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广泛期小细胞肺癌患者中奈达铂和伊立替康的 II 期研究。

Phase II study of nedaplatin and irinotecan in patients with extensive small-cell lung cancer.

机构信息

Department of Thoracic Oncology Kanagawa Cancer Center, Nakao 1-1-2, Asahi-ku, Yokohama 241-0815, Japan.

出版信息

Cancer Chemother Pharmacol. 2013 Feb;71(2):345-50. doi: 10.1007/s00280-012-2011-y. Epub 2012 Nov 3.

DOI:10.1007/s00280-012-2011-y
PMID:23124649
Abstract

BACKGROUND

The standard chemotherapy for Japanese patients with extensive disease of small-cell lung cancer (ED-SCLC) is cisplatin and irinotecan.

METHODS

Patients with untreated ED-SCLC were treated with nedaplatin (NP) at 50 mg/m(2) and irinotecan (CPT) at 50 mg/m(2) on days 1 and 8 every 4 weeks for four cycles.

RESULTS

Twenty-five patients were registered. Nineteen patients were male and six female, with a median age of 64 years (50-79 years). Two patients had a performance status of 2. Nineteen of them were able to receive 4 courses of NP and CPT chemotherapy. Grade 3 or 4 anemia, neutropenia, and thrombocytopenia occurred in 8.0, 68.0, and 36.0 % of patients, respectively. Other grade 3 toxicities were SGOT, hyponatremia, fatigue, vomiting, diarrhea, hypotension, febrile neutropenia, oral hemorrhage, and pneumonia. Grade 4 fatigue occurred in one patient. There was no treatment-related death. The overall response rate was 100 %. The median progression-free and overall survivals were 6.6 and 16.0 months, respectively, and the 2-year survival rate was 28 %.

CONCLUSION

NP with CPT is effective and safe for patients with ED-SCLC.

摘要

背景

广泛期小细胞肺癌(ED-SCLC)日本患者的标准化疗方案是顺铂和伊立替康。

方法

未经治疗的 ED-SCLC 患者接受奈达铂(NP)50mg/m²和伊立替康(CPT)50mg/m²,第 1 天和第 8 天,每 4 周为一个周期,共 4 个周期。

结果

共登记了 25 例患者。19 例为男性,6 例为女性,中位年龄为 64 岁(50-79 岁)。2 例患者的体能状态为 2 分。19 例患者能够接受 4 个周期的 NP 和 CPT 化疗。分别有 8.0%、68.0%和 36.0%的患者出现 3 级或 4 级贫血、中性粒细胞减少和血小板减少。其他 3 级毒性反应包括 SGOT、低钠血症、疲劳、呕吐、腹泻、低血压、发热性中性粒细胞减少、口腔出血和肺炎。1 例患者出现 4 级疲劳。无治疗相关死亡。总缓解率为 100%。中位无进展生存期和总生存期分别为 6.6 个月和 16.0 个月,2 年生存率为 28%。

结论

NP 联合 CPT 治疗 ED-SCLC 患者是有效且安全的。

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