9248 Safety of romiplostim for treatment of chemotherapy-induced thrombocytopenia (CIT) in patients with advanced non-small cell lung cancer (NSCLC)

Natale, R.; Charu, Vivek; Schütte, W.; Albert, István; Tehenes, S.; McCoy, Jason; Berger, Daniel

doi:10.1016/s1359-6349(09)71939-1

Cited by 11 publications

(9 citation statements)

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“…Preliminary studies with the thrombopoietic agonist romiplostim could establish neither the optimal timing, nor the optimal dosage of the drug in CIT either in NSLCC or in lymphoma patients [2,3]. Both studies failed to demonstrate efficacy regarding reduction of platelet nadir, or duration of grade 3 or 4 thrombocytopenia.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Romiplostim in the Treatment of Chemotherapy Induced Thrombocytopenia (CIT) in a Patient with Mantle Cell Lymphoma

Demeter

Istenes

Fodor

et al. 2010

Pathol. Oncol. Res.

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Chemotherapy induced thrombopenia (CIT) is difficult to treat, as previous treatment options, including recombinant human thrombopoietin proved to be of limited efficacy. Here we report a case of a mantle cell lymphoma patient treated with intensive chemotherapy, who belongs to Yehova's witnesses and therefore did not accept platelet transfusions. At the time of severe thrombocytopenia (zero thrombocytes/ per mikroliter) and gastrointestinal bleeding, on day 13 following the start of hyperCVAD B chemotherapy, romiplostim treatment was given resulting in quick normalisation of the platelet count followed by thrombocytosis. Based on our observation in further studies modification of the dose and timing of romiplostim injection in CIT should be considered.

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Section: Introductionmentioning

confidence: 99%

Efficacy of Romiplostim in the Treatment of Chemotherapy Induced Thrombocytopenia (CIT) in a Patient with Mantle Cell Lymphoma

Demeter

Istenes

Fodor

et al. 2010

Pathol. Oncol. Res.

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“…Data from the thrombopoietic agent arms of 10 studies [ 24 – 26 , 34 , 51 , 57 , 62 , 64 , 68 , 69 , 71 ] and control arms of 6 studies [ 24 – 26 , 57 , 62 , 71 ] were included in the meta-analysis for grade 3/4 thrombocytopenia ( Fig 2 , Table 2 , S4 Fig ). Rates of grade 3/4 thrombocytopenia appeared to be similar for thrombopoietic agents and placebo or no treatment (39.3% vs 34.8%; P = 0.789) ( Fig 2 , Table 2 ).…”

Section: Resultsmentioning

confidence: 99%

Systematic literature review and meta-analysis on use of Thrombopoietic agents for chemotherapy-induced thrombocytopenia

et al. 2022

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Background Currently, there are no approved options to prevent or treat chemotherapy-induced thrombocytopenia (CIT). We performed a systematic literature review and meta-analysis on use of thrombopoietic agents for CIT. Patients and methods We searched Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PubMed, EMBASE, ClinicalTrials.gov, and health technology assessments from January 1995 to March 2021 for studies evaluating thrombopoietic agents for CIT, including recombinant human thrombopoietin (rhTPO), megakaryocyte growth and development factor (MGDF), romiplostim, and eltrombopag. Random effects meta-analyses were conducted for efficacy and safety endpoints. Results We screened 1503 titles/abstracts, assessed 138 articles, and abstracted data from 39 publications (14 recombinant human thrombopoietin, 7 megakaryocyte growth and development factor, 9 romiplostim, 8 eltrombopag, and 1 romiplostim/eltrombopag). Random effects meta-analyses of data from multiple studies comparing thrombopoietic agents versus control (comparator, placebo, or no treatment) showed that thrombopoietic agents did not significantly improve chemotherapy dose delays and/or reductions (21.1% vs 40.4%, P = 0.364), grade 3/4 thrombocytopenia (39.3% vs 34.8%; P = 0.789), platelet transfusions (16.7% vs 31.7%, P = 0.111), grade ≥ 2 bleeding (6.7% vs 16.5%; P = 0.250), or thrombosis (7.6% vs 12.5%; P = 0.131). However, among individual studies comparing thrombopoietic agents with placebo or no treatment, thrombopoietic agents positively improved outcomes in some studies, including significantly increasing mean peak platelet counts (186 x 109/L with rhTPO vs 122 x 109/L with no treatment; P < 0.05) in one study and significantly increasing platelet count at nadir (56 x 109/L with rhTPO vs 28 x 109/L with not treatment; P < 0.05) in another study. Safety findings included thrombosis (n = 23 studies) and bleeding (n = 11), with no evidence of increased thrombosis risk with thrombopoietic agents. Conclusion Our analyses generate the hypothesis that thrombopoietic agents may benefit patients with CIT. Further studies with well-characterized bleeding and platelet thresholds are warranted to explore the possible benefits of thrombopoietic agents for CIT.

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“…Forty-six trials were on the wrong participant group (Bai 2004a; Bai 2004b; Basser 1996; Basser 1997; Bowen 2010; Bussel 2006; Bussel 2007; EudraCT number 2010-022890-33; Eudra CT number 2014-000174-19; Giagounidis 2014; Greenberg 2013; Höchsmann 2014; Jain 2013; Kantarjian 2010a; Kantarjian 2010b; Kellum 2010; Korte 2009; Malyszko 1990; Mannucci 1986; Natale 2009; NCT00102726; NCT00413283; NCT00614523; NCT00688272; NCT00903422; NCT01072162; NCT01147809; NCT01893372; NCT02052882; NCT02093325; NCT02094417; NCT02446145; Oliva 2013; Platzbecker 2015; Risitano 2014; Schuster 2002; Sekeres 2011; Seza 1997; Somlo 1999; Wang 2012; Wang 2013; Williams 2009; Winer 2015; Wire 2012; Wroblewski 2010). Seven of these trials were included in a separate review that included participants with bone marrow failure receiving no treatment or low-dose chemotherapy (Fricke 1991; Giagounidis 2014; Greenberg 2013; Kantarjian 2010a; Mannucci 1986; Platzbecker 2015; Wang 2012).…”

Section: Resultsmentioning

confidence: 99%

Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation

Desborough

Estcourt

Dorée

et al. 2016

Cochrane Database of Systematic Reviews

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There is insufficient evidence to determine if platelet-poor plasma or TPO mimetics reduce bleeding for participants with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation. To detect a decrease in the proportion of participants with clinically significant bleeding from 12 in 100 to 6 in 100 would require a trial containing at least 708 participants (80% power, 5% significance). The six ongoing trials will provide additional information about the TPO mimetic comparison (424 participants) but this will still be underpowered to demonstrate this level of reduction in bleeding. None of the included or ongoing trials include children. There are no completed or ongoing trials assessing artificial platelet substitutes, fibrinogen concentrate, recombinant activated factor VII or desmopressin in people undergoing intensive chemotherapy or stem cell transplantation for haematological malignancies.

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9248 Safety of romiplostim for treatment of chemotherapy-induced thrombocytopenia (CIT) in patients with advanced non-small cell lung cancer (NSCLC)

Cited by 11 publications

References 0 publications

Efficacy of Romiplostim in the Treatment of Chemotherapy Induced Thrombocytopenia (CIT) in a Patient with Mantle Cell Lymphoma

Efficacy of Romiplostim in the Treatment of Chemotherapy Induced Thrombocytopenia (CIT) in a Patient with Mantle Cell Lymphoma

Systematic literature review and meta-analysis on use of Thrombopoietic agents for chemotherapy-induced thrombocytopenia

Alternatives, and adjuncts, to prophylactic platelet transfusion for people with haematological malignancies undergoing intensive chemotherapy or stem cell transplantation

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