Crinò L, Latini P, Meacci M, Corgna E, Maranzano E, Darwish S, Minotti V, Santucci A, Tonato M
Division of Medical Oncology, Policlinico Hospital, Perugia, Italy.
Ann Oncol. 1993 Dec;4(10):847-51. doi: 10.1093/oxfordjournals.annonc.a058391.
High-dose radiation therapy is generally recommended as standard treatment in regionally advanced unresectable non-small-cell lung cancer (NSCLC), but median- and long-term survival remain poor. Some reports have recently shown an improvement of results in advanced NSCLC when cisplatin was included in the chemotherapy regimens. Therefore, we designed a randomized trial to determine whether induction chemotherapy before high-dose radiotherapy improves response rate and survival in stage III NSCLC over that achieved with radiotherapy alone.
From March, 1984 to December, 1988, 66 consecutive patients with stage III unresectable NSCLC were randomized to one of two treatment arms; 61 were evaluable for survival and 58 for response and toxicity. Patients randomly assigned to arm A received cisplatin (CDDP 100 mg/m2 on day 1) and etoposide (VP 16 120 mg/m2 on days 1, 2, 3) every 3 wks for 3 courses followed by radiotherapy 56 Gy on pre-treatment tumor volume and 40 Gy on mediastinum and bilateral supraclavicular nodes. Patients assigned to arm B received only the same radiotherapy. The 61 eligible patients were comparable in terms of age, performance status, histology and treatment.
Response rate was 53% in arm A and 32% in arm B. The median survival was 52 wks for the combined treatment arm and 36 wks for the radiation therapy arm. At six years of follow-up all the patients were dead. Toxicity was mild and no treatment-related deaths were recorded.
Induction chemotherapy produced a better response rate and a trend of improved survival (4 months) but a significant survival advantage was not achieved (p < 0.11), probably because of the small number of patients enrolled in the trial.
大剂量放射治疗通常被推荐作为局部晚期不可切除非小细胞肺癌（NSCLC）的标准治疗方法，但患者的中位生存期和长期生存率仍然较低。最近一些报告显示，在化疗方案中加入顺铂后，晚期NSCLC的治疗效果有所改善。因此，我们设计了一项随机试验，以确定大剂量放疗前的诱导化疗是否比单纯放疗能提高Ⅲ期NSCLC的缓解率和生存率。
从1984年3月至1988年12月，66例连续的Ⅲ期不可切除NSCLC患者被随机分为两个治疗组；61例可评估生存情况，58例可评估缓解情况和毒性反应。随机分配到A组的患者每3周接受一次顺铂（第1天，顺铂100mg/m²）和依托泊苷（第1、2、3天，依托泊苷120mg/m²）治疗，共3个疗程，随后对治疗前肿瘤体积给予56Gy放疗，对纵隔和双侧锁骨上淋巴结给予40Gy放疗。分配到B组的患者仅接受相同的放疗。61例符合条件的患者在年龄、体能状态、组织学类型和治疗方面具有可比性。
A组的缓解率为53%，B组为32%。联合治疗组的中位生存期为52周，放疗组为36周。随访6年后，所有患者均死亡。毒性反应较轻，未记录到与治疗相关的死亡病例。
诱导化疗产生了更好的缓解率和生存改善趋势（4个月），但未实现显著的生存优势（p<0.11），可能是因为试验纳入的患者数量较少。
