阿帕替尼聯合調強放射治療治療不可切除肝細胞癌患者的 2

StephenW

阿帕替尼聯合調強放射治療治療不可切除肝細胞癌患者的 2 期試驗
S Ke 1 , H Qiu 1 , J Peng 2 , Y Chen 1
隸屬關係
隸屬關係

    1
    武漢大學人民醫院腫瘤科，武漢，中國。
    2
    武漢大學中南醫院放射與腫瘤內科，武漢，中國。

    PMID：34700548 DOI：10.1016/j.ijrobp.2021.07.113

抽象的

目的/目的：評估阿帕替尼聯合調強放射治療 (IMRT) 治療的不可切除晚期肝細胞癌 (HCC) 患者的臨床結果和安全性。

材料/方法：本研究是阿帕替尼聯合 IMRT 治療不可切除晚期 HCC 患者的開放標籤、單臂、2 期臨床試驗。 2017 年 3 月至 2020 年 9 月期間，年齡在 18 至 75 歲、血液學、肝腎功能充足且 ECOG 體能狀態為 1 或更低的患者被納入研究。患者接受了 IMRT（BED：46-60Gy），並持續接受阿帕替尼 (250-500 mg/d) 口服直至疾病進展或出現不可接受的毒性作用。主要終點是無進展生存期（PFS），次要終點包括總生存期（OS）、疾病控制率（DCR）、客觀緩解率（ORR）和安全性。本報告對數據進行了分析，截止日期為 2021 年 2 月 1 日。

結果：共篩選了 46 名患者，其中 33 名參加了本研究。該隊列的中位年齡為 56.7 歲（範圍 32-77），31 人（93.9%）ECOG PS 0-1，28 人（84.85%）男性。 25 名 (75.76%) 患者患有乙型肝炎，32 名 (96.7%) 為 BCLC B-C 期，31 名 (93.9%) 為 Child-Pugh A-B，8 名 (24.2%) 有門靜脈受累。接受一線和二線或二線治療的患者分別為 21 (63.6%) 和 12 (36.4%)。在中位隨訪 11.6 個月時，中位 PFS 為 7.80 個月（95% 置信區間：3.92-11.69）。 6 個月和 12 個月的總生存率分別為 96.7% 和 66.2%。根據實體瘤 1.1 版的反應評估標準，ORR 和 DCR 分別為 15% 和 82%。有 15 例 (15.2%) 3-4 級治療相關不良事件，包括中性粒細胞減少症、血小板減少症、高血壓、蛋白尿和手足綜合徵。沒有與治療相關的死亡。

結論：阿帕替尼聯合 IMRT 在改善 PFS 和 DCR 方面是安全有效的，並表明在不可切除的晚期 HCC 患者中具有令人鼓舞的抗腫瘤活性。

版權所有 © 2021。Elsevier Inc. 出版。

StephenW

A Phase 2 Trial of Apatinib Combined With Intensity Modulated Radiation Therapy for Patients With Unresectable Hepatocellular Carcinoma
S Ke  1 , H Qiu  1 , J Peng  2 , Y Chen  1
Affiliations
Affiliations

    1
    Department of Oncology, Renmin Hospital of Wuhan University, Wuhan, China.
    2
    Department of Radiation and Medical Oncology, Zhongnan Hospital of Wuhan University, Wuhan, China.

    PMID: 34700548 DOI: 10.1016/j.ijrobp.2021.07.113

Abstract

Purpose/objective(s): To estimate the clinical outcomes and safety for patients with unresectable advanced hepatocellular carcinoma (HCC) treated with apatinib in combination with intensity modulated radiation therapy (IMRT).

Materials/methods: This study was an open-label, single-arm, phase 2 clinical trial of apatinib combined with IMRT for treatment of patients with unresectable advanced HCC. Patients aged between 18 and 75 years with adequate hematologic, liver, and renal functions, and ECOG performance status of 1 or less were included in the study between March 2017 and September 2020. Patients received IMRT (BED: 46-60Gy), and continuous apatinib (250-500 mg/d) orally until disease progression or unacceptable toxic effects. The primary end point was progression-free survival (PFS), the secondary end points included overall survival (OS), disease control rate (DCR), objective response rate (ORR) and safety. The data were analyzed for this report with cutoff on February 1, 2021.

Results: A total of 46 patients were screened and 33 were enrolled in this study. The cohort had a median age of 56.7 years (range 32-77), 31 (93.9%) were ECOG PS 0-1, 28 (84.85%) were men. 25 (75.76%) patients had hepatitis B, 32 (96.7%) were BCLC stage B-C, 31 (93.9%) were Child-Pugh A-B, and 8 (24.2%) had portal vein involvement. Receiving first-line and second- or later-line treatment were 21 (63.6%) and 12 (36.4%), respectively. At a median follow-up of 11.6 months, the median PFS was 7.80 months (95% confidence interval:3.92-11.69). The 6-month and 12-month overall survival rates were 96.7% and 66.2%, respectively. According to Response Evaluation Criteria in Solid Tumors Version 1.1, the ORR and DCR were 15% and 82%, respectively. There were 15 (15.2%) grade 3-4 treatment-related adverse events including neutropenia, thrombocytopenia, hypertension, proteinuria and hand and foot syndrome. There were no treatment-related deaths.

Conclusion: Apatinib in combination with IMRT was safe and effective in improving PFS and DCR, and suggested an encouraging anti-tumor activity in patients with unresectable advanced HCC.

Copyright © 2021. Published by Elsevier Inc.

StephenW

https://www.redjournal.org/article/S0360-3016(21)00983-4/pdf