Kubota K, Furuse K, Kawahara M, Kodama N, Yamamoto M, Ogawara M, Negoro S, Masuda N, Takada M, Matsui K
Department of Internal Medicine, National Kinki Central Hospital for Chest Diseases, Sakai, Japan.
J Clin Oncol. 1994 Aug;12(8):1547-52. doi: 10.1200/JCO.1994.12.8.1547.
For patients with locally advanced (stage III) non-small-cell lung cancer (NSCLC), radiotherapy (RT) has been used conventionally for many years. Few prospective trials have determined the role of RT. Recently, chemotherapy (CT) has been shown to produce excellent responses in regionally advanced disease. We therefore conducted a randomized trial using cisplatin (P)-based CT regimens with or without thoracic irradiation.
We randomly assigned 92 patients with locally advanced NSCLC to receive one of three arms of P-based combination chemotherapy: vindesine (V) plus P, mitomycin (M) plus V plus P, or etoposide (E) plus P alternating with V plus M. After two cycles of CT, patients were reevaluated and those with stage III were again randomized to receive RT or not. RT consisted of 50 to 60 Gy in 5 to 6 weeks; 2 Gy was delivered once daily in conventional fractions.
Sixty-three patients were included in the second randomization. The patients in the CT/RT group (n = 32) and CT-alone group (n = 31) were comparable in terms of age, sex, performance status, histologic features, stage of disease, and induction CT regimen. The median durations of survival were similar for the two groups (461 days in CT/RT group and 447 days in CT-alone group). The survival rate in the CT/RT group was 58% at 1 year, 36% at 2 years, and 29% at 3 years, as compared with 66%, 9%, and 3% at 1, 2, and 3 years, respectively, in the CT-alone group. One patient in the CT/RT group died of pneumonitis, but there were no CT-related deaths.
In locally advanced NSCLC, P-based combination CT followed by chest irradiation significantly increases the number of long-term survivors as compared with CT alone. RT to bulky disease in the thorax is thus an important part of combined modality therapy, and a necessary part of further studies in locally advanced disease.
对于局部晚期（III期）非小细胞肺癌（NSCLC）患者，放射治疗（RT）已常规使用多年。很少有前瞻性试验确定RT的作用。最近，化疗（CT）已被证明对局部晚期疾病有良好疗效。因此，我们进行了一项随机试验，采用含顺铂（P）的CT方案联合或不联合胸部照射。
我们将92例局部晚期NSCLC患者随机分为三组，接受含P的联合化疗方案之一：长春地辛（V）加P、丝裂霉素（M）加V加P或依托泊苷（E）加P与V加M交替使用。在两个周期的CT治疗后，对患者进行重新评估，III期患者再次随机分组接受或不接受RT。RT包括在5至6周内给予50至60 Gy；以常规分割方式每天给予2 Gy。
63例患者纳入第二次随机分组。CT/RT组（n = 32）和单纯CT组（n = 31）患者在年龄、性别、体能状态、组织学特征、疾病分期和诱导CT方案方面具有可比性。两组的中位生存期相似（CT/RT组为461天，单纯CT组为447天）。CT/RT组1年、2年和3年的生存率分别为58%、36%和29%，而单纯CT组1年、2年和3年的生存率分别为66%、9%和3%。CT/RT组有1例患者死于肺炎，但无CT相关死亡病例。
在局部晚期NSCLC中，与单纯CT相比，含P的联合CT后进行胸部照射显著增加了长期存活者的数量。因此，对胸部大块病灶进行RT是综合治疗模式的重要组成部分，也是局部晚期疾病进一步研究的必要组成部分。
