紫杉醇为主的方案治疗复发性小细胞肺癌的临床观察

Clinical observation of paclitaxol-based chemotherapy on recurrent small-cell lung cancer

目的评价紫杉醇为主的方案治疗复发性小细胞肺癌(SCLC)的有效性和安全性。方法经病理组织学或细胞学检查确诊的复发性小细胞肺癌(SCLC)17例接受紫杉醇联合顺铂或氟尿嘧啶的化疗方案,其中紫杉醇135～175mg/m2静脉滴注(周疗法,第1、8和15天),顺铂20mg第1～5天或氟尿嘧啶750mg第1～5天,每28天为1个周期。按照RECIST标准评价近期疗效,参照Karnofsky评分(KPS)变化评价生活质量(QOL),按照NCICTC3.0版标准评价毒性反应。用药1周期即可评价毒性,2周期后方可评价疗效。结果全组17例患者中,14例可以评价客观疗效,16例可进行安全性评价,1例因紫杉醇过敏退出治疗,其中CR1例(7.1%)、PR3例(21.4%)、SD3例(21.4%)、PD7例(50.0%),即RR为28.6%(4/14),DCR为50%。中位TTP为3个月,中位OS为12.5个月。生活质量改善者有8例(50.0%),6例稳定(37.5%),仅2例下降(2.5%)。G3/4级毒性主要有:白细胞下降为25.0%(4/16),血小板下降12.5%(2/16)和消化道反应为6.7%(1/16)。全组中有1例出现过敏反应,表现为皮疹及轻度支气管痉挛。结论紫杉醇为主的方案治疗复发性SCLC近期疗效良好,毒副作用可以耐受,值得临床尝试和进一步研究。

[Objective] To investigate the efficacy and safety of paclitaxol-based chemotherapy on recurrent patients with small-cell lung cancer （SCLC）. [Methods] 17 refractory or recurrent patients with SCLC onfirmed by histopathology or cytopathology were enrolled into this study. Paclitaxol was administrated intravenously with the dose of 135-175 mg/m^2 weekly for three weeks, while combined with Cisplatin 20 mg or 5-FU 750 mg on day 1 to 5. The regimen was repeated every 28 days. The efficacy was evaluated strictly after 2 cycles according to RECIST criteria, and quality of life （QOL） was evaluated according to Karnofsky scores. Otherwise safety was evaluated after 1 cycle according to NCI CTC 3.0 version criteria. [Results] 14 cases were evaluable for efficacy among the total 17 cases, and 16 cases were capable of safety evaluation （1 cases discontinued due to hypersensitive to Paclitaxol）. Among the 14 evaluable cases, there were 1 （7.1%） case achieved CR, 3 （21.4%） cases of PR, and 3 （21.4%） cases of SD. The objective response rate （RR） was 28.6% （4/14） and disease control rate （DCR） was 50.0% （7/14）. Median time to progression （TTP） and overall survival （OS） were 3 months and 12.5 months, respectively. The quality of life （QOL） were improved on 8 cases （50.0%）, stabled on 6 cases （37.5%）, and decreased on 2 cases （12.5%）. The occurrence rates of G3/4 toxicities were low, including neutroponia （4/16, 25%）, thrombocytopenia （2/16, 12.5%）, nausea/ vomiting （1/16, 6.7%）. 1 case hypersensitive to paclitaxol was observed, appeared as rash and mild brorlch spasm. [Conclusions] Paclitaxol-based chemotherapy is effective and tolerable on refractory or recurrent patients with SCLC and worthy of clinical generalization and further clinical observation.