Keller S M, Adak S, Wagner H, Herskovic A, Komaki R, Brooks B J, Perry M C, Livingston R B, Johnson D H
Department of Surgery, Beth Israel Medical Center, New York, NY 10003, USA.
N Engl J Med. 2000 Oct 26;343(17):1217-22. doi: 10.1056/NEJM200010263431703.
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.
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).
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.
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.
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。
在进行手术分期和肿瘤切除（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四个28天周期的顺铂（体表面积每平方米60毫克，第1天静脉注射）和依托泊苷（体表面积每平方米120毫克，第1、2和3天静脉注射），同时进行放疗（总量50.4 Gy，分28次每日给予）或单纯放疗（总量50.4 Gy，分28次每日给予）。
在纳入该研究的488例患者中，242例被分配接受单纯放疗，246例被分配接受化疗加放疗。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%，化疗加放疗组为1.6%。单纯放疗组的中位生存期为39个月，化疗加放疗组为38个月（对数秩检验P = 0.56）。与单纯接受放疗的患者相比，接受化疗加放疗的患者的相对生存可能性为0.93（95%置信区间，0.74至1.18）。单纯放疗组234例患者中有30例（13%）在放射野内出现胸内疾病复发，化疗加放疗组236例患者中有28例（12%）出现复发（P = 0.84）；18例患者无复发数据。
与单纯放疗相比，顺铂和依托泊苷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的胸内复发风险或延长生存期。
