Summary The usefulness of post-operatively serial serum CA15-3 determination with CEA and TPA was evaluated in a group of 285 breast cancer patients. In particular, the CAI 5-3 sensitivity to 'early' diagnosis and monitoring of the response to treatment of breast cancer relapses, was compared with those of the two other markers in order to'define the most suitable association. Moreover, in a group of 169 non relapsed patients with a prolonged follow-up (40±8 months; mean±s.d.) CA15-3 specificity was investigated.During post-operative follow-up in 27 (10%) patients, distant metastases occurred. In most of them, elevated values of one or more tumour markers were the first pathological sign and CA15-3, CEA and TPA sensitivity to 'early' diagnosis of metastases were 46%, 7% and 63% respectively. When each tumour marker was considered in combination, CA15-3-CEA-TPA association showed a higher sensitivity (87%) than both CA15-3-TPA (83%) and the CEA-TPA (70%). Serum CA15-3 increase preceded the certain sign of metastases 2.7 ± 2.6 months (mean ± s.d. In our previous study (Nicolini et al., 1989) we showed that their serial serum determinations with contemporaneous urinary hydroxyproline-creatinine ratio (OHP/Cr) measurement (the latter as a bone tissue marker) provide guidelines for a rational post-operative follow-up of breast cancer patients. In fact, in most patients, high values of these tumour markers were the first sign of relapse; furthermore, they are easily repeatable and harmless examinations. More recently, a new antigenic determinant defined by two monoclonal antibodies (115 D8 and DF3), has been found in blood of patients with breast cancer. Thus, an immunoradiometric assay (IRMA), has been developed with these two MAbs to measure the breast cancer associated antigen 115 D8/DF3 (CA15-3).So far, the collected data also suggest that this tumour marker is not useful for the diagnosis of the primary tumour (Gion et al., 1986;Schmidt-Rhode et al., 1987). Moreover, they indicate that this new marker correlates with the stage of disease and in metastatic patients with the response to treatment (Colomer et al., 1986;Hilkens et al., 1984;Omar et al., 1988).Nevertheless, there are insufficient data to define whether this marker is advisable for use with or in place of the more commonly used markers for the post-operative follow-up of breast cancer patients.In our Center since 1985, all breast cancer patients followed-up with CEA and TPA have also been followed with serial serum CA15-3 determinations.The prolonged period of observation and the large number of patients studied allowed us to evaluate the usefulness of serum CA15-3 measurement in 'early diagnosis' and in the monitoring of response to therapy of breast cancer relapses. Moreover, these findings were compared with those of CEA and TPA to define the most suitable association of these three tumour markers.
Materials and methods
PatientsSince June 1985 until September 1989, 285 breast cancer patients, aged 29 to 84 years, followed-up post-operatively with se...