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伊马替尼治疗不可切除和转移性胃肠道间质瘤患者的 14 年随访结果。

Fourteen-year follow-up results of imatinib therapy in patients with unresectable and metastatic gastrointestinal stromal tumors.

机构信息

Department of Gastroenterology, Southern TOHOKU General Hospital, 7-115 Yatsuyamada, Koriyama, Fukushima, 963-8563, Japan.

Division of Digestive and General Surgery, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Niigata, Japan.

出版信息

Int J Clin Oncol. 2024 Dec;29(12):1870-1877. doi: 10.1007/s10147-024-02631-y. Epub 2024 Sep 30.

DOI:10.1007/s10147-024-02631-y
PMID:39343814
Abstract

BACKGROUND

Imatinib therapy is the gold standard for the treatment of unresectable and metastatic gastrointestinal stromal tumors (GISTs). However, few studies have reported the long-term outcomes of the treatment.

METHODS

Seventy patients who underwent imatinib therapy for unresectable and metastatic GISTs were enrolled between 2001 and 2009, and follow-up data were collected until October 2023. One hundred and sixty-eight months had passed since the final enrollment. The outcome measures were patient survival and the status of GIST and imatinib therapy. The cumulative incidence of disease progression (PD) and the chronological changes in PD hazard rate (HR) were also analyzed.

RESULTS

The 5-, 10-, 15-, and 20-year overall survival rates were 64.3%, 30.0%, 16.8%, and 12.2%, respectively. Sixty of the 70 enrolled patients died before the data cutoff date: 47 (78.3%) patients died of GIST progression while the remaining 13 (21.7%) died of diseases other than GISTs. The cumulative incidence of PD logarithmically increased, and PD continued even after 10 years of treatment. PD HR decreased over time to reach the lowest value at 9.6 years after the initiation of treatment (HR 0.00027; 95% CI 0.00007-0.00174) and after that formed a small peak at 13 years (HR 0.00144; 95% CI 0.00043-0.00436).

CONCLUSIONS

Imatinib therapy showed high clinical efficacy in terms of long-term survival in GIST patients. However, patients undergoing imatinib therapy were at continuous risk of PD even after the 10-year treatment. Long-term treatment and follow-up beyond 10 years are necessary for unresectable and metastatic GIST patients.

摘要

背景

伊马替尼治疗是不可切除和转移性胃肠道间质瘤(GIST)的金标准。然而,很少有研究报告其治疗的长期结果。

方法

2001 年至 2009 年间共纳入 70 例接受伊马替尼治疗的不可切除和转移性 GIST 患者,并收集随访数据至 2023 年 10 月。末次入组后已过去 168 个月。主要观察终点为患者生存和 GIST 及伊马替尼治疗状况。分析疾病进展(PD)的累积发生率和 PD 风险比(HR)的时间变化。

结果

5 年、10 年、15 年和 20 年的总生存率分别为 64.3%、30.0%、16.8%和 12.2%。在数据截止日期前,70 例入组患者中有 60 例死亡:47 例(78.3%)死于 GIST 进展,其余 13 例(21.7%)死于非 GIST 疾病。PD 的累积发生率呈对数增加,治疗 10 年后仍持续存在 PD。PD HR 随时间逐渐下降,在治疗开始后 9.6 年达到最低值(HR 0.00027;95%CI 0.00007-0.00174),之后在 13 年时形成一个小高峰(HR 0.00144;95%CI 0.00043-0.00436)。

结论

伊马替尼治疗可显著提高 GIST 患者的长期生存。然而,即使在治疗 10 年后,接受伊马替尼治疗的患者仍持续存在 PD 风险。对于不可切除和转移性 GIST 患者,需要长期治疗和 10 年以上的随访。

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无法切除或转移性胃肠道间质瘤患者的 10 年无进展生存和总生存:欧洲癌症研究与治疗组织、意大利肉瘤研究组和澳大拉西亚胃肠肿瘤试验组间组 3 期随机试验中伊马替尼两种剂量水平的长期分析。
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