Schaake-Koning C, van den Bogaert W, Dalesio O, Festen J, Hoogenhout J, van Houtte P, Kirkpatrick A, Koolen M, Maat B, Nijs A
Netherlands Cancer Institute, Amsterdam.
Lung Cancer. 1994 Mar;10 Suppl 1:S263-70. doi: 10.1016/0169-5002(94)91690-x.
A three-arm randomized trial was performed to assess the acute and late toxicity and the impact on survival of the combination high-dose, split-course radiotherapy with 30 mg/m2 cisplatin (cDDP) weekly, with 6 mg/m2 cisplatin daily compared to radiotherapy alone in patients with non-small cell lung cancer (NSCLC). The study started in May 1984 and was closed in May 1989 after 331 patients were randomised. The analysis was performed after a minimum follow-up period of 22 months. Radiotherapy (RT) consisted of 30 Gy, 10 fractions, five fractions a week; then a 3-week split followed by 25 Gy in 10 fractions. Nausea and vomiting were increased for a majority of the patients in the combined treatment arms during treatment. There was no addition of bone marrow suppression, renal dysfunction or esophagitis. Increase of late radiation damage was not observed. Local control (= absence of local progression) was improved for patients treated according to the daily cisplatin arm. This has lead to an improvement in overall survival. There was no effect in time to distant metastasis due to the combined modality. The treatment influence was confirmed in the multivariate analysis.
local control and survival can be improved by combining radiotherapy with daily low-dose cisplatin in patients with inoperable NSCLC.
进行了一项三臂随机试验，以评估高剂量、分割疗程放疗联合每周30 mg/m²顺铂（cDDP）与每日6 mg/m²顺铂相比单独放疗对非小细胞肺癌（NSCLC）患者的急性和晚期毒性以及生存的影响。该研究于1984年5月开始，在331例患者随机分组后于1989年5月结束。在最短随访22个月后进行分析。放疗（RT）包括30 Gy，分10次，每周5次；然后间隔3周，接着再进行25 Gy，分10次。联合治疗组的大多数患者在治疗期间恶心和呕吐有所增加。未出现额外的骨髓抑制、肾功能不全或食管炎。未观察到晚期放射性损伤增加。每日顺铂治疗组的患者局部控制（=无局部进展）得到改善。这导致了总生存期的改善。联合治疗对远处转移时间没有影响。多因素分析证实了该治疗的影响。
对于无法手术的NSCLC患者，放疗联合每日低剂量顺铂可改善局部控制和生存。
