Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer
Phase III study of concurrent versus sequential thoracic radiotherapy in combination with mitomycin, vindesine, and cisplatin in unresectable stage III non-small-cell lung cancer
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DOI：
10.1200/jco.1999.17.9.2692
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发表时间：
1999-09-01
影响因子：
45.3
通讯作者：
Ariyoshi, Y
中科院分区：
文献类型：
--
作者：
Furuse, K;Fukuoka, M;Ariyoshi, Y
目的：进行了一项III期研究，以确定放疗（87）和化疗（CT）同时或顺序治疗是否能提高不可切除的III期非小细胞肺癌（NSCLC）的生存率。患者和方法：患者被分为两个治疗组。在同期组，化疗包括顺铂（80mg /m(2)，第1天和第29天），长春地辛（3mg /m(2)，第1、8、29和36天）和丝裂霉素（8mg /m，第1天和29天）。放疗于第2天开始，剂量为28 Gy（每剂量2 Gy，每周5次，共14次），随后休息10天，然后重复。在顺序组中，给予相同的CT，但在CT完成后开始PT，由56 Gy（每剂量2 Gy，每周5次，共28次）组成。结果：320例患者被纳入研究。预处理特征在治疗组之间得到很好的平衡。同时治疗组的有效率（84.0%）显著高于序贯治疗组（66%）（P = 0.0002），同时治疗组的中位生存时间（16.5个月）显著优于序贯治疗组（13.3个月）（P = 0.03998）。同时治疗组的2年、3年、4年和5年生存率（分别为34.6%、22.3%、16.9%和15.8%）优于顺序治疗组（分别为27.4%、14.7%、10.1%和8.9%）。同时治疗组的骨髓抑制明显大于序贯治疗组（P = 0.0001）。结论：在选定的无法切除的III期NSCLC患者中，与顺序入路相比，并行入路的反应率和中位生存期显著提高。
Purpose: A phase III study was performed to determine whether concurrent or sequential treatment with radiotherapy (87) and chemotherapy (CT) improves survival in unresectable stage III non-small-cell lung cancer (NSCLC).Patients and Methods: Patients were assigned to the two treatment arms. In the concurrent arm, chemotherapy consisted of cisplatin (80 mg/m(2) on days 1 and 29), vindesine (3 mg/m(2) on days 1, 8, 29, and 36), and mitomycin (8 mg/m2 on days 1 and 29). RT began on day 2 at a dose of 28 Gy (2 Gy per fraction and 5 fractions per week for a total of 14 fractions) followed by a rest period of 10 days, and then repeated, In the sequential arm, the same CT was given, but PT was initiated after completing CT and consisted of 56 Gy (2 Gy per fraction and 5 fractions per week for a total of 28 fractions).Results: Three hundred twenty patients were entered onto the study. Pretreatment characteristics were well balanced between the treatment arms. The response rate for the concurrent arm was significantly higher (84.0%) than that of the sequential arm (66%) (P = .0002), The median survival duration was significantly superior in patients receiving concurrent therapy (16.5 months), as compared with those receiving sequential therapy(13.3 months) (P = .03998). Two-, 3-, 4-, and 5-year survival rates in the concurrent group (34.6% 22.3%, 16.9%, and 15.8%, respectively) were better than those in the sequential group (27.4%, 1 4.7%, 10.1%, and 8.9% respectively). Myelosuppression was significantly greater among patients on the concurrent arm than on the sequential arm (P = .0001).Conclusion: In selected patients with unresectable stage III NSCLC, the concurrent approach yields a significantly increased response rate and enhanced median survival duration when compared with the sequential approach.