Search

Background: Primary tumor (PT) sidedness is an established prognostic marker in metastatic colorectal cancer (mCRC) and has a predictive impact on the efficacy of anti-epidermal growth factor receptor (anti-EGFR) antibody [monoclonal antibody (mAb)] in patients with RAS wild-type mCRC. This investigation focuses on patients with BRAF V600E -mutated (BRAFmt) mCRC and examines the efficacy of anti-EGFR mAbs in relation to primary tumor sidedness (PTS)., Patient and Methods: This pooled analysis was carried out using individual patient data from five randomized studies in the first-line setting of mCRC. The population of interest was limited to patients with BRAFmt mCRC and known PTS. For analysis, treatment was stratified into two groups: those treated with anti-EGFR mAbs and those without. Dichotomous variables, such as overall response rate and objective response rate (ORR), were compared using chi-square or Fisher's exact test. Time-to-event endpoints [progression-free survival (PFS) and overall survival (OS)] were analyzed using the Kaplan-Meier method, log-rank test, and Cox regression. An interaction test was carried out via Cox regression., Results: A total of 102 patients with BRAFmt mCRC were identified. The type of targeted therapy (anti-EGFR-based versus non-anti-EGFR) did not significantly impact the outcome. However, in patients with left-sided primary tumors, anti-EGFR mAb-based treatment, compared with non-anti-EGFR, was associated with a higher ORR (58% versus 34%; P < 0.01), trended toward improved PFS [hazard ratio (HR) 0.62; 95% confidence interval (CI) 0.34-1.13; P = 0.12], and demonstrated prolonged OS (HR 0.38; 95% CI 0.20-0.72; P < 0.01). In patients with right-sided primary tumors, anti-EGFR-based therapy had no effect on ORR (33% versus 36%; P > 0.99), induced inferior PFS (HR 1.97; 95% CI 1.12-3.47; P = 0.02), and trended toward a worse OS (HR 1.76; 95% CI 0.99-3.13; P = 0.05)., Conclusion: This analysis suggests that PTS has predictive value for the efficacy of anti-EGFR mAb in the first-line treatment of BRAFmt mCRC., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Purpose: Surrogate end points are commonly used to estimate treatment efficacy in clinical studies of chronic lymphocytic leukemia (CLL). This patient- and trial-level analysis describes the correlation between progression-free survival (PFS) and minimal residual disease (MRD) with overall survival (OS) in first-line trials for CLL., Patients and Methods: First, patient-level correlation was confirmed using source data from 12 frontline German CLL Study Group (GCLLSG)-trials. Additionally, a joint-frailty copula model was fitted to validate correlation in the setting of targeted therapies (TT). Second, a meta-analysis of first-line phase III trials in CLL from 2008 to 2024 was performed. Treatment effect correlation was quantified from seven GCLLSG and nine published trials, using hazard ratios (HRs) for time-to-event and odds ratios for binary end points., Results: The GCLLSG analysis set comprised 4,237 patients. Patient-level correlation for PFS/OS was strong with Spearman Rho >0.9. The joint-frailty copula indicated a weak correlation for chemotherapy/chemoimmunotherapy (C/CIT) with a tau of 0.52 (95% CI, 0.49 to 0.55) while the correlation was strong for TT (tau, 0.91 [95% CI, 0.89 to 0.93). The meta-analysis set contained a total of 8,065 patients including 5,198 (64%) patients treated with C/CIT and 2,867 (36%) treated with TT. Treatment-effect correlation of the HRs for PFS and OS was R = 0.75 (95% CI, 0.74 to 0.76, R 2 = 0.56) while correlation of end-of-treatment MRD with PFS and OS was R = 0.88 (95% CI, -0.87 to 0.89; R 2 = 0.78) and 0.71 (95% CI, 0.69 to 0.73; R 2 = 0.5), respectively., Conclusion: Patient-level correlation was confirmed in the setting of TTs while treatment-effect correlation between PFS and OS remains uncertain. MRD response status showed a high treatment-effect correlation with PFS but not OS, with the caveat of a limited number of randomized trials with available MRD data.

Long-term data of chronic lymphocytic leukemia (CLL) patients with favorable risk who were treated with fludarabine, cyclophosphamide, and rituximab (FCR) within clinical trials show good efficacy. We here report long-term data collected within the GCLLSG registry. Altogether, 417 CLL patients who received first-line treatment with FCR were analyzed, of which 293 (70.3%) were treated outside of clinical trials. The median observation time from first-line was 95.8 (interquartile range 58.7-126.8) months. Focusing on data of 194 (46.5%) patients who received FCR first-line treatment after 2013 (start of data collection within GCLLSG registry), responses were documented in 85% of the patients, non-responses in 15%, and for 3.6% the assessment was missing. Median event-free survival (EFS, time until disease progression, subsequent treatment, or death) was 60.2 months with a 5-year EFS-rate of 50.6%. Patients with higher-risk disease, characterized by unmutated IGHV (N = 78), had a median EFS of 45.4 months with a 5-year EFS rate of 36.3%, while the median EFS was 77.5 months with a 5-year EFS rate of 60.3% in patients with mutated IGHV (N = 40). Median overall survival was not reached with a 5-year survival rate of 92.7%. In summary, first-line FCR was associated with long EFS, especially in patients exhibiting a mutated IGHV status., (© 2024 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.)

Competing Interests: Nadine Kutsch: Honoraria: AbbVie, AstraZeneca, BMS, Kite/Gilead; Research support: AstraZeneca, Gilead. travel grants: AbbVie, AstraZeneca, Beigene, Celgene, Janssen. Sandra Robrecht: Honoraria: AstraZeneca. Anna Fink: Research funding: AstraZeneca and Celgene, Travel grants: AbbVie. Elisabeth Lange: no COIs. Rudolf Weide: Personal fees from AstraZeneca, BeiGene, Biotest, CSL Behring, Daiichi Sankyo, Eisai, Gilead, Hexal, Incyte, Medac, Menarini‐Stemline, Pierre Fabre, Roche, SeaGen, Sobi, and Takeda. Our institution has received research funding from Amgen, Biotest, Celgene, CSL Behring, Daiichi Sankyo, Eisai, GSK, Hexal, Lilly, Medac, Mundipharma, Octapharma, Sobi, and Takeda. Michael G. Kiehl: no COIs. Martin Sökler: no COIs. Rudolf Schlag: no COIs. Ursula Vehling‐Kaiser: no COIs. Georg Köchling: no COIs. Christoph Plöger: no COIs. Michael Gregor: no COIs. Torben Plesner: advisory board: Celgene/BMS. Michael R. Clausen: no COIs. Ilske Oschlies: no COIs. Matthias Ritgen: grants from F. Hoffman‐La Roche; and personal fees from F. Hoffmann‐La Roche and AbbVie. Marco Herling: no COIs. Kirsten Fischer: Advisory Board: AbbVie, Roche, AstaZeneca, Honoraria: Roche, AstraZeneca, Travel Support: Roche. Hartmut Döhner: Advisory role with honoraria for AbbVie, AstraZeneca, Gilead, Janssen, Jazz, Pfizer, Servier, Stemline, Syndax; clinical research funding (to institution) from AbbVie, Astellas, Bristol Myers Squibb, Celgene, Jazz Pharmaceuticals, Kronos Bio, Servier. Clemens‐Martin Wendtner: Research grants, advisory boards and travel grants by Hoffmann‐La Roche, Janssen‐Cilag, AstraZeneca, AbbVie, BeiGene and GSK. Karl‐Anton Kreuzer: consultant or advisory board member, honoraria and research support by AbbVie, Amgen, F. Hoffmann‐LaRoche, Gilead, Janssen‐Cilag and Mundipharma. Stephan Stilgenbauer: Advisory board, honoraria, research support, travel support, speaker fees, trial participation: AbbVie, Amgen, AstraZeneca, BeiGene, BMS, Celgene, Gilead, GSK, Hoffmann‐La Roche, Janssen, Lilly, Novartis, Sunesis. Michael Hallek: Consultant or advisory board member, honoraria, and research support by AbbVie, Amgen, Celgene, F. Hoffmann‐LaRoche, Gilead, Janssen‐Cilag and Mundipharma. Sebastian Böttcher: research funding from Janssen and AbbVie; and honoraria from Roche, Janssen, AbbVie, Novartis, Becton Dickinson, AstraZeneca, and Sanofi. Wolfram Klapper: Research grants from Roche, Amgen, Janssen, InCyte Regeneraon, Takeda and advisory role (Roche) paid to my institution. All without relevance for the current manuscript. Barbara Eichhorst: Consultant or advisory board member, research support or travel support by AbbVie, AstraZeneca, Celgene, F. Hoffmann‐LaRoche, Gilead, Janssen‐Cilag.

Purpose: To analyze the 3-month life expectancy rate in pancreatic cancer (PC) patients treated within prospective trials from the German AIO study group., Patients and Methods: A pooled analysis was conducted for patients with advanced PC that were treated within five phase II/III studies conducted between 1997 and 2017 (Gem/Cis, Ro96, RC57, ACCEPT, RASH). The primary goal for the current report was to identify the actual 3-month survival rate, a standard inclusion criterion in oncology trials., Results: Overall, 912 patients were included, 83% had metastatic and 17% locally advanced PC; the estimated median overall survival (OS) was 7.1 months. Twenty-one percent of the participants survived < 3 months, with a range from 26% in RC57 to 15% in RASH. Significant predictors for not reaching 3-month OS were > 1 previous treatment line (p < 0.001) and performance status (p < 0.001)., Conclusions: Despite the definition of a life expectancy of > 3 months as a standard inclusion criterion in clinical trials for advanced PC, a significant proportion of study patients does not survive > 3 months., Trial Registration Numbers: NCT00440167 (AIO-PK0104), NCT01729481 (RASH), NCT01728818 (ACCEPT)., (© 2023. The Author(s).)

Background: The inflammation-based modified Glasgow Prognostic Score (mGPS) combines serum levels of C-reactive protein and albumin and was shown to predict survival in advanced cancer. We aimed to elucidate the prognostic impact of mGPS on survival as well as its predictive value when combined with gender in unselected metastatic colorectal cancer (mCRC) patients receiving first-line chemotherapy in the randomized phase III XELAVIRI trial., Patients and Methods: In XELAVIRI, mCRC patients were treated with either fluoropyrimidine/bevacizumab followed by additional irinotecan at first progression (sequential treatment arm; Arm A) or upfront combination of fluoropyrimidine/bevacizumab/irinotecan (intensive treatment arm; Arm B). In the present post hoc analysis, survival was evaluated with respect to the assorted mGPS categories 0, 1 or 2. Interaction between mGPS and gender was analyzed., Results: Out of 421 mCRC patients treated in XELAVIRI, 362 [119 women (32.9%) and 243 men (67.1%)] were assessable. For the entire study population a significant association between mGPS and overall survival (OS) was observed [mGPS = 0: median 28.9 months, 95% confidence interval (CI) 25.9-33.6 months; mGPS = 1: median 21.4 months, 95% CI 17.6-26.1 months; mGPS = 2: median 16.8 months, 95% CI 14.3-21.2 months; P < 0.00001]. Similar results were found when comparing progression-free survival between groups. The effect of mGPS on survival did not depend on the applied treatment regimen (P = 0.21). In female patients, a trend towards longer OS was observed in Arm A versus Arm B, with this effect being clearly more pronounced in the mGPS cohort 0 (41.6 versus 25.5 months; P = 0.056). By contrast, median OS was longer in male patients with an mGPS of 1-2 treated in Arm B versus Arm A (20.8 versus 17.4 months; P = 0.022)., Conclusion: We demonstrate the role of mGPS as an independent predictor of OS regardless of the treatment regimen in mCRC patients receiving first-line treatment. mGPS may help identify gender-specific subgroups that benefit more or less from upfront intensive therapy., Competing Interests: Disclosure MB: employment: Servier Germany. DPM: honoraria: Merck Serono, Amgen, Roche, Servier, Bristol-Myers Squibb, Pfizer, Sirtex Medical; consulting or advisory role: Merck Serono, Amgen, Bayer; research funding: Merck Serono (Inst), Roche (Inst), Amgen (Inst); travel, accommodations, expenses: Amgen, Merck Serono, Bayer, Servier, Bristol-Myers Squibb. IR: consulting or advisory role: Roche. LFvW: honoraria: Novartis, Roche, Sanofi; travel, accommodations, expenses: Amgen. TD: consulting or advisory role: Novartis. UG: honoraria: Servier, Boehringer Ingelheim, Sirtex Medical, Daiichi Sankyo; consulting or advisory role: Novartis, Merck, Amgen, Hexal, Bristol-Myers Squibb; travel, accommodations, expenses: Merck, Amgen. CD: consulting or advisory role: Amgen, Roche, Janssen Pharmaceuticals; travel, accommodations, expenses: Celgene, Janssen Pharmaceuticals, Novartis. KH: honoraria: Roche; travel, accommodations, expenses: Lilly, Amgen, Celgene. AJ: consulting or advisory role: Boehringer Ingelheim, Roche, Biocartis, Bristol-Myers Squibb, Amgen, AstraZeneca, Thermo Fisher Scientific, Merck; speakers' bureau: AstraZeneca, Roche, Bristol-Myers Squibb, Amgen. SS: honoraria: Merck, Roche, Amgen, Bayer, Sanofi, Sirtex Medical, Eli Lilly; consulting or advisory role: Merck, Roche, Sanofi, Bayer, Amgen, Boehringer Ingelheim, Eli Lilly, Takeda; travel, accommodations, expenses: Merck, Roche, Sanofi, Bayer, Sirtex Medical, Amgen, Eli Lilly, Takeda. VH: honoraria: Roche, Celgene, Amgen, Sanofi, Merck, Sirtex Medical, Baxalta, Eli Lilly, Boehringer Ingelheim, Taiho Pharmaceutical, Servier; consulting or advisory role: Merck, Amgen, Roche, Sanofi, Boehringer Ingelheim, Celgene, Sirtex Medical, Baxalta, Servier, Halozyme, MSD, Bristol-Myers Squibb. MM: honoraria: MSD, BMS, Lilly, Roche, Pierre Fabre, AstraZeneca, Novartis, Merck, Sanofi, SIRTeX, Roche; travel, accommodations, expenses: SIRTeX, Sobi, Roche, Novartis, AstraZeneca, Merck, Sanofi, Lilly, Servier; consulting or advisory role: Amgen, Pierre Fabre, BMS, AstraZeneca, Novartis, Merck, Sanofi, Lilly, MSD, Servier, Milteny, Takeda; research funding: SIRTeX, Servier. All other authors have declared no conflicts of interest., (Copyright © 2024. Published by Elsevier Ltd.)

Purpose: The outcome of older patients with mantle cell lymphoma (MCL) has improved by the introduction of immunochemotherapy, followed by rituximab (R)-maintenance. Assessment of minimal residual disease (MRD) represents a promising tool for individualized treatment decisions and was a prospectively planned part of the European MCL Elderly trial. We investigated how MRD status influenced the efficacy of R-maintenance and how MRD can enable tailored consolidation strategies., Patients and Methods: Previously untreated patients with MCL age 60 years or older have been randomly assigned to R versus interferon-alpha maintenance after response to rituximab, fludarabine, cyclophosphamide (R-FC) versus rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP). MRD monitoring was performed by real-time quantitative polymerase chain reaction (qPCR) following EuroMRD guidelines., Results: A qPCR assay with a median sensitivity of 1 × 10 -5 could be generated in 80% of 288 patients in an international, multicenter, multilaboratory setting. More extensive tumor dissemination facilitated the identification of a molecular marker. The efficacy of R-maintenance in clinical remission was confirmed for MRD-negative patients at the end of induction in terms of progression-free survival (PFS; hazard ratio [HR], 0.38 [95% CI, 0.21 to 0.63]) and overall survival (OS; HR, 0.37 [95% CI, 0.20 to 0.68]), particularly in R-CHOP-treated patients (PFS-HR, 0.23 [95% CI, 0.10 to 0.52]; OS-HR, 0.19 [95% CI, 0.07 to 0.52]). R-maintenance appeared less effective in MRD-positive patients (PFS-HR, 0.51 [95% CI, 0.26 to 1.02]) overall and after R-CHOP induction (PFS-HR, 0.59 [95% CI, 0.28 to 1.26]). R-FC achieved more frequent and faster MRD clearance compared with R-CHOP. MRD positivity in clinical remission after induction was associated with a short median time to clinical progression of approximately 1-1.7 years., Conclusion: The results confirm the strong efficacy of R-maintenance in patients who are MRD-negative after induction. Treatment de-escalation for MRD-negative patients is discouraged by our results. More effective consolidation strategies should be explored in MRD-positive patients to improve their long-term prognosis.

Background: Currently, a conclusive experience on the uniform implementation and benefits of day hospice structures and interventions is lacking in Germany. The following questions should be clarified: (1) Which structural conditions and interventional measures should be established in day hospices from the point of view of patients, relatives, and specialist staff?; (2) Are the planned structures or interventions feasible and implementable under real conditions and accepted by patients, relatives, and staff?; (3) How can a final implementation and intervention catalog for day hospices be designed?; (4) Is this final catalog of services feasible, reasonable, economical, and effective under everyday conditions in day hospices?, Methods: We planned to perform a multistage investigation, guided by the Medical Research Council Framework for the development and evaluation of complex interventions. In Stage 1, an initial theoretical construct on structures and interventions will be established through an extensive literature and guideline review on day hospices and through qualitative interviews. In a nominal group process, we will create a catalog of offers. In Stage 2, feasibility testing is conducted in a single-day hospice under real-life conditions using quantitative quality indicators and qualitative interviews. Structures and interventions can be adapted here if necessary. In a second nominal group process, a final structure and offer catalog is created, which is then implemented in Stage 3 in the day hospice under investigation and evaluated under real daily conditions through a process and effectiveness test. For this purpose, qualitative and quantitative quality indicators will be used and a comparative cohort of patients who are not cared for in the day hospice - but in the same network structure (oncology-palliative care network Lower Bavaria) - is examined., Discussion: Finally, the initial statements on the reasonable and realizable structures or interventions in day hospices and their benefits in daily real-life conditions as well as possible optimization processes shall be made., Trial Registration: The study was retrospectively registered in the German Clinical Trials Register (DRKS-ID DRKS00031613, registration date April 04, 2023) and the display portal of the Center for Clinical Trials of the University Hospital Regensburg (Z-2022-1734-6, registration date July 01, 2023)., (© 2024. The Author(s).)

Background and Objective: Ultrasound-guided interventions (such as biopsies) of unclear lesions are indicated if microcirculatory changes indicate possible malignant lesions. These place high demands on the ultrasound device used. In order to potentially reduce the often associated high technical effort, the wireless ultrasound device Vscan AirTM was examined as a possible ultrasound device for the intervention biopsy., Methods: As part of an advanced training course on Computertomographie- and ultrasound-guided biopsy and ablation procedures, participants were asked about the image quality of the handheld device used by means of questionnaires. Various lesions were evaluated at a depth of 1.0 to 5.0 cm in an in vitro liver model. The image quality was evaluated independently before, during and after the intervention. The rating scale contained values from 0 (no assessment possible) to 5 (maximum high image quality). A high-end device was used as a reference., Results: A total of 11 participants took part in the study (n = 4 male [36.4%], n = 7 female [63.6%]). A total of five tumor like lesions at different depths (1 cm, 2 cm, 3 cm, 4 cm, >4 cm) were assessed separately. In all cases, an adequate biopsy of the target lesion (1 cm in length, core filling 5 mm) was successful. From a depth of 3 cm, the image quality of the mobile device increasingly decreased, but the image quality of the high-end system was still not impaired. Compared to the high-end device, there was a highly significant difference in image quality from a depth of 3 cm (p < 0.01). Assessment by inexperienced examiners using a handheld device was adequately possible., Conclusions: Mobile interventional ultrasound represents a potential alternative for the biopsy of unclear tumorous lesions with microcirculatory disorders with limited depth localization.

In patients with chronic lymphocytic leukemia, Richter transformation (RT) reflects the development of an aggressive lymphoma that is associated with poor response to chemotherapy and short survival. We initiated an international, investigator-initiated, prospective, open-label phase 2 study in which patients with RT received a combination of the PD-1 inhibitor tislelizumab plus the BTK inhibitor zanubrutinib for 12 cycles. Patients responding to treatment underwent maintenance treatment with both agents. The primary end point was overall response rate after six cycles. Of 59 enrolled patients, 48 patients received at least two cycles of treatment and comprised the analysis population according to the study protocol. The median observation time was 13.9 months, the median age was 67 (range 45-82) years. Ten patients (20.8%) had received previous RT-directed therapy. In total, 28 out of 48 patients responded to induction therapy with an overall response rate of 58.3% (95% confidence interval (CI) 43.2-72.4), including 9 (18.8%) complete reponse and 19 (39.6%) partial response, meeting the study's primary end point by rejecting the predefined null hypothesis of 40% (P = 0.008). Secondary end points included duration of response, progression-free survival and overall survival. The median duration of response was not reached, the median progression-free survival was 10.0 months (95% CI 3.8-16.3). Median overall survival was not reached with a 12-month overall survival rate of 74.7% (95% CI 58.4-91.0). The most common adverse events were infections (18.0%), gastrointestinal disorders (13.0%) and hematological toxicities (11.4%). These data suggest that combined checkpoint and BTK inhibition by tislelizumab plus zanubrutinib is an effective and well-tolerated treatment strategy for patients with RT. ClinicalTrials.gov Identifier: NCT04271956 ., (© 2023. The Author(s).)

The prospective, multicenter, noninterventional TACTIC study assessed effectiveness and safety of trifluridine/tipiracil (FTD/TPI) in patients with metastatic colorectal cancer (mCRC) in a real-world setting in Germany, thus evaluating the external validity of the findings from the pivotal RECOURSE trial. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS), safety, and quality of life (QoL). Subgroups comprised patients with good (<3 metastatic sites at inclusion, ≥18 months from diagnosis of first metastasis to inclusion) or poor (remaining patients) prognostic characteristics (GPC/PPC). GPC without liver metastases was considered best prognostic characteristics (BPC). In total, 307 eligible patients (pretreated or not suitable for other available therapies) were treated with FTD/TPI. Overall, median [95%-CI] OS was 7.4 months [6.4-8.6], median PFS was 2.9 months [2.8-3.3]. In BPC (n = 65) and GPC (n = 176) compared to PPC (n = 124) subgroup, median OS (13.3 [9.1-17.6] vs 8.9 [7.6-9.8] vs 5.1 [4.4-7.0] months) and median PFS (4.0 [3.3-5.3] vs 3.4 [3.0-3.7] vs 2.6 [2.4-2.8] months) were longer. Patient-reported QoL, assessed by validated questionnaires (EQ-5D-5L, PRO-CTCAE), was stable throughout FTD/TPI treatment. Predominant FTD/TPI-related adverse events of grades 3 or 4 were neutropenia (13.0%), leukopenia (7.5%), and anemia (5.2%). Altogether, palliative FTD/TPI therapy in patients with pretreated mCRC was associated with prolonged survival, delayed progression, maintained health-related QoL, and manageable toxicity. Low metastatic burden and indolent disease were favorable prognostic factors for survival. TACTIC confirms the effectiveness and safety of FTD/TPI, highlighting its value in routine clinical practice., (© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)

Precision medicine has revolutionised cancer treatments; however, actionable biomarkers remain scarce. To address this, we develop the Oncology Biomarker Discovery (OncoBird) framework for analysing the molecular and biomarker landscape of randomised controlled clinical trials. OncoBird identifies biomarkers based on single genes or mutually exclusive genetic alterations in isolation or in the context of tumour subtypes, and finally, assesses predictive components by their treatment interactions. Here, we utilise the open-label, randomised phase III trial (FIRE-3, AIO KRK-0306) in metastatic colorectal carcinoma patients, who received either cetuximab or bevacizumab in combination with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI). We systematically identify five biomarkers with predictive components, e.g., patients with tumours that carry chr20q amplifications or lack mutually exclusive ERK signalling mutations benefited from cetuximab compared to bevacizumab. In summary, OncoBird characterises the molecular landscape and outlines actionable biomarkers, which generalises to any molecularly characterised randomised controlled trial., (© 2023. Springer Nature Limited.)

Introduction: In further-line mCRC treatment, median progression-free survival (PFS) is rather short, and many patients do not benefit from any antitumor treatment and should therefore be treated according to best-supportive care. A risk score based on standard laboratory values using markers of tumor inflammation aims to define a patient cohort with high treatment benefit and might offer insights into tumor biology. As regorafenib has been dropped off the German market due to an unfavorable risk-benefit ratio, patient selection is key for any further-line treatment option., Methods: We used Cox regression analysis to determine laboratory markers that are independent prognostic factors of OS and PFS outcome. The influence of these variables was weighted using an estimator, which was calculated using Cox regression analysis. The estimators were implemented as multiplication factors, resulting in a risk score. A cut-off value for the resulting risk values was then determined via Cox regression analysis resulting in a low- and high-risk subgroup., Results: Using data of 82 patients, a risk score identifying long-term survival in patients with last-line mCRC treatment could be calculated. The following parameters were associated with significantly longer survival in multivariate analysis: NLR ≤5 (p = &lt;0.001), AP ≤200 U/L (p = 0.001), CRP ≤3.2 mg/dL (p = &lt;0.001). The following estimator values were used to calculate a risk score: NLR: 0.132 (p = 0.046), AP: 0.004 (p = 0.014), and CRP: 0.032 (p = 0.039). Implementing the estimators as multiplication factors yielded the following risk score: 0.132*NLR + 0.004*AP + 0.032*CRP = Risk value. Cox regression resulted in low- and high-risk subgroups with risk values below and above 1.4, respectively. In the group with a low-risk score (&lt;1.4), patients had a median OS of 10.5 months after initiating regorafenib. Patients with a high-risk score (&gt;1.4) survived only 3.3 months after starting therapy with regorafenib (n = 43, p &lt; 0.001, HR = 3.76)., Conclusions: The presented composite risk score stratifies patients into two prognostic subgroups characterized by standard laboratory values. Patients with signs of systemic inflammation characterized by elevated NLR, AP, and CRP have a high composite risk score and a significant shorter overall survival. Although this score needs to be prospectively validated in larger cohorts, it may be used to stratify patients suitable for further-line treatment studies., (© 2023 The Author(s). Published by S. Karger AG, Basel.)

Introduction: The Covid-19 pandemic has caused great personal stress for medical staff. To ensure adequate outpatient care for cancer patients, extensive safety and hygiene measures must be taken. This interview-based study examines the effects-both personal and professional-of the pandemic on the work routine of outpatient hematology/oncology nurses and medical assistants., Patients, Materials and Methods: Half a year after the outbreak of Covid-19 and the introduction of infection control regulations in three outpatient hematological/oncological centers, the affected medical staff (n = 15) were surveyed about the consequences for patient care and clinical work using audio-recorded telephone interviews. The interviews were transcribed and analyzed using a qualitative content analysis., Results: The Covid-19 pandemic has complicated the medical care of cancer patients, but only a slight deterioration of medical and psycho-oncological care was observed. The level of stress experienced by medical staff is moderate, with hygiene and safety measures at the workplace helping to reduce stress., Conclusion: From the point of view of medical staff, the Covid-19 pandemic has had a moderate impact on the outpatient care of cancer patients. Safety measures against Covid-19 are decisive for ensuring the continuation of therapy and for motivating employees., Competing Interests: F.K. has expert activities for Elsevier, Astellas, GSK, MSD, Novartis, Pierre-Fabre and Servier. All other authors have no conflicts of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Background: More than 80% of the residents in German hospices suffer from tumor disease. But the administration of supportive-oncological therapies in hospices for symptom control is controversially discussed., Objectives: This study aims to investigate the care situation of tumor patients in German hospices with regard to medical care and the use of supportive-oncological therapies., Methods: In February 2019, all hospices in Germany were offered the opportunity to participate in an anonymous online survey on medical and drug care for their tumor patients. The survey was conducted using the online platform SoSci Survey and ended in April 2019. The analysis was descriptive., Results: Of 202 hospices, 112 responded to the questionnaire. The hospices were distributed nationwide. Most have 8 to 10 places. More than 80% of hospice residents are tumor patients, and the length of stay is usually three to four weeks. Medical care is primarily provided by primary care physicians. While specialized outpatient palliative care is increasingly involved in care, hematologists/oncologists are rarely represented. Supportive-oncological therapies are rarely prescribed, whereas medication for other chronic conditions is often continued. The percentage of supportive-oncological therapies prescribed is higher in hospices with oncology co-care., Conclusions: Although most hospice residents suffer from malignant disease, co-care by a hematologist/oncologist is rare. Supportive-oncology therapies, particularly for symptom relief, may therefore be rarely used. However, since a small select group of hospice residents may benefit from these therapies, further investigation in this direction should be undertaken., Competing Interests: U.K., U.V.-K., and A.H. have no conflict of interests. F.K. indicates consulting activities for Servier, Elsevier, Astellas, GSK, MSD, and Novartis., (© Ulrich Kaiser et al., 2022; Published by Mary Ann Liebert, Inc.)