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Original Research

Thromboembolism profiles associated with cyclin-dependent kinase 4/6 inhibitors: a real-world pharmacovigilance study and a systematic review

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Pages 599-609 | Received 02 Sep 2022, Accepted 23 Jan 2023, Published online: 23 Feb 2023

References

  • Prandoni P, Falanga A, Piccioli A. Cancer and venous thromboembolism. Lancet Oncol. 2005;6(6):401–410.
  • Abdol Razak NB, Jones G, Bhandari M, et al. Cancer-associated thrombosis: an overview of mechanisms, risk factors, and treatment. Cancers (Basel). 2018;10(10):380.
  • Ramot Y, Nyska A, Spectre G. Drug-induced thrombosis: an update. Drug Saf. 2013;36(8):585–603.
  • Gervaso L, Montero AJ, Jia X, et al. Venous thromboembolism in breast cancer patients receiving cyclin-dependent kinase inhibitors. J Thromb Haemost. 2020;18(1):162–168.
  • West MT, Smith CE, Kaempf A, et al. CDK 4/6 inhibitors are associated with a high incidence of thrombotic events in women with breast cancer in real-world practice. Eur J Haematol. 2021;106(5):634–642.
  • Watson NW, Wander SA, Shatzel JJ, et al. Venous and arterial thrombosis associated with abemaciclib therapy for metastatic breast cancer. Cancer. 2022;128(17):3224–3232.
  • Yan MM, Wu SS, Qi YP, et al. Association between cyclin-dependent kinase 4/6 inhibitors and venous thromboembolism: analysis of F.A.E.R.S. Data. Expert Opin Drug Saf 2022;21(2):277–283.
  • Raschi E, Fusaroli M, Ardizzoni A, et al. Thromboembolic events with cyclin-dependent kinase 4/6 inhibitors in the FDA adverse event reporting system. Cancers (Basel). 2021 [Published 2021 Apr 7];13(8):1758.
  • Almenoff J, Tonning JM, Gould AL, et al. Perspectives on the use of data mining in pharmaco-vigilance. Drug Saf. 2005;28(11):981–1007.
  • Johnston SRD, Harbeck N, Hegg R, et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J Clin Oncol. 2020;38(34):3987–3998.
  • Thein KZ, Htut TW, Ball S, et al. Venous thromboembolism risk in patients with hormone receptor-positive HER2-negative metastatic breast cancer treated with combined CDK 4/6 inhibitors plus endocrine therapy versus endocrine therapy alone: a systematic review and meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2020;183(2):479–487.
  • Guyatt GH, Akl EA, Crowther M, et al. American college of chest physicians antithrombotic therapy and prevention of thrombosis panel. executive summary: antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines [published correction appears in chest. Dosage error in article text] [published correction appears in Chest. 2012 Dec;142(6):1698.Dosage error in article text]. Chest. 2012;141(2Suppl):7S-47S. 2012Apr;141(4):1129.
  • Finney DJ. Systemic signalling of adverse reactions to drugs. Methods Inf Med. 1974;13(1):1–10.
  • Almenoff JS, Pattishall EN, Gibbs TG, et al. Novel statistical tools for monitoring the safety of marketed drugs. Clin Pharmacol Ther. 2007;82(2):157–166.
  • Bate A, Evans SJW. Quantitative signal detection using spontaneous ADR reporting. Pharmacol. Drug Saf 2009;18:427–436.
  • Raschi E, Fusaroli M, Ardizzoni A, et al. Cyclin-dependent kinase 4/6 inhibitors and interstitial lung disease in the FDA adverse event reporting system: a pharmacovigilance assessment. Breast Cancer Res Treat. 2021;186(1):219–227.
  • Böhm R, Höcker J, Cascorbi I, et al. OpenVigil–free eyeballs on AERS pharmacovigilance data. Nat Biotechnol. 2012 [Published 2012 Feb 8];30(2):137–138.
  • Moher D, Liberati A, Tetzlaff J. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med. 2009;6:e1000097.
  • Higgins J, Thomas J, Chandler J, et al. (2019) Cochrane handbook for systematic reviews of interventions version 6.0. Cochrane, https://onlinelibrary.wiley.com/doi/book/10.1002/9781119536604, Accessed 2020 Jun 20
  • Fairlie J-L, Ferrer P, Gouverneur A, et al. A new risk of bias checklist applicable to randomized trials, observational studies, and systematic reviews was developed and validated to be used for systematic reviews focusing on drug adverse events. J Clin Epidemiol. 2017;86:168–175.
  • Higgins JP, Thompson SG, Deeks JJ, et al. Measuring inconsistency in meta-analyses. BMJ (Clin Res Ed). 2003;327(7414):557–560.
  • Prat A, Saura C, Pascual T, et al. Ribociclib plus letrozole versus chemotherapy for postmenopausal women with hormone receptor-positive, HER2-negative, luminal B breast cancer (CORALLEEN): an open-label, multicentre, randomised, phase 2 trial. Lancet Oncol. 2020;21(1):33–43.
  • Tan AR, Wright GS, Thummala AR, et al. Trilaciclib plus chemotherapy versus chemotherapy alone in patients with metastatic triple-negative breast cancer: a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2019;20(11):1587–1601.
  • Tripathy D, Im SA, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904–915.
  • Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol. 2018;36(24):2465–2472.
  • Adkins DR, Lin JC, Sacco A, et al. Palbociclib and cetuximab compared with placebo and cetuximab in platinum-resistant, cetuximab-naïve, human papillomavirus-unrelated recurrent or metastatic head and neck squamous cell carcinoma: a double-blind, randomized, phase 2 trial. Oral Oncol. 2021;115:105192.
  • Mayer EL, Dueck AC, Martin M, et al. Palbociclib with adjuvant endocrine therapy in early breast cancer (PALLAS): interim analysis of a multicentre, open-label, randomised, phase 3 study. Lancet Oncol. 2021;22(2):212–222.
  • Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer [published correction appears in. Ann Oncol. 2019 Nov 1;30(11):1842. Ann Oncol. 2018;29(7):1541-1547.
  • Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875–2884.
  • Albanell J, Martínez MT, Ramos M, et al. Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2-advanced breast cancer: GEICAM/2014-12 (FLIPPER). Eur J Cancer. 2022;161:26–37.
  • Weiss JM, Csoszi T, Maglakelidze M, et al. Myelopreservation with the CDK4/6 inhibitor trilaciclib in patients with small-cell lung cancer receiving first-line chemotherapy: a phase Ib/randomized phase II trial. Ann Oncol. 2019;30(10):1613–1621.
  • Goldman JW, Mazieres J, Barlesi F, et al. A randomized phase iii study of abemaciclib versus erlotinib in patients with stage IV non-small cell lung cancer with a detectable KRAS mutation who failed prior platinum-based therapy: JUNIPER. Front Oncol. 2020 [Published 2020 Oct 26];10:578756.
  • Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017;35(32):3638–3646.
  • Palmbos PL, Daignault-Newton S, Tomlins SA, et al. A Randomized phase ii study of androgen deprivation therapy with or without palbociclib in RB-positive metastatic hormone-sensitive prostate cancer. Clin Cancer Res. 2021;27(11):3017–3027.
  • Zhang QY, Sun T, Yin YM, et al. MONARCH plus: abemaciclib plus endocrine therapy in women with HR+/HER2- advanced breast cancer: the multinational randomized phase III study. Ther Adv Med Oncol. 2020 [Published 2020 Oct 22];12:1758835920963925.
  • Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25–35.
  • Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925–1936.
  • Tolaney SM, Wardley AM, Zambelli S, et al. Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with hormone receptor-positive, HER2-positive advanced breast cancer (monarcHER): a randomised, open-label, phase 2 trial [published correction appears in. Lancet Oncol. 2021Mar; 223: e92 ][published correction appears in Lancet Oncol. 2021 Nov;22(11):e472]. Lancet Oncol. 2020;21(6):763-775
  • Verma S, Bartlett CH, Schnell P, et al. Palbociclib in combination with fulvestrant in women with hormone receptor-positive/HER2-negative advanced metastatic breast cancer: detailed safety analysis from a multicenter, randomized, placebo-controlled, phase iii study (PALOMA-3). Oncologist. 2016;21(10):1165–1175.
  • Xu B, Hu X, Li W, et al. Palbociclib plus letrozole versus placebo plus letrozole in Asian postmenopausal women with oestrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: primary results from PALOMA-4. Eur J Cancer. 2022;175:236–245.
  • Daniel D, Kuchava V, Bondarenko I, et al. Trilaciclib prior to chemotherapy and atezolizumab in patients with newly diagnosed extensive-stage small cell lung cancer: a multicentre, randomised, double-blind, placebo-controlled Phase II trial [published online ahead of print, 2020 Dec 21]. Int J Cancer. 2020;148(10):2557–2570.
  • Hart LL, Ferrarotto R, Andric ZG, et al. Myelopreservation with trilaciclib in patients receiving topotecan for small cell lung cancer: results from a randomized, double-blind, placebo-controlled phase ii study. Adv Ther. 2021;38(1):350–365.
  • Abdel-Razeq H, Sharaf B, AlMasri R, et al. Thromboembolic events in patients with HER2-negative, hormone receptor-positive, metastatic breast cancer treated with ribociclib combined with letrozole or fulvestrant: a real-world data. Cancer Manag Res. 2022 [Published 2022 Mar 8];14:1033–1041.
  • Bolzacchini E, Pomero F, Fazio M, et al. Risk of venous and arterial thromboembolic events in women with advanced breast cancer treated with CDK 4/6 inhibitors: a systematic review and meta-analysis. Thromb Res. 2021;208:190–197.
  • Master S. Cardiac complications of CDK4/6 inhibitors for breast cancer. J clin oncol. 2020;38:e13038–e13038.
  • Gatti M, Raschi E, Poluzzi E, et al. The complex management of atrial fibrillation and cancer in the COVID-19 Era: drug interactions, thromboembolic risk, and proarrhythmia. Curr Heart Fail Rep. 2020;17(6):365–383.
  • Chong QY, Kok ZH, Bui NL, et al. A unique CDK4/6 inhibitor: current and future therapeutic strategies of abemaciclib. Pharmacol Res. 2020;156:104686.
  • Gebbia V, Valerio MR, Firenze A, et al. Abemaciclib: safety and effectiveness of a unique cyclin-dependent kinase inhibitor. Expert Opin Drug Saf. 2020;19(8):945–954.

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