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目的对比研究多西他赛一线单药每周给药方案与3周给药方案治疗高龄、晚期非小细胞肺癌(NSCLC)患者的疗效和不良反应。方法67例患者随机分成两组,每周组33例,给药方案:多西他赛35mg/m2加入生理盐水100ml静脉滴注1h,d1、d8、d15,28d重复;三周组34例,给药方案:多西他赛75mg/m2加入生理盐水100ml静脉滴注1h,21d重复。结果有效率、1年生存率、中位生存期每周组分别为33.3%(11/33)、30.3%、8.9个月;三周组分别为29.4%(10/34)、26.5%、7.1个月,两组间差异无统计学意义(P>0.05)。PS评分为2分的患者,每周组(8例)和三周组(9例)中位生存期分别为5.6个月和2.6个月,差异有统计学意义(P<0.001)。不良反应中Ⅲ度以上中性粒细胞减少、粒细胞减少性发热、恶心呕吐,每周组分别为8例(24.2%)、3例(9.1%)、9例(27.3%),三周组分别为19例(55.9%)、11例(32.4%)、18例(52.9%)。以上3种副作用在两组之间比较均有统计学差异(P<0.05)。结论多西他赛单药每周给药对于高龄、晚期的NSCLC患者与每3周给药疗效相近,但是不良反应轻,对于PS评分为2分的患者可延长生存期。
Objective To compare the efficacy and side effects of docetaxel first-line once-weekly and three-week regimens in the treatment of advanced and advanced non-small cell lung cancer (NSCLC). Methods Sixty-seven patients were randomly divided into two groups (n = 33 in each week). The protocol was as follows: docetaxel 35 mg / m 2 was injected into 100 ml normal saline for 1 hour, and d 1, d 8, d 15, Dosing program: Docetaxel 75mg / m2 added saline 100ml intravenous infusion 1h, 21d repeat. Results The effective rate, 1-year survival rate and median survival time were 33.3% (11/33), 30.3% and 8.9 months in the weekly group, 29.4% (10/34), 26.5% and 7.1% Month, there was no significant difference between the two groups (P> 0.05). The median survival of patients with PS score of 2 was 5.6 months and 2.6 months in the weekly group (8 cases) and the three weeks group (9 cases), respectively. The difference was statistically significant (P <0.001). Adverse reactions in grade Ⅲ or more neutropenia, neutropenic fever, nausea and vomiting, the weekly group were 8 cases (24.2%), 3 cases (9.1%), 9 cases (27.3% They were 19 (55.9%), 11 (32.4%) and 18 (52.9%) respectively. The above three side effects in the two groups were statistically significant (P <0.05). CONCLUSIONS: Weekly weekly doses of docetaxel are similar in efficacy to the older and advanced NSCLC patients as they are administered every 3 weeks, but adverse reactions are mild and survival is prolonged in patients with a PS score of 2.