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IntroductionTo better understand the impact of stereotactic body radiotherapy (SBRT) and its treatment-related toxicity on early-stage non-small cell lung cancer (ES-NSCLC) patients, we conducted the Lung PLUS study in a real-world setting.MethodsThis is a monocentric prospective longitudinal study up to 12 months post-treatment, evaluating clinician- and patient-reported toxicity (resp. CTCAE and PRO-CTCAE), health-related quality of life (HRQoL) (EORTC QLQ-C30 and LC-13), activities of daily living (HAQ-DI) and functional exercise capacity (6 Minute Walking Test (6MWT)). A mixed model approach was applied to analyze the data.ResultsAt baseline, clinicians and patients (n=51) reported mostly fatigue (63% vs 79%), cough (49% vs 75%) and dyspnea (65% vs 73%) of any grade. Dyspnea (p=.041) increased over time. Meaningful clinical improvements were particularly seen in pain, fatigue, and cough. Clinician reported clinically meaningful improvements and deteriorations over time in fatigue, cough, and dyspnea. Almost at every timepoint, more people reported deterioration to the clinician than improvement in aforementioned toxicities. Overall HRQoL (p=.014), physical (p=.011) and emotional (p

Population-based cancer registries are responsible for collecting incidence and survival data on all reportable neoplasms within a defined geographical area. During the last decades, the role of cancer registries has evolved beyond monitoring epidemiological indicators, as they are expanding their activities to studies on cancer aetiology, prevention, and quality of care. This expansion relies also on the collection of additional clinical data, such as stage at diagnosis and cancer treatment. While the collection of data on stage, according to international reference classification, is consolidated almost everywhere, data collection on treatment is still very heterogeneous in Europe. This article combines data from a literature review and conference proceedings together with data from 125 European cancer registries contributing to the 2015 ENCR-JRC data call to provide an overview of the status of using and reporting treatment data in population-based cancer registries. The literature review shows that there is an increase in published data on cancer treatment by population-based cancer registries over the years. In addition, the review indicates that treatment data are most often collected for breast cancer, the most frequent cancer in women in Europe, followed by colorectal, prostate and lung cancers, which are also more common. Treatment data are increasingly being reported by cancer registries, though further improvements are required to ensure their complete and harmonised collection. Sufficient financial and human resources are needed to collect and analyse treatment data. Clear registration guidelines are to be made available to increase the availability of real-world treatment data in a harmonised way across Europe.

IntroductionThis report investigates the impact of systemic treatments (chemotherapy or immunotherapy) with(out) loco-regional radiotherapy, on HRQoL, toxicity and neurocognitive functioning (NCF) in locally advanced and metastatic non-small cell lung cancer patients enrolled in the PRO-Long study.Materials and MethodsData on patient-reported HRQoL and fourteen toxicities was collected, while NCF was tested, up to one-year post-treatment. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30. Lung cancer, treatment and neuro-psychological related toxicities were scored with the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. NCF was evaluated with six neurocognitive tests. Mixed model analyses were conducted to determine statistical significance (p = .01). Meaningful clinical important differences (MCIDs) were applied for changes in HRQoL and NCF data, while toxicities were compared to baseline values.ResultsIn total, 50 patients were enrolled. Overall HRQoL (p = .357) nor its domains (physical, p = .643; role, p = .069; emotional, p = .254; cognitive, p = 494; social, p = .735) changed significantly over time. Meaningful improvements in overall HRQoL were seen in 22, 38 and 39% and deteriorations in 22, 5 and 28% of patients at 2–3, 6 and 12 months respectively post-treatment. Overall toxicity (p = .007), lack of appetite (p = .001), nausea (p = .004) and dysphagia (p = .000) significantly decreased over time. Treatment caused acute toxicity, such as dyspnoea (45%) and memory problems (42%), but also alleviated pre-existing symptoms, including lack of appetite (32%), anxiety (29%) and depression (28%) at 2/3 months. The NCF domains of visual memory (p = .000) and cognitive processing speed (p = .000) showed significant improvements over time. In terms of MCIDs, at 2–3 months (18%) and 6 months (15%), verbal memory was particularly impacted; at 12 months, visual memory (18%) and executive function (18%) deteriorated primarily.ConclusionThe results suggest that therapy has no significant negative impact on overall HRQoL, its domains, and NCF. About one-third of patients reported a meaningful improved HRQoL at 1 year post-treatment. Treatment caused toxicity, but also alleviated pre-existing symptoms.

Background: Acute skin toxicity is a common and usually transient side-effect of breast radiotherapy although, if sufficiently severe, it can affect breast cosmesis, aftercare costs and the patient's quality-of-life. The aim of this study was to develop predictive models for acute skin toxicity using published risk factors and externally validate the models in patients recruited into the prospective multi-center REQUITE (validating pREdictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve QUalITy of lifE in cancer survivors) study.Methods: Patient and treatment-related risk factors significantly associated with acute breast radiation toxicity on multivariate analysis were identified in the literature. These predictors were used to develop risk models for acute erythema and acute desquamation (skin loss) in three Radiogenomics Consortium cohorts of patients treated by breast-conserving surgery and whole breast external beam radiotherapy (n = 2,031). The models were externally validated in the REQUITE breast cancer cohort (n = 2,057).Results: The final risk model for acute erythema included BMI, breast size, hypo-fractionation, boost, tamoxifen use and smoking status. This model was validated in REQUITE with moderate discrimination (AUC 0.65), calibration and agreement between predicted and observed toxicity (Brier score 0.17). The risk model for acute desquamation, excluding the predictor tamoxifen use, failed to validate in the REQUITE cohort.Conclusions: While most published prediction research in the field has focused on model development, this study reports successful external validation of a predictive model using clinical risk factors for acute erythema following radiotherapy after breast-conserving surgery. This model retained discriminatory power but will benefit from further re-calibration. A similar model to predict acute desquamation failed to validate in the REQUITE cohort. Future improvements and more accurate predictions are expected through the addition of genetic markers and application of other modeling and machine learning techniques.

For many years, conventional oncologic treatments such as surgery, chemotherapy, and radiotherapy (RT) have dominated the field of non-small-cell lung cancer (NSCLC). The recent introduction of immunotherapy (IT) in clinical practice, especially strategies targeting negative regulators of the immune system, so-called immune checkpoint inhibitors, has led to a paradigm shift in lung cancer as in many other solid tumors. Although antibodies against programmed death protein-1 (PD-1) and programmed death ligand-1 (PD-L1) are currently on the forefront of the immuno-oncology field, the first efforts to eradicate cancer by exploiting the host's immune system date back to several decades ago. Even then, researchers aimed to explore the addition of RT to IT strategies in NSCLC patients, attributing its potential benefit to local control of target lesions through direct and indirect DNA damage in cancer cells. However, recent pre-clinical and clinical data have shown RT may also modify antitumor immune responses through induction of immunogenic cell death and reprogramming of the tumor microenvironment. This has led many to reexamine RT as a partner therapy to immuno-oncology treatments and investigate their potential synergy in an exponentially growing number of clinical trials. Herein, the authors review the rationale of combining IT and RT across all NSCLC disease stages and summarize both historical and current clinical evidence surrounding these combination strategies. Furthermore, an overview is provided of active clinical trials exploring the IT-RT concept in different settings of NSCLC.

Background: The majority of lung cancer patients are diagnosed with advanced non-small cell lung cancer (NSCLC), the bulk of which receive palliative systemic treatment with the goal to provide effective symptom palliation and safeguard health-related quality of life (HRQoL). Advanced NSCLC trials with HRQoL endpoints face methodological constraints limiting interpretability.Objectives: We provide a comprehensive overview of recent clinical trials evaluating the impact of systemic therapies on HRQoL in advanced NSCLC, focusing on the methodological quality, with the ultimate goal to improve interpretation, comparison and reporting of HRQoL data.Methods: A systematic literature review was performed. Prospective studies published over the last decade evaluating the impact of systemic treatments on HRQoL in advanced NSCLC were included. Methodological quality of HRQoL reporting was assessed with the CONSORT-PRO extension.Results: Hundred-twelve manuscripts describing 85 trials met all criteria. No formal conclusion can be drawn regarding the impact on HRQoL of different treatments. We report an important variety in methodological quality in terms of definitions of HRQoL, missing data points, lack of standardization of analyzing and presenting HRQoL and no standard follow-up time. The quality of HRQoL data reporting varies substantially between studies but improves over time.Conclusion: This review shows that in the heterogeneous landscape of trials addressing HRQoL in advanced stage NSCLC. Methodology reporting remains generally poor. Adequate reporting of HRQoL outcome data is equally important to support clinical decision-making as to correctly inform health policy regarding direct approval and reimbursement of the new drugs and combinations that will come online.