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目的 :系统评价拓扑替康不同剂型在化疗敏感复发小细胞肺癌治疗中的疗效及不良反应。方法 :76例敏感复发小细胞肺癌患者,根据给药方式不同分为2组。口服组37例,每天口服拓扑替康(2.3 mg/m~2),连续5 d;静脉组39例,每天静脉滴注拓扑替康1.5 mg/m~2,连续5 d;21 d为1个周期。有72例患者完成2~6个周期,每2个周期评价1次疗效。主要观察指标为客观缓解率、疾病控制率、无进展生存时间、总生存时间和不良反应。结果 :口服组与静脉组的客观缓解率分别为22.8%和21.6%,疾病控制率分别为71.4%和75.7%,2组差异均无统计学意义(P值均>0.05);2组患者的中位无进展生存时间分别为12和10周,差异无统计学意义(P=0.867);中位总生存时间分别为21和19周,差异无统计学意义(P=0.876)。2组的不良反应均主要为骨髓抑制,口服组3~4度中性粒细胞减少症的发生率为5.4%,明显低于静脉组的21.3%,差异具有统计学意义(P=0.029);口服组血小板下降的发生率为2.7%,低于静脉组的7.7%,但两者的差异无统计学意义(P>0.05);贫血率口服组低于静脉组,2组均未出现3~4度的贫血反应。2组患者非血液学毒性主要是恶心、呕吐、乏力、发热和脱发等,组间差异均无统计学意义(P值均>0.05)。结论 :对于经过一线化疗的敏感型复发小细胞肺癌患者,拓扑替康作为二线用药,口服制剂与静脉制剂疗效相当,但口服制剂的骨髓抑制的发生率更低,应用更方便。
OBJECTIVE: To systematically evaluate the efficacy and adverse reactions of topotecan in different forms of chemotherapy-responsive recurrent small cell lung cancer. Methods: 76 patients with recurrent small cell lung cancer were divided into 2 groups according to different administration methods. 37 patients in oral group were treated with topotecan (2.3 mg / m ~ 2) orally daily for 5 days. In intravenous group, 39 patients were intravenously administered with topotecan 1.5 mg / m 2 intravenously for 5 consecutive days. A cycle. 72 patients completed 2 to 6 cycles and evaluated every 2 cycles. The main observation indicators were objective response rate, disease control rate, progression-free survival time, total survival time and adverse reactions. Results: The objective response rates of oral and intravenous groups were 22.8% and 21.6% respectively, and the disease control rates were 71.4% and 75.7% respectively. There was no significant difference between the two groups (P> 0.05) The median progression-free survival time was 12 and 10 weeks, respectively, with no significant difference (P = 0.867). The median overall survival was 21 and 19 weeks, respectively, with no significant difference (P = 0.876). Adverse reactions in both groups were mainly myelosuppression. The incidence of 3 ~ 4 degree neutropenia in oral group was 5.4%, which was significantly lower than that in intravenous group (21.3%), the difference was statistically significant (P = 0.029). The incidence of thrombocytopenia in oral group was 2.7%, which was lower than that in intravenous group (7.7%), but there was no significant difference between the two groups (P> 0.05); anemia was lower in oral group than in intravenous group, 4 degrees of anemia. The non-hematological toxicities of the two groups were mainly nausea, vomiting, fatigue, fever and hair loss. There was no significant difference between the two groups (P> 0.05). CONCLUSIONS: Topotecan, as a second-line drug, responds to first-line chemotherapy in patients with sensitive-onset small-cell lung cancer, oral and intravenous formulations, but the incidence of myelosuppression is lower and the application is more convenient.