Agostinelli Veronica, Musacchio Lucia, Camarda Floriana, Salutari Vanda, Carbone Maria Vittoria, Ghizzoni Viola, Nero Camilla, Ricci Caterina, Perri Maria Teresa, Giudice Elena, Lardino Sara, Berardi Rossana, Scambia Giovanni, Lorusso Domenica
Oncologic Clinic, Università Politecnica delle Marche, Ancona, Italy.
Department of Woman, Child and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy.
Cancer Manag Res. 2023 Sep 27;15:1063-1072. doi: 10.2147/CMAR.S294080. eCollection 2023.
Cervical cancer is the fourth most common type of cancer in women worldwide. It is associated with a high death rate, despite the fact that it is a nearly 100% preventable disease because of very effective primary and secondary preventive strategies. Advanced and recurrent disease is uncurable with a high relapse risk and the second-line therapies are limited with modest response rates and short durability. Investigating alternative mechanisms of action is crucial because of the high request for effective new therapies. Tisotumab vedotin (TV) is the first antibody-drug conjugated to target a cell surface-expressed tissue factor, and preliminary data in patients with metastatic and recurrent cervical cancer have been promising. In addition, the trials showed a favorable tolerability profile, with limited incidence of grade 3 or worse adverse events. According to the data of ENGOT-cx6/GOG-3023/innovaTV 204, the US Food and Drug Administration granted expedited approval of TV on September 20, 2021, for women with recurrent or metastatic cervical cancer. Actually, two other trials testing TV alone or in combination with other agents are ongoing. ENGOT-cx8/GOG-3024/innovaTV 205 is a Phase Ib/II trial of TV in combination with platinum or bevacizumab or pembrolizumab, in patients with recurrent or metastatic cervical cancer who have not received prior systemic therapy or who have progressed after no more than two prior systemic therapies. ENGOT-cx12/GOG-3057/InnovaTV 301 is a Phase 3 trial of TV vs investigator's choice chemotherapy in patients with advanced or recurrent cervical cancer who had received no more than 2 prior chemotherapy lines. The outcomes of these two trials will potentially confirm and reinforce the use of TV as a new standard of care in advanced or recurrent cervical cancer.
宫颈癌是全球女性中第四大常见癌症类型。尽管由于非常有效的一级和二级预防策略，它几乎是100%可预防的疾病，但它仍与高死亡率相关。晚期和复发性疾病无法治愈，复发风险高，二线治疗有限，缓解率适中且持续时间短。由于对有效新疗法的需求很高，研究替代作用机制至关重要。替索妥单抗（Tisotumab vedotin，TV）是首个靶向细胞表面表达的组织因子的抗体药物偶联物，在转移性和复发性宫颈癌患者中的初步数据很有前景。此外，试验显示其耐受性良好，3级或更严重不良事件的发生率有限。根据ENGOT-cx6/GOG-3023/innovaTV 204的数据，美国食品药品监督管理局于2021年9月20日加速批准TV用于复发性或转移性宫颈癌女性患者。实际上，另外两项单独测试TV或与其他药物联合使用的试验正在进行中。ENGOT-cx8/GOG-3024/innovaTV 205是一项Ib/II期试验，研究TV联合铂类或贝伐单抗或帕博利珠单抗，用于未接受过先前全身治疗或在不超过两次先前全身治疗后病情进展的复发性或转移性宫颈癌患者。ENGOT-cx12/GOG-3057/InnovaTV 301是一项3期试验，比较TV与研究者选择的化疗方案，用于接受不超过2线先前化疗的晚期或复发性宫颈癌患者。这两项试验的结果可能会证实并加强TV作为晚期或复发性宫颈癌新的护理标准的应用。
