EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 III期临床试验总生存期的最终分析

IF 7.6 1区医学 Q1 ONCOLOGY

European Journal of Cancer Pub Date : 2025-02-05 DOI:10.1016/j.ejca.2024.115146

Ana Oaknin , Bradley J. Monk , Andreia Cristina de Melo , Hee Seung Kim , Yong Man Kim , Alla S. Lisyanskaya , Vanessa Samouëlian , Domenica Lorusso , Fernanda Damian , Chih-Long Chang , Evgeniy Gotovkin , Shunji Takahashi , Daniella Ramone , Beata Maćkowiak-Matejczyk , Laura Polastro , Eva Maria Guerra Alia , Nicoletta Colombo , Yulia Makarova , Jeffrey C. Goh , Kosei Hasegawa , Krishnansu S. Tewari

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引用次数: 0

摘要

目的：在一线含铂化疗后复发的宫颈癌患者中，Cemiplimab的生存期明显长于医生选择的化疗。我们报告III期随机研究（EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9）的最终生存分析。方法：每3周给予头孢米单抗（n = 304）或化疗（n = 304）。主要终点是总生存期（OS）。无论患者的程序性细胞死亡-配体1 （PD-L1）状态如何，均纳入研究。结果：中位随访47.3个月（数据截止日期：2023年4月20日），接受塞米单抗和化疗的患者中位OS分别为11.7个月和8.5个月（风险比0.67,95%可信区间0.56-0.80,p）。结论：该最终分析证实，无论PD-L1表达如何，在一线铂治疗进展的复发性宫颈癌患者中，与化疗相比，塞米单抗保持了生存获益。安全性与已发表的数据一致；化疗组和西米单抗组的不良事件发生率相似。这些结果支持在复发性宫颈癌患者中使用二线头孢米单抗。

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Cemiplimab in recurrent cervical cancer: Final analysis of overall survival in the phase III EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial

Aim

Cemiplimab has demonstrated significantly longer survival than physician’s choice of chemotherapy in patients with recurrent cervical cancer after first-line platinum-containing chemotherapy. We report the final survival analysis from the phase III randomized study (EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9).

Methods

Cemiplimab (n = 304) or chemotherapy (n = 304) were administered every 3 weeks. The primary endpoint was overall survival (OS). Patients were included regardless of programmed cell death-ligand 1 (PD-L1) status.

Results

At a median follow-up of 47.3 months (data cut-off: April 20, 2023), median OS was 11.7 versus 8.5 months for patients treated with cemiplimab and chemotherapy, respectively (hazard ratio 0.67, 95 % confidence interval 0.56–0.80, p < .00001). OS benefit was seen in PD-L1 positive and negative populations, even though more patients with PD-L1 < 1 % (n = 92), had poor performance status in the cemiplimab arm than the chemotherapy arm (61.4 % vs 47.9 %).

Conclusion

This final analysis confirms that cemiplimab maintains survival benefit compared with chemotherapy in recurrent cervical cancer after progression on first-line platinum therapy, regardless of PD-L1 expression. The safety profile was consistent with published data; incidences of adverse events were similar between cemiplimab and chemotherapy groups. These results support the use of second-line cemiplimab for patients with recurrent cervical cancer.

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来源期刊

European Journal of Cancer 医学-肿瘤学

CiteScore

11.50

自引率

4.80%

发文量

953

审稿时长

23 days

期刊介绍： The European Journal of Cancer (EJC) serves as a comprehensive platform integrating preclinical, digital, translational, and clinical research across the spectrum of cancer. From epidemiology, carcinogenesis, and biology to groundbreaking innovations in cancer treatment and patient care, the journal covers a wide array of topics. We publish original research, reviews, previews, editorial comments, and correspondence, fostering dialogue and advancement in the fight against cancer. Join us in our mission to drive progress and improve outcomes in cancer research and patient care.