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Background

CA15-3 is an oncofetal antigen, expressed by several carcinomas, notably breast carcinoma. It is often measured with other tumor markers.

CLINICAL UTILITY CHARACTERIZATION
BREAST CANCER  

Prognostic value in predicting overall survival of two mucinous markers: CA 15-3 and CA 125 in breast cancer patients at first relapse of disease.

Berruti A, Tampellini M, Torta M, Buniva T, Gorzegno G, Dogliotti L. Ospedale

San Luigi Gonzaga, Torino, Italy.

Eur J Cancer 1994;30A(14):2082-4 Abstract quote

The role of circulating tumour markers in providing prognostic information has been scarcely studied.

We evaluated the prognostic significance of two mucinous markers: CA 15-3 and CA 125 in 115 breast cancer patients at first recurrence of disease.

At diagnosis of advanced disease bone involvement was found in 64 patients, lung in 57, skin lymph nodes in 21, liver in 20, and brain in 5. Patients were recruited and treated in the same institution with conventional chemo- or endocrine therapy. The follow-up ranged from 3 to 54+ months (median 35). Serum samples were drawn at first recurrence of disease before the start of any endocrine and/or chemotherapy. Patients with CA 15-3 < 30 U/ml survived significantly longer than those with CA 15-3 > 30 U/ml (median 50+ versus 26 months, P < 0.02). Similarly, overall survival of patients with CA 125 < 35 U/ml was significantly higher in comparison with patients with CA 125 > 35 U/ml (median 34.5 versus 18.5 months, P < 0.001). CA 125, but not CA 15-3, maintained its prognostic value in the subgroup of patients with visceral metastases.

Both markers were found to be independent prognostic variables in multivariate analysis according to Cox's model. CA 15-3 and CA 125 appeared to be powerful prognostic indicators, in addition to visceral metastases, in patients with advanced breast cancer.

c-erbB-2 oncoprotein, CEA, and CA 15.3 in patients with breast cancer: prognostic value.

Molina R, Jo J, Filella X, Zanon G, Pahisa J, Mu noz M, Farrus B, Latre ML, Escriche C, Estape J, Ballesta AM.

Laboratory of Clinical Biochemistry, Hospital Clinic, Medical School, Barcelona, Spain.

Breast Cancer Res Treat 1998 Sep;51(2):109-19 Abstract quote

The diagnostic value of a new tumor marker, c-erbB-2, was studied in the sera of 50 healthy subjects, 58 patients with benign breast diseases, and 413 patients with breast cancer (186 locoregional, 185 with advanced disease, and 42 with no evidence of disease).

Using 15 U/ml as the cut-off, no healthy subjects or patients with benign diseases and only 2.4% of no evidence of disease patients had elevated serum levels. Abnormal c-erbB-2 levels were found in 29% (101/370) of the patients with breast carcinoma (locoregional 9%, metastases 45.4%). CEA (cut-off 5 U/ml) and CA 15.3 (cut-off 35 U/ml) sensitivity was 18% and 16% in patients with locoregional disease and 61% and 70% in those patients with advanced disease, respectively. A trend toward higher serum levels of all three tumor markers in patients with nodal involvement or greater tumor size was found, but was statistically significant only with CEA (p < 0.01). By contrast, c-erbB-2 was related to steroid receptors, in both locoregional and metastatic tumors.

When the prognostic value of these markers was evaluated, patients with abnormally high presurgical CEA and c-erbB-2 had a worse prognosis than those patients with normal values, in both node-negative (p < 0.05 and p < 0.001, respectively) and node-positive patients (p < 0.556 and p < 0.001, respectively).

By contrast, no relationship was found between CA 15.3 values and prognosis. Multivariate analysis showed that CEA and c-erbB-2 were also prognostic factors. The correlation between serum and tissue levels of c-erbB-2 was studied in the tumors of 161 patients. Significantly higher c-erbB-2 serum levels were found in patients with overexpression in tissue by immunohistochemistry, in both locoregional and advanced disease (p = 0.0001). Serum concentrations in patients with advanced disease were related to the site of recurrence, with significantly higher values in patients with metastases (mainly in those with liver metastases) than in those with locoregional recurrence.

In summary, c-erbB-2 serum levels seem to be a useful tumor marker in the prognosis of patients with breast cancer. Using all three tumor markers, sensitivity was 35% in patients with locoregional breast cancer and 88% in patients with recurrence.

Preoperative CA 15-3 concentrations predict outcome of patients with breast carcinoma.

Shering SG, Sherry F, McDermott EW, O'Higgins NJ, Duffy MJ.

Department of Surgery, University Hospital of Wales, Heath Park, Cardiff.

Cancer 1998 Dec 15;83(12):2521-7 Abstract quote

BACKGROUND: CA 15-3 is a breast-associated mucin that is elevated in the majority of breast carcinoma patients with distant metastases. Currently, the main application of this marker is in monitoring and detecting recurrences in patients with diagnosed breast carcinoma.

METHODS: Preoperative serum concentrations (prior to excision of the primary tumor) of CA 15-3 were measured in 368 patients undergoing potentially curative surgical treatment for early breast carcinoma. These results were compared with prospectively recorded clinicopathologic characteristics and patient outcome data.

RESULTS: A weak but significant positive association was found between CA 15-3 concentrations and both tumor stage and the number of involved axillary lymph nodes but not between CA 15-3 concentrations and estrogen receptor status. Patients with high concentrations of CA 15-3 had a significantly worse prognosis than patients with low concentrations. Using an optimum cutoff value of 30.38 U/mL, the probability of disease free survival at 5 years was 44% in patients with high CA 15-3 levels compared with 65% in patients with low CA 15-3 levels (P = 0.002, Mantel-Cox log rank test). The corresponding probabilities for overall survival were 67% and 83%, respectively (P < 0.001). The association of preoperative CA 15-3 levels with outcome was maintained in multivariate survival analysis and was not explained by the association between CA 15-3 and tumor size or lymph node burden. The relation between CA 15-3 and outcome also was found within some patient subgroups identified by traditional prognostic factors (axillary lymph node positive patients, patients with primary tumors >2 cm in greatest dimension, and patients with estrogen receptor positive tumors).

CONCLUSIONS: Preoperative serum concentrations of CA 15-3 appear to have a significant relation to outcome in patients with early breast carcinoma and may have a role in the rational selection of patients for appropriate adjuvant treatments. To the authors' knowledge, CA 15-3 thus is one of the first circulating markers shown to be an independent prognostic indicator in patients with breast carcinoma.

Tumour markers CEA and CA 15-3 as Prognostic factors in breast cancer--univariate and multivariate analysis.

Ebeling FC, Schmitt UM, Untch M, Nagel D, Fateh-Moghadam A, Stieber P, Seidel D.

Institute of Clinical Chemistry, Klinikum Grosshadern, Ludwig-Maximilians-University Munich, Federal Republic of Germany.

Anticancer Res 1999 Jul-Aug;19(4A):2545-50 Abstract quote

Tumour markers are putative prognostic indicators for patients with breast cancer, but have not been elevated independently by multivariate analysis in a large patient number. In 550 patients with breast cancer without known metastases the levels of the serum tumour markers CEA und CA 15-3 were determined preoperatively and during follow-up.

The prognostic relevance of these markers for recurrence (n = 128/487) and death of disease (n = 55/550) was evaluated in relation to established prognostic factors. In univariate analysis tumour size, lymph nodes, histological grading, age, hormone receptors, preoperative value of CEA (cut-off 2 ng/mL) and CA 15-3 (cut-off 25 U/mL) and their decrease of more than 33% within seven months after operation were significant for relapse. The results for death of disease were similar except for age. In multivariate analysis tumour size, lymph nodes and decrease of CEA > 33% (p < 0.001) were independent prognostic factors for recurrence.

For overall survival tumour size, lymph nodes, histological grading and preoperative levels of CEA > or = 2 ng/mL (p = 0.038) and of CA 15-3 > or = 25 U/mL (p = 0.007) were independent prognostic factors. Pre- and postoperative values of the tumour markers CEA und CA 15-3 are strong independent prognostic factors for relapse and survival in breast cancer patients.

Comparison of CEA, MCA, CA 15-3 and CA 27-29 in follow-up and monitoring therapeutic response in breast cancer patients.

Lauro S, Trasatti L, Bordin F, Lanzetta G, Bria E, Gelibter A, Reale MG, Vecchione A.

Dipartimento di Medicina Sperimentale e Patologia, Policlinico Umberto I, Universita La Sapienza, Rome, Italy.

Anticancer Res 1999 Jul-Aug;19(4C):3511-5 Abstract quote

In order to define the most useful tumor marker panel in breast cancer patients' follow-up and in monitoring treatment response, serological levels of CEA, MCA, Ca 15-3 and Ca 27-29 were evaluated in 220 patients.

180 patients had no evidence of disease (NED) after primary treatment, and 40 had metastases at first diagnosis time; in a 4 years follow-up, 30 of the NED patients relapsed, and were then included in the group of metastatic patients subjected to anticancer treatment. Overall sensitivity in metastatic patients was: CEA 40%, MCA 35%, Ca 15-3 79%, Ca 27-29 70%, with the highest percentages and mean values in liver and bone localizations. Combination of Ca 15-3 and Ca 27-29 improved sensitivity in bone lesion (85% vs 80%), in locoregional relapses only association with CEA increased sensitivity (60% vs 40%). Ca 15-3 and Ca 27-29 values increased on average 3 months before clinical diagnosis.

In treated patients there was a better correlation with a clinical course of disease for Ca 15-3 and Ca 27-29 (both 81%) as compared to the other determined markers.

C-erbB-2, CEA and CA 15.3 serum levels in the early diagnosis of recurrence of breast cancer patients.

Molina R, Jo J, Filella X, Zanon G, Farrus B, Munoz M, Latre ML, Pahisa J, Velasco M, Fernandez P, Estape J, Ballesta AM.

Laboratory of Biochemistry (Unit for Cancer Research), Hospital Clinic, School of Medicine, Barcelona, Spain.

Anticancer Res 1999 Jul-Aug;19(4A):2551-5 Abstract quote

C-erbB-2, CEA and CA 15.3 serial serum determinations were performed in 250 patients (follow-up: 1-4 years, mean 2.5 years) with primary breast cancer and no evidence of residual disease (NED) after radical treatment (radical mastectomy or simple mastectomy and radiotherapy). Ninety-five patients developed metastases during follow-up.

RESULTS: Abnormal c-erbB-2, CEA and CA 15.3 serum levels (> 20 U/ml, > 10 ng/ml or > 60 U/ml, respectively) prior to diagnosis were found in 28.4%, 31.6% and 46.3% of the 95 patients with recurrence, with a lead time of 4.2 +/- 2.4, 5.0 +/- 2.5 and 4.6 +/- 2.7 months, respectively. One of the tumor markers was the first sign of recurrence in 69.5% of the patients. Tumor marker specificity was 100% with levels lower than the cut-point in all 155 patients without recurrence. Tumor marker sensitivity was clearly related to the site of recurrence, with the lowest sensitivity found in locoregional relapse and the highest in patients with liver or bone metastases. C-erbB-2 sensitivity in early diagnosis was significantly higher in patients with c-erbB-2 overexpression in tissue (10/12, 83.3%) than in those without overexpression (1/34, 2.9%) (p = 0.0001). Likewise, higher levels of both, c-erbB-2 and CA 15.3 at diagnosis of recurrence, higher sensitivity in early diagnosis of relapse and a higher lead time were found in PgR+ patients (CA 15.3) or in PgR- patients (C-erbB-2) (p < 0.015).

In conclusion, tumor markers are useful tools for the early diagnosis of metastases, being the first sign of recurrence in 69.5% of patients with relapse (76.3% in patients with metastases).

The prognostic value of the tumor marker CA 15-3 at initial diagnosis of patients with breast cancer.

McLaughlin R, McGrath J, Grimes H, Given HF.

National Breast Cancer Research Institute, University College Hospital Galway, Ireland.

Int J Biol Markers 2000 Oct-Dec;15(4):340-2 Abstract quote

CA 15-3 has been most widely used as a serum tumor marker in follow-up and detection of breast cancer recurrence. In this study we have specifically focused upon the prognostic implications and utility of preoperative CA 15-3 levels. We have identified on our database 414 patients with breast cancer in whom serial levels of the serum tumor marker CA 15-3 had been determined at diagnosis and follow-up.

We have analyzed the follow-up and clinical outcomes in these patients and from this data we have assessed the potential of CA 15-3 as a predictor of five-year overall and disease-free survival. Our results show that an initially elevated CA 15-3 level is associated with a very poor prognosis in both early and late stage disease. Elevated pre-biopsy CA 15-3 levels are associated with 14% five-year disease-free survival rates and 17% overall survival rates at five years. In contrast, normal CA 15-3 levels are associated with 47% five-year disease-free survival rates and 54% overall survival rates at five years (p<0.01).

Comparison of five-year survival rates between patients with elevated and normal CA 15-3 levels in early breast cancer (stage I and II) also showed significant differences, with survival being 41% and 75%, respectively (p<0.01).

Preoperative values of CA 15-3 and CEA as prognostic factors in breast cancer: a multivariate analysis.

Canizares F, Sola J, Perez M, Tovar I, De Las Heras M, Salinas J, Penafiel R, Martinez P.

Department of Clinical Chemistry, University Hospital Virgen de la Arrixaca, Murcia, Spain.

Tumour Biol 2001 Sep-Oct;22(5):273-81 Abstract quote

The role of circulating tumor markers in providing prognostic information has not been widely studied. In the current study, serum levels of the carbohydrate antigen 15-3 (CA 15-3) and carcinoembryonic antigen (CEA) were determined preoperatively in 364 breast cancer patients with no clinical signs of metastasis.

The prognostic relevance of these markers for recurrence (175/364) and death of disease (104/175) was determined by Cox multivariate analysis, including the comparison with classical prognostic factors. High levels of both tumor markers were associated with aneuploid tumors with high S-phase fraction and high ornithine decarboxylase activity. CA 15-3 was highly associated with the number of positive lymph nodes and peritumoral lymphatic or blood vessel invasion. No significant associations were found between CEA or CA 15-3 levels and histologic grade, necrosis and steroid receptor status.

In univariate analysis, preoperative values, using optimum cutoff values of CA 15-3 (40 U/ml) and CEA (6 ng/ml), were statistically significant for relapse-free survival and overall survival.

In multivariate analysis, only node status, DNA ploidy and ornithine decarboxylase activity were independent predictors for relapse-free survival; the estrogen receptor status was a predictor of overall survival. In node-negative patients, ornithine decarboxylase activity was the only factor selected for relapse-free survival.

In node-positive patients, the number of lymph nodes and DNA ploidy were the only variables selected for relapse-free survival or overall survival. Estrogen receptor and ornithine decarboxylase activity were excluded for relapse-free survival, but were significant prognostic factors for overall survival.



Prognostic role of serum CA15.3 in 362 node-negative breast cancers. An old player for a new game.

Gion M, Boracchi P, Dittadi R, Biganzoli E, Peloso L, Mione R, Gatti C, Paccagnella A, Marubini E.

Centro Regionale per lo Studio degli Indicatori Biochimici di Tumore, Ospedale Civile, ULSS12 Venice, Italy.

Eur J Cancer 2002 Jun;38(9):1181-8 Abstract quote

The aims of the present investigation were to evaluate the association between serum CA15.3 levels and other biological and clinical variables and its prognostic role in patients with node-negative breast cancer.

We evaluated 362 patients operated upon primary breast cancer from 1982 to 1992 (median follow-up 69 months). Serum CA15.3 was measured by an immunoradiometric assay. The association between variables was investigated by a Principal Component Analysis (PCA) and the prognostic role of CA15.3 on relapse-free survival (RFS) was investigated by Cox regression models adjusting for age, oestrogen receptor (ER), tumour stage, and ER x age interaction, with both the likelihood ratio test and Harrell's c statistic. The prognostic contribution of CA 15.3 was highly significant. Log relative hazard of relapse was constant until approximately 10 (U/ml) of CA15.3 and increased thereafter with increasing marker levels. CA15.3 showed a significant contribution using as a cut-off point a value of 31 U/ml. However, the contribution to the model of the marker as a continuous variable is much greater.

From these findings, we can conclude that: (i) CA15.3 is a prognostic marker in node-negative breast cancer; (ii) its relationship with prognosis is continuous, with the risk of relapse increasing progressively from approximately 10 U/ml.


Serum tumor marker CA 15.3 and stage are the two most powerful predictors of survival in primary breast cancer.

Kumpulainen EJ, Keskikuru RJ, Johansson RT.

Department of Oncology, Kuopio University Hospital, Finland

Breast Cancer Res Treat 2002 Nov;76(2):95-102 Abstract quote

The purpose of this prospective study was to evaluate the usefulness of tumor marker CA 15.3 determined at the time of primary diagnosis as a prognostic factor in breast cancer. The power of CA 15.3 to predict survival was compared to established prognostic markers, namely stage, grade, receptor status, and histological subtype.

CA 15.3 was abnormal (> or = 30U/ml) in 31 (11%) of the 272 patients. During the median follow-up of 9.8 years, 83 (31%) of the patients died of breast cancer. The disease-specific survival at 5 years were 86 and 45% with normal and abnormal CA 15.3 values, respectively (p < 0.00005).

When using univariate analysis, tumor size, nodal status, M status, stage, tumor grade, and CA 15.3 were significantly related to patient outcome. In the regression analysis, stage (p = 0.00023) and CA 15.3 (p = 0.00006) were prognostic factors for survival. These results indicate that CA 15.3 can predict survival in primary breast cancer.

OVARY  


Ovarian thecoma associated with a large quantity of ascites and elevated serum ca 125 and ca 15-3.

Renaud MC, Plante M, Roy M.

Gynaecologic Oncology Service, L'Hotel-Dieu de Quebec, Centre Hospitalier Universitaire de Quebec, Laval University, Quebec City, QC, Canada.

J Obstet Gynaecol Can 2002 Dec;24(12):963-5 Abstract quote

BACKGROUND: Elevation of tumour marker CA (cancer antigen) 125 associated with Meigs' or atypical Meigs' syndrome is widely recognized. Other tumour markers are available to assist in distinguishing between benign and malignant ovarian masses in the preoperative diagnosis.

CASE PRESENTATION: A 57-year-old woman presented with a suspicious pelvic mass and abundant ascites. Preoperative tumour markers CA 125 and CA 15-3 were elevated at 1750 U/mL and 60 U/mL, respectively. The woman underwent surgery, and 9 L of straw-coloured ascites were drained along with a solid-cystic ovarian mass. The final pathology disclosed an ovarian thecoma. Six months later, both tumour markers were normal.

CONCLUSION: This first report of 2 elevated tumour markers associated with atypical Meigs' syndrome cautions us not to rely on tumour markers to differentiate benign from malignant masses.


Comparison of TPS with CEA and CA 15.3 in follow-up of Chinese breast cancer patients.

Hu XC, Day W, Jones B, Loo WT, Chow LW.

Department of Surgery, University of Hong Kong Medical Center, Queen Mary Hospital, Hong Kong.

Anticancer Res 2002 May-Jun;22(3):1865-8 Abstract quote

Serum levels of serum tissue polypeptide specific antigen (TPS) were compared with levels of carcinoembryonic antigen (CEA) and CA 15.3 with regards to their clinical values in Chinese breast cancer patients.

A total of 81 patients were recruited and followed-up prospectively for disease recurrence and death. The median of follow-up was 33.1 months. CEA and CA15.3 correlated with the prognostic factors associated with poor prognosis. CA15.3 was associated with disease-free survival and overall survival.

Multivariate analyses showed that the pre-operational serum CA15.3 level was an independent prognostic factor for disease-free survival. However, TPS was associated with neither prognostic factors nor patient survival. In conclusion, TPS is not a good serum tumor marker for breast cancer of Chinese patients, compared with CEA and CA 15.3.



Prognostic role of serum CA15.3 in 362 node-negative breast cancers. An old player for a new game.

Gion M, Boracchi P, Dittadi R, Biganzoli E, Peloso L, Mione R, Gatti C, Paccagnella A, Marubini E.

Centro Regionale per lo Studio degli Indicatori Biochimici di Tumore, Ospedale Civile, ULSS12 Venice, Italy.

Eur J Cancer 2002 Jun;38(9):1181-8 Abstract quote

The aims of the present investigation were to evaluate the association between serum CA15.3 levels and other biological and clinical variables and its prognostic role in patients with node-negative breast cancer.

We evaluated 362 patients operated upon primary breast cancer from 1982 to 1992 (median follow-up 69 months). Serum CA15.3 was measured by an immunoradiometric assay. The association between variables was investigated by a Principal Component Analysis (PCA) and the prognostic role of CA15.3 on relapse-free survival (RFS) was investigated by Cox regression models adjusting for age, oestrogen receptor (ER), tumour stage, and ER x age interaction, with both the likelihood ratio test and Harrell's c statistic. The prognostic contribution of CA 15.3 was highly significant. Log relative hazard of relapse was constant until approximately 10 (U/ml) of CA15.3 and increased thereafter with increasing marker levels. CA15.3 showed a significant contribution using as a cut-off point a value of 31 U/ml. However, the contribution to the model of the marker as a continuous variable is much greater.

From these findings, we can conclude that: (i) CA15.3 is a prognostic marker in node-negative breast cancer; (ii) its relationship with prognosis is continuous, with the risk of relapse increasing progressively from approximately 10 U/ml.


Relationship of serum HER-2/neu and serum CA 15-3 in patients with metastatic breast cancer.

Ali SM, Leitzel K, Chinchilli VM, Engle L, Demers L, Harvey HA, Carney W, Allard JW, Lipton A.

The M.S. Hershey Medical Center, PA 17033, USA.

Clin Chem 2002 Aug;48(8):1314-20 Abstract quote

BACKGROUND: Serum HER-2/neu antigen concentrations have been reported to correlate with increased tumor volume in patients with breast cancer. We measured serum CA 15-3, a surrogate marker of disease burden, and correlated serum CA 15-3 with serum HER-2/neu and analyzed the association of both markers with clinical outcomes.

METHODS: Pretreatment serum samples from 566 patients were retrospectively analyzed from 2 phase III clinical trials of estrogen receptor-positive (ER(+)), ER(-)/progesterone receptor-positive, or ER status unknown metastatic breast cancer patients randomized in two similar studies to receive second-line hormone therapy with either megestrol acetate or an aromatase inhibitor (fadrozole). The extracellular domain of the HER-2/neu (c-erbB-2) oncogene and serum CA 15-3 were measured by ELISA on the Bayer Immuno 1.

RESULTS: Serum HER-2/neu protein was increased in 168 patients (30%), and CA 15-3 was increased in 337 (60%) patients. Serum CA 15-3 and HER-2/neu were weakly correlated (r = 0.39; P <0.0001). The clinical benefit (complete responses plus partial responses plus stable disease) of endocrine therapy was significantly lower in patients with increased serum HER-2/neu. When adjusted for serum HER-2/neu, serum CA 15-3 was not predictive of response rates. The median time to progression was shorter in patients with increased serum HER-2/neu (89 days) compared with patients with normal serum HER-2/neu (176 days). Survival was significantly shorter in patients with increased serum HER-2/neu (513 vs 869 days; P <0.0001) or increased serum CA 15-3 (689 vs 939 days; P <0.0001). This observation was confirmed by multivariate analysis.

CONCLUSIONS: Serum HER-2/neu is a significant independent predictive and prognostic factor in hormone receptor-positive metastatic breast cancer, even when adjusted for tumor burden as measured by CA 15-3. The combination of increased serum HER-2/neu and increased serum CA 15-3 predicts a worse prognosis than does increased CA 15-3 alone.

 

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G-CSF induces elevation of circulating CA 15-3 in breast carcinoma patients treated in an adjuvant setting.

Briasoulis E, Andreopoulou E, Tolis CF, Bairaktari E, Katsaraki A, Dimopoulos MA, Fountzilas G, Seferiadis C, Pavlidis N.

Department of Medical Oncology, University of Ioannina, Ioannina, Greece.

Cancer 2001 Mar 1;91(5):909-17 Abstract quote

BACKGROUND: Cancer antigen 15-3 (CA 15-3), a circulating marker that determines secreted products of the polymorphic MUC1 gene, has been established as a convenient tool for monitoring breast carcinoma patients.

METHODS: The authors investigated alterations of soluble CA 15-3 in 57 postoperative breast carcinoma patients while they were receiving intensified adjuvant chemotherapy with granulocyte colony stimulating factor (G-CSF) support; 26 patients had American Joint Committee on Cancer (AJCC) Stage II, and 31 patients had AJCC Stage III breast carcinoma. Serial CA 15-3 values recorded thoughout the treatment were compared with baseline values, analyzed for correlation with hematologic and biochemical parameters, and compared with clinicopathologic characteristics and patient outcome. At a median follow-up time of 32 months, 47 of these patients remained relapse-free.

RESULTS: A twofold increase of CA 15-3 was detected at the end of the second week of treatment, remained significantly elevated in most patients at above the cutoff level of 30 U/mL throughout the treatment period (P < 0.0001), and subsided to pretreatment values 1-2 months after treatment cessation. CA 15-3 values were found to be associated strongly with absolute neutrophil count, serum lactate dehydrogenase, and alkaline phosphatase. The median values and the kinetics of tumor markers did not differ over time in regard to hormonal receptor status and disease recurrence.

CONCLUSIONS: These data provide strong evidence that G-CSF administration can induce elevation of CA 15-3 and indicate that false-positive results should be considered when evaluating CA 15-3 in patients who are receiving G-CSF. It is speculated that this phenomenon occurs through the induction of MUC1 antigen of unknown origin by G-CSF. Experimental investigation of this clinical observation is warranted.

Henry JB. Clinical Diagnosis and Management by Laboratory Methods. Twentieth Edition. WB Saunders. 2001.


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