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Phase II biomarker trial of a multimarker diagnostic for ovarian cancer.

Edgell T, Martin-Roussety G, Barker G, Autelitano DJ, Allen D, Grant P, Rice GE - J. Cancer Res. Clin. Oncol. (2010)

Bottom Line: The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01).At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

View Article: PubMed Central - PubMed

Affiliation: HealthLinx Limited, 576 Swan Street, Richmond, VIC 3121, Australia. t.edgell@healthlinx.com.au

ABSTRACT

Purpose: The primary hypothesis to be tested in this study was that the diagnostic performance (as assessed by the area under the receiver operator characteristic curve, AUC) of a multianalyte panel to correctly identify women with ovarian cancer was significantly greater than that for CA-125 alone.

Methods: A retrospective, case-control study (phase II biomarker trial) was conducted that involved 362 plasma samples obtained from women with ovarian cancer (n = 150) and healthy controls (n = 212). A multivariate classification model was developed that incorporated five biomarkers of ovarian cancer, CA-125; C-reactive protein (CRP); serum amyloid A (SAA); interleukin 6 (IL-6); and interleukin 8 (IL-8) from a modelling cohort (n = 179). The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.

Results: The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01). At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

Conclusions: The use of a panel of plasma biomarkers for the identification of women with ovarian cancer delivers a significant increase in diagnostic performance when compared to the performance of CA-125 alone.

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Related in: MedlinePlus

Association between ovarian cancer disease stage and predicted posterior probabilities. Median values are represented by horizontal lines. Control versus case comparisons (Mann–Whitney test) for all cohorts were significantly different (p < 0.01)
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Fig4: Association between ovarian cancer disease stage and predicted posterior probabilities. Median values are represented by horizontal lines. Control versus case comparisons (Mann–Whitney test) for all cohorts were significantly different (p < 0.01)

Mentions: Estimates of the sensitivity and specificity for CA-125 (at a threshold value ≥35 U/ml) and biomarker panel (at threshold values of 0.3 and 0.5) are presented in Table 6 for the validation and early stage cohorts. The relationship between ρP and disease stage is presented in Fig. 4. No significant effect of tumor type on ρP was identified (p > 0.05, Kruskal–Wallis test, data not shown).Table 6


Phase II biomarker trial of a multimarker diagnostic for ovarian cancer.

Edgell T, Martin-Roussety G, Barker G, Autelitano DJ, Allen D, Grant P, Rice GE - J. Cancer Res. Clin. Oncol. (2010)

Association between ovarian cancer disease stage and predicted posterior probabilities. Median values are represented by horizontal lines. Control versus case comparisons (Mann–Whitney test) for all cohorts were significantly different (p < 0.01)
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2874491&req=5

Fig4: Association between ovarian cancer disease stage and predicted posterior probabilities. Median values are represented by horizontal lines. Control versus case comparisons (Mann–Whitney test) for all cohorts were significantly different (p < 0.01)
Mentions: Estimates of the sensitivity and specificity for CA-125 (at a threshold value ≥35 U/ml) and biomarker panel (at threshold values of 0.3 and 0.5) are presented in Table 6 for the validation and early stage cohorts. The relationship between ρP and disease stage is presented in Fig. 4. No significant effect of tumor type on ρP was identified (p > 0.05, Kruskal–Wallis test, data not shown).Table 6

Bottom Line: The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01).At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

View Article: PubMed Central - PubMed

Affiliation: HealthLinx Limited, 576 Swan Street, Richmond, VIC 3121, Australia. t.edgell@healthlinx.com.au

ABSTRACT

Purpose: The primary hypothesis to be tested in this study was that the diagnostic performance (as assessed by the area under the receiver operator characteristic curve, AUC) of a multianalyte panel to correctly identify women with ovarian cancer was significantly greater than that for CA-125 alone.

Methods: A retrospective, case-control study (phase II biomarker trial) was conducted that involved 362 plasma samples obtained from women with ovarian cancer (n = 150) and healthy controls (n = 212). A multivariate classification model was developed that incorporated five biomarkers of ovarian cancer, CA-125; C-reactive protein (CRP); serum amyloid A (SAA); interleukin 6 (IL-6); and interleukin 8 (IL-8) from a modelling cohort (n = 179). The performance of the model was evaluated using an independent validation cohort (n = 183) and compared with of CA-125 alone.

Results: The AUC for the biomarker panel was significantly greater than the AUC for CA-125 alone for a validation cohort (p < 0.01) and an early stage disease cohort (i.e. Stages I and II; p < 0.01). At a threshold of 0.3, the sensitivity and specificity of the multianalyte panel were 94.1 and 91.3%, respectively, for the validation cohort and 92.3 and 91.3%, respectively for an early stage disease cohort.

Conclusions: The use of a panel of plasma biomarkers for the identification of women with ovarian cancer delivers a significant increase in diagnostic performance when compared to the performance of CA-125 alone.

Show MeSH
Related in: MedlinePlus