Medical Oncology, Sakai Hospital, Kinki University School of Medicine, Osaka, Japan.
J Thorac Oncol. 2011 Nov;6(11):1881-8. doi: 10.1097/JTO.0b013e31822722b6.
There are a large number of global clinical trials ongoing for patients with non-small cell lung cancer (NSCLC). Ethnic difference in toxicity has not been adequately studied.
We performed a systematic search in PubMed for randomized phase II and III trials of NSCLC from January 2000 to December 2009, examining ethnic difference in hematological toxicity due to cytotoxic chemotherapy. Ethnicity was classified into Asian and non-Asian. We chose three treatment regimens used for NSCLC globally: cisplatin plus gemcitabine (CG), cisplatin plus vinorelbine (CV), and carboplatin plus paclitaxel (CP). We applied sensitivity analysis to examine unreported ethnic differences in hematological toxicities by changing the percentage of Asian patients from 0 to 18% in trials reported from the United States and Europe.
We identified 12 phase II trials and 38 phase III trials of NSCLC with a total of 11,271 patients. Among these, 14 trials had reported ethnic origins. Grade 3/4 toxicities were more frequently observed in the Asian studies. On the basis of sensitivity analysis, odds ratio of grade 3/4 neutropenia was significantly higher in Asian patients than non-Asian, when treated with CG (OR = 1.55-3.45, p < 0.001), CV (OR = 2.99-4.43, p < 0.001), and CP (OR = 4.79-6.22, p < 0.001). Grade 3/4 anemia was also significantly higher in Asians with CG (OR = 3.10-3.27, p < 0.001), CV (OR = 1.99-2.43, p < 0.001), and CP (OR = 1.34-1.52, p < 0.001-0.004). However, no significant difference was observed in thrombocytopenia with CG (OR = 0.66-2.04, p < 0.001-1.000), CV (OR = 0.42-0.57, p = 0.097-0.323), or CP (OR = 1.21-1.39, p = 0.114-0.152).
Severe hematological toxicity was frequently observed in Asian patients compared with non-Asian (mostly whites) in the treatment of chemotherapy for NSCLC.
目前有大量针对非小细胞肺癌（NSCLC）患者的全球临床试验正在进行。毒性的种族差异尚未得到充分研究。
我们在 PubMed 上进行了一项系统检索，检索了 2000 年 1 月至 2009 年 12 月期间的 NSCLC 随机 II 期和 III 期试验，研究了细胞毒性化疗引起的血液学毒性的种族差异。种族分为亚洲人和非亚洲人。我们选择了三种在全球范围内用于 NSCLC 的治疗方案：顺铂加吉西他滨（CG）、顺铂加长春瑞滨（CV）和卡铂加紫杉醇（CP）。我们通过在美国和欧洲报道的试验中改变亚洲患者的百分比（从 0 到 18%），进行敏感性分析以检查未报告的血液学毒性的种族差异。
我们确定了 12 项 NSCLC 的 II 期试验和 38 项 III 期试验，共有 11271 名患者。其中，有 14 项试验报告了种族来源。亚洲研究中更频繁地观察到 3/4 级毒性。基于敏感性分析，与非亚洲人相比，亚洲人接受 CG（OR=1.55-3.45，p<0.001）、CV（OR=2.99-4.43，p<0.001）和 CP（OR=4.79-6.22，p<0.001）治疗时，3/4 级中性粒细胞减少症的比值比更高。亚洲人接受 CG（OR=3.10-3.27，p<0.001）、CV（OR=1.99-2.43，p<0.001）和 CP（OR=1.34-1.52，p<0.001-0.004）时，3/4 级贫血也明显更高。然而，CG（OR=0.66-2.04，p<0.001-1.000）、CV（OR=0.42-0.57，p=0.097-0.323）或 CP（OR=1.21-1.39，p=0.114-0.152）时，血小板减少症无显著差异。
与非亚洲人（主要是白人）相比，亚洲人在接受 NSCLC 化疗治疗时经常出现严重的血液学毒性。
