Evaluation of electronic patient-reported outcome assessment in inpatient cancer care: a feasibility study.

PURPOSE: Patient-reported outcome (PRO) measures are increasingly important in evaluating medical care. The increased integration of technology within the healthcare systems allows for collection of PROs electronically. The objectives of this study were to Ashley et al. J Med Internet Res (2013) implement an electronic assessment of PROs in inpatient cancer care and test its feasibility for patients and Dawson et al. BMJ (2010) determine the equivalence of the paper and electronic assessment. METHODS: We analyzed two arms from a study that was originally designed to be an interventional, three-arm, and multicenter inpatient trial. A self-administered questionnaire based on validated PRO-measures was applied and completed at admission, 1 week after, and at discharge. For this analysis - focusing on feasibility of the electronic assessment - the following groups will be considered: Group A (intervention arm) received a tablet version, while group B (control arm) completed the questionnaire on paper. A feasibility questionnaire, that was adapted from Ashley et al. J Med Internet Res (2013), was administered to group A. RESULTS: We analyzed 103 patients that were recruited in oncology wards. ePRO was feasible to most patients, with 84% preferring the electronic over paper-based assessment. The feasibility questionnaire contained questions that were answered on a scale ranging from "1" (illustrating non achievement) to "5" (illustrating achieving goal). The majority (mean 4.24, SD .99) reported no difficulties handling the electronic tool and found it relatively easy finding time for filling out the questionnaire (mean 4.15, SD 1.05). There were no significant differences between the paper and the electronic assessment regarding the PROs. CONCLUSION: Results indicate that electronic PRO assessment in inpatient cancer care is feasible.

The association of Health-Related Quality of Life and 1-year-survival in sarcoma patients-results of a Nationwide Observational Study (PROSa).

BACKGROUND: Sarcomas are rare cancers of high heterogeneity. Health-Related Quality of Life (HRQoL) has been shown to be a prognostic factor for survival in other cancer entities but it is unclear whether this applies to sarcoma patients. PATIENTS AND METHODS: HRQoL was prospectively assessed in adult sarcoma patients from 2017 to 2020 in 39 German recruiting sites using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Vital status was ascertained over the course of 1 year. HRQoL domains were analysed by multivariable cox-regressions including clinical and socio-economic risk factors. RESULTS: Of 1102 patients, 126 (11.4%) died during follow-up. The hazard ratio (HR) for global health was 0.73 per 10-point increase (95% confidence interval (CI) 0.64-0.85). HR for the HRQoL-summary score was 0.74 (CI 0.64-0.85) and for physical functioning 0.82 (CI 0.74-0.89). There was also evidence that fatigue (HR 1.17, CI 1.10-1.25), appetite loss (HR 1.15, CI 1.09-1.21) and pain (HR 1.14, CI 1.08-1.20) are prognostic factors for survival. CONCLUSION: Our study adds sarcoma-specific evidence to the existing data about cancer survival in general. Clinicians and care-givers should be aware of the relations between HRQoL and survival probability and include HRQoL in routine assessment.

Distress in soft-tissue sarcoma and gastrointestinal stromal tumours patients-Results of a German multicentre observational study (PROSa).

OBJECTIVE: Soft tissue sarcomas (STS) and gastrointestinal stromal tumours (GIST) are a group of rare malignant tumours with a high and heterogenous disease burden. As evidence is scarce, we analysed the prevalence of increased emotional distress and identified distress-associated factors in these patients. METHODS: The PROSa-study (Burden and medical care of sarcoma) was conducted between 2017 and 2020 in 39 study centres. Cross-sectional data from adult STS and GIST patients were analysed. Distress was measured with the Patient Health Questionnaire (PHQ-4). The relation of socioeconomic and clinical factors with distress was explored in adjusted logistic regression models. RESULTS: Among 897 patients, 17% reported elevated anxiety and 19% reported depression. Unemployed patients (odds ratio [OR] 6.6; 95% CI 2.9-15.0), and those with a disability pension (OR 3.1; 95% CI 1.9-5.0) were more likely to experience distress compared to employed patients. Also, patients with a disability pass had higher odds of increased distress than those without (OR 1.8; 95% CI 1.2-2.7). Lowest distress was observed in patients 2 to <5 years and ≥5 years after diagnosis (comparison: <6 months) (OR 0.4; 95% CI 0.2-0.6) and (0.3; 95% CI 0.2-0.6). Patients with thoracic STS (vs. lower limbs) had twice the odds to experience distress (OR 2.0; 95% CI 1.1-3.6). Distress was seen almost twice as often in patients with progressive disease (vs. complete remission) (OR 1.7; 95% CI 1.1-2.8). CONCLUSION: The prevalence of elevated distress in STS and GIST patients is high. In unemployed patients, in those with a disability pension and in newly diagnosed patients a noticeable increase was observed. Clinicians should be aware of these factors and consider the social aspects of the disease.

Financial toxicity in sarcoma patients and survivors in Germany: results from the multicenter PROSa study.

PURPOSE: Cancer patients have been shown to frequently suffer from financial burden before, during, and after treatment. However, the financial toxicity of patients with sarcoma has seldom been assessed. Therefore, the aim of this study was to evaluate whether financial toxicity is a problem for sarcoma patients in Germany and identify associated risk factors. METHODS: Patients for this analysis were obtained from a multicenter prospective cohort study conducted in Germany. Using the financial difficulties scale of the EORTC QLQ-C30, financial toxicity was considered to be present if the score exceeded a pre-defined threshold for clinical importance. Comparisons to an age- and sex-matched norm population were performed. A multivariate logistic regression using stepwise backward selection was used to identify factors associated with financial toxicity. RESULTS: We included 1103 sarcoma patients treated in 39 centers and clinics; 498 (44.7%) patients reported financial toxicity. Sarcoma patients had 2.5 times the odds of reporting financial difficulties compared to an age- and sex-matched norm population. Patient age < 40 and > 52.5 years, higher education status, higher income, and disease progression (compared to patients with complete remission) were associated with lower odds of reporting financial toxicity. Receiving a disability pension, being currently on sick leave, and having a disability pass were statistically significantly associated with higher odds of reporting financial toxicity. CONCLUSION: Financial toxicity is present in about half of German sarcoma patients, making it a relevant quality of life topic for patients and decision-makers.

Quality of life of GIST patients with and without current tyrosine kinase inhibitor treatment: Cross-sectional results of a German multicentre observational study (PROSa).

OBJECTIVE: We investigated the health-related quality of life (HRQoL) of patients with gastrointestinal stromal tumours (GIST). METHODS: In the multicentre PROSa study, the HRQoL of adult GIST patients was assessed between 2017 and 2019 using the European Organisation for Research and Treatment of Cancer HRQoL questionnaire (EORTC QLQ-C30). We performed group comparisons and multivariate linear regressions. RESULTS: Among 130 patients from 13 centres, the mean global HRQoL was 63.3 out of 100 points. Higher sores indicate better HRQoL. The highest restrictions were in emotional, social, role functioning, insomnia, fatigue, and pain. In multivariate linear regression, we found no significant differences between patients receiving tyrosine kinase inhibitor (TKI) treatment and those without TKI treatment as well as between patients treated with curative or with palliative intent. Patients who received multiple lines of TKI treatment had the most restrictions, notably in physical (unstandardized regression coefficient [B] = -15.7), role (B = -25.7), social (B = -18.4), and cognitive functioning (B = -19.7); fatigue (B = 15.93); general health (B = -14.23); and EORTC-sum score (B = -13.82) compared to all other patients. CONCLUSION: The highest HRQoL restrictions were in GIST patients receiving multiple lines of TKI therapy. Underlying causes need further investigation.

Benefits and risks of a percutaneous endoscopic gastrostomy (PEG) for decompression in patients with malignant gastrointestinal obstruction.

PURPOSE: Gastrointestinal obstruction presents many burdens for patients with end-stage abdominal cancer, such as nausea and vomiting. Few detailed data on the efficacy of a percutaneous endoscopic gastrostomy (PEG) for decompression exists. This retrospective cohort study investigates the quantity of symptom relief realized with PEG and the corresponding complications. METHODS: Chart reviews of 75 patients with malignant gastrointestinal obstruction, who received a PEG for decompression, were performed. Abstracted data includes symptoms (vomiting, nausea, abdominal pain) and medication up to 7 days before and after the intervention, complications, demographics, potential influencing factors and survival. Generalized estimating equations (GEE) models determined symptom reduction. RESULTS: PEG decreased the mean frequency of vomiting per day from 2.2 (95% confidence interval (CI) 1.7-2.7) to 0.4 (95% CI 0.3-0.6) (p < 0.001). The probability of the occurrence of nausea on a given day was 80% (95% CI 74-85%) prior to the PEG placement and 40% (95% CI 34-47%) afterwards (p < 0.001). One hundred twelve complications were reported in 56 patients (none 19/75 patients (25%), minor 52/75 (69%), major 18/75 (24%)). Stomal leakage (18/75 patients), mild wound pain (17/75) and tube occlusion (13/75) occurred most frequently. The failure of the first attempt of the PEG placement (7/75) presented as the leading major complication. CONCLUSIONS: The PEG for decompression significantly reduces vomiting and nausea in patients with malignant gastrointestinal obstruction (p < 0.001). Minor complications are common and should be discussed prior to the intervention. Nevertheless, the PEG appears to demonstrate prevailing benefits in comparison to the risks.

Efficacy and safety of Dexrazoxane (DRZ) in sarcoma patients receiving high cumulative doses of anthracycline therapy - a retrospective study including 32 patients.

BACKGROUND: Anthracyclines, as the most effective therapy, are the cornerstone of advanced stage sarcoma treatment. However, anthracyclines can also contribute to myocardial dysfunction and congestive heart failure, ultimately limiting the therapeutic potential of the drug. Coadministration of Dexrazoxane has been shown to effectively reduce cardiotoxicity, however primarily in patients suffering in diseases other than sarcoma. METHODS: The aim of this retrospective analysis was to evaluate safety and efficacy of chemotherapy with high cumulative doses of anthracyclines in combination with Dexrazoxane. The medical charts of 32 patients treated in four institutions were analyzed. Reasons for coadministration were rechallenge, reaching the cumulative anthracycline dose and preexisting heart failure. RESULTS: The median age was 54 years [18-68 years]. The median cumulative anthracycline dose before adding DRZ was 450 mg/m(2) and after administration of last anthracycline containing therapy 750 mg/m(2). Either during treatment or follow up, 2/27 patients (7 %) without preexisting major cardiac findings developed anthracycline-induced cardiotoxicity. The median overall survival (OS) from start of the first anthracycline containing chemotherapy was 46 months and 17 months from the initial coadministration of DRZ. At rechallenge, the median progression free survival (PFS) with DRZ was 7 months. In continuous therapy, the median PFS was 13 months from beginning of chemotherapy and 9 months from the addition of DRZ. CONCLUSION: Chemotherapy with high cumulative doses of anthracyclines in addition with DRZ demonstrated a remarkable OS in these advanced disease patients. Cardiac side-effects due to high cumulative doses of anthracyclines requiring discontinuation of anthracycline treatment were rare. A PFS of 9 months from the beginning of the coadministration of DRZ indicates that continuing anthracycline therapy beyond established cumulative doses is a promising therapeutic option.

Implementation of a mobile inpatient quality of life (QoL) assessment for oncology nursing.

PURPOSE: Cancer patients suffer from a variety of symptoms, but little is known about changes during hospitalization and symptom burden at discharge. We implemented an electronic quality of life (QoL) assessment used by the nursing team in routine inpatient care. Feasibility, acceptance, and the course of QoL were investigated. METHODS: A self-administered electronic questionnaire based on the EQ-5D and the EORTC QLQ-C30 was applied in clinical routine. Cancer patients were approached by the nursing staff to complete the QoL assessment twice, at admission and at the day of discharge. Both the feedback of the nursing staff as well as characteristics of participants were used to evaluate the electronic assessment. RESULTS: Out of 210 patients from an oncologic ward, 85 patients (40 %) were invited to participate, 95 % of whom (n = 81) agreed to participate. Participation rate depended on the day of admission, the presence of the coordinating nurse, the overall morbidity assessed by patient clinical complexity level, and the patient age. Forty-six patients (56 %) asked for assistance in completing the questionnaire. Patients older than 53 years and male patients were more likely to need assistance. Twenty-two percent of the nursing staff (n = 5) use the information assessed for individual patient care. Fifty-two percent (n = 12) rated the additional workload as very little or little and 68 % (n = 15) agreed that handling for the patient was easy. Global QoL improved during the stay. Most severe symptoms at admission included fatigue, pain, appetite loss, and insomnia. CONCLUSIONS: The results of this study indicate that it is feasible to implement and use an electronic QoL assessment by the nursing staff in routine inpatient cancer care. Obstacles and worries of staff members have to be considered when further developing this program.

Histological response assessment following neoadjuvant isolated limb perfusion in patients with primary, localised, high-grade soft tissue sarcoma.

PURPOSE: Histological response assessment following neoadjuvant treatment can help identify patients at a higher risk for systemic disease progression. Our goal was to evaluate whether mitotic count and the amount of viable tumour following neoadjuvant isolated limb perfusion (ILP) for primary, locally advanced, non-metastatic, high-grade extremity soft tissue sarcoma correlate with prognosis. PATIENTS AND METHODS: This study is a retrospective analysis of 61 patients who underwent neoadjuvant ILP followed by surgical resection with curative intent between 2001 and 2011. Non-parametric analyses were carried out with the Mann-Whitney U and the Wilcoxon signed-rank test. Survival curves were calculated with the Kaplan-Meier method and compared with the log-rank test. RESULTS: The median follow-up was 44 months for all patients and 55 months for survivors. The amount of viable tumour after ILP had no correlation with overall (OS) (P = 0.227) or event-free (EFS) (P = 0.238) survival probability. Patients with a low mitotic count after ILP had a significantly higher OS (P < 0.001), EFS (P = 0.002) and post-relapse survival probability (P = 0.030) compared to patients with an intermediate or high mitotic count. CONCLUSIONS: The mitotic count following ILP for primary, high-grade, locally advanced, non-metastatic soft tissue sarcoma appears to significantly correlate with prognosis. If these results are validated in a prospective setting, they could provide a rationale for the design of adjuvant systemic chemotherapy trials with the goal of improving the prognosis of patients with an intermediate or high mitotic count after ILP.

Gemcitabine and docetaxel for epithelioid sarcoma: results from a retrospective, multi-institutional analysis.

OBJECTIVE: Epithelioid sarcoma (ES) presents unique clinical features in comparison to other sarcoma subtypes. Data regarding the benefits of chemotherapy are very limited. Combination regimens using gemcitabine and docetaxel (Gem/Doce) have proven to be effective, especially in uterine and nonuterine leiomyosarcoma. Yet, there is no available data on the efficacy of Gem/Doce in ES. METHODS: A retrospective analysis of the three participating institutions was performed. Twenty-eight patients with an ES diagnosis presented at one of the participating institutions between 1989 and 2012. Of this group, 17 patients received chemotherapy. RESULTS: Patients' median overall survival (OS) after the beginning of palliative chemotherapy was 21 months, and the 1-year OS was 87%. Twelve patients received Gem/Doce with a clinical benefit rate of 83%. The median progression-free survival (PFS) was 8 months for all patients receiving Gem/Doce. The best response was complete remission in 1 patient and partial remission in 6 patients. All 6 patients receiving Gem/Doce as a first-line treatment showed measurable responses with a median PFS of 9 months. CONCLUSIONS: In this retrospective study, Gem/Doce was an effective chemotherapeutic regimen for ES. Prospective studies are needed to better assess the effects of this combination drug therapy.

Geriatric Assessment of Older Patients Receiving Trabectedin in First-Line Treatment for Advanced Soft Tissue Sarcomas: The E-TRAB Study from The German Interdisciplinary Sarcoma Group (GISG-13).

E-TRAB was a non-interventional, prospective trial investigating the feasibility and predictive value of geriatric assessments (GA) in older STS patients treated with trabectedin as first-line therapy. Primary endpoints were overall survival (OS), quality of life and individual clinical benefit assessed by the patient-reported outcome measures QLQ-C30 and PRO-CTCAE. Further, several GA tools were applied and correlated with clinical outcomes and treatment-related toxicities. The final analyses included 69 patients from 12 German-speaking sites. The median age of patients was 78 years (range: 55 to 88). Baseline data on PROs and GA identified a diverse population of older patients with respect to their global health status, although a large proportion of them suffered from limitations, required geriatric help and had a high risk of morbidity. The Cancer and Age Research Group (CARG) score classified 38%, 29% and 23% of the patients with low, intermediate and high risks for therapy-related side effects, respectively. Median OS was 11.2 months [95%CI: 5.6; 19.4]. The study confirmed that trabectedin as first-line treatment in older patients with STS has an acceptable and manageable safety profile. Potential prognostic factors for clinical outcome and therapy-related toxicity were identified among the GA tools. Long Timed Up and Go (TUG) showed a significant correlation to OS and early death, whereas a high CARG score (>9) was associated with an increase in unplanned hospitalizations and the incidence of toxicities grade ≥ 3.

Electronic Patient Reported Outcome (ePRO) Measures in Patients with Soft Tissue Sarcoma (STS) Receiving Palliative Treatment.

The PazoQoL prospective, randomized, controlled, multicenter study was designed to continuously assess global health related quality of life (HRQoL) during treatment with pazopanib or physician-preferred chemotherapy over a 9-week period. The questionnaires were completed by the patients at home with great reliability during this time period. Continuous electronic patient reported outcome (ePRO) enabled early detection of the onset of deterioration and timely initiation of countermeasures. The Cancer Therapy Satisfaction Questionnaire (CTSQ) showed high interindividual variability and decline over a 9-week period, whereas the Time Trade-off (TTO) proved to be an efficient method for assessing individual benefit from cancer therapy. In our cohort, the TTO clearly demonstrated that the prolongation of life and the side effect profile of continued therapy were not as satisfactory as expected by patients when starting a new therapy. Although the study had to be stopped early due to the pandemic, our findings could translate into clinical practice without much effort and outside of a trial.

Working situation and burden of work limitations in sarcoma patients: results from the multi-center prospective PROSa study.

PURPOSE: We investigated predictors of limitations in work performance, odds of drop out of work, and odds of receiving disability pension in sarcoma patients. METHODS: We measured clinical and sociodemographic data in adult sarcoma patients and recorded if the patients received a (1) disability pension at baseline or (2) had dropped out of work 1 year after initial assessment. (3) Work limitations were assessed using the Work-limitations questionnaire (WLQ©). We analyzed exploratively. RESULTS: (1) Amongst 364 analyzed patients, odds to receive a disability pension were higher in patients with abdominal tumors, older patients, high grade patients and with increasing time since diagnosis. (2) Of 356 patients employed at baseline, 21% (n = 76) had dropped out of work after 1 year. The odds of dropping out of work were higher in bone sarcoma patients and in patients who received additive radiotherapy ± systemic therapy compared with patients who received surgery alone. Odds of dropping out of work were less amongst self-employed patients and dropped with increasing time since diagnosis. (3) Work limitations were higher in woman and increased with age. Patients with bone and fibrous sarcomas were more affected than liposarcoma patients. Patients with abdominal tumors reported highest restrictions. Sarcoma treatment in the last 6 months increased work limitations. CONCLUSION: Work limitations, drop out of work and dependence on a disability pension occurs frequently in patients with sarcoma adding to the burden of this condition. We were able to identify vulnerable groups in both the socioeconomic and disease categories.

The health-related quality of life of sarcoma patients treated with neoadjuvant versus adjuvant radiotherapy - Results of a multi-center observational study.

AIM: The sequence of radiotherapy and resection in patients with soft tissue sarcomas is usually discussed on an individual basis. Better understanding of potential differences of health-related quality of life (QoL) between patients undergoing adjuvant (ART) versus neoadjuvant radiotherapy (NART) is therefore helpful for clinical decision making. METHODS: Adult sarcoma patients from 39 hospitals completed the European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30). Differences in global QoL, physical functioning, role functioning, fatigue, pain, and insomnia between ART versus NART were investigated with multivariate regression, adjusting for age, gender, chemotherapy, grading, stage, tumor location, recurrence/distant metastasis, sarcoma type, time since last treatment, and treatment status using validated thresholds. RESULTS: A total of 1110 patients participated. Of them, 340 had received radiotherapy (NART: n = 95, 28%; ART: n = 245, 72%). Global QoL was 59.3 on average after NART and 60.5 after ART (Badj = 1.0, p = 0.74). Physical functioning was 65.9 compared to 70.5 (Badj = 4.2; p = 0.16), role function 48.8 vs. 56.7 (Badj = 7.0, p = 0.08), fatigue 47.5 vs. 45.4 (Badj = -1.2; p = 0.71), pain 40.2 vs. 34.1 (Badj = -6.8; p = 0.08), and insomnia 33.7 vs. 41.6 (Badj = 5.5, p = 0.16). Among patients with NART, clinically relevant QoL impairments were less frequent 2 years after treatment compared to < 2 years thereafter (n = 6 vs. n = 4 on average). CONCLUSION: There is little evidence for QoL differences in most domains and overall QoL between the two irradiation groups. However, patients after NART might experience worse role functioning and pain but fewer problems with insomnia compared to patients after ART.

A post hoc analysis of the EPAZ trial: The role of geriatric variables in elderly soft tissue sarcoma patients on toxicity and outcome.

OBJECTIVE: The EPAZ study (NCT01861951) showed recently that pazopanib was non-inferior to doxorubicin in patients ≥60 years treated in first line for advanced soft tissue sarcoma . The current post-hoc analysis aimed to assess the prognostic impact of frailty. METHODS: Geriatric assessments were evaluated at baseline. Age >75 years, liposarcoma, ECOG = 2, G8 ≤14, instrumental activities of daily living (IADL) ≥1 and Charlson Comorbidity Index ≥2 were tested for their impact on progression-free survival (PFS), overall survival (OS), CTCAE grade 3/4 adverse events (AEs) or serious AEs (SAEs), using univariate and multivariate analysis models. RESULTS: univariate analysis showed an increased risk of grade 3/4 AEs and SAEs for ECOG = 2, G8 score ≤14 or IADL ≥1, independent of treatment. The multivariate analysis exhibited for pazopanib a significantly reduced risk for grade 3/4 AEs (HR 0.53; p = 0.033), and in patients with G8 ≤14 an increased risk for SAEs (HR 2.67; p = 0.011). In the multivariate analysis, G8 ≤14 was a negative prognostic factor for PFS (HR 1.82; p = 0.009) and IADL ≥1 for OS (HR 2.02; p = 0.007). ECOG = 2 was the strongest negative predictor for PFS (HR 4.39; p = 0.001) and OS (HR 3.74; p = 0.004). Neither age nor Charlson Comorbidity Index showed any impact on PFS, OS, incidence of grade 3/4 AEs or SAEs. CONCLUSIONS: This post hoc analysis demonstrated that age is not a denominator for outcome or toxicity in elderly patients with soft tissue sarcoma . Instead, geriatric and functional assessments should be used to counsel patients and tailor therapy to individual needs. Moreover, pazopanib has a reduced risk for grade 3/4 AEs compared to doxorubicin.

Health related Quality of Life over time in German sarcoma patients. An analysis of associated factors - results of the PROSa study.

Introduction: Sarcomas are rare cancers and very heterogeneous in their location, histological subtype, and treatment. Health-Related Quality of Life (HRQoL) of sarcoma patients has rarely been investigated in longitudinal studies. Methods: Here, we assessed adult sarcoma patients and survivors between September 2017 and February 2020, and followed-up for one year in 39 study centers in Germany. Follow-up time points were 6 (t1) and 12 months (t2) after inclusion. We used a standardized, validated questionnaire (the European Organisation for Research and Treatment of Cancer Quality of Life Core Instrument (EORTC QLQ-C30) and explored predictors of HRQoL in two populations (all patients (Analysis 1), patients in ongoing complete remission (Analysis 2)) using generalized linear mixed models. Results: In total we included up to 1111 patients at baseline (915 at t1, and 847 at t2), thereof 387 participants were in complete remission at baseline (334 at t1, and 200 at t2). When analyzing all patients, HRQoL differed with regard to tumor locations: patients with sarcoma in lower extremities reported lower HRQoL values than patients with sarcomas in the upper extremities. Treatment which included radiotherapy and/or systemic therapy was associated with lower HRQoL. For patients in complete remission, smoking was associated with worse HRQoL-outcomes. In both analyses, bone sarcomas were associated with the worst HRQoL values. Being female, in the age group 55-<65 years, having lower socioeconomic status, and comorbidities were all associated with a lower HRQoL, in both analyses. Discussion: HRQoL increased partially over time since treatment and with sporting activities. HRQoL improved with time since treatment, although not in all domains, and was associated with lifestyle and socioeconomic factors. Bone sarcomas were the most affected subgroup. Methods to preserve and improve HRQoL should be developed for sarcoma patients.

Transferability of Health-Related Quality of Life Data of Large Observational Studies to Clinical Practice: Comparing Retroperitoneal Sarcoma Patients from the PROSa Study to a TARPS-WG Cohort.

INTRODUCTION: Health-related quality of life (HRQoL) is crucial for shared decision-making. The "Patient-Reported Outcome measures in Sarcoma" (PROSa) study evaluated HRQoL in general. We evaluated the transferability of PROSa data to clinical practice for the subgroup of retroperitoneal sarcoma (RPS). METHODS: To obtain a PROSa-RPS cohort, we excluded patients with bone sarcomas and gastrointestinal stromal tumors from the complete PROSa cohort (n = 1,113), limited tumor localization to trunk and retroperitoneum, and excluded patients with metastases. We evaluated the HRQoL data of the resulting 76 patients and compared their clinical data to those of the Transatlantic Autralasian Retroperitoneal Sarcoma Working Group (TARPS-WG, n = 1,007). RESULTS: Confidence intervals for patient sex, histological subtype (LPS vs. non-LPS), grading (G1 vs. G2/3), surgical margins (R2 vs. no R2), and perioperative chemo- and radiotherapy (yes vs. no) were overlapping in both cohorts. EORTC QLQ-C30 from RPS-PROSa patients demonstrated that two-thirds had clinically relevant restrictions in physical functioning. Two-thirds reported dyspnea, followed by fatigue and pain. CONCLUSION: Clinical data from RPS-PROSa patients are comparable to those of an RPS reference cohort from expert centers. We believe that HRQoL data of RPS patients extracted from PROSa are transferable to clinical practice.

The Therapeutic Role of Plastic and Reconstructive Surgery in the Interdisciplinary Treatment of Soft-Tissue Sarcomas in Germany-Cross-Sectional Results of a Prospective Nationwide Observational Study (PROSa).

Although the involvement of plastic surgery has been deemed important in the treatment of sarcoma patients to avoid oncological compromises and ameliorate patient outcomes, it is not ubiquitously available. The accessibility of defect reconstruction and its therapeutic impact on sarcoma care is the subject of this analysis. Cross-sectional data from 1309 sarcoma patients were collected electronically at 39 German study centers from 2017 to 2019. A total of 621 patients with surgical treatment for non-visceral soft-tissue sarcomas were included. The associated factors were analyzed exploratively using multifactorial logistic regression to identify independent predictors of successful defect reconstruction, as well Chi-squared and Cochran-Mantel-Haenszel tests to evaluate subgroups, including limb-salvage rates in extremity cases. A total of 76 patients received reconstructive surgery, including 52 local/pedicled versus 24 free flaps. Sarcomas with positive margins upon first resection (OR = 2.3, 95%CI = 1.2-4.4) that were excised at centers with lower degrees of specialization (OR = 2.2, 95%CI = 1.2-4.2) were independently associated with the need for post-oncological defect coverage. In this context, the inhouse availability of plastic surgery (OR = 3.0, 95%CI = 1.6-5.5) was the strongest independent predictor for successful flap-based reconstruction, which in turn was associated with significantly higher limb-salvage rates (OR = 1.4, 95%CI = 1.0-2.1) in cases of extremity sarcomas (n = 366, 59%). In conclusion, consistent referral to specialized interdisciplinary sarcoma centers significantly ameliorates patient outcomes by achieving higher rates of complete resections and offering unrestricted access to plastic surgery. The latter in particular proved indispensable for limb salvage through flap-based defect reconstruction after sarcoma resection. In fact, although there remains a scarcity of readily available reconstructive surgery services within the current sarcoma treatment system in Germany, plastic and reconstructive flap transfer was associated with significantly increased limb-salvage rates in our cohort.

Medical Care and Survival of Soft-Tissue and Bone Sarcoma Patients: Results and Methodological Aspects of a German Subnational Cohort Study Based on Administrative Healthcare Data.

INTRODUCTION: Medical care of soft-tissue sarcoma (STS) and bone sarcoma (BS) patients in Germany has rarely been investigated. The objectives of this article were (1) to investigate medical care and survival in STS and BS patients, and (2) to examine methodological aspects of corresponding analyses based on administrative healthcare data. METHODS: We analyzed data from a statutory health insurance located in Saxony, Germany, covering approximately 2 million individuals. We identified incident STS and BS patients in the period 2012-2016 using 4 different case definitions. We examined treatment rates and visits to medical oncologists and medical practices descriptively, and then compared results between case definitions. We investigated survival prospects using a relative survival analysis and estimated hazard ratios (HRs) for risk factors for mortality using Cox regression. RESULTS: Across case definitions, the number of included sarcoma patients (STS: n = 871-1,757; BS: n = 216-689) and applied treatments (STS: 42.2-83.1%; BS: 28.3-77.8%) varied substantially. Irrespective of the case definition, the minority of patients visited medical oncologists (STS: 9.8-10.8% BS: 4.4-7.9%) and "experienced" medical practices (STS: 27.7-38.4%; BS: 18.3-23.6%). Survival prospects were better for patients who visited "experienced" medical practices (STS: HR = 0.55; BS: HR = 0.42). CONCLUSION: Treatment rates clearly <100% and evidence from survival analyses indicate the potential for improvements in the care of sarcoma patients in Germany, e.g., by physicians in "experienced" medical practices.

Utilization of Interdisciplinary Tumor Boards for Sarcoma Care in Germany: Results from the PROSa Study.

BACKGROUND: Data on institutional structures of sarcoma care in Germany are scarce. The utilization of an interdisciplinary tumor board (IDTB) is an essential part of modern cancer care. We investigated to which extent and when IDTB are used in sarcoma care. We hypothesized that IDTB before treatment initiation were used more often at certified cancer centers and at high-volume centers and that IDTB utilization increased over time. METHODS: From 2017 to 2020 we conducted a prospective cohort study, undertaking major efforts to include the whole spectrum of sarcoma treatment facilities. To analyze potential predictors of IDTB utilization, we calculated multivariable logistic regressions. RESULTS: Patients and survivors (n = 1,309) from 39 study centers (22 tertiary referral hospitals, 9 other hospitals, and 8 office-based practices) participated; 88.3% of the patients were discussed at some stage of their disease in an IDTB (56.1% before treatment, 78% after therapy, and 85.9% in metastatic disease). Hypotheses were confirmed regarding the utilization of IDTB in certified cancer centers (vs. all others: OR = 5.39; 95% CI 3.28-8.85) and the time of diagnosis (2018/2019 vs. until 2013: OR = 4.95; 95% CI 2.67-9.21). CONCLUSION: Our study adds to the evidence regarding the institutional structures of sarcoma care in Germany. Utilization of a tumor board before therapy seems to be in an implementation process that is making progress but is far from complete. Certification is a possible tool to accelerate this development.