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肺癌工作组报告。

Lung cancer working group report.

机构信息

Medical Oncology Division, Kinki University School of Medicine, 377-2 Ono-Higashi, Osaka-Sayama City, Osaka 589-8511, Japan.

出版信息

Jpn J Clin Oncol. 2010 Sep;40 Suppl 1:i7-12. doi: 10.1093/jjco/hyq121.

Abstract

Asia needs a guideline for non-small-cell lung cancer because of differences in medical care, medical care insurance, ethnic variation and drug approval lag within Asian countries and compared with Western countries. Due to ethnic differences, drug dosages are often higher in the USA than in Japan. EGFR mutation in non-small-cell lung cancer was detected in 32% of Asians but only 6% of non-Asians, while differences in irinotecan metabolism cause higher frequencies of toxicity (leukopenia, diarrhea) in Asians. Pharmacodynamic ethnic differences in relation to paclitaxel/carboplatin resulted in longer median survival and a higher 1-year survival rate for Japanese-advanced non-small-cell lung cancer patients compared with Americans. To solve the problem of drug lag, pharmaceutical companies must perform multinational Asian clinical trials with quick accrual of patients, while regulatory authorities must establish high-quality, efficient approval processes, and achieve regulatory harmonization. The National Comprehensive Cancer Network promotes creation of national clinical practice guidelines, and Korea, China and Thailand adapted the National Comprehensive Cancer Network guidelines. Many Asian countries still lack such guidelines, and there are no pan-Asian guidelines for non-small-cell lung cancer. Japan developed its own non-small-cell lung cancer guidelines and also a gefitinib guidance. The study group members concluded that immediate establishment of an Asian non-small-cell lung cancer guideline will be difficult because of the differences among the countries. Asian collaborative trials on treatment of non-small-cell lung cancer need to be started at an early date to generate Asian data.

摘要

亚洲需要一份非小细胞肺癌指南,因为亚洲国家在医疗保健、医疗保险、种族差异和药物审批方面与西方国家存在差异。由于种族差异,美国的药物剂量通常比日本高。亚洲非小细胞肺癌患者中 EGFR 突变的检出率为 32%,而非亚洲患者为 6%,而伊立替康代谢的差异导致亚洲患者毒性(白细胞减少症、腹泻)的发生率更高。紫杉醇/卡铂与药效学的种族差异导致日本晚期非小细胞肺癌患者的中位生存期更长,1 年生存率更高。为了解决药物滞后问题,制药公司必须在亚洲进行快速招募患者的跨国临床试验,而监管机构必须建立高质量、高效的审批流程,并实现监管协调。国家综合癌症网络促进了国家临床实践指南的制定,韩国、中国和泰国采用了国家综合癌症网络的指南。许多亚洲国家仍然缺乏此类指南,也没有针对非小细胞肺癌的泛亚洲指南。日本制定了自己的非小细胞肺癌指南和吉非替尼指南。研究小组成员得出结论,由于各国之间的差异,立即制定亚洲非小细胞肺癌指南将非常困难。需要尽早开始针对非小细胞肺癌的亚洲协作试验,以产生亚洲数据。

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