Identification of patients with persistent trophoblastic disease by means of a normal human chorionic gonadotropin regression curve.

OBJECTIVE: Data from the Dutch Central Registry of Hydatidiform Mole were used to establish a reference human chorionic gonadotropin regression curve after molar pregnancy. STUDY DESIGN: A normal serum human chorionic gonadotropin regression corridor was constructed after fitting data from 130 patients with uneventful human chorionic gonadotropin regression after evacuation of a complete hydatidiform mole. Retrospectively, data from 77 patients with persistent trophoblastic disease were analyzed by means of this normal corridor. Measurements were performed with a radioimmunoassay for both native and free human chorionic gonadotropin beta-subunits. RESULTS: Human chorionic gonadotropin disappearance curves showed a biphasic decline with median serum half-lives of 1.8 and 12.8 days. Median time until normalization was 74 days (range 28 to 430). With the 95th percentile line, 71 of 77 patients (92%) with persistent trophoblastic disease could be identified. In > 50% of cases this could be achieved within 6 weeks from evacuation. CONCLUSION: The normal regression corridor allows identification of patients with persistent trophoblastic disease and an expectant attitude within the limits of the corridor.

Comparison of five immunoassay procedures for the ovarian carcinoma-associated antigenic determinant CA 125 in serum.

Interassay variability in CA 125 values was studied in 77 serum samples (covering a range of CA 125 values between 8.9 and 310 arb. U/ml as measured by the original Centocor RIA) using three 125I-labeled RIA kits (Centocor, Byk and Cis) and two enzyme-labeled immunoassays (Abbott and Roche). Taking the Centocor RIA as a reference, orthogonal regression equations resulted in slopes varying between 0.74 and 1.35, with y-axis intercepts varying between -6.5 and +6.2, and correlation coefficients ranging from 0.88 to 0.94. Compared with the results of the Centocor RIA, the EIAs of Abbott and Roche gave overall lower CA 125 values, whereas the Cis and the Byk RIAs gave higher assay results. At the 35 arb. U/ml Centocor cut-off, serum levels with the other assays varied between 23 and 53 arb. U/ml. The 65 arb. U/ml cut-off level corresponded with CA 125 serum levels between 45 and 94 arb. U/ml. When classifying CA 125 values in three clinically relevant categories based on Centocor RIA results, ('normal' < or = 35 arb. U/ml, 'slightly elevated' > 35- < or = 65 arb. U/ml and 'elevated' > 65 arb. U/ml), discordances ranged from 26% with the Cis RIA to 40% utilizing the Byk RIA. The five CA 125 assays tested do not give equal assay results. As a consequence, the interpretation of CA 125 serum concentrations should be done with caution in disease monitoring and in the assessment of ovarian masses, especially when using different serum assays.

Carcinoma-associated mucin serum markers CA M26 and CA M29: efficacy in detecting and monitoring patients with cancer of the breast, colon, ovary, endometrium and cervix.

Two recently developed monoclonal antibody (MAb)-based anti-mucin assays, CA M26 and CA M29, were studied in 250 cancer patients and compared to 3 well-established marker tests, viz., CA 125, CA 15.3 and SCC, in order to assess their clinical usefulness as serum tumor markers. Pre-treatment sera were obtained from patients with predominantly low-stage epithelial malignancies comprising 200 adenocarcinomas (of the ovary, endometrium, breast and large intestine) and 50 squamous-cell carcinomas (of the uterine cervix). Pretreatment sera of 50 patients with benign ovarian tumors were included to evaluate levels in benign disease, CA M26 and CA M29 cut-off levels were established in 89 healthy controls. In patients with adenocarcinomas, overall positivity for CA M29 was 24%, ranging from 10% in breast cancer to 60% in ovarian cancer. Overall positivity was highest for CA 125 (30%) and lowest for CA M26 (18%) with CA M29 (24%) being similar to CA 15.3 (25%). In adenocarcinomas the combined CA M26-CA M29 assays equalled results obtained with the CA 125-CA 15.3 combination (33% vs. 36%). Elevation of 2 or more markers was highly indicative of advanced disease (p less than 0.025). A majority of positive patients showed either CA M26 or CA M29 elevations, indicating that both antibodies detect distinct epitopes. After adjustment for tumor site and stage, the profile of CA M26 as a single marker differed significantly from the profiles of CA 125 and of CA M29. CA M26 was frequently (32%) elevated in patients with squamous-cell carcinoma of the cervix and CA M26 levels were often independently elevated. CA M26 seems to be valuable as an additional marker in breast cancer and perhaps as a new marker in cervical cancer. CA M29 may be useful in ovarian cancer in addition to CA 125.