Department of Surgery, The University of California, Orange, CA, USA.
Ann Surg Oncol. 2010 Jul;17(7):1794-801. doi: 10.1245/s10434-010-0943-1. Epub 2010 Feb 17.
The role of carbohydrate antigen (CA) 19-9 in the evaluation of patients with resectable pancreatic cancer treated with neoadjuvant therapy prior to planned surgical resection is unknown. We evaluated CA 19-9 as a marker of therapeutic response, completion of therapy, and survival in patients enrolled on two recently reported clinical trials.
We analyzed patients with radiographically resectable adenocarcinoma of the head/uncinate process treated on two phase II trials of neoadjuvant chemoradiation. Patients without evidence of disease progression following chemoradiation underwent pancreaticoduodenectomy (PD). CA 19-9 was evaluated in patients with a normal bilirubin level.
We enrolled 174 patients, and 119 (68%) completed all therapy including PD. Pretreatment CA 19-9 <37 U/ml had a positive predictive value (PPV) for completing PD of 86% but a negative predictive value (NPV) of 33%. Among patients without evidence of disease at last follow-up, the highest pretreatment CA 19-9 was 1,125 U/ml. Restaging CA 19-9 <61 U/ml had a PPV of 93% and a NPV of 28% for completing PD among resectable patients. The area under the receiver-operating characteristics curve of pretreatment and restaging CA 19-9 levels for completing PD was 0.59 and 0.74, respectively. We identified no association between change in CA 19-9 and histopathologic response (P = 0.74).
Although the PPV of CA 19-9 for completing neoadjuvant therapy and undergoing PD was high, its clinical utility was compromised by a low NPV. Decision-making for patients with resectable PC should remain based on clinical assessment and radiographic staging.
在计划进行手术切除之前,接受新辅助治疗的可切除胰腺癌患者中,糖抗原(CA)19-9 的作用尚不清楚。我们评估了 CA 19-9 作为两种最近报道的临床试验中入组患者的治疗反应、治疗完成和生存的标志物。
我们分析了在两项新辅助放化疗的 II 期试验中接受治疗的影像学可切除的头/钩突腺癌患者。放化疗后无疾病进展证据的患者接受胰十二指肠切除术(PD)。在胆红素水平正常的患者中评估 CA 19-9。
我们共入组了 174 例患者,其中 119 例(68%)完成了包括 PD 在内的所有治疗。治疗前 CA 19-9<37 U/ml 对完成 PD 的阳性预测值(PPV)为 86%,但阴性预测值(NPV)为 33%。在最后一次随访时无疾病证据的患者中,最高的治疗前 CA 19-9 为 1125 U/ml。在可切除患者中,再分期 CA 19-9<61 U/ml 对完成 PD 的 PPV 为 93%,NPV 为 28%。治疗前和再分期 CA 19-9 水平对完成 PD 的受试者工作特征曲线下面积分别为 0.59 和 0.74。我们没有发现 CA 19-9 变化与组织病理学反应之间的关联(P=0.74)。
尽管 CA 19-9 对完成新辅助治疗和接受 PD 的 PPV 较高,但由于 NPV 较低,其临床实用性受到限制。具有可切除 PC 的患者的决策应仍然基于临床评估和影像学分期。