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JGOG2046:一项针对临床诊断为 FIGO 分期 IVb 期子宫内膜癌的新辅助化疗后减瘤手术的可行性研究。

JGOG2046: a feasibility study of neoadjuvant chemotherapy followed by debulking surgery for clinically diagnosed FIGO stage IVb endometrial cancer.

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Tohoku Medical and Pharmaceutical University, 1-15-1 Fukumuro, Miyagino-Ku, Sendai, Miyagi, 983-8536, Japan.

Department of Gynecology, Aichi Cancer Center Hospital, Nagoya, Aichi, Japan.

出版信息

Int J Clin Oncol. 2023 Mar;28(3):436-444. doi: 10.1007/s10147-022-02284-9. Epub 2023 Feb 2.

DOI:10.1007/s10147-022-02284-9
PMID:36729215
Abstract

BACKGROUND

We evaluated the feasibility of neoadjuvant chemotherapy, followed by debulking surgery, for clinically diagnosed FIGO stage IVb endometrial cancer (protocol number: JGOG2046).

METHODS

The experimental treatment consisted of 3 cycles of paclitaxel (180 mg/m2) plus carboplatin (AUC5) followed by debulking surgery, including total abdominal hysterectomy, bilateral salpingo-oophorectomy, and 3 cycles of adjuvant chemotherapy. Patients were considered as eligible if they were pathologically diagnosed as primary endometrial cancer, and had both endometrial tumor and distant metastasis confirmed by imaging examinations. The primary endpoint was the incidence of patients who completed debulking surgery after the neoadjuvant chemotherapy.

RESULTS

While 51 patients were enrolled from 23 hospitals, the final study cohort consisted of 49 patients with a mean age of 59.0 years. Although the response ratio of the neoadjuvant chemotherapy was 65.3% (95% CI 50.4-78.3%), 67.3% (95% confidence interval (CI) 52.5-80.1%) underwent debulking surgery after the neoadjuvant chemotherapy and 59.2% (95% CI 45.2-71.8%) completed the protocol treatment including 3 courses of adjuvant chemotherapy. The median disease-free survival time was 9.1 months (95% CI 6.5-11.9), while the median overall survival time was 23.2 months (95% CI 11.9-27.8). A patient with sigmoid colon cancer and another with cervical cancer were included in this study.

CONCLUSIONS

Neoadjuvant chemotherapy followed by debulking surgery was a feasible and acceptable treatment for metastatic endometrial cancer. (225 words).

摘要

背景

我们评估了新辅助化疗后进行减瘤手术治疗临床诊断为 FIGO 分期 IVb 期子宫内膜癌的可行性(方案编号:JGOG2046)。

方法

实验组治疗方案包括 3 个周期紫杉醇(180mg/m2)联合卡铂(AUC5),随后进行减瘤手术,包括全子宫切除术、双侧附件切除术,以及 3 个周期的辅助化疗。如果患者病理诊断为原发性子宫内膜癌,且影像学检查证实存在子宫内膜肿瘤和远处转移,则认为符合入组条件。主要终点是新辅助化疗后完成减瘤手术的患者比例。

结果

23 家医院共入组 51 例患者,最终研究队列包括 49 例患者,平均年龄为 59.0 岁。虽然新辅助化疗的缓解率为 65.3%(95%可信区间 50.4-78.3%),但 67.3%(95%可信区间 52.5-80.1%)的患者在新辅助化疗后接受了减瘤手术,59.2%(95%可信区间 45.2-71.8%)完成了包括 3 个疗程辅助化疗的方案治疗。无疾病进展生存时间的中位数为 9.1 个月(95%可信区间 6.5-11.9),总生存时间的中位数为 23.2 个月(95%可信区间 11.9-27.8)。本研究纳入了 1 例乙状结肠癌和 1 例宫颈癌患者。

结论

新辅助化疗后进行减瘤手术是转移性子宫内膜癌一种可行且可接受的治疗方法。(225 个单词)

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