Lungenfachklinik Immenhausen, Immenhausen, Germany.
Institute of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.
BMC Pulm Med. 2022 Jun 27;22(1):252. doi: 10.1186/s12890-022-02048-1.
Smoking cessation in patients with diagnosed lung cancer has positive effects on cancer therapy and overall prognosis. Despite this, knowledge on smoking cessation in lung cancer patients is sparse.
This is an observational single centre, 12-week, prospective, single-arm trial at a tertiary lung cancer centre. Responsive patients were enrolled following confirmed lung cancer diagnosis. Smoking cessation intervention included counselling as well as pharmacotherapy. The primary endpoint was the point prevalence abstinence rate at week 12 based on biochemical verification. Secondary endpoints were the abstinence rate at week 26, quality of life and side effects.
80 patients were enrolled. Mean age was 62.6 ± 7.9 years. Most patients (63%) were treated with chemotherapy or radiochemotherapy. 39 patients used nicotine replacement therapy, 35 varenicline whereas six patients did not use pharmacotherapy. During the study period 13 patients died. Data were available in 72 patients after 12 weeks and 57 patients at week 24. Point prevalence abstinence rates were 37.5% (95% CI 26.4-49.7%) at week 12 and 32.8% (95% CI 21.8-45.4%) at week 26, respectively. Quality of life and side effects were not significantly affected by pharmacotherapy.
In conclusion, our results suggest that smoking cessation is feasible in patients with newly diagnosed lung cancer. The observed abstinence rate is comparable to other patient cohorts. Furthermore, pharmacotherapy in addition to cancer therapy was safe and did not show novel side effects in these seriously ill patients. Thus, smoking cessation should be an integral part of lung cancer treatment. Trial registration The study was conducted in accordance with good clinical practice standards (GCP) and approved by the local ethics committee (16/3/14), the European PAS registry (EUPAS8748) and the German BfArM (NIS-Studien-Nr. 5508). All patients provided written informed consent before study enrollment.
在确诊肺癌的患者中戒烟对癌症治疗和整体预后有积极影响。尽管如此,肺癌患者戒烟方面的知识仍然匮乏。
这是一项在一家三级肺癌中心进行的观察性、单中心、12 周、前瞻性、单臂试验。在确诊肺癌后,招募有反应的患者。戒烟干预包括咨询以及药物治疗。主要终点是基于生物化学验证的第 12 周时的点患病率戒断率。次要终点是第 26 周的戒断率、生活质量和副作用。
共纳入 80 例患者。平均年龄为 62.6±7.9 岁。大多数患者(63%)接受化疗或放化疗。39 例患者使用尼古丁替代疗法,35 例使用伐尼克兰,6 例未使用药物治疗。在研究期间,有 13 例患者死亡。12 周后有 72 例患者和 24 周后有 57 例患者可获得数据。第 12 周时的点患病率戒断率分别为 37.5%(95%CI:26.4-49.7%)和第 26 周时的 32.8%(95%CI:21.8-45.4%)。药物治疗并未显著影响生活质量和副作用。
总之,我们的结果表明,新诊断肺癌患者戒烟是可行的。观察到的戒断率与其他患者队列相当。此外,在这些重病患者中,除癌症治疗外,联合药物治疗是安全的,并且没有出现新的副作用。因此,戒烟应成为肺癌治疗的一个组成部分。
该研究符合良好临床实践标准(GCP),并得到当地伦理委员会(16/3/14)、欧洲 PAS 注册中心(EUPAS8748)和德国联邦药物与医疗器械管理局(NIS-Studien-Nr.5508)的批准。所有患者在入组前均签署了书面知情同意书。