吉西他滨+白蛋白紫杉醇对比吉西他滨单药治疗不可切除局部晚期或转移性胰腺导管腺癌患者的生活质量研究：AX-PANC-SY001，一项随机 2 期研究。
Quality of life study of patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma treated with gemcitabine+nab-paclitaxel versus gemcitabine alone: AX-PANC-SY001, a randomized phase-2 study.
机构信息
Hacettepe University Faculty of Medicine, Ankara, Turkey.
Hacettepe University Cancer Institute, Ankara, Turkey.
出版信息
BMC Cancer. 2020 Mar 30;20(1):259. doi: 10.1186/s12885-020-06758-9.
BACKGROUND
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.
METHODS
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.
RESULTS
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 6 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.
CONCLUSIONS
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.
TRIAL REGISTRATION
This study has been registered in ClinicalTrials.gov as NCT03807999 on January 8, 2019 (retrospectively registered).
背景
吉西他滨联合 nab-紫杉醇的临床疗效优于单纯吉西他滨。然而，在晚期胰腺腺癌的一线治疗中，这种联合治疗相关的健康相关生活质量（QoL）尚不清楚。
方法
共 125 例患者随机分为联合治疗组（吉西他滨 1000mg/m2+ nab-紫杉醇 125mg/m2）和单药吉西他滨组（1000mg/m2），每周治疗 7 天，8 周后治疗 4 周，直至疾病进展或发生严重毒性。主要终点为 3 个月时无疾病进展的患者比例和 QoL。
结果
总体 QoL 分析显示，吉西他滨组和吉西他滨+nab-P 组第 3 个月 QoL 评分无恶化的患者分别为 34%和 58.3%（p=0.018）。在 6 个月的评估中，这些比例分别为 27.3%和 36.6%（p=0.357）。联合治疗组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）。这些治疗组的中位无进展生存期分别为 6.28 个月和 3.22 个月（HR：0.58，95%CI：0.39-0.87，p=0.008）。在无进展生存期方面，中位时间为 5.36 个月 vs 3.68 个月，客观缓解率为 37.1% vs 23.7%（p=0.009）。
结论
吉西他滨联合 nab-紫杉醇治疗晚期胰腺癌的总生存期和无进展生存期优于单纯吉西他滨。此外，联合治疗组的毒性无增加，且 QoL 未恶化，但客观缓解率更高。吉西他滨联合 nab-紫杉醇治疗可能为晚期胰腺癌患者带来显著获益。
试验注册
本研究于 2019 年 1 月 8 日在 ClinicalTrials.gov 上注册（追溯注册），注册号为 NCT03807999。
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