Best hope or last hope: access to phase III clinical trials of HER‐2/neu for advanced stage breast cancer patients

Strauss, Beth

doi:10.1046/j.1365-2648.2000.01302.x

Cited by 4 publications

(5 citation statements)

References 30 publications

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“…Finally, we obtained the following parameters: (1) the enhancement echogenicity (heteroenhancement or homo-enhancement); (2) the enhancement intensity (hyper-enhancement, hypo-enhancement, or iso-enhancement); (3) the enhancement shape (regular or irregular); (4) the enhancement border (well-defined or ill-defined border); (5) the enhancement size (larger than vs. equal to the US size); and (6) the crab-like sign (present or absent, defined as the nourishing vessels around the tumor). The features of hyperenhancement, enlarged, and crab-like sign in the contrast mode are related to malignant lesions, according to the findings of our earlier study and other studies (18)(19)(20). If the CEUS result was positive, the original BI-RADS score remained unchanged.…”

Section: Ceus and Analysissupporting

confidence: 64%

“…Numerous studies have concentrated on the molecular diagnosis and prognosis of breast cancer since the incidence rate and prognosis of breast diseases with different pathological types vary greatly ( 3 – 6 ). The human epidermal growth factor receptor 2 gene (Her-2) is a member of the HER family, which prevents apoptosis and promotes cell proliferation ( 7 , 8 ). Breast cancers that overexpress Her-2 are aggressive, accounting for 25% of all breast cancer cases ( 1 , 9 ).…”

Section: Introductionmentioning

confidence: 99%

“…In addition, malignancies present overlapping US features between Her-2 overexpressing cancers and other malignancies (OMs) ( 15 – 17 ). Studies have evaluated the relationships between prognosis and preoperative demographic information and serum and cancer biomarkers, but they have reported contrasting findings ( 18 , 19 ). Previous studies including our study found that the features on contrast enhanced ultrasound (CEUS) are significant tools for characterizing breast lesions ( 20 – 22 ).…”

Section: Introductionmentioning

confidence: 99%

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A nomogram based on combining clinical features and contrast enhanced ultrasound is not able to identify Her-2 over-expressing cancer from other breast cancers

et al. 2023

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ObjectiveThe aim of this study was to evaluate whether a predictive model based on a contrast enhanced ultrasound (CEUS)-based nomogram and clinical features (Clin) could differentiate Her-2-overexpressing breast cancers from other breast cancers.MethodsA total of 152 pathology-proven breast cancers including 55 Her-2-overexpressing cancers and 97 other cancers from two units that underwent preoperative CEUS examination, were included and divided into training (n = 102) and validation cohorts (n = 50). Multivariate regression analysis was utilized to identify independent indicators for developing predictive nomogram models. The area under the receiver operating characteristic (AUC) curve was also calculated to establish the diagnostic performance of different predictive models. The corresponding sensitivities and specificities of different models at the cutoff nomogram value were compared.ResultsIn the training cohort, 7 clinical features (menstruation, larger tumor size, higher CA153 level, BMI, diastolic pressure, heart rate and outer upper quarter (OUQ)) + enlargement in CEUS with P < 0.2 according to the univariate analysis were submitted to the multivariate analysis. By incorporating clinical information and enlargement on the CEUS pattern, independently significant indicators for Her-2-overexpression were used for further predictive modeling as follows: Model I, nomogram model based on clinical features (Clin); Model II, nomogram model combining enlargement (Clin + Enlargement); Model III, nomogram model based on typical clinical features combining enlargement (MC + BMI + diastolic pressure (DP) + outer upper quarter (OUQ) + Enlargement). Model II achieved an AUC value of 0.776 at nomogram cutoff score value of 190, which was higher than that of the other models in the training cohort without significant differences (all P>0.05). In the test cohort, the diagnostic efficiency of predictive model was poor (all AUC<0.6). In addition, the sensitivity and specificity were not significantly different between Models I and II (all P>0.05), in either the training or the test cohort. In addition, Clin exhibited an AUC similar to that of model III (P=0.12). Moreover, model III exhibited a higher sensitivity (70.0%) than the other models with similar AUC and specificity, only in the test cohort.ConclusionThe main finding of the study was that the predictive model based on a CEUS-based nomogram and clinical features could not differentiate Her-2-overexpressing breast cancers from other breast cancers.

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Section: Ceus and Analysissupporting

confidence: 64%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A nomogram based on combining clinical features and contrast enhanced ultrasound is not able to identify Her-2 over-expressing cancer from other breast cancers

et al. 2023

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“…Through MAPK and PI3K signaling pathways, Her-2 prevents apoptosis and promotes cell proliferation. 8,9 Her-2 overexpression leads to an aggressive form of breast cancer, 10 which comprises 25% of all breast cancer cases. 11 The Her-2 positive breast cancer patients have a lower survival rate than patients without Her-2 overexpression.…”

Section: Introductionmentioning

confidence: 99%

Comparative study of Her-2, p53, Ki-67 expression and clinicopathological characteristics of breast cancer in a cohort of northern China female patients

Zhang

et al. 2017

Bioengineered

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The objective was to study the relationship among Her-2, Ki-67, p53 expression and the clinicopathologic characteristics of breast cancer in the patients of northern China. Expression of Her-2, Ki-67, p53 and clinical characteristics of 260 breast cancer patients were retrospectively studied. Her-2 overexpression led to higher incidence rates of infiltrating ductal carcinoma and axillary lymph node metastasis, bigger diameters of the primary tumors, later pTNM staging, and a lower incidence rate of ductal carcinoma in situ (p < 0.05). High expression of ER and PR led to fewer patients classified histologically in higher grade (p D 0.001), while high expression of Ki-67 and p53 caused more patients classified histologically in higher grade (p D 0.001). In patients histologically classified in grade 1 and 2, the expression of Ki-67 and p53 was significantly (p D 0.001) higher, and the expression of ER and PR was significantly lower, in Her-2 positive patients than Her-2 negative patients. Breast cancer with Her-2 overexpression was more likely to recur and metastasize than Her-2 negative breast cancer. Higher coincidence of high expression of p53 and Ki-67 with Her-2 overexpression and more progressed tumors suggested that in addition to p53, Ki-67 might also be a prognostic biomarker of breast cancer.

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“…The exploration of diverse barriers and enablers to public participation in clinical research has become a vital resource for understanding existing recruitment limitations and provides a basis for developing proposals on how to address these . This literature shows that patients have very diverse and also multiple reasons for either participating or not participating in research . A closely related body of scholarship explores the under‐representation of certain groups of patients in research, reflecting underlying concerns about equity and equality, and about the impact of under‐representation of specific groups on the validity of the research.…”

Section: Discussionmentioning

confidence: 99%

Patient‐initiated recruitment for clinical research: Evaluation of an outpatient letter research statement

Wienroth

Caffrey

Wolfe

et al. 2017

Health Expectations

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Background UK Hospital Trusts are charged with increasing patients’ research awareness and willingness to take part in research. This includes implementing strategies to encourage patient‐initiated enquiries about participation.ObjectivesTo evaluate the impact of a research statement inserted in outpatient letters in one clinical service, and to derive suggestions on potential steps towards increasing patient‐initiated recruitment.SettingA medical outpatient clinic of a research‐active hospital trust, serving an inner‐city multi‐ethnic population across two boroughs.MethodsPre‐intervention and post‐intervention questionnaires were administered face‐to‐face to new patients. Questionnaires included closed questions and one open comments section. Data were analysed for frequencies, with thematic coding of open‐ended responses.ResultsThe response rates were 87% for the pre‐intervention survey and 92% for the post‐intervention survey. In the post‐intervention survey, 85% of patients did not notice the research statement in the letter. More than half found the statement “a little unclear,” whilst one‐third considered it “clear.” Three‐quarters of respondents perceived the statement to be “a little helpful.” Only one person enquired about participating in clinical research having read the statement in the outpatient letter.ConclusionThe analysis suggests that simple, single‐solution approaches such as including research statements in outpatient letters are unlikely to be sufficient to significantly facilitate patient‐initiated recruitment. Recruitment efforts need to take into consideration the diversity of patient constituencies including the reasons they seek health care, and how patients can meaningfully access information (research literacy).

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Best hope or last hope: access to phase III clinical trials of HER‐2/neu for advanced stage breast cancer patients

Cited by 4 publications

References 30 publications

A nomogram based on combining clinical features and contrast enhanced ultrasound is not able to identify Her-2 over-expressing cancer from other breast cancers

A nomogram based on combining clinical features and contrast enhanced ultrasound is not able to identify Her-2 over-expressing cancer from other breast cancers

Comparative study of Her-2, p53, Ki-67 expression and clinicopathological characteristics of breast cancer in a cohort of northern China female patients

Patient‐initiated recruitment for clinical research: Evaluation of an outpatient letter research statement

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