局部晚期非小细胞肺癌患者诱导化疗后同步放化疗中毒性发生模式的特征：基于CALGB/联盟试验个体患者数据的汇总分析
Characteristics of toxicity occurrence patterns in concurrent chemoradiotherapy after induction chemotherapy for patients with locally advanced non-small cell lung cancer: a pooled analysis based on individual patient data of CALGB/Alliance trials.
作者信息
Yang Lexie Zidanyue, He Qihua, Zhang Jianrong, Ganti Apar Kishor, Stinchcombe Thomas E, Pang Herbert, Wang Xiaofei
机构信息
Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.
Department of Oncology, the First Affiliated Hospital of Guangzhou Medical University, China State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou, China.
出版信息
Transl Cancer Res. 2022 Oct;11(10):3506-3521. doi: 10.21037/tcr-22-2006.
BACKGROUND
For patients with locally advanced non-small cell lung cancer (NSCLC), concurrent chemoradiotherapy is the foundational treatment strategy. Adding induction chemotherapy did not achieve a superior efficacy but increased the burden from toxicity. Accordingly, we retrospectively investigated the toxicity patterns through pooling individual patient data of the Cancer and Leukemia Group B (CALGB)/Alliance trials.
METHODS
We included a total of 637 patients with unresectable stage III NSCLC who received induction chemotherapy with a platinum doublet and concurrent chemoradiotherapy and experienced at least one adverse event (AE) in CALGB 9130, 9431, 9534, 30105, 30106 and 39801 trials. The following toxicity occurrence patterns were evaluated: top 10 most frequent AEs, AE distribution by grade, rate of treatment discontinuation due to AEs, associations of AE occurrence with patient characteristics and treatment phase, the time to the first grade ≥3 AE occurrence and its associations with patient characteristics and treatment phase.
RESULTS
The occurrence of AEs was the main reason accounting for treatment discontinuation (60 of 637 among all patients; 18 of 112 patients who experienced the induction phase only; 42 of 525 patients who experienced both phases). All patients experienced a total of 11,786 AEs (grade ≥3: 1,049 of 5,538 in induction phase, 1,382 of 6,248 in concurrent phase). Lymphocytes and white blood count were of top 3 grade ≥3 AEs that patients experienced the most in the either phase. Multivariable analysis found AE occurrence was associated with age ≥65 [any grade: odds ratio (OR) =1.44, 95% confidence interval (CI): 1.12-1.86] and the concurrent phase (grade ≥3: OR =1.86, 95% CI: 1.41-2.47; any grade: OR =1.47, 95% CI: 1.19-1.81). Patients in the concurrent phase were more likely and earlier to develop grade ≥3 AEs than those in the induction phase [hazard ratio (HR) =4.37, 95% CI: 2.52-7.59].
CONCLUSIONS
The report provides a better understanding regarding the toxicity occurrence patterns in concurrent chemoradiotherapy after induction chemotherapy.
背景
对于局部晚期非小细胞肺癌（NSCLC）患者，同步放化疗是基础治疗策略。添加诱导化疗并未取得更好的疗效，反而增加了毒性负担。因此，我们通过汇总癌症与白血病B组（CALGB）/联盟试验的个体患者数据，回顾性研究了毒性模式。
方法
我们纳入了CALGB 9130、9431、9534、30105、30106和39801试验中总共637例不可切除的III期NSCLC患者，这些患者接受了铂类双药诱导化疗和同步放化疗，且至少经历了一次不良事件（AE）。评估了以下毒性发生模式：前10种最常见的AE、按等级划分的AE分布、因AE导致的治疗中断率、AE发生与患者特征和治疗阶段的关联、首次出现≥3级AE的时间及其与患者特征和治疗阶段的关联。
结果
AE的发生是导致治疗中断的主要原因（所有患者中637例中有60例；仅经历诱导期的112例患者中有18例；经历两个阶段的525例患者中有42例）。所有患者共经历了11,786次AE（≥3级：诱导期5,538次中有1,049次，同步期6,248次中有1,382次）。淋巴细胞和白细胞是患者在任何一个阶段经历最多的前3种≥3级AE。多变量分析发现，AE的发生与年龄≥65岁相关[任何等级：比值比（OR）=1.44，95%置信区间（CI）：1.12 - 1.86]以及同步期相关（≥3级：OR =1.86，95% CI：1.41 - 2.47；任何等级：OR =1.47，95% CI：1.19 - 1.81）。同步期的患者比诱导期的患者更有可能且更早出现≥3级AE[风险比（HR）=4.37，95% CI：2.52 - 7.59]。
结论
本报告为诱导化疗后同步放化疗中的毒性发生模式提供了更好的理解。
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