Lung Cancer Symptom Research Articles

An evaluation of a national mass media campaign to raise public awareness of possible lung cancer symptoms in England in 2016 and 2017

BackgroundA two-phase ‘respiratory symptoms’ mass media campaign was conducted in 2016 and 2017 in England raising awareness of cough and worsening shortness of breath as symptoms warranting a general practitioner (GP) visit.MethodA prospectively planned pre–post evaluation was done using routinely collected data on 15 metrics, including GP attendance, GP referral, emergency presentations, cancers diagnosed (five metrics), cancer stage, investigations (two metrics), outpatient attendances, inpatient admissions, major lung resections and 1-year survival. The primary analysis compared 2015 with 2017. Trends in metrics over the whole period were also considered. The effects of the campaign on awareness of lung cancer symptoms were evaluated using bespoke surveys.ResultsThere were small favourable statistically significant and clinically important changes over 2 years in 11 of the 15 metrics measured, including a 2.11% (95% confidence interval 1.02–3.20, p < 0.001) improvement in the percentage of lung cancers diagnosed at an early stage. However, these changes were not accompanied by increases in GP attendances. Furthermore, the time trends showed a gradual change in the metrics rather than steep changes occurring during or after the campaigns.ConclusionThere were small positive changes in most metrics relating to lung cancer diagnosis after this campaign. However, the pattern over time challenges whether the improvements are wholly attributable to the campaign. Given the importance of education on cancer in its own right, raising awareness of symptoms should remain important. However further research is needed to maximise the effect on health outcomes.

Economic costs of cigarette smoking among adolescents in Nigeria

BackgroundCigarette smoking is an established cause of preventable death and often initiated during adolescence. We estimated the short- and long-term costs of cigarette smoking among currently smoking adolescents in Nigeria.MethodsA cross-sectional survey among adolescents in Oyo state, Nigeria and a review of mortality records of patients managed for lung cancer in a tertiary facility in Ibadan, Nigeria were conducted. Short-term costs estimated were: (a) average weekly costs of purchasing cigarettes by currently smoking adolescents, and (b) costs of managing at least an episode of chronic cough occurring within 12 months of the survey. Long-term costs were limited to: (a) life-time expenditure on purchasing cigarettes, and (b) direct medical and non-medical (transportation) costs of managing lung cancer. Long-term costs were first projected to the approximate year when the adolescents (mean age:16.0 ± 1.8 years) might be diagnosed with lung cancer based on the average age at presentation with symptoms of lung cancer obtained from the records (59.8 years), and then discounted to 2020 prices. This was estimated as 44 years from the base year (2020). Costs were reported in 2020 prices in Nigerian Naira (NGN) and US dollar (USD) equivalent using the Central Bank of Nigeria, June 2020 exchange rate of USD 1: NGN 360.50.ResultsApproximately 3.8% of the adolescents were current cigarette smokers. Average weekly expenditure on cigarettes was NGN 306.82 ± 5.74 (USD 0.85 ± 0.02). About 26% had experienced at least an episode of chronic cough which cost them an average of NGN 1226.81 ± 6.18 (USD 3.40 ± 0.02) to manage. Total future costs of cigarette smoking in 2020 prices for the 43 adolescents who were current smokers in the event that they develop lung cancer were approximately NGN 175.7 million (USD 487.3 thousand), NGN 871.8 million (USD 2.4 million) and NGN 4.6 trillion (USD 12.7 million) at assumed annual inflation rates of 10%, 15%, and 20% respectively and discount rate of 4.25%.ConclusionThe estimated economic costs of smoking were very high. Efforts to prevent smoking initiation among adolescents in our study area should be intensified. Interventions to subsidize the medical cost of health-related consequences of cigarette smoking are also required, especially as treatment costs are currently largely borne out-of-pocket.

P62.01 PREVALUNG: Evaluation of Lung Cancer Prevalence in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases

Lung cancer is the leading cause of cancer related death in France and Worldwide. Lung cancer screening based on low dose thoracic computed tomography (low dose CT) in patients selected on age and lifelong tobacco consumption has proven to improve lung cancer related mortality. However, the definition and identification of patients eligible for lung cancer screening is a challenge that may limit lung cancer screening program implementation. Epidemiological data shows that 30 to 40% of patients with lung cancer present a history of cardiovascular disease, mainly atheromatous diseases such as peripheral arterial diseases and coronary artery stenoses. We hypothesized that patients with history of smoking who developed atheromatous disease could represent a population at high risk to develop lung cancer. Our main objective was to evaluate the prevalence of lung cancer among patients with atherosclerotic disease and history of tobacco consumption. Our second objective was to evaluate the lung cancer screening program implemented to measure the prevalence. We implemented a monocentric prospective epidemiological study to evaluate the prevalence of lung cancer among 500 patients with inclusion criteria i.e age 45-75 years old, history of at least 10 years of daily tobacco consumption preceding the onset of an atherosclerotic disease. Principal exclusion criteria were history of active carcinoma < 5 years, symptoms of lung cancer, follow-up for lung nodules and grade IV dyspnea. Patients with inclusion criteria are referred for an inclusion visit (V0) with a thoracic surgeon by adult cardiologists, vascular surgeons and adult cardiac surgeons in charge of the patient. After information and inclusion, a low dose CT scan is scheduled within 7 months and a smoking cessation visit is proposed in case of active smoking. Blood and gut microbiota samples are harvested the day of the low dose CT. Positive low-dose CT are discussed weekly at the multidisciplinary thoracic oncologic staff meeting and managed accordingly to the current European and national recommendations. A clinical follow-up is scheduled by phone at 3, 6 and 12 months after the low-dose CT to evaluate oncologic and cardiovascular events. Between November 2019 and April 2021 we included 487 of the 500 patients scheduled, 330 low dose CT were completed, 7 localized primary lung cancer were resected by minimally invasive lobectomy, 1 patient was treated by radiation alone without pathological proof for a lung nodule, 1 patient was related with systemic therapy for a stage IV primary lung cancer and 2 patients are waiting for surgical resection for clinically localized lung cancers. The implementation of a lung cancer screening program dedicated to patients followed-up for tobacco related atherosclerotic diseases is feasible and will allow to evaluate both lung cancer prevalence and short-term benefits of lung cancer screening in this population.

Effect of Self-Care Guidelines on Symptoms Burden for Patients with Lung Cancer Undergoing Chemotherapy

Context: Lung cancer is common cancer worldwide. Because of the high-symptoms burden and severe morbidity, effective symptoms management requires comprehensive self-care strategies.&#x0D; Aim: This study was aimed to assess the effect of self-care guidelines on symptoms burden for patients with lung cancer undergoing chemotherapy.&#x0D; Methods: This study was conducted at the outpatient clinics in Radiation Oncology and Nuclear Medicine Center, affiliated to Ain Shams University. A quasi-experimental (pre/posttest) design was employed on a purposive sample of 50 adult patients were recruited for this study. The data were collected through a structured interview questionnaire to assess the patients’ socio-demographic characteristics, medical health profile, and knowledge about lung cancer. Lung Cancer and Chemotherapy Associated Symptoms Self-care Practices’ Assessment Questionnaire and M. D. Anderson Symptom Inventory-Lung Cancer (MDASI-LC) were also used.&#x0D; Results: The present study revealed that 36% of the patients had a satisfactory level of knowledge pre-implementation of self-care guidelines, which improved significantly for 48% of the patients post-implementation at p 0.007. 26.3% of them exhibit a satisfactory level of self-care practice pre-implementation of self-care guidelines that improved significantly (57.9%) post-implementation at p 0.001. Also, lung cancer symptom burdens and symptoms' influence on patients' lives were significantly improved after the implementation compared with preintervention level at p 0.001. A non-significant difference between pre and post-implementation of self-care guidelines regarding symptoms interference with patients' life was revealed at p 0.801. There were statistically negative correlations between patients' total symptom severity and self-care practice pre- and post-self-care guidelines implementation. &#x0D; Conclusion: self-care guidelines have a statistically significant positive effect on decreasing the severity of lung cancer symptoms. While chemotherapy-associated symptoms were slightly improved, there were no significant differences between pre and post-self-care guidelines implementation regarding symptoms interference with patients’ life. Health education programs about the disease and its management should be provided for lung cancer patients.

Feasibility and acceptability of a community pharmacy referral service for suspected lung cancer symptoms

BackgroundLung cancer survival rates in the UK are among the lowest in Europe, principally due to late-stage diagnosis. Alternative routes to earlier diagnosis of lung cancer are needed in socioeconomically...

Sleep and quality of life in lung cancer patients and survivors.

Lung cancer patients and survivors are vulnerable to disturbed sleep and impaired quality of life (QOL) across the continuum of illness. Few studies have sought to identify predictors of QOL using well-validated measures of both sleep quality and QOL in this population. The purpose of this study was to examine factors associated with lung cancer that are predictive of QOL in adult lung cancer patients and survivors in the outpatient setting. Cross-sectional data collected exclusively in the outpatient setting from three lung cancer clinics in the Northeastern United States were pooled and analyzed. The pooled sample (N = 103) data included cancer type and stage, body mass index, Pittsburgh Sleep Quality Index, and Functional Assessment of Cancer Treatment-Lung information. Significant correlations between sleep quality, lung cancer symptom severity, and QOL were observed. Sleep quality and lung cancer symptoms were found to be statistically significant predictors of QOL. No significant differences in QOL were found based on cancer type or recruitment source. Demographic factors and cancer stage were also not predictive of overall QOL. Lung cancer symptoms and sleep quality were important determinants of QOL in this pooled sample of lung cancer patients and survivors. Patients and survivors of lung cancer require routine screening for sleep disturbance, lung cancer symptoms, and QOL needs. Nurse practitioners can help improve QOL in this population by screening for and treating sleep disturbance and lung cancer symptoms.

P2X Receptors: Potential Therapeutic Targets for Symptoms Associated With Lung Cancer - A Mini Review.

Symptoms associated with lung cancer mainly consist of cancer-associated pain, cough, fatigue, and dyspnea. However, underlying mechanisms of lung cancer symptom clusters remain unclear. There remains a paucity of effective treatment to ameliorate debilitating symptoms and improve the quality of life of lung cancer survivors. Recently, extracellular ATP and its receptors have attracted increasing attention among researchers in the field of oncology. Extracellular ATP in the tumor microenvironment is associated with tumor cell metabolism, proliferation, and metastasis by driving inflammation and neurotransmission via P2 purinergic signaling. Accordingly, ATP gated P2X receptors expressed on tumor cells, immune cells, and neurons play a vital role in modulating tumor development, invasion, progression, and related symptoms. P2 purinergic signaling is involved in the development of different lung cancer-related symptoms. In this review, we summarize recent findings to illustrate the role of P2X receptors in tumor proliferation, progression, metastasis, and lung cancer- related symptoms, providing an outline of potential anti-neoplastic activity of P2X receptor antagonists. Furthermore, compared with opioids, P2X receptor antagonists appear to be innovative therapeutic interventions for managing cancer symptom clusters with fewer side effects.

Segmentation and classification of ground glass nodule on CT images

AbstractThe symptoms of lung cancer mainly manifest as lung nodules. The recognition and diagnosis of a ground glass nodule (GGN) are relatively difficult, and its image features are not easy to extract. To improve the accuracy of segmentation and invasive classification of GGN, a region adaptive Markov random field (MRF) model and a two‐channel integrated network based on densely connected convolutional neural networks (DenseNet) are developed in this paper. First, the lung parenchyma is segmented coarsely, and the corresponding contour is repaired. Afterwards, the fuzzy C‐means (FCM) clustering algorithm and a simple MRF model for the coarse segmentation of GGN are applied. Then, the region adaptive MRF model for the fine segmentation of GGN is used. Moreover, the two‐channel integrated network based on DenseNet is used for GGN invasive classification. Results show that the average value of the overlapping area ratio of the segmentation result to that obtained by one physician was 0.9144, and the accuracy of the proposed GGN invasive classification model, the specificity, sensitivity, and the area under curve were 92.553%, 87.500%, 97.826%, and 0.9715, respectively. The proposed segmentation method can segment GGN more accurately, and the corresponding GGN invasive classification model achieved satisfying classification performance.

Automatic detect lung node with deep learning in segmentation and imbalance data labeling

In this study, a novel method with the U-Net-based network architecture, 2D U-Net, is employed to segment the position of lung nodules, which are an early symptom of lung cancer and have a high probability of becoming a carcinoma, especially when a lung nodule is bigger than 15 mathrm{mm}^2. A serious problem of considering deep learning for all medical images is imbalanced labeling between foreground and background. The lung nodule is the foreground which accounts for a lower percentage in a whole image. The evaluation function adopted in this study is dice coefficient loss, which is usually used in image segmentation tasks. The proposed pre-processing method in this study is to use complementary labeling as the input in U-Net. With this method, the labeling is swapped. The no-nodule position is labeled. And the position of the nodule becomes non-labeled. The result shows that the proposal in this study is efficient in a small quantity of data. This method, complementary labeling could be used in a small data quantity scenario. With the use of ROI segmentation model in the data pre-processing, the results of lung nodule detection can be improved a lot as shown in the experiments.

The association between the coronavirus disease 2019 (COVID-19) pandemic and quality of life and depression symptoms in patients with advanced lung cancer.

12122 Background: It is unclear whether patients with cancer experience greater distress as a result of the COVID-19 pandemic. Thus, we assessed the relationship of the COVID-19 pandemic with quality of life (QOL) and depression symptoms in patients newly diagnosed with advanced lung cancer. Methods: We conducted a cross-sectional study of patients with advanced lung cancer enrolled in two multisite randomized supportive care trials. We enrolled adult patients within 12 weeks of diagnosis of advanced lung cancer and an Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 to 3 across 23 institutions in the United States. At the time of enrollment, participants completed the Functional Assessment of Cancer Therapy-Lung (FACT-L), which includes four wellbeing subscales (i.e., physical, social, emotional, and functional) as well as lung cancer symptoms, and the Patient Health Questionnaire-9 (PHQ-9) to assess their QOL and depression symptoms, respectively. We compared QOL and depression symptoms between participants enrolled prior to COVID-19 (i.e., those enrolled in the following time periods: March 2018 to January 2019 and March 2019 to January 2020) and during the COVID-19 pandemic (March 2020 to January 2021). We used linear regression models adjusting for age, race, gender, and time since diagnosis of advanced cancer to examine the relationship between the period of enrollment and patients’ QOL and depression symptoms. Results: A total of 860 patients were included in this analysis (665 participants enrolled prior to COVID-19 and 195 participants during COVID-19). The two cohorts did not differ significantly with respect to baseline demographic factors [Mean age 65.4 (SD = 11.4), 51.9% female]. In multivariate regression models, enrollment during COVID-19 was not associated with physical (B = -0.16, SE = 0.52, P = 0.763), social (B = -0.48, SE = 0.39, P = 0.217), emotional (B = -0.16, SE = 0.41, P = 0.693), functional (B = -0.83, SE = 0.55, P = 0.128) wellbeing, or lung cancer symptoms (B = -0.11, SE = 0.44, P = 0.806). Enrollment during COVID-19 was not associated with overall QOL (FACT-L: B = -1.32, SE = 1.69, P = 0.436) or depression symptoms (PHQ-9: B = -0.02, SE = 0.45, P = 0.973). Conclusions: Despite the prevailing belief that COVID-19 has negatively impacted QOL and distress in patients with cancer, we found no differences in QOL or depression symptoms in patients newly diagnosed with advanced lung cancer during the COVID-19 pandemic compared to those diagnosed prior to the pandemic. These findings suggest that factors other than the COVID-19 pandemic, such as patients’ experience with their cancer, contribute to their QOL and depression symptoms.

Health-related quality of life for pembrolizumab (pembro) plus ipilimumab (ipi) versus pembro plus placebo in patients with metastatic NSCLC with PD-L1 tumor proportion score ≥ 50%: KEYNOTE-598.

9038 Background: In the phase 3 KEYNOTE-598 study (NCT03302234), OS (HR, 1.08; 95% CI, 0.85–1.37; P = 0.74) and PFS (1.06; 95% CI, 0.86–1.30; P = 0.72) were not improved for pembro + ipi vs pembro + placebo in patients (pts) with previously untreated metastatic NSCLC with PD-L1 tumor proportion score (TPS) ≥50% and without EGFR/ALK genomic alterations. Incidence of treatment-related grade 3–5 AEs, fatal AEs, and AEs leading to discontinuation was higher with pembro + ipi vs pembro + placebo. We present prespecified patient-reported outcome (PRO) analyses from KEYNOTE-598. Methods: Pts (n = 568) with previously untreated stage IV NSCLC with PD-L1 TPS ≥50% were randomized 1:1 to pembro 200 mg Q3W for up to 35 cycles + ipi 1 mg/kg or placebo Q6W for up to 18 cycles. The EORTC QLQ-C30, QLQ-LC13, EQ-5D-5L, and NSCLC-SAQ were administered at cycles 1‒7, then every 3 cycles through cycle 19, and every 4 cycles until PD or a maximum of 35 cycles. Change from baseline in global health status (GHS)/quality of life (QoL) score from the QLQ-C30 and the time to true deterioration (TTD) in the composite endpoint of cough (LC13), chest pain (LC13), or dyspnea (C30) were secondary objectives in KEYNOTE-598. Change from baseline in GHS/QoL was analyzed using a constrained longitudinal data analysis model with missing at random assumption. Difference in TTD was evaluated using a Cox proportional hazards model and stratified log-rank test. PROs were analyzed in all pts who completed ≥1 PRO assessment and received ≥1 dose of study treatment. P values are two-sided and nominal. Results: As of data cutoff (Sept 1, 2020), PRO analyses included 280 pts in the pembro + ipi group and 280 pts in the pembro + placebo group. QLQ-C30 completion rates were 95.7% in the pembro + ipi group vs 96.1% in the pembro + placebo group at baseline and 63.6% vs 70.0% at week 18. QLQ-LC13 completion rates were 95.4% vs 96.4% at baseline and 63.6% vs 69.6% at week 18. Mean QLQ-C30 GHS/QoL scores at baseline were 62.8 in the pembro + ipi group and 64.2 in the pembro + placebo group and were similar between the groups across the follow-up period. Least squares (LS) mean (95% CI) change from baseline to week 18 in GHS/QoL scores was improved in both groups (pembro + ipi: 3.7 [0.9‒6.5]; pembro + placebo: 4.1 [1.4‒6.9]), with no significant difference between groups (LS mean difference −0.4 [−4.0 to 3.1], P = 0.82). Median TTD in composite of cough, chest pain, or dyspnea was not reached (NR; 95% CI, 13.0 mo–NR) in the pembro + ipi group vs 20.0 (95% CI, 12.7–NR) mo in the pembro + placebo group (hazard ratio, 0.98 [95% CI, 0.74‒1.30]; P = 0.91). Conclusions: There was no difference in health-related QoL or TTD in lung cancer symptoms between pembro + ipi and pembro + placebo in pts with previously untreated metastatic NSCLC with PD-L1 TPS ≥50%. Clinical trial information: NCT03302234.

Patient-reported outcomes (PRO) from the phase 2 CodeBreaK 100 trial evaluating sotorasib in KRAS p.G12C mutated non-small cell lung cancer (NSCLC).

9057 Background: In the registrational phase 2 CodeBreaK 100 trial, sotorasib demonstrated a response rate of 37.1% with median duration of 10.0 months, a median progression-free survival of 6.8 months, and a tolerable safety profile in patients with pretreated KRAS p.G12C mutated NSCLC. Patients received a median of 2 prior lines of therapy. Here, we report PRO measures of health-related quality of life (QoL), physical functioning, and key lung cancer symptoms from this trial. Methods: Eligible patients had KRAS p.G12C mutated advanced NSCLC and received prior standard therapies. Sotorasib was given at an oral daily dose of 960 mg with 21-day treatment cycles until disease progression. Disease-related symptoms and health-related QoL were evaluated as exploratory endpoints on day 1 of each cycle from baseline to discontinuation, using the European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and its lung cancer module, EORTC QLQ-LC13. The single item, 5-point scale GP5, of the Functional Assessment of Cancer Therapy-General version was used to evaluate the impact of side effects. Predefined analyses included change from baseline using descriptive statistics and mixed model for repeated measures for global health status/QoL, physical functioning, and key lung cancer symptoms of cough, dyspnea and chest pain. Results: Of 126 patients enrolled, compliance rates for each of the questionnaires were high throughout the study ( &gt; 70%). Data up to cycle 11 (where n &gt; 20) are presented. EORTC QLQ-C30 global health status/QoL and physical functioning were maintained over time (least-square mean changes ranged from -3.5 to 0.2 and 0.1 to 3.9, respectively). EORTC QLQ-C30 symptoms of fatigue, nausea/vomiting, pain, dyspnea, insomnia, appetite loss, and constipation were stable or improved. Similarly, key lung cancer-related symptoms, as measured by EORTC QLQ-LC13, remained stable or improved from baseline, with the greatest least-square mean change of -11.2 (95% Cl: -16.2, -6.1) for cough, -4.9 (95% Cl: -10.3, 0.4) for chest pain, and -3.4 (95% Cl: -7.8, 1.0) for dyspnea. Most patients reported on the GP5 that they were “not at all” (54.2%-79.2%) or “a little bit” (8.3%-33.3%) bothered by side effects from sotorasib, with 0%-7.4% reporting being bothered as “quite a bit” and 0% as “very much”. Conclusions: In patients from the single-arm phase 2 trial of sotorasib, PRO measures suggested maintenance or improvement of global health status/QoL, physical functioning, and the severity of key lung cancer-related symptoms, including cough, dyspnea, and chest pain. Self-reported side effect bother was minimal. These data, together with the encouraging efficacy and safety profiles, strongly support the use of sotorasib in this population. Clinical trial information: NCT03600883.

Predictors of early hospice or death in patients with inoperable lung cancer treated with curative intent.

e20525 Background: Treatment for inoperable stage II-III non-small cell lung cancer (NSCLC) involves aggressive chemo-radiotherapy (CRT). While outcomes have improved with immunotherapy, some patients transition to hospice or die early in their treatment course. To help identify these patients, we developed a predictive model for early poor outcomes in NSCLC patients treated with curative intent. Methods: In a statewide consortium involving 27 sites, information was collected prospectively on stage II-III NSCLC patients who received curative CRT from April 2012 to November 2019. We defined an early poor outcome as termination of treatment due to hospice enrollment or death within 5 months of initiating radiation therapy. Potential predictors included clinical characteristics and patient reported outcomes (PROs) from validated questionnaires. Logistic regression models were used to assess potential predictors and build predictive models. Multiple imputation was used to handle missing data. We used Lasso regularized logistic regression to build a predictive model with multiple predictor variables. Results: Of the total of 2267 included patients, 128 patients discontinued treatment early due to hospice enrollment or death. The mean age of the 128 patients was 71 years old (range 48-91) and 59% received concurrent chemotherapy. Significant uni-variable predictors of early hospice or death were advanced age, worse ECOG performance status, high PTV volume, short distance to normal tissue critical structures, high mean heart dose, uninsured status, lower scores on the Functional and Physical Well-Being scale and the Lung Cancer Symptoms sub-scale of the FACT-L quality of life instrument, as well as higher levels of patient-reported lack of energy, cough, and shortness of breath. The best predictive model included age, ECOG performance status, PTV volume, mean heart dose, patient insurance status, and patient-reported lack of energy and cough. The pooled estimate of area under the curve (AUC) for this multivariable model was 0.71, with a negative predictive value of 95%, specificity of 97%, positive predictive value of 23%, and sensitivity of 16% at a predicted risk threshold of 20%. Conclusions: Our models identified a combination of clinical variables and PROs that may help identify individuals with inoperable NSCLC undergoing curative intent chemo-radiotherapy who are at a high risk of early hospice enrollment or death. These preliminary results are encouraging and warrant further evaluation in a larger cohort of patients.

High intensity interval training safety and efficacy in patients with advanced NSCLC receiving systemic treatment: Results of a prospective trial.

12054 Background: Patients with advanced NSCLC experience fatigue and physical deconditioning altering their quality of life. Safety and feasibility of high intensity exercise in advanced NSCLC has not been explored yet. Methods: We report the results of a single-center, prospective two-arm study. Patients with advanced NSCLC actively receiving systemic therapy or having completed treatment less than 2 months prior to enrollment were included. Patients were allocated to either an intervention arm consisting of kinesiologist supervised high intensity interval training (HIIT) at 2 sessions per week for a total of 12 weeks; or a control arm of home exercise guided by an informative pamphlet. All patients were evaluated at baseline, 6 and 12 weeks by a kinesiologist. Quality of life (QoL) exercise surveys and measurement of strength were measured. Results: Sixty patients were enrolled between January 2018 and March 2020. The study was interrupted due to COVID-19. Thirty-two patients were included in the exercise program and 28 patients in the control group. Both groups were balanced in respect to baseline characteristics. A total of 32 (53%) patients went off protocol, 13 (18%) patients stopped due to symptomatic disease progression which included 2 (3%) deaths, 2 (3%) stopped due to COVID-19 preoccupations and the remaining patients withdrew for other reasons. 42 (70%) patients were evaluated at 6-weeks and 28 (47%) completed the 12-week follow-up, with equal distribution in each group. There were no significant difference at 12 weeks in the physical assessment nor the overall QoL scores between both groups: FACT-L on 135 points (+4.1 vs +1.7, p = 0.342) and FACIT on 52 points (+3 vs -0.2, p = 0.832). Patients in the exercise group demonstrated a significant improvement at 12 weeks in the Lung Cancer Symptoms domain on 28 points (22.3 vs 19.8, p = 0.015) as well as the Physical Wellbeing domain on 28 points (23.6 vs 20.6, p = 0.056) compared to the control group, respectively. No significant exercise related complications were reported. After the study, 9 of the 14 patients (64%) who completed the HIIT program continued to exercise virtually with a kinesiologist in contrast to none in the control group. Conclusions: This study demonstrated the safety and potential benefit of a HIIT program on lung-specific and physical wellbeing in patients with advanced NSCLC on active treatment. This study provides further support on the role of supervised physical exercise in patients living with cancer. Clinical trial information: 16.229.

Patient-reported symptoms, functioning, and quality of life (QoL) in patients treated with cemiplimab monotherapy for first-line treatment of advanced NSCLC with PD-L1 ≥ 50%: Results from EMPOWER-Lung 1 study.

9078 Background: Cemiplimab, a PD-1 inhibitor, improved survival and progression-free survival vs platinum doublet chemotherapy (chemo) in patients (pts) with advanced NSCLC and PD-ligand(L)1 expression ≥50% in the EMPOWER-Lung 1 Phase 3 study (NCT03088540). Since pts with advanced NSCLC have a high symptom burden that adversely impacts QoL and functioning, these outcomes were evaluated as secondary endpoints in the clinical trial. Methods: Pts with advanced NSCLC with PD-L1 expression ≥50% and ECOG performance status ≤1 were randomized to IV cemiplimab 350 mg Q3W (n=356) or platinum doublet chemo (n=354). At baseline (BL) and day 1 of each treatment cycle (C) to C15, pts were administered the EORTC core questionnaire (QLQ-C30) and its lung cancer specific module (QLQ-LC13) to assess symptoms, functioning, and Global Health Status (GHS)/QoL. In the intent-to-treat population, mixed-effects repeated measures models were used to estimate least squares (LS) mean change from BL on all scales. Kaplan–Meier analysis estimated time to definitive deterioration, defined as worsening ≥10 points from BL observed at all subsequent time points or patient withdrawal after worsening; hazard ratios (HR) with 95% CIs estimated the likelihood of definitive deterioration. Results: BL scores showed moderate to high levels of functioning and low symptom burden. Cemiplimab-treated pts had lower likelihood of definitive deterioration vs chemo on key symptoms of dyspnea, cough, pain in chest, pain in other body parts, fatigue, nausea/vomiting, appetite loss, constipation, and diarrhea vs chemo (all P&lt;.05). Treatment-related symptoms of peripheral neuropathy and alopecia had a lower likelihood of definitive deterioration with cemiplimab vs chemo (both P&lt;.05). Cemiplimab resulted in significantly greater improvements vs chemo on all functioning scales and reduced the likelihood of definitive deterioration as indicated by HR &lt;1 (Table). GHS/QoL improvements with cemiplimab at C2 were maintained to C15; LS mean change (SE) from BL across all timepoints was 7.1 (1.0) for cemiplimab vs 1.7 (1.2) for chemo ( P&lt;.0001). Conclusions: In pts with advanced NSCLC and PD-L1 expression ≥50%, cemiplimab significantly improved GHS/QoL, functioning, and most symptoms vs chemo. Over 1 year of treatment, cemiplimab delayed worsening of key lung cancer symptoms and functioning. Clinical trial information: NCT03088540. [Table: see text]

Validation of the Japanese version of the Manchester Cough in Lung Cancer Scale.

Cough is one of the most common distressing symptoms of lung cancer. However, there is no specific measure of cough in lung cancer in Japanese. The present study aimed to determine the validity of the Japanese version of the Manchester Cough in Lung Cancer Scale (MCLCS). The MCLCS is a cough-specific quality of life (QOL) questionnaire for lung cancer that consists of 10 items on cough frequency, distress, impact, and severity. Items are evaluated on a scale of 1-5 (1: never, 2: some of the time, 3: often, 4: most of the time, and 5: all of the time). Total scores can range from 1 to 50, with higher scores indicating worse cough-related QOL. The Japanese version of the MCLCS was created through forward and backward translation. Patients completed the Japanese version of the MCLCS, the Leicester Cough Questionnaire (LCQ), and the cough visual analog scale (VAS). To confirm the reliability of the MCLCS, Cronbach's α coefficient was calculated, and for validity, the Spearman's rank correlation coefficient was used to assess the correlations between MCLCS and LCQ or cough VAS. Of the total 192 lung cancer patients enrolled in this study, 73 had a cough in the preceding week. The median MCLCS score was 28, demonstrating an excellent internal consistency (Cronbach's α coefficient=0.83). MCLCS was strongly and significantly correlated with LCQ and cough VAS. The Japanese version of MCLCS is a valid tool for assessing cough in lung cancer patients.

Comprehensive TCM treatments combined with chemotherapy for advanced non-small cell lung cancer: A randomized, controlled trial.

Objective:We conducted this study to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in advanced non-small cell lung cancer (NSCLC) patients who underwent chemotherapy.Design:This was a prospective, open-label, randomized controlled trial. NSCLC patients at stage IIIA, IIIB, or IV were randomly assigned to either TCM plus chemotherapy or chemotherapy alone. The comprehensive TCM treatment consisted of Kang Ai injection, herbal decoction, and Zhenqifuzheng capsules. The primary endpoint was quality of life (QOL) measured by the Functional Assessment of Cancer Therapy-Lung version 4.0. The secondary endpoints were chemotherapy completion rate, tumor response, and adverse events. All assessments were done at baseline, the third week, and the sixth week.Results:Thirty-nine participants were randomly assigned to the treatment group and 36 to the control group. The QOL scores were significantly improved in the treatment group compared with those of the control group in social well-being (cycle 1, P = .048; cycle 2, P = .015), emotional well-being (cycle 1, P = .047; cycle 2, P = 4.29E-05), and functional well-being (cycle 1, P = .030; cycle 2, P = .003), while the QOL scores in the above 3 domains declined in the control group (P < .05). Both groups had a decline in the physical well-being score (cycle 1, P = .042; cycle 2, P = .017) and lung cancer symptom score (cycle 1, P = .001; cycle 2, P = .001) after 2 courses of intervention. The deterioration in physical well-being and lung cancer symptoms was noticeably smaller in the treatment group (P < .05). There were significant differences between the 2 groups in social well-being, emotional well-being, functional well-being, lung cancer symptom domain, and the total score (P < .05). Patients in the treatment group had a significantly lower incidence of platelet reduction than the control group (P = .028) after 2 cycles of treatment. No significant difference in nonhematological adverse events (AEs) was observed.Conclusion:This study illustrated that comprehensive TCM treatment could promote the QOL of NSCLC patients, alleviate symptoms, and reduce the AEs caused by chemotherapy, verifying the synergistic and attenuating effects of TCM in NSCLC patients undergoing chemotherapy.Trial registration:Chinese Clinical Trial Registry (www.chictr.org.cn): ChiCTR-TRC-13003637

A nomogram to predict the overall survival of patients with symptomatic extensive-stage small cell lung cancer treated with thoracic radiotherapy.

BackgroundSmall cell lung cancer (SCLC) makes up 13% of lung malignancies. Only one-third of SCLC patients received their diagnosis at the limited stage. Treatment for symptomatic extensive-stage (ES) SCLC with persistent intrathoracic disease is still controversial. The present research aimed to analyze the impact of palliative thoracic radiotherapy (TRT) as a treatment for this patient group and build a prognostic nomogram.MethodsIn this retrospective, multi-center study, we analyzed 120 patients with ES-SCLC and a World Health Organization performance status of 1–2 who were diagnosed between March 2014 and September 2019. A nomogram was formulated to predict the patients’ 1- and 2-year overall survival (OS).ResultsThe study cohort had a median age of 62 years, and males accounted for 85% of enrollees. A significant extension was observed in the median OS in the TRT group compared to the no TRT group (P<0.001). When the patients were stratified by TRT dose, no significant differences in OS were noted (P=0.530). However, higher levels of inflammatory markers prior to TRT were associated with a shorter OS (neutrophil-to-lymphocyte ratio, P=0.002; platelet/lymphocyte ratio, P=0.023). The nomogram’s Harrell’s concordance (C)-statistic reached 0.70, and the calibration curve analysis revealed goodness of fit.ConclusionsThe neutrophil-to-lymphocyte ratio is an independent factor predicting survival in ES-SCLC patients treated with palliative TRT. Our nomogram, which incorporates immunological markers, has higher accuracy than existing models for the prediction of individuals’ chances of survival, and it could be a significant tool for clinicians in the development of tailored therapeutic strategies.

A Prospective Pilot Study of Lung Cancer Screening in Patients at High Risk for Lung Cancer Who do not Meet Current Screening Guidelines

Abstract Purpose: To describe the results of a lung cancer screening (LCS) study of high-risk individuals ineligible for screening by Medicare (CMS) guidelines and prospectively selected by 6-year risk score. Methods: Study inclusion criteria included individuals 40–82 years old, with a 6-yr risk score of ≥1.5% for &amp;lt;77 years or age or &amp;gt;4% for 78–82 years of age, calculated by the PLCOm2012 model, no symptoms of lung cancer, and willingness to sign a consent form. Enrollment was offered to eligible individuals referred for screening through the University of Colorado Hospital LCS program that did not meet CMS screening guidelines (55–77 years old, ≥30 pack year smoking history, current smoker or quit within the past 15 years). Enrolled participants completed a shared design making visit with a LCS clinic provider, underwent a LDCT read in Lung-RADs (LR) by thoracic radiologists, and received follow-up and additional referrals, if indicated, from the LCS clinic. Individuals could undergo up to 3 LDCTs as part of the study. Results: The study completed 66 LDCTs on 48 participants. Screened individuals were 52% male, 85% white, 52% former smokers, had a mean baseline age of 69(±9) years, and a mean 6-year risk score of 5.6%(±5.9%). LR results of the index LDCTs included 46% LRs 1, 44% LRs 2, 4% LRs 3, and 6% LRs 4. 35% of screened participants had a significant incidental finding; 59% were coronary calcifications. Reasons screened individuals were ineligible by CMS guidelines included: 12% &amp;lt;55 years, 21% &amp;gt;77 years, 27% &amp;lt;30 pack year smoking history, and 40% quit smoking &amp;gt;15 years prior. The study diagnosed two lung cancers, a stage 1A adenocarcinoma diagnosed in 74 yr old white female with a 3.3% 6-yr risk score and a carcinoid diagnosed in a 77 yr old white male with a risk score of 7.5%. Both individuals had quit smoking &amp;gt;15 years prior. Conclusions: Early stage lung cancers can be detected in asymptomatic individuals who are prospectively selected by risk calculators and fall outside current CMS guidelines. However, the two cancers were diagnosed in people that would not qualify for the proposed expanded US Preventive Service Task Force guidelines, lowering eligibility to 50 years of age and tobacco exposure to 20 pack years.

Public & private accounts of help-seeking: The implications of research methods on the presentation of narratives

ABSTRACT For people with symptoms that could indicate cancer, prompt presentation to a health care practitioner facilitates early diagnosis, improves survival, and is encouraged by public health agencies and cancer charities. Nevertheless, time to presentation from symptom onset (the patient interval) is known to vary widely. We report findings from a mixed-methods study examining help-seeking among people with symptoms of lung or colorectal cancer. Patients referred for urgent investigation were invited to complete a questionnaire about their symptoms and help-seeking experiences; 26 of these participants then took part in a semi-structured interview. Discrepant accounts of help-seeking were reported through the different research methods, with longer ‘patient intervals’ reported in interviews. We use the concept of ‘public and private accounts’ to reflect upon why socially conforming accounts of early presentation were presented in the questionnaires, whilst accounts of longer ‘patient intervals’ tended to be presented within an interview encounter.