吉非替尼治疗非小细胞肺癌有效六个月后疾病进展继续原药治疗的临床观察

Continuing administration of gefitinib after gefitinib in non-small cell lung cancer initially responding to it more than 6 months

目的观察吉非替尼治疗非小细胞肺癌(NSCLC)有效6个月后疾病进展的患者,继续采用原药治疗的临床表现、生活质量和后续生存时间。方法采用吉非替尼250mg/d治疗有效超过6个月后,疾病进展的NSCLC患者继续原药治疗者为观察组(37例),未进展的患者继续原药治疗者为对照组(29例),采用KPS和FLIC量表评价两组患者的生活质量,并比较观察组不同进展部位对后续生存时间的影响。结果观察组患者进展后良好的KPS和FLIC量表评分能维持1～24个月,中位时间为6个月,直到死亡前1～3个月与对照组比较,差异无统计学意义(P=0.101,0.548)。观察组患者初始进展至加速进展与加速进展后至死亡两个时间段的生活质量差异有统计学意义(P=0.011,0.017)。在观察组中,肺部病灶进展的后续中位生存时间为7个月,仅有脑和(或)骨病灶进展的后续中位生存时间为10个月,两者差异有统计学意义(P=0.037)。结论吉非替尼治疗NSCLC进展后,原药继续治疗在一定时间内仍可能获益,特别是对脑和(或)骨病灶进展的患者。

Objective To observe the clinical manifestation, quality of life and follow-up survival time of patients with non-small cell lung cancer（ NSCLC ） who had initial response to gefitinib for more than 6 months and maintained administration of the regimen even after failure of gefitinib. Methods Gefitinib was taken orally at a dosage of 250rag daily. The NSCLC patients were divided into the observation group （whose disease progressed） and the control group （whose disease didn＇t progress） who had been admin- istrated the regimen successfully more than 6 months. Quality of life for patients with KPS and FLIC were evaluated. The follow-up survival time of the target lesions progression and the non-target lesions progres- sion were calculated. Results The observation group and the control group were thirty-seven and twenty- nine respectively. The favorable KPS and FLIC scores were still kept on 1 - 24 months to the patients in the observation group, and the median time was 6 months. KPS and FLIC scores were compared by the two groups, and the differences were no significance （ P = 0. 101, 0. 548 ）. KPS and FLIC scores were compared by the period of initial progress to disease flare and the period of disease flare to death in the ob- servation group, and the differences were statistical significance （P = 0. 011,0. 017）. The median follow-up survival time of patients with the target lesions progress and with non-target lesions progress were 7 months and 10 months respectively in the observation group, the difference was statistical significance （P = 0. 037）. Conclusions The patients with NSCLC could gain clinical benefits from continuing the adminis-tration of gefitinib, who acquired resistance to the regimen in spite of initial responses to it, especially for the patients with non-target lesion progress.