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目的观察广泛期小细胞肺癌(SCLC)患者顺铂联合依托泊苷(EP)一线化疗后口服依托泊苷(VP-16)维持治疗的临床疗效。方法 50例广泛期SCLC患者经EP一线治疗后随机分为口服组与空白组,各25例。口服组口服VP-16(25 mg,b.i.d.,d1~20)维持治疗,空白组给予临床观察,4~6个治疗周期后对比两组临床疗效、无进展生存期(PFS)、总生存期(OS)与毒性反应情况。结果口服组总有效率、临床获益率分别为44%、88%,均高于空白组的32%、72%,差异具有统计学意义(P<0.05)。口服组PFS(5.73±0.26)个月明显高于空白组的(4.51±0.75)个月,差异具有统计学意义(P<0.01)。口服组1年生存率88%与空白组80%比较差异无统计学意义(P>0.05),而口服组2年生存率32%明显高于空白组的20%,差异具有统计学意义(P<0.05)。口服组毒性反应发生率60%与空白组的64%比较差异无统计学意义(P>0.05)。结论广泛期SCLC患者EP一线化疗后口服VP-16维持治疗可以明显延长患者的生存期,而且患者对VP-16毒性反应可耐受,可以作为广泛期SCLC持续治疗的首选用药方案在临床中推广应用。
Objective To observe the clinical efficacy of oral etoposide (VP-16) maintenance therapy in cisplatin combined with first-line chemotherapy with etoposide (EP) in patients with extensive-stage small cell lung cancer (SCLC). Methods Fifty patients with extensive SCLC were randomly divided into oral group and blank group by EP first-line treatment, with 25 cases in each group. Oral group VP-16 (25 mg, bid, d1 ~ 20) maintenance treatment, the blank group were given clinical observation, 4 to 6 treatment cycles after the two groups were compared clinical efficacy, progression-free survival (PFS), overall survival OS) and toxicity. Results The total effective rate and the clinical benefit rate in the oral group were 44% and 88%, respectively, which were higher than those in the blank group (32% and 72%, respectively). The difference was statistically significant (P <0.05). PFS in oral group (5.73 ± 0.26) months was significantly higher than that in blank group (4.51 ± 0.75) months, the difference was statistically significant (P <0.01). The 1-year survival rate of oral group was 88% compared with that of blank group (P> 0.05), while the 2-year survival rate of oral group was significantly higher than that of blank group (P <0.05), and the difference was statistically significant <0.05). There was no significant difference in the incidence of toxic reaction between the oral group and the blank group (60% vs 64%) (P> 0.05). Conclusions Oral VP-16 maintenance therapy can significantly prolong the survival of patients with extensive-stage SCLC after EP first-line chemotherapy, and the patients are tolerant to VP-16 toxicity and can be used as the first choice of regimen for sustained SCLC application.