Developing tumor-specific PRO-CTCAE item sets: analysis of a cross-sectional survey in three German outpatient cancer centers.

BACKGROUND: To include the patient perspective in the assessment of adverse events in oncology, a patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (CTCAE) was developed by the US National Cancer Institute, the so called PRO-CTCAE. The objective of this study was the development of disease-specific PRO-CTCAE item sets for patients with breast cancer (BC), multiple myeloma (MM), and prostate cancer (PC). METHODS: The cross-sectional survey was conducted at three German outpatient cancer centers. Prevalence and importance of the 78 PRO-CTCAE symptoms were assessed using a patient questionnaire. To select the most relevant PRO-CTCAE items for each tumor entity, symptoms were ranked based on patient answers. RESULTS: 101 patients with BC, 107 with MM, and 66 with PC participated. The final item sets contained 21 symptoms (BC) or 19 symptoms (MM and PC), respectively. Eight symptoms (fatigue, muscle pain, insomnia, joint pain, general pain, dizziness, shortness of breath, and swelling) were represented in all three item sets. Fatigue was the symptom with the highest ranking across item sets followed by insomnia. Symptoms with the highest rankings represented in only one item set were symptoms affecting the urogenital system in the PC item set, blurred vision in the BC item set, and decreased appetite in the MM item set. CONCLUSIONS: Individual PRO-CTCAE item sets for a German patient population were developed for the three tumor entities on the basis of patients' differences in symptom profiles and perceptions. The quality and psychometric criteria of the newly compiled item sets should be evaluated in validation studies.

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.

Loss of Anks6 leads to YAP deficiency and liver abnormalities.

ANKS6 is a ciliary protein that localizes to the proximal compartment of the primary cilium, where it regulates signaling. Mutations in the ANKS6 gene cause multiorgan ciliopathies in humans, which include laterality defects of the visceral organs, renal cysts as part of nephronophthisis and congenital hepatic fibrosis (CHF) in the liver. Although CHF together with liver ductal plate malformations are common features of several human ciliopathy syndromes, including nephronophthisis-related ciliopathies, the mechanism by which mutations in ciliary genes lead to bile duct developmental abnormalities is not understood. Here, we generated a knockout mouse model of Anks6 and show that ANKS6 function is required for bile duct morphogenesis and cholangiocyte differentiation. The loss of Anks6 causes ciliary abnormalities, ductal plate remodeling defects and periportal fibrosis in the liver. Our expression studies and biochemical analyses show that biliary abnormalities in Anks6-deficient livers result from the dysregulation of YAP transcriptional activity in the bile duct-lining epithelial cells. Mechanistically, our studies suggest, that ANKS6 antagonizes Hippo signaling in the liver during bile duct development by binding to Hippo pathway effector proteins YAP1, TAZ and TEAD4 and promoting their transcriptional activity. Together, this study reveals a novel function for ANKS6 in regulating Hippo signaling during organogenesis and provides mechanistic insights into the regulatory network controlling bile duct differentiation and morphogenesis during liver development.

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.

The underestimated burden of monogenic kidney disease in adults waitlisted for kidney transplantation.

PURPOSE: Chronic kidney disease (CKD) is a major health-care burden. Increasing evidence suggests that a considerable proportion of patients are affected by a monogenic kidney disorder. METHODS: In this study, the kidney transplantation waiting list at the Charité was screened for patients with undetermined cause of CKD. By next-generation sequencing (NGS) we targeted all 600 genes described and associated with kidney disease or allied disorders. RESULTS: In total, 635 patients were investigated. Of these, 245 individuals had a known cause of CKD (38.5%) of which 119 had a proven genetic disease (e.g., ADPKD, Alport). The other 340 patients (53.5%) were classified as undetermined diagnosis, of whom 87 had kidney failure (KF) onset <40 years. To this latter group genetic testing was offered as well as to those patients (n = 29) with focal segmental glomerulosclerosis (FSGS) and all individuals (n = 21) suspicious for thrombotic microangiopathy (TMA) in kidney biopsy. We detected diagnostic variants in 26 of 126 patients (20.6%) of which 14 of 126 (11.1%) were pathogenic or likely pathogenic. In another 12 of 126 (9.5%) patients, variants of unknown significance (VUS) were detected. CONCLUSION: Our study demonstrates the diagnostic value of comprehensive genetic testing among patients with undetermined CKD.

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.

Cancer patients' control preferences in decision making and associations with patient-reported outcomes: a prospective study in an outpatient cancer center.

PURPOSE: "Shared decision making" has been proposed as a prerequisite of patient-centered care. However, little is known on factors, which may influence cancer patients' decision control preferences (DCP) in routine care. This study investigated possible determinants of the patients' DCP with respect to patient characteristics and patient-reported outcomes (PROs). METHODS: Consecutive patients presenting at a comprehensive cancer center between May 2014 and October 2014 were offered a self-administered electronic questionnaire including standardized PRO measures and patients' DCP. Results were linked with patient characteristics from the hospital information system and analyzed using cross-sectional methods. RESULTS: Out of 126 patients participating, 102 (81%; 65% male; mean age 62 years) completed the DCP-item. Overall, 49% (n = 50) preferred shared treatment decision responsibility, 29% (n = 30) preferred to leave the control to his/her physician, whereas 22% (n = 22) preferred to be in control of his/her treatment decision. Higher age (p = 0.035) and elevated distress levels (p = 0.038) were significantly associated with an increased willingness to leave the decision control to the physician. Further sociodemographic and PRO measures were not associated with patients' DCP. CONCLUSION: Our findings demonstrate that DCP assessment in routine cancer care is possible and provides important information to the treating oncologist. Information on DCP combined with PRO may contribute to more individualized decision making in cancer care.

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.

Electronic real-time assessment of patient-reported outcomes in routine care-first findings and experiences from the implementation in a comprehensive cancer center.

PURPOSE: Cancer patients suffer from a variety of physical and mental complaints. Since physician assessment of symptoms seems insufficient to reveal the complete range of patients' ailments, patient-reported outcomes (PRO) have become of key importance in modern cancer treatment. The implementation and first results of a systematic electronic real-time assessment of PRO in routine care is described. METHODS: Consecutive patients presenting for the first time to a German comprehensive cancer center were asked to fill in an adaptive self-administered electronic questionnaire consisting of standardized PRO measures. After completion, patient-reported data was linked to the patients' medical files for discussion in the first consultation with the treating physician. Interviews with staff were conducted to identify barriers in implementation. RESULTS: Out of 160 cancer patients, 126 (79 %; mean age 63 years, 67 % males) agreed to participate. The number of recruited patients increased over time. Of participating patients, 67 % provided complete information on all PRO-related scales. On average, 31 min (range 3-140) were required to fill in the questionnaire. Of participating patients, 53.0 % comprised need for psychooncological support and 62 % revealed moderate to severe psychosocial distress. The mean score for global quality of life according to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) was 55.2 (SD ±25.6). CONCLUSIONS: Comprehensive oncological treatment needs to consider disease symptoms, quality of life, preferences, and comorbidities of individual patients in a structured, standardized, and transparent way. Our findings indicate that an adaptive, self-administered electronic assessment tool for cancer patients to report a broad set of PRO can be feasibly implemented and is well accepted by patients in a realistic setting.

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.

Trabectedin clinical cases: use according to indication in diverse clinical scenarios.

BACKGROUND: Key distinguishing characteristics of trabectedin in the treatment of advanced soft tissue sarcoma are its prolonged tumor control activity in multiple histological subtypes, positive outcomes in translocation-related sarcomas, maintenance of response, option to rechallenge after treatment interruption and lack of cumulative toxicity. Trabectedin is indicated for use in advanced soft tissue sarcoma after failure of anthracyclines and ifosfamide, or as front-line treatment in patients unsuited to receive these agents. METHODS: In this review, cases studies are presented in which trabectedin was used according to its indication but in diverse clinical settings. RESULTS: As second-line treatment of uterine leiomyosarcoma, trabectedin produced prolonged tumor control with good quality of life. In treatment of recurrent synovial sarcoma, the best objective response (partial response) and longest disease control (37 months) was achieved under treatment with trabectedin. As neoadjuvant treatment of undifferentiated pleomorphic sarcoma in a patient unsuited to receive doxorubicin-based chemotherapy, trabectedin induced a pathological response with 85% of necrosis. CONCLUSION: These cases illustrate the broad range of indications for trabectedin in advanced soft tissue sarcoma and highlight how its unique characteristics can be optimized to achieve maximum clinical benefit.

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.

Prognostic relevance of ¹8F-FDG PET uptake in patients with locally advanced, extremity soft tissue sarcomas undergoing neoadjuvant isolated limb perfusion with TNF-α and melphalan.

PURPOSE: The objective of this study was to determine whether (18)F-fluorodeoxyglucose (FDG) positron emission tomography (PET) can adequately assess the risk of systemic disease progression in patients with primary, localized, high-grade soft tissue sarcomas of the extremities undergoing neoadjuvant isolated limb perfusion (ILP) with tumour necrosis factor and melphalan. METHODS: This was a retrospective analysis of the files of 35 patients who underwent a PET or PET/CT scan prior to and after ILP followed by surgical resection with curative intent between 2006 and 2012. SUVmax1 was defined as the maximum standardized uptake value (SUV) at diagnosis, SUVmax2 as the maximum SUV after ILP and ΔSUVmax as the percentage difference between SUVmax1 and SUVmax2. RESULTS: The median follow-up was 40 months for all patients. The median SUVmax1 amounted to 7.6, while the median SUVmax2 was 4.7. The median ΔSUVmax was -44%. Overall survival (OS) probability at 2 and 5 years amounted to 78 and 70%, respectively, while metastasis-free survival (MFS) probability at 2 and 5 years was 67 and 64%, respectively. Receiver-operating characteristic (ROC) curve analysis showed that both SUVmax2 and ΔSUVmax could predict systemic disease progression, while SUVmax1 could not adequately identify patients who went on to develop metastatic disease. The optimal cut-off value was 6.9 for SUVmax2 and -31 % for ΔSUVmax. Patients with an SUVmax2 <6.9 had a 2-year MFS of 80%, compared to 31 % for patients with an SUVmax2 ≥ 6.9 (p < 0.001). Patients with a ΔSUVmax < -31 %, i.e. patients with a higher metabolic response, had an MFS of 76% at 2 years, compared to 42% for patients with a ΔSUVmax ≥ -31% (p = 0.050). CONCLUSION: SUVmax after ILP for primary, locally advanced, non-metastatic high-grade soft tissue sarcomas of the extremities appears to be significantly correlated with prognosis. Whether patients with a high SUVmax after ILP will benefit from standard or experimental adjuvant systemic treatment options should be evaluated in future studies.

Adult inguinoscrotal sarcomas: outcome analysis of 21 cases, systematic review of the literature and meta-analysis.

PURPOSE: Inguinoscrotal sarcomas are exceedingly rare tumors. The aim of this study was to enable clinicians an easy and rapid access to the available information on this tumor entity. METHODS: An updated series of 21 men treated for sarcoma of the inguinoscrotal region at our institution between 1992 and 2012 was analyzed, and a systematic review of the literature with meta-analysis of outcome data was performed. The review was focused on demographic data, survival rates, prognostic factors, sites of relapse and complete remissions or successful treatments for metastatic disease. RESULTS: With only 38 %, the proportion of high-grade tumors in our sample was lower than reported in the literature and the 10-year relapse-free, disease-specific and overall survival rates were favorable with 77, 93 and 81 %. Beside our series, twelve studies including 345 patients were identified in the literature. The weighed mean 10-year relapse-free, disease-specific and overall survival rates were 63, 64 and 50 %. Only in patients with rhabdomyosarcoma, durable control of metastatic disease has been reported in more than one case (n = 4). Successful treatment in these cases consisted of a combination of complete surgical resection of metastatic lesions, subsequent chemotherapy and (optional) radiotherapy. CONCLUSIONS: Overall, about two-thirds of inguinoscrotal sarcomas may be cured. In series with a predominance of low-grade tumors, the long-term survival rates in completely excised inguinoscrotal sarcomas may be as favorable as in testicular germ cell tumors. Life-long surveillance is advisable to detect late recurrences.

Medication Risks and Their Association with Patient-Reported Outcomes in Inpatients with Cancer.

BACKGROUND: We aimed to assess medication risks and determine factors influencing the health-related quality of life (HRQOL) in cancer inpatients. METHODS: A retrospective analysis was conducted to identify drug-related problems (DRPs) based on medication reviews, including patient-reported outcomes (PROs). Multiple linear regression analyses were performed to identify sociodemographic, disease-related, and drug therapy-related factors influencing changes from hospital admission to discharge in the scales of the EORTC QLQ-C30 questionnaire. RESULTS: A total of 162 inpatients with various hematological and solid cancer diseases was analyzed. Patients received a mean of 11.6 drugs and 92.6% of patients exhibited polymedication resulting in a mean of 4.0 DRPs per patient. Based on PRO data, 21.5% of DRPs were identified. Multiple linear regression models described the variance of the changes in global HRQOL and physical function in a weak-to-moderate way. While drug therapy-related factors had no influence, relapse status and duration of hospital stay were identified as significant covariates for global HRQOL and physical function, respectively. CONCLUSION: This analysis describes underlying DRPs in a German cancer inpatient population. PROs provided valuable information for performing medication reviews. The multiple linear regression models for global HRQOL and physical function provided explanations for changes during hospital stay.