Kubota Kaoru, Watanabe Koshiro, Kunitoh Hideo, Noda Kazumasa, Ichinose Yukito, Katakami Nobuyuki, Sugiura Takahiko, Kawahara Masaaki, Yokoyama Akira, Yokota Soichiro, Yoneda Shuichi, Matsui Kaoru, Kudo Shinzo, Shibuya Masahiko, Isobe Takeshi, Segawa Yoshihiko, Nishiwaki Yutaka, Ohashi Yasuo, Niitani Hisanobu
Thoracic Oncology Division, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba 277-8577, Japan.
J Clin Oncol. 2004 Jan 15;22(2):254-61. doi: 10.1200/JCO.2004.06.114.
Few randomized trials have demonstrated survival benefit of combination chemotherapy involving new agents plus cisplatin compared with classic combination chemotherapy in advanced non-small-cell lung cancer (NSCLC). The primary aim of this study was to test whether docetaxel plus cisplatin (DC) improves survival compared with vindesine plus cisplatin (VdsC) in patients with previously untreated stage IV NSCLC.
Eligible, stage IV, chemotherapy-naive patients (n = 311) were randomly assigned to receive docetaxel 60 mg/m(2) intravenously on day 1 plus cisplatin 80 mg/m(2) intravenously on day 1 of a 3- or 4-week cycle, or vindesine 3 mg/m(2) intravenously on days 1, 8, and 15 plus cisplatin 80 mg/m(2) intravenously on day 1 of a 4-week cycle. Cross-over administration of docetaxel and vindesine was prohibited for both treatment groups.
Overall, 302 patients were eligible for evaluation. The DC arm demonstrated significant improvements compared with the VdsC arm in overall response rates (37% v 21%, respectively; P <.01) and median survival times (11.3 v 9.6 months, respectively; P =.014). Two-year survival rates were 24% for the DC arm compared with 12% for the VdsC arm. The physical domain of the Quality of Life for Cancer Patients Treated with Anticancer Drugs measure was significantly better in the DC arm than in the VdsC arm (P =.020). Toxicity was predominantly hematologic and was more severe in the VdsC arm.
As first-line treatment for stage IV NSCLC, DC resulted in greater clinical benefit in terms of response rate (with marked improvements in overall and 2-year survival rates) and quality of life than did treatment with VdsC.
在晚期非小细胞肺癌（NSCLC）中，很少有随机试验证明与经典联合化疗相比，含新药物加顺铂的联合化疗能带来生存获益。本研究的主要目的是检验在先前未接受治疗的IV期NSCLC患者中，多西他赛加顺铂（DC）与长春地辛加顺铂（VdsC）相比是否能提高生存率。
符合条件的IV期、未接受过化疗的患者（n = 311）被随机分配接受在3周或4周周期的第1天静脉注射多西他赛60mg/m²加第1天静脉注射顺铂80mg/m²，或在4周周期的第1、8和15天静脉注射长春地辛3mg/m²加第1天静脉注射顺铂80mg/m²。两个治疗组均禁止交叉使用多西他赛和长春地辛。
总体而言，302例患者符合评估条件。DC组与VdsC组相比，在总缓解率（分别为37%对21%；P <.01）和中位生存时间（分别为11.3个月对9.6个月；P =.014）方面有显著改善。DC组的2年生存率为24%，而VdsC组为12%。接受抗癌药物治疗的癌症患者生活质量量表的身体领域在DC组明显优于VdsC组（P =.020）。毒性主要为血液学毒性，且在VdsC组更严重。
作为IV期NSCLC的一线治疗，与VdsC治疗相比，DC在缓解率（总生存率和2年生存率有显著提高）和生活质量方面带来了更大的临床获益。
