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一线化疗治疗晚期胃癌的最佳持续时间:AGAMENON 登记研究的数据。

Optimal duration of first-line chemotherapy for advanced gastric cancer: data from the AGAMENON registry.

机构信息

Medical Oncology Department, Complejo Hospitalario de Navarra (CHN), OncobionaTras Unit, Navarrabiomed, Navarrabiomed Biomedical Center, IdiSNA, Irunlarrea 3, 31008, Pamplona, Navarra, Spain.

Hematology and Medical Oncology Department, Hospital Universitario Morales Meseguer, University of Murcia, IMIB, Murcia, Spain.

出版信息

Clin Transl Oncol. 2020 May;22(5):734-750. doi: 10.1007/s12094-019-02183-y. Epub 2019 Aug 5.

Abstract

BACKGROUND

The optimal duration of first-line chemotherapy for patients with advanced gastric cancer is unknown. Diverse clinical trials have proposed different strategies including limited treatment, maintenance of some drugs, or treatment until progression.

METHOD

The sample comprises patients from the AGAMENON multicenter registry without progression after second evaluation of response. The objective was to explore the optimal duration of first-line chemotherapy. A frailty multi-state model was conducted.

RESULTS

415 patients were divided into three strata: discontinuation of platinum and maintenance with fluoropyrimidine until progression (30%, n = 123), complete treatment withdrawal prior to progression (52%, n = 216), and full treatment until progression (18%, n = 76). The hazard of tumor progression decreased by 19% per month with the full treatment regimen. However, we found no evidence that fluoropyrimidine maintenance (hazard ratio [HR] 1.07, confidence interval [CI] 95%, 0.69-1.65) worsened progression-free survival (PFS) with respect to treatment until progression. Predictive factors for PFS were ECOG performance status, ≥ 3 metastatic sites, prior tumor response, and bone metastases. Toxicity grade 3/4 was more common in those who continued the full treatment until progression vs fluoropyrimidine maintenance (16% vs 6%).

CONCLUSION

The longer duration of the full initial regimen exerted a protective effect on the patients of this registry. Platinum discontinuation followed by fluoropyrimidine maintenance yields comparable efficacy to treatment up to PD, with a lower rate of serious adverse events.

摘要

背景

晚期胃癌患者一线化疗的最佳持续时间尚不清楚。不同的临床试验提出了不同的策略,包括有限的治疗、维持某些药物或治疗直至进展。

方法

该样本包括来自 AGAMENON 多中心登记处的患者,这些患者在第二次反应评估后没有进展。目的是探索一线化疗的最佳持续时间。进行了脆弱性多状态模型。

结果

415 名患者分为 3 个亚组:铂类药物和氟嘧啶停药直至进展(30%,n=123)、进展前完全停止治疗(52%,n=216)和直至进展的完全治疗(18%,n=76)。完全治疗方案的肿瘤进展风险每月降低 19%。然而,我们没有发现氟嘧啶维持(危险比 [HR] 1.07,95%置信区间 [CI] 0.69-1.65)相对于进展时治疗会恶化无进展生存期(PFS)的证据。PFS 的预测因素为 ECOG 表现状态、≥3 个转移部位、既往肿瘤反应和骨转移。与氟嘧啶维持相比,继续完全治疗直至进展的患者毒性 3/4 级更为常见(16%比 6%)。

结论

本研究登记处患者的初始全疗程持续时间较长,对患者有保护作用。铂类药物停药后继续氟嘧啶维持治疗与直至 PD 治疗的疗效相当,但严重不良事件发生率较低。

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