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索拉非尼作为原发性肝细胞癌患者的一线治疗:结局评估。

Sorafenib as first-line treatment for patients with primary hepatocellular carcinoma: an outcome evaluation.

机构信息

Department of On-demand GI Medical Oncology, Hanoi Oncology Hospital, Hanoi, Vietnam.

出版信息

J Int Med Res. 2023 Jun;51(6):3000605231179928. doi: 10.1177/03000605231179928.

Abstract

OBJECTIVE

To evaluate the clinical outcomes following first-line treatment with sorafenib in patients with primary hepatocellular carcinoma (HCC).

METHODS

This retrospective cohort study enrolled patients with primary HCC that had been treated with sorafenib. Their data were collected from the hospital medical records database at three time-points: after three cycles, after six cycles and at the end of the sorafenib treatment regimen. The starting dose was 800 mg/day sorafenib but this could be reduced to 600 mg/day or 400 mg/day if patients developed adverse events (AEs).

RESULTS

A total of 98 patients participated in the study. Of these, nine (9.2%) had a partial response, 47 patients (48.0%) had stable disease and 42 patients (42.9%) had progressive disease. The overall disease control rate was 57.1% (56 of 98 patients). Median progression-free survival for the overall cohort was 4.7 months. The most common AEs were hand-foot skin reaction (49 of 98 patients; 50.0%), fatigue (41 of 98 patients; 41.8%), appetite loss (39 of 98 patients; 39.8%) and hepatotoxicity/transaminitis (24 of 98 patients; 24.5%). The majority of the AEs were toxicity grades 1 and 2.

CONCLUSION

Sorafenib as a first-line treatment for primary HCC patients provided survival benefits and the AEs were well tolerated by patients.

摘要

目的

评估索拉非尼一线治疗原发性肝细胞癌(HCC)患者的临床结局。

方法

这是一项回顾性队列研究,纳入了接受索拉非尼治疗的原发性 HCC 患者。他们的数据是从医院的病历数据库中收集的,在三个时间点进行收集:三个疗程后、六个疗程后和索拉非尼治疗方案结束时。起始剂量为 800mg/天的索拉非尼,但如果患者出现不良反应(AE),剂量可减少至 600mg/天或 400mg/天。

结果

共有 98 名患者参与了这项研究。其中,9 名(9.2%)患者有部分缓解,47 名(48.0%)患者病情稳定,42 名(42.9%)患者病情进展。总疾病控制率为 57.1%(98 例中有 56 例)。全队列的中位无进展生存期为 4.7 个月。最常见的不良反应是手足皮肤反应(98 例中有 49 例;50.0%)、乏力(98 例中有 41 例;41.8%)、食欲下降(98 例中有 39 例;39.8%)和肝毒性/转氨酸升高(98 例中有 24 例;24.5%)。大多数不良反应为 1 级和 2 级毒性。

结论

索拉非尼作为原发性 HCC 患者的一线治疗药物提供了生存获益,且患者能够耐受不良反应。

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