeutic option for patients with untreated advanced NSCLC.
迄今为止，尚未发表关于奈达铂与每周一次紫杉醇用于晚期非小细胞肺癌（NSCLC）患者的II期试验。研究了奈达铂与每周一次紫杉醇联合用药在NSCLC患者中的安全性和疗效。
既往未接受过治疗的NSCLC患者，若为伴有胸腔积液的IIIB期或IV期，且其体能状态为0至2、年龄在75岁及以下且器官功能良好，则符合入组条件。患者接受奈达铂（第1天80mg/m²）和每周一次紫杉醇（第1、8和15天90mg/m²）治疗。
从2005年3月至2008年3月，共入组47例患者（31例男性和16例女性；中位年龄66岁；年龄范围38至75岁）。总缓解率为53.2%（95%置信区间，38.1%至67.9%）。中位生存时间为13个月（范围1至36个月），1年生存率为62%，疾病进展的中位时间为5个月（范围1至19个月）。3至4级血液学毒性包括38.3%的患者出现中性粒细胞减少、2.1%的患者出现血小板减少和23.4%的患者出现贫血。尽管常见的非血液学毒性为恶心、肝功能障碍和周围神经病变，但所有病例均仅为轻度至中度严重程度。虽然有1例患者因药物性肺炎出现3级肺部毒性，但该患者在接受类固醇治疗后康复。
这种联合化疗有效且耐受性良好，是未经治疗的晚期NSCLC患者可接受的治疗选择。
