Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03
Multicenter phase II trial of gefitinib first-line therapy followed by chemotherapy in advanced non-small-cell lung cancer (NSCLC): SAKK protocol 19/03
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DOI：
10.1093/annonc/mdm564
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发表时间：
2008-04-01
影响因子：
50.5
通讯作者：
Betticher, D. C.
中科院分区：
文献类型：
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作者：
D'Addario, G.;Rauch, D.;Betticher, D. C.
背景：吉非替尼对预治疗的非小细胞肺癌（NSCLC）患者有效。我们评估了吉非替尼一线治疗晚期NSCLC的活性和毒性，随后在疾病进展时进行化疗。患者和方法：在所有的化疗初治IIIB/IV期NSCLC患者中，63例接受吉非替尼250 mg/天。在疾病进展时，吉非替尼被顺铂80 mg/m2（第1天）和吉西他滨1250 mg/m2（第1、8天）取代，最多持续6个3周周期。结果：吉非替尼治疗12周后，病情稳定率（DSR）为24%，有效率（RR）为8%。中位疾病进展时间（TtP）为2.5个月，中位总生存期（OS）为11.5个月。从不吸烟者（n = 9）的DSR为56%，中位OS为20.2个月;表皮生长因子受体（EGFR）突变患者（n = 4）的DSR为75%，随访21.6个月后未达到中位OS。在所有，41例患者接受化疗的总体RR为34%，DSR为71%，中位TtP为6.7 months.Conclusions：一线吉非替尼单药治疗导致DSR为24%，在12周的一个cardiac患者人群。从不吸烟者和携带EGFR突变的患者往往有更好的结局;因此，有必要在选定的患者中进行进一步的试验。
Background: Gefitinib is active in patients with pretreated non-small-cell lung cancer (NSCLC). We evaluated the activity and toxicity of gefitinib first-line treatment in advanced NSCLC followed by chemotherapy at disease progression.Patients and methods: In all, 63 patients with chemotherapy-naive stage IIIB/IV NSCLC received gefitinib 250 mg/day. At disease progression, gefitinib was replaced by cisplatin 80 mg/m(2) on day 1 and gemcitabine 1250 mg/m(2) on days 1, 8 for up to six 3-week cycles. Primary end point was the disease stabilization rate (DSR) after 12 weeks of gefitinib.Results: After 12 weeks of gefitinib, the DSR was 24% and the response rate (RR) was 8%. Median time to progression (TtP) was 2.5 months and median overall survival (OS) 11.5 months. Never smokers (n = 9) had a DSR of 56% and a median OS of 20.2 months; patients with epidermal growth factor receptor (EGFR) mutation (n = 4) had a DSR of 75% and the median OS was not reached after the follow-up of 21.6 months. In all, 41 patients received chemotherapy with an overall RR of 34%, DSR of 71% and median TtP of 6.7 months.Conclusions: First-line gefitinib monotherapy led to a DSR of 24% at 12 weeks in an unselected patients population. Never smokers and patients with EGFR mutations tend to have a better outcome; hence, further trials in selected patients are warranted.