Adjuvant nab-paclitaxel plus gemcitabine versus gemcitabine in resected pancreatic ductal adenocarcinoma: A Chinese single institution experience.

Journal of global oncology Pub Date : 2019-10-07 DOI:10.1200/jgo.2019.5.suppl.85

Z. Yin, Rong Liu

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Abstract

85 Background: Adjuvant chemotherapy with gemcitabine (GEM) is standard care for resected pancreatic ductal adenocarcinoma (PDAC). Nab-paclitaxel plus gemcitabine (AG) vs gemcitabine (GEM) have shown better survival and tumor response with in advanced or metastatic PDAC. We aimed to determine the efficacy and safety of AG compared with GEM for resected PDAC. Methods: We retrospectively reviewed resectable PDAC patients (pts) who received AG or GEM as adjuvant chemotherapy from January 2013 to December 2016 at the Chinese PLA General Hospital, Bei Jing, China. Pts received nab-paclitaxel (125mg/m2) followed by GEM (1,000 mg/m2) on days 1, 8 every 3 weeks or GEM (1,000 mg/m2) alone on days 1, 8 every 3 weeks for 6 cycles unless disease progression or there was unacceptable level of adverse events. Disease free survival (DFS), overall survival (OS) and toxicity were analyzed. Results: Among 70 pts received AG or GEM as adjuvant chemotherapy, 10 pts were excluded due to the serious complication or R2 resection. The analysis was based on 30 pts in each group undergone complete macroscopic (R0 or R1) resection. Median DFS was 15.8 months (95% CI 13.1-18.5) in AG group (6 pts not arrived) compared with 12.2 months in GEM group (95% CI 9.6-14.8, P = 0.039, 3 pts not arrived). Median OS was 28.3 months (95% CI 21.9-34.6) in AG group (11 pts not arrived) as compared with 20.6 months in GEM group (95% CI 11.2-29.9, P= 0.028, 7 pts not arrived). The 2 years survival rate was 63.3% versus 43.3% in AG group versus GEM group. The most common adverse events of grade 3 or higher were leukopenia (32.3% in AG group vs. 20.7% in GEM group, P= 0.387), neutropenia (45.2% vs.31%, P= 0.298), G-CSF use (41.9% vs. 24.1%, P= 0.177), sensory peripheral neuropathy (51.6% vs. 24.1%, P= 0.036) and fatigue (3.2% vs. 3.4%, P= 0.737). Conclusions: Our results provide the evidence that the adjuvant combination of nab-paclitaxel plus gemcitabine significantly improved DFS and OS of resected PDAC.

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nab-紫杉醇+吉西他滨与吉西他滨在胰腺导管腺癌切除术中的辅助治疗:中国单一机构的经验。

背景:吉西他滨辅助化疗(GEM)是切除胰腺导管腺癌(PDAC)的标准治疗。nab -紫杉醇加吉西他滨(AG)与吉西他滨(GEM)在晚期或转移性PDAC中显示出更好的生存和肿瘤反应。我们的目的是确定AG与GEM在切除PDAC中的疗效和安全性。方法:回顾性分析2013年1月至2016年12月在北京中国人民解放军总医院接受AG或GEM辅助化疗的可切除PDAC患者。除非疾病进展或出现不可接受的不良事件，否则患者接受nab-紫杉醇治疗(125mg/m2)，随后每3周第1、8天接受GEM治疗(1000 mg/m2)，或每3周第1、8天单独接受GEM治疗(1000 mg/m2)，持续6个周期。分析无病生存期(DFS)、总生存期(OS)和毒性。结果:70例患者接受AG或GEM辅助化疗，10例患者因并发症严重或R2切除而被排除。分析基于每组30例患者进行完全宏观(R0或R1)切除。AG组的中位DFS为15.8个月(95% CI 13.1-18.5)(6名患者未到达)，而GEM组的中位DFS为12.2个月(95% CI 9.6-14.8, P = 0.039, 3名患者未到达)。AG组的中位OS为28.3个月(95% CI 21.9-34.6)(11例未到达)，而GEM组的中位OS为20.6个月(95% CI 11.2-29.9, P= 0.028, 7例未到达)。AG组和GEM组2年生存率分别为63.3%和43.3%。3级及以上最常见的不良事件是白细胞减少(AG组32.3% vs. GEM组20.7%，P= 0.387)、中性粒细胞减少(45.2% vs.31%， P= 0.298)、G-CSF使用(41.9% vs. 24.1%， P= 0.177)、感觉周围神经病变(51.6% vs. 24.1%， P= 0.036)和疲劳(3.2% vs. 3.4%， P= 0.737)。结论:我们的研究结果提供了nab-紫杉醇联合吉西他滨辅助治疗可显著改善PDAC切除的DFS和OS的证据。

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来源期刊

Journal of global oncology ONCOLOGY-

自引率

0.00%

发文量

审稿时长

20 weeks

期刊介绍： The Journal of Global Oncology (JGO) is an online only, open access journal focused on cancer care, research and care delivery issues unique to countries and settings with limited healthcare resources. JGO aims to provide a home for high-quality literature that fulfills a growing need for content describing the array of challenges health care professionals in resource-constrained settings face. Article types include original reports, review articles, commentaries, correspondence/replies, special articles and editorials.