Long-term outcomes of neoadjuvant gemcitabine, nab-paclitaxel, and S1 (GAS) in borderline resectable pancreatic cancer with arterial contact: Results from a phase II trial

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC ACS Applied Electronic Materials Pub Date : 2023-12-29 DOI:10.1002/jhbp.1412
Kenichiro Uemura, Naru Kondo, Takeshi Sudo, Tatsuaki Sumiyoshi, Ryuta Shintakuya, Kenjiro Okada, Kenta Baba, Takumi Harada, Yoshiaki Murakami, Shinya Takahashi
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Abstract

Background/Purpose

This study reports the long-term results of a phase II trial evaluating the clinical efficacy of neoadjuvant gemcitabine, nab-paclitaxel, and S1 (GAS) in borderline resectable pancreatic cancer with arterial contact (BRPC-A).

Methods

A multicenter, single-arm, phase II trial was conducted. Patients received six cycles of GAS and patients without progressive disease were intended for R0 resection.

Results

Of the 47 patients, 45 (96%) underwent pancreatectomy. At the time of this analysis, all patients were updated with no loss to follow-up. A total of 30 patients died, while the remaining 17 patients were followed for a median of 68.1 months. The updated median overall survival (OS) was 41.0 months, with 2- and 5-year OS rates of 68.0% and 44.6%, respectively. Multivariate analysis in the preoperative model showed that a tumor diameter reduction rate ≥10% and a CA19-9 reduction rate ≥95% after neoadjuvant chemotherapy remained independently associated with favorable survival. In the postoperative multivariate model, no lymph node metastasis, no major surgical complications, and completion of adjuvant chemotherapy were independently associated with improved OS.

Conclusions

This long-term evaluation of the neoadjuvant GAS trial demonstrated the high efficacy of the regimen, suggesting that it is a promising treatment option for patients with BRPC-A.

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吉西他滨、纳布-紫杉醇和 S1(GAS)新辅助治疗动脉接触性边缘可切除胰腺癌的长期疗效:II期试验结果。
背景/目的:本研究报告了一项II期试验的长期结果,该试验评估了吉西他滨、纳布-紫杉醇和S1(GAS)新辅助治疗动脉接触性边缘可切除胰腺癌(BRPC-A)的临床疗效:进行了一项多中心、单臂 II 期试验。患者接受6个周期的GAS治疗,疾病无进展的患者拟行R0切除术:结果:47 名患者中,45 人(96%)接受了胰腺切除术。在进行分析时,所有患者的病情都得到了更新,没有失去随访机会。共有30名患者死亡,其余17名患者的随访时间中位数为68.1个月。更新后的中位总生存期(OS)为 41.0 个月,2 年和 5 年 OS 率分别为 68.0% 和 44.6%。术前模型的多变量分析显示,新辅助化疗后肿瘤直径缩小率≥10%和CA19-9缩小率≥95%仍与良好的生存率独立相关。在术后多变量模型中,无淋巴结转移、无重大手术并发症和完成辅助化疗与OS改善独立相关:结论:对新辅助 GAS 试验的长期评估表明,该方案疗效显著,是 BRPC-A 患者的理想治疗方案。
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CiteScore
7.20
自引率
4.30%
发文量
567
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