Summary Plasma prolactin (PRL) and carcinoembryonic antigen (CEA) were measured by radioimmunoassay in 74 patients with adenocarcinoma of colon and rectum. The markers were correlated with disease stage, histological grade and progression/remission of disease. The circulating preoperative median PRL and CEA levels were significantly higher in colorectal cancer patients than in their respective controls. PRL was elevated in all Dukes stages and in all histological grades of the tumour whereas the rise in CEA was more pronounced in Dukes D. Out of 74 patients, 29% (21/74) developed recurrent disease and 31% (23/74) responded to the treatment. With regard to monitoring recurrence(s), the predictive value of PRL was 94% which was significantly greater than that of CEA which was only 62%. In patients who developed liver metastases PRL remained elevated whereas CEA showed more than 100-fold increase. Therefore, we feel that CEA is a better marker for monitoring patients who developed liver metastases. From our results, we suggest that PRL can be used as a better overall marker for detecting recurrence(s) in patients with colorectal adenocarcinoma.Recently, we have published data on circulating prolactin levels in patients with breast cancer (80% of these had advanced disease i.e. with stage III and IV). The data mainly concern relationship between circulating prolactin and histologic grade, estrogen-and progesterone-receptor (ER, PR) and 2 years postoperative survival (Bhatavdekar et al., 1990a). We have also found plasma prolactin useful both as an indicator of disease progression and as short-term prognosticator in patients with advanced breast cancer (Bhatavdekar et al., 1990b;1992). In light of the interesting and convincing results obtained by us in breast cancer patients, we have now tested the significance of prolactin in colorectal cancer, another common cancer in this region, by comparing simultaneously prolactin results with those of CEA.In this study therefore, we have compared the sensitivity and specificity of prolactin and CEA and thus the relative usefulness of these markers in monitoring recurrences in patients with colorectal adenocarcinomas. In addition, plasma prolactin and CEA levels were also correlated with disease stage and histologic grade. Plasma PRL and CEA were assayed using double antibody RIA kits (Diagnostic Products Co., USA). The assays were performed in duplicate with an intra-and inter-assay coefficient of variation (CV) of 3-5% and 5-8% respectively. PRL values > 15.0 ng ml-' for males, > 20.0 ng ml-' for premenopausal and > 10.0 ng ml-' for postmenopausal females were considered for % elevation. CEA levels above 5.0 ng ml-' was regarded as % elevated.Criteria for positive tests were: continual rise in the marker level after an initial fall or persistent high level of the marker as an indicator of relapse and/or no response to treatment. Statistical analysisThe statistical significance of differences between various groups was calculated by Mann-Whitney U-test. a-value
Background: Our group and others have identified a subset of ER/PR(−) breast cancers characterized by expression of the androgen receptor (AR) and androgen-dependent growth (Doane 2006). We conducted a proof-of-concept multicenter phase II study to test the efficacy of the AR-antagonist, bicalutamide for the treatment of AR(+) ER/PR(−) MBC (NCT00468715). Results of the primary endpoint, clinical benefit rate (CBR), were presented at ASCO (Gucalp 2012). Data for the impact of bicalutamide on circulating hormone levels in women are limited. Elevations in serum testosterone (T) and estradiol (E) have been observed for men treated with bicalutamide. We hypothesized comparable patterns of change in circulating endocrine markers in response to bicalutamide for women with MBC. Methods: Patients (pts) with AR(+) (IHC ≥10%), ER/PR(−) (IHC <10%) MBC were eligible for treatment (tx) if ECOG performance status ≤2 and normal organ function regardless of menopausal status. There was no limit to prior tx except prior trastuzumab required if HER2(+). Tx consisted of bicalutamide 150mg orally daily in 28-day cycles (C). Toxicity assessed q4 weeks, response q12wks. Primary endpoint was CBR. Peripheral blood was collected for total and free T, E and sex hormone binding globulin (SHBG) at baseline, start of C2 (C2) and at end of study (EOS). Standard institutional assays were used. A Wilcoxon signed-rank test was done to compare baseline to C2 and EOS values. Results: 26 patients with AR(+) ER/PR(−) MBC were treated on study. Evaluable number (n) of pts at baseline, C2 and EOS are 26, 26 and 19 respectively. Two pts remain on study. Menopausal status: pre=2, post=24. Baseline median total and free T and estradiol were consistent with expected norms, however a wide range was observed (Table). There were no significant differences observed for median free T, total T, E or SHBG between baseline and C2 or baseline and EOS. Changes in hormone levels could not be stratified by menopausal status or response to bicalutamide given small sample size. Given the wide range of baseline values, we examined the percent change for each endocrine biomarker from baseline to C2 and EOS. As shown in the Table, there was no difference in median percent change observed across time points for each biomarker. Conclusions: No discernible patterns of change in T, E or SHBG were observed in response to bicalutamide therapy when given to women for the treatment of AR(+), ER/PR(−) MBC. These circulating hormones require further evaluation for use as a pharmacodynamic marker. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P6-05-02.
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