Use of CA125 and HE4 serum markers to predict ovarian cancer in elevated-risk women.

BackgroundSerum markers are used before pelvic imaging to improve specificity and positive predictive value (PPV) of ovarian cancer multimodal screening strategies.MethodsWe conducted a randomized controlled pilot trial to estimate surgical PPV of a "2 of 3 tests positive" screening rule, and to compare use of HE4 as a first-line (Arm 1) versus a second-line (Arm 2) screen, in women at high and elevated risk for epithelial ovarian cancer (EOC) at five study sites. Semiannual screening was offered to 208 women ages 25 to 80 years with deleterious BRCA germline mutations and to 834 women ages 35 to 80 years with pedigrees suggesting inherited susceptibility. Annual screening was offered to 130 women ages 45 to 80 years (Risk Group 3) with epidemiologic and serum marker risk factors. Rising marker levels were identified using the parametric empirical Bayes algorithm.ResultsBoth strategies yielded surgical PPV above 25%. Protocol-indicated surgery was performed in 6 women, identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33% (95% confidence interval: 4%-78%), 25% in Arm 1 and 50% in Arm 2. Surgical consultation was recommended for 37 women (26 in Arm 1 and 11 in Arm 2). On the basis of 12 women with at least 2 of 3 tests positive (CA125, HE4, or imaging), an intent-to-treat analysis yielded PPV of 14% in Arm 1 and 20% in Arm 2.ConclusionsPositive screens were more frequent when HE4 was included in the primary screen.ImpactHE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen

Use of CA125 and HE4 serum markers to predict ovarian cancer in elevated-risk women.

BackgroundSerum markers are used before pelvic imaging to improve specificity and positive predictive value (PPV) of ovarian cancer multimodal screening strategies.MethodsWe conducted a randomized controlled pilot trial to estimate surgical PPV of a "2 of 3 tests positive" screening rule, and to compare use of HE4 as a first-line (Arm 1) versus a second-line (Arm 2) screen, in women at high and elevated risk for epithelial ovarian cancer (EOC) at five study sites. Semiannual screening was offered to 208 women ages 25 to 80 years with deleterious BRCA germline mutations and to 834 women ages 35 to 80 years with pedigrees suggesting inherited susceptibility. Annual screening was offered to 130 women ages 45 to 80 years (Risk Group 3) with epidemiologic and serum marker risk factors. Rising marker levels were identified using the parametric empirical Bayes algorithm.ResultsBoth strategies yielded surgical PPV above 25%. Protocol-indicated surgery was performed in 6 women, identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33% (95% confidence interval: 4%-78%), 25% in Arm 1 and 50% in Arm 2. Surgical consultation was recommended for 37 women (26 in Arm 1 and 11 in Arm 2). On the basis of 12 women with at least 2 of 3 tests positive (CA125, HE4, or imaging), an intent-to-treat analysis yielded PPV of 14% in Arm 1 and 20% in Arm 2.ConclusionsPositive screens were more frequent when HE4 was included in the primary screen.ImpactHE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen

An evaluation of labeling-then-doing with moderately handicapped persons: acquisition and generalization with complex tasks.

We conducted two experiments in which moderately mentally retarded persons were trained first to label and then to enter characters into a computer, calculator, or checkbook (label-then-do) within a multiple baseline design. In Experiment 1, 5 young adults were trained to enter statistical programs into computers in an office setting. Following training, all subjects' use of verbal labels and key-entry skills generalized across tasks (programs) and settings (offices and computer terminals). In Experiment 2, 3 junior high school students were trained with self-labeling procedures to complete a key-entry task and to balance a checkbook. The performance of all students generalized across tasks and settings, and the use of labels generalized for 2 of the students. Results are discussed relative to mediated generalization and to establishing verbal control over behavior

Use of CA125 and HE4 Serum Markers to Predict Ovarian Cancer in Elevated-Risk Women

BACKGROUND: Serum markers are used prior to pelvic imaging to improve specificity and positive predictive value (PPV) of ovarian cancer multimodal screening strategies. METHODS: We conducted a randomized controlled pilot trial to estimate surgical PPV of a “2 of 3 tests positive” screening rule, and to compare use of HE4 as a 1(st)-line (Arm 1) vs. a 2(nd)-line (Arm 2) screen, in women at high and elevated risk for EOC at five study sites. Semi-annual screening was offered to 208 women aged 25-80 with deleterious BRCA germ-line mutations, and to 834 women aged 35-80 with pedigrees suggesting inherited susceptibility. Annual screening was offered to 130 women aged 45-80 (Risk Group 3) with epidemiologic and serum marker risk factors. Rising marker levels were identified using the parametric empirical Bayes algorithm. RESULTS: Both strategies yielded surgical PPV above 25%. Protocol-indicated surgery was performed in six women, identifying two ovarian malignancies and yielding a surgical PPV in both arms combined of 33% (95% CI: 4%-78%), 25% in Arm 1 and 50% in Arm 2. Surgical consultation was recommended for 37 women (26 in Arm 1, 11 in Arm 2). Based on 12 women with at least 2 of 3 tests positive (CA125, HE4 or imaging), an intent-to-treat analysis yielded PPV of 14% in Arm 1 and 20% in Arm 2. CONCLUSIONS: Positive screens were more frequent when HE4 was included in the primary screen. Impact. HE4 may be useful as a confirmatory screen when rising CA125 is used alone as a primary screen