Machtay Mitchell, Hsu Chuanchieh, Komaki Ritsuko, Sause William T, Swann R Suzanne, Langer Corey J, Byhardt Roger W, Curran Walter J
Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, USA.
Int J Radiat Oncol Biol Phys. 2005 Nov 1;63(3):667-71. doi: 10.1016/j.ijrobp.2005.03.037. Epub 2005 May 31.
To determine whether overall treatment time affects outcomes after definitive concurrent chemoradiotherapy for locally advanced non-small-cell lung carcinoma (NSCLC).
Data were analyzed from 3 prospective Radiation Therapy Oncology Group trials (RTOG 91-06, 92-04, and 94-10) in which immediate concurrent chemoradiation (cisplatin-based) was the primary therapy for good-performance status Stage III (and selected inoperable Stage II) NSCLC. "Short" overall treatment time (per protocol) was defined as completing treatment within 5 days of plan; other patients were considered to have had "prolonged" treatment time (protocol violation); treatment time was also analyzed as a continuous variable in a multivariate model. Actuarial analysis was performed for overall survival, progression-free survival, freedom from local-regional progression, and toxicity.
A total of 474 patients were analyzed. Median follow-up for surviving patients was 6.1 years. Treatment time was delivered per protocol in 387 (82%), whereas 87 patients (18%) had a prolonged treatment time. Long treatment time was significantly associated with severe acute esophagitis. Median survival was slightly better in patients completing treatment on time (19.5 months vs. 14.8 months), but this did not reach statistical significance (p = 0.15) in the univariate analysis. However, in the multivariate analysis of treatment time as a continuous variable, prolonged treatment time was significantly associated with poorer survival (p = 0.02), indicating a 2% increase in the risk of death for each day of prolongation in therapy. Histology (squamous fared worse) and performance status were also significant in the multivariate model.
This retrospective analysis demonstrates a correlation between prolonged overall radiotherapy treatment time and survival in patients with locally advanced NSCLC, even when concurrent chemotherapy is used. Further study of novel radiation-chemotherapy dose/fractionation regimens is warranted.
确定总治疗时间是否会影响局部晚期非小细胞肺癌（NSCLC）行根治性同步放化疗后的疗效。
分析了3项前瞻性放射肿瘤学组试验（RTOG 91 - 06、92 - 04和94 - 10）的数据，其中即刻同步放化疗（以顺铂为基础）是体能状态良好的Ⅲ期（以及部分不可切除的Ⅱ期）NSCLC的主要治疗方法。“短”总治疗时间（按方案）定义为在计划的5天内完成治疗；其他患者被认为治疗时间“延长”（违反方案）；治疗时间在多变量模型中也作为连续变量进行分析。对总生存、无进展生存、无局部区域进展和毒性进行了精算分析。
共分析了474例患者。存活患者的中位随访时间为6.1年。387例（82%）患者按方案完成了治疗时间，而87例（18%）患者治疗时间延长。长治疗时间与严重急性食管炎显著相关。按时完成治疗的患者中位生存期略好（19.5个月对14.8个月），但在单变量分析中未达到统计学显著性（p = 0.15）。然而，在将治疗时间作为连续变量的多变量分析中，延长的治疗时间与较差的生存率显著相关（p = 0.02），表明治疗每延长一天死亡风险增加2%。组织学类型（鳞状细胞癌预后较差）和体能状态在多变量模型中也具有显著性。
这项回顾性分析表明，即使使用同步化疗，局部晚期NSCLC患者延长的总放疗治疗时间与生存率之间存在相关性。有必要对新的放化疗剂量/分割方案进行进一步研究。
