The role of surgery for invasive pulmonary aspergillosis in paediatric hemato-oncology patients-Can we better define it?

BACKGROUND: Invasive pulmonary aspergillosis (IPA) is a serious condition with high morbidity and mortality in paediatric patients with cancer, haematological diseases or immunodeficiencies with or without allogeneic haematopoietic stem cell transplantation (HSCT). The role of surgical intervention for the management of IPA has scarcely been investigated. OBJECTIVES: The aim of this study was to present a single center experience of management of IPA in paediatric patients of an oncological ward, to determine the short and long-term outcomes after thoracic surgical interventions, and to outline the indications of surgical interventions in selected patients. PATIENTS/METHODS: We conducted a retrospective study of 44 paediatric patients with proven and probable IPA treated in our institution between January 2003 and December 2021. The primary endpoint was the overall survival after surgical interventions. Secondary endpoints included post-operative morbidity and mortality. RESULTS: The median age at diagnosis of IPA in our cohort was 11.79 years (range 0.11-19.6). The underlying conditions were malignancies in 34 (77%) patients and haematological or immunological disorders with allogeneic HSCT in 9 (23%) patients. We performed thoracic surgical interventions in 10 (22.7%) patients. Most patients received a video assisted thoracic surgery. Only one patient died within 90 days after surgery with a median follow-up time of 50 months. No other major post-operative complications occurred. The calculated 5-year survival rate from IPA for patients after surgical intervention with curative intention was 57% and 56% for patients without (p = .8216). CONCLUSIONS: IPA resulted in relevant morbidity and mortality in our paediatric patient cohort. Thoracic surgical interventions are feasible and may be associated with prolonged survival as a part of multidisciplinary approach in selected paediatric patients with IPA. Larger scale studies are necessary to investigate the variables associated with the necessity of surgery.

[Surgical and Percutaneous Dilatational Tracheostomy - Technique and Pitfalls]. / Plastische und dilatative Tracheostomie ­ Technik und Fallstricke.

A tracheostomy is usually necessary for long-term mechanical ventilation or complicated weaning. Other indications include swallowing disorders with recurrent aspiration in neuromuscular disease and high-grade subglottic stenosis. The tracheostomy can be performed as a percutaneous dilatational tracheostomy or as a surgical tracheostomy. The complication rate is low, and intraoperative complications are differentiated from early and late postoperative complications. This article aims to present the indications, the techniques and complications of percutaneous dilatational and surgical tracheostomy, and highlights the long-term complications of tracheal stenosis and tracheomalacia.

Robotic diaphragm plication: functional and surgical outcomes of a single-center experience.

BACKGROUND: Diaphragm plication remains the only effective treatment for diaphragm paralysis. Robot-assisted thoracoscopic (RATS) diaphragm plication combines advantages of open and thoracoscopic techniques. We present our experiences focussing on lung-function improvement and surgical outcome. METHODS: In this single-center retrospective study with comparative analysis, perioperative data of all patients who underwent RATS or thoracoscopic (VATS) diaphragm plication between 2015 and 2022 at our institution were assessed. Functional outcome was analysed with pre- and postoperative pulmonary function tests in sitting and supine position. RESULTS: We included 43 diaphragm plications, of which 31 were performed via RATS. Morbidity in the RATS- and VATS-cohort were 13 and 8%, respectively (p = 0.64), without any major complication (Clavien-Dindo ≥ III, 0%). Surgical time for RATS diaphragm plication was reduced drastically with a median operating time for the first 16 patients of 136 min (range 84-185) and 84 min (range 56-122) for the most recent 15 patients (p < 0.0001). Pulmonary function testing after RATS-plication showed a mean increase in vital capacity (VC) of 9% (SD 8, p < 0.0001) and of 7% (SD 9, p = 0.0009) in forced expiratory volume in 1 s (FEV1) when sitting and 9% (SD 8, p < 0.0001) for VC as well as 10% (SD 8, p = 0.0001) for FEV1 when in supine position. CONCLUSION: RATS diaphragm plication is a very safe and feasible approach, yielding good results in improving patients' pulmonary function. Further studies are required to elucidate possible advantages over VATS or open approaches.

[Robotic Diaphragm Plication]. / Roboterassistierte thorakoskopische Zwerchfellraffung.

Acquired unilateral hemidiaphragm elevation is characterised by dyspnoea, which is typically aggravated when lying down, bending over or during swimming. The most common causes are idiopathic or due to injury to the phrenic nerve during cervical or cardio-thoracic surgery. To date, surgical diaphragm plication remains the only effective treatment. The aim of the procedure is to plicate the diaphragm to restore its tension and thus improve breathing mechanics, increase the available space for the lung and reduce compression from abdominal organs. In the past, various techniques using open and minimally invasive approaches have been described. Robot-assisted thoracoscopic diaphragm plication combines the advantages of a minimally invasive approach with excellent visualisation and freedom of movement. It was shown to be a safe technique which is easy to establish and can significantly improve pulmonary function.

[Surgery for Thoracic Malignancies during the COVID-19 Pandemic: a Case-control Study Investigating the Risk for Postoperative Complications]. / Onkologische Thoraxchirurgie während der COVID-19-Pandemie: eine Fallkontrollstudie zum Risiko für postoperative Komplikationen.

BACKGROUND: The COVID-19 pandemic led to a major disturbance in the health care system. Many elective operations were postponed, including surgical oncology cases. Besides the need to contain hospital resources, this was also due to concerns about the safety to perform surgery during the pandemic and the impact of perioperative infections on postoperative outcomes. In this study we investigate the safety of surgery for thoracic malignancies during the COVID-19 pandemic. METHODS: We retrospectively analysed the outcome of surgery for thoracic malignancies during the first, second and third waves of the COVID-19 pandemic (from 01.01. to 30.04.2020 and from 01.01. to 30.04.2021). As a control group we included the patients who received thoracic oncology surgeries during the same period in the last 2 years before the onset of the pandemic. The primary outcome was the rate of postoperative complications. RESULTS: 236 operations were included in the pandemic group and 227 operations in the control group. There was no statistically significant difference in the rate of postoperative minor complications (16.1% vs. 18.5%, p = 0.5395) or major complications (12.2% vs. 10.13 %, p = 0.5563). The risk to develop postoperative pulmonary complications was not higher in the pandemic group (odds ratio 1.193, 95% CI 0.6515-2.203, p = 0.8232). There were 5 cases with COVID-19 infection after the operation in the pandemic group. There was no difference in the rate of postoperative mortalities (2 (0.85%) vs. 1 (0.44%), p > 0.9999) There was no COVID-19 related mortality. CONCLUSION: Maintaining oncologic thoracic surgery during the COVID-19 pandemic is safe, feasible and not associated with increased risks of postoperative complications or mortalities.

[Postoperative Haemothorax Following Thoracic Surgery]. / Postoperative Blutung nach thoraxchirurgischen Eingriffen.

Postoperative haemothorax following thoracic surgery is a rare complication, but associated with a high mortality. In the literature, this complication occurs in 0.6 to 4.6% of patients and with a mortality of 5.1 to 17.8%. In minor cases, chest tube placement, application of fresh frozen plasma (FFP) or transfusion can be sufficient to control the situation. In severe cases, re-thoracotomy is mandatory. The most frequent origin of bleeding is a bronchial or intercostal vessel (21 and 16%) or the area of pleural adhesions that were separated (10.5%). The pulmonal artery or vein were the origin of bleeding in 16% of cases while in most cases (37%) active bleeding could no longer be detected. A positive effect on postoperative outcome is observed after an early reoperation.

[The Significance of Surgery for Oligometastatic and Oligoprogressive Non-small Cell Lung Cancer]. / Die Bedeutung der Chirurgie beim oligometastatischen und oligoprogressiven nicht kleinzelligen Lungenkarzinom.

An increased understanding of tumour biology as well as novel therapeutic options have led to a further differentiation of metastatic non-small cell lung cancer. Oligometastatic lung cancer has a relatively benign clinical course with few metastases, which are often confined to a single organ. To create the best outcomes, the ideal treatment must be used for each individual tumor biology, with consideration of the different treatment modalities. Surgery is of increasing significance in curative treatment concepts in metastatic lung cancers. In analogy to oligometastatic disease, the term "oligoprogression" has emerged in recent years. This describes a state in which metastatic lung cancers which express sensitizing mutations show progression of disease only at a limited number of anatomical sites whilst under therapy with tyrosine kinase inhibitors. Current studies have shown encouraging results for surgical therapy in combination with systemic therapy of both oligometastatic and oligoprogressive disease in well selected patients. It remains to be determined whether the observed survival benefits are based on the favourable tumour biology or the applied treatment modalities. Moreover, robust molecular markers have to be determined to identify patients who will benefit from aggressive surgical treatment, in order to avoid overtreatment.

Significance of the resection margin in bronchopulmonary carcinoids.

BACKGROUND: Complete surgical resection is the treatment of choice in bronchopulmonary carcinoids. Previously published data showed no inferiority of sublobar versus lobar resection. Data on the length of resection margins are lacking; thus, we aimed to analyze resection margins in pulmonary carcinoids and correlated them with survival and recurrence. METHODS: We retrospectively analyzed 85 patients who underwent surgery for atypical (AC) or typical (TC) pulmonary carcinoids. Patient charts were reviewed, and clinicopathologic and survival data were collected. Pathology reports were reviewed for length of resection margins. RESULTS: The median follow-up period was 42.3 mo (range, 0.3-172.2). There was no statistically significant difference in disease-free survival (DFS) when comparing resection margins ≤2 mm to >2 mm (P = 0.93, hazard ratio = 1.7). When looking at AC alone, a worse DFS can be seen if the resection margin was smaller than 2 mm (P = 0.06, hazard ratio = 15.8). In AC, likelihood of recurrence was higher when the resection margin was ≤1 cm (odds ratio = 5.1, P = 0.28). In TC, this tendency was not present (odds ratio = 1.2, P = 1). CONCLUSIONS: There is a trend toward a worse prognosis and higher likelihood of recurrence in smaller resection margins in AC in contrast to TC. Owing to low sample size, no definitive statements can be made based on this study; however, respective data on these rare tumors cannot be drawn from tumor databases. The resection margin is one of the critical issues for the treating surgeon, and any information on this topic is of highest importance to the field.

Prognostic factors in solitary fibrous tumors of the pleura.

BACKGROUND: Solitary fibrous tumors of the pleura (SFTP) are rare neoplasms originating from submesothelial mesenchymal cells with fibroblastic differentiation. The clinical behavior of SFTPs is mostly benign; however, up to 20% of patients develop local recurrence and/or distant metastasis. Although different risk-stratification models have been described, definitive criteria to predict a malignant clinical course of SFTP are still lacking. METHODS: In a retrospective analysis at a single-institution, 25 patients with histologically proven SFTP were identified. Clinicopathologic and survival data were collected and pathologic sections reviewed. Different markers and risk-stratification models were correlated with disease- and overall-free survival by Kaplan-Meier analysis. RESULTS: Of 25 SFTP, 8 tumors (32%) were classified as malignant according to the World Health Organization criteria. Three patients (12%) developed recurrence. Cohort median follow-up was 28 mo, and median overall survival was 160 mo. Comparison of proliferation markers showed higher mitosis count per high-power field and MIB-1 labeling index (MIB) in malignant compared with nonmalignant SFTP. MIB was identified as a predictor for disease-free survival. Applying the previously reported classifications to categorize SFTP according to the probability to show malignant behavior, significant differences in disease-free survival were also present in our cohort. CONCLUSIONS: In the present analysis of rare SFTP, previously proposed staging systems were applicable for prediction of disease-free survival. Independently of treatment, MIB was the only sole predictive marker. A prospective multi-institutional database could be helpful in establishing detailed predictive criteria in patients diagnosed with SFTP.

Low densities of immune cells indicate unfavourable overall survival in patients suffering from squamous cell carcinoma of the lung.

Carcinogenesis and tumor proliferation are characterized by a complex interaction of cancer cells with the tumor microenvironment. In particular, a tumor-promoting effect can be assumed for the stroma and its fibroblasts. An influence of the immune system on non small cell lung cancer (NSCLC) is now also suspected. In our study, we examined 309 sections of squamous cell carcinoma (SCC), a subtype of NSCLC. We determined the cell densities and areas of the different tissues in SCC using the software QuPath. Spearman rank correlation showed a significant positive correlation between the different tumor cell densities and stromal cell densities, and between tumor cell densities and immune cell densities. Overall survival curves by the Kaplan-Meier method revealed a prominent negative curve in cases of low immune cell density. Based on our results, we can assume a positive influence of the tumor microenvironment, especially the stromal cells, on tumor proliferation in SCC. We have also revealed that low density of immune cells is prognostically unfavorable.

Multimodal Treatment of Pleural Mesothelioma with Cytoreductive Surgery and Hyperthermic Intrathoracic Chemotherapy: Impact of Additive Chemotherapy.

Cytoreductive surgery (CRS) combined with hyperthermic intrathoracic chemoperfusion (HITOC) is a promising treatment strategy for pleural mesothelioma (PM). The aim of this study was to evaluate the impacts of this multimodal approach in combination with systemic treatment on disease-free survival (DFS) and overall survival (OS). In this retrospective multicenter study, clinical data from patients after CRS and HITOC for PM at four high-volume thoracic surgery departments in Germany were analyzed. A total of 260 patients with MPM (220 epithelioid, 40 non-epithelioid) underwent CRS and HITOC as part of a multimodal treatment approach. HITOC was administered with cisplatin alone (58.5%) or cisplatin and doxorubicin (41.5%). In addition, 52.1% of patients received neoadjuvant and/or adjuvant chemotherapy. The median follow-up was 48 months (IQR = 38 to 58 months). In-hospital mortality was 3.5%. Both the resection status (macroscopic complete vs. incomplete resection) and histologic subtype (epithelioid vs. non-epithelioid) had significant impacts on DFS and OS. In addition, adjuvant chemotherapy (neoadjuvant/adjuvant) significantly increased DFS (p = 0.003). CRS and HITOC within a multimodal treatment approach had positive impacts on the survival of patients with epithelioid PM after macroscopic complete resection. The addition of chemotherapy significantly prolonged the time to tumor recurrence or progression.

Detection of obstructive sleep apnoea by an electronic nose.

Diagnosis of obstructive sleep apnoea syndrome (OSAS) is technically demanding, cost-intensive and time-consuming. The measurement of volatile organic compounds by an electronic nose is an innovative method that determines distinct molecular patterns of exhaled breath in different patient groups. We addressed the following questions: What is the diagnostic accuracy of an electronic nose in the detection of OSAS and the ability to detect effects of standard therapy in patients with OSAS? Are these results related to changes in distinct markers of airway inflammation and extracellular remodelling? We included 40 OSAS patients and 20 healthy controls. Exhaled breath of all participants was analysed using the Cyranose 320 electronic nose. Pharyngeal washings were performed to sample the upper airway compartment. For statistical analysis linear discriminant analysis was employed. We identified a linear discriminant function separating OSAS from control (p<0.0001). The corresponding area under the receiver-operating curve was 0.85 (95% CI 0.75-0.96; sensitivity 0.93 and specificity 0.7). In pharyngeal washing fluids of OSAS patients, we observed higher levels of α1-antitrypsin and markers of extracellular remodelling compared to controls. The electronic nose can distinguish between OSAS patients and controls with high accuracy.

Surgery for thoracic oligoprogression in metastatic renal cell cancer in the era of new systemic therapies.

Background: Novel systemic therapies have improved response rates and survival in metastatic renal cell cancer (mRCC) and are considered standard of care for this entity. However, complete remission (CR) is rare and often oligoprogression is observed. Here, we analyse the role of surgery for oligoprogressive lesions in mRCC. Methods: We retrospectively analyzed all patients who underwent surgery for thoracic oligoprogressive lesions of mRCC after receiving systemic therapy including immunotherapy, tyrosine kinase inhibitors (TKI), and/or multikinase inhibitors at our institution between 2007 and 2021 regarding treatment modalities, progression-free survival (PFS) and overall survival (OS). Results: Ten patients with oligoprogressive mRCC were included. The median interval between nephrectomy and oligoprogression was 65 months (range, 16-167). Median PFS after surgery for oligoprogression was 10 months (range, 2-29) and median OS after resection 24 months (range, 2-73). In 4 patients, CR was achieved of whom three showed no progression at last follow-up (PFS median 15 months, range, 10-29). In 6 patients, removal of the progressive site resulted in stable disease (SD) for a median of 4 months (range, 2-29), before 4 of them progressed. Conclusions: In selected cases, surgery can lead to sustained disease control in patients with oligoprogressive mRCC after systemic treatment including immunotherapy and novel treatment agents.

Surgical cytoreduction and hyperthermic intrathoracic chemotherapy for thymic tumours with pleural spread is effective on survival: results from the multicentre German hyperthermic intrathoracic chemotherapy study.

OBJECTIVES: Cytoreductive surgery and hyperthermic intrathoracic chemotherapy (HITOC) is effective on survival for patients with pleural metastatic thymic tumours. METHODS: Multicentre, retrospective analysis of patients with stage IVa thymic tumours treated with surgical resection and HITOC. Primary end point was overall survival, secondary end points were recurrence-/progression-free survival and morbidity/mortality. RESULTS: A total of n = 58 patients (thymoma, n = 42; thymic carcinoma, n = 15; atypical carcinoid of the thymus, n = 1) were included, who had primary pleural metastases (n = 50; 86%) or pleural recurrence (n = 8; 14%). Lung-preserving resection (n = 56; 97%) was the preferred approach. Macroscopically complete tumour resection was achieved in n = 49 patients (85%). HITOC was performed with cisplatin alone (n = 38; 66%) or in combination with doxorubicin (n = 20; 34%). Almost half of the patients (n = 28; 48%) received high-dose cisplatin > 125 mg/m2 body surface area. Surgical revision was required in 8 (14%) patients. In-hospital mortality rate was 2%. During follow-up, tumour recurrence/progression was evident in n = 31 (53%) patients. Median follow-up time was 59 months. The 1-, 3- and 5-year survival rates were 95%, 83% and 77%, respectively. Recurrence/progression-free survival rates were 89%, 54% and 44%, respectively. Patients with thymoma had significantly better survival compared to patients with thymic carcinoma (P-value ≤0.001). CONCLUSIONS: Promising survival rates in patients with pleural metastatic stage IVa in thymoma (94%) and even in thymic carcinoma (41%) were achieved. Surgical resection and HITOC is safe and effective for treatment of patients with pleural metastatic thymic tumours stage IVa.

Outcome after cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy in patients with secondary pleural metastases.

Background: The role of cytoreductive surgery combined with hyperthermic intrathoracic chemotherapy (CRS+HITOC) for patients with secondary pleural metastases has scarcely been investigated. Patients and Methods: We conducted a retrospective, multicentre study investigating the outcome of CRS+HITOC for 31 patients with pleural metastases from different primary tumours in four high-volume departments of thoracic surgery in Germany. The primary endpoint was overall survival (OS). Secondary endpoints included postoperative complications and recurrence/progression-free survival (RFS/PFS). Results: The primary tumour was non-small cell lung cancer in 12 (39%), ovarian cancer in 5 (16%), sarcoma in 3 (10%), pseudomyxoma peritonei in 3 (10%), and others in 8 (26%) patients. A macroscopic complete resection (R/1) could be achieved in 28 (90%) patients. Major postoperative complications as classified by Clavien-Dindo (III-V) were observed in 11 (35%) patients. The postoperative mortality rate was 10% (n=3). A total of 13 patients received additive chemotherapy (42%). The median time of follow up was 30 months (95% CI = 17- 43). The median OS was 39 months (95% CI: 34-44 months) with 1-month, 3-month, 1-, 3-, and 5-year survival estimates of 97%, 89%, 77%, 66%, and 41%. There was a significantly prolonged OS in patients who received additive chemotherapy compared to patients with only CRS+HITOC (median OS 69 vs 38 months; p= 0.048). The median RFS was 14 months (95% CI: 7-21 months). Conclusions: We observed that CRS+HITOC is a feasible approach with reasonable complications and prolonged survival as a part of multimodal concept for highly selected patients with secondary pleural metastases.

Study Protocol for a Randomised Controlled Trial on Pulmonary Metastasectomy vs. Standard of Care in Colorectal Cancer Patients With ≥ 3 Lung Metastases (PUCC-Trial).

This is a multicentre prospective randomised controlled trial for patients with 3 or more resectable pulmonary metastases from colorectal carcinoma. The study investigates the effects of pulmonary metastasectomy in addition to standard medical treatment in comparison to standard medical treatment plus possible local ablative measures such as SBRT. This trial is intended to demonstrate an overall survival difference in the group undergoing pulmonary metastasectomy. Further secondary and exploratory endpoints include quality of life (EORTC QLQ-C30, QLQ-CR29 and QLQ-LC29 questionnaires), progression-free survival and impact of mutational status. Due to the heterogeneity and complexity of the disease and treatment trajectories in metastasised colorectal cancer, well powered trials have been very challenging to design and execute. The goal of this study is to create a setting which allows treatment as close to the real life conditions as possible but under well standardised conditions. Based on previous trials, in which patient recruitment in the given setting hindered successful study completion, we decided to (1) restrict inclusion to patients with 3 or more metastases (since in case of lesser, surgery will probably be the preferred option) and (2) allow for real world standard of care (SOC) treatment options before and after randomisation including watchful waiting (as opposed to a predefined treatment protocol) and (3) possibility that patient can receive SOC externally (to reduce patient burden). Moreover, we chose to stipulate 12 weeks of systemic treatment prior to possible resection to further standardize treatment response and disease course over a certain period of time. Hence, included patients will be in the disease state of oligopersistence rather than primary oligometastatic. The trial was registered in the German Clinical Trials Register (DRKS-No.: DRKS00024727).

Should cardiovascular comorbidities be a contraindication for pulmonary metastasectomy?

Background: Limited information is available about the impact of cardiovascular comorbidities (CVC) on the postoperative course of patients undergoing pulmonary metastasectomy (PM). In this study, we aim to compare the postoperative morbidity, mortality, and the long-term survival of patients with and without CVC undergoing PM. Methods: A retrospective monocentric study was conducted including 760 patients who underwent PM in curative intention. Patients were divided into two groups depending on the presence of CVC. Results: The data from 164 patients with CVC (21.6%) and 596 patients without CVC (78.4%) were investigated. In both groups, zero in-hospital-mortality and limited 30-day mortality was detected. Postoperative complications occurred more often in patients with CVC (N=47, 28.7% vs. N=122, 20.5%, P=0.02). However, most of them were minor (N=37, 22.6% vs. N=93, 15.6%, P=0.03). The presence of multiple CVC (N=18 patients, 40% vs. N=28, 23.9%, P=0.04) and reduced left ventricular function (N=5, 62.5% vs. N=42, 27.1%, P=0.03) were identified as risk factors for postoperative morbidity. Patients with CVC showed reduced overall survival (5-year survival rate: 75.8% vs. 68%, P=0.03). In the multivariate analysis lobectomy [hazard ratio (HR) 0.3, 95% confidence interval (CI): 0.1-0.8, P=0.02] and general vascular comorbidities (HR 2.1, 95% CI: 1.1-3.9, P=0.01) were identified as independent negative prognostic factors. Conclusions: Resection of pulmonary metastases can be performed safely in selected patients with stable CVC. The presence of CVC in patients undergoing PM is associated with reduced overall survival compared to patients without CVC in the long term follow up. However, a prolonged 5-year survival rate of 68% could be achieved.

Neoadjuvant Prehabilitation Therapy for Locally Advanced Non-Small-Cell Lung Cancer: Optimizing Outcomes Throughout the Trajectory of Care.

BACKGROUND: Prehabilitation is well established for improving outcomes in cancer surgery. Combining prehabilitation with neoadjuvant treatments may provide an opportunity to rapidly initiate cancer-directed therapy while improving functional status in preparation for local consolidation. In this proof-of-concept study, we analyzed non-small-cell lung cancer patients who underwent simultaneous prehabilitation and neoadjuvant therapy. PATIENTS AND METHODS: We retrospectively analyzed all patients who underwent neoadjuvant treatment for non-small-cell lung cancer followed by curative intent surgery between 2015 and 2021. Patients who were screened for the prehabilitation program were identified. The screening included assessment of physical performance, nutritional status, and signs of anxiety and depression. RESULTS: We identified a total of 141 patients who underwent neoadjuvant therapy. Twenty patients were screened to undergo a prehabilitation program. Four patients did not complete the exercise program (1 surgical intervention too soon, 1 drop-out after the first session, and 2 patients were deemed fit without intervention). The postoperative median length of stay was 2 days (range 1-18). Patients improved their 6-minute-walk test despite undergoing neoadjuvant treatment by a mean of 33 meters (± 50, P = .1). Self-reported functional status (DASI) showed significant improvement by a mean of 10 points (± 11, P = .03), and HADS-anxiety-score was significantly reduced after the prehabilitation program by a mean of 1.5 points (± 1, P = .005). CONCLUSION: Neoadjuvant prehabilitation therapy is feasible and associated with encouraging results. The performance of all measures remains a logistic challenge. With multimodal strategies for lung cancer treatment becoming key to optimal outcomes, neoadjuvant prehabilitation therapy is a concept worthy of prospective multi-center evaluation.

Development of an updated, standardized, patient-centered outcome set for lung cancer.

BACKGROUND: In 2016, the International Consortium for Health Outcomes Measurement (ICHOM) defined an international consensus recommendation of the most important outcomes for lung cancer patients. The European Health Outcomes Observatory (H2O) initiative aimed to develop an updated patient-centered core outcome set (COS) for lung cancer, to capture the patient perspective of the impact of lung cancer and (novel) treatments using a combination of patient-reported outcome (PRO) instruments and clinical data as a means to drive value-based health-care. MATERIAL AND METHODS: An international, expert team of patient representatives, multidisciplinary healthcare professionals, academic researchers and pharmaceutical industry representatives (n = 17) reviewed potential outcomes generated through literature review. A broader group of patients/patient representatives (n = 31), healthcare professionals / academic researchers (n = 83), pharmaceutical industry representatives (n = 26), and health authority representatives (n = 6) participated in a Delphi study. In two survey rounds, participants scored the relevance of outcomes from a preliminary list. The threshold for consensus was defined as ≥ 70 % of participants scoring an outcome as 'highly relevant'. In concluding consensus-meeting rounds, the expert multidisciplinary team finalized the COS. RESULTS: The preliminary list defined by the core group consisted of 102 outcomes and was prioritized in the Delphi procedure to 64. The final lung cancer COS includes: 1) case-mix factors (n = 27); 2) PROs related to health-related quality of life (HRQoL) (n = 25); 3) clinical outcomes (n = 12). Patient-reported symptoms beyond domains included in the ICHOM lung cancer set in 2016 were insomnia, nausea, vomiting, anxiety, depression, lack of appetite, gastric problems, constipation, diarrhoea, dysphagia, and haemoptysis. CONCLUSIONS: We will implement the lung cancer COS in Europe within the H2O initiative by collecting the outcomes through a combination of clinician-reported measures and PRO measures. The COS will support the adoption and reporting of lung cancer measures in a standardized way across Europe and empower patients with lung cancer to better manage their health care.