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2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会在芝加哥举办。6月4日上午的消化系统（结直肠）肿瘤壁报专场上，香港中文大学的Stephen Lam Chan教授在壁报上呈现了一项摘要号为3566的研究，该试验探索了血清叶酸水平和卡培他滨毒性之间的联系，医脉通整理如下：
在卡培他滨治疗期间，毒性发生率在西方和东方患者之间存在差异，血清叶酸会引起高加索人群的较多毒性反应。研究人员开展了一项前瞻性研究用来确定中国患者卡培他滨治疗期间血清叶酸水平和毒性之间的关系。
关键纳入标准：接受卡培他滨或以卡培他滨为基础治疗的结肠癌患者。排除标准包括ECOG PS＞2；放疗或伊立替康同时给药；肌酐清除率＜30ml/min。签署同意书后，每例患者的相关数据在基线被记录，采取血清用于叶酸水平分析。患者被开始每3周的卡培他滨2500mg/m2/d D1-14单独应用或者当联合奥沙利铂时，卡培他滨2000mg/m2/d D1-14。研究人员根据CTCAE 4.0确定前4个周期的毒性。主要目标是确定血清叶酸水平和≥2级毒性发生率之间的关系。
从2013年10月到2015年9月，一共有193例患者被招募，其中136例患者符合条件。中位年龄是60岁（范围26-82）。肿瘤分期：II期（13例；9.6%）；III期（78例；57.3%）；IV期（45例；33.1%）。36例患者单纯应用卡培他滨，100例患者接受卡培他滨组合治疗。G2和G3毒性发生率分别为30.9%和12.5%。G2毒性发生率（类型）是49.3%（恶心）；11.8%（呕吐）；25.0%（腹泻）；13.2%（粘膜炎）；5.9%（色素沉着）；25.7%（手足反应）；19.1%（中性粒细胞减少）。平均血清叶酸是27.4nmol/L（范围：12.8-45.4；SD：27.4）。血清叶酸水平会引起较高的G2毒性（P=0.0043；OR=1.086），而且在调整人口统计，肾和肝功能参数后，血清叶酸水平仍然是≥G2毒性的一个独立预测因子（P=0.0186；OR=1.072）。应用75%的临界值，相比于低叶酸组，高叶酸组有更多的患者出现≥G2毒性（91.4% vs 69.3%；P=0.0183）。
综上所述，血清叶酸水平在中国人群接受卡培他滨治疗期间会引起较高的≥G2毒性发生率。进一步的研究正在计划中。（由HMRF 01120226支持）
会议专题》》》2016年ASCO年会专题报道
原文摘要：
The association between serum folate level and toxicity of capecitabine.(Abstract3566)
Authors：Stephen Lam Chan, Brigette Ma,et al
Session Type：Poster Session
Background: During capecitabine treatment, it has been suggested that the rate of toxicity differs between Western and Eastern patients (pt), and serum folate is associated with more toxicity in the Caucasian population. We conducted a prospective study to determine the association between serum folate level and toxicity during capecitabine treatment in Chinese pt.
Methods: Key inclusion criteria: colon cancer pt with a plan of capecitabine or capecitabine-based treatment. Exclusion criteria included ECOG PS > 2; concomitant administration of radiotherapy or irinotecan; creatinine clearance < 30ml/min. After consent, relevant data of each pt were documented at baseline and serum was taken for assay of folate level. Pt were started 3-weekly capecitabine 2500mg/m2/day D1-14 alone or capecitabine 2000mg/m2/day D1-14 when combined with oxaliplatin. The toxicity of the first 4 cycles was determined by investigators according to CTCAE 4.0. The primary objective was to determine the association between serum folate level and the rate of ≥ Grade 2 toxicity.
Results: Total 193 patients were recruited from Oct 2013 to Sept 2015, of which 136 of them were eligible. The median age was 60 years (Range 26-82). Tumor stage: Stage II (13; 9.6%); Stage III (78; 57.3%) and Stage IV (45; 33.1%). 36 pt had capecitabine alone and 100 pt underwent capecitabine combinational treatment. The rate of G2 andG3 toxicity was 30.9% and 12.5%, respectively. The G2 toxicity rate (type) was 49.3% (Nausea); 11.8% (Vomiting); 25.0% (diarrhea); 13.2% (mucositis); 5.9% (pigmentation); 25.7% (Hand-foot reaction); 19.1% (neutropenia). The mean serum folate was 27.4nmol/L (range: 12.8-45.4; SD: 27.4). Serum folate level was associated with more ≥ G2 toxicity (p = 0.0043; OR = 1.086) and remained an independent predictor of ≥ G2 toxicity (p = 0.0186; OR = 1.072) after adjustment with demographics, renal and liver function parameters. Using cutoff at 75thpercentile, more pts had ≥ G2 toxicity in the high folate group (91.4% vs. 69.3%; p = 0.0183) than the low folate group.
Conclusions: Serum folate level is associated with higher rate of ≥ G2 toxicity during capecitabine treatment in Chinese population. Further dietary studies are under planning. (Supported by HMRF 01120226).
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