培美曲塞单药与联合铂类药物二线治疗晚期非小细胞肺癌的临床观察

Clinical observation of pemetrexed monotherapy or in combination with platinum as second line treatment for advanced non-small cell lung cancer

目的晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)一线化疗有效率仅30%～40%。复发或初治无效患者的治疗,需引入新的药物及治疗方法。本试验观察培美曲塞单药或联合铂类二线治疗复发晚期NSCLC的疗效及毒副反应。方法回顾性分析经病理学或细胞学确诊的复发或转移性NSCLC腺癌患者共66例。其中应用培美曲塞单药治疗32例,培美曲塞联合铂类药物治疗34例。患者均接受2～4个周期该方案治疗。结果 66例患者均可评价疗效及毒副反应,CR 0例,PR 17例,SD 20例,PD 29例。其中单药组CR 0例、PR 7例、SD 10例、PD 15例,联合组CR 0例、PR 10例、SD 10例、PD 14例。单药与联合组的DCR(CR+PR+SD)、1年生存率、中位PFS、中位OS分别为53.1%和58.8%(P=0.64)、26.4%和35.3%(P=0.17)、2.5个月和2.7个月(P=0.09)、8.4个月和10.1个月(P=0.39),均无统计学差异。两组的主要不良反应均为白细胞减少、贫血和消化道反应。但老年组(≥65岁)亚组分析结果显示单药组的血液学毒性、消化道反应及皮疹的发生率均显著低于联合组。结论培美曲塞单药或联合铂类药物方案用于复发晚期NSCLC腺癌的二线治疗疗效和毒副反应均无显著性差异。培美曲塞单药对比联合铂类药物对于老年患者安全性更高。

Objective The first line chemotherapy effective rate was 30% - 40% in the advanced non-small cell lung cancer （NSCLC）. For the recurrent or metastasis NSCLC patients, it is necessary to introduce new drugs and treatments. Pemetrexed is a standard second line therapy in advanced NSCLC. The efficacy and toxicities of advanced NSCLC patients treated by pemetrexed monotherapy or pemetrexed plus platinum were compared. Method 66 advanced recurrent or me- tastasis NSCLC patients confirmed with pathology or cyology were enrolled in this study. Pemetrexed monotherapy group included 32 cases and pemetrexed plus platinum group included 34 cases. All of the patients accepted 2 - 4 cycles of treat- ment. Result The efficacy and side effects of all patients were evaluable. In total, the cases with CR, PR, SD and PD were 0, 17, 20 and 29, respectively. There was 0 case with CR, but 7 cases of PR, 10 cases of SD, 15 cases of PD inthe pemetrexed monotherapy group. While the cases in the pemetrexed plus platinum group were 0, 10, l0 and 14, re- spectively. No statistical significance was found between the two regimens in DCR （53.1% vs 58.8% , P =0. 64） , 1- year survival rate （26. 4% vs 35.3% , P =0. 17）, mPFS （2. 5 months vs 2.7 months, P =0.09） and mOS （8.4 months vs 10. 1 months, P = 0. 39）. The most common side effects of the two regimens were hematological and gastrointestinal toxicities. No significant difference was found in terms of toxicity between the two regimens, either. But pemetrexed monotherapy is of higher safety than pemetrexed plus platinum for the elder palients （ ≥65 years old）. And the incidences of hematological and gastrointestinal toxicities were significantly lower compared with combination therapy in elder patients. Conclusion There is no significant difference in the effects and toxicities of advanced NSCLC patients treated by the pem- etrexed monotherapy or pemetrexed plus platinum. Pemetrexed monotherapy is of higher safety for the eider patients com- pared with the combination therapy.