吉西他滨单药及联合卡铂治疗初治的老年晚期非小细胞肺癌疗效观察

Efficacy study of single-agent gemcitabine versus gemcitabine plus carboplatin in untreated elderly patients with stage Ⅲb/Ⅳ non-small-cell lung cancer

目的探讨适合于老年晚期非小细胞肺癌（NSCLC）的化疗方案。方法70岁及以上HIb期和Ⅳ期老年NSCLC患者68例，按随机数字表法分入吉西他滨单药治疗组（单药组）和吉西他滨联合卡铂治疗组（联合组），每组34例。单药组吉西他滨1000mg／m^2第1、8天静脉滴注，21d为1个周期；联合组吉西他滨1000mg／m^2第1、8天静脉滴注，卡铂按曲线下面积=5的剂量水平给药，第2天静脉滴人，21d为1个周期；均化疗3个周期。结果单药组完全缓解（CR）1例，部分缓解（PR）12例，有效率为38％；联合组CR1例，PR13例，有效率为41％，组间差异无统计学意义（P〉0．05）。单药组中位生存时间为9．9个月，1、2年生存率分别为31％和12％；联合组中位生存时间为9．8个月，1、2年生存率分别为32％和14％，组间差异均无统计学意义（均P〉0．05）。联合组3～4度白细胞减少及3～4度血小板减少发生率（分别为47％和38％）明显高于单药组（分别为24％和15％，均P〈0．05）。肺癌症状量表观察者表评分显示单药组治疗后食欲缺乏、乏力及疼痛评分均较治疗前明显改善（P〈0．05），而联合组无明显改善；治疗后单药组3种症状评分均明显高于联合组（均P〈0．05）。结论占阿他滨单药化疗方案是治疗老年晚期NSCLC疗效及耐受性均较好的方案。

Objective To explore a chemotherapeutic regimen suitable for non-small cell lung cancer （NSCLC） in elderly patients. Methods A total of 68 elderly patients with NSCLC （stage Ⅲ b/Ⅳ ） were equally and randomly divided into single-agent and combinded groups. Patients in single-agent group received gemcitabine 1000 mg/m^2 at Days 1 and 8 for a 21-day cycle. Those in combined group received gemcitabine 1000 mg/m^2 at Days 1 and 8 in combination carboplatin AUC5 at Day 2 for a 21-day cycle. The drugs were intravenously administered. All patients received 3 cycles of treatment. Results In single-agent and combined groups, CR 1 and 1, PR 12 and 13, response rates 38% and 41% were respectively observed. There was no statistically significant difference between two groups （ P 〉 0. 05 ）. The 1-year and 2-year survival rates of single-agent and combined groups were 31% vs 32% and 12% vs 14% with a median survival of 9. 9 and 9. 8 months without a statistically significant difference （ P 〉 0. 05 ）. The rates of leucopenia and thrombocytopenia （ Ⅲ - Ⅳdegree） were 47% and 38% in combined group and they were higher than 24% and 15% in single-agent group with a statistically significant difference （P 〈0. 05）. The observer scale of lung cancer symptom scale showed that the post-treatment scores of appetite, fatigue and pain significantly improved in single-agent group while no improvement was observed in combined group. Also the scores of appetite, fatigue and pain of single-agent group were higher than those of combined group after chemotherapy （ P 〈 0. 05 ） . Conclusion Single-agent gemcitabine regimen is more suitable for advanced NSCLC in elderly patients.