一项IIb期随机安慰剂对照试验，测试MAG-EPA长链omega-3脂肪酸膳食补充剂对前列腺癌增殖的影响。
A phase IIb randomized placebo-controlled trial testing the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation.
作者信息
Robitaille Karine, Guertin Marie-Hélène, Jamshidi Afshin, Xu Hui Wen, Hovington Hélène, Pelletier Jean-François, Beaudoin Lisanne, Gevariya Nikunj, Lacombe Louis, Tiguert Rabi, Caumartin Yves, Dujardin Thierry, Toren Paul, Lodde Michele, Racine Étienne, Trudel Dominique, Perigny Martine, Duchesne Thierry, Savard Josée, Julien Pierre, Fradet Yves, Fradet Vincent
机构信息
CHU de Québec-Université Laval Research Center, Québec, QC, G1R 3S1, Canada.
Centre de recherche sur le Cancer de l'Université Laval, Québec, QC, G1R 3S3, Canada.
出版信息
Commun Med (Lond). 2024 Mar 22;4(1):56. doi: 10.1038/s43856-024-00456-4.
BACKGROUND
High prostate eicosapentaenoic fatty acid (EPA) levels were associated with a significant reduction of upgrading to grade group (GG) ≥ 2 prostate cancer in men under active surveillance. We aimed to evaluate the effect of MAG-EPA long-chain omega-3 fatty acid dietary supplement on prostate cancer proliferation.
METHODS
A phase II double-blind randomized placebo-controlled trial was conducted in 130 men diagnosed with GG ≥ 2 prostate cancer and undergoing radical prostatectomy between 2015-2017 (Clinicaltrials.gov: NCT02333435). Participants were randomized to receive 3 g daily of either MAG-EPA (n = 65) or placebo (n = 65) for 7 weeks (range 4-10) prior to radical prostatectomy. The primary outcome was the cancer proliferation index quantified by automated image analysis of tumor nuclear Ki-67 expression using standardized prostatectomy tissue microarrays. Additional planned outcomes at surgery are reported including plasma levels of 27 inflammatory cytokines and fatty acid profiles in circulating red blood cells membranes and prostate tissue.
RESULTS
Cancer proliferation index measured by Ki-67 expression was not statistically different between the intervention (3.10%) and placebo (2.85%) groups (p = 0.64). In the per protocol analyses, the adjusted estimated effect of MAG-EPA was greater but remained non-significant. Secondary outcome was the changes in plasma levels of 27 cytokines, of which only IL-7 was higher in MAG-EPA group compared to placebo (p = 0.026). Men randomized to MAG-EPA prior to surgery had four-fold higher EPA levels in prostate tissue compared to those on placebo.
CONCLUSIONS
This MAG-EPA intervention did not affect the primary outcome of prostate cancer proliferation according to nuclear Ki-67 expression. More studies are needed to decipher the effects of long-chain omega-3 fatty acid dietary supplementation in men with prostate cancer.
背景
在接受主动监测的男性中，前列腺中高含量的二十碳五烯酸（EPA）与升级为≥2级前列腺癌的显著减少相关。我们旨在评估MAG-EPA长链ω-3脂肪酸膳食补充剂对前列腺癌增殖的影响。
方法
在2015年至2017年间，对130名被诊断为≥2级前列腺癌且正在接受根治性前列腺切除术的男性进行了一项II期双盲随机安慰剂对照试验（Clinicaltrials.gov：NCT02333435）。参与者被随机分为两组，在根治性前列腺切除术之前的7周（4 - 10周）内，每天分别服用3克MAG-EPA（n = 65）或安慰剂（n = 65）。主要结局是通过使用标准化前列腺切除组织微阵列对肿瘤细胞核Ki-67表达进行自动图像分析来量化癌症增殖指数。报告了手术时的其他计划结局，包括27种炎性细胞因子的血浆水平以及循环红细胞膜和前列腺组织中的脂肪酸谱。
结果
通过Ki-67表达测量的癌症增殖指数在干预组（3.10%）和安慰剂组（2.85%）之间无统计学差异（p = 0.64）。在符合方案分析中，MAG-EPA的调整后估计效应更大，但仍无统计学意义。次要结局是27种细胞因子血浆水平的变化，其中与安慰剂相比，MAG-EPA组中只有IL-7水平更高（p = 0.026）。术前随机分配到MAG-EPA组的男性前列腺组织中的EPA水平是服用安慰剂组的四倍。
结论
根据细胞核Ki-67表达，这种MAG-EPA干预并未影响前列腺癌增殖的主要结局。需要更多研究来解读长链ω-3脂肪酸膳食补充剂对前列腺癌男性的影响。
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