Shanghai Lung Tumor Clinical Medical Center, Chest Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200030, China.
Chin Med J (Engl). 2009 Oct 20;122(20):2472-6.
Pemetrexed is a novel folic acid antagonist with multiple targets, which has been widely used in the treatment of non-small cell lung cancer (NSCLC). The objective of this study was to compare the effects and toxicities in NSCLC patients treated with pemetrexed monotherapy versus pemetrexed plus a platinum combination agent, so as to provide a basis for standard second-line chemotherapy.
The clinical data of 52 patients with NSCLC who were admitted to Shanghai Chest Hospital from August 2006 to October 2008 were retrospectively analyzed. Ten of the 52 patients received pemetrexed monotherapy, and the other 42 patients received the pemetrexed plus platinum regimen. The primary end point was overall survival (OS). The progression-free survival time (PFS) was analyzed and the effects and toxicities were assessed. Survival analysis was evaluated by Kaplan-Meier method. Single factor analysis and the COX regression model were done to analyze the relationship between the influential factors and the prognosis of disease. The elderly patients (> or = 60 years old) were analyzed separately as a subgroup.
No statistically significant increase in OS (chi(2) = 0.09, P = 0.76), PFS (chi(2) = 0.15, P = 0.70), disease control rate (DCR) (chi(2) = 0.06, P = 0.81) or 1-year survival rate (chi(2) = 0.33, P = 0.57) was found between the two regimens. Single factor analysis showed that the factors including surgery history, PS score before treatment, clinical stage, and response to second-line treatment influenced the prognosis of NSCLC (all P < 0.05). COX regression analysis demonstrated that surgery history (P = 0.041) and performance status (PS) score before treatment (P = 0.043) may be associated with survival. The toxicity of the two regimens was similar. In the subgroup of elderly patients, no significant difference in OS (chi(2) = 0.01, P = 0.94), PFS (chi(2) = 0.14, P = 0.70), DCR (chi(2) = 0.004, P = 0.95), or 1-year survival rate (chi(2) = 0.03, P = 0.87) was found between the two regimens. The toxicity of combination therapy was significantly higher in terms of hematologic (chi(2) = 9.95, P = 0.01) and gastrointestinal adverse events (chi(2) = 7.66, P = 0.03).
There is no significant difference in survival or side effects between these two regimens. For elderly patients (> or = 60), pemetrexed monotherapy shows similar efficacy and a better safety profile when compared with pemetrexed combination therapy.
培美曲塞是一种新型叶酸拮抗剂，具有多种作用靶点，已广泛用于治疗非小细胞肺癌（NSCLC）。本研究旨在比较培美曲塞单药治疗与培美曲塞联合铂类药物治疗 NSCLC 患者的疗效和毒性，为标准二线化疗提供依据。
回顾性分析 2006 年 8 月至 2008 年 10 月上海胸科医院收治的 52 例 NSCLC 患者的临床资料。52 例患者中，10 例接受培美曲塞单药治疗，42 例接受培美曲塞联合铂类药物治疗。主要终点为总生存期（OS）。分析无进展生存期（PFS），评估疗效和毒性。生存分析采用 Kaplan-Meier 法。单因素分析和 COX 回归模型分析影响疾病预后的因素。对>60 岁的老年患者进行亚组分析。
两组患者 OS（chi(2) = 0.09，P = 0.76）、PFS（chi(2) = 0.15，P = 0.70）、疾病控制率（DCR）（chi(2) = 0.06，P = 0.81）和 1 年生存率（chi(2) = 0.33，P = 0.57）差异均无统计学意义。单因素分析显示，手术史、治疗前 PS 评分、临床分期和二线治疗反应是影响 NSCLC 预后的因素（均 P < 0.05）。COX 回归分析表明，手术史（P = 0.041）和治疗前 PS 评分（P = 0.043）可能与生存有关。两组的毒性相似。在老年患者亚组中，两组患者 OS（chi(2) = 0.01，P = 0.94）、PFS（chi(2) = 0.14，P = 0.70）、DCR（chi(2) = 0.004，P = 0.95）和 1 年生存率（chi(2) = 0.03，P = 0.87）差异均无统计学意义。联合治疗的血液学毒性（chi(2) = 9.95，P = 0.01）和胃肠道不良事件（chi(2) = 7.66，P = 0.03）发生率显著高于单药治疗。
两组患者的生存或不良反应无显著差异。对于≥60 岁的老年患者，培美曲塞单药治疗与培美曲塞联合治疗的疗效相似，安全性更好。
