Pujol J L, Hayot M, Rouanet P, Le Chevalier T, Michel F B
Chest Department, Hôpital Arnaud de Villeneuve, Montpellier, France.
Chest. 1994 Nov;106(5):1451-5. doi: 10.1378/chest.106.5.1451.
Thirty-three patients with T3,N2,M0 or T4,N2,M0, non-small-cell lung cancer (NSCLC) took part in a phase 2 study in an attempt to evaluate the feasability of neoadjuvant chemotherapy followed by surgery and thoracic radiotherapy. Chemotherapy consisted of daily administration of the following treatment: etoposide, 100 mg/m2; cisplatin, 25 mg/m2; ifosfamide, 1.5 g/m2; and mesna, 1.8 g/m2 for 4 days. Three cycles were planned starting every 21 days. Responding patients underwent a thoracotomy in order to attempt a resection and then received a 45 Gy of thoracic radiotherapy. The results of response and resection rates have been published and the present final report deals with the long-term results. Chemotherapy induced a 55 percent partial response rate and a 15 percent complete response rate allowing a complete resection in 55 percent of the patients. Complete remission was histologically confirmed for the five complete responders. Although the median survival was short (10 months), six patients were long-term survivors (3-year survival rate: 19 percent). Survival was significantly influenced by the type of resection: patients for whom a complete resection was possible survived the longest with a median survival three times that of the other patients. Modalities of relapses differed according to the results of surgery: 8 of the 15 patients who did not undergo a complete surgical resection experienced a local relapse during the first 18 months of follow-up whereas in the complete resection group, central nervous system metastasis was the main site of relapse. We conclude that the neoadjuvants ifosfamide, cisplatin, and etoposide in patients with locally advanced NSCLC are feasible to use and allow a 19 percent 3-year survival rate. These results are the rationale of an ongoing randomized study comparing neoadjuvant chemotherapy followed by surgery and surgery alone. This study is designed to test whether neoadjuvant chemotherapy improves survival of patients with locally advanced NSCLC.
33例T3、N2、M0或T4、N2、M0期非小细胞肺癌（NSCLC）患者参与了一项2期研究，旨在评估新辅助化疗后行手术及胸部放疗的可行性。化疗方案为每日给予以下治疗：依托泊苷，100mg/m²；顺铂，25mg/m²；异环磷酰胺，1.5g/m²；美司钠，1.8g/m²，共4天。计划每21天开始1个周期，共3个周期。有反应的患者接受开胸手术以尝试切除肿瘤，然后接受45Gy的胸部放疗。反应率和切除率的结果已发表，本最终报告涉及长期结果。化疗诱导的部分缓解率为55%，完全缓解率为15%，55%的患者能够完全切除肿瘤。5例完全缓解者经组织学证实为完全缓解。尽管中位生存期较短（10个月），但6例患者为长期存活者（3年生存率：19%）。生存情况受切除类型的显著影响：能够完全切除的患者生存期最长，中位生存期是其他患者的3倍。复发方式根据手术结果而异：15例未行完全手术切除的患者中有8例在随访的前18个月内出现局部复发，而在完全切除组中，中枢神经系统转移是主要的复发部位。我们得出结论，对于局部晚期NSCLC患者，新辅助使用异环磷酰胺、顺铂和依托泊苷是可行的，3年生存率为19%。这些结果是正在进行的一项随机研究的理论依据，该研究比较新辅助化疗后手术与单纯手术的疗效。本研究旨在测试新辅助化疗是否能提高局部晚期NSCLC患者的生存率。
