Combination of gemcitabine and nab-paclitaxel has superior clinical efficacy than gemcitabine alone. Nevertheless, health-related quality of life. (QoL) associated with this combination therapy when administered at first-line in advanced pancreatic adenocarcinoma is unknown. A total of 125 patients were randomized to combination therapy (1000 mg/m2 gemcitabine + 125 mg/m2 nab-paclitaxel) and single-agent gemcitabine (1000 mg/m2) arms to take treatment weekly for 7 of 8 weeks, and following 3 of 4 weeks, until progression or severe toxicity. Primary endpoints were three-months of definitive deterioration free percent of patients, and QoL. Overall QoL analyses showed that 34 and 58.3% of cases in gemcitabine and gemcitabine+nab-P arms had no deterioration in 3rd month QoL scores (p = 0.018). These proportions were 27.3 and 36.6% in 6th month assessments, respectively (p = 0.357). Median overall survivals in combination and single-agent arms were 9.92 months and 5.95 months, respectively (HR: 0.64, 95% CI: 0.42–0.86, p = 0.038). Median progression free survivals in these treatment arms were 6.28 and 3.22 months, respectively (HR: 0.58, 95% CI: 0.39–0.87, p = 0.008). Median time-to-deterioration were 5.36 vs 3.68 months, and objective response rates were 37.1% vs 23.7% (p = 0.009), respectively in combination and single-agent arms. Combination therapy with gemcitabine + nab-paclitaxel had better overall and progression-free survival than gemcitabine alone. Also, combination therapy showed increased response rate without toxicity or deteriorated QoL. Combination treatment with gemcitabine and nab-paclitaxel may provide significant benefit for advanced pancreatic cancer. This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).

中文翻译：

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吉西他滨+ nab-紫杉醇与单独吉西他滨治疗的局部不能切除的局部晚期或转移性胰腺癌患者的生活质量研究：AX-PANC-SY001，一项随机的2期研究

吉西他滨和纳布-紫杉醇的组合比单独使用吉西他滨具有更好的临床疗效。尽管如此，健康相关的生活质量。一线给药在晚期胰腺腺癌中与这种联合治疗相关的药物（QoL）尚不清楚。共有125位患者被随机分组​​接受联合治疗（1000 mg / m2吉西他滨+ 125 mg / m2纳布-紫杉醇）和单药吉西他滨（1000 mg / m2）组，每周进行治疗，共8周，共7周，随后3周4周，直到进展或严重毒性。主要终点指标是患者三个月的无恶化率和QoL。总体QoL分析显示，吉西他滨和吉西他滨+ nab-P组的34％和58.3％的患者在第3个月的QoL评分中没有恶化（p = 0.018）。这些比例分别为27.3和36。在第6个月的评估中分别为6％（p = 0.357）。联合用药和单药治疗组的中位总生存期分别为9.92个月和5.95个月（HR：0.64、95％CI：0.42-0.86，p = 0.038）。在这些治疗组中，无进展生存的中位数分别为6.28和3.22个月（HR：0.58，95％CI：0.39–0.87，p = 0.008）。联合用药和单药治疗组的中位恶化时间分别为5.36和3.68个月，客观缓解率分别为37.1％和23.7％（p = 0.009）。吉西他滨+纳布-紫杉醇联合治疗比单独使用吉西他滨具有更好的总体生存率和无进展生存期。同样，联合治疗显示出增加的反应率，而无毒性或QoL降低。吉西他滨和纳布紫杉醇的联合治疗可能为晚期胰腺癌提供重大益处。