Le Péchoux C, Arriagada R, Le Chevalier T, Bretel J J, Cosset B P, Ruffié P, Baldeyrou P, Grunenwald D
Lung Unit, Institut Gustave Roussy, Villejuif, France.
Int J Radiat Oncol Biol Phys. 1996 Jun 1;35(3):519-25. doi: 10.1016/0360-3016(96)00148-4.
Local failure is a major problem in locally advanced nonsmall cell lung cancer. The main objective of this Phase II trial was to test the feasibility of a combined concurrent radiotherapy and chemotherapy approach in an attempt to improve local control.
From December 1989 to December 1992, 34 patients were included. The treatment schedule consisted of hyperfractionated radiotherapy (60 Gy in 48 fractions and 6 weeks with two daily sessions of 1.25 Gy), cisplatin (6 mg/m2 every day of radiotherapy), and vindesine (2.5 mg/m2 once weekly). After a 3-week rest period, two full cycles of cisplatin (120 mg/m2 on weeks 10 and 14) and vindesine (2.5 mg/m2 on weeks 11, 12, and 13) were given. Treatment evaluation with thoracic computed scan, bronchoscopy, and bronchial biopsies was performed 3 months after completion of radiation therapy. Failure rates were estimated using a competing risk approach.
The complete response rate was 50%. Local failure rates at 1 and 3 years were 53 and 56%, respectively. Distant metastases rates at 1 and 3 years were 26.5 and 29%. Overall survival rates at 1, 2, and 3 years were respectively 53, 33, and 12%. Severe esophagitis was observed in three patients (9%). Lethal toxicity was observed in two patients.
This Phase II trial confirms the feasibility of this type of approach with specific dose reduction and suggests that it may improve local control compared to conventional approaches.
局部失败是局部晚期非小细胞肺癌的一个主要问题。这项II期试验的主要目的是测试同步放化疗联合方案的可行性,以期改善局部控制。
1989年12月至1992年12月,共纳入34例患者。治疗方案包括超分割放疗(48次分割,6周内给予60 Gy,每日两次,每次1.25 Gy)、顺铂(放疗期间每日6 mg/m²)和长春地辛(每周一次,2.5 mg/m²)。休息3周后,给予两个完整周期的顺铂(第10周和第14周各120 mg/m²)和长春地辛(第11周、第12周和第13周各2.5 mg/m²)。放疗结束3个月后,通过胸部计算机断层扫描、支气管镜检查和支气管活检进行治疗评估。使用竞争风险方法估计失败率。
完全缓解率为50%。1年和3年的局部失败率分别为53%和56%。1年和3年的远处转移率分别为26.5%和29%。1年、2年和3年的总生存率分别为53%、33%和12%。3例患者(9%)出现严重食管炎。2例患者出现致命毒性。
这项II期试验证实了这种特定剂量降低方法的可行性,并表明与传统方法相比,它可能改善局部控制。