Publications

Cancer rehabilitation support by cancer counselling centres (CARES): study protocol of a quasi-experimental feasibility study.

Abstract (Expand)

INTRODUCTION: While maintaining or restoring work ability after a cancer diagnosis is an essential aim of the rehabilitation process for working-age patients, problems can arise during the return to … work (RTW) or when retaining work. Counselling could provide support for patients with or after cancer with employment-related questions (eg, questions related to RTW and work retention). Outpatient psychosocial cancer counselling centres in Germany offer counselling on work-related questions; however, resources for this are limited. This protocol presents a feasibility study of an intensified needs-based counselling intervention that supports those seeking employment-related advice. METHODS AND ANALYSIS: The CARES (cancer rehabilitation support by cancer counselling centres) project is a feasibility study for a newly developed counselling intervention. The intervention is being developed as part of the project and piloted in about 20 outpatient cancer counselling centres. The CARES study has a quasi-experimental pre-post design with a control cohort. First, patients who undergo regular counselling are recruited. Second, after the counsellors have been trained for the newly developed intervention, participants for the intervention group are recruited from the cancer counselling centres. Quantitative and formative evaluations will be performed in accordance with the existing guidelines. The quantitative evaluation comprises three patient surveys (at the beginning of the counselling process, 3 months into the counselling process and, for the intervention group, at the end of the counselling process) and routine data of the counselling process. The formative evaluation includes interviews with patients, counsellors and other stakeholders, as well as participatory observations of counselling sessions. ETHICS AND DISSEMINATION: Approval has been obtained from the ethics committee of the Medical Faculty of the University Bonn (061/22; 09.04.2022). A data protection concept ensures adherence to data protection regulations for the handled data. The dissemination strategies include discussing the results with the cancer counselling centres. TRIAL REGISTRATION NUMBER: German Clinical Trials Register (DRKS00028121); Pre-results.

Authors: K. Hiltrop, P. Heidkamp, C. Breidenbach, C. Kowalski, G. Bruns, N. Ernstmann

Date Published: 11th Aug 2023

Publication Type: Journal

Berufsbezogene Beratung im Rahmen der Cancer-Rehabilitation-Support-by-Cancer-Counseling-Centers(CARES)-Studie

Abstract (Expand)

**Hintergrund** Bei Krebsbetroffenen im erwerbsfähigen Alter stellen sich von Diagnose und Behandlungsbeginn an zumeist auch arbeitsbezogene Fragestellungen. In der CARES-Studie (Cancer Rehabilitation … Support by Cancer Counseling Centers) wurden Berufslots\*innen in Krebsberatungsstellen (KBS) fortgebildet, die Ratsuchende rund um berufliche Themen unterstützen können. **Fragestellung** Wer nimmt das Berufslots\*innenangebot in Anspruch? Welche Vorteile und Optimierungsmöglichkeiten nehmen Ratsuchende, Berufslots\*innen und Zuweisende vom Berufslots\*innenprogramm wahr? **Methode** CARES ist eine quasiexperimentelle Machbarkeitsstudie. In 19 KBS wurden zunächst Ratsuchende vor Einführung des Berufslots\*innenprogramms (Vergleichsgruppe [VG]) und anschließend Ratsuchende nach Schulung der Berufslots\*innen (Interventionsgruppe [IG], vorläufige Ergebnisse) eingeschlossen. In diesem Beitrag werden Befragungsdaten zum ersten Befragungszeitpunkt zu Beginn der Beratung berichtet. Zudem wurden semistrukturierte Interviews geführt. Diese wurden inhaltsanalytisch ausgewertet. **Ergebnisse** Teilnehmende an CARES (VG: n = 293/IG: n = 326) waren mehrheitlich weiblich und hatten einen (Fach‑)Hochschulabschluss. An den Interviews nahmen 16 Ratsuchende, 11 Berufslots\*innen und 5 Zuweisende teil. Als Vorteile des Programms wurden u. a. die unmittelbare Unterstützung und Hilfe bei bürokratischen Prozessen, erhöhte zeitliche Kapazitäten sowie die Schließung einer Lücke in der Versorgungslandschaft genannt. Als Optimierungsmöglichkeiten wurden u. a. Beratungstermine in den Abendstunden bzw. im Onlineformat. **Schlussfolgerung** Ratsuchende, Berufslots\*innen wie auch Zuweisende nehmen das Berufslots\*innenprogramm als vorteilhaft wahr, z. B. als Möglichkeit, Patient\*innen mit Bedarf für Unterstützung bei beruflichen Themen zu verweisen und so eine Lücke in der Versorgung zu schließen.

Authors: Clara Breidenbach, Paula Heidkamp, Kati Hiltrop, Lina Heier, Johanna Weiß, Marie Rösler, Sabine Schneider, Sophie Schellack, Johannes Soff, Christoph Kowalski, Nicole Ernstmann

Date Published: 2nd Aug 2024

Publication Type: Journal

Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study.

Abstract (Expand)

The Evaluating Nilotinib Efficacy and Safety in Clinical Trials as First-Line Treatment (ENEST1st) study included 1089 patients with newly diagnosed chronic myeloid leukemia in chronic phase. The rate … of deep molecular response (MR(4) (BCR-ABL1⩽0.01% on the International Scale or undetectable BCR-ABL1 with ⩾10,000 ABL1 transcripts)) at 18 months was evaluated as the primary end point, with molecular responses monitored by the European Treatment and Outcome Study network of standardized laboratories. This analysis was conducted after all patients had completed 24 months of study treatment (80.9% of patients) or discontinued early. In patients with typical BCR-ABL1 transcripts and ⩽3 months of prior imatinib therapy, 38.4% (404/1052) achieved MR(4) at 18 months. Six patients (0.6%) developed accelerated or blastic phase, and 13 (1.2%) died. The safety profile of nilotinib was consistent with that of previous studies, although the frequencies of some nilotinib-associated adverse events were lower (for example, rash, 21.4%). Ischemic cardiovascular events occurred in 6.0% of patients. Routine monitoring of lipid and glucose levels was not mandated in the protocol. These results support the use of frontline nilotinib, particularly when achievement of a deep molecular response (a prerequisite for attempting treatment-free remission in clinical trials) is a treatment goal.

Authors: A. Hochhaus, G. Rosti, N. C. Cross, J. L. Steegmann, P. le Coutre, G. Ossenkoppele, L. Petrov, T. Masszi, A. Hellmann, L. Griskevicius, W. Wiktor-Jedrzejczak, D. Rea, D. Coriu, T. H. Brummendorf, K. Porkka, G. Saglio, G. Gastl, M. C. Muller, P. Schuld, P. Di Matteo, A. Pellegrino, L. Dezzani, F. X. Mahon, M. Baccarani, F. J. Giles

Date Published: 7th Oct 2015

Publication Type: Journal

Comparison Between 5-Azacytidine Treatment and Allogeneic Stem-Cell Transplantation in Elderly Patients With Advanced MDS According to Donor Availability (VidazaAllo Study)

Abstract (Expand)

PURPOSE In contrast to 5-azacytidine (5-aza), allogeneic stem-cell transplantation (HSCT) represents a curative treatment strategy for patients with myelodysplastic syndromes (MDS), but therapy-related …plastic syndromes (MDS), but therapy-related mortality (TRM) limits its broader use in elderly patients with MDS. The present prospective multicenter study compared HSCT following 5-aza pretreatment with continuous 5-aza treatment in patients with higher-risk MDS age 55-70 years. METHODS One hundred ninety patients with a median age of 63 years were enrolled. Patients received 4-6 cycles of 5-aza followed by HLA-compatible HSCT after reduced-intensity conditioning or by continuous 5-aza if no donor was identified. RESULTS Twenty-eight patients did not fulfill inclusion criteria (n = 20), died (n = 2) withdrew informed consent (n = 5), or were excluded for an unknown reason (n = 1). 5-aza induction started in 162 patients, but only 108 (67%) were eligible for subsequent allocation to HSCT (n = 81) or continuation of 5-aza (n = 27) because of disease progression (n = 26), death (n = 12), or other reasons (n = 16). Seven percent died during 5-aza before treatment allocation. The cumulative incidence of TRM after HSCT at 1 year was 19%. The event-free survival and overall survival after 5-aza pretreatment and treatment allocation at 3 years were 34% (95% CI, 22 to 47) and 50% (95% CI, 39 to 61) after allograft and 0% and 32% (95% CI, 14 to 52) after continuous 5-aza treatment ( P < .0001 and P = .12), respectively. Fourteen patients progressing after continuous 5-aza received a salvage allograft from an alternative donor, and 43% were alive at last follow-up. CONCLUSION In older patients with MDS, reduced-intensity conditioning HSCT resulted in a significantly improved event-free survival in comparison with continuous 5-aza therapy. Bridging with 5-aza to HSCT before is associated with a considerable rate of dropouts because of progression, mortality, and adverse events.

Authors: Nicolaus Kröger, Katja Sockel, Christine Wolschke, Wolfgang Bethge, Richard F. Schlenk, Dominik Wolf, Michael Stadler, Guido Kobbe, Gerald Wulf, Gesine Bug, Kerstin Schäfer-Eckart, Christof Scheid, Florian Nolte, Jan Krönke, Matthias Stelljes, Dietrich Beelen, Marion Heinzelmann, Detlef Haase, Hannes Buchner, Gabriele Bleckert, Aristoteles Giagounidis, Uwe Platzbecker

Date Published: 20th Oct 2021

Publication Type: Journal

A Noninterventional, Observational, European Post-Authorization Safety Study of Patients With Relapsed/Refractory Multiple Myeloma Treated With Lenalidomide.

Abstract (Expand)

INTRODUCTION: Lenalidomide plus dexamethasone is effective and well tolerated in relapsed/refractory multiple myeloma (RRMM). In this observational, noninterventional European post-authorization safety … study, the safety profile of lenalidomide plus dexamethasone was investigated and compared with that of other agents in the treatment of RRMM in a real-world setting. PATIENTS AND METHODS: Patients had received >/= 1 prior antimyeloma therapy; prior lenalidomide was excluded. Treatment was per investigator's routine practice. Adverse events were analyzed by incidence rates per 100 person-years to account for differences in observation length and treatment duration. RESULTS: In total, 2150 patients initiated lenalidomide, and 1479 initiated any other antimyeloma therapy, predominately bortezomib (80.3%), which was primarily administered intravenously (74.3%). The incidence rate of neuropathy was lower with lenalidomide (10.5) than with bortezomib (78.9) or thalidomide (38.7). Lenalidomide also had a lower incidence rate of infections (68.7) versus bortezomib (95.9) and thalidomide (76.0). Conversely, the incidence rate of neutropenia was higher with lenalidomide (38.0) than with bortezomib (18.2) or thalidomide (25.7). The incidence rates of thrombocytopenia were 24.4, 40.4, and 14.4 with lenalidomide, bortezomib, and thalidomide, respectively. CONCLUSION: No new safety signals for lenalidomide were identified in this study, which is the largest prospective real-world European study of lenalidomide in patients with RRMM to date. These results confirm that the safety profile of lenalidomide plus dexamethasone in RRMM in a real-world setting is comparable to that reported in clinical trials.

Authors: B. Gamberi, C. Berthou, M. Hernandez, G. Semenzato, E. Tholouli, R. Hajek, J. Caers, M. Dimopoulos, M. C. Minnema, B. Andreasson, J. Parreira, G. Crotty, K. Remes, E. Kueenburg, B. Rosettani, A. Di Micco, S. Peters, P. Bacon, I. W. Blau

Date Published: 2nd Jul 2020

Publication Type: Journal

GMMG MM5 Trial In Newly Diagnosed Multiple Myeloma To Evaluate PAd Vs VCD Induction Prior To High Dose Treatment Followed By Lenalidomide Consolidation and Maintenance – Final Analysis On Induction Therapy

Abstract (Expand)

Abstract Background The MM5 phase III trial of the German-Speaking Myeloma Multicenter Group (GMMG) was designed to address two independent primary objectives: 1.) demonstration of non-inferiority of …objectives: 1.) demonstration of non-inferiority of VCD (bortezomib, cyclophosphamide, dexamethasone) induction compared to PAd (bortezomib, adriamycin, dexamethasone) induction therapy with respect to response rate (very good partial response or better). 2.) determination of the best of four treatment strategies with respect to progression-free survival (PFS). The four treatment strategies were defined by PAd vs. VCD induction treatment, high dose melphalan (HDM) followed by autologous stem cell transplantation (ASCT) as well as consolidation and maintenance treatment with lenalidomide for 2 years vs. lenalidomide until complete response (CR). Methods 504 patients were included in the trial between July 2010 and October 2012. A non-inferiority analysis of VCD compared to PAd with respect to response rates after induction treatment with a non-inferiority margin of 10% for the difference in response rates (VGPR and better; first primary endpoint) and a safety analysis were performed. During the induction phase the patients were treated with 3 cycles of PAd or VCD. PAd was dosed as bortezomib 1.3 mg/m2, days 1, 4, 8, 11, doxorubicin 9 mg/m2, days 1-4, dexamethasone 20 mg, days 1-4, 9-12, 17-20 (repeated every 28 days). VCD consisted of bortezomib 1.3 mg/m2, days 1, 4, 8, 11, cyclophosphamide 900 mg/m2 day 1, dexamethasone 40 mg, days 1-2, 4-5, 8-9, 11-12 (repeated every 21 days). The route of administration for bortezomib was changed from intravenously to subcutaneously in all study arms by a protocol amendment in February 2012 after inclusion of 314 patients. The non-inferiority analysis was based on intention-to-treat (ITT) population (502 evaluable patients) and per-protocol (PP) population (473 evaluable patients). Responses were assessed according to the response criteria of the International Myeloma Working Group (IMWG). Results In the ITT population, patients treated with PAd or VCD were equally distributed for ISS and Durie-Salmon disease stage, LDH, kidney function and the cytogenetic abnormalities translocation t(4;14), deletion 17p13 and gain 1q21. In the PAd group, the median age of the patients was higher (59.4 vs. 58.7, p=0.04). 229 of 251 patients (91.2%) in the PAd group and 241 of 251 patients (96.0%) in the VCD group completed induction treatment. Observed response rates (PAd vs. VCD) were 4.4% vs 8.4% for complete response, 34.3% vs. 37.0% for ≥ very good partial response and 72.1% vs. 78.1% for ≥ partial response. Non-inferiority of VCD compared to PAd was shown (two-sided p=0.0026). Similar results were obtained in the PP analysis. The proportion of patients with any adverse event (AEs) was comparable in PAd vs. VCD (61.3% vs. 64.0%, p=0.58), but more serious adverse events (SAEs) were observed during PAd induction (32.7% vs. 24.0%, p=0.037). VCD led to a significantly higher proportion of leukopenia and neutropenia CTCAE grade 3 and 4 (PAd: 11.3% vs. VCD: 35.2%; p<0.001). There was no significant difference in the number of infections (≥ CTCAE grade 2) during PAd induction compared to VCD induction (24.6% vs. 22.4%; p=0.60). Interestingly, compared to the infection rate (≥ CTCAE grade 2) of 49% during PAD (dexamethasone 40 mg days 1-4, 9-12, 17-20) in the HOVON65/GMMG-HD4-trial, a reduction in MM5 during induction was observed. In the PAd arm more deaths were observed compared to the VCD arm (6 vs. 1). Conclusion PAd and VCD are well tolerated with more than 90% of the patients receiving all three planned induction cycles. Non-inferiority of VCD compared to PAd was shown in ITT and PP analysis. In conclusion, VCD was found to be a valid alternative to PAd with comparable efficacy and a favourable toxicity profile. Disclosures: Goldschmidt: Celgene: Consultancy, Honoraria, Research Funding; Chugai: Research Funding; Janssen Cilag: Consultancy, Honoraria, Research Funding. Duerig:Janssen Cilag: Honoraria; Celgene: Honoraria. Schmidt-Wolf:Janssen: Honoraria; Novartis: Honoraria. Weisel:Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria, Research Funding. Scheid:Janssen Cilag: Honoraria; Celgene: Honoraria; Novartis: Honoraria. Salwender:Janssen Cilag: Honoraria; Celgene: Honoraria.

Authors: Hartmut Goldschmidt, Jan Duerig, Uta Bertsch, Christina Kunz, Thomas Hielscher, Mathias Haenel, Igor Wolfgang Blau, Dirk Hose, Anna Jauch, Baerbel Schurich, Kai Neben, Anja Seckinger, Barbara Huegle-Doerr, Maximilian Merz, Markus Munder, Walter Lindemann, Matthias Zeis, Christian Gerecke, Ingo GH Schmidt-Wolf, Katja Weisel, Christof Scheid, Hans Salwender

Date Published: 15th Nov 2013

Publication Type: Journal

A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic haematopoietic cell transplant recipients.

Abstract (Expand)

BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B … and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who received >/=1 dose of ASP0113/placebo. The primary efficacy endpoint was the proportion of allo-HCT recipients with composite all-cause mortality and adjudicated CMV end-organ disease (EOD) by 1 year post-transplant. ClinicalTrials.gov: NCT01877655 (not recruiting). FINDINGS: Patients were recruited between Sept 11, 2013 and Sept 21, 2016. Overall, 501 patients received >/=1 dose of ASP0113 (n = 246) or placebo (n = 255). The proportion of patients with composite all-cause mortality and adjudicated CMV EOD by 1 year post-transplant was 35.4% (n = 87) with ASP0113 and 30*2% (n = 77) with placebo (odds ratio 1.27; 95% confidence interval: 0.87 to 1.85; p = 0.205). Incidence of injection site-related treatment-emergent adverse events (TEAEs) was higher with ASP0113 than placebo. Overall incidence and severity of other TEAEs was similar between groups. T-cell response to pp65 increased over time and was greater with placebo than ASP0113 (p = 0.027). INTERPRETATION: ASP0113 did not reduce overall mortality or CMV EOD by 1 year post-transplant. Safety findings were similar between groups. FUNDING: Astellas Pharma Global Development, Inc .

Authors: P. Ljungman, A. Bermudez, A. C. Logan, M. A. Kharfan-Dabaja, P. Chevallier, R. Martino, G. Wulf, D. Selleslag, K. Kakihana, A. Langston, D. G. Lee, C. Solano, S. Okamoto, L. R. Smith, M. Boeckh, J. R. Wingard, B. Cywin, C. Fredericks, C. Lademacher, X. Wang, J. Young, J. Maertens

Date Published: 12th Apr 2021

Publication Type: Journal

Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.

Abstract (Expand)

The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in … newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.

Authors: H. Goldschmidt, E. K. Mai, J. Durig, C. Scheid, K. C. Weisel, C. Kunz, U. Bertsch, T. Hielscher, M. Merz, M. Munder, H. W. Lindemann, B. Hugle-Dorr, D. Tichy, N. Giesen, D. Hose, A. Seckinger, S. Huhn, S. Luntz, A. Jauch, A. Elmaagacli, B. Rabold, S. Fuhrmann, P. Brossart, M. Goerner, H. Bernhard, M. Hoffmann, J. Hillengass, M. S. Raab, I. W. Blau, M. Hanel, H. J. Salwender

Date Published: 9th Feb 2020

Publication Type: Journal

Phase III trial of bortezomib, cyclophosphamide and dexamethasone (VCD) versus bortezomib, doxorubicin and dexamethasone (PAd) in newly diagnosed myeloma.

Abstract (Expand)

We aimed at demonstrating non-inferiority of bortezomib/cyclophosphamide/dexamethasone (VCD) compared to bortezomib/doxorubicin/dexamethasone (PAd) induction therapy with respect to very good partial … response rates or better (⩾VGPR) in 504 newly diagnosed, transplant-eligible multiple myeloma patients. VCD was found to be non-inferior to PAd with respect to ⩾VGPR rates (37.0 versus 34.3%, P=0.001). The rates of progressive disease (PD) were 0.4% (VCD) versus 4.8% (PAd; P=0.003). In the PAd arm, 11 of 12 patients with PD had either renal impairment (creatinine ⩾2 mg/dl) at diagnosis or the cytogenetic abnormality gain 1q21, whereas no PD was observed in these subgroups in the VCD arm. Leukocytopenia/neutropenia (⩾3 degrees ) occurred more frequently in the VCD arm (35.2% versus 11.3%, P<0.001). Neuropathy rates (⩾2 degrees ) were higher in the PAd group (14.9 versus 8.4%, P=0.03). Serious adverse events, both overall and those related to thromboembolic events, were higher in the PAd group (32.7 versus 24.0%, P=0.04 and 2.8 versus 0.4%, P=0.04). Stem cell collection was not impeded by VCD. VCD is as effective as PAd in terms of achieving ⩾VGPR rates with fewer PD and has a favorable toxicity profile. Therefore, VCD is preferable to PAd as induction therapy.

Authors: E. K. Mai, U. Bertsch, J. Durig, C. Kunz, M. Haenel, I. W. Blau, M. Munder, A. Jauch, B. Schurich, T. Hielscher, M. Merz, B. Huegle-Doerr, A. Seckinger, D. Hose, J. Hillengass, M. S. Raab, K. Neben, H. W. Lindemann, M. Zeis, C. Gerecke, I. G. Schmidt-Wolf, K. Weisel, C. Scheid, H. Salwender, H. Goldschmidt

Date Published: 20th Mar 2015

Publication Type: Journal

Peripheral neuropathy associated with subcutaneous or intravenous bortezomib in patients with newly diagnosed myeloma treated within the GMMG MM5 phase III trial.

Abstract

Not specified

Authors: M. Merz, H. Salwender, M. Haenel, E. K. Mai, U. Bertsch, C. Kunz, T. Hielscher, I. W. Blau, C. Scheid, D. Hose, A. Seckinger, A. Jauch, J. Hillengass, M. S. Raab, B. Schurich, M. Munder, P. Brossart, C. Gerecke, H. W. Lindemann, M. Zeis, K. Weisel, J. Duerig, H. Goldschmidt

Date Published: 20th Aug 2016

Publication Type: Journal

Powered by
 (v.1.15.2)
About NFDI4Health | Partners and Funding | Credits
Copyright © 2008 - 2023 The University of Manchester and HITS gGmbH