Komaki R, Scott C B, Sause W T, Johnson D H, Taylor S G, Lee J S, Emami B, Byhardt R W, Curran W J, Dar A R, Cox J D
UT/RK M.D. Anderson Cancer Center, Houston, TX 77030, USA.
Int J Radiat Oncol Biol Phys. 1997 Oct 1;39(3):537-44. doi: 10.1016/s0360-3016(97)00365-9.
To analyze disease failure patterns by pretreatment characteristics and treatment groups in a prospective randomized trial.
Patients with medically inoperable Stage II, unresectable IIIA and IIIB nonsmall cell lung cancer with KPS > or =70 and weight loss < or =5% were randomized to one of three treatment groups: standard radiation therapy with 60 Gy at 2.0 Gy per day (STD RT), induction chemotherapy with cisplatin 100 mg/m2 days 1 and 29 with vinblastine 5 mg/m2 weekly for 5 weeks followed by 60 Gy at 2.0 Gy per day (CT + RT), or hyperfractionated radiation therapy with 69.6 Gy at 1.2 Gy b.i.d. (HFX RT). Of 490 patients enrolled, 458 were evaluable. Minimum and median periods of observation for this analysis were 4 years and 6 years, respectively.
Pretreatment characteristics were equally distributed. Toxicities were previously reported. Median survival rates were 11.4, 13.6, and 12.3 months for STD RT, CT + RT, and HFX RT, respectively (log rank p = 0.05, Wilcoxon p = 0.04). Survivals were 20, 31, and 24% at 2 years, and 4, 11, and 9% at 4 years in the STD RT, CT + RT, and HFX RT groups, respectively. There were no differences in local tumor control rates among the treatments. Patterns of first failure showed less distant metastasis (DM) (other than brain) for CT + RT compared to the RT alone arms (p = 0.04). Within squamous cell carcinoma (SCC), DM (other than brain) rates were 43%, 16%, and 38% in SCC for STD RT, CT + RT, and HFX RT, respectively (p = 0.0015). Patients with peripheral/chest wall lesions were significantly more likely to fail first in the thorax when treated on STD RT compared to CT + RT and HFX RT (p = 0.009). Survival rates were similar among the treatment arms for patients with squamous cell carcinoma. Among patients with nonsquamous cell carcinoma, failure patterns did not differ by treatment group, but survival was significantly better in those who were treated by induction chemotherapy (p = 0.04).
Patients with squamous cell carcinoma treated on the CT + RT arm had a significant reduction of first DM other than brain, but there was difference in survival. Survival favored CT + RT in nonsquamous carcinoma despite similar failure patterns. Reasons for improved survival with CT + RT in NSCLC are not yet available.
在一项前瞻性随机试验中，根据治疗前特征和治疗组分析疾病失败模式。
患有医学上无法手术的II期、不可切除的IIIA期和IIIB期非小细胞肺癌，KPS≥70且体重减轻≤5%的患者被随机分为三个治疗组之一：标准放疗，每天2.0 Gy，共60 Gy（STD RT）；诱导化疗，顺铂100 mg/m²，第1天和第29天给药，长春碱5 mg/m²，每周一次，共5周；然后每天2.0 Gy，共60 Gy（CT + RT）；或超分割放疗，每天两次，每次1.2 Gy，共69.6 Gy（HFX RT）。在入组的490例患者中，458例可评估。本次分析的最短和中位观察期分别为4年和6年。
治疗前特征分布均匀。毒性反应先前已有报道。STD RT、CT + RT和HFX RT的中位生存率分别为11.4个月、13.6个月和12.3个月（对数秩检验p = 0.05，Wilcoxon检验p = 0.04）。STD RT、CT + RT和HFX RT组在2年时的生存率分别为20%、31%和24%，在4年时分别为4%、11%和9%。各治疗组之间的局部肿瘤控制率无差异。首次失败模式显示，与单纯放疗组相比，CT + RT组远处转移（DM）（脑转移除外）较少（p = 0.04）。在鳞状细胞癌（SCC）中，STD RT、CT + RT和HFX RT组的DM（脑转移除外）率分别为43%、16%和38%（p = 0.0015）。与CT + RT和HFX RT相比，接受STD RT治疗的外周/胸壁病变患者首次在胸部出现失败的可能性显著更高（p = 0.009）。鳞状细胞癌患者各治疗组的生存率相似。在非鳞状细胞癌患者中，失败模式在治疗组之间无差异，但诱导化疗患者的生存率显著更高（p = 0.04）。
接受CT + RT治疗的鳞状细胞癌患者首次脑转移以外的远处转移显著减少，但生存率存在差异。尽管失败模式相似，但非鳞状细胞癌患者的生存率CT + RT组更优。NSCLC患者CT + RT治疗后生存率提高的原因尚不清楚。
