Department of Thoracic Oncology, Kinki-chuo Chest Medical Center, Osaka, Japan.
Japan Clinical Oncology Group Data Center, National Cancer Center Hospital, Tokyo, Japan.
Clin Lung Cancer. 2018 Sep;19(5):e619-e627. doi: 10.1016/j.cllc.2018.04.018. Epub 2018 May 5.
In the phase III JCOG0301 trial, chemoradiotherapy (CRT) with daily low-dose carboplatin showed significant benefits in elderly patients with locally advanced non-small-cell lung cancer (NSCLC) compared with radiotherapy (RT) alone. However, the long-term patterns and cumulative incidences of toxicity associated with CRT and RT in elderly patients are not well elucidated. We report long-term survival data and late toxicities after a minimum follow-up of 6.4 years.
Eligible patients were older than 70 years and had unresectable stage III NSCLC. They were randomly assigned to RT or CRT. Prognosis and adverse events data were collected beyond those in the initial report. Late toxicities were defined as occurring more than 90 days after RT initiation.
From September 2003 to May 2010, 200 patients (RT arm, n = 100; CRT arm, n = 100) were enrolled. Consistent with the initial report, the CRT arm had better overall survival than the RT arm (hazard ratio, 0.743; 95% confidence interval, 0.552-0.998; 1-sided P = .0239). The proportion of Grade 3/4 late toxicities were 7.4% (heart 2.1%, lung 5.3%) in the RT arm (n = 94) and 7.5% (esophagus 1.1%, lung 6.5%) in the CRT arm (n = 93). No additional cases of late toxicity (Grade 3/4) and treatment-related death have been seen since the initial report that was published.
Long-term follow-up confirmed the survival benefits of CRT for elderly patients with locally advanced NSCLC. There was no observed increase in late toxicity with CRT compared with RT alone.
在 III 期 JCOG0301 试验中，与单纯放疗（RT）相比，每日低剂量卡铂的放化疗（CRT）在老年局部晚期非小细胞肺癌（NSCLC）患者中显示出显著的获益。然而，在老年患者中，CRT 和 RT 相关的长期毒性模式和累积发生率尚不清楚。我们报告了至少随访 6.4 年后的长期生存数据和晚期毒性。
符合条件的患者年龄大于 70 岁，且患有不可切除的 III 期 NSCLC。他们被随机分配到 RT 或 CRT 组。除了初始报告中的预后和不良事件数据外，还收集了后续数据。晚期毒性定义为在 RT 开始后 90 天以上发生。
从 2003 年 9 月至 2010 年 5 月，共纳入 200 名患者（RT 组，n=100；CRT 组，n=100）。与初始报告一致，CRT 组的总生存优于 RT 组（风险比，0.743；95%置信区间，0.552-0.998；单侧 P=0.0239）。RT 组（n=94）和 CRT 组（n=93）中，3/4 级晚期毒性的比例分别为 7.4%（心脏 2.1%，肺 5.3%）和 7.5%（食管 1.1%，肺 6.5%）。自初始报告发表以来，未观察到 CRT 组晚期毒性（3/4 级）和治疗相关死亡的增加。
长期随访证实了 CRT 对老年局部晚期 NSCLC 患者的生存获益。与单纯 RT 相比，CRT 并未增加晚期毒性。
