Wolfgang Abenhardt’s research while affiliated with University Medical Center Hamburg - Eppendorf and other places

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Publications (54)


Results of a Prospective Non-Interventional Post-Authorization Safety Study of Idelalisib in Germany
  • Article

April 2022

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11 Reads

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2 Citations

Clinical Lymphoma, Myeloma and Leukemia

Manuela A. Hoechstetter

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Wolfgang Knauf

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Silvia Dambacher

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[...]

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Mathias Rummel

Background In pivotal studies, idelalisib demonstrated remarkable efficacy and manageable tolerability in patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL). This prospective, multicenter, non-interventional post-authorization study assessed the characteristics, clinical management, and outcome of CLL and FL patients receiving idelalisib in routine clinical practice in Germany. Patients Observational study in CLL and FL patients treated with idelalisib between September 2015 and December 2020. Results A total of 147 patients with CLL and FL were included with a median age of 75 and 71 years, respectively. More than 80% of patients presented with comorbidity and many CLL patients with documented high-risk genetic features, including del(17p)/TP53 mutation or unmutated IGHV. The median progression-free survival (PFS) and overall survival (OS) were not reached in the CLL cohort irrespective of del(17p)/TP53 or unmutated IGHV. The estimated 6-month PFS and OS rates in CLL were 82% and 92%. The estimated 6-month PFS and OS rates for FL were 32.2% and 77.2%. Overall response rates in the CLL and FL cohorts were 70.4% and 36.4%, with the presence of high-risk genetics having no negative impact. No unexpected adverse events were observed. Most frequently reported adverse drug reactions (ADRs) were diarrhea, nausea, pneumonia, rash, and fatigue. Conclusion This real-world study shows that idelalisib is an effective therapy for CLL and FL, regardless of age and high-risk genetic features, consistent with results from previous clinical trials. Collected safety data and the pattern of ADRs reflect those from previous studies.


Rare lymphomas in routine practice – Treatment and outcome in marginal zone lymphoma in the prospective German Tumour Registry Lymphatic Neoplasms
  • Article
  • Full-text available

May 2021

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42 Reads

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7 Citations

Hematological Oncology

Owing to its heterogeneity and rarity, management of disseminated marginal zone B‐cell lymphoma (MZL) remains largely understudied. We present prospective data on choice of systemic treatment and survival of patients with MZL treated in German routine practice. Of 175 patients with MZL who had been documented in the prospective clinical cohort study Tumour Registry Lymphatic Neoplasms (NCT00889798) collecting data on systemic treatment, 58 were classified as extranodal MZL of mucosa‐associated lymphoid tissue (MALT) and 117 as non‐MALT MZL. We analyzed the most commonly used first‐line and second‐line chemo(immuno)therapies between 2009 and 2016 and examined objective response rate (ORR), progression‐free survival (PFS), overall survival (OS) and prognostic factors for survival. Compared to patients with MALT MZL, those with non‐MALT MZL more often presented with bone marrow involvement (43% vs. 14%), Ann Arbor stage III/IV (72% vs. 57%) and were slightly less often in good general condition (ECOG = 0; 41% vs. 47%). In German routine practice, rituximab‐bendamustine for a median of 6 cycles was the most frequently used first‐line (76%) and second‐line treatment (36%), with no major differences between MZL subtypes. The ORR for patients encompassing any positive response was 81%. For patients with MALT and non‐MALT MZL, respectively, 5‐years PFS was 69% (95% CI 52%–81%) and 66% (95% CI 56%–75%), 5‐years OS 79% (95% CI 65%–89%) and 75% (95% CI 66%–83%). Cox proportional hazards models showed a significantly increased risk of mortality for higher age in all patient groups. Our prospective real world data give valuable insights into the management and outcome of non‐selected patients with MZL requiring systemic treatment and can help optimize therapy recommendations.

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Rare lymphomas in routine practice—Treatment and outcome in Waldenström's macroglobulinaemia in the prospective German Tumour Registry Lymphatic Neoplasms

May 2020

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65 Reads

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1 Citation

Hematological Oncology

Waldenström's macroglobulinaemia (WM) is a rare indolent B‐cell lymphoma for which only little prospective phase III evidence exists. Thus, real world data are important to provide insight into treatment and survival. We present here data on choice and outcome of systemic treatment of patients with WM treated in German routine practice. In total, 139 patients with WM who had been documented in the prospective clinical cohort study Tumour Registry Lymphatic Neoplasms (NCT00889798) were included into this analysis. We analysed the most frequently used first‐line and second‐line treatments between 2009 and 2017 and examined best response, progression‐free survival (PFS) and overall survival (OS). Bendamustine plus rituximab, with a median of six cycles, was by far the most frequently used first‐line treatment (81%). Second‐line treatment was more heterogenous and mainly based on bendamustine, cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP), fludarabine or ibrutinib, the latter approved in 2014. Three‐year PFS from start of first‐line treatment was 83% (95% confidence interval [CI] 74%‐88%), 3‐year OS was 87% (95% CI 80%‐92%). These prospective data give valuable insights into the management and outcome of non‐selected patients with WM treated in German routine practice. In the lack of prospective phase III clinical trials, real world data can help bridging the gap of evidence.


CONSORT flow diagram. The reason “adverse event” includes both inacceptable toxicity and (serious) adverse events. After prescreening for identification of biomarker status, patients were screened for eligibility and assigned to the respective subgroup by molecular stratification. Study recruitment was terminated by sponsor due to reevaluation of the risk‐benefit profile of buparlisib. Abbreviations: n: number (of events); PIK3CA: Phosphatidylinositol 4,5‐bisphosphate 3‐kinase catalytic subunit alpha isoform; PTEN, Phosphatase and tensin homolog; ITT, intention‐to‐treat; SAF, safety set
Kaplan‐Meier Estimate of Progression‐Free Survival. Displayed are progression‐free survival in the total patient population (A) and in the prespecified subgroups: PIK3CA mut = “PIK3CA mut/ PTEN preserved”; PTEN loss = “PIK3CA mut or wt/ PTEN loss”; wild‐type = “PIK3CA wt/ PTEN preserved” (B) in the SAF population. Abbreviations: CI, confidence interval; n, number (of events); NA, not reached; PFS, progression‐free survival
Buparlisib in combination with tamoxifen in pretreated patients with hormone receptor‐positive, HER2‐negative advanced breast cancer molecularly stratified for PIK3CA mutations and loss of PTEN expression

April 2020

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62 Reads

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10 Citations

The PIKTAM study evaluated the efficacy and safety of the PI3K inhibitor buparlisib in combination with tamoxifen in hormone receptor‐positive (HR⁺), HER2‐negative advanced breast cancer patients after failure of prior endocrine therapy. In this open‐label, single‐arm phase II trial, 25 patients were enrolled in 11 sites in Germany. Patients were stratified according to PIK3CA mutation status (tissue and cfDNA from serum samples) and/or loss of PTEN expression. Patients received buparlisib (100 mg) and tamoxifen (20 mg) once daily on a continuous schedule (28‐day cycle) until progression or unacceptable toxicity. Primary endpoint was overall 6‐month progression‐free survival (PFS) rate. Key secondary endpoints included the 6‐month PFS rate in subpopulations, PFS, overall survival, overall response rate (ORR), disease control rate (DCR), and safety. Overall, the 6‐month PFS rate was 33.3% (n/N = 7/21, one‐sided 95% CI 16.8‐100) and median PFS was 6.1 (CI 2.6‐10.6) months. The ORR and DCR were 12.5% and 44%. The PIK3CA‐mutated subgroup consistently showed the highest 6‐month PFS rate (62.5%, n/N = 5/8), median PFS (8.7 months), ORR (40%), and DCR (80%). No new safety signals emerged. Most common adverse events were gastrointestinal disorders (56%), psychiatric/mood disorders (48%), skin rash/hypersensitivity (44%), cardiovascular (40%), and hepatic (32%) events. The trial was prematurely terminated due to the substantially altered risk‐benefit profile of buparlisib. Nevertheless, PIK3CA mutations emerged as a clinically feasible and useful biomarker for combined PI3K inhibition and endocrine therapy in patients with HR⁺ breast cancer. Further biomarker‐stratified studies with isoform‐specific PI3K inhibitors are warranted. EudraCT No: 2014‐000599‐24.


Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group

April 2020

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318 Reads

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39 Citations

Leukemia

The heterogeneity of early stage CLL challenges prognostication, and refinement of prognostic indices for risk-adapted management in this population is essential. The aim of the multicenter, prospective CLL1 trial was to explore a novel prognostic model (CLL1-PM) developed to identify risk groups, separating patients with favorable from others with dismal prognosis. A cohort of 539 clinically, biochemically, and genetically characterized Binet stage A patients were observed until progression, first-line treatment, or death. Multivariate analysis identified six independent factors associated with overall survival (OS) and time-to-first treatment (TTFT): del(17p), unmutated IGHV, del(11q), ß2-microglobulin >3.5 mg/dL, lymphocyte doubling time (LDT) <12 months, and age >60 years. These factors were integrated into the CLL1-PM, which stratified patients into four risk groups. The CLL1-PM was prognostic for OS and TTFT, e.g., the risk of treatment at 5 years was 85.9, 51.8, 27.6, and 11.3% for very low (0–1.5), low (2–4), high (4.5–6.5), and very high-risk (7–14) scores, respectively (P < 0.001). Notably, in addition to factors comprising CLL-IPI, we substantiated del(11q) and LDT as prognostic factors in early CLL. Altogether, our findings would be useful to effectively stratify Binet stage A patients, particularly within the scope of clinical trials evaluating novel agents.


Cohort definition. Number of patients enrolled in the TLN from April 2009 until August 2014, split up according to different types of lymphoid B‐cell neoplasms. Of all patients with aggressive NHL, those patients with DLBCL were included into this analysis who had been prospectively enrolled at the start of first‐line treatment with at least 2 documented cycles of either R‐CHOP‐14 or R‐CHOP‐21 (n = 582), classified by the length of the first cycle with a tolerance of ±3 d (11‐17 d = R‐CHOP‐14; 18‐24 d = R‐CHOP‐21). Of these patients with R‐CHOP‐14 (n = 264) and R‐CHOP‐21 (n = 318), those patients with at least 5 documented cycles were further classified by the length of the first 4 cycles resulting in 135 patients with R‐CHOP‐14 and 176 with R‐CHOP‐21. Data cut‐off for this analysis was August 31, 2017. Abbreviations: CLL, chronic lymphocytic leukaemia; MM, multiple myeloma; DLBCL, diffuse large B‐cell lymphoma; NHL, non‐Hodgkin's lymphoma; R‐CHOP, drug combination including rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone
Progression‐free survival and overall survival of patients treated with either R‐CHOP‐14 or R‐CHOP‐21. Prospectively documented patients with DLBCL at start of first‐line treatment who had at least 2 documented cycles of either R‐CHOP‐14 or R‐CHOP‐21: (A) first‐line PFS and (B) first‐line OS of all patients included, classified by the length of the first cycle (n = 582); (C) first‐line PFS and (D) first‐line OS of those patients with at least 5 documented cycles, classified by the length of the first 4 cycles (n = 311); Abbreviations: CI, confidence interval; NA, not applicable (not reached); OS, overall survival; PFS, progression‐free survival; R‐CHOP, drug combination including rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. See also Table 3 for details on survival data [Colour figure can be viewed at wileyonlinelibrary.com]
Similar effectiveness of R‐CHOP‐14 and ‐21 in diffuse large B‐cell lymphoma—data from the prospective German Tumour Registry Lymphatic Neoplasms

September 2019

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57 Reads

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17 Citations

Objectives R‐CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) is the standard therapy for patients with previously untreated diffuse large B‐cell lymphomas (DLBCL). Dose‐dense two‐weekly ‘R‐CHOP‐14’ was not superior over three‐weekly ‘R‐CHOP‐21’ in randomised clinical trials (RCTs). We present real‐world data on effectiveness of R‐CHOP‐14 and R‐CHOP‐21 in patients with DLBCL treated in German routine practice. Methods We identified 582 patients with DLBCL treated with R‐CHOP‐14 or R‐CHOP‐21 in 92 sites from the prospective clinical cohort study Tumour Registry Lymphatic Neoplasms. Patients’ schedules were classified by (a) length of the initial first cycle and (b) length of cycles 1‐4. Results About 55% of patients received R‐CHOP‐21, 45% R‐CHOP‐14, in median 6 cycles. 51% and 55% of patients, respectively, were able to continue their initial R‐CHOP‐14 and R‐CHOP‐21 schedule. While most characteristics between the patient cohorts were similar, patients receiving R‐CHOP‐21 presented slightly more often with tumour stage I and lower IPI risk. 3‐year overall survival of patients with R‐CHOP‐14 and R‐CHOP‐21 did not differ: 84% vs 84% (first cycle), 87% vs 89% (cycles 1‐4). Conclusions Patients with DLBCL in Germany are slightly more likely to receive R‐CHOP‐21 than R‐CHOP‐14. Both schedules are similarly effective in routine practice confirming the results from RCTs.


PATIENT-BASED PROSPECTIVE REAL WORLD DATA ANALYSIS SHOWS THAT THE DURATION OF TREATMENT INTERRUPTIONS WITH SUBSEQUENT RESUMPTION OF IDELALISIB THERAPY CAN VARY FROM DAYS TO MONTHS: PS1163

June 2019

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16 Reads

Background Idelalisib, a first‐in‐class PI3Kδ‐inhibitor, is licensed in the European Union in relapsed chronic lymphocytic leukemia (CLL) and refractory follicular lymphoma (FL). Treatment should be continued until disease progression or unacceptable toxicity and may continue for several months or years. Optimal therapy management is therefore important and may include temporary treatment interruptions (TIs) and dose modifications to manage idelalisib associated adverse drug reactions (ADRs). Aims Recent data from a retrospective analysis of idelalisib clinical studies suggest that patients may benefit from optimal ADR management of idelalisib via TI and subsequent resumption of therapy [Ma et al. ASH 2018]. Here we analyzed frequency and duration of TIs within a prospective observational study. To understand the effect of TIs on the course of disease, we additionally analyzed lymphocyte counts during and after treatment interruption on an individual patient level. Methods Post‐hoc analysis of a prospective, two‐cohort, multicenter, non‐interventional post‐authorization safety study (PASS) reporting real world safety and effectiveness data on the use of idelalisib in Germany. Inclusion of patients was based on the physician's decision to initiate treatment with idelalisib in accordance with the European Summary of Product Characteristics. Detailed methods, patient characteristics and results were already published at two conferences [Hoechstetter et al. DGHO 2018; Hoechstetter et al. ASH 2018]. Descriptive statistics were used for data analysis. Idelalisib TIs were defined as documented interruptions with subsequent resumption of idelalisib therapy. Results 96 patients (84 CLL and 12 FL patients) enrolled at 45 sites were included until data cut in February 2018 with a median follow‐up of 9.7 months. 58 patients had documented permanent discontinuation of idelalisib therapy. 49 patients had one or more documented TIs with 26 patients (one TI n = 20, two TI n = 6) subsequently resuming therapy. After interruptions, treatment was resumed with the standard or a reduced idelalisib dose of 150 mg or 100 mg twice daily, respectively. The most frequently reported reason for both dose reduction and TI was ADR, only 9 TIs followed an adverse event (AE) not related to idelalisib. The 3 most commonly reported ADRs (events) resulting in TI were diarrhea (9), pulmonary complications (4) and rash (3). The duration of TIs varied widely from only a few to 235 days. The median (range) duration of a single TI was 15 (1–235) days, representing 15 (1–86) days for the first and 16 (5–235) days for the second interruption, respectively. 9 patients had a single interruption with a duration of >30 days. Patient level data demonstrate stable or only moderate changes in lymphocyte counts during this treatment interruption. Summary/Conclusion Optimal management of idelalisib therapy to achieve best outcomes for patients may include temporary TIs and/or dose modifications. However, little information is available about the duration of idelalisib TIs and the possibility to resume therapy in routine clinical practice. Our analysis of prospectively collected real world data shows that the duration of TIs may vary widely from a few days to several months with about 50% of patients with a TI resuming idelalisib therapy. Patient level data suggest that lymphocyte counts were relatively stable during and after TIs. Our results therefore provide evidence that idelalisib treatment may be interrupted to allow treatment of ADRs/AEs with subsequent resumption of idelalisib therapy. image


Abstract P6-17-22: Progression free survival (PFS) and overall survival (OS) of patients treated with trastuzumab emtansine (T-DM1) after previous treatment with pertuzumab in patients with advanced breast cancer (NCT02338167)

February 2019

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32 Reads

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2 Citations

Cancer Research

Background Studies leading to the approval of trastuzumab emtansine (T-DM1) have been conducted without pertuzumab as previous therapy. Therefore data about patient characteristics and the efficacy of T-DM1 after a treatment with pertuzumab is scarce. Aim of this study was to analyze a real world patient cohort of advanced breast cancer (aBC) patients, who were treated with T-DM1 after a treatment containing pertuzumab in the metastatic setting with regard to patient characteristics and progression free survival (PFS). Methods The PRAEGNANT metastatic breast cancer registry (NCT02338167) is a prospective registry for metastatic breast cancer patients with focus on molecular biomarkers. Patients of all therapy lines with any kind of treatment are eligible for this registry. Collected data comprises all relevant patient and tumor characteristics, therapies, adverse events, quality of life, patient reported outcomes, response and survival (PFS/OS). Here we report on the patient characteristics and PFS data for HER2 positive patients treated with T-DM1 after a treatment with pertuzumab. Patients had to be included before or at the beginning of the T-DM1 therapy. Results A total of 58 patients could be identified, who were suitable for the analysis. Of those 34 were treated in the second line, 14 in the third line and 10 in the fourth line or higher. Most of the pertuzumab therapies before T-DM1 were conducted in first line (n=46; 79.3%). Median PFS for all patients was 4.8 months (95% CI: 3.0-7.8 months). Median PFS for patients treated in the 3rdline and 4thline or higher was 4.2 months(95%CI: 2.3 - NA) and 4.0 months (95%CI: 1.8-N.A.), respectively. In patients treated 2ndline with T-DM1 PFS was 7.7 months (95%CI: 2.8 – 12.2). Conclusion T-DM1 is effective as 2ndand further line therapy following pretreatment with pertuzumab. Overall PFS was about 5 months with 7.7 months as 2nd-line therapy. The PFS in higher therapy lines might be shorter. As the sample size of this real world cohort was rather low and analyses have to be considered exploratory, this data need to be confirmed in studies with a larger sample size. Citation Format: Schneeweiss A, Lux MP, Hartkopf AD, Volz B, Kolberg H-C, Hadji P, Tesch H, Haeberle L, Ettl J, Lüftner DI, Wallwiener M, Müller V, Beckmann MW, Belleville E, Wimberger P, Hielscher C, Geberth M, Lermann J, Abenhardt W, Kurbacher C, Wuerstlein R, Thomssen C, Untch M, Overkamp F, Huober J, Taran F-A, Janni W, Wallwiener D, Brucker SY, Fasching PA, Fehm TN. Progression free survival (PFS) and overall survival (OS) of patients treated with trastuzumab emtansine (T-DM1) after previous treatment with pertuzumab in patients with advanced breast cancer (NCT02338167) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-22.


Abstract P6-17-37: Therapy landscape of patients with metastatic, HER2 positive breast cancer - Data from the real world breast cancer registry PRAEGNANT (NCT02338167)

February 2019

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20 Reads

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1 Citation

Cancer Research

Purpose: This analysis describes comprehensive real-world data concerning the use of anti-HER2 therapies in HER2 positive metastatic breast cancer (MBC). Specifically, it describes the therapy patterns of treatments with trastuzumab (TZM), pertuzumab+trastuzumab (PTZ/TZM), lapatinib (LAP) and trastuzumab emtansine (T-DM1). Methods: The PRAEGNANT study is a real-time, real-world registry for patients with MBC. Patients can be registered for PRAEGNANT at any time during the course of their metastatic disease and are followed up until death. All therapy lines are documented. This analysis presents the utilization of anti-HER2 therapies as well as therapy sequences. Results: Of 1936 patients within PRAEGNANT at the time of database closure 451 were HER2 positive (23.3%). Within the analysis set (417 patients after an unilateral breast cancer diagnosis), of which 53% were included in PRAEGNANT in the 1stline setting, 241 were treated with TZM (58%), 237 with PTZ (57%), 85 with LAP (20%) and 125 with T-DM1 (30%) during the course of their therapies. The sequence PTZ/TZMàT-DM1 was given to 51 patients (12%). Worse ECOG, negative hormone receptor status, and visceral or brain metastases were associated with a more frequent use of this therapy sequence. Most patients received T-DM1 after a therapy with pertuzumab. Conclusions: Both novel therapies (PTZ/TZM and T-DM1) are utilized in a high proportion of HER2 positive breast cancer patients. As most patients receive T-DM1 after pertuzumab real world data might help to understand whether this sequence has similar efficacy like in the approval study. Citation Format: Lux MP, Hartkopf AD, Huober J, Volz B, Taran F-A, Overkamp F, Hadji P, Tesch H, Haeberle L, Ettl J, Lueftner DI, Wallwiener M, Müller V, Beckmann MW, Belleville E, Wimberger P, Hielscher C, Geberth M, Lermann J, Abenhardt W, Kurbacher C, Wuerstlein R, Thomssen C, Untch M, Fasching PA, Janni W, Fehm TN, Wallwiener D, Brucker SY, Schneeweiss A, Kolberg H-C. Therapy landscape of patients with metastatic, HER2 positive breast cancer - Data from the real world breast cancer registry PRAEGNANT (NCT02338167) [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-37.


Patient flow chart and patient selection.
Table 2 . Cont.
Proportion of human epidermal growth factor receptor 2 (HER2)-positive patients with 95% confidence intervals relative to the year in which the metastases were diagnosed.
Frequencies of patients who received the respective treatments. The patients are categorized here into four mutually exclusive (distinct) patient groups according to the number of documented therapy lines. The percentages of patients treated are marked in bold. The numbers and percentages of treated patients refer to the cumulative number of patients treated up to the highest documented therapy line. For example, in the group of patients with three therapy lines documented and treated after 2013, 33 patients have been treated with trastuzumab in one of the first three therapy lines.
Therapy Landscape in Patients with Metastatic HER2-Positive Breast Cancer: Data from the PRAEGNANT Real-World Breast Cancer Registry

December 2018

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464 Reads

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36 Citations

This study presents comprehensive real-world data on the use of anti-human epidermal growth factor receptor 2 (HER2) therapies in patients with HER2-positive metastatic breast cancer (MBC). Specifically, it describes therapy patterns with trastuzumab (H), pertuzumab + trastuzumab (PH), lapatinib (L), and trastuzumab emtansine (T-DM1). The PRAEGNANT study is a real-time, real-world registry for MBC patients. All therapy lines are documented. This analysis describes the utilization of anti-HER2 therapies as well as therapy sequences. Among 1936 patients in PRAEGNANT, 451 were HER2-positive (23.3%). In the analysis set (417 patients), 53% of whom were included in PRAEGNANT in the first-line setting, 241 were treated with H, 237 with PH, 85 with L, and 125 with T-DM1 during the course of their therapies. The sequence PH → T-DM1 was administered in 51 patients. Higher Eastern Cooperative Oncology Group (ECOG) scores, negative hormone receptor status, and visceral or brain metastases were associated with more frequent use of this therapy sequence. Most patients received T-DM1 after treatment with pertuzumab. Both novel therapies (PH and T-DM1) are utilized in a high proportion of HER2-positive breast cancer patients. As most patients receive T-DM1 after PH, real-world data may help to clarify whether the efficacy of this sequence is similar to that in the approval study.


Citations (33)


... Despite this, our study showed comparable results with previously published real-world analyses of ibrutinib or Ridela. [10][11][12][13][14][15][16][17] Table 5 summarises the principal data from reallife studies investigating the efficacy and safety of R-idela. We demonstrated significantly longer PFS with ibrutinib versus R-idela (40.5 months vs. 22.0 months), which is consistent with literature. ...

Reference:

Idelalisib plus rituximab versus ibrutinib in the treatment of relapsed/refractory chronic lymphocytic leukaemia: A real‐world analysis from the Chronic Lymphocytic Leukemia Patients Registry (CLLEAR)
Results of a Prospective Non-Interventional Post-Authorization Safety Study of Idelalisib in Germany
  • Citing Article
  • April 2022

Clinical Lymphoma, Myeloma and Leukemia

... Data regarding response rates to antibiotics in the other subtypes are limited, with case series indicating regression of cutaneous EMZL in 6 of 11 cases treated with Borrelia-directed antibiotic therapy (ceftriaxone) 66 74 Similar results were evident in the German prospective registry data. 75 Of note, 20% of patients received rituximab maintenance and this was associated with prolongation in PFS but not OS. The IELSG19 investigators randomized 454 patients to chlorambucil monotherapy or chlorambucil with rituximab, with a protocol amendment adding a third arm of rituximab monotherapy. ...

Rare lymphomas in routine practice – Treatment and outcome in marginal zone lymphoma in the prospective German Tumour Registry Lymphatic Neoplasms

Hematological Oncology

... The median PFS was 6.1 months but reached 8.7 months in PIK3CA-mutated patients. The study was prematurely stopped because of the significant rate of buparlisib-related toxicity [56]. ...

Buparlisib in combination with tamoxifen in pretreated patients with hormone receptor‐positive, HER2‐negative advanced breast cancer molecularly stratified for PIK3CA mutations and loss of PTEN expression

... In all trials, fludarabine-based therapies were administered prior to alemtuzumab consolidation. [26][27][28][29] Alemtuzumab maintenance therapy improved the quality of responses and led to prolonged progression-free survival compared to patients who did not receive a consolidation therapy. A phase III trial of the GCLLSG assessed the efficacy of alemtuzumab after induction therapy with fludarabine alone or in combination with cyclophosphamide. ...

Dose Escalation Study To Evaluate Dose Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and Safety of Alemtuzumab for Consolidation Therapy in Patients with Chronic Lymphoycytic Leukemia: Phase I/II Trial of the German CLL Study Group (GCLLSG).
  • Citing Article
  • November 2007

Blood

... Fludarabine inhibits phosphorylation of STAT1 via enhancing protein tyrosine phosphatases, such as cluster of differentiation 45 (CD45), protein tyrosine phosphatase-1B (PTP1B), T cell protein tyrosine phosphatase (TC-PTP)) or phosphatase-like activity, without affecting JAK2 activation [65]. Two recent clinical trials showed extended patient survival upon fludarabine treatment [66,67]. ...

Early and Risk-Adapted Therapy with Fludarabine in High-Risk Binet Stage A CLL Patients Prolongs Progression Free Survival but Not Overall Survival: Results of the CLL1 Protocol of the German CLL Study Group (GCLLSG).
  • Citing Article
  • November 2007

Blood

... The CLL international prognostic index (CLL-IPI) is currently the best validated model to predict OS in advanced-stage CLL patients receiving chemoimmunotherapy [11]. Increasing evidence suggests that it also allows to predict OS in asymptomatic early-stage CLL patients [5], although its predictive value of OS in CLL patients treated upfront with targeted agents remains less well defined [5,[12][13][14]. Interestingly, increased beta-2-microglobulin (B2M) plasma levels account for two scoring points in the CLL-IPI and are given the same prognostic impact as an unmutated immunoglobulin heavy chain (IGHV) status-a wellestablished molecular feature associated with biologically more aggressive disease [15,16]. ...

Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group

Leukemia

... • Bendamustine and rituximab (Eichhorst et al., 2016;Fischer et al., 2011Fischer et al., , 2012Knauf et al., 2012) • Ibrutinib, bendamustine, and rituximab (Chanan-Khan et al., 2016) • Idelalisib, bendamustine, and rituximab (Zelenetz et al., 2017 • Bendamustine and rituximab (Eichhorst et al., 2016;Fischer et al., 2011Fischer et al., , 2012Knauf et al., 2012) • Ibrutinib, bendamustine, and rituximab (Chanan-Khan et al., 2016) • Idelalisib, bendamustine, and rituximab (Zelenetz et al., 2017) • Chlorambucil and rituximab (Foà et al., 2014;Hillmen et al., 2014) • Obinutuzumab and chlorambucil (Goede et al., 2014) • Chlorambucil and ofatumumab (Hillmen et al., 2015) Note ...

Bendamustine-Rituximab (BR) Replaces R-CHOP As “Standard of Care” in the Treatment of Indolent Non-Hodgkin Lymphoma in German Hematology Outpatient Centres
  • Citing Article
  • November 2012

Blood

... the real-world experience with reference rituximab plus CHOP. This is the first clinical or real-world study to report HRQoL data in patients with DLBCL receiving a rituximab biosimilar [20][21][22][23][24][25]. Additionally, this study reinforces the recent recommendations from oncological societies to obtain robust clinical data to ensure continued efficacy and safety of biosimilars [26,27]. ...

Similar effectiveness of R‐CHOP‐14 and ‐21 in diffuse large B‐cell lymphoma—data from the prospective German Tumour Registry Lymphatic Neoplasms

... From this point of view, RWE could integrate the evidence of RCTs, especially in those treatment settings characterized by the recent introduction of therapeutic news. For instance, in the setting of human epidermal growth receptor 2 (HER2)-positive breast cancer, the population of patients of the pivotal trial of second-line trastuzumab emtansine (T-DM1), showing the efficacy of the drug and leading to its approval for clinical practice, had not received pertuzumab as part of their firstline treatment [18]. RWE can be helpful to produce data about these sequences [19]. ...

Abstract P6-17-37: Therapy landscape of patients with metastatic, HER2 positive breast cancer - Data from the real world breast cancer registry PRAEGNANT (NCT02338167)
  • Citing Article
  • February 2019

Cancer Research