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Comprehensive Cancer Care stands for a concept of broad care providing substantial benefits to cancer patients. Beside prevention of cancer as first pillar and curative therapy as second pillar, comprehensive care also encompasses palliative care representing a third pillar providing service for incurable cancer patients burdened with physical symptoms and psychological, social and spiritual needs. This article describes the integration of palliative medicine into comprehensive cancer care for patients with gastrointestinal cancer., Competing Interests: Die Autorinnen/Autoren geben an, dass kein Interessenkonflikt besteht., (Thieme. All rights reserved.)

Context: Leading oncology societies recommend monitoring symptoms and support needs through patient-reported outcome measures (PROMs), but their use for assessing specialist palliative care (SPC) need has not yet been explored. Research on SPC integration has focused on staff-assessed screening tools, which are time-consuming., Objectives: This study aimed to assess the diagnostic validity of the Integrated Palliative Outcome Scale (IPOS) and NCCN Distress Thermometer (NCCN DT) in identifying need for SPC in patients with incurable cancer., Methods: In a cross-sectional study, patients with incurable cancer (prognosis <2 years) completed PROMs. In an independent process, the palliative care consultation service (PCCS) assessed the need for SPC in each patient through multiprofessional case review, and this was used as the reference standard. ROC analyses were employed to determine diagnostic validity., Results: Of the 208 participants, 71 (34.1 %) were classified as having SPC need by the PCCS. Aiming for a minimum sensitivity of 80%, a cut-off of ≥2 items with high/very high burden in the IPOS resulted in a 90.2% sensitivity (specificity = 50; AUC = 0.791; CI 95%= 0.724-0.858). A cut-off of ≥5 resulted in a sensitivity of 80 % for NCCN DT (specificity = 49.5 %; AUC = 0.687; CI 95% = 0.596-0.777)., Conclusion: PROMs are useful for identifying SPC need in cancer patients. Their implementation might facilitate timely integration of SPC. Future research should focus on an integrated assessment approach with PROMs that combines the requirements of the different specialties to save patient and staff resources., (Copyright © 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.)

Background: Implications for research (IfR) sections are an important part of systematic reviews (SRs) to inform health care researchers and policy makers. PRISMA 2020 recommends reporting IfR, while Cochrane Reviews require a separate chapter on IfR. However, it is unclear to what extent SRs discuss IfR. We aimed i) to assess whether SRs include an IfR statement and ii) to evaluate which elements informed IfR statements., Methods: We conducted a meta-research study based on SRs of interventions in advanced cancer patients from a previous project (CRD42019134904). As suggested in the Cochrane Handbook, we assessed if the following predefined variables were referred to in IfR statements: patient, intervention, control, outcome (PICO) and study design; concepts underlying Grading of Recommendations, Assessment, Development and Evaluation (GRADE) domains: risk of bias, inconsistency, indirectness, imprecision, publication bias. Data were independently extracted by three reviewers after piloting the data extraction form. Discrepancies were resolved in weekly in-depth discussions., Results: We included 261 SRs. The majority evaluated a pharmacological intervention (n = 244, 93.5%); twenty-nine were Cochrane Reviews (11.1%). Four out of five SRs included an IfR statement (n = 210, 80.5%). IfR statements commonly addressed 'intervention' (n = 121, 57.6%), 'patient ' (n = 113, 53.8%), and 'study design' (n = 107, 51.0%). The most frequent PICO and study design combinations were 'patient and intervention ' (n = 71, 33.8%) and 'patient, intervention and study design ' (n = 34, 16.2%). Concepts underlying GRADE domains were rarely used for informing IfR recommendations: 'risk of bias ' (n = 2, 1.0%), and 'imprecision ' (n = 1, 0.5%), 'inconsistency ' (n = 1, 0.5%). Additional elements informing IfR were considerations on cost effectiveness (n = 9, 4.3%), reporting standards (n = 4, 1.9%), and individual patient data meta-analysis (n = 4, 1.9%)., Conclusion: Although about 80% of SRs included an IfR statement, the reporting of PICO elements varied across SRs. Concepts underlying GRADE domains were rarely used to derive IfR. Further work needs to assess the generalizability beyond SRs in advanced cancer patients. We suggest that more specific guidance on which and how IfR elements to report in SRs of interventions needs to be developed. Utilizing PICO elements and concepts underlying GRADE according to the Cochrane Handbook to state IfR seems to be a reasonable approach in the interim., Registration: CRD42019134904., (© 2023. The Author(s).)

Pain caused by the tumor or aromatase inhibitors (AIs) is a disabling symptom in breast cancer survivors. Their mechanisms are unclear, but pro-algesic and inflammatory mediators seem to be involved. Kinins are endogenous algogenic mediators associated with various painful conditions via B 1 and B 2 receptor activation, including chemotherapy-induced pain and breast cancer proliferation. We investigate the involvement of the kinin B 1 and B 2 receptors in metastatic breast tumor (4T1 breast cancer cells)-caused pain and in aromatase inhibitors (anastrozole or letrozole) therapy-associated pain. A protocol associating the tumor and antineoplastic therapy was also performed. Kinin receptors' role was investigated via pharmacological antagonism, receptors protein expression, and kinin levels. Mechanical and cold allodynia and muscle strength were evaluated. AIs and breast tumor increased kinin receptors expression, and tumor also increased kinin levels. AIs caused mechanical allodynia and reduced the muscle strength of mice. Kinin B 1 (DALBk) and B 2 (Icatibant) receptor antagonists attenuated these effects and reduced breast tumor-induced mechanical and cold allodynia. AIs or paclitaxel enhanced breast tumor-induced mechanical hypersensitivity, while DALBk and Icatibant prevented this increase. Antagonists did not interfere with paclitaxel's cytotoxic action in vitro. Thus, kinin B 1 or B 2 receptors can be a potential target for treating the pain caused by metastatic breast tumor and their antineoplastic therapy., (© 2023. The Author(s).)

Introduction: A range of referral criteria and scores have been developed in recent years to help with screening for the need of specialist palliative care (SPC) in advanced, incurable cancer patients. However, referral criteria have not yet been widely implemented in oncology, as they usually need to be revised by physicians or nurses with limited time resources. To develop an easily applicable screening for the need for SPC in incurable cancer inpatients, we aim to (a) test inter-rater reliability of multiprofessional expert opinion as reference standard for SPC need (phase I) and (b) explore the diagnostic validity of selected patient-reported outcome measures (PROMs) and routine data for the need of SPC (phase II)., Methods and Analysis: Inclusion criteria for patients are metastatic or locally advanced, incurable cancer, ≥18 years of age and informed consent by patient or proxy. (Exclusion criteria: malignant haematological disease as main diagnosis). In phase I, three palliative care consultation teams (PCTs) of three German university hospitals assess the SPC need of 20 patient cases. Fleiss' Kappa will be calculated for inter-rater reliability. In phase II, 208 patients are consecutively recruited in four inpatient oncology wards of Freiburg University Hospital. The PCT will provide assessment of SPC need. As potential referral criteria, patients complete PROMs and a selection of routine data on person, disease and treatment is documented. Logistic regression models and ROC analyses are employed to test their utility in screening for SPC need., Ethics and Dissemination: Our findings will be published in peer-reviewed journals and presented at national and international scientific meetings and congresses. Ethical approval was granted by the Ethics Committee of Albert-Ludwigs-University Freiburg, Germany (approval no. 20-1103)., Trial Registration Number: German Clinical Trials Register, DRKS00021686, registered on 17 December 2020., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Using the Hartung-Knapp method and 95% prediction intervals (PIs) in random-effects meta-analyses is recommended by experts but rarely applied. Therefore, we aimed to reevaluate statistically significant meta-analyses using the Hartung-Knapp method and 95% PIs. In this methodological study, three databases were searched from January 2010 to July 2019. We included systematic reviews reporting a statistically significant meta-analysis of at least four randomized controlled trials in advanced cancer patients using either a fixed-effect or random-effects model. We investigated the impact of switching from fixed-effect to random-effects meta-analysis and of using the recommended Hartung-Knapp method in random-effects meta-analyses. Furthermore, we calculated 95% PIs for all included meta-analyses. We identified 6234 hits, of which 261 statistically significant meta-analyses were included. Our recalculations of these 261 meta-analyses produced statistically significant results in 132 of 138 fixed-effect and 114 of 123 random-effects meta-analyses. When switching to a random-effects model, 19 of 132 fixed-effect meta-analyses (14.4%) were no longer statistically significant. Using the Hartung-Knapp method in random-effects meta-analyses resulted in 34 of 114 nonsignificant meta-analyses (29.8%). In the full sample (N = 261), the null effect was included by the 95% PI in 195 (74.7%) and the opposite effect (e.g., hazard ratio 0.5, opposite effect 2) in 98 meta-analyses (37.5%). Using the Hartung-Knapp method and PIs substantially influenced the interpretation of many published, statistically significant meta-analyses. We strongly encourage researchers to check if using the Hartung-Knapp method and reporting 95% PIs is appropriate in random-effects meta-analyses., (© 2021 The Authors. Research Synthesis Methods published by John Wiley & Sons Ltd.)

Objective: To assess the methodological quality and the consideration of heterogeneity in systematic reviews (SRs)., Study Design and Setting: We conducted a methodological study (CRD42019134904) and searched three databases from January 2010 to July 2019. Interventional SRs with a statistically significant meta-analysis of at least four randomized controlled trials in advanced cancer patients were included. A MeaSurement Tool to Assess Systematic Reviews (AMSTAR) 2 was used to evaluate the SRs' methodological quality. The consideration of heterogeneity was categorized in clinical or/and methodological heterogeneity and not explored., Results: From 6234 identified references, 261 SRs were included. Most SRs had a critically low quality (230, 88.1%). The majority of them (209, 80.1%) was classified as critically low because of non-registration (222, 85.1%) combined with the non-reporting of excluded full-texts and missing justifications for exclusion (218, 83.5%). Heterogeneity in trial results was not explored at all in 51 (19.5%) SRs whereas clinical heterogeneity was considered in 117 (44.8%), methodological heterogeneity in 13 (5.0%), and both clinical and methodological heterogeneity in 80 (30.7%) SRs., Conclusion: The consideration of these findings in trainings for review authors and peer reviewers could improve the awareness of quality criteria and the quality of future SRs., Trial Registration: PROSPERO-ID: CRD42019134904., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Purpose: The aim of this study was to identify symptoms of severe intensity or very low scores for quality of life (QoL) domains in newly diagnosed outpatients with advanced cancer., Methods: This multicenter cohort study from a state-wide palliative care network included adult outpatients with advanced cancer diagnosed within the preceding 8 weeks from four comprehensive cancer centers (DRKS00006162, registered on 19 May 2014). We used the Palliative Outcome Scale (POS), Hospital Anxiety and Depression Scale, and European Organization for Research and Treatment of Cancer QoL Questionnaire-C30. For each questionnaire, cut-off scores defined symptoms and QoL domains that were considered "severe" or "very low.", Results: Of 3155 patients screened, 481/592 (81.3%) were analyzed (mean age 62.4; women n = 245, 50.9%). We identified 324/481 (67.4%) patients experiencing at least one severe symptom or a very low QoL domain (median 2; range 0 to 16). Role functioning (n = 180, 37.4%), fatigue (n = 162, 33.7%), and social functioning (n = 126, 26.2%) were most commonly affected. QoL was very low in 89 patients (18.5%). Women experienced more anxiety symptoms, fatigue, and had lower POS scores. Patients often mentioned physical symptoms and fears of adverse events resulting from disease-modifying therapies (e.g., chemotherapy) as most relevant problems., Conclusions: Already within the first 8 weeks after diagnosis, the majority of patients reported at least one severe symptom or a very low QoL domain. Gender differences were evident. The findings illustrate the value of early routine assessment of patient burden and the development of multi-professional and interdisciplinary palliative care.

Purpose: Transcutaneous electrical nerve stimulation (TENS) is a treatment option for cancer pain, but the evidence is inconclusive. We aimed to evaluate the efficacy and safety of TENS., Methods: A blinded, randomized, sham-controlled pilot cross-over trial (NCT02655289) was conducted on an inpatient specialist palliative care ward. We included adult inpatients with cancer pain ≥ 3 on an 11-point numerical rating scale (NRS). Intensity-modulated high TENS (IMT) was compared with placebo TENS (PBT). Patients used both modes according to their preferred application scheme during 24 h with a 24-h washout phase. The primary outcome was change in average pain intensity on the NRS during the preceding 24 h. Responders were patients with at least a "slight improvement.", Results: Of 632 patients screened, 25 were randomized (sequence IMT-PBT = 13 and PBT-IMT = 12). Finally, 11 patients in IMT-PBT and 9 in PBT-IMT completed the study (N = 20). The primary outcome did not differ between groups (IMT minus PBT: - 0.2, 95% confidence interval - 0.9 to 0.6). However, responder rates were higher in IMT (17/20 [85%] vs. 10/20 [50%], p = 0.0428). Two patients experienced an uncomfortable feeling caused by the current, one after IMT and one after PBT. Seven patients (35%) desired a TENS prescription. Women and patients with incident pain were most likely to benefit from TENS., Conclusion: TENS was safe, but IMT was unlikely to offer more analgesic effects than PBT. Even though many patients desired a TENS prescription, 50% still reported at least "slight pain relief" from PBT. Differences for gender and incident pain aspects demand future trials.

Introduction : Therapeutic drug monitoring in oncology is used to prevent major toxicities of selected anticancer agents due to overexposure by individualizing the dose based on a pharmacokinetic target. Areas covered : Numerous studies relating a relation between pharmacokinetic variability and toxicity have been reported since the eighties but very few have been implemented in clinical practice due to a lack of validation and harmonization, logistical constraints and reluctance from oncologists. Following recent recommendations, this paper highlights the current-validated applications of pharmacokinetic monitoring in oncology focusing on the safety of anticancer therapies. Expert opinion : Paradoxically given the oldness of the agents, guidelines of dose adjustment have been recently available for intravenous busulfan, 5-fluorouracil, and high-dose methotrexate. Interestingly, besides the enhancement of tolerability, it applies to potential curative clinical situations. In an era of personalized oncology that integrates complex molecular factors in the treatment of cancer, education is needed for oncologists to show the benefits of this valuable (even old) resource for the safety of patients. Therapeutic drug monitoring for busulfan, 5-fluorouracil and methotrexate will still hold in the future unless more active agents are available in the concerned indications.

Background: In oncology, pain control is a persistent problem. Significant barriers to cancer pain management are patient related. Pain self-management support interventions have shown to reduce pain intensity and patient-related barriers. Comparative effectiveness research is a suitable approach to test whether effects are sustained in clinical practice., Objective: In this pilot randomized controlled trial, the implementation of the ANtiPain intervention into clinical practice was tested to assess the effects on pain intensity, function-related outcomes, self-efficacy, and patient-related barriers to pain management to prepare a larger effectiveness trial., Methods: Within 14 months, 39 adult oncology patients with pain scores of 3 or higher on a 10-point numeric rating scale were recruited in an academic comprehensive cancer center in Southern Germany. Patients in the control group (n = 19) received standard care. Patients in the intervention group (n = 20) received ANtiPain, a cancer pain self-management support intervention based on 3 key strategies: provision of information, skill building, and nurse coaching. An intervention session was performed in-hospital. After discharge, follow-up was provided via telephone calls. Data were collected at baseline and 1 and 6 weeks after discharge. Effect sizes were calculated for all outcomes., Results: Large effects were found for activity hindrance (Cohen d = 0.90), barriers (d = 0.91), and self-efficacy (d = 0.90). Small to moderate effects were found for average and worst pain (Cohen d = 0.17-0.45)., Conclusions: Key findings of this study involved function-related outcomes and self-efficacy., Implications for Practice: Because these outcomes are particularly meaningful for patients, the integration of ANtiPain to routine clinical practice may be substantial. A larger study will be based on these findings.

Background: The intent of this pooled analysis as part of the German society for radiation oncology (DEGRO) stereotactic body radiotherapy (SBRT) initiative was to analyze the patterns of care of SBRT for liver oligometastases and to derive factors influencing treated metastases control and overall survival in a large patient cohort., Methods: From 17 German and Swiss centers, data on all patients treated for liver oligometastases with SBRT since its introduction in 1997 has been collected and entered into a centralized database. In addition to patient and tumor characteristics, data on immobilization, image guidance and motion management as well as dose prescription and fractionation has been gathered. Besides dose response and survival statistics, time trends of the aforementioned variables have been investigated., Results: In total, 474 patients with 623 liver oligometastases (median 1 lesion/patient; range 1–4) have been collected from 1997 until 2015. Predominant histologies were colorectal cancer (n = 213 pts.; 300 lesions) and breast cancer (n = 57; 81 lesions). All centers employed an SBRT specific setup. Initially, stereotactic coordinates and CT simulation were used for treatment set-up (55%), but eventually were replaced by CBCT guidance (28%) or more recently robotic tracking (17%). High variance in fraction (fx) number (median 1 fx; range 1–13) and dose per fraction (median: 18.5 Gy; range 3–37.5 Gy) was observed, although median BED remained consistently high after an initial learning curve. Median follow-up time was 15 months; median overall survival after SBRT was 24 months. One- and 2-year treated metastases control rate of treated lesions was 77% and 64%; if maximum isocenter biological equivalent dose (BED) was greater than 150 Gy EQD2Gy, it increased to 83% and 70%, respectively. Besides radiation dose colorectal and breast histology and motion management methods were associated with improved treated metastases control., Conclusion: After an initial learning curve with regards to total cumulative doses, consistently high biologically effective doses have been employed translating into high local tumor control at 1 and 2 years. The true impact of histology and motion management method on treated metastases control deserve deeper analysis. Overall survival is mainly influenced by histology and metastatic tumor burden.

Epidermal growth-factor receptor (EGFR) is involved in cell growth and proliferation and is over-expressed in malignant tissues. Although anti-EGFR-based immunotherapy became a standard of care for patients with EGFR-positive tumors, this strategy of addressing cancer tumors by targeting EGFR with monoclonal antibodies is less-developed for patient diagnostic and monitoring. Indeed, antibodies exhibit a slow blood clearance, which is detrimental for positron emission tomography (PET) imaging. New molecular probes are proposed to overcome such limitations for patient monitoring, making use of low-molecular-weight protein scaffolds as alternatives to antibodies, such as Nanofitins with better pharmacokinetic profiles. Anti-EGFR Nanofitin B10 was reformatted by genetic engineering to exhibit a unique cysteine moiety at its C-terminus, which allows the development of a fast and site-specific radiolabeling procedure with 18 F-4-fluorobenzamido-N-ethylamino-maleimide ( 18 F-FBEM). The in vivo tumor targeting and imaging profile of the anti-EGFR Cys-B10 Nanofitin was investigated in a double-tumor xenograft model by static small-animal PET at 2 h after tail-vein injection of the radiolabeled Nanofitin 18 F-FBEM-Cys-B10. The image showed that the EGFR-positive tumor (A431) is clearly delineated in comparison to the EGFR-negative tumor (H520) with a significant tumor-to-background contrast. 18 F-FBEM-Cys-B10 demonstrated a significantly higher retention in A431 tumors than in H520 tumors at 2.5 h post-injection with a A431-to-H520 uptake ratio of 2.53 ± 0.18 and a tumor-to-blood ratio of 4.55 ± 0.63. This study provides the first report of Nanofitin scaffold used as a targeted PET radiotracer for in vivo imaging of EGFR-positive tumor, with the anti-EGFR B10 Nanofitin used as proof-of-concept. The fast generation of specific Nanofitins via a fully in vitro selection process, together with the excellent imaging features of the Nanofitin scaffold, could facilitate the development of valuable PET-based companion diagnostics.

According to the German S3-guideline 'Palliative Medicine' which has been supported by the German Guideline Program in Oncology, constipation in palliative patients requires a consistent prophylaxis and therapy. Constipation is caused by immobilisation, poor health, exsiccosis, a low-fiber diet or a preexisting functional constipation. Further important causes are substances with constipating side effects, such as opioids or anticholinergic drugs. Pragmatically, constipation should be assessed by subjective parameters such as the feeling of incomplete evacuation, straining, or other complaints. Objective parameters are hard stool or reduced number of bowel movements. For the early detection of constipation the amount of the stool mass and the stool frequency are applicable. If constipation occurs, a standardized escalating protocol applying adequate fluid intake, a high fibre diet, and laxatives is recommended. New prokinetic agents, secretagogues, or opioid antagonists may be used as reserve drugs., (© Georg Thieme Verlag KG Stuttgart · New York.)

End-of-life care is an essential element of quality cancer care. Nevertheless, a majority of physicians and nurses working at cancer centers feel unprepared for this task. As part of a larger survey study, we investigated what suggestions experienced physicians and nurses have to improve education/training on end-of-life care. In an open question, participants were requested to suggest changes to the end-of-life curriculum for physicians and nurses. Answers to this question were content analyzed using the qualitative data analysis software MAXQDA. Physicians and nurses at 10 cancer centers throughout Baden-Wuerttemberg were surveyed. From the total 1131 survey participants, 675 (483 nurses, 167 physicians, 25 unknown) responded to the open question regarding suggestions for education/training in end-of-life care. Two main categories were inductively developed: (1) format (i.e., structure and method of teaching) and (2) content (i.e., knowledge and know-how required for care of the dying). Regarding format, both professional groups most often wished for more practical experiences with dying patients (e.g., internships at hospices). Regarding content, physicians and nurses most frequently requested (1) more basic information on palliative care, (2) increased skills training in communication, and (3) knowledge of how to appropriately care for patients' caregivers. The results of our analysis reflect already trained physicians' and nurses' interest in furthering their knowledge and skills to care for dying patients. The suggestions of experienced physicians and nurses should be integrated into the further development of palliative care curricula.

Chronic obstructive pulmonary disease (COPD) is a growing cause of morbidity and mortality worldwide. However, many patients with severe COPD do not receive adequate palliative care. The main goals of our study were to identify the percentage of hospital patients with palliative care needs, particularly those who suffer from COPD.Data were collected prospectively from inpatients at the University Medical Centre Freiburg (Freiburg, Germany). Based on the World Health Organization definition of palliative care, the treating physician reported for each patient discharged whether the patient had palliative care needs or not. Data from 39 849 patients could be analysed, of which 1455 were suffering from COPD.Of all COPD patients, 9.1% had palliative care needs. In COPD patients with palliative care needs, hospital stay was significantly longer (13.7 versus 10.3 days) than in the group without palliative care needs, and significantly more patients died during their hospital stay (8.3% versus 3.7%). The presence of metastases was the highest risk factor for developing palliative care needs (OR 4.18). Furthermore, a main diagnosis of COPD implied an increased probability of palliative care needs (OR 1.87).Our results show that COPD patients have a high risk of developing palliative care needs. Further efforts are required to provide palliative care to COPD patients., (Copyright ©ERS 2015.)

Background: Randomized controlled trials (RCTs) are important sources of information on the benefits and harms patients may expect from treatment options. The aim of this structured literature review by the German Institute for Quality and Efficiency in Health Care was to explore whether and how the end-of-life (EoL) situation of patients with advanced cancer is considered in RCTs investigating anti-cancer treatments., Methods: Our journal pool comprised 19 medical journals, namely five preselected key general medical journals as well as 14 specialist journals (mainly cancer) identified via a scoping search. We systematically searched these journals in MEDLINE to identify RCTs investigating anti-cancer treatments for the following four cancer types: glioblastoma, lung cancer (stage IIIb-IV), malignant melanoma (stage IV), and pancreatic cancer (search via OVID; November 2012). We selected a representative sample of 100 publications, that is, the 25 most recent publications for each cancer type. EoL was defined as a life expectancy of ≤ two years. We assessed the information provided on (1) the descriptions of the terminal stage of the disease, (2) the therapeutic goal (i.e. the intended therapeutic benefit of the intervention studied), (3) the study endpoints assessed, (4) the authors' concluding appraisal of the intervention's effects, and (5) the terminology referring to the patients' EoL situation., Results: Median survival was ≤ one year for each of the four cancer types. Descriptions of the terminal stage of the disease were ambiguous or lacking in 29/100 publications. One or more therapeutic goals were mentioned in 51/100 publications; these goals were patient-relevant in 38 publications (survival alone: 30/38; health-related quality of life (HRQoL) or HRQoL and survival: 6/38; symptom control or symptom control and survival: 2/38). Primary endpoints included survival (50%), surrogates (44%), and safety (3%). Patient-reported outcomes (PROs) were assessed in 36/100 RCTs. The implications of treatment-related harms for the patients were discussed in 22/100 appraisals. Terminology referring to the patients' EoL situation (e.g. "terminal") was scarce, whereas terms suggesting control of the disease (e.g. "cancer control") were common., Conclusions: The EoL situation of patients with advanced cancer should be more carefully considered in clinical trials. Although the investigation and robust reporting of PROs is a prerequisite for informed decision-making in healthcare, they are rarely defined as endpoints and HRQoL is rarely mentioned as a therapeutic goal. Suggestions for improving standards for study design and reporting are presented.

Background: International medical organizations such as the American Society of Medical Oncology recommend early palliative care as the "gold standard" for palliative care in patients with advanced cancer. Nevertheless, even in Comprehensive Cancer Centers, early palliative care is not yet routine practice. The main goal of the EVI project is to evaluate whether early palliative care can be implemented-in the sense of "putting evidence into practice"-into the everyday clinical practice of Comprehensive Cancer Centers. In addition, we are interested in (1) describing the type of support that patients would like from palliative care, (2) gaining information about the effect of palliative care on patients' quality of life, and (3) understanding the economic burden of palliative care on patients and their families., Methods/design: The EVI project is a multi-center, prospective cohort study with a sequential control group design. The study is a project of the Palliative Care Center of Excellence (KOMPACT) in Baden-Württemberg, Germany, which was recently established to combine the expertise of five academic, specialist palliative care departments. The study is divided into two phases: preliminary phase (months 1-9) and main study phase (months 10-18). In each of all five participating academic Comprehensive Cancer Centers, an experienced palliative care physician will be hired for 18 months. During the preliminary phase, the physician will be allowed time to establish the necessary structures for early palliative care within the Comprehensive Cancer Center. In the main study phase, patients with metastatic cancer will be offered a consultation with the palliative care physician within eight weeks of diagnosis. After the initial consultation, follow-up consultations will be offered as needed. The study is built upon a convergent parallel design. In the quantitative arm, patients will be surveyed in both the preliminary and main study phase at three points in time (baseline, 12 weeks, 24 weeks). Standardized questionnaires will be used to measure patients' quality of life, symptom burden and mood. Using interviews with palliative care physicians, oncologists, department heads, patients and their caregivers, the qualitative arm will explore (1) what factors encourage and hinder the early integration of palliative care into standard oncology care, (2) what support patients and their caregivers would like from palliative care, and (3) what effect palliative care has on the economic disease burden of patients and their families., Discussion: The study proposed is meant to serve as a catalyzer. Local palliative care teams should be put in position to routinely cooperate with the primary treating department at their respective cancer center. The long-term goal of this project is to create sustainable improvements in the care of patients with incurable cancer., Trial Registration: DRKS00006162 ; date of registration: 19/05/2014.

Background: Prior research has shown that hospitals are often ill-prepared to provide care for dying patients. This study assessed whether the circumstances for dying on cancer center wards allow for a dignified death., Methods: In this cross-sectional study, the authors surveyed physicians and nurses in 16 hospitals belonging to 10 cancer centers in Baden-Wuerttemberg, Germany. A revised questionnaire from a previous study was used, addressing the following topics regarding end-of-life care: structural conditions (ie, rooms, staff), education/training, working environment, family/caregivers, medical treatment, communication with patients, and dignified death., Results: In total, 1131 surveys (response rate = 50%) were returned. Half of the participants indicated that they rarely have enough time to care for dying patients, and 55% found the rooms available for dying patients unsatisfactory. Only 19% of respondents felt that they had been well-prepared to care for the dying (physicians = 6%). Palliative care staff reported much better conditions for the dying than staff from other wards (95% of palliative care staff indicated that patients die in dignity on their ward). Generally, physicians perceived the circumstances much more positively than nurses, especially regarding communication and life-prolonging measures. Overall, 57% of respondents believed that patients could die with dignity on their ward., Conclusions: Only about half of the respondents perceived that a dignified death is possible on their ward. We recommend that cancer centers invest more in staffing, adequate rooms for dying patients, training in end-of-life care, advance-care planning standards, and the early integration of specialist palliative care services., (© 2014 American Cancer Society.)

Purpose: Quality of life (QoL) is one of the most important outcomes in cancer care. Although a number of instruments to measure health-related QoL (HRQoL) exist, there are few suitable instruments to measure individual QoL. The best established instrument is the Schedule for the Evaluation of Individual Quality of Life (SEIQoL). The disadvantage of this questionnaire is its use of semi-structured interviews, which are very time-consuming. The purpose of our study was to transform the SEIQoL into an economical instrument that can be used in clinical trials with large samples., Methods: We developed the SEIQoL-Questionnaire (SEIQoL-Q) on the basis of the SEIQoL-Direct Weighting (SEIQoL-DW) by transforming the interview guide into a written questionnaire. Patients (N = 1,108) in all three phases of radiation treatment (first consultation, ongoing irradiation, and aftercare) were asked to complete the SEIQoL-Q and the European Organization for Research and Treatment of Cancer QLQ-C30., Results: While the average HRQoL measured by the QLQ-C30 was 55.6, the average SEIQoL-Q index was 59.6. The most important life domain was "physical health," followed by "emotional well-being" and "family." Patients attributed the highest level of satisfaction to "home/housing," followed by "family" and "partnership." Male patients were shown to have a significantly better QoL than females. The SEIQoL-Q index correlates moderately with the QLQ-C30 functioning scale "global quality of life" [r = .42 (p < .001)]., Conclusions: According to our findings, the SEIQoL-Q appears to be a feasible and economical instrument for use in quantitative research among cancer patients in different stages of their disease.

Purpose of Review: A survey was performed to assess whether authors who report about palliative treatments or palliative care share a common understanding of 'curative' treatments., Recent Findings: Of 107 authors from publications about cancer who used both 'palliative' and 'curative' in the same abstract, 42 (39%) responded. The majority (n=24; 57%) understood 'curative' treatments as 'aimed at complete absence of disease for the rest of life', but 43% (n=18) did not share this view. For example, 19% (n=7) stated that the term describes cancer-directed therapy for prolongation of life or even regardless of the aspired goal., Summary: In the care for cancer patients, unambiguous terminology is essential for the participatory and interdisciplinary decision-making process. Clinicians, researchers and policy makers should be aware of the difference between curative and disease-modifying therapies. Otherwise, this may be a major source of misunderstandings as disease-modifying therapy may be indicated in the incurable stages of the disease as well. In these palliative situations, it is essential to identify the realistic aim(s) of the therapy: prolongation of life, alleviation of suffering or both.

Purpose: To analyze the need for palliative care in hospital patients who have cancer. Palliative care is an essential component of comprehensive cancer care and identification of palliative care needs (PCNs) of patients with cancer is a topic that has not been thoroughly studied., Patients and Methods: Data were collected prospectively from inpatients of University Medical Center Freiburg in Freiburg, Germany, with 982 hospital beds included in the study. During the observation period of 17 months, each patient discharged from a hospital ward was screened by surveying the treating physician who was responsible for dismissal about patients' PCNs based on the WHO 1990 definition of palliative care. To complete obligatory electronic discharge management, a modified dismissal form asking to classify the patient as having PCN "yes/no" had to be filled out for each patient discharged., Results: The response rate was 96% with data for 39,849 patients that could be analyzed. A total of 6.9% of all hospital patients and 9.1% of patients older than age 65 years were considered to have PCNs. Of the 2,757 patients with PCNs, 67% (n = 1,836) had cancer. Among the 11,584 patients with cancer, 15.8% were classified as having PCNs. PCNs were particularly high in patients with head and neck cancer (28.3%), malignant melanoma (26.0%), and brain tumors (18.2%). Suffering from cancer increases the probability of developing PCNs by a factor of 3.63 (95% CI, 3.27 to 4.04). For patients with metastatic cancer, the risk of developing PCNs is increased 12-fold (odds ratio, 12.27; 95% CI, 11.07 to 13.60)., Conclusion: Structures to provide palliative care for patients with cancer are needed.

Background and Purpose: Recent studies have shown a very high importance of relatives in decisions about medical interventions. Therefore, the situation of this group was investigated in the sense of a stocktaking by interviewing the closest relatives of radiotherapy patients. INTERVIEWED PERSONS AND METHODS: In a defined span of time (6 weeks), a total of 470 relatives (evaluable: n = 287, 61%) of radiotherapy patients were interviewed by a newly developed questionnaire about their contentment with their inclusion in the therapy course. Further, they gave information about specific needs of relatives as well as proposals for direct improvements in the context of a radiation therapy., Results: In total, the relatives were satisfied with their inclusion in the radiotherapy course and with the patient care. As an example, more than 95% of the relatives agreed with the statement "Here in the hospital my ill relative is cared for well." Nevertheless, direct possibilities for improvements were found in the interdisciplinary information about oncologic topics and in the organization of the therapy course., Conclusion: In the stocktaking the situation of radiotherapy patients' relatives was generally satisfactory. Further improvements for the future can be expected mainly from interdisciplinary cancer centers having the best suppositions to care for the relatives, if necessary. Structures known from palliative care can be used as a model.

A guideline on the management of symptomatic malignant ascites by abdominal paracentesis, diuretics and peritoneovenous shunting, based on a systematic review of the literature is presented. Thirty-two relevant studies were identified. None were randomized control trials, one was a non-randomized open controlled trial, five were cohort studies or prospective uncontrolled trials, 26 studies were non-analytic studies like case series. Although paracentesis, diuretics and shunting are commonly used procedures, the evidence is weak. Available data show good, although temporary effect of paracentesis on symptom relief. Fluid withdrawal speed and concurrent intravenous hydration is not sufficiently studied. Peritoneovenous shunts can control ascites in patients with malignant ascites, but have to be balanced by the potential risks of this procedure. The available data about diuretics in treatment of malignant ascites are controversial. The use of diuretics therefore should be considered in all patients, but has to be evaluated individually.

Background: In Germany, a sufficient system of palliative care does not exist. Possibilities for participation of radiooncologists in the further development of this promising part of medical action are reported., Material and Methods: Experiences from interdisciplinary work in the field of palliative care are described. This experience is communicated for use in the actual discussion about the future of palliative care in Germany, especially in the field of radiooncology., Results: A palliative care unit can only work in a team of different professions, which means different physicians, but also nurses, social workers, psychologists or pastors. A palliative care unit will benefit from working with radiooncologists as well as radiooncologists will do from working in the field of palliative care., Conclusion: In times of growing interest in and need for palliative care, radiooncologists should actively participate in the development of palliative care units in Germany. The aim of this participation should be to reasonably arrange the treatment of incurably ill patients with the chances of modern radiotherapy. Another aim should be to improve the treatment of "classic" radiation oncology patients by ideas of palliative care. The further development of palliative care in Germany should not take place without the participation of radiooncologists. This will meet the interests of palliative care and radiotherapy and-most importantly-the patients' interests.

Background: Infections and malignancies are important causes of mortality and morbidity in renal allograft recipients. Their risk increases with increasing immunosuppression., Methods: In an attempt to quantitate the increase in the risk of these complications in association with antirejection therapy, we reviewed the records of all renal allograft recipients of our center transplanted during the cyclosporin era. We sub-divided the patients into three groups based on acute rejection episodes during the first 6 months posttransplant, and the treatment for acute rejection: those who did not develop AR--group 1 (n=168); those who had one or more episodes of acute rejection and were treated with high dose corticosteroids --group 2 (n=169); those who in addition to corticosteroids required cytolytics (OKT3) and/or other drugs--group 3 (n=141)., Results: 52% patients in group 1, 71% patients in group 2 and 86% patients in group 3 had one or more episodes of infection during the first 6 months posttransplantation. Relative risk for group 2 and 3 were 1.56 (P=0.0002) and 2.98 (P<0.00001), respectively. Infection/patient rates at 6 months were 0.67, 1.23, and 2.79 in groups 1, 2, and 3 respectively. Groups 1 and 2 had a similar number of cases with squamous and basal cell carcinoma, however, there were few cases with these malignancies in group 3. No case of lymphoma was seen in group 1; there were four cases in group 2 and nine in group 3. There was no significant difference in patient survival in group 1 and 2, however, patients in group 3 had a reduced patient survival (1 vs. 3 P<0.001, 2 vs. 3 P=0.067). Graft survival was best in group 1 and worst in group 3 (1 vs. 2 P<0.05; 1 vs. 3 P<0.00001; 2 vs. 3 P<0.01)., Conclusions: In renal transplant recipients the risk of infections and lymphoma increases with increasing immunosuppression and hence mortality and morbidity associated with it. When adding a potent immunosuppressive agent to rescue a kidney one needs to consider the serious and at times fatal side effects given the modest beneficial effect on long-term outcome.