FDA于5月5日批准新药Iressa (gefitinib)用于治疗终末期非小细胞肺癌。该药仅被批准用于经过标准含铂类方案和泰素化疗后进展的肺癌(即除非是在临床试验中，不应用于一线治疗)。这一批准给了终末期非小细胞肺癌患者最后的机会。      Iressa是根据FDA有关加速批准有前途的治疗方法或药物使患有危及生命疾病的患者能够尽早接受治疗的计划的一部分。根据这一计划，一种药物可能在所有的临床试验尚未完成的情况下即被批准应用行临床。目前仍有必要证实临床效益，并评估长期安全性。    但是有关Iressa的安全性和有效性仍受到各方面的关注。有些研究显示Iressa在联合化疗时并不能提高生存或改善症状(注意，FDA并未批准联合化疗应用Iressa)。生产Iressa的AstraZeneca公司现在被要求进一步临床试验以证实该药对病人具有确实的疗效。在日本，经过批准进入临床一年后，有小部分患者出现了严重的毒副反应，如间质性肺炎 (ILD，可导致肺部炎症，疤痕和组织破坏)，并有部分病人死亡。鉴于这些原因，民间组织Public Citizen敦促FDA不要批准Iressa上市。该组织认为FDA的批准将会使病人置于危险之中。    面对有关的批评的声音，美国FDA发言人称根据研究，Iressa给病人所带来的利大于弊！FDA经过三个月来对有关该药报告的分析显示：在大约23,000 接受Iressa的患者中，有约 2%的日本患者出现ILD，但是仅有0.3%的美国患者出现ILD，其中约三分之一的患者死亡于ILD。但FDA认为，由肺癌本身或药物所致的ILD难以诊断，而另一方面，晚期非小细胞肺癌患者一旦在化疗无效的情况下，病人的预期寿命将会是非常短的。对于终末期的非小细胞肺癌患者而言，Iressa带来的益处要超过其损害。同时在研究中还发现Iressa可能在妇女(在肿瘤缩小的患者中，男女比例为5%比17%)和非吸烟者中疗效更优。     Iressa每日服一片(250mg)，使用较为方便，病人的依从性高。主要毒副反应包括：腹泻，恶心，呕吐，皮疹和痤疮等。另外还会增加服用抗凝药物华法令的患者出现出血的机会。     随着美国FDA批准Iressa上市，Iressa在世界范围内加速上市的趋势不可避免。可以预见，Iressa将会成为晚期非小细胞肺癌治疗的最后一道防线。在带来希望的同时，也要注意Iressa在东方人身上可能毒副反应，从而真正达到利大于弊，使病人获益。 Iressa (gefitinib) Iressa (gefitinib) Improves Progression-free Survival over Standard Chemotherapy in Patients with NSCLC with EGFR Mutations. Researchers from Japan have reported that Iressa (gefitinib) alone improves outcomes of patients with non–small cell lung cancer (NSCLC) with epithelial growth factor receptor (EGFR) mutations compared with patients receiving Paraplatin (carboplatin) and Taxol (paclitaxel). The details of this study were presented at the Joint ECCO 15 – 34th ESMO Multidisciplinary Congress in Berlin, September 20-24, 2009. Oral Iressa (gefitinib) is approved in the United States as a single-agent treatment for patients with advanced NSCLC who have failed platinum- and taxane-based treatment. Iressa is a selective inhibitor of EGFR-tyrosine kinase. Epidermal growth factor receptor is expressed, overexpressed, or dysregulated in many human solid tumors, including NSCLC. Activation of this receptor is believed to promote tumor growth by blocking apoptosis and by increasing cell proliferation, adhesion and invasive capacity, and motility. Responsive lung tumors are likely to be adenocarcinomas or bronchio-alveolar carcinomas and occur more frequently in non-smokers and women. Responses also occur more frequently in patients with specific mutations of EGFR. Recently, researchers from Asia have reported that first-line treatment with Iressa improves progression-free survival (PFS) over combination treatment with Paraplatin and Taxol in advanced NSCLC among nonsmokers and former light smokers. The current study included 198 patients with NSCLC with sensitive EGFR mutations who had received no prior chemotherapy. They were randomly allocated to receive Iressa alone or Paraplatin and Taxol. Overall response rate was 74.5% for patients receiving Iressa versus 29% for patients receiving Paraplatin and Taxol. Grade 4 neutropenia occurred in 1% of patients receiving Iressa and 33% of patients receiving chemotherapy. Grade 3-4 liver dysfunction occurred in 33% of patients receiving Iressa versus 1% receiving chemotherapy. Grade 3 neuropathy occurred in 0% of patients receiving Iressa and 5% of patients receiving chemotherapy. PFS was 10.4 months following Iressa treatment versus 5.5 months for chemotherapy. Overall survival was 28.0 months for patients receiving Iressa and 23.6 months for patients receiving chemotherapy (P=0.357). This study shows that Iressa improves PFS in patients with NSCLC with EGFR mutations compared with conventional chemotherapy. These authors suggest that Iressa be considered the new standard treatment for “sensitive EGFR mutation-positive NSCLC patients.”