A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIa non-small-cell lung cancer.
A randomized trial of postoperative adjuvant therapy in patients with completely resected stage II or IIIa non-small-cell lung cancer.
复制标题
DOI：
10.1056/nejm200010263431703
复制
发表时间：
2000-10-26
影响因子：
158.5
通讯作者：
Johnson, DH
中科院分区：
文献类型：
--
作者：
Keller, SM;Adak, S;Johnson, DH
背景：我们进行了一项随机试验，以确定在完全切除的II期或IIIa期非小细胞肺癌患者中，联合化疗加胸部放疗在延长生存期和预防局部复发方面是否优于单纯胸部放疗。
方法：在对肿瘤进行手术分期和切除（通常通过肺叶切除术或全肺切除术）后，患者被随机分配接受4个28天周期的顺铂（第1天按体表面积每平方米60毫克静脉注射）和依托泊苷（第1、2、3天按体表面积每平方米120毫克静脉注射）并同时进行放疗（总量50.4戈瑞，每日分割为28次），或者仅接受放疗（总量50.4戈瑞，每日分割为28次）。
结果：在纳入研究的488名患者中，242名被分配接受单纯放疗，246名被分配接受化疗和放疗。中位随访时间为44个月。单纯放疗组的治疗相关死亡率为1.2%，化疗和放疗组为1.6%。放疗组的中位生存期为39个月，化疗和放疗组为38个月（对数秩检验P = 0.56）。与单纯接受放疗的患者相比，被分配接受化疗和放疗的患者的相对生存可能性为0.93（95%置信区间，0.74 - 1.18）。在放疗组的234名患者中有30名（13%）在放疗区域内出现胸腔内疾病复发，在化疗和放疗组的236名患者中有28名（12%）出现复发（P = 0.84）；18名患者无复发数据。
结论：与单纯放疗相比，使用顺铂和依托泊苷的辅助放疗和化疗并不能降低完全切除的II期或IIIa期非小细胞肺癌患者胸腔内复发的风险，也不能延长生存期。
Background: We conducted a randomized trial to determine whether combination chemotherapy plus thoracic radiotherapy is superior to thoracic radiotherapy alone in prolonging survival and preventing local recurrence in patients with completely resected stage II or IIIa non-small-cell lung cancer.Methods: After surgical staging and resection of the tumor (usually by lobectomy or pneumonectomy), the patients were randomly assigned to receive either four 28-day cycles of cisplatin (60 mg per square meter of body-surface area intravenously on day 1) and etoposide (120 mg per square meter intravenously on days 1, 2, and 3) administered concurrently with radiotherapy (a total of 50.4 Gy, given in 28 daily fractions) or radiotherapy alone (a total of 50.4 Gy, given in 28 daily fractions).Results: Of the 488 patients who were enrolled in the study, 242 were assigned to receive radiotherapy alone and 246 were assigned to receive chemotherapy and radiotherapy. The median duration of follow-up was 44 months. Treatment-associated mortality was 1.2 percent in the group given radiotherapy alone and 1.6 percent in the group given chemotherapy and radiotherapy. The median survival was 39 months in the group given radiotherapy and 38 months in the group given chemotherapy and radiotherapy (P= 0.56 by the log-rank test). The relative likelihood of survival among patients assigned to receive chemotherapy and radiotherapy, as compared with those assigned to receive radiotherapy alone, was 0.93 (95 percent confidence interval, 0.74 to 1.18). Intrathoracic disease recurred within the radiation field in 30 of 234 patients (13 percent) in the group given radiotherapy and in 28 of 236 patients (12 percent) in the group given chemotherapy and radiotherapy (P=0.84); data on recurrence were not available for 18 patients.Conclusions: As compared with radiotherapy alone, adjuvant radiotherapy and chemotherapy with cisplatin and etoposide does not decrease the risk of intrathoracic recurrence or prolong survival in patients with completely resected stage II or IIIa non-small-cell lung cancer.