As an increasing number of emerging anti-tumor drugs are approved and marketed, the imperative for clinical safety monitoring and risk information management has grown significantly. Drug-induced neuropathy associated with these drugs exhibit characteristics such as insidious onset, rapid progression, and challenging treatment, ultimately leading to treatment failures. Therefore, a comprehensive understanding of the risk of neuropathy induced by emerging anti-tumor drugs, coupled with risk surveillance and early warning, as well as management and reporting, can significantly reduce the incidence and severity of drug-related diseases. This paper provides a review of the neuropathy caused by emerging anti-tumor drugs, introduces the pharmacovigilance system and risk information management measures in clinical usage, aiming to provide a reference for guiding the rational clinical use and minimizing the incidence of drug-induced diseases.

1.World Health Organization. WHO outlines steps to save 7 million lives from cancer [EB/OL]. (2020-02-04) [2023-04-28]. https://www.who.int/zh/news/item/04-02-2020-who-outlines-steps-to-save-7-million-lives-from-cancer.

2.Xia C, Dong X, Li H, et al. Cancer statistics in China and United States, 2022: profiles, trends, and determinants[J]. Chin Med J (Engl), 2022, 135(5): 584-590. DOI: 10.1097/CM9.0000000000002108.

3.国家卫健委办公厅. 国家卫生健康委办公厅关于印发新型抗肿瘤药物临床应用指导原则(2022年版)的通知 [EB/OL]. (2022-12-29) [2023-04-30]. http://www.nhc.gov.cn/yzygj/s7659/202212/8df034c9afb44a9d95cd986d4e12fbd8.shtml.

4.Spain L, Walls G, Julve M, et al. Neurotoxicity from immune-checkpoint inhibition in the treatment of melanoma: a single centre experience and review of the literature[J]. Ann Oncol, 2017, 28(2): 377-385. DOI: 10.1093/annonc/mdw558.

5.Was H, Borkowska A, Bagues A, et al. Mechanisms of chemotherapy-induced neurotoxicity[J]. Front Pharmacol, 2022, 13: 750507. DOI: 10.3389/fphar.2022.750507.

6.Li JY, Ren YP, Yuan Y, et al. Preclinical PK/PD model for combined administration of erlotinib and sunitinib in the treatment of A549 human NSCLC xenograft mice[J]. Acta Pharmacol Sin, 2016, 37(7): 930-940. DOI: 10.1038/aps.2016.55.

7.Bhullar KS, Lagarón NO, McGowan EM, et al. Kinase-targeted cancer therapies: progress, challenges and future directions[J]. Mol Cancer, 2018, 17(1): 48. DOI: 10.1186/s12943-018-0804-2.

8.杨飒, 蒲兴祥, 王倩之, 等. 1例奥希替尼致神经毒性不良反应报道[J]. 肿瘤药学, 2022, 12(2): 272-276. [Yang S, Pu XX, Wang QZ, et al. A case report of osimertinib-induced neurotoxicity[J]. Anti-Tumor Pharmacy, 2022, 12(2): 272-276.] DOI: 10.3969/j.issn.2095-1264.2022.02.22.

9.俞燕华. 吉非替尼致神经性耳聋1例[J]. 医药导报, 2019, 38(8): 1098-1099. [Yu YH. Neurogenic deafness induced by gefitinib: a case report[J]. Herald of Medicine, 2019, 38(8): 1098-1099.] DOI: 10.3870/j.issn.1004-0781.2019.08.027.

10.López BM, Toro BC, Sais GE, et al. Probable drug-drug interaction between erlotinib and amiodarone causes severe neurotoxicity in a patient with advanced lung cancer[J]. Anticancer Drugs, 2018, 29(4): 380-383. DOI: 10.1097/CAD.0000000000000600.

11.Koshikawa H, Tsukie T, Kurita A, et al. Guillain-Barré syndrome in a patient with renal cell carcinoma following the first course of pazopanib therapy[J]. J Infect Chemother, 2017, 23(11): 798-799. DOI: 10.1016/j.jiac.2017.04.014.

12.Kanaan Z, Kulairi Z, Titianu M, et al. Guillain-Barré syndrome following treatment with sunitinib malate[J]. Case Rep Oncol Med, 2014, 2014: 712040. DOI: 10.1155/2014/712040.

13.Aparicio-Gallego G, Blanco M, Figueroa A, et al. New insights into molecular mechanisms of sunitinib-associated side effects[J]. Mol Cancer Ther, 2011, 10(12): 2215-2223. DOI: 10.1158/1535-7163.

14.Reed M, Rosales AS, Chioda MD, et al. Consensus recommendations for management and counseling of adverse events associated with lorlatinib: a guide for healthcare practitioners[J]. Adv Ther, 2020, 37(6): 3019-3030. DOI: 10.1007/s12325-020-01365-3.

15.Staropoli N, Ciliberto D, Del Giudice T, et al. The era of PARP inhibitors in ovarian cancer: "Class Action" or not? A systematic review and meta-analysis[J]. Crit Rev Oncol Hematol, 2018, 131: 83-89. DOI: 10.1016/j.critrevonc.2018.08.011.

16.Zhao H, Sifakis EG, Sumida N, et al. PARP1- and CTCF-mediated interactions between active and repressed chromatin at the lamina promote oscillating transcription[J]. Mol Cell, 2015, 59(6): 984-997. DOI: 10.1016/j.molcel.2015.07.019.

17.李玲, 林安, 林亮, 等. PARP抑制剂在卵巢癌维持治疗中非血液学不良反应的管理[J]. 现代妇产科进展, 2020, 29(10): 783-787. [Li L, Lin A, Lin L, et al. Management of nonhematological adverse effects of PARP inhibitors in ovarian cancer maintenance therapy[J]. Progress in Obstetrics and Gynecology, 2020, 29(10): 783-787.] DOI: 10.13283/j.cnki.xdfckjz.2020.10.012.

18.中国药师协会肿瘤专科药师分会, 中国抗癌协会肿瘤临床药学专业委员会, 浙江省抗癌协会肿瘤临床药学专业委员会, 等. 聚腺苷二磷酸核糖聚合酶抑制剂药物相互作用管理中国专家共识(2023版)[J]. 中华肿瘤杂志, 2023, 45(7): 584-593. DOI: 10.3760/cma.j.cn112152-20221223-00849.

19.Adams J, Kauffman M. Development of the proteasome inhihitor veleade (bortezomib)[J]. Cancer Invest, 2004, 22(2): 304-311. DOI: 10.1081/cnv-120030218.

20.任咏惠, 李丽, 汪梅, 等. 硼替佐米致多发性骨髓瘤患者周围神经病变的研究进展[J]. 临床医学研究与实践, 2022, 7(4): 196-198. [Ren YH, Li L, Wang M, et al. Research progress of bortezomib-induced peripheral neuropathy in patients with multiple myeloma[J]. Clinical Research and Practice, 2022, 7(4): 196-198.] DOI: 10.19347/j.cnki.2096-1413.202204056.

21.Sheng Z, Li G, Li B, et al. Carfilzomib-containing combinations as frontline therapy for multiple myeloma: a meta-analysis of 13 trials[J]. Eur J Haematol, 2017, 98(6): 601-607. DOI: 10.1111/ejh.12877.

22.郭志成, 吴涛, 白海. 伊沙佐米治疗多发性骨髓瘤研究进展[J]. 白血病·淋巴瘤, 2020, 29(8): 505-508. [Guo ZC, Wu T, Bai M. Research progress of isazzomib in the treatment of multiple myeloma[J]. Journal of Leukemia and Lymphoma, 2020, 29(8): 505-508.] DOI: 10.3760/cma.j.cn115356-20191014-00201.

23.Staff NP, Grisold A, Grisold W, et al. Chemotherapy-induced peripheral neuropathy: a current review[J]. Ann Neurol, 2017, 81(6): 772-781. DOI: 10.1002/ana.24951.

24.张文庆, 吴菁, 谢地, 等. 临床新兴抗肿瘤治疗方法发展概述[J]. 肿瘤防治研究, 2022, 49(3): 176-181. [Zhang WQ, Wu J, Xie D, et al. Review of development of emerging clinical antitumor therapeutics[J]. Cancer Research on Prevention and Treatment, 2022, 49(3): 176-181.] DOI: 10.3971/j.issn.1000-8578.2022.21.1034.

25.Michot JM, Lappara A, Le Pavec J, et al. The 2016-2019 immunoTOX assessment board report of collaborative management of immune-related adverse events, an observational clinical study[J]. Eur J Cancer, 2020, 130: 39-50. DOI: 10.1016/j.ejca.2020.02.010.

26.Albarrán V, Chamorro J, Rosero DI, et al. Neurologic toxicity of immune checkpoint inhibitors: a review of literature[J]. Front Pharmacol, 2022, 13: 774170. DOI: 10.3389/fphar.2022.774170.

27.吴汀溪, 张杨, 石延枫, 等. 基于美国FAERS数据库对免疫检查点抑制剂相关神经毒性的分析研究[J]. 中国药物应用与监测, 2023, 20(1): 50-54. [Wu TX, Zhang Y, Shi YF, et al. Analysis of neurological toxicities associated with immune checkpoint inhibitor based on the FDA adverse event reporting system[J]. Chinese Journal of Drag Application and Monitoring, 2023, 20(1): 50-54.] DOI: 10.3969/j.issn.1672-8157.2023.01.012.

28.Johnson DB, Manouchehri A, Haugh AM, et al. Neurologic toxicity associated with immune checkpoint inhibitors: a pharmacovigilance study[J]. J Immunother Cancer, 2019, 7(1): 134. DOI: 10.1186/s40425-019-0617-x.

29.Moreira A, Loquai C, Pföhler C, et al. Myositis and neuromuscular side-effects induced by immune checkpoint inhibitors[J]. Eur J Cancer, 2019, 106: 12-23. DOI: 10.1016/j.ejca.2018.09.033.

30.Haugh AM, Probasco JC, Johnson DB. Neurologic complications of immune checkpoint inhibitors[J]. Expert Opin Drug Saf, 2020, 19(4): 479-488. DOI: 10.1080/14740338.2020.1738382.

31.Schneider BJ, Naidoo J, Santomasso BD, et al. Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy: ASCO Guideline update[J]. J Clin Oncol, 2021, 39(36): 4073-4126. DOI: 10.1200/JCO.21.01440.

32.田磊, 王志妍, 杨琼, 等. 使用利妥昔单抗后出现可逆性后部脑病综合征1例[J]. 临床药物治疗杂志, 2020, 18(10): 83-86. [Tian L, Wang ZY, Yang Q, et al. Posterior reversible encephalopathy syndrome after rituximab administration：a case report[J]. Clinical Medication Journal, 2020, 18(10): 83-86.] DOI: 10.3969/j.issn.1672-3384.2020.10.019.

33.曹义海. 血管生成在疾病治疗中的应用与展望[J]. 山东大学学报(医学版), 2021, 59(9): 9-14. [Cao YH. Targeting angiogenesisfor disease therapy[J]. Journal of Shandong University (Health Sciences), 2021, 59(9): 9-14.] DOI: 10.6040/j.issn.1671-7554.0.2021.0936.

34.Matsuoka A, Maeda O, Mizutani T, et al. Bevacizumab exacerbates paclitaxel-induced neuropathy: a retrospective cohort study[J]. PLoS One, 2016, 11(12): e0168707. DOI: 10.1371/journal.pone.0168707.

35.Eaton JS, Miller PE, Mannis MJ, et al. Ocular adverse events associated with antibody - drug conjugates in human clinical trials[J]. J Ocul Pharmacol Ther, 2015, 31: 589-604. DOI: 10.1089/jop.2015.0064.

36.Sterenczak KA, Stache N, Bohn S, et al. Burst of corneal dendritic cells during trastuzumab and paclitaxel treatment[J]. Diagnostics (Basel), 2021, 11(5): 838. DOI: 10.3390/diagnostics11050838.

37.Strebhardt K, Ullrich A. Paul Ehrlich's magic bullet concept: 100 years of progress[J]. Nat Rev Cancer, 2008, 8(6): 473-480. DOI: 10.1038/nrc2394.

38.Liu K, Li YH, Zhang X, et al. Incidence and risk of severe adverse events associated with trastuzumab emtansine (T-DM1) in the treatment of breast cancer: an up-to-date systematic review and meta-analysis of randomized controlled clinical trials[J]. Expert Rev Clin Pharmacol, 2022, 15(11): 1343-1350. DOI: 10.1080/17512433.2022.2121704.

39.宋红芳, 徐香, 朱霞明, 等. 16例贝林妥欧单抗治疗的急性淋巴细胞白血病患者临床护理报告[J]. 护理实践与研究, 2023, 20(5): 784-788. [Song HF, Xu X, Zhu MX, et al. Clinical care report of 16 patients with acute lymphoblastic leukemia treated with belintuzumab[J]. Nursing Practice and Research, 2023, 20(5): 784-788.] DOI: 10.3969/j.issn.1672-9676.2023.05.032.

40.Lühder F, Höglund P, Allison JP, et al. Cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) regulates the unfolding of autoimmune diabetes[J]. J Exp Med, 1998, 187(3): 427-432. DOI: 10.1084/jem.187.3.427.

41.Wolchok JD, Weber JS, Hamid O, et al. Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials[J]. Cancer Immun, 2010, 10: 9. https://pubmed.ncbi.nlm.nih.gov/20957980/.

42.Inamura K. Roles of microbiota in response to cancer immunotherapy[J]. Semin Cancer Biol, 2020, 65: 164-175. DOI: 10.1016/j.semcancer.2019.12.026.

43.杨春松, 杨亚亚, 林芸竹, 等. 四川地区抗肿瘤药物风险分级现状及需求研究[J]. 儿科药学杂志, 2023, 29(2): 7-12. [Yang CS, Yang YY, Lin YZ, et al. Study on the status and demand of risk classification of antitumor drugs in Sichuan[J]. Journal of Pediatric Phaemacy, 2023, 29(2): 7-12.] DOI: 10.13407/j.cnki.jpp.1672-108X.2023.02.002.

44.邰宵辉,张玲芳,党春艳,等. 抗肿瘤药物致心脏损伤的药物防治进展[J]. 临床肿瘤学杂志, 2023, 28(1): 70-76. [Tai XH, Zhang LF, Dang CY, et al. Advances in the prevention and treatment of cardiotoxicity caused by anti-tumor drugs[J]. Chinese Clinical Oncology, 2023, 28(1): 70-76.] DOI: 10.3969/j.issn.1009-0460.2023.01.010.

45.彭楠茵,余国龙. 抗肿瘤药物心血管毒性及其相关风险评估研究进展[J]. 实用药物与临床, 2022, 25(8): 745-749. [Peng NY, Yu GL. Research progress on cardiovascular toxicity of anti-tumor drugs and related risk assessment[J]. Practical Pharmacy and Clinical Remedies, 2022, 25(8): 745-749.] DOI: 10.14053/j.cnki.ppcr.202208015.

46.傅晶. 风险管理在医院抗肿瘤药物安全管理中的应用[J]. 中医药管理杂志, 2021, 29(10): 204-205. [Fu J. Application of risk management in safety management of antitumor drugs in hospital[J]. Journal of Traditional Chinese Medicine Management, 2021, 29(10): 204-205.] https://d.wanfangdata.com.cn/periodical/zyyglzz202110089.

47.杨志敏. 药品说明书的规范性与风险控制——以新型抗肿瘤药为例[J]. 中国食品药品监管, 2019, (11): 40-47. [Yang ZM. Standardization and risk control of drug package inserts-- noval antitumor drugs, for example[J]. China Food & Drug Administration Magazine, 2019, (11): 40-47.] DOI: 10.3969/j.issn.1673-5390.2019.11.

48.洪英子, 胡骏. 新型抗肿瘤药的药物警戒体系概述[J]. 上海医药, 2022, 43(z2): 116-120. [Hong YZ, Hu Jun. Pharmacovigilance system in novel anti-tumor drugs[J]. Shanghai Medical & Pharmaceutical Journal, 2022, 43(z2): 116-120.] DOI: 10.3969/j.issn.1006-1533.2022.z2.015.

49.胡歆雅, 梁玉清, 曾亚莉, 等. 中美药物警戒制度的比较研究[J]. 中国合理用药探索, 2020, (2): 21-25. [Hu XY, Liang YQ, Zeng YL, et al. A comparative analysis of the pharmacovigilance system in China and the United States[J]. Chinese Journal of Rational Drug Use, 2020, (2): 21-25.] DOI: 10.3969/j.issn.2096-3327.2020.2.004.

50.Gutiérrez-Gutiérrez G, Sereno M, Miralles A, et al. Chemotherapy-induced peripheral neuropathy: clinical features, diagnosis, prevention and treatment strategies[J]. Clin Transl Oncol, 2010, 12(2): 81-91. DOI: 10.1007/S12094-010-0474-z.

51.Beijers AJ, Jongen JL, Vreugdenhil G. Chemotherapy-induced neurotoxicity: the value of neuroprotective strategies[J]. Neth J Med, 2012, 70(1): 18-25. https://pubmed.ncbi.nlm.nih.gov/22271810/.

52.García-Sanz R, Corchete LA, Alcoceba M, et al. Prediction of peripheral neuropathy in multiple myeloma patients receiving bortezomib and thalidomide: a genetic study based on a single nucleotide polymorphism array[J]. Hematol Oncol, 2017, 35(4): 746-751. DOI: 10.1002/hon.2337.

53.董超. 抗肿瘤药物所致神经毒性防治的研究进展[J]. 重庆医学, 2018, 47(2): 268-272. [Dong C. Research progress in prevention and treatment of neurotoxicity caused by antitumor drugs[J]. Chongqing Medicine, 2018, 47(2): 268-272.] DOI: 10.3969/j.issn.1671-8348.2018. 02.043.

54.Zajączkowska R, Kocot-Kępska M, Leppert W, et al. Mechanisms of chemotherapy-induced peripheral neuropathy[J]. Int J Mol Sci, 2019, 20(6): 1451. DOI: 10.3390/ijms20061451.

55.张晓雯, 侯文斌, 杨鸣, 等. 药物警戒研究在癌症治疗领域的机遇与挑战[J]. 中国药物警戒, 2021, 18(11): 1034-1038. [Zhang XW, He WB, Yang M, et al. Opportunities and Challenges of Pharmacovigilance in Cancer Treatment[J]. Chinese Journal of Pharmacovigilance, 2021, 18(11): 1034-1038.] DOI: 10.19803/j.1672-8629. 2021.11.08.

56.曹聚耕, 马明慧, 许丽扬, 等. 欧盟电子健康(eHealth)国家战略与我国卫生信息化刍议[C]. 中华医学会第十七次全国医学信息学术会议论文集, 2011: 1-3.