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  • 1
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    CTNI-04. RECURRENT GLIOBLASTOMA LONG-TERM SURVIVORS TREATED WITH CUSP9v3
    Oxford University Press (OUP) ; 2021
    In:  Neuro-Oncology Vol. 23, No. Supplement_6 ( 2021-11-12), p. vi59-vi59
    Details
    In: Neuro-Oncology, Oxford University Press (OUP), Vol. 23, No. Supplement_6 ( 2021-11-12), p. vi59-vi59
    Abstract: CUSP9v3 is a new treatment regimen for glioblastoma. It consists of continuous daily use of 9 drugs repurposed from general medicine. Their primary non-oncology uses are given in parentheses: aprepitant (nausea), auranofin (rheumatoid arthritis), celecoxib (pain), captopril (hypertension), disulfiram (alcohol abuse), itraconazole (fungal infection), minocycline (bacterial infection), ritonavir (viral infection) and sertraline (depression). All drugs have preclinical or clinical data indicating that they can retard glioblastoma growth, as reviewed in the published background papers. In CUSP9v3 all 9 medicines are given daily with added metronomic, low-dose (20 mg/m2 BSA twice daily) temozolomide. After 3 years of daily, uninterrupted use of CUSP9v3, of an initial cohort of 10 recurrent glioblastoma patients, as of May 2021, 3 are alive, functioning well, progression-free at 44, 44, and 57 months after recurrence and CUSP9v3 started. We report now that there were no unexpected toxicities from this combination of 10 daily drugs, although all patients required dose reduction of one or more of the drugs. CUSP9v3 was reasonably well-tolerated. Ritonavir, temozolomide, captopril and itraconazole were the drugs most frequently requiring dose reduction or pausing. The most common adverse events were nausea, headache, fatigue, diarrhea and ataxia. There were no treatment-related deaths. In the 3 long-term survivors, the median neutrophil-to-lymphocyte ratio decreased from 2.5 to 1.5 during CUSP9v3 treatment. In the group of the 3 shortest-term survivors that ratio increased from 4.7 to 14.3. CUSP9v3 follows the injunction of Palmer et al. that cancer therapy can be constructed using drug combinations that are independently effective, with non-overlapping mechanisms of action, and non-overlapping resistance pathways. We interpret the data accrued over the last few decades on the ever-shifting spatial and temporal growth drives active at any given moment in glioblastoma as requiring a complex pharmacological approach like CUSP9v3.
    Type of Medium: Online Resource
    ISSN: 1522-8517 , 1523-5866
    URL: Article
    DOI: 10.1093/neuonc/noab196.229
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 2094060-9
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  • 2
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    A phase Ib/IIa trial of 9 repurposed drugs combined with temozolomide for the treatment of recurrent glioblastoma: CUSP9v3
    Oxford University Press (OUP) ; 2021
    In:  Neuro-Oncology Advances Vol. 3, No. 1 ( 2021-01-01)
    Details
    In: Neuro-Oncology Advances, Oxford University Press (OUP), Vol. 3, No. 1 ( 2021-01-01)
    Abstract: The dismal prognosis of glioblastoma (GBM) may be related to the ability of GBM cells to develop mechanisms of treatment resistance. We designed a protocol called Coordinated Undermining of Survival Paths combining 9 repurposed non-oncological drugs with metronomic temozolomide—version 3—(CUSP9v3) to address this issue. The aim of this phase Ib/IIa trial was to assess the safety of CUSP9v3. Methods Ten adults with histologically confirmed GBM and recurrent or progressive disease were included. Treatment consisted of aprepitant, auranofin, celecoxib, captopril, disulfiram, itraconazole, minocycline, ritonavir, and sertraline added to metronomic low-dose temozolomide. Treatment was continued until toxicity or progression. Primary endpoint was dose-limiting toxicity defined as either any unmanageable grade 3–4 toxicity or inability to receive at least 7 of the 10 drugs at ≥ 50% of the per-protocol doses at the end of the second treatment cycle. Results One patient was not evaluable for the primary endpoint (safety). All 9 evaluable patients met the primary endpoint. Ritonavir, temozolomide, captopril, and itraconazole were the drugs most frequently requiring dose modification or pausing. The most common adverse events were nausea, headache, fatigue, diarrhea, and ataxia. Progression-free survival at 12 months was 50%. Conclusions CUSP9v3 can be safely administered in patients with recurrent GBM under careful monitoring. A randomized phase II trial is in preparation to assess the efficacy of the CUSP9v3 regimen in GBM.
    Type of Medium: Online Resource
    ISSN: 2632-2498
    URL: Article
    DOI: 10.1093/noajnl/vdab075
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 3009682-0
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  • 3
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    Superiority of temozolomide over radiotherapy for elderly patients with RTK II methylation class, MGMT promoter methylated malignant astrocytoma
    Oxford University Press (OUP) ; 2020
    In:  Neuro-Oncology Vol. 22, No. 8 ( 2020-08-17), p. 1162-1172
    Details
    In: Neuro-Oncology, Oxford University Press (OUP), Vol. 22, No. 8 ( 2020-08-17), p. 1162-1172
    Abstract: O6-methylguanine DNA-methyl transferase (MGMT) promoter methylation status is predictive for alkylating chemotherapy, but there are non-benefiting subgroups. Methods This is the long-term update of NOA-08 (NCT01502241), which compared efficacy and safety of radiotherapy (RT, n = 176) and temozolomide (TMZ, n = 193) at 7/14 days in patients & gt;65 years old with anaplastic astrocytoma or glioblastoma. DNA methylation patterns and copy number variations were assessed in the biomarker cohort of 104 patients and in an independent cohort of 188 patients treated with RT+TMZ-containing regimens in Heidelberg. Results In the full NOA-08 cohort, median overall survival (OS) was 8.2 [7.0–10.0] months for TMZ treatment versus 9.4 [8.1–10.4] months for RT; hazard ratio (HR) = 0.93 (95% CI: 0.76–1.15) of TMZ versus RT. Median event-free survival (EFS) [3.4 (3.2–4.1) months vs 4.6 (4.2–5.0) months] did not differ, with HR = 1.02 (0.83–1.25). Patients with MGMT methylated tumors had markedly longer OS and EFS when treated with TMZ (18.4 [13.9–24.4] mo and 8.5 [6.9–13.3] mo) versus RT (9.6 [6.4–13.7] mo and 4.8 [4.3–6.2] mo, HR 0.44 [0.27–0.70] , P & lt; 0.001 for OS and 0.46 [0.29–0.73], P = 0.001 for EFS). Patients with glioblastomas of the methylation classes receptor tyrosine kinase I (RTK I) and mesenchymal subgroups lacked a prognostic impact of MGMT in both cohorts. Conclusion MGMT promoter methylation is a strong predictive biomarker for the choice between RT and TMZ. It indicates favorable long-term outcome with initial TMZ monotherapy in patients with MGMT promoter-methylated tumors primarily in the RTK II subgroup.
    Type of Medium: Online Resource
    ISSN: 1522-8517 , 1523-5866
    URL: Article
    DOI: 10.1093/neuonc/noaa033
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2020
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  • 4
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    U-DCS: characterization of the first permanent human dendritic sarcoma cell line
    Springer Science and Business Media LLC ; 2020
    In:  Scientific Reports Vol. 10, No. 1 ( 2020-12-04)
    Details
    In: Scientific Reports, Springer Science and Business Media LLC, Vol. 10, No. 1 ( 2020-12-04)
    Abstract: A dendritic cell sarcoma cell line, U-DCS, was established from a dendritic cell sarcoma in a 53-year-old Caucasian male patient. Since its establishment, U-DCS has maintained stable phenotypic characteristics in vitro and has a doubling time of approximately 2 days under standard culture conditions. U-DCS is growing with typical dendritic cell morphology in tissue and expresses the dendritic cell sarcoma immunophenotypic markers S100 protein, MHCI, MHCII, and vimentin. Expression analysis revealed transcripts for the toll-like receptors TLR3, -4, -9 and DDX58 (RIG-I), but not for TLR2. U-DCS shows functional features of dendritic cells with the ability of phagocytosis and antigen-specific T cell stimulation. Karyotype-, CGH-, and mFISH analysis point to a chromosomal instability and a hypotetraploid karyotype with approximately 130 chromosomes. U-DCS is the first immortalized human dendritic cell sarcoma cell line and has some morphological and functional features of dendritic cells without dependency on growth factors.
    Type of Medium: Online Resource
    ISSN: 2045-2322
    URL: Article
    DOI: 10.1038/s41598-020-77471-7
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2615211-3
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  • 5
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    Table_3.pdf
    Frontiers Media SA ; 2023
    In:  Frontiers in Psychology Vol. 14 ( 2023-9-7)
    Details
    In: Frontiers in Psychology, Frontiers Media SA, Vol. 14 ( 2023-9-7)
    Abstract: Psycho-oncological interventions can reduce distress by activating individual resources and enhancing coping skills. Since medical cancer treatment is performed increasingly in outpatient settings, there is a growing need for evidence-based and brief interventions to be integrated seamlessly into these treatment procedures. The aim of the present pilot study is to examine the feasibility of brief interventions to cope with illness in this area. Methods A single center quasi-experimental design was developed in oncological outpatients at the University Medical Center Ulm, Germany, including N  = 60 individuals with cancer undergoing chemotherapy or immunotherapy. The intervention group (IG) consisted of N  = 40 participants. These were assigned to either cognitive behavioral interventions (CBI) or hypnotherapeutic interventions (HTI). The interventions each comprised three individual one-hour sessions. In addition, a waiting control group (WCG of N  = 20) was set up, receiving care-as-usual. Primary outcomes were feasibility measures such as recruitment rates, participant retention rates, and complete data rates. Clinical results were discussed for the feasibility of a comprehensive efficacy study. Results The recruitment and completion rates illustrate demand and acceptance of the offer. Of the 208 individuals with cancer offered to participate in the study, 77 were interested in enrolling. This rate of 37% roughly corresponds to the use of psycho-oncological services in general. 17 individuals (22%) withdraw from participation before the intervention began due to severe deterioration in their disease. Once started, all 40 individuals of the IG (100%) completed the intervention, and 17 individuals of the WCG (85%) completed the accompanying questionnaires. Tentative results on clinical outcomes indicate that brief interventions on resource activation could have lasting effects on well-being and stress management. Discussion With this feasibility study, we aimed to explore the potential of brief interventions such as hypnotherapeutic and cognitive-behavioral approaches in psycho-oncology as an integral part of oncology day care. Even with a small number of participants results seem to indicate that the study design and brief interventions such as those presented can offer a low-threshold service that can be seamlessly integrated into oncological therapy. Given the promising results of this pilot study, we propose a full RCT on the effectiveness of such a brief intervention program. Clinical trial registration https://www.drks.de, German Trials Register (DRKS00019095).
    Type of Medium: Online Resource
    ISSN: 1664-1078
    URL: Article
    URL: Article
    URL: Article
    URL: Article
    DOI: 10.3389/fpsyg.2023.1253423
    DOI: 10.3389/fpsyg.2023.1253423.s001
    DOI: 10.3389/fpsyg.2023.1253423.s002
    DOI: 10.3389/fpsyg.2023.1253423.s003
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2023
    detail.hit.zdb_id: 2563826-9
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  • 6
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    Neurocognitive functioning and health-related quality of life in adult medulloblastoma patients: long-term outcomes of the NOA-07 study
    Springer Science and Business Media LLC ; 2020
    In:  Journal of Neuro-Oncology Vol. 148, No. 1 ( 2020-05), p. 117-130
    Details
    In: Journal of Neuro-Oncology, Springer Science and Business Media LLC, Vol. 148, No. 1 ( 2020-05), p. 117-130
    Abstract: Combined radiochemotherapy followed by maintenance chemotherapy with cisplatin, lomustine and vincristine within the NOA-07 study resulted in considerable short-term toxicity in adult medulloblastoma patients. Here we investigated the long-term impact of this treatment, focusing on neurocognitive functioning and health-related quality of life (HRQoL). Methods Neurocognitive functioning and HRQoL scores over time were determined, and differences between the post-treatment and follow-up assessments were calculated up to 18 months for neurocognition and 60 months for HRQoL. Results 28/30 patients were analyzed. The three preselected HRQoL scales (role, social and cognitive functioning) showed improved scores, to a clinically relevant extent (≥ 10 points), compared to post-treatment levels up to 30 months, but decreased afterwards. Z-scores for verbal working memory were worse during follow-up compared to post-treatment scores and remained impaired during 18 months follow-up (i.e. z-score below − 1 standard deviation). Attention was impaired post-treatment, and remained impaired to a clinically relevant extent during follow-up. Coordination/processing speed and lexical verbal fluency improved compared to post-treatment scores, and remained within the normal range thereafter. Other tests of verbal fluency were stable over time, with z-scores within the normal range. Conclusions This long-term follow-up study showed that the NOA-07 treatment regimen was not associated with a deterioration in HRQoL in the post-treatment period. Verbal working memory deteriorated, while other neurocognitive domains did not seem to be impacted negatively by the treatment.
    Type of Medium: Online Resource
    ISSN: 0167-594X , 1573-7373
    URL: Article
    DOI: 10.1007/s11060-020-03502-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2007293-4
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  • 7
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    Severe symptoms and very low quality-of-life among outpatients newly diagnosed with advanced cancer: data from a multicenter cohort study
    Springer Science and Business Media LLC ; 2020
    In:  Supportive Care in Cancer Vol. 28, No. 11 ( 2020-11), p. 5547-5555
    Details
    In: Supportive Care in Cancer, Springer Science and Business Media LLC, Vol. 28, No. 11 ( 2020-11), p. 5547-5555
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 0941-4355 , 1433-7339
    URL: Article
    DOI: 10.1007/s00520-020-05388-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 1463166-0
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  • 8
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    Systematic symptom screening in patients with advanced cancer treated in certified oncology centers: results of the prospective multicenter German KeSBa project
    Springer Science and Business Media LLC ; 2023
    In:  Journal of Cancer Research and Clinical Oncology Vol. 149, No. 11 ( 2023-09), p. 8829-8842
    Details
    In: Journal of Cancer Research and Clinical Oncology, Springer Science and Business Media LLC, Vol. 149, No. 11 ( 2023-09), p. 8829-8842
    Abstract: Guidelines recommend a structured symptom screening (SC) for especially advanced cancer patients (CPs). The aim of this multicenter German prospective quality assurance project KeSBa (Kennzahl Symptom- und Belastungserfassung) was to gain knowledge on SC procedures in Oncology Centers (OCs) for advanced cancer patients and a first impression on the consequences of SC. Methods The KeSBa project consisted of three phases: pilot, 3 months screening and feedback phase. Participating OCs decided to use either the Minimal Documentation System (MIDOS) or the Integrated Palliative care Outcome Scale (IPOS) and defined the cutoff values for positive screening results. Results Out of 172 certified German OCs, 40 (23%) participated in the KeSBa pilot phase, 29 (16.8%) in the 3 months screening phase using MIDOS ( n  = 18, 58.6%) or IPOS ( n  = 11, 41.3%) and in the feedback round. 25/29 performed paper-based screening (86.2%). 2.963 CPs were screened. Results were documented for 1255 (42.2%, SC +) positive and 874 (29.5%, SC–) negative screenings depending on the center´s schedules: 452 SC + CPs (28.4%) and 42 SC– CPs (2.6%) had contact to specialized palliative care or other supportive specialist teams afterwards, 458 SC + CPs (28.8%) and 605 SC– CPs (38.1%) remained in standard oncology care. In the feedback round missing resources (personal and IT) and improved communication were mentioned most often. Conclusion Routine SC is feasible in advanced CPs treated in OCs but associated with considerable workload. In 42.2% of CPs SC was classified as positive, indicating the need of further diagnostics or professional judgment. SC requires staff and IT resources.
    Type of Medium: Online Resource
    ISSN: 0171-5216 , 1432-1335
    URL: Article
    DOI: 10.1007/s00432-023-04818-8
    RVK:
    XA 52301
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 1459285-X
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  • 9
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    Osteosarcoma and Causes of Death. A Report of 1.520 Deceased Patients from the Cooperative Osteosarcoma Study Group (COSS)
    Elsevier BV ; 2022
    In:  SSRN Electronic Journal
    Details
    In: SSRN Electronic Journal, Elsevier BV
    Type of Medium: Online Resource
    ISSN: 1556-5068
    URL: Article
    DOI: 10.2139/ssrn.4123434
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
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  • 10
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    Feasibility, use and benefits of patient-reported outcome measures in palliative care units: a multicentre observational study
    Springer Science and Business Media LLC ; 2023
    In:  BMC Palliative Care Vol. 22, No. 1 ( 2023-01-14)
    Details
    In: BMC Palliative Care, Springer Science and Business Media LLC, Vol. 22, No. 1 ( 2023-01-14)
    Abstract: Research has shown that routinely assessed, patient-reported outcome measures (PROMs) have positive effects in patients with advanced oncologic diseases. However, the transferability of these results to specialist palliative care is uncertain because patients are more impaired and staff doubt the feasibility and benefits. The aim of this study is to evaluate the feasibility of patient self-assessment of PROMs, their use by staff and the benefits in palliative care wards. Method A multicentre observational study was conducted in the context of the implementation of the Integrated Patient Outcome Scale (IPOS) in three specialist palliative care wards at university hospitals in Germany. All admitted patients who screened positive regarding their ability to complete questionnaires were asked to participate and complete the IPOS on paper weekly, with assistance if necessary. Feasibility of questionnaire completion (e.g. proportion of patients able to complete them), use (e.g. involvement of different professional groups) and benefit (e.g. unexpected information in IPOS as rated by treating physicians) were assessed. Staff members’ opinion was obtained in a written, anonymous evaluation survey, patients’ opinion in a short written evaluation. Results A total of 557 patients were screened for eligibility, 235 were assessed as able to complete the IPOS (42.2%) and 137 participated in the study (24.6%). A majority needed support in completing the IPOS; 40 staff members and 73 patients completed the evaluation. Unexpected information was marked by physicians in 95 of the 137 patient questionnaires (69.3%). The staff differed in their opinions on the question of whether this also improved treatment. A majority of 32 staff members (80.0%) were in favour of continuing the use of IPOS (4 against continuation, 4 no answer); 43 (58.9%) patients rated their overall experience of IPOS use as ‘positive’, 29 (39.7%) as ‘neutral’ and 1 (1.4%) as ‘negative’. Conclusions While most staff wished to continue using IPOS, it was a challenge to integrate the effort to support the completion of IPOS into daily practice. Digital implementation was not successful, despite various attempts. To explore the effects on care and patient outcomes, multicentre cluster-randomised trials could be employed. Trial registration German Clinical Trials Register DRKS-ID: DRKS00016681 (24/04/2019).
    Type of Medium: Online Resource
    ISSN: 1472-684X
    URL: Article
    DOI: 10.1186/s12904-022-01123-y
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2023
    detail.hit.zdb_id: 2091556-1
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