Lung Screening, Tobacco, and Health (LSTH) Trial data

ABSTRACT Background. Lung cancer mortality is reduced via low-dose CT screening and treatment of early-stage disease. Evidence-based smoking cessation treatment in the lung screening setting can further reduce mortality. We report the results of a cessation trial from the NCI’s SCALE collaboration. Methods. Eligible patients (N=818) aged 50-80 were randomized (May 2017-January 2021) to the Intensive vs. Minimal arms (8 vs. 3 phone sessions plus 8 vs. 2 weeks of nicotine patches, respectively). Bio-verified (primary) and self-reported 7-day abstinence rates were assessed 3-, 6-, and 12-months post-randomization. Logistic regression analyses evaluated the effects of study arm. All statistical tests were two-sided. Results. Participants reported 48.0 (SD=17.2) pack-years and 51.6% were not ready to quit in <30 days. Self-reported 3-month quit rates were significantly higher in the Intensive vs. Minimal arm (14.3% vs. 7.9%; OR=2.00, 95% confidence interval [CI] = 1.26,3.18). Bio-verified abstinence was lower but with similar relative differences between arms (9.1% vs. 3.9%; OR=2.70, 95% CI = 1.44, 5.08). Compared to the Minimal arm, the Intensive arm was more effective among those with greater nicotine dependence (OR=3.47, 95% CI = 1.55, 7.76), normal screening results (OR=2.58, 95% CI = 1.32, 5.03), high engagement in counseling (OR=3.03, 95% CI = 1.50, 6.14) and patch use (OR=2.81, 95% CI = 1.39, 5.68). Abstinence rates did not differ significantly between arms at 6-months (OR=1.2, 95% CI = 0.68, 2.11) or 12-months (OR=1.4, 95% CI = 0.82, 2.42). Conclusions. Delivering intensive telephone counseling and nicotine replacement with lung screening is an effective strategy to increase short-term smoking cessation. Methods to maintain short-term effects are needed. Even with modest quit rates, integrating cessation treatment into lung screening programs may have a large impact on tobacco-related mortality.摘要 背景：肺癌死亡率可通过低剂量CT（low-dose CT）筛查与早期疾病治疗得到降低。在肺癌筛查场景中，基于循证医学的戒烟干预可进一步降低死亡率。本文报告了美国国家癌症研究所（National Cancer Institute, NCI）SCALE合作项目开展的一项戒烟临床试验的结果。 方法：本研究纳入年龄介于50~80岁的合格受试者共818例，于2017年5月至2021年1月期间将其随机分配至强化组与极简组，两组分别接受8次与3次电话咨询服务，同时分别辅以8周与2周的尼古丁贴片治疗。在随机化后的第3、6、12个月，分别评估经生物标志物验证的（主要研究终点）与自我报告的7天戒烟率。采用Logistic回归分析评估研究分组的干预效应，所有统计检验均采用双侧检验。 结果：受试者的平均吸烟包年数为48.0（标准差SD=17.2），51.6%的受试者在入组后30天内暂无戒烟意愿。随机化后3个月时，强化组的自我报告戒烟率显著高于极简组（14.3% vs. 7.9%；优势比OR=2.00，95%置信区间CI=[1.26, 3.18]）。经生物标志物验证的戒烟率相对更低，但两组间的相对差异趋势一致（9.1% vs. 3.9%；OR=2.70，95%CI=[1.44, 5.08]）。与极简组相比，强化组在以下亚群中干预效果更显著：尼古丁依赖程度较高者（OR=3.47，95%CI=[1.55, 7.76]）、肺癌筛查结果正常者（OR=2.58，95%CI=[1.32, 5.03]）、咨询参与度较高者（OR=3.03，95%CI=[1.50, 6.14]）以及尼古丁贴片使用依从性较高者（OR=2.81，95%CI=[1.39, 5.68]）。在6个月时（OR=1.2，95%CI=[0.68, 2.11]）与12个月时（OR=1.4，95%CI=[0.82, 2.42]），两组的戒烟率均无显著统计学差异。 结论：在肺癌筛查流程中整合强化电话咨询与尼古丁替代治疗，可有效提升短期戒烟率，目前仍需探索可维持短期戒烟效果的干预方案。尽管整体戒烟率相对有限，但将戒烟干预纳入肺癌筛查项目，或可对烟草相关死亡率产生显著的公共健康影响。