Ogawa Y, Ishikawa T, Ikeda K, Nakata B, Sawada T, Ogisawa K, Kato Y, Hirakawa K
First Department of Surgery, Osaka City University Medical School, Osaka, Japan.
Clin Cancer Res. 2000 Oct;6(10):4069-72.
The utility of serum KL-6 as a tumor marker for breast cancer was evaluated in this study. The sera from 146 patients with breast cancer, 13 with benign breast disease, and 108 healthy individuals were measured for KL-6 titer using a sandwich enzyme immunoassay method. Carcinoembryonic antigen (CEA) and carbohydrate antigen 15-3 (CA15-3) titers were also tested in the same sera from the patients. The mean KL-6 titer of patients with primary breast cancer was 673 units/ml, which was significantly higher than that of benign and healthy individuals (P = 0.037 and P < 0.0001, respectively). The titer of patients with relapsed breast cancer was 1964 units/ml, which was also higher than that of primary cancer (P = 0.013). KL-6 titer was related to tumor stage, distant metastasis, and relapse site (P = 0.0053, P < 0.0001, and P = 0.0251, respectively). Using the cutoff value of 467 units/ml, the sensitivity of KL-6 was 31% for primary breast cancer (16% for stage I and 29% for stage II) and 73% for relapsed breast cancer (50% for local relapse and 89% for distant relapse). The specificity was 92%. The sensitivity of KL-6 was higher than that of CA15-3 and CEA. Combination of the three markers, followed by KL-6 and CEA, raised the sensitivity for primary breast cancer. Single use of KL-6 demonstrated a higher sensitivity than in each combination for relapsed breast cancer. In conclusion, serum KL-6 may be helpful for clinical use as a tumor marker for breast cancer, and it may play an important role, especially in the surveillance of disease relapse.
本研究评估了血清KL-6作为乳腺癌肿瘤标志物的效用。采用夹心酶免疫测定法，对146例乳腺癌患者、13例乳腺良性疾病患者和108名健康个体的血清进行KL-6滴度检测。同时检测这些患者相同血清中的癌胚抗原（CEA）和糖类抗原15-3（CA15-3）滴度。原发性乳腺癌患者的平均KL-6滴度为673单位/毫升，显著高于良性疾病患者和健康个体（分别为P = 0.037和P < 0.0001）。复发性乳腺癌患者的滴度为1964单位/毫升，也高于原发性癌症患者（P = 0.013）。KL-6滴度与肿瘤分期、远处转移及复发部位相关（分别为P = 0.0053、P < 0.0001和P = 0.0251）。以467单位/毫升为临界值，KL-6对原发性乳腺癌的敏感性为31%（I期为16%，II期为29%），对复发性乳腺癌的敏感性为73%（局部复发为50%，远处复发为89%）。特异性为92%。KL-6的敏感性高于CA15-3和CEA。三种标志物联合使用，其次序为KL-6和CEA，可提高原发性乳腺癌的敏感性。单独使用KL-6对复发性乳腺癌的敏感性高于每种联合使用情况。总之，血清KL-6作为乳腺癌的肿瘤标志物可能有助于临床应用，尤其在疾病复发监测中可能发挥重要作用。
