Managing adverse events of sacituzumab govitecan

References

• Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529–1541.
   PubMed Web of Science ®Google Scholar
• Modi S, Jacot W, Yamashita T, et al. Trastuzumab deruxtecan in Previously treated HER2-low advanced breast cancer. N Engl J Med. 2022;387(1):9–20. doi: 10.1056/NEJMoa2203690
   PubMed Web of Science ®Google Scholar
• Verma S, Miles D, Gianni L, et al. Trastuzumab emtansine for HER2-positive advanced breast cancer. N Engl J Med. 2012;367(19):1783–1791. doi: 10.1056/NEJMoa1209124
   PubMed Web of Science ®Google Scholar
• Taniguchi H, Yagisawa M, Satoh T, et al. Tissue-agnostic efficacy of trastuzumab deruxtecan (T-DXd) in advanced solid tumors with HER2 amplification identified by plasma cell-free DNA (cfDNA) testing: results from a phase 2 basket trial (HERALD/EPOC1806). J Clin Oncol. 2023 Jun;41(16_suppl):3014–3014. doi: 10.1200/JCO.2023.41.16_suppl.3014
   Web of Science ®Google Scholar
• Stepan LP, Trueblood ES, Hale K, et al. Expression of Trop2 cell surface glycoprotein in normal and tumor tissues: potential implications as a cancer therapeutic target. J Histochem Cytochem. 2011;59(7):701–710. doi: 10.1369/0022155411410430
   PubMed Web of Science ®Google Scholar
• Jeon Y, Jo U, Hong J, et al. Trophoblast cell-surface antigen 2 (TROP2) expression in triple-negative breast cancer. BMC Cancer. 2022;22(1):1014. doi: 10.1186/s12885-022-10076-7
   PubMed Web of Science ®Google Scholar
• Drago JZ, Modi S, Chandarlapaty S. Unlocking the potential of antibody-drug conjugates for cancer therapy. Nat Rev Clin Oncol. 2021;18(6):327–344. doi: 10.1038/s41571-021-00470-8
   PubMed Web of Science ®Google Scholar
• Ogitani Y, Hagihara K, Oitate M, et al. Bystander killing effect of DS-8201a, a novel anti-human epidermal growth factor receptor 2 antibody-drug conjugate, in tumors with human epidermal growth factor receptor 2 heterogeneity. Cancer Sci. 2016;107(7):1039–1046. doi: 10.1111/cas.12966
   PubMed Web of Science ®Google Scholar
• Kumagai K, Aida T, Tsuchiya Y, et al. Interstitial pneumonitis related to trastuzumab deruxtecan, a human epidermal growth factor receptor 2-targeting Ab-drug conjugate, in monkeys. Cancer Sci. 2020;111(12):4636–4645. doi: 10.1111/cas.14686
   PubMed Web of Science ®Google Scholar
• Nicolò E, Repetto M, Boscolo Bielo L, et al. Antibody-drug conjugates in breast cancer: what is beyond HER2? Cancer J. 2022;28(6):436–445. doi: 10.1097/PPO.0000000000000629
   PubMed Web of Science ®Google Scholar
• Rugo HS, Tolaney SM, Loirat D, et al. Safety analyses from the phase 3 ASCENT trial of sacituzumab govitecan in metastatic triple-negative breast cancer. NPJ Breast Cancer. 2022;8(1):98. doi: 10.1038/s41523-022-00467-1
   PubMed Web of Science ®Google Scholar
• 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
   PubMed Web of Science ®Google Scholar
• Bardia A, Hurvitz SA, Tolaney SM, et al. Sacituzumab govitecan in metastatic triple-negative breast cancer. N Engl J Med. 2021;384(16):1529–1541. doi: 10.1056/NEJMoa2028485
   PubMed Web of Science ®Google Scholar
• Bardia A, Tolaney SM, Loirat D, et al. Sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (pts) with previously treated, metastatic triple-negative breast cancer (mTNBC): final results from the phase 3 ASCENT study. J Clin Oncol. 2022;40(16_suppl):1071. doi: 10.1200/JCO.2022.40.16_suppl.1071
   Web of Science ®Google Scholar
• Bardia A, Tolaney SM, Punie K, et al. Biomarker analyses in the phase III ASCENT study of sacituzumab govitecan versus chemotherapy in patients with metastatic triple-negative breast cancer. Ann Oncol. 2021;32(9):1148–1156. doi: 10.1016/j.annonc.2021.06.002
   PubMed Web of Science ®Google Scholar
• Rugo HS, Bardia A, Marmé F, et al. Primary results from TROPiCS-02: a randomized phase 3 study of sacituzumab govitecan (SG) versus treatment of physician’s choice (TPC) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2-) advanced breast cancer. J Clin Oncol. 2022;40(17_suppl):LBA1001–LBA. doi: 10.1200/JCO.2022.40.17_suppl.LBA1001
   Web of Science ®Google Scholar
• Kalinsky K, Diamond JR, Vahdat LT, et al. Sacituzumab govitecan in previously treated hormone receptor-positive/HER2-negative metastatic breast cancer: final results from a phase I/II, single-arm, basket trial. Ann Oncol. 2020;31(12):1709–1718. doi: 10.1016/j.annonc.2020.09.004
   PubMed Web of Science ®Google Scholar
• 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. 2022;40(29):3365–3376. doi: 10.1200/JCO.22.01002
   PubMed Web of Science ®Google Scholar
• Tolaney S, Bardia A, Marmé F, et al. Final overall survival (OS) analysis from the phase 3 TROPiCS-02 study of sacituzumab govitecan (SG) in patients (pts) with hormone receptor–positive/HER2-negative (HR+/HER2–) metastatic breast cancer (mBC). J Clin Oncol. 2023;41(16_suppl):1003. doi: 10.1200/JCO.2023.41.16_suppl.1003
   Web of Science ®Google Scholar
• Tagawa ST, Balar AV, Petrylak DP, et al. TROPHY-U-01: a phase II open-label study of sacituzumab govitecan in patients with metastatic urothelial carcinoma progressing after platinum-based chemotherapy and checkpoint inhibitors. J Clin Oncol. 2021;39(22):2474–2485. doi: 10.1200/JCO.20.03489
   PubMed Web of Science ®Google Scholar
• DeMichele A, Takano T, Rugo HS, et al. ASCENT-05/OptimICE-RD (AFT-65): phase 3, randomized, open-label study of adjuvant sacituzumab govitecan (SG) + pembrolizumab (pembro) vs pembro ± capecitabine (cape) in patients (pts) with triple-negative breast cancer (TNBC) and residual disease after neoadjuvant therapy (NAT) and surgery. J Clin Oncol. 2023;41(16_suppl):TPS619–TPS.
   Web of Science ®Google Scholar
• Garrido-Castro AC, Keenan TE, Li T, et al. Saci-IO TNBC: randomized phase II trial of sacituzumab govitecan (SG) ± pembrolizumab in PD-L1– metastatic triple-negative breast cancer (mTNBC). J Clin Oncol. 2021;39(15_suppl):TPS1106–TPS. doi: 10.1200/JCO.2021.39.15_suppl.TPS1106
   Google Scholar
• Tolaney SM, de Azambuja E, Emens LA, et al. 276TiP ASCENT-04/KEYNOTE-D19: phase III study of sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs treatment of physician’s choice (TPC) plus pembro in first-line (1L) programmed death-ligand 1-positive (PD-L1+) metastatic triple-negative breast cancer (mTNBC). Ann Oncol. 2022;33(Supplement 7):S664–S665.
   Web of Science ®Google Scholar
• de Man FM, Goey AKL, van Schaik RHN, et al. Individualization of irinotecan treatment: a review of pharmacokinetics, pharmacodynamics, and pharmacogenetics. Clin Pharmacokinet. 2018;57(10):1229–1254.
   PubMed Web of Science ®Google Scholar
• Karas S, Innocenti F. All you need to know about UGT1A1 genetic testing for patients treated with irinotecan: a practitioner-friendly Guide. JCO Oncol Pract. 2022;18(4):270–277. doi: 10.1200/OP.21.00624
   PubMedGoogle Scholar
• Ocean AJ, Starodub AN, Bardia A, et al. Sacituzumab govitecan (IMMU‐132), an anti‐Trop‐2‐SN‐38 antibody‐drug conjugate for the treatment of diverse epithelial cancers: safety and pharmacokinetics. Cancer. 2017;123(19):3843–3854. doi: 10.1002/cncr.30789
   PubMed Web of Science ®Google Scholar
• Behrendt CE, Yu W, Bosserman LD, et al. UGT1A1 *28/*28 genotype and risk of toxicity and disease progression in breast cancer patients treated with sacituzumab govitecan-hziy. J Clin Oncol. 2023;41(16_suppl):1033. doi: 10.1200/JCO.2023.41.16_suppl.1033
   Web of Science ®Google Scholar
• Marmé F, Rugo HS, Tolaney SM, et al. 194P safety outcomes by UGT1A1 status in the phase III TROPiCS-02 study of sacituzumab govitecan (SG) in HR+/HER2– metastatic breast cancer (mBC). ESMO Open. 2023;8(1_Suppl 4):101383. doi: 10.1016/j.esmoop.2023.101383
   Google Scholar
• Zimmer AJ, Freifeld AG. Optimal management of neutropenic fever in patients with cancer. J Oncol Pract. 2019;15(1):19–24. doi: 10.1200/JOP.18.00269
   PubMed Web of Science ®Google Scholar
• Klastersky J, de Naurois J, Rolson K, et al. Management of Febrile Neutropaenia: ESMO clinical practice guidelines. Ann Oncol. 2016;27(suppl 5):v111–v118. doi: 10.1093/annonc/mdw325
   PubMed Web of Science ®Google Scholar
• Bhat K, Sandler K, Duhachek-Muggy S, et al. Serum erythropoietin levels, breast cancer and breast cancer-initiating cells. Breast Cancer Res. 2019;21(1):17. doi: 10.1186/s13058-019-1100-9
   PubMedGoogle Scholar
• Cochrane handbook for Systematic Reviews of Interventions (version 5.1.0). 8.5 the cochrane Collaboration’s tool for assessing risk of bias. https://handbook-5-1.cochrane.org/chapter_8/table_8_5_a_the_cochrane_collaborations_tool_for_assessing.htm
   Google Scholar
• Ferrarotto R, Anderson I, Medgyasszay B, et al. Trilaciclib prior to chemotherapy reduces the usage of supportive care interventions for chemotherapy-induced myelosuppression in patients with small cell lung cancer: pooled analysis of three randomized phase 2 trials. Cancer Med. 2021;10(17):5748–5756. doi: 10.1002/cam4.4089
   PubMed Web of Science ®Google Scholar
• 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. doi: 10.1093/annonc/mdz278
   PubMed Web of Science ®Google Scholar
• Initial results from phase 2 trial demonstrate potential of trilaciclib to reduce adverse events related to an antibody drug conjugate (ADC). News Release. G1 Therapeutics, Inc. Nov 2, 2022. [cited 2023 Jul 7]. Available from: http://bit.ly/3DUA6rO
   Google Scholar
• TRODELVY. Prescribing information. 2020. [cited 2023 Jul 11]. Available from: https://trodelvy.com/pdf/PrescribingInformation.pdf
   Google Scholar
• Antiemesis NCCN clinical practice guidelines in Oncology (NCCN guidelines®) version 22023. [cited 2023 7].
   Google Scholar
• Fujii H, Hirata T, Mura T, et al. Risk factors and prophylaxis of irinotecan induced cholinergic syndrome in sight of supportive care. J Clin Oncol. 2017;35(31_suppl):216. doi: 10.1200/JCO.2017.35.31_suppl.216
   Web of Science ®Google Scholar
• Nangia J, Wang T, Osborne C, et al. Effect of a scalp cooling device on alopecia in women undergoing chemotherapy for breast cancer: the SCALP randomized Clinical trial. JAMA. 2017;317(6):596–605. doi: 10.1001/jama.2016.20939
   PubMed Web of Science ®Google Scholar
• Tolaney SM, DeMichele A, Takano T, et al. ASCENT-05/OptimICE-RD (AFT-65): phase 3, randomized, open-label study of adjuvant sacituzumab govitecan (SG) + pembrolizumab (pembro) vs pembro ± capecitabine (cape) in patients (pts) with triple-negative breast cancer (TNBC) and residual disease after neoadjuvant therapy (NAT) and surgery. J Clin Oncol. 2023;41(16_suppl):TPS619–TPS.
   Web of Science ®Google Scholar
• Bardia A, Punie K, Barrios CH, et al. 275TiP ASCENT-03: phase III study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in first-line (1L) metastatic triple-negative breast cancer (mTNBC). Ann Oncol. 2022;33:S663–S4. doi: 10.1016/j.annonc.2022.07.1859
   Web of Science ®Google Scholar