Incidence of Antibody-drug Conjugate-induced Peripheral Neuropathy in Patients with Breast Cancer: A Systematic Review and Meta-analysis
Journal: Journal of Clinical Medicine Research DOI: 10.32629/jcmr.v6i3.4409
Abstract
Background: Although ADCs have revolutionized breast cancer treatment, their risk of peripheral neuropathy has not been systematically evaluated. Methods: We systematically reviewed articles and conference abstracts published up to May 10, 2024, from Web of Science, PubMed, and Cochrane Library databases. Data were extracted independently and analyzed using a random-effects model, with heterogeneity assessed by I2 statistics and p-values. Results: Our meta-analysis found the overall incidence of any-grade peripheral neuropathy in breast cancer patients treated with ADCs to be 17.99% (95% CI, 13.73–22.65%). The incidence was 12.95% (95% CI, 9.03–17.4%) for ADC monotherapy regimens, with trastuzumab deruxtecan (T-DXd) having the highest incidence at 18.17% (95% CI, 4.96–35.89%). Conclusions: ADC-associated peripheral neuropathy is common in breast cancer treatment. The highest rate of neuropathy was seen with T-DXd, followed by T-DM1 and SG.
Keywords
antibody–drug conjugate, breast cancer, meta-analysis, peripheral neuropathy
Full Text
PDF - Viewed/Downloaded: 1 TimesReferences
[1] Sievers EL, Senter PD. Antibody-Drug Conjugates in Cancer Therapy. Annu Rev Med. 2013;64(1):15-29. doi:10.1146/annurev-med-050311-201823
[2] Smith LM, Nesterova A, Alley SC, Torgov MY, Carter PJ. Potent cytotoxicity of an auristatin-containing antibody-drug conjugate targeting melanoma cells expressing melanotransferrin/p97. Mol Cancer Ther. 2006;5(6):1474-1482. doi:10.1158/1535-7163.MCT-06-0026
[3] Law CL, Cerveny CG, Gordon KA, et al. Efficient Elimination of B-Lineage Lymphomas by Anti-CD20–Auristatin Conjugates. Clin Cancer Res. 2004;10(23):7842-7851. doi:10.1158/1078-0432.CCR-04-1028
[4] Hafeez U, Parakh S, Gan HK, Scott AM. Antibody–Drug Conjugates for Cancer Therapy. Molecules. 2020;25(20):4764. doi:10.3390/molecules25204764
[5] Yu J, Fang T, Yun C, Liu X, Cai X. Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. Front Mol Biosci. 2022;9:847835. doi:10.3389/fmolb.2022.847835
[6] Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy‐induced peripheral neuropathy: A current review. Ann Neurol. 2017;81(6):772-781. doi:10.1002/ana.24951
[7] Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023;25(11):1227-1235. doi:10.1007/s11912-023-01449-7
[8] Park SB, Lin CSY, Krishnan AV, Goldstein D, Friedlander ML, Kiernan MC. Oxaliplatin-induced neurotoxicity: changes in axonal excitability precede development of neuropathy. Brain. 2009;132(10):2712-2723. doi:10.1093/brain/awp219
[9] Sittl R, Lampert A, Huth T, et al. Anticancer drug oxaliplatin induces acute cooling-aggravated neuropathy via sodium channel subtype Na V 1.6-resurgent and persistent current. Proc Natl Acad Sci. 2012;109(17):6704-6709. doi:10.1073/pnas.1118058109
[10] Komiya Y, Tashiro T. Effects of taxol on slow and fast axonal transport. Cell Motil. 1988;11(3):151-156. doi:10.1002/cm.970110302
[11] Podratz JL, Knight AM, Ta LE, et al. Cisplatin induced Mitochondrial DNA damage in dorsal root ganglion neurons. Neurobiol Dis. 2011;41(3):661-668. doi:10.1016/j.nbd.2010.11.017
[12] Zhang S. Chemotherapy-induced peripheral neuropathy and rehabilitation: A review. Semin Oncol. 2021;48(3):193-207. doi:10.1053/j.seminoncol.2021.09.004
[13] Krop IE, Beeram M, Modi S, et al. Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer. J Clin Oncol. 2010;28(16):2698-2704. doi:10.1200/JCO.2009.26.2071
[14] Krop IE, LoRusso P, Miller KD, et al. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. J Clin Oncol. Published online 2012. doi:10.1200/JCO.2011.40.5902
[15] Beeram M, Krop IE, Burris HA, et al. A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer. Cancer. 2012;118(23):5733-5740. doi:10.1002/cncr.27622
[16] Miller KD, Diéras V, Harbeck N, et al. Phase IIa Trial of Trastuzumab Emtansine With Pertuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive, Locally Advanced, or Metastatic Breast Cancer. J Clin Oncol. 2014;32(14):1437-1444. doi:10.1200/JCO.2013.52.6590
[17] Yardley DA, Krop IE, LoRusso PM, et al. Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents: Results From the T-PAS Expanded Access Study. Cancer J. 2015;21(5):357-364. doi:10.1097/PPO.0000000000000144
[18] Kashiwaba M, Ito Y, Takao S, et al. A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer. Jpn J Clin Oncol. 2016;46(5):407-414. doi:10.1093/jjco/hyw013
[19] Watanabe J, Ito Y, Saeki T, et al. Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. Vivo Athens Greece. 2017;31(3):493-500. doi:10.21873/invivo.11088
[20] Jain S, Shah AN, Santa-Maria CA, et al. Phase I study of alpelisib (BYL-719) and trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer (MBC) after trastuzumab and taxane therapy. Breast Cancer Res Treat. 2018;171(2):371-381. doi:10.1007/s10549-018-4792-0
[21] Kojima Y, Yoshie R, Kawamoto H, et al. Trastuzumab Emtansine (T-DM1) Plus S-1 in Patients with Trastuzumab-Pretreated HER2-Positive Advanced or Metastatic Breast Cancer: A Phase Ib Study. Oncology. 2019;96(6):309-317. doi:10.1159/000497276
[22] Ji D, Shen W, Zhang J, et al. A phase I study of pharmacokinetics of trastuzumab emtansine in Chinese patients with locally advanced inoperable or metastatic human epidermal growth factor receptor 2-positive breast cancer who have received prior trastuzumab-based therapy. Medicine (Baltimore). 2020;99(44):e22886. doi:10.1097/MD.0000000000022886
[23] Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol Off J Eur Soc Med Oncol. 2020;31(10):1350-1358. doi:10.1016/j.annonc.2020.06.020
[24] Waks AG, Keenan TE, Li T, et al. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. J Immunother Cancer. 2022;10(10):e005119. doi:10.1136/jitc-2022-005119
[25] Hk A, Sh S, Kj S, et al. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022;8(9). doi:10.1001/jamaoncol.2022.2310
[26] Jenkins S, Zhang W, Steinberg SM, et al. Phase I Study and Cell-Free DNA Analysis of T-DM1 and Metronomic Temozolomide for Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases. Clin Cancer Res Off J Am Assoc Cancer Res. 2023;29(8):1450-1459. doi:10.1158/1078-0432.CCR-22-0855
[27] Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019;380(8):741-751. doi:10.1056/NEJMoa1814213
[28] Padua TC de, Moschini M, Martini A, et al. Efficacy and toxicity of antibody-drug conjugates in the treatment of metastatic urothelial cancer: A scoping review. Urol Oncol. 2022;40(10):413-423. doi:10.1016/j.urolonc.2022.07.006
[29] Ma P, Tian H, Shi Q, et al. High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive/mutated malignancies: a pharmacovigilance study based on the FAERS database. Expert Opin Drug Saf. 2023;22(8):685-696. doi:10.1080/14740338.2023.2204228
[30] Krop IE, Modi S, LoRusso PM, et al. Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. Breast Cancer Res BCR. 2016;18(1):34. doi:10.1186/s13058-016-0691-7
[31] Martin M, Fumoleau P, Dewar JA, et al. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol Off J Eur Soc Med Oncol. 2016;27(7):1249-1256. doi:10.1093/annonc/mdw157
[32] Patel TA, Ensor JE, Creamer SL, et al. A randomized, controlled phase II trial of neoadjuvant ado-trastuzumab emtansine, lapatinib, and nab-paclitaxel versus trastuzumab, pertuzumab, and paclitaxel in HER2-positive breast cancer (TEAL study). Breast Cancer Res BCR. 2019;21(1):100. doi:10.1186/s13058-019-1186-0
[33] Diéras V, Miles D, Verma S, et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(6):732-742. doi:10.1016/S1470-2045(17)30312-1
[34] Hurvitz SA, Martin M, Symmans WF, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018;19(1):115-126. doi:10.1016/S1470-2045(17)30716-7
[35] Perez EA, Barrios C, Eiermann W, et al. Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2-positive advanced breast cancer: Final results from MARIANNE. Cancer. 2019;125(22):3974-3984. doi:10.1002/cncr.32392
[36] Masuda N, Ohtani S, Takano T, et al. A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer. Breast Cancer Res Treat. 2020;180(1):135-146. doi:10.1007/s10549-020-05524-6
[37] Emens LA, Esteva FJ, Beresford M, et al. Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial. Lancet Oncol. 2020;21(10):1283-1295. doi:10.1016/S1470-2045(20)30465-4
[38] Mamounas EP, Untch M, Mano MS, et al. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Ann Oncol Off J Eur Soc Med Oncol. 2021;32(8):1005-1014. doi:10.1016/j.annonc.2021.04.011
[39] Tolaney SM, Tayob N, Dang C, et al. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol Off J Am Soc Clin Oncol. 2021;39(21):2375-2385. doi:10.1200/JCO.20.03398
[40] H W, T M, S M, et al. Long term outcome data from the EORTC 75111-10114 ETF/BCG randomized phase II study: Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer, followed by T-DM1 after progression. Breast Edinb Scotl. 2022;64. doi:10.1016/j.breast.2022.05.004
[41] Krop IE, Im SA, Barrios C, et al. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol Off J Am Soc Clin Oncol. 2022;40(5):438-448. doi:10.1200/JCO.21.00896
[42] O’Shaughnessy J, Brufsky A, Rugo HS, et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022;195(2):127-139. doi:10.1007/s10549-022-06602-7
[43] Rugo HS, Bardia A, Marmé F, et al. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2022;40(29):3365-3376. doi:10.1200/JCO.22.01002
[44] Norsworthy KJ, Ko CW, Lee JE, et al. FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia. The Oncologist. 2018;23(9):1103-1108. doi:10.1634/theoncologist.2017-0604
[45] Thomas A, Teicher BA, Hassan R. Antibody–drug conjugates for cancer therapy. Lancet Oncol. 2016;17(6):e254-e262. doi:10.1016/S1470-2045(16)30030-4
[46] Flatters SJL, Dougherty PM, Colvin LA. Clinical and preclinical perspectives on Chemotherapy-Induced Peripheral Neuropathy (CIPN): a narrative review. Br J Anaesth. 2017;119(4):737-749. doi:10.1093/bja/aex229
[47] Tanay M a. L, Armes J, Ream E. The experience of chemotherapy-induced peripheral neuropathy in adult cancer patients: a qualitative thematic synthesis. Eur J Cancer Care (Engl). 2017;26(5). doi:10.1111/ecc.12443
[48] Cioroiu C, Weimer LH. Update on Chemotherapy-Induced Peripheral Neuropathy. Curr Neurol Neurosci Rep. 2017;17(6):47. doi:10.1007/s11910-017-0757-7
[49] Oh PJ, Kim YL. Effectiveness of Non-Pharmacologic Interventions in Chemotherapy Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis. J Korean Acad Nurs. 2018;48(2):123. doi:10.4040/jkan.2018.48.2.123
[50] Farshchian N, Alavi A, Heydarheydari S, Moradian N. Comparative study of the effects of venlafaxine and duloxetine on chemotherapy-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2018;82(5):787-793. doi:10.1007/s00280-018-3664-y
[51] Zhu Y, Liu K, Wang K, Zhu H. Treatment‐related adverse events of antibody–drug conjugates in clinical trials: A systematic review and meta‐analysis. Cancer. 2023;129(2):283-295. doi:10.1002/cncr.34507
[52] Kotani D, Shitara K. Trastuzumab deruxtecan for the treatment of patients with HER2-positive gastric cancer. Ther Adv Med Oncol. 2021;13:175883592098651. doi:10.1177/1758835920986518
[53] Masters JC, Nickens DJ, Xuan D, Shazer RL, Amantea M. Clinical toxicity of antibody drug conjugates: a meta-analysis of payloads. Invest New Drugs. 2018;36(1):121-135. doi:10.1007/s10637-017-0520-6
[2] Smith LM, Nesterova A, Alley SC, Torgov MY, Carter PJ. Potent cytotoxicity of an auristatin-containing antibody-drug conjugate targeting melanoma cells expressing melanotransferrin/p97. Mol Cancer Ther. 2006;5(6):1474-1482. doi:10.1158/1535-7163.MCT-06-0026
[3] Law CL, Cerveny CG, Gordon KA, et al. Efficient Elimination of B-Lineage Lymphomas by Anti-CD20–Auristatin Conjugates. Clin Cancer Res. 2004;10(23):7842-7851. doi:10.1158/1078-0432.CCR-04-1028
[4] Hafeez U, Parakh S, Gan HK, Scott AM. Antibody–Drug Conjugates for Cancer Therapy. Molecules. 2020;25(20):4764. doi:10.3390/molecules25204764
[5] Yu J, Fang T, Yun C, Liu X, Cai X. Antibody-Drug Conjugates Targeting the Human Epidermal Growth Factor Receptor Family in Cancers. Front Mol Biosci. 2022;9:847835. doi:10.3389/fmolb.2022.847835
[6] Staff NP, Grisold A, Grisold W, Windebank AJ. Chemotherapy‐induced peripheral neuropathy: A current review. Ann Neurol. 2017;81(6):772-781. doi:10.1002/ana.24951
[7] Molinares D, Kurtevski S, Zhu Y. Chemotherapy-Induced Peripheral Neuropathy: Diagnosis, Agents, General Clinical Presentation, and Treatments. Curr Oncol Rep. 2023;25(11):1227-1235. doi:10.1007/s11912-023-01449-7
[8] Park SB, Lin CSY, Krishnan AV, Goldstein D, Friedlander ML, Kiernan MC. Oxaliplatin-induced neurotoxicity: changes in axonal excitability precede development of neuropathy. Brain. 2009;132(10):2712-2723. doi:10.1093/brain/awp219
[9] Sittl R, Lampert A, Huth T, et al. Anticancer drug oxaliplatin induces acute cooling-aggravated neuropathy via sodium channel subtype Na V 1.6-resurgent and persistent current. Proc Natl Acad Sci. 2012;109(17):6704-6709. doi:10.1073/pnas.1118058109
[10] Komiya Y, Tashiro T. Effects of taxol on slow and fast axonal transport. Cell Motil. 1988;11(3):151-156. doi:10.1002/cm.970110302
[11] Podratz JL, Knight AM, Ta LE, et al. Cisplatin induced Mitochondrial DNA damage in dorsal root ganglion neurons. Neurobiol Dis. 2011;41(3):661-668. doi:10.1016/j.nbd.2010.11.017
[12] Zhang S. Chemotherapy-induced peripheral neuropathy and rehabilitation: A review. Semin Oncol. 2021;48(3):193-207. doi:10.1053/j.seminoncol.2021.09.004
[13] Krop IE, Beeram M, Modi S, et al. Phase I Study of Trastuzumab-DM1, an HER2 Antibody-Drug Conjugate, Given Every 3 Weeks to Patients With HER2-Positive Metastatic Breast Cancer. J Clin Oncol. 2010;28(16):2698-2704. doi:10.1200/JCO.2009.26.2071
[14] Krop IE, LoRusso P, Miller KD, et al. A Phase II Study of Trastuzumab Emtansine in Patients With Human Epidermal Growth Factor Receptor 2–Positive Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab, Lapatinib, an Anthracycline, a Taxane, and Capecitabine. J Clin Oncol. Published online 2012. doi:10.1200/JCO.2011.40.5902
[15] Beeram M, Krop IE, Burris HA, et al. A phase 1 study of weekly dosing of trastuzumab emtansine (T‐DM1) in patients with advanced human epidermal growth factor 2–positive breast cancer. Cancer. 2012;118(23):5733-5740. doi:10.1002/cncr.27622
[16] Miller KD, Diéras V, Harbeck N, et al. Phase IIa Trial of Trastuzumab Emtansine With Pertuzumab for Patients With Human Epidermal Growth Factor Receptor 2–Positive, Locally Advanced, or Metastatic Breast Cancer. J Clin Oncol. 2014;32(14):1437-1444. doi:10.1200/JCO.2013.52.6590
[17] Yardley DA, Krop IE, LoRusso PM, et al. Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Metastatic Breast Cancer Previously Treated With Chemotherapy and 2 or More HER2-Targeted Agents: Results From the T-PAS Expanded Access Study. Cancer J. 2015;21(5):357-364. doi:10.1097/PPO.0000000000000144
[18] Kashiwaba M, Ito Y, Takao S, et al. A multicenter Phase II study evaluating the efficacy, safety and pharmacokinetics of trastuzumab emtansine in Japanese patients with heavily pretreated HER2-positive locally recurrent or metastatic breast cancer. Jpn J Clin Oncol. 2016;46(5):407-414. doi:10.1093/jjco/hyw013
[19] Watanabe J, Ito Y, Saeki T, et al. Safety Evaluation of Trastuzumab Emtansine in Japanese Patients with HER2-Positive Advanced Breast Cancer. Vivo Athens Greece. 2017;31(3):493-500. doi:10.21873/invivo.11088
[20] Jain S, Shah AN, Santa-Maria CA, et al. Phase I study of alpelisib (BYL-719) and trastuzumab emtansine (T-DM1) in HER2-positive metastatic breast cancer (MBC) after trastuzumab and taxane therapy. Breast Cancer Res Treat. 2018;171(2):371-381. doi:10.1007/s10549-018-4792-0
[21] Kojima Y, Yoshie R, Kawamoto H, et al. Trastuzumab Emtansine (T-DM1) Plus S-1 in Patients with Trastuzumab-Pretreated HER2-Positive Advanced or Metastatic Breast Cancer: A Phase Ib Study. Oncology. 2019;96(6):309-317. doi:10.1159/000497276
[22] Ji D, Shen W, Zhang J, et al. A phase I study of pharmacokinetics of trastuzumab emtansine in Chinese patients with locally advanced inoperable or metastatic human epidermal growth factor receptor 2-positive breast cancer who have received prior trastuzumab-based therapy. Medicine (Baltimore). 2020;99(44):e22886. doi:10.1097/MD.0000000000022886
[23] Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial☆. Ann Oncol Off J Eur Soc Med Oncol. 2020;31(10):1350-1358. doi:10.1016/j.annonc.2020.06.020
[24] Waks AG, Keenan TE, Li T, et al. Phase Ib study of pembrolizumab in combination with trastuzumab emtansine for metastatic HER2-positive breast cancer. J Immunother Cancer. 2022;10(10):e005119. doi:10.1136/jitc-2022-005119
[25] Hk A, Sh S, Kj S, et al. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022;8(9). doi:10.1001/jamaoncol.2022.2310
[26] Jenkins S, Zhang W, Steinberg SM, et al. Phase I Study and Cell-Free DNA Analysis of T-DM1 and Metronomic Temozolomide for Secondary Prevention of HER2-Positive Breast Cancer Brain Metastases. Clin Cancer Res Off J Am Assoc Cancer Res. 2023;29(8):1450-1459. doi:10.1158/1078-0432.CCR-22-0855
[27] Bardia A, Mayer IA, Vahdat LT, et al. Sacituzumab Govitecan-hziy in Refractory Metastatic Triple-Negative Breast Cancer. N Engl J Med. 2019;380(8):741-751. doi:10.1056/NEJMoa1814213
[28] Padua TC de, Moschini M, Martini A, et al. Efficacy and toxicity of antibody-drug conjugates in the treatment of metastatic urothelial cancer: A scoping review. Urol Oncol. 2022;40(10):413-423. doi:10.1016/j.urolonc.2022.07.006
[29] Ma P, Tian H, Shi Q, et al. High risks adverse events associated with trastuzumab emtansine and trastuzumab deruxtecan for the treatment of HER2-positive/mutated malignancies: a pharmacovigilance study based on the FAERS database. Expert Opin Drug Saf. 2023;22(8):685-696. doi:10.1080/14740338.2023.2204228
[30] Krop IE, Modi S, LoRusso PM, et al. Phase 1b/2a study of trastuzumab emtansine (T-DM1), paclitaxel, and pertuzumab in HER2-positive metastatic breast cancer. Breast Cancer Res BCR. 2016;18(1):34. doi:10.1186/s13058-016-0691-7
[31] Martin M, Fumoleau P, Dewar JA, et al. Trastuzumab emtansine (T-DM1) plus docetaxel with or without pertuzumab in patients with HER2-positive locally advanced or metastatic breast cancer: results from a phase Ib/IIa study. Ann Oncol Off J Eur Soc Med Oncol. 2016;27(7):1249-1256. doi:10.1093/annonc/mdw157
[32] Patel TA, Ensor JE, Creamer SL, et al. A randomized, controlled phase II trial of neoadjuvant ado-trastuzumab emtansine, lapatinib, and nab-paclitaxel versus trastuzumab, pertuzumab, and paclitaxel in HER2-positive breast cancer (TEAL study). Breast Cancer Res BCR. 2019;21(1):100. doi:10.1186/s13058-019-1186-0
[33] Diéras V, Miles D, Verma S, et al. Trastuzumab emtansine versus capecitabine plus lapatinib in patients with previously treated HER2-positive advanced breast cancer (EMILIA): a descriptive analysis of final overall survival results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2017;18(6):732-742. doi:10.1016/S1470-2045(17)30312-1
[34] Hurvitz SA, Martin M, Symmans WF, et al. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018;19(1):115-126. doi:10.1016/S1470-2045(17)30716-7
[35] Perez EA, Barrios C, Eiermann W, et al. Trastuzumab emtansine with or without pertuzumab versus trastuzumab with taxane for human epidermal growth factor receptor 2-positive advanced breast cancer: Final results from MARIANNE. Cancer. 2019;125(22):3974-3984. doi:10.1002/cncr.32392
[36] Masuda N, Ohtani S, Takano T, et al. A randomized, 3-arm, neoadjuvant, phase 2 study comparing docetaxel + carboplatin + trastuzumab + pertuzumab (TCbHP), TCbHP followed by trastuzumab emtansine and pertuzumab (T-DM1+P), and T-DM1+P in HER2-positive primary breast cancer. Breast Cancer Res Treat. 2020;180(1):135-146. doi:10.1007/s10549-020-05524-6
[37] Emens LA, Esteva FJ, Beresford M, et al. Trastuzumab emtansine plus atezolizumab versus trastuzumab emtansine plus placebo in previously treated, HER2-positive advanced breast cancer (KATE2): a phase 2, multicentre, randomised, double-blind trial. Lancet Oncol. 2020;21(10):1283-1295. doi:10.1016/S1470-2045(20)30465-4
[38] Mamounas EP, Untch M, Mano MS, et al. Adjuvant T-DM1 versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer: subgroup analyses from KATHERINE. Ann Oncol Off J Eur Soc Med Oncol. 2021;32(8):1005-1014. doi:10.1016/j.annonc.2021.04.011
[39] Tolaney SM, Tayob N, Dang C, et al. Adjuvant Trastuzumab Emtansine Versus Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT): A Randomized Clinical Trial. J Clin Oncol Off J Am Soc Clin Oncol. 2021;39(21):2375-2385. doi:10.1200/JCO.20.03398
[40] H W, T M, S M, et al. Long term outcome data from the EORTC 75111-10114 ETF/BCG randomized phase II study: Pertuzumab and trastuzumab with or without metronomic chemotherapy for older patients with HER2-positive metastatic breast cancer, followed by T-DM1 after progression. Breast Edinb Scotl. 2022;64. doi:10.1016/j.breast.2022.05.004
[41] Krop IE, Im SA, Barrios C, et al. Trastuzumab Emtansine Plus Pertuzumab Versus Taxane Plus Trastuzumab Plus Pertuzumab After Anthracycline for High-Risk Human Epidermal Growth Factor Receptor 2-Positive Early Breast Cancer: The Phase III KAITLIN Study. J Clin Oncol Off J Am Soc Clin Oncol. 2022;40(5):438-448. doi:10.1200/JCO.21.00896
[42] O’Shaughnessy J, Brufsky A, Rugo HS, et al. Analysis of patients without and with an initial triple-negative breast cancer diagnosis in the phase 3 randomized ASCENT study of sacituzumab govitecan in metastatic triple-negative breast cancer. Breast Cancer Res Treat. 2022;195(2):127-139. doi:10.1007/s10549-022-06602-7
[43] Rugo HS, Bardia A, Marmé F, et al. Sacituzumab Govitecan in Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer. J Clin Oncol Off J Am Soc Clin Oncol. 2022;40(29):3365-3376. doi:10.1200/JCO.22.01002
[44] Norsworthy KJ, Ko CW, Lee JE, et al. FDA Approval Summary: Mylotarg for Treatment of Patients with Relapsed or Refractory CD33-Positive Acute Myeloid Leukemia. The Oncologist. 2018;23(9):1103-1108. doi:10.1634/theoncologist.2017-0604
[45] Thomas A, Teicher BA, Hassan R. Antibody–drug conjugates for cancer therapy. Lancet Oncol. 2016;17(6):e254-e262. doi:10.1016/S1470-2045(16)30030-4
[46] Flatters SJL, Dougherty PM, Colvin LA. Clinical and preclinical perspectives on Chemotherapy-Induced Peripheral Neuropathy (CIPN): a narrative review. Br J Anaesth. 2017;119(4):737-749. doi:10.1093/bja/aex229
[47] Tanay M a. L, Armes J, Ream E. The experience of chemotherapy-induced peripheral neuropathy in adult cancer patients: a qualitative thematic synthesis. Eur J Cancer Care (Engl). 2017;26(5). doi:10.1111/ecc.12443
[48] Cioroiu C, Weimer LH. Update on Chemotherapy-Induced Peripheral Neuropathy. Curr Neurol Neurosci Rep. 2017;17(6):47. doi:10.1007/s11910-017-0757-7
[49] Oh PJ, Kim YL. Effectiveness of Non-Pharmacologic Interventions in Chemotherapy Induced Peripheral Neuropathy: A Systematic Review and Meta-Analysis. J Korean Acad Nurs. 2018;48(2):123. doi:10.4040/jkan.2018.48.2.123
[50] Farshchian N, Alavi A, Heydarheydari S, Moradian N. Comparative study of the effects of venlafaxine and duloxetine on chemotherapy-induced peripheral neuropathy. Cancer Chemother Pharmacol. 2018;82(5):787-793. doi:10.1007/s00280-018-3664-y
[51] Zhu Y, Liu K, Wang K, Zhu H. Treatment‐related adverse events of antibody–drug conjugates in clinical trials: A systematic review and meta‐analysis. Cancer. 2023;129(2):283-295. doi:10.1002/cncr.34507
[52] Kotani D, Shitara K. Trastuzumab deruxtecan for the treatment of patients with HER2-positive gastric cancer. Ther Adv Med Oncol. 2021;13:175883592098651. doi:10.1177/1758835920986518
[53] Masters JC, Nickens DJ, Xuan D, Shazer RL, Amantea M. Clinical toxicity of antibody drug conjugates: a meta-analysis of payloads. Invest New Drugs. 2018;36(1):121-135. doi:10.1007/s10637-017-0520-6
Copyright © 2025 Meijie Wu, Hengheng Zhang, Ping Yang, Junnan Ma, Zhen Liu, Haining Zhao
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
