Post-marketing safety concerns with palbociclib: a disproportionality analysis of the FDA adverse event reporting system

References

• Kashyap D, Pal D, Sharma R, et al. Global increase in breast cancer incidence: risk factors and preventive measures. Bio Med Res Int. 2022;2022:1–16. doi: 10.1155/2022/9605439
   Google Scholar
• Trapani D, Ginsburg O, Fadelu T, et al. Global challenges and policy solutions in breast cancer control. Cancer Treat Rev. 2022 Mar;104:102339. doi: 10.1016/j.ctrv.2022.102339
   PubMed Web of Science ®Google Scholar
• Smolarz B, Nowak AZ, Romanowicz H. Breast cancer—epidemiology, classification, pathogenesis and treatment (review of literature). Cancers (Basel). 2022 May 23;14(10):2569. doi: 10.3390/cancers14102569
   PubMed Web of Science ®Google Scholar
• Loibl S, André F, Bachelot T, et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;35(2):159–182. doi: 10.1016/j.annonc.2023.11.016
   PubMedGoogle Scholar
• 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 Jan;16(1):25–35.
   PubMed Web of Science ®Google Scholar
• Spring LM, Zangardi ML, Moy B, et al. Clinical management of potential toxicities and drug interactions related to cyclin-dependent kinase 4/6 inhibitors in breast cancer: practical considerations and recommendations. Oncology. 2017 Sep;22(9):1039–1048.
   Google Scholar
• Ippolito E, Greco C, Silipigni S, et al. Concurrent radiotherapy with palbociclib or ribociclib for metastatic breast cancer patients: Preliminary assessment of toxicity. Breast. 2019 Aug;46:70–74. doi: 10.1016/j.breast.2019.05.001
   PubMed Web of Science ®Google Scholar
• Roberts PJ, Bisi JE, Strum JC, et al. Multiple roles of cyclin-dependent kinase 4/6 inhibitors in cancer therapy. J Natl Cancer Inst. 2012 Mar 21;104(6):476–487. doi: 10.1093/jnci/djs002
   PubMedGoogle Scholar
• Spring LM, Wander SA, Andre F, et al. Cyclin-dependent kinase 4 and 6 inhibitors for hormone receptor-positive breast cancer: past, present, and future. Lancet. 2020 Mar 7;395(10226):817–827. doi: 10.1016/S0140-6736(20)30165-3
   PubMed Web of Science ®Google Scholar
• Llombart-Cussac A, Pérez-García JM, Bellet M, et al. Fulvestrant-palbociclib vs letrozole-palbociclib as initial therapy for endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer: a randomized clinical trial. JAMA Oncol. 2021 Dec 1;7(12):1791–1799. doi: 10.1001/jamaoncol.2021.4301
   PubMed Web of Science ®Google Scholar
• Dias P, Penedones A, Alves C, et al. The role of disproportionality analysis of pharmacovigilance databases in safety regulatory actions: a systematic review. Curr Drug Saf. 2015;10(3):234–250. doi: 10.2174/1574886310666150729112903
   PubMedGoogle Scholar
• Wilson AM, Thabane L, Holbrook A. Application of data mining techniques in pharmacovigilance. Br J Clin Pharmacol. 2004 Feb;57(2):127–134. doi: 10.1046/j.1365-2125.2003.01968.x
   PubMed Web of Science ®Google Scholar
• van Puijenbroek EP, Bate A, Leufkens HG, et al. A comparison of measures of disproportionality for signal detection in spontaneous reporting systems for adverse drug reactions. Pharmacoepidemiol Drug Saf. 2002 Jan;11(1):3–10.
   PubMed Web of Science ®Google Scholar
• Finn RS, Martin M, Rugo HS, et al. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925–1936. doi: 10.1056/NEJMoa1607303
   PubMed Web of Science ®Google Scholar
• Jud SM, Fasching PA, Maihofner C, et al. Pain perception and detailed visual pain mapping in breast cancer survivors. Breast Cancer Res Treat. 2010 Jan;119(1):105–110.
   PubMed Web of Science ®Google Scholar
• Zajaczkowska R, Kocot-Kepska M, Leppert W, et al. Bone pain in cancer patients: mechanisms and current treatment. Int J Mol Sci. 2019 Nov 30;20(23):6047. doi: 10.3390/ijms20236047
   PubMed Web of Science ®Google Scholar
• Jenkins V, Low R, Mitra S. Hearing sensitivity in women following chemotherapy treatment for breast cancer: results from a pilot study. Breast. 2009 Oct;18(5):279–283. doi: 10.1016/j.breast.2009.07.004
   PubMed Web of Science ®Google Scholar
• Kilicdag EB, Yavuz H, Bagis T, et al. Effects of estrogen therapy on hearing in postmenopausal women. Am J Obstet Gynecol. 2004 Jan;190(1):77–82.
   PubMed Web of Science ®Google Scholar
• Norman H, Lee KT, Stearns V, et al. Incidence and severity of myelosuppression with palbociclib after palliative bone radiation in advanced breast cancer: a single center experience and review of literature. Clin Breast Cancer. 2022 Jan;22(1):e65–e73.
   PubMed Web of Science ®Google Scholar
• Tibau A, Martinez MT, Ramos M, et al. Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial. Ther Adv Med Oncol. 2023;15:17588359221148921. doi: 10.1177/17588359221148921
   Web of Science ®Google Scholar
• Okura F, Sato Y, Murakami E, et al. A case of interstitial pneumonitis induced by palbociclib. Gan To Kagaku Ryoho. 2020 Jun;47(6):997–999.
   PubMedGoogle Scholar
• Di Cosimo S, Pérez-García JM, Bellet M, et al. Palbociclib with Fulvestrant or Letrozole in Endocrine-Sensitive Patients with HR-Positive/HER2-Negative Advanced Breast Cancer: A Detailed Safety Analysis of the Randomized PARSIFAL Trial. Onco. 2023;28(1): 23–32. doi: 10.1093/oncolo/oyac205
   Google Scholar
• Jazieh KA, Budd GT, Dalpiaz N, et al. Can CDK4/6 inhibitors cause fatal lung injury? Expert Rev Anticancer Ther. 2019 Nov;19(11):917–919.
   PubMed Web of Science ®Google Scholar
• Gong J, Cho M, Yu KW, et al. A single institution experience with palbociclib toxicity requiring dose modifications. Breast Cancer Res Treat. 2018 Apr;168(2):381–387.
   PubMed Web of Science ®Google Scholar
• 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. Ann Oncol. 2018 Jul 1;29(7):1541–1547. doi: 10.1093/annonc/mdy155
   PubMed Web of Science ®Google Scholar
• Birnhuber A, Egemnazarov B, Biasin V, et al. CDK4/6 inhibition enhances pulmonary inflammatory infiltration in bleomycin-induced lung fibrosis. Respir Res. 2020 Jul 2;21(1):167. doi: 10.1186/s12931-020-01433-w
   PubMed Web of Science ®Google Scholar
• Mathew N, Joel A, Andrews AG, et al. CDK 4/6 inhibitor induced lung injury: a case report and review of literature. Ecancermedicalscience. 2021;15:1245. doi: 10.3332/ecancer.2021.1245
   PubMed Web of Science ®Google Scholar
• Sarkisian S, Markosian C, Ali Z, et al. Palbociclib-induced pneumonitis: a case report and review of the literature. Cureus. 2020 Jun 30;12(6):e8929. doi: 10.7759/cureus.8929
   PubMed Web of Science ®Google Scholar
• 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 May;106(5):634–642.
   PubMed Web of Science ®Google Scholar
• 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;14:1033–1041. doi: 10.2147/CMAR.S353584
   PubMed Web of Science ®Google Scholar
• Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340–1347. doi: 10.1161/CIRCRESAHA.115.306841
   PubMed Web of Science ®Google Scholar
• 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 Apr 7;13(8):1758. doi: 10.3390/cancers13081758
   PubMed Web of Science ®Google Scholar
• Raschi E, Fusaroli M, La Placa M, et al. Skin toxicities with cyclin-dependent kinase 4/6 inhibitors in breast cancer: signals from disproportionality analysis of the FDA adverse event reporting system. Am J Clin Dermatol. 2022 Mar;23(2):247–255.
   PubMed Web of Science ®Google Scholar
• Groenland SL, Martinez-Chavez A, van Dongen MGJ, et al. Clinical Pharmacokinetics and pharmacodynamics of the cyclin-dependent kinase 4 and 6 inhibitors palbociclib, ribociclib, and abemaciclib. Clin Pharmacokinet. 2020 Dec;59(12):1501–1520.
   PubMed Web of Science ®Google Scholar
• Nasir UM, Mozeika AM, Sayan M, et al. Severe gastrointestinal mucositis following concurrent palbociclib and palliative radiation therapy. Anticancer Res. 2020 Sep;40(9):5291–5294.
   PubMed Web of Science ®Google Scholar
• McDonald ES, Clark AS, Tchou J, et al. Clinical diagnosis and management of breast cancer. J Nucl Med. 2016 Feb;57(Suppl 1):9S–16S.
   PubMedGoogle Scholar