诱导化疗后吉非替尼维持治疗晚期非小细胞肺癌的临床研究

目的：评价晚期非小细胞肺癌（ＮＳＣＬＣ）诱导化疗后给予吉非替尼单药维持治疗的临床价值。方法：２００２年５月～２００５年２月，晚期ＮＳＣＬＣ患者根据最后一个化疗方案疗效分为两组，疗效为部分缓解（ＰＲ）或稳定（ＳＤ）的为吉非替尼维持治疗组，疗效为进展（ＰＤ）的为吉非替尼解救治疗组。入组后给予口服吉非替尼治疗，每日１次，每次２５０ｍｇ，持续服用到疾病进展。结果：共有１１９例患者入组，其中吉非替尼维持治疗组为７９例，解救治疗组为４０例。维持治疗组总有效率（ＲＲ）３１.６％（２５／７７），其中３例ＣＲ，解救治疗组ＲＲ为２７.５％（１１／４０），两组之间无统计学差异（Ｐ＝０.６４５）。吉非替尼维持治疗组的进展时间（ＴＴＰ）为６.０个月，显著长于解救治疗组的４.０个月（Ｐ＝０.０３）。维持治疗中位生存期（ＯＳ）为１１.０个月，而解救治疗组的中位ＯＳ为７.０个月，二者差异具有统计学意义（Ｐ＝０.０１９）。维持治疗组中腺癌患者的有效率显著高于鳞癌患者（３９.７％ ｖｓ.１２.５％，Ｐ＝０.０４１），ＴＴＰ也显著长于鳞癌患者（７.５个月ｖｓ．３.０个月，Ｐ＝０.０２）；女性患者的中位ＯＳ显著长于男性患者（１８.５个月ｖｓ．９.０个月，Ｐ＝０.００２）。毒副作用多数较轻，且可逆，以１、２级为主。结论：吉非替尼作为晚期ＮＳＣＬＣ诱导化疗后的维持治疗，有较好的疗效和安全性。与化疗进展后再使用吉非替尼方案相比，化疗未进展时使用能更好地发挥该药的优势，给予患者更大的生存获益。

Maintenance therapy with gefitinib after chemotherapy for patients in advanced non-small cell lung cancer

Objective：To evaluate the efficacy of using gefitinib as maintenance therapy after chemotherapy. Methods：Patients with stage ⅢB/Ⅳ NSCLC were devided into maintenance group achieved partial response or disease stabilization following the last chemotherapy and treatment group achieved progressive disease. Cefitinib was administered at the dose of 250 mg/d. Results： From May 2002 to February 2005, we enrolled 119 patients. Response rate to gefitinib was 31.6% （25/77）in maintenance group and 27.5% （11/40）in treatment group （P = 0. 645 ）. In comparison with patients in treatment group, patients of maintenance group had better time to progression（ median, 6. 0 vs. 4. 0 months ; P = 0. 03 ） and overall survival（ median, 11.0 vs. 7.0 months ; P = 0. 019）. The toxicity profile was mild and there was no significant difference between two groups. Conclusion： Maintenance therapy with gefitinib after chemotherapy was feasible and safe, which produced significantly longer TTP and OS compared to using gefitinib after failure to chemotherapy.