一线序贯应用厄洛替尼与化疗治疗晚期非小细胞肺癌的临床研究

 目的　评价化疗后序贯给予厄洛替尼在一线治疗非小细胞肺癌（NSCLC）中的客观缓解率和不良反应。方法　23例PS 0～1分的ⅢB～Ⅳ期NSCLC患者一线接受GC化疗方案（吉西他滨1250 mg／m2 第1、8天，顺铂75 mg／m2 第1天或卡铂AUC＝5第1天），并序贯给予厄洛替尼（150 mg，第15天至第28天），每28 d为1个周期，观察患者的客观疗效及不良反应。结果　23例患者接受95个周期的化疗，所有患者均可评价疗效。完全缓解（CR）0例，部分缓解（PR）7例（30.4 %），疾病稳定（SD）14例（60.9 %），疾病进展（PD）2 例（8.7 %）；总体客观缓解（RR）30.4 %，疾病控制（DCR ）91.3 %。Ⅲ度以上不良反应为白细胞减少3例（13.0 %），皮疹2例（8.7 %），恶心呕吐、血小板减少各2例（8.7 %），没有出现治疗相关的间质性肺病。结论　GC化疗方案序贯厄洛替尼治疗模式的近期疗效较好，不良反应在患者可耐受范围内，远期疗效有待进一步观察。

Study of sequential erlotinib and chemotherapy as first-line treatment for advanced non-small-cell lung cancer

Objective To observe the short-term efficacy and safety of sequential administration of erlotinib and chemotherapy in unselected, chemonaive patients with advanced non-small-cell lung cancer (NSCLC). Methods Previously-untreated patients (n=23) with stage Ⅲ_B/Ⅳ NSCLC and ECOG PS of 0/1 received erlotinib (150 mg/d) on days 15-28 of a 4-week cycle that included gemcitabine (1250 mg/m~2, days 1 and 8), and either cisplatin (75 mg/m~2, day 1) or carboplatin (AUC=5, day 1). The primary end points were tumor response rate and safety. Results 23 patients received a total of 95 cycles of treatment, and all were evaluable for efficacy and toxicity. The overall response rate was 30.4%, 0 case achieved complete responses (CR), 7 cases (30.4%) achieved partial responses (PR), 14 cases (60.9 %) achieved stable disease (SD), 2 cases (8.7 %) achieved progression disease (PD). The disease control rate was 91.3 %. The sequential administration of erlotinib following gemcitabine/platinum chemotherapy was well tolerated. The major grade 3 treatment-related adverse events were eutropenia (13.4%), rash (8.7%), nausea (8.7%) and thrombocytopenia (8.7%). No treatment-related interstitial lung disease. Conclusion equential administration of erlotinib following gemcitabine/platinum chemotherapy was effective, and the toxicity was tolerable. This treatment strategy warrants further investigation.