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EP+IP交替方案与单用EP方案治疗小细胞肺癌随机对照多中心临床研究 被引量:7

The clinical trial EP plus IP versus EP regiments in the patints of small cell lung cancer:A multi-center,randomized controlled observation
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摘要 目的观察EP+IP(依托泊苷,顺铂+伊立替康,顺铂)交替方案与单用EP方案治疗小细胞肺癌(SCLC)的近期疗效,生活质量改善,不良反应及疾病进展时间(TTP),生存时间。方法 44例SCLC患者随机分为两组,交替组22例应用EP+IP交替方案,对照组22例单用EP方案,所有患者均完成2个周期以上化疗。结果 44例患者均可评价疗效,交替组:CR 5例,pR 14例,SD0例,PD 3例,OR(总缓解率)86 4%。对照组:获CR0例,pR20例,SD0例,PD 2例ORR 90.9%。两组比较差异无统计学意义(P=0.29)。两组生活质量均有改善,交替组患者的中位TTP为10.0月,对照组患者的中位TTP为10.0月,差异无统计学意义(P=0.813).交替组患者的中位OS为13.0月,对照组患者的中位OS为16.5月,差异无统计学意义(P=0.740),两组不良反应主要为骨髓抑制和胃肠道反应,对照组在骨髓抑制方面3~4级较交替组增加,两组均无化疗相关性死亡。结论 EP+IP交替方案或EP单用方案均是一线治疗SCLC,特别是广泛期SCLC较为有效的方案。 Objective The observation of clinical effect using EP + IP (VP-16/DDP + CPT-11/DDP) alternating plan and only EP scheme in the patients of local or excension small cell lung cancer (SCLC). Method The 44 cases of SCLC patients were randomly divided into two groups,who are alternating group 22 cases in application of EP + IP alternating plan and the control 22 cases in application of EP plan, all patients were completed two or more cycle chemotherapy. Results All 44 cases could be evaluated, alternating groups: CR 5, PR 14, SD 0, PD 3, ORR 86.4%. The control group: CR 0, PR 20, SD 0, PD 2, ORR 90.9 %. The clinical effect of two groups was not statistically significant (P = 0.29). Two groups oflife quality are improved, The times of TIP, OS in two groups were 10.Omouth, 13mouth(alternating group); 10.0mouth, 16.5mouth(EP group), the differences were not statistically significant (P =0.813), two groups of toxic retions were mainly bone marrow suppression and gastrointestinal reaction and the toxic reaction in marrow aspects of 3-4 grade was more common in control group, the chemotherapy correlation death was not seen in two groups. Conclusion The EP + IP alternating scheme or only EP is first-line relatively effective therapy regiments in SCLC, especially extensive period patients.
出处 《肿瘤药学》 CAS 2011年第1期60-63,共4页 Anti-Tumor Pharmacy
关键词 小细胞肺癌 化疗 依托泊苷 顺铂 伊立替康 Small cell lung cancer , Chemotherapy Etoposide Cisplatin, Irinotecam
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