Medical Oncology Unit, Santa Chiara Hospital, Trento, Italy; Digestive Molecular Clinical Oncology Research Unit, University of Verona, Verona, Italy.
Oncology Unit, A.R.N.A.S. Civico, Palermo, Italy.
Clin Oncol (R Coll Radiol). 2024 Feb;36(2):87-97. doi: 10.1016/j.clon.2023.12.005. Epub 2023 Dec 15.
The combination of 5-fluorouracil/leucovorin (5-FU/LV) plus oxaliplatin (FOLFOX) is widely acknowledged as the standard regimen for second-line treatment in patients with advanced biliary tract cancer. Nanoliposomal irinotecan (nal-IRI) has demonstrated its activity in patients with advanced pancreatic cancer. Recent studies have investigated the activity of nal-IRI in combination with 5-FU/LV for biliary tract cancer. However, the results have been contradictory. We conducted a meta-analysis to assess survival outcomes and response rates in randomised trials investigating the activity of nal-IRI in previously treated biliary tract cancer patients.
We systematically collected potentially relevant findings from PubMed/Medline, the Cochrane library and EMBASE. Abstracts presented at major international oncological meetings were also reviewed. We extracted hazard ratios and 95% confidence intervals for progression-free survival and overall survival, as well as odds ratios and 95% confidence intervals for objective response rate. The outcomes of the accessible randomised studies evaluating the activity of nal-IRI plus 5-FU/LV were analysed.
The combination therapy exhibited a statistically significant decrease in the risk of progression (hazard ratio 0.70; 95% confidence interval 0.50-0.97) when compared with 5-FU/LV alone. Additionally, the dual regimen yielded longer overall survival and a higher objective response rate.
Our meta-analysis showed that nal-IRI plus 5-FU/LV had a superior activity in comparison with 5-FU/LV. Further investigations are required to elucidate the role of nal-IRI in this setting and to identify subgroups of patients who could derive the greatest benefit from its administration.
5-氟尿嘧啶/亚叶酸钙（5-FU/LV）联合奥沙利铂（FOLFOX）被广泛认为是晚期胆道癌二线治疗的标准方案。纳米脂质体伊立替康（nal-IRI）已在晚期胰腺癌患者中显示出其活性。最近的研究探讨了 nal-IRI 联合 5-FU/LV 治疗胆道癌的活性。然而，结果存在争议。我们进行了一项荟萃分析，以评估在先前治疗的胆道癌患者中研究 nal-IRI 活性的随机试验中的生存结果和反应率。
我们系统地从 PubMed/Medline、Cochrane 图书馆和 EMBASE 中收集潜在相关的发现。还审查了主要国际肿瘤学会议上提交的摘要。我们提取了无进展生存期和总生存期的风险比和 95%置信区间，以及客观缓解率的优势比和 95%置信区间。分析了评估 nal-IRI 加 5-FU/LV 活性的可获得随机研究的结果。
与单独使用 5-FU/LV 相比，联合治疗在降低进展风险方面具有统计学意义（风险比 0.70；95%置信区间 0.50-0.97）。此外，双重方案还延长了总生存期和客观缓解率。
我们的荟萃分析表明，nal-IRI 加 5-FU/LV 比 5-FU/LV 具有更高的活性。需要进一步研究阐明 nal-IRI 在这种情况下的作用，并确定从其给药中获益最大的患者亚组。
