Department of Internal Medicine III with Haematology, Medical Oncology, Haemostaseology, Infectiology and Rheumatology, Oncologic Center, Paracelsus Medical University, Salzburg, Austria.
Salzburg Cancer Research Institute, Center for Clinical Cancer and Immunology Trials, Salzburg, Austria.
Cancer Med. 2023 Aug;12(16):16997-17004. doi: 10.1002/cam4.6334. Epub 2023 Aug 3.
Pancreatic cancer is mostly diagnosed in an advanced stage and treated with systemic therapy with palliative intent. Nowadays, the doublet chemotherapy of Gemcitabine and nab-paclitaxel (Gem-Nab) is one of the most frequently used regimens worldwide, but is not ubiquitarily available or reimbursed. Therefore, we compared the clinical efficacy of Gem-Nab to a historical control of patients treated with gemcitabine and oxaliplatin (Gem-Ox) at our tertiary cancer center, which was the standard treatment prior to the introduction of FOLFIRINOX.
This single-center retrospective real world study includes 121 patients diagnosed with locally advanced or primary metastatic pancreatic adenocarcinoma who were treated with chemotherapy doublet, with either Gem-Nab or Gem-Ox in palliative first-line. Survival rates were analyzed using the Kaplan-Meier method, and comparisons were made with log-rank tests. Gem-Ox was considered as standard first line therapy at our institution for patients who were deemed fit for doublet chemotherapy between the years 2006 to 2012. These patients were compared to a cohort of patients treated with the new standard first-line therapy of Gem-Nab between 2013 and 2020.
A total of 554 patients with pancreatic cancer of all stages were screened, and 73 patients treated with Gem-Nab and 48 patients treated with Gem-Ox in the palliative first-line setting were identified and included in this analysis. Patients receiving Gem-Ox had a statistically significantly better performance score (ECOG PS) when compared to the Gem-Nab group (Odds ratio (OR) 0.28, 95% CI 0.12-0.65, p = 0.005), more often suffered from locally advanced than metastatic disease (OR 3.10, 95% CI 1.27-7.91, p = 0.019) and were younger in age (OR 0.95, 95% CI 0.91-0.99, p = 0.013). Median overall survival (OS) of the whole study cohort was 10.3 months (95% CI 8.5-11.6). No statistically significant difference in OS could be observed between the Gem-Nab and the Gem-Ox cohort (median OS: 8.9 months (95% CI 6.4-13.5) versus 10.9 months (95% CI 9.5-13.87, p = 0.794, HR 1.27, 95% CI 0.85-1.91)). Median progression-free survival (PFS) was 6.8 months in the entire cohort (95% CI 4.9-8.4). No statistically significant difference in PFS could be observed between the Gem-Nab and the Gem-Ox cohort (median PFS: 5.8 months (95% CI 4.3-8.2) versus 7.9 months (95% CI 5.4-9.5) p = 0.536, HR 1.11, 95% CI 0.74-1.67). Zero-truncated negative binomial regressions on OS and PFS adjusting for gender, age, performance status (ECOG PS), and CA19-9 levels yielded no significant difference between Gem-Nab or Gem-Ox.
From our analysis, we could evidence no difference in outcome parameters in this retrospective analysis despite the worse prognostic pattern for GemOX. Therefore, we suggest Gem-Ox as potential first line treatment option for inoperable locally advanced or metastatic pancreatic cancer, especially if Gem-Nab is not available.
胰腺癌大多在晚期诊断,并采用姑息性全身治疗。如今,吉西他滨联合 nab-紫杉醇(Gem-Nab)的双联化疗是全球最常用的方案之一,但并非普遍可用或可报销。因此,我们比较了我们的三级癌症中心的 Gem-Nab 与之前引入 FOLFIRINOX 之前作为标准治疗的吉西他滨联合奥沙利铂(Gem-Ox)的历史对照患者的临床疗效。
这项单中心回顾性真实世界研究纳入了 121 名局部晚期或原发性转移性胰腺腺癌患者,他们接受了姑息性一线化疗双联治疗,采用 Gem-Nab 或 Gem-Ox。使用 Kaplan-Meier 方法分析生存率,并进行对数秩检验比较。在 2006 年至 2012 年间,我们机构认为 Gem-Ox 是适合接受双联化疗的患者的标准一线治疗。这些患者与 2013 年至 2020 年期间接受新的标准一线治疗 Gem-Nab 的患者进行了比较。
共筛选了 554 名各期胰腺癌患者,确定了 73 名接受 Gem-Nab 姑息性一线治疗和 48 名接受 Gem-Ox 姑息性一线治疗的患者,并纳入了本分析。与 Gem-Nab 组相比,接受 Gem-Ox 的患者的体能状况评分(ECOG PS)有统计学意义上的显著改善(比值比(OR)0.28,95%置信区间(CI)0.12-0.65,p=0.005),更多患有局部晚期而不是转移性疾病(OR 3.10,95%CI 1.27-7.91,p=0.019),年龄更轻(OR 0.95,95%CI 0.91-0.99,p=0.013)。整个研究队列的中位总生存期(OS)为 10.3 个月(95%CI 8.5-11.6)。在 Gem-Nab 和 Gem-Ox 队列中,OS 无统计学显著差异(中位 OS:8.9 个月(95%CI 6.4-13.5)与 10.9 个月(95%CI 9.5-13.87,p=0.794,HR 1.27,95%CI 0.85-1.91))。整个队列的中位无进展生存期(PFS)为 6.8 个月(95%CI 4.9-8.4)。在 Gem-Nab 和 Gem-Ox 队列中,PFS 无统计学显著差异(中位 PFS:5.8 个月(95%CI 4.3-8.2)与 7.9 个月(95%CI 5.4-9.5,p=0.536,HR 1.11,95%CI 0.74-1.67))。对 OS 和 PFS 进行零截断负二项回归分析,调整性别、年龄、体能状况评分(ECOG PS)和 CA19-9 水平,结果表明 Gem-Nab 或 Gem-Ox 之间没有显著差异。
尽管 Gem-Ox 的预后模式较差,但从我们的分析中,我们在回顾性分析中没有证据表明在结局参数上存在差异。因此,我们建议 Gem-Ox 作为无法手术的局部晚期或转移性胰腺癌的潜在一线治疗选择,特别是如果无法使用 Gem-Nab。