Electronic Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: Long-Term Results of a Multicenter, Randomized, Controlled Trial.

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical Trial Updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.We previously reported superior symptom control of electronic patient-reported outcome (ePRO)-based symptom management after lung cancer surgery for up to 1 month postdischarge. Here, we present the long-term results (1-12 months) of this multicenter, randomized trial, where patients were assigned 1:1 to receive postoperative ePRO-based symptom management or usual care daily postsurgery, twice weekly postdischarge until 1 month, and at 3, 6, 9, and 12 months postdischarge. Long-term patient-reported outcomes were assessed with MD Anderson Symptom Inventory-Lung Cancer module. Per-protocol analyses were performed with 55 patients in the ePRO group and 57 in the usual care group. At 12 months postdischarge, the ePRO group reported significantly fewer symptom threshold events (any of the five target symptom scored ≥4; median [IQR], 0 [0-0] v 0 [0-1]; P = .040) than the usual care group. From 1 to 12 months postdischarge, the ePRO group consistently reported significantly lower composite scores for physical interference (estimate, -0.86 [95% CI, -1.32 to -0.39]) and affective interference (estimate, -0.70 [95% CI, -1.14 to -0.26]). Early intensive ePRO-based symptom management after lung cancer surgery reduced symptom burden and improved functional status for up to 1 year postdischarge, supporting its integration into standard care.

Challenges and controversies in resectable non-small cell lung cancer: a clinician's perspective.

The treatment landscape of resectable early-stage non-small cell lung cancer (NSCLC) is transforming due to the approval of novel adjuvant and neoadjuvant systemic treatments. The European Medicines Agency (EMA) recently approved adjuvant osimertinib, adjuvant atezolizumab, adjuvant pembrolizumab, and neoadjuvant nivolumab combined with chemotherapy, and the approval of other agents or new indications may follow soon. Despite encouraging results, many unaddressed questions remain. Moreover, the transformed treatment paradigm in resectable NSCLC can pose major challenges to healthcare systems and magnify existing disparities in care as differences in reimbursement may vary across different European countries. This Viewpoint discusses the challenges and controversies in resectable early-stage NSCLC and how existing inequalities in access to these treatments could be addressed.

New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.

The treatment landscape of resectable early-stage non-small cell lung cancer (NSCLC) is set to change significantly due to encouraging results from randomized trials evaluating neoadjuvant and adjuvant immunotherapy, as well as adjuvant targeted therapy. As of January 2024, marketing authorization has been granted for four new indications in Europe, and regulatory approvals for other study regimens are expected. Because cost-effectiveness and reimbursement criteria for novel treatments often differ between European countries, access to emerging developments may lead to inequalities due to variations in recommended and available lung cancer care throughout Europe. This Series paper (i) highlights the clinical studies reshaping the treatment landscape in resectable early-stage NSCLC, (ii) compares and contrasts approaches taken by the European Medicines Agency (EMA) for drug approval to that taken by the United States Food and Drug Administration (FDA), and (iii) evaluates the differences in access to emerging treatments from an availability perspective across European countries.

Cohort study investigating evolution and factors associated with dyspnoea after anatomic lung resection.

Background: Dyspnoea is common following surgical resection for non-small cell lung cancer (NSCLC). The effects range from reduced quality of life to impact on adjuvant therapy outcomes. Currently, dyspnoea beyond the immediate postoperative phase and risk factors are not well characterised. We hope to assess the evolution of patient-reported dyspnoea after anatomic lung resection and associated factors. Methods: Single-centre cohort study with analysis on data collected longitudinally of 131 patients undergoing anatomic lung resections for NSCLC between September 2014 and December 2018. The European Organization for Research and Treatment Lung Cancer-specific Quality of Life Questionnaire Dyspnoea Scale was used to measure dyspnoea before and after surgery. Multivariable regression analysis was used to identify factors associated with clinically meaningful perioperative changes in dyspnoea at 6-12 months. Results: Mean Dyspnoea Scale scores preoperatively and 6-12 months after resection were 12.6 (standard deviation 17.4) and 17.9 (standard deviation 20.5), respectively. Of all patients 31% experienced a clinically meaningful increase in dyspnoea, defined as >10 points between Dyspnoea Scale scores preoperatively and at 6-12 months. Comparatively, 71% of patients without preoperative symptoms of dyspnoea developed a clinically meaningful increase of dyspnoea postoperatively. After adjusting the analysis for baseline factors and preoperative Dyspnoea Scale score, female sex remained the only patient factor associated with increased postoperative dyspnoea at 6-12 months after surgery (P=0.046). A total of 34% of patients reported increased dyspnoea after lobectomies and 9% after segmentectomies (P=0.014). Segmentectomy (as opposed to larger resections) was the only surgical factor associated with lower risk of increased dyspnoea (P=0.057). Conclusions: A clinically meaningful increase in dyspnoea is frequent after lung resection. Postoperative evolution of dyspnoea is non-predictable using objective baseline factors highlighting the importance of patient reported symptoms and involvement in clinical consultation.

The Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) protocol to explore the feasibility of embedding behavioural modifications into the clinical pathway for patients undergoing radical radiotherapy for lung cancer.

Patients with curable non-surgical lung cancer are often current smokers, have co-existing medical comorbidities and are treated with curative radiotherapy. To maximise the benefits of modern radiotherapy, there is an urgent need to optimise the patient's health to improve survival and quality of life. METHODS AND ANALYSIS: The Yorkshire Cancer Research-funded Prehabilitation Radiotherapy Exercise, smoking Habit cessation and Balanced diet Study (PREHABS) (L426) is a single-centre prospective feasibility study to assess embedding behavioural changes into the radical radiotherapy pathway of patients with lung cancer. Feasibility will be assessed by measuring acceptability, demand and implementation. The duration of the study is 24 months. PREHABS has two workstreams: the intervention study and the theory of change (ToC) study.Intervention study: PREHABS will commence at the R-IDEAL phase 2 trial (exploratory) based on existing evidence and includes support for smoking cessation, increasing activity and dietary well-being. Patients undergoing radical radiotherapy for lung cancer will be recruited from the oncology department at Leeds Teaching Hospitals NHS Trust (LTHT). ToC study: to maximise the acceptability and adherence to the PREHABS, we will use a ToC approach to qualitatively explore the key barriers and enablers of implementing a tailored programme of 'prehabilitation'. The PREHABS ToC study participants will be recruited from patients with lung cancer undergoing radical radiotherapy and staff from the LTHT oncology department. ANALYSIS: The primary endpoint analysis will report the number of participants and adherence to the study interventions. Secondary endpoints include continued engagement with study interventions post-treatment. The analysis will focus on descriptive statistics. Thematic analysis of the qualitative data from the ToC study will identify consensus on intervention optimisation and delivery. ETHICS AND DISSEMINATION: On 12 May 2021, the Cambridge East Ethics Committee granted ethical approval (21/EE/0048). The study is registered in the National Institute for Health and Care Research (NIHR) portfolio. The results will be disseminated through publication in peer-reviewed scientific journals and presented at conferences. TRIAL REGISTRATION NUMBER: NIHR portfolio 48420.

Gender representation among speaking and leader roles at European cardio-thoracic surgical annual meetings.

OBJECTIVES: Our goal was to evaluate gender representation among session leaders and abstract presenters at European cardio-thoracic surgical annual meetings. METHODS: We did a descriptive study of the gender distribution among session leaders and abstract presenters at 2 European cardio-thoracic international meetings from 2017 to 2022. Data from publicly available programmes were used to generate a list of session leaders and abstract presenters. The primary outcome was to evaluate the proportion of female sessions leaders at the annual meetings. Descriptive analyses were performed including the Cochran-Armitage trend test for linear trend of proportions. RESULTS: A total of 1025 sessions of 11 annual meetings of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Society of Thoracic Surgeons were examined. A total of 397 (13.2%) out of 3007 total session leaders and 955 (15.2%) out of 6251 abstract presenters were female. From 2017 to 2022, the proportions of both female session leaders and abstract presenters trended significantly [10.4% to 21.9% (P < 0.001) and 13.7% to 18.3% (P < 0.001), respectively]. The EACTS female members and female meeting attendees significantly increased from 2017 to 2022 [11.1% to 15.9% (P < 0.001) and 23.7% to 26.9% (P < 0.001)], respectively. Most of the women attendees at the EACTS and the European Society of Thoracic Surgeons meetings who were session leaders and speakers came from Germany, Italy, the United Kingdom and the United States. CONCLUSIONS: Women are under-represented compared to men in leadership and speaking roles at European cardio-thoracic surgical annual meetings. In the past few years, an encouraging positive trend over time for female leadership roles has been noted; as a result, the proportion of female society members is represented at the annual meetings. However, a substantial gender gap still exists in leading roles of meeting attendees.

International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.

In June 2021, the US Food and Drug Administration (FDA) released a draft guidance for industry on core patient-reported outcomes (PROs) and related considerations for instrument selection and trial design in registrational cancer clinical trials, building on prior communications about the use of PROs to assess efficacy and tolerability in oncology drug development. The International Society for Quality of Life Research (ISOQOL) Standards and Best Practices Committee led an initiative to draft a commentary about the guidance, focusing on its positive aspects and areas that would benefit from additional clarification and consideration. For comprehensiveness, the authors reviewed existing public comments on the draft guidance, and the commentary underwent a thorough review process through three ISOQOL Special Interest Groups (Psychometrics, Clinical Practice, and Regulatory and Health Technology Assessment Engagement) followed by the ISOQOL Board. The goal of this commentary is to situate this new and relevant guidance document within the context of recent regulatory efforts on PROs and highlight areas in which further work may ultimately benefit the field.

Longitudinal patient-reported outcomes 1 year after thoracoscopic segmentectomy versus lobectomy for early-stage lung cancer: a multicentre, prospective cohort study protocol.

INTRODUCTION: Segmentectomy and lobectomy are the main surgical procedures for early-stage lung cancer. However, few studies have analysed patient-reported outcomes after segmentectomy versus lobectomy. This study aims to compare patient-reported outcomes-such as symptoms, daily functioning and quality of life-between thoracoscopic segmentectomy and lobectomy for early-stage lung cancer during the 1 year after surgery. METHODS AND ANALYSIS: Overall, 788 newly diagnosed patients with early-stage lung cancer (tumour size ≤2 cm), who are scheduled to undergo thoracoscopic segmentectomy or lobectomy, will be recruited in this multicentre, prospective cohort study. The patients will receive standardised care after surgery. The Perioperative Symptom Assessment for Lung Surgery-a validated lung cancer surgery-specific scale-will be used to assess the symptoms and functions at baseline, at discharge and monthly after discharge for 1 year. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Lung Cancer module 29 will be used to assess the patients' quality of life at the same time points. The primary outcome will be the shortness of breath scores during the first year after thoracoscopic segmentectomy and lobectomy and will be compared using mixed-effects models. The secondary outcomes will include other symptoms, indicators of daily functioning, quality of life scores and traditional clinical outcomes. These will be compared using mixed-effects models and the Student's t-test, non-parametric test or Χ2 test. Propensity score matching will be used to ensure an even distribution of known confounders between the groups. ETHICS AND DISSEMINATION: The Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital approved this study (approval number: SCCHEC-02-2022-002). All participants will be instructed to provide informed consent. The manuscript is based on protocol version 3.0. The study results will be presented at medical conferences and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2200060753.

Giant thymoma with complete superior vena cava obstruction.

Thymomas are rare epithelial tumors of the mediastinum with relatively good prognosis compared to other thoracic malignancies. Surgery is considered the best treatment and the most important determinant of long-term survival even in advanced stages. Nevertheless, complete resection may be challenging and require a multimodality approach. We present a case of a stage IVa thymoma surgically treated. The superior vena cava was completely occluded and, after resection, reconstruction was deemed unnecessary due to sufficient venous return through the azygos-inferior vena cava system. In our opinion, despite the morbidity of surgery in advanced thymomas, it should always be considered in expert hands.

Patient-reported Physical Function Is Associated With Survival After Lung Resection for Non-Small Cell Lung Cancer.

BACKGROUND: We investigated the association between preoperative quality of life and long-term survival in patients undergoing surgical resection for non-small cell lung cancer. METHODS: Retrospective analysis was conducted on 388 consecutive patients who completed the quality of life assessment through the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 and lung cancer specific module (LC13), before anatomic lung resection for non-small cell lung cancer (2014-2018). Survival distribution was estimated by the Kaplan-Meier method. Cox proportional hazards regression and competing risk regression analyses were used to assess the independent association of preoperative patient-reported outcomes with overall and cancer-specific survival. RESULTS: Higher score in patient-reported physical functioning was significantly associated with longer overall survival. Factors significantly associated with poorer overall survival remained older age (P = .005), low body mass index (P = .007), male sex (P < .001), and nodal involvement (P = .007). Competing regression analysis found that worse baseline lung cancer-specific dyspnea (P = .03), low body mass index (P = .01), worse performance status (P = .03), and lymph node involvement (P = .01) were significantly associated with poorer cancer-specific survival. CONCLUSIONS: Higher patient-reported physical function score was associated with longer overall survival after resection. Our study highlights the significance of routinely collecting quality of life data to aid preoperative decision making in non-small cell lung cancer.

Healthcare professional experiences of making surgical oncology decisions and delivering COVID-19 safe care: a qualitative study.

BACKGROUND: The COVID-19 pandemic was declared a public health emergency in March 2020. The British National Health Service (NHS) redirected medical attention towards prioritising COVID-19-positive patients in favour of less urgent care affecting cancer service provision. This study aims to explore experiences of healthcare professionals (HCPs) and investigate the impact of COVID-19 on decision-making in surgical oncology. METHODS: HCPs with experience in surgical oncology were recruited from January 2021 to June 2021. Qualitative semi-structured telephone interviews were conducted and transcribed verbatim. Interviews were conducted until data saturation. Thematic analysis was used to identify frequently discussed themes. RESULTS: A total of 13 participants were interviewed, identifying three main pandemic-related challenges: multi-disciplinary team (MDT) processes - telephone pre-operative assessments impoverished information elicited from in-person examination; service delivery - personal protective equipment (PPE) added complexity to surgical practice and more difficult communication; work routines - increased workload to deliver COVID-safe remote practices and decreased training time. CONCLUSIONS: COVID-19 influenced cancer service provision with teams making significant changes to ensure that effective clinical reasoning and surgical standards were maintained. Managing safe COVID-19 surgical care impacted daily-life and work stressors. Post crisis, service delivery is looking to integrate telemedicine within care whilst reducing its impact on workload and in-practice training.

Women in thoracic, cardiac and vascular surgery claim for a change in the working situation: an Italian national survey.

Background: Women's participation in the surgical workforce has increased. The aim of the study is to acquire objective data regarding practice, training, satisfaction, and discrimination of women surgeons working in cardiothoracic and vascular surgery in Italy. Methods: An 83-item questionnaire was distributed through social media and sent to e-mails of women surgeons from November through December 2020. A sub-analysis on women working in cardiac, thoracic, and vascular surgery was performed. Results: Overall, 222 respondents were included (48 cardiac, 62 thoracic, and 112 vascular surgeons). Thirty-six percent partially abandoned surgical activities in favor of other professional activities, not including the operating room. On average, our respondents took part in 33% of all surgical cases performed in their units; however, of 12 high complexity surgeries per month, less than one is performed by them. Only 7 female participants who answered the questionnaire were in leadership positions. Many respondents struggle with lack of mentorship and missing opportunities in operating room. A high percentage of women experienced discrimination due to their gender in their professional life, and 59% claimed to have been subject to sexual harassment. Conclusions: In Italy, women thoracic, cardiac, and vascular surgeons face lack of mentorship, opportunities in the operating room, and gender-related issues including some episodes of sexual harassment. Diversity, equity, and inclusion should become strategic priorities in all institutions. Among our respondents, surgical exposure is limited, which may deter a surgical career and play a crucial role in surgeons' dissatisfaction, that also include poor work-life-balance, and a large amount of administrative work. Surgical societies may address these issues by providing structured mentorship programs and networking opportunities. Societies' contributions might substantially impact supporting and retaining women at different stages of their careers.

Surgical Management of Primary Spontaneous Pneumothorax Without Lung Bullae.

INTRODUCTION: Primary spontaneous pneumothorax (PSP) is a relatively common disease. Different studies have been published but lung resection, when no emphysema-like changes (ELC) are detected, is unclear. The aim of our study is to retrospectively investigate the role of lung resection of the apex of the lung in patients with no ELC. METHODS: This is a retrospective multicenter study of 516 patients who underwent surgical treatment of PSP with no ELC between January 2007 and December 2017. Patients were divided into two groups: pleurodesis alone group, only mechanical pleurodesis performed (53 patients), and apical resection group, apical resection of the lung and mechanical pleurodesis performed (463 patients). The following were the primary end points considered: recurrence rate and perioperative complications; the following were the secondary end points considered: length of stay, chest tube removal, residual pleural space, prolonged air leak, and reoperation rate. RESULTS: No differences were found in the baseline and operative characteristics of the two groups. Both primary end points were statistically different: recurrence rate (15.1% versus 6.5%, P = 0.023) and perioperative complications (18.9% versus 7.3%, P = 0.004). Among secondary end points length of stay (6.94 versus 5.55, P = 0.033) and prolonged air leak (15.1% versus 4.3%, P = 0.001) were statistically different. On multivariate analysis, lung resection emerged as a protective factor for recurrence (hazard ratio 0.182, P < 0.001). CONCLUSIONS: In our experience, apical lung resection in patients without ELC may reduce recurrence rate and perioperative complications when compared with pleurodesis alone.

Postoperative Symptom Burden in Patients Undergoing Lung Cancer Surgery.

CONTEXT: Previous studies on quality of life (QOL) after lung cancer surgery have identified a long duration of symptoms postoperatively. We first performed a systematic review of QOL in patients undergoing surgery for lung cancer. A subgroup analysis was conducted focusing on symptom burden and its relationship with QOL. OBJECTIVE: To perform a qualitative review of articles addressing symptom burden in patients undergoing surgical resection for lung cancer. METHODS: The parent systematic review utilized search terms for symptoms, functional status, and well-being as well as instruments commonly used to evaluate global QOL and symptom experiences after lung cancer surgery. The articles examining symptom burden (n = 54) were analyzed through thematic analysis of their findings and graded according to the Oxford Centre for Evidence-based Medicine rating scale. RESULTS: The publication rate of studies assessing symptom burden in patients undergoing surgery for lung cancer have increased over time. The level of evidence quality was 2 or 3 for 14 articles (cohort study or case control) and level of 4 in the remaining 40 articles (case series). The most common QOL instruments used were the Short Form 36 and 12, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire, and the Hospital Anxiety and Depression Score. Thematic analysis revealed several key findings: 1) lung cancer surgery patients have a high symptom burden both before and after surgery; 2) pain, dyspnea, cough, fatigue, depression, and anxiety are the most commonly studied symptoms; 3) the presence of symptoms prior to surgery is an important risk factor for higher acuity of symptoms and persistence after surgery; and 4) symptom burden is a predictor of postoperative QOL. CONCLUSION: Lung cancer patients undergoing surgery carry a high symptom burden which impacts their QOL. Measurement approaches use myriad and heterogenous instruments. More research is needed to standardize symptom burden measurement and management, with the goal to improve patient experience and overall outcomes.