Background and Aims

We determined the incremental predictive value of pancreatic cyst fluid molecular analysis to assessing malignancy risk over long-term follow-up of a well-characterized cohort, given the underlying predictive value of imaging parameters routinely used to triage such patients.

Methods

Patients who lacked initial cytologic malignancy in cyst fluid and had final pathology or a follow-up period of more than 2 years were included. Patient outcomes determined the malignancy-free survival of patients with high-risk stigmata (HRS), worrisome features (WFs), and DNA abnormalities. DNA analysis included 3 abnormalities: loss of heterozygosity mutations among a panel of tumor suppressor genes, Kras mutation, and elevated DNA quantity.

Results

Included were 478 patients; 209 had surgical pathology–derived outcomes and 269 had clinical follow-up of >2 years. Eleven percent had malignant outcome. Forty-two patients had HRS, 272 lacked both HRS and WFs, and 164 lacked HRS but had WFs. DNA abnormalities did not statistically change long-term malignancy risk in patients with HRS or in patients lacking both HRS and WFs. Among patients with WFs, the presence of ≥2 DNA abnormalities significantly increased malignancy risk (relative risk, 5.2; P = .002) and the absence of all DNA abnormalities significantly decreased risk (relative risk, .4; P = .040). Sensitivity analysis confirmed results of survival analysis over differing baseline malignancy probabilities.

Conclusions

Our study defines the clinical characteristic of patients in which DNA abnormality testing has the greatest impact on patient outcomes. Use of DNA abnormality testing is supported in a carefully selected patient population limited to cysts with WFs.

中文翻译：

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按临床危险因素分层分析胰腺囊肿中DNA分析的增量价值

背景和目标

考虑到常规用于对这类患者进行分类的成像参数的潜在预测价值，我们确定了胰腺囊肿分子分析在评估长期随访的恶性肿瘤风险方面的递增预测价值。

方法

囊性液体缺乏初始细胞学恶性肿瘤并具有最终病理或随访期超过2年的患者也包括在内。患者的预后决定了具有高风险柱头（HRS），令人担忧的特征（WFs）和DNA异常的患者的无恶性生存率。DNA分析包括3个异常：一组肿瘤抑制基因之间的杂合突变丢失，K ras突变和DNA含量升高。

结果

其中包括478例患者。209例来自手术病理学结果，而269例进行了2年以上的临床随访。11％的患者有恶性结局。42名患有HRS的患者，其中272名既缺乏HRS和WF，又有164名缺乏HRS但具有WF。在患有HRS的患者或同时缺乏HRS和WF的患者中，DNA异常在统计学上不会改变长期恶性肿瘤的风险。在WF患者中，≥2个DNA异常的存在显着增加了恶性肿瘤风险（相对风险，5.2；P  = .002），而没有所有DNA异常均显着降低了风险（相对风险，.4；P  = .040）。敏感性分析证实了不同基线恶性肿瘤可能性的生存分析结果。

结论

我们的研究确定了患者的临床特征，其中DNA异常检测对患者的预后影响最大。DNA异常测试的使用在经过仔细选择的仅限于WF囊肿的患者人群中得到支持。