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肝细胞癌根治性切除术后的术后辅助化疗:一项随机对照试验。

Postoperative adjuvant chemotherapy after curative resection of hepatocellular carcinoma: a randomized controlled trial.

作者信息

Lai E C, Lo C M, Fan S T, Liu C L, Wong J

机构信息

Department of Surgery, The University of Hong Kong, Queen Mary Hospital, People's Republic of China.

出版信息

Arch Surg. 1998 Feb;133(2):183-8. doi: 10.1001/archsurg.133.2.183.

DOI:10.1001/archsurg.133.2.183
PMID:9484732
Abstract

OBJECTIVE

To study the effect of adjuvant chemotherapy after curative hepatic resection in patients with hepatocellular carcinoma.

DESIGN

A randomized controlled trial.

SETTING

A tertiary referral center.

PATIENTS

During a 54-month period, 142 patients with hepatocellular carcinoma underwent hepatic resection at 1 institution. Sixty-six patients who survived the operation and had no demonstrable evidence of residual disease on ultrasonographic examination and hepatic angiographic testing at 1 month after surgery agreed to participate in the study. The median follow-up time was 28.3 months.

INTERVENTION

Thirty patients received a combination of intravenous epirubicin hydrochloride (8 doses of 40 mg/m2 each at 6-week intervals) and transarterial chemotherapy using an emulsion of iodized oil and cisplatin (3 courses with a maximum dose of 20 mL each at 2-month intervals). Thirty-six patients had no adjuvant treatment.

MAIN OUTCOME MEASURES

Recurrence rate and disease-free survival.

RESULTS

A total of 138 courses of intravenous epirubicin was given to the 30 patients. Sixty-one courses of transarterial chemotherapy were given to only 29 of the 30 patients assigned to the treatment group, because the hepatic artery in 1 patient was thrombosed. Six patients (20%) had chemotherapy-related complications with no mortality. Twenty-three of 30 patients in the treatment group and 17 of 36 patients in the control group had recurrences (P=.01). Patients who received adjuvant chemotherapy had a higher incidence of extrahepatic metastases (11 patients vs 5 patients; P=.03). The respective disease-free survival rates at 1, 2, and 3 years were 50%,36%, and 18% for the treatment group and 69%, 53%, and 48% for the control group (P=.04).

CONCLUSION

In a group of patients who underwent curative resection of hepatocellular carcinoma, postoperative adjuvant chemotherapy using the present regimen was associated with more frequent extrahepatic recurrences and a worse outcome.

摘要

目的

研究肝细胞癌患者根治性肝切除术后辅助化疗的效果。

设计

一项随机对照试验。

地点

一家三级转诊中心。

患者

在54个月期间,142例肝细胞癌患者在1家机构接受了肝切除术。66例术后存活且术后1个月超声检查和肝血管造影检查未发现残留疾病证据的患者同意参与本研究。中位随访时间为28.3个月。

干预措施

30例患者接受静脉注射盐酸表柔比星(每6周8剂,每剂40mg/m²)与经动脉化疗联合使用碘化油和顺铂乳剂(3个疗程,每2个月1次,最大剂量为每次20mL)。36例患者未接受辅助治疗。

主要观察指标

复发率和无病生存率。

结果

30例患者共接受138个疗程的静脉表柔比星化疗。30例分配到治疗组的患者中只有29例接受了61个疗程的经动脉化疗,因为1例患者的肝动脉血栓形成。6例患者(20%)出现化疗相关并发症,无死亡病例。治疗组30例患者中有23例复发,对照组36例患者中有17例复发(P=0.01)。接受辅助化疗的患者肝外转移发生率更高(11例对5例;P=0.03)。治疗组1年、2年和3年的无病生存率分别为50%、36%和18%,对照组分别为69%、53%和48%(P=0.04)。

结论

在一组接受肝细胞癌根治性切除术的患者中,使用本方案的术后辅助化疗与更频繁的肝外复发和更差的预后相关。

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