دورية أكاديمية
Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, PlaceboControlled Phase II Study
| العنوان: | Myelopreservation with Trilaciclib in Patients Receiving Topotecan for Small Cell Lung Cancer: Results from a Randomized, Double-Blind, PlaceboControlled Phase II Study |
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| المؤلفون: | Hart Lowel L, Ferrarotto Renata, Andrić Zoran G, Beck Thaddeus J, Subramanian Janakiraman, Radosavljević Davorin Z, Zarić Bojan, Hanna Wahid T, Aljumaily Raid, Owonikoko Taofeek K, Verhoeven Didier, Xiao Jie, Morris Shannon R, Antal Joyce M, Hussein Maen A |
| المصدر: | Adv Ther 38 350-365 |
| سنة النشر: | 2020 |
| المجموعة: | Zenodo |
| مصطلحات موضوعية: | Anemia, Chemotherapy, Myelopreservation, Myelosuppression, Neutropenia, Patient-reported outcomes, small cell lung cancer, Topotecan, Trilaciclib |
| الوصف: | Introduction. Multilineage myelosuppression is an acute toxicity of cytotoxic chemotherapy, resulting in serious complications and dose modifications. Current therapies are lineage specific and administered after chemotherapy damage has occurred. Trilaciclib is a cyclin-dependent kinase 4/6 inhibitor that is administered prior to chemotherapy to preserve hematopoietic stem and progenitor cells and immune system function during chemotherapy (myelopreservation). Methods. In this randomized, double-blind, placebo-controlled phase II trial, patients with previously treated extensive-stage small cell lung cancer (ES-SCLC) were randomized to receive intravenous trilaciclib 240 mg/m2 or placebo before topotecan 1.5 mg/m2 on days 1–5 of each 21-day cycle. Primary endpoints were duration of severe neutropenia (DSN) in cycle 1 and occurrence of severe neutropenia (SN). Additional endpoints were prespecified to further assess the effect of trilaciclib on myelopreservation, safety, patient-reported outcomes (PROs), and antitumor efficacy. Results. Thirty-two patients received trilaciclib, and 29 patients received placebo. Compared with placebo, administration of trilaciclib prior to topotecan resulted in statistically significant and clinically meaningful decreases in DSN in cycle 1 (mean [standard deviation] 2 [3.9] versus 7 [6.2] days; adjusted one-sided P < 0.0001) and occurrence of SN (40.6% versus 75.9%; adjusted one-sided P = 0.016), with numerical improvements in additional neutrophil, red blood cell, and platelet measures. Patients receiving trilaciclib had fewer grade ≥ 3 hematologic adverse events than patients receiving placebo, particularly neutropenia (75.0% versus 85.7%) and anemia (28.1% versus 60.7%). Myelopreservation benefits extended to improvements in PROs, specifically in those related to fatigue. Antitumor efficacy was comparable between treatment arms. Conclusions .Compared with placebo, the addition of trilaciclib prior to topotecan for the treatment of patients with previously treated ES-SCLC ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| العلاقة: | https://static-content.springer.com/esm/art%3A10.1007%2Fs12325-020-01538-0/MediaObjects/12325_2020_1538_MOESM1_ESM.pdfTest; https://static-content.springer.com/esm/art%3A10.1007%2Fs12325-020-01538-0/MediaObjects/12325_2020_1538_MOESM2_ESM.pdfTest; https://static-content.springer.com/esm/art%3A10.1007%2Fs12325-020-01538-0/MediaObjects/12325_2020_1538_MOESM3_ESM.docxTest; pmcid:PMC7854399; https://zenodo.org/communities/iorsTest; https://zenodo.org/record/4709814Test; https://doi.org/10.1007/s12325-020-01538-0Test; oai:zenodo.org:4709814 |
| DOI: | 10.1007/s12325-020-01538-0 |
| الإتاحة: | https://doi.org/10.1007/s12325-020-01538-0Test https://zenodo.org/record/4709814Test |
| حقوق: | info:eu-repo/semantics/openAccess ; https://creativecommons.org/licenses/by/4.0/legalcodeTest |
| رقم الانضمام: | edsbas.F493FFD4 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1007/s12325-020-01538-0 |
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