Optimizing Longitudinal Tobacco Cessation Treatment in Lung Cancer Screening: A Sequential, Multiple Assignment, Randomized Trial.

Importance: Nearly half of the 14.8 million US adults eligible for lung cancer screening (LCS) smoke cigarettes. The optimal smoking cessation program components for the LCS setting are unclear. Objective: To assess the effect of adding a referral to prescription medication therapy management (MTM) to the tobacco longitudinal care (TLC) program among patients eligible for LCS who smoke and do not respond to early tobacco treatment and to assess the effect of decreasing the intensity of TLC among participants who do respond to early treatment. Design, Setting, and Participants: This randomized clinical trial included patients who currently smoked cigarettes daily and were eligible for LCS. Recruitment took place at primary care centers and LCS programs at 3 large health systems in the US and began in October 2016, and 18-month follow-up was completed April 2021. Interventions: (1) TLC comprising intensive telephone coaching and combination nicotine replacement therapy for 1 year with at least monthly contact; (2) TLC with MTM, MTM offered pharmacist-referral for prescription medications; and (3) Quarterly TLC, intensity of TLC was decreased to quarterly contact. Intervention assignments were based on early response to tobacco treatment (abstinence) that was assessed either 4 weeks or 8 weeks after treatment initiation. Main outcomes and Measures: Self-reported, 6-month prolonged abstinence at 18-month. Results: Of 636 participants, 228 (35.9%) were female, 564 (89.4%) were White individuals, and the median (IQR) age was 64.3 (59.6-68.8) years. Four weeks or 8 weeks after treatment initiation, 510 participants (80.2%) continued to smoke (ie, early treatment nonresponders) and 126 participants (19.8%) had quit (ie, early treatment responders). The 18 month follow-up survey response rate was 83.2% (529 of 636). Across TLC groups at 18 months follow-up, the overall 6-month prolonged abstinence rate was 24.4% (129 of 529). Among the 416 early treatment nonresponders, 6-month prolonged abstinence for TLC with MTM vs TLC was 17.8% vs 16.4% (adjusted odds ratio [aOR] 1.13; 95% CI, 0.67-1.89). In TLC with MTM, 98 of 254 participants (39%) completed at least 1 MTM visit. Among 113 early treatment responders, 6-month prolonged abstinence for Quarterly TLC vs TLC was 24 of 55 (43.6%) vs 34 of 58 (58.6%) (aOR, 0.54; 95% CI, 0.25-1.17). Conclusions and Relevance: In this randomized clinical trial, adding referral to MTM with TLC for participants who did not respond to early treatment did not improve smoking abstinence. Stepping down to Quarterly TLC among early treatment responders is not recommended. Integrating longitudinal tobacco cessation care with LCS is feasible and associated with clinically meaningful quit rates. Trial Registration: ClinicalTrials.gov Identifier: NCT02597491.

Latent constructs identified in older individuals who smoke cigarettes and are eligible for lung cancer screening: Factor analysis of baseline data from the PLUTO smoking cessation trial.

Introduction: Lung cancer screening (LCS) combined with smoking cessation intervention is currently recommended for older individuals with a history of heavy smoking. Tailoring tobacco treatment for this patient population of older, people who smoke (PWS) may improve cessation rates while efficiently using limited smoking cessation resources. Although some older people who smoke will need more intensive treatment to achieve sustained abstinence, others may be successful with less intensive treatment. A framework to identify them a priori would be helpful to distribute smoking cessation resources accordingly. Methods: Baseline demographic, smoking, and health data are reported from a randomized clinical trial of longitudinal smoking cessation interventions delivered in the setting of LCS. Candidate variables were factor analyzed to identify latent factors, or constructs, to identify subgroups of older participants among the heterogenous population of older people who smoke. Results: We identified three factor-derived constructs: self-reported health status, heaviness of smoking, and nicotine dependence. Nicotine dependence was moderately correlated with both of the other two factors. Conclusions: This factor analysis of baseline participant characteristics identified a set of latent constructs - based on a few practical clinical variables -- that can be used to classify the heterogenous population of older people who smoke to identify. We propose this framework to identify subgroups of people who smoke who might successfully quit with less intense treatment at the time of lung cancer screening.

Self-reported exercise capacity among current smokers eligible for lung cancer screening: Distribution and association with key comorbidities.

ONE CONCERN: as lung cancer screening (LCS) is implemented is that patients will be screened who are too ill to benefit. Poor exercise capacity (EC) predicts adverse outcomes following lung resection. OBJECTIVE: Describe the distribution of EC among smokers eligible for LCS and examine associations with comorbidities. METHODS: Cross-sectional analysis of baseline data from a randomized controlled trial of tobacco treatment in the context of LCS. Participants responded regarding limitations in moderate activities, ability to climb stairs, and frequency of dyspnea on a scale from never/almost never to all or most of the time. Responses were assigned a numeric score and summed to categorize exercise limitation. Associations between poor EC and key comorbidities were examined using adjusted logistic regression. RESULTS: 660 participants completed a survey with the following characteristics: 64.4% male, 89.5% white, mean age 64.5. Overall EC categories were: good 39.0%, intermediate 41.6%, and poor 19.4%.  Prevalence of poor EC was higher among patients with COPD (OR 4.62 95%CI 3.05-7.02), heart failure (OR 3.07 95%CI 1.62-5.82) and cardiovascular disease (OR 2.24, 95%CI 1.45-3.47), and was highest among patients with multimorbidity. Among patients with COPD and heart failure, 57% had poor and 0% had good EC. In adjusted logistic regression, only COPD and Charlson comorbidity index remained significantly associated with poor EC. CONCLUSIONS: Many patients eligible for LCS reported poor EC, with increased odds of poor EC among patients with comorbidities. More research is needed to determine how to best integrate EC and comorbidity into eligibility and shared decision-making conversations.

Impact of 2016 SCCT/STR guidelines for coronary artery calcium scoring of noncardiac chest CT scans on lung cancer screening CT reporting.

The 2016 SCCT/STR guideline for coronary artery calcification (CAC) scoring on non-cardiac chest CT (NCCT) scans explicitly calls for the reporting of CAC. Whether the publication of the 2016 SCCT/STR guideline has had any impact on CAC reporting in lung cancer screening (LCS) scans has not been investigated. Consecutive patients with a LCS scan were identified from the University of Minnesota LCS registry and evaluated for CAC reporting in 3 separate cohorts: 6 months before, 6 months after, and 1 year after the publication of the 2016 SCCT/STR guideline. Scans were evaluated for CAC and quantified using the Agatston method. CAC reporting, downstream testing and initiation of preventive therapy were assessed. Among 614 patients (50% male, mean age 64.1 ± 6.0 years), CAC was present in 460 (74.9%) with a median Agatston score of 62 (IQR 0, 230). Of these, 196 (31.9%) had a CAC score of 1-100, 125 (20.4%) had 101-300, and 118 (19.2%) had > 300. Overall, CAC was reported in 325 (70.7%) patients with CAC present. CAC reporting relative to publication of the 2016 SCCT/STR guideline was as follows: 6 months prior-74.1%, 6 months after-64.6%, and 1 year after-77.5%. In the 308 patients with a new diagnosis of sub-clinical CAD based on CAC presence, 6 (1.9%) patients were referred to cardiology, and 15 (4.9%) patients underwent testing for obstructive CAD. Only 6 (1.9%) and 9 (2.9%) patients were newly started on aspirin and statin respectively. CAC detected incidentally on lung cancer screening CT scans is prevalent, and rarely acted upon clinically. CAC reporting is fairly high, and publication of the 2016 SCCT/STR guideline for CAC scoring on NCCT scans did not have any significant impact on CAC reporting.

Comparison of Cancer Prevalence in Patients With Neurofibromatosis Type 1 at an Academic Cancer Center vs in the General Population From 1985 to 2020.

Importance: Neurofibromatosis type 1 (NF1) is a complex genetic disorder that is associated with not only neurofibromas, but also an increased susceptibility to other neoplasms. Objective: To evaluate the prevalence of neoplasia and outcomes among patients with NF1. Design, Setting, and Participants: This cohort study was conducted among patients with NF1 at a single academic cancer center from 1985 to 2020 with median (range) follow-up of 2.9 years (36 days to 30.5 years). Of 2427 patients evaluated for NF1, 1607 patients who met the National Institutes of Health consensus criteria for NF1 were included. This group was compared with estimates from Surveillance, Epidemiology, and End Results (SEER) Cancer Statistics Review 1975 to 2015 and SEER participants database unless otherwise specified. Data were analyzed from August 2018 to March 2020. Main Outcomes and Measures: Disease-specific survival (DSS) was measured from diagnosis date to date of neoplasm-specific death or censorship and calculated using the Kaplan-Meier method. Survival curves were compared using the log-rank test. Deaths from disease were considered a DSS end point; other deaths were considered censored observations. Secondary outcome measures were comparisons of (1) overall survival of patients with NF1 with neurofibroma neoplasms vs those without nonneurofibroma neoplasms, (2) neoplasm prevalence in the NF1 group vs general population estimates, and (3) age at diagnosis in the NF1 group vs general population estimates for the most common neoplasms in the NF1 group. Results: Among 1607 patients with NF1, the median (range) age at initial visit was 19 years (1 month to 83 years) and 840 (52.3%) were female patients. Among 666 patients who developed other neoplasms in addition to neurofibromas (41.4%), 295 patients (18.4%) developed glioma and 243 patients (15.1%) developed malignant peripheral nerve sheath tumor (MPNST), the most common neoplasms. Patients with NF1, compared with the general population, developed several neoplasms at a younger mean (SD) age (low-grade glioma: 12.98 [11.09] years vs 37.76 [24.53] years; P < .0001; high-grade glioma [HGG]: 27.31 [15.59] years vs 58.42 [19.09] years; P < .0001; MPNST: 33.88 [14.80] years vs 47.06 [20.76] years; P < .0001; breast cancer: 46.61 [9.94] years vs 61.71 [13.85] years; P < .0001). Patients with NF1 developed neoplasms more frequently compared with the general population (odds ratio, 9.5; 95% CI, 8.5-10.5; P < .0001). Among patients with NF1, significantly lower 5-year DSS rates were found among those with undifferentiated pleomorphic sarcoma (1 of 5 patients [20.0%]), HGG (8 of 34 patients [23.1%]), MPNST (72 of 228 patients [31.6%]), ovarian carcinoma (4 of 7 patients [57.1%]), and melanoma (8 of 12 patients [66.7%]) compared with those who had neoplasms classified as other (110 of 119 patients [92.4%]) (all P < .001) . Conclusions and Relevance: This cohort study found that among patients with NF1, those who developed undifferentiated pleomorphic sarcoma, HGG, MPNST, ovarian carcinoma, or melanoma had significantly lower DSS rates compared with those who developed other neoplasms. This study also found that patients with NF1 developed some neoplasms more frequently and at a younger age compared with individuals without NF1. HGGs and MPNST were noteworthy causes of death among patients NF1. This information may be useful for NF1 patient counseling and follow-up.