Case-adjusted bortezomib-based strategy in routine therapy of relapsed/refractory multiple myeloma shown to be highly effective—A report by Polish Myeloma Study Group

Walter‐Croneck, Adam; Grząśko, Norbert; Soroka-Wojtaszko, Maria; Jurczyszyn, Artur; Torosian, Tigran; Rymko, Marcin; Nowicki, Adam; Druzd‐Sitek, Agnieszka; Lech-Maranda, Ewa; Mądro, Elżbieta; Zielińska, Patrycja; Grygoruk-Wiśniowska, Iwona; Blonska, Danuta; Usnarska−Zubkiewicz, Lidia; Potoczek, S; Iskierka, Elżbieta; Masternak, Anna; Hołojda, Jadwiga; Dawidowska, Dorota; Gawron, Ludmila; Barchnicka, Agnieszka; Olszewska-Szopa, Magdalena; Rybicka, Malwina; Gontarska, Agnieszka; Jachalska, Anna; Rzepecki, Piotr; Subocz, Edyta; Boguradzki, Piotr; Charliński, Grzegorz; Dzierżak‐Mietła, Monika; Wiśniewska-Piąty, Katarzyna; Świstek, Wojciech; Kopacz, Agnieszka; Blajer-Olszewska, Beata; Świderska, Alina; Dmoszyńska, Anna

doi:10.1016/j.leukres.2014.04.011

Cited by 5 publications

(7 citation statements)

References 22 publications

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“…dara 16 mg/m2 + bor1.3 mg/m2 + dex20 mg25118.56421.8432. bor1.3 mg/m2 + dex20 mg2477.2Observational trials Avet-Loiseau et al [40]dex40mg + len25mg2079.66531.744 Chang et al [41]bor1.3 mg/m2659.554> = 21.331 Fukushima et al [72]bor1.3 mg/m2 + dex20mg2216.86922.141 Hou et al [73]dex20/40 mg + len25mg1998.36042.847 Kneppers et al [42]dex40mg + len25mg11710613.52.737 Lacy et al [74]dex40mg + pom2mg344.86241.732 Moore et al [43]bor1.3 mg/m252137212.640 Oehrlein et al [75]Dex < 160-480 mg2611.67122.854Len10-25 mg Pantani et al [76]bor1.3 mg/m2 + dex20mg858.75822.440 Richardson et al [77]bor1.3 mg/m2 + dex40mg + pan20mg555.46141.947 Terpos et al [78]dex40mg + thal200mg3586322.234 Walter-Croneck et al [44]bor1.3 mg/m2708146012.155 bev bevacizumab, bor bortezomib, carf carfilzomib, cyc cyclophosphamide, dara daratumumab, dex dexamethasone, elo elozum...…”

Section: Resultsmentioning

confidence: 99%

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The use of single armed observational data to closing the gap in otherwise disconnected evidence networks: a network meta-analysis in multiple myeloma

Schmitz

Maguire

Morris

et al. 2018

BMC Med Res Methodol

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BackgroundNetwork meta-analysis (NMA) allows for the estimation of comparative effectiveness of treatments that have not been studied in head-to-head trials; however, relative treatment effects for all interventions can only be derived where available evidence forms a connected network. Head-to-head evidence is limited in many disease areas, regularly resulting in disconnected evidence structures where a large number of treatments are available. This is also the case in the evidence of treatments for relapsed or refractory multiple myeloma.MethodsRandomised controlled trials (RCTs) identified in a systematic literature review form two disconnected evidence networks. Standard Bayesian NMA models are fitted to obtain estimates of relative effects within each network. Observational evidence was identified to fill the evidence gap. Single armed trials are matched to act as each other’s control group based on a distance metric derived from covariate information. Uncertainty resulting from including this evidence is incorporated by analysing the space of possible matches.ResultsTwenty five randomised controlled trials form two disconnected evidence networks; 12 single armed observational studies are considered for bridging between the networks. Five matches are selected to bridge between the networks. While significant variation in the ranking is observed, daratumumab in combination with dexamethasone and either lenalidomide or bortezomib, as well as triple therapy of carfilzomib, ixazomib and elozumatab, in combination with lenalidomide and dexamethasone, show the highest effects on progression free survival, on average.ConclusionsThe analysis shows how observational data can be used to fill gaps in the existing networks of RCT evidence; allowing for the indirect comparison of a large number of treatments, which could not be compared otherwise. Additional uncertainty is accounted for by scenario analyses reducing the risk of over confidence in interpretation of results.Electronic supplementary materialThe online version of this article (10.1186/s12874-018-0509-7) contains supplementary material, which is available to authorized users.

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Section: Resultsmentioning

confidence: 99%

“…Five studies had no matched pair below the threshold and were not included in the base case [40–44]. Of the eight matches explored, one strengthens the within white network evidence, two the within black network evidence and five matches connect both networks allowing for a comparison between all treatment regimens.…”

Section: Resultsmentioning

confidence: 99%

The use of single armed observational data to closing the gap in otherwise disconnected evidence networks: a network meta-analysis in multiple myeloma

Schmitz

Maguire

Morris

et al. 2018

BMC Med Res Methodol

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“…The translocations t(14;16), t(14;20), t(4;14) as well as gains of 1q21 and losses of 17p13 and, to some extent, also 13q14 deletions were defined as high risk factors (Fonseca et al , ; Munshi et al , ; Munshi & Avet‐Loiseau, ; Neben et al , ; Shaughnessy et al , ), although there is some evidence that initial treatment with novel agents, e.g., the proteasome inhibitor bortezomib, may overcome the adverse prognosis of an underlying t(4;14) or 17p13 deletion (Avet‐Loiseau et al , ; Bergsagel et al , ; Caltagirone et al , ; Neben et al , ; Sonneveld et al , ). In addition, bortezomib was also described to have a positive influence in relapsed/refractory MM (Dimopoulos et al , ; Richardson et al , ; Walter‐Croneck et al , ).…”

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confidence: 99%

The molecular spectrum and clinical impact of DIS3 mutations in multiple myeloma

et al. 2014

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SummaryMultiple myeloma (MM) is a plasma cell neoplasm that presents with a major biological and clinical heterogeneity. We here investigated the spectrum of clonal and subclonal mutations of DIS3, an active part of the exosome complex, that may play a role in the development or progression of MM. The whole coding sequence of DIS3 was subjected to deep sequencing in 81 uniformly-treated MM patients and 12 MM cell lines and the overall occurrence of DIS3 mutations as well as the presence of DIS3 mutations in minor and major subclones were correlated with cytogenetic alterations and clinical parameters. Our study identified DIS3 mutations in 9/81 patients that were associated with 13q14 deletions and IGH translocations on the cytogenetic level. Specifically, we detected seven novel somatic DIS3 single nucleotide variants (SNVs) and defined three hot spot mutations within the RNB domain. Lastly, we found a trend towards a shorter median overall survival for patients with DIS3 mutations, and patients carrying DIS3 mutations in minor subclones of their tumours showed a significantly worse response to therapy compared to patients with DIS3 mutations in the major subclone.

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“…Proteasome inhibitors used as monotherapy were reported in nine studies in MM ( 69 , 70 , 80 , 81 , 83 , 94 , 95 , 98 , 135 ) and three in NHL ( 109 , 123 , 126 ). In addition, 18 studies in MM ( 71 , 76 – 78 , 82 , 84 – 87 , 89 , 90 , 93 , 96 – 99 , 136 ) and two studies in NHL ( 107 , 124 ) reported the use in combination with other agents ( Table 4 ). No data were reported on the use of proteasome in patients with CLL.…”

Section: Resultsmentioning

confidence: 99%

Agents contributing to secondary immunodeficiency development in patients with multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin lymphoma: A systematic literature review

et al. 2023

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IntroductionPatients with hematological malignancies (HMs), like chronic lymphocytic leukemia (CLL), multiple myeloma (MM), and non-Hodgkin lymphoma (NHL), have a high risk of secondary immunodeficiency (SID), SID-related infections, and mortality. Here, we report the results of a systematic literature review on the potential association of various cancer regimens with infection rates, neutropenia, lymphocytopenia, or hypogammaglobulinemia, indicative of SID.MethodsA systematic literature search was performed in 03/2022 using PubMed to search for clinical trials that mentioned in the title and/or abstract selected cancer (CLL, MM, or NHL) treatments covering 12 classes of drugs, including B-lineage monoclonal antibodies, CAR T therapies, proteasome inhibitors, kinase inhibitors, immunomodulators, antimetabolites, anti-tumor antibiotics, alkylating agents, Bcl-2 antagonists, histone deacetylase inhibitors, vinca alkaloids, and selective inhibitors of nuclear export. To be included, a publication had to report at least one of the following: percentages of patients with any grade and/or grade ≥3 infections, any grade and/or grade ≥3 neutropenia, or hypogammaglobulinemia. From the relevant publications, the percentages of patients with lymphocytopenia and specific types of infection (fungal, viral, bacterial, respiratory [upper or lower respiratory tract], bronchitis, pneumonia, urinary tract infection, skin, gastrointestinal, and sepsis) were collected.ResultsOf 89 relevant studies, 17, 38, and 34 included patients with CLL, MM, and NHL, respectively. In CLL, MM, and NHL, any grade infections were seen in 51.3%, 35.9% and 31.1% of patients, and any grade neutropenia in 36.3%, 36.4%, and 35.4% of patients, respectively. The highest proportion of patients with grade ≥3 infections across classes of drugs were: 41.0% in patients with MM treated with a B-lineage monoclonal antibody combination; and 29.9% and 38.0% of patients with CLL and NHL treated with a kinase inhibitor combination, respectively. In the limited studies, the mean percentage of patients with lymphocytopenia was 1.9%, 11.9%, and 38.6% in CLL, MM, and NHL, respectively. Two studies reported the proportion of patients with hypogammaglobulinemia: 0–15.3% in CLL and 5.9% in NHL (no studies reported hypogammaglobulinemia in MM).ConclusionThis review highlights cancer treatments contributing to infections and neutropenia, potentially related to SID, and shows underreporting of hypogammaglobulinemia and lymphocytopenia before and during HM therapies.

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Case-adjusted bortezomib-based strategy in routine therapy of relapsed/refractory multiple myeloma shown to be highly effective—A report by Polish Myeloma Study Group

Cited by 5 publications

References 22 publications

The use of single armed observational data to closing the gap in otherwise disconnected evidence networks: a network meta-analysis in multiple myeloma

The use of single armed observational data to closing the gap in otherwise disconnected evidence networks: a network meta-analysis in multiple myeloma

The molecular spectrum and clinical impact of DIS3 mutations in multiple myeloma

Agents contributing to secondary immunodeficiency development in patients with multiple myeloma, chronic lymphocytic leukemia and non-Hodgkin lymphoma: A systematic literature review

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