Hotta Katsuyuki, Fujiwara Yoshiro, Matsuo Keitaro, Suzuki Takeshi, Kiura Katsuyuki, Tabata Masahiro, Takigawa Nagio, Ueoka Hiroshi, Tanimoto Mitsune
Department of Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Cancer. 2007 Mar 1;109(5):939-48. doi: 10.1002/cncr.22478.
Few studies have assessed formally whether treatment outcomes have improved substantially over the years for patients with advanced nonsmall cell lung cancer (NSCLC) enrolled in Phase III trials. The objective of the current investigation was to determine the time trends in outcomes for the patients in those trials.
The literature was searched to identify trials that addressed the role of chemotherapy regimens in the first-line setting for the treatment of advanced NSCLC. Trends were tested by using multiple regression analysis.
In total, 121 Phase III trials were identified that involved 42,768 patients with 263 chemotherapy arms and 11 best supportive care (BSC) arms, all of which were initiated between 1982 and 2002. Although the number of randomized patients and the proportion of patients with metastatic disease had increased over the years, the number of patients with a poor performance status who were accrued into the trials had decreased. Cisplatin-based chemotherapy was been investigated most frequently during the period. The multiple regression analysis revealed a significant improvement in median survival and in the median time to disease progression over the years, with annual prolongations of 0.1203 months (3.609 days) and 0.0617 months (1.851 days), respectively (P< .0001 and P < .0130, respectively). In addition, the use of cisplatin and carboplatin was associated significantly with survival prolongation. The median survival for patients who received BSC also increased progressively over the years (P = .0487).
The survival of patients with NSCLC in Phase III trials improved slowly but steadily over time, although the main factors responsible for this improvement remain unknown. Nonetheless, the current results also suggested that novel targets and new agents will be required in the future fight against advanced NSCLC.
很少有研究正式评估多年来参加Ⅲ期试验的晚期非小细胞肺癌（NSCLC）患者的治疗结果是否有显著改善。本研究的目的是确定这些试验中患者的预后随时间的变化趋势。
检索文献以确定探讨化疗方案在晚期NSCLC一线治疗中作用的试验。采用多元回归分析检验趋势。
共确定了121项Ⅲ期试验，涉及42768例患者，有263个化疗组和11个最佳支持治疗（BSC）组，所有试验均在1982年至2002年期间启动。尽管多年来随机分组的患者数量和转移性疾病患者的比例有所增加，但纳入试验的身体状况较差的患者数量有所减少。在此期间，基于顺铂的化疗研究最为频繁。多元回归分析显示，多年来中位生存期和疾病进展的中位时间有显著改善，每年分别延长0.1203个月（3.609天）和0.0617个月（1.851天）（分别为P<0.0001和P<0.0130）。此外，顺铂和卡铂的使用与生存期延长显著相关。接受BSC治疗的患者的中位生存期多年来也逐渐增加（P=0.0487）。
Ⅲ期试验中NSCLC患者的生存期随时间缓慢但稳步改善，尽管导致这种改善的主要因素尚不清楚。尽管如此，目前的结果也表明，未来对抗晚期NSCLC需要新的靶点和新的药物。
