Albers Peter, Siener Roswitha, Kliesch Sabine, Weissbach Lothar, Krege Susanne, Sparwasser Christoph, Schulze Harald, Heidenreich Axel, de Riese Werner, Loy Volker, Bierhoff Erhard, Wittekind Christian, Fimmers Rolf, Hartmann Michael
Department of Urology, Bonn University, D-53105 Bonn, Germany.
J Clin Oncol. 2003 Apr 15;21(8):1505-12. doi: 10.1200/JCO.2003.07.169.
To prospectively assess potential risk factors for relapse in clinical stage I nonseminomatous germ cell tumors of the testis (CS I NSGCT).
From September 1996 to May 2002, 200 patients with CS I NSGCT were prospectively assigned to retroperitoneal lymph node dissection (RPLND), and risk factor assessment was performed within a multicenter protocol. One hundred sixty-five patients had an adequate minimum follow-up of 12 months (mean, 34.5 months) or had pathologic stage II.
Pathologic stage II disease was found in 27.9% of patients. Only 0.6% of patients relapsed in the retroperitoneum after confirmation of pathologic stage I disease. With reference pathology, vascular invasion (VI) was most predictive of stage in multifactorial analysis (accuracy, 65.1%). However, the positive predictive value (PPV) of VI to predict patients who have metastatic disease or relapse during follow-up was only 52.7%. With absent VI, low-risk patients had a negative predictive value (NPV) of 76.9%. With a combination of several risk factors, the PPV increased to 63.6% and the negative predictive value increased to 86.5%.
Even with an optimal combination of prognostic factors and reference pathology, more than one third of patients predicted to have pathologic stage II or relapse during follow-up will not harbor metastatic disease and, therefore, would be overtreated with adjuvant therapy. However, patients at low risk may be predicted at an 86.5% level, and thus, surveillance in highly compliant patients would be a valuable option. For high-risk patients, further reduction of adjuvant treatment is necessary.
前瞻性评估睾丸临床I期非精原细胞瘤性生殖细胞肿瘤(CS I NSGCT)复发的潜在风险因素。
从1996年9月至2002年5月,200例CS I NSGCT患者被前瞻性分配至腹膜后淋巴结清扫术(RPLND),并在多中心方案内进行风险因素评估。165例患者有至少12个月的充分随访(平均34.5个月)或病理分期为II期。
27.9%的患者发现有病理II期疾病。在病理I期疾病确诊后,仅0.6%的患者腹膜后复发。参照病理结果,在多因素分析中,血管侵犯(VI)对分期的预测性最强(准确率65.1%)。然而,VI预测随访期间有转移性疾病或复发患者的阳性预测值(PPV)仅为52.7%。无VI时,低风险患者的阴性预测值(NPV)为76.9%。多种风险因素联合时,PPV增至63.6%,NPV增至86.5%。
即使结合最佳的预后因素和参照病理结果,预测在随访期间有病理II期或复发的患者中,超过三分之一实际上并无转移性疾病,因此辅助治疗会导致过度治疗。然而,低风险患者的预测准确率可达86.5%,因此,对依从性高的患者进行监测将是一个有价值的选择。对于高风险患者,有必要进一步减少辅助治疗。