[The efficacy and safety of anlotinib combined with niraparib in treating patients with platinum-resistant recurrent ovarian cancer].

Publisher: Chinese Medical Association Country of Publication: China NLM ID: 7910681 Publication Model: Print Cited Medium: Print ISSN: 0253-3766 (Print) Linking ISSN: 02533766 NLM ISO Abbreviation: Zhonghua Zhong Liu Za Zhi Subsets: MEDLINE

Publication: Peking : Chinese Medical Association
Original Publication: Beijing, Zhonghua yi xue hui.

Indazoles*/adverse effects ; Indazoles*/therapeutic use ; Ovarian Neoplasms*/drug therapy ; Indoles*/adverse effects ; Indoles*/administration & dosage ; Indoles*/therapeutic use ; Drug Resistance, Neoplasm* ; Piperidines*/adverse effects ; Piperidines*/administration & dosage ; Piperidines*/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols*/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols*/adverse effects ; Quinolines*/adverse effects ; Quinolines*/therapeutic use ; Quinolines*/administration & dosage ; Neoplasm Recurrence, Local*/drug therapy; Humans ; Female ; Platinum/therapeutic use ; Progression-Free Survival ; Adult ; Middle Aged ; Aged ; BRCA1 Protein/genetics ; Poly(ADP-ribose) Polymerase Inhibitors/adverse effects ; Poly(ADP-ribose) Polymerase Inhibitors/administration & dosage ; Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use ; BRCA2 Protein/genetics

Objectives: To investigate the efficacy and safety of anlotinib combined with niraparib in treating patients with platinum-resistant ovarian cancer. Methods: Thirty-five patients with pathological confirmed platinum-resistant ovarian cancer who experienced progression after receiving at least two lines of standard treatment were eligible. All of them were treated with anlotinib combined with niraparib between September 2019 and October 2021. The primary endpoint was progression-free survival (PFS). The second endpoints included overall survival, objective response rate (ORR), disease control rate (DCR) and safety. Survival analysis was performed using the Kaplan-Meier method and Log-rank test, and influence factor analysis was performed using Cox proportional risk regression models. Results: The best overall response showed that partial response was observed in 14 patients, stable disease was noted within 13 patients, and progressive disease was found in 8 patients. Therefore, the ORR and DCR of these 35 patients were 40.0% (95% CI :22.9%-57.1%) and 77.1% (95% CI :62.9%-91.4%), respectively. The median follow-up duration was 18.9 months (6.9-32.2). The median PFS was 6.5 months (95% CI :5.35-7.66). Multivariate Cox regression analysis for PFS indicated that age, Eastern Cooperative Oncology Group performance status (ECOG PS) score, International Federation of Gynecology and Obstetrics (FIGO) stage, and BRCA mutation status were independent factors influencing PFS ( P ＜0.05). Additionally, the PFS in patients with BRCA mutation who have never received PARP inhibitor treatment was significantly longer than that in patients without BRCA mutation who have been exposed to prior PARPi treatment (15.0 vs 6.0 month, P =0.029). The most common treatment-related adverse reactions were fatigue (85.7%), hematologic toxic (85.7%) and hypertension (74.3%). There were no treatment-related deaths. Conclusion: Anlotinib combined with niraparib shows a promising efficacy and tolerable safety in platinum-resistant ROC patients.

B19087CT Bethune Medical Science Research Fund; SZ2020QN023 In-hospital Research Project of Shenzhen Hospital, Cancer Hospital of Chinese Academy of Medical Sciences

Local Abstract: [Publisher, Chinese] 目的： 探讨安罗替尼联合尼拉帕利治疗铂耐药复发卵巢癌的有效性和安全性。 方法： 选取2019年9月至2021年10月中国医学科学院肿瘤医院深圳医院收治的35例铂耐药复发卵巢癌患者，既往接受过二线及以上化疗。所有患者均给予安罗替尼联合尼拉帕利治疗，主要观察终点为无进展生存时间（PFS），次要观察指标为总生存时间（OS）、客观有效率（ORR）、疾病控制率（DCR）及安全性。生存分析采用Kaplan-Meier法和Log rank检验，影响因素分析采用Cox比例风险回归模型。 结果： 35例接受治疗的患者中，部分缓解14例，病情稳定13例，疾病进展8例，ORR为40.0%（95% CI ：22.9%～57.1%），DCR为77.1%（95% CI ：62.9%～91.4%）。中位随访时间为18.9个月（6.9～32.2个月），中位PFS为6.5个月（95% CI ：5.4～7.7个月），中位OS为18.4个月（95% CI ：16.1～20.8个月）。多因素回归分析结果提示，美国东部肿瘤协作组功能状态评分、国际妇产科联盟分期、乳腺癌易感基因（BRCA）突变是PFS的独立影响因素（均 P ＜0.05）。首次接受PARP抑制剂治疗含BRCA突变的患者PFS（15.0个月）较未接受过PARP抑制剂治疗且不含BRCA突变的患者长（6.0个月， P =0.029）。常见的治疗相关不良反应为乏力（85.7%，30/35）、骨髓抑制（85.7%，30/35）及高血压（74.3%，26/35）。 结论： 安罗替尼联合尼拉帕利治疗能延长铂耐药复发卵巢癌患者的生存时间，且安全性可控。.

HMC2H89N35 (niraparib)
0 (Indazoles)
0 (anlotinib)
0 (Indoles)
0 (Piperidines)
0 (Quinolines)
49DFR088MY (Platinum)
0 (BRCA1 Protein)
0 (Poly(ADP-ribose) Polymerase Inhibitors)
0 (BRCA2 Protein)

Date Created: 20240722 Date Completed: 20240722 Latest Revision: 20240722

20240722

10.3760/cma.j.cn112152-20231024-00224

39034805