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1. Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.

Author

Delaloge, Suzette, Piccart, Martine, Rutgers, Emiel, Litière, Saskia, van 't Veer, Laura J, van den Berkmortel, Franchette, Brain, Etienne, Dudek-Peric, Aleksandra, Gil-Gil, Miguel, Gomez, Patricia, Hilbers, Florentine S, Khalil, Zaman, Knox, Susan, Kuemmel, Sherko, Kunz, Georg, Lesur, Anne, Pierga, Jean-Yves, Ravdin, Peter, Rubio, Isabel T, Saghatchian, Mahasti, Smilde, Tineke J, Thompson, Alastair M, Viale, Giuseppe, Zoppoli, Gabriele, Vuylsteke, Peter, Tryfonidis, Konstantinos, Poncet, Coralie, Bogaerts, Jan, and Cardoso, Fatima

Subjects
Genetics, Rare Diseases, Breast Cancer, Clinical Trials and Supportive Activities, Human Genome, Cancer, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Anthracyclines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Capecitabine, Docetaxel, Female, Humans, Middle Aged, Prospective Studies, MINDACT investigators and the TRANSBIG Consortium, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeMINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen.Patients and methodsR-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety.ResultsOf 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]).ConclusionAlthough underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

Published
2020

2. Communicating Risks of Adjuvant Chemotherapy for Breast Cancer: Getting Beyond the Laundry List.

Author

Brauer, Eden R, Long, Elisa F, Melnikow, Joy, Ravdin, Peter M, and Ganz, Patricia A

Subjects
Humans, Breast Neoplasms, Antineoplastic Combined Chemotherapy Protocols, Chemotherapy, Adjuvant, Risk Assessment, Risk Factors, Communication, Medical Oncology, Quality of Health Care, Female, Surveys and Questionnaires, Clinical Decision-Making, Oncologists, Cancer Survivors, Patient Safety, Breast Cancer, Clinical Research, Cancer, Rehabilitation, Management of diseases and conditions, 6.1 Pharmaceuticals, 7.1 Individual care needs, Evaluation of treatments and therapeutic interventions, 7.3 Management and decision making, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeAccording to the Institute of Medicine, high-quality cancer care should include effective communication between clinicians and patients about the risks and benefits, expected response, and impact on quality of life of a recommended therapy. In the delivery of oncology care, the barriers to and facilitators of communication about potential long-term and late effects, post-treatment expectations, and transition to survivorship care have not been fully defined.Patients and methodsWe collected qualitative data through semistructured interviews with medical oncologists and focus groups with breast cancer survivors and applied the Theoretical Domains Framework to systematically analyze and identify the factors that may influence oncologists' communication with patients with breast cancer about the long-term and late effects of adjuvant therapy.ResultsEight key informant interviews with medical oncologists and two focus groups with breast cancer survivors provided data. Both oncologists and patients perceived information on long-term effects as valuable in terms of improved clinical communication but had concerns about the feasibility of inclusion before treatment. They described the current approaches to communication of therapy risks as a brief laundry list that emphasized acute adverse effects and minimized more long-term issues. We describe the barriers to communication about potential long-term effects from the perspectives of both groups.ConclusionThis study provides insight into oncologists' communication with patients with breast cancer regarding the potential long-term and late effects of adjuvant chemotherapy and about setting realistic expectations for life after treatment. Opportunities to improve oncologists' communication about the potential toxicities of therapy, particularly regarding long-term and late effects, should be examined further.

Published
2019

6. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer

Author

Sparano, Joseph A., Gray, Robert J., Ravdin, Peter M., Makower, Della F., Pritchard, Kathleen I., Albain, Kathy S., Hayes, Daniel F., Geyer, Charles E., Dees, Elizabeth C., Goetz, Matthew P., Olson, John A., Lively, Tracy, Badve, Sunil S., Saphner, Thomas J., Wagner, Lynne I., Whelan, Timothy J., Ellis, Matthew J., Chir, B., Paik, Soonmyung, Wood, William C., Keane, Maccon M., Gomez Moreno, Henry L., Reddy, Pavan S., Goggins, Timothy F., Mayer, Ingrid A., Brufsky, Adam M., Kaklamani, V.G., Toppmeyer, Deborah L., Kaklamani, Virginia G., Berenberg, Jeffrey L., Abrams, Jeffrey, and Sledge, George W.

Subjects
Oncology, Adult, medicine.medical_specialty, Antineoplastic Agents, Hormonal, Receptor, ErbB-2, medicine.medical_treatment, Breast Neoplasms, 030204 cardiovascular system & hematology, Disease-Free Survival, Article, law.invention, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Randomized controlled trial, law, Risk Factors, Internal medicine, medicine, Adjuvant therapy, Humans, 030212 general & internal medicine, Prospective Studies, Prospective cohort study, Aged, Proportional Hazards Models, Chemotherapy, Proportional hazards model, business.industry, Gene Expression Profiling, Age Factors, Estrogen Antagonists, General Medicine, Middle Aged, medicine.disease, Prognosis, Tamoxifen, Premenopause, Chemotherapy, Adjuvant, Female, Neoplasm Recurrence, Local, business, Adjuvant, Algorithms, medicine.drug
Abstract

BACKGROUND: The use of adjuvant chemotherapy in patients with breast cancer may be guided by clinicopathological factors and a score based on a 21-gene assay to determine the risk of recurrence. Whether the level of clinical risk of breast cancer recurrence adds prognostic information to the recurrence score is not known. METHODS: We performed a prospective trial involving 9427 women with hormone-receptor–positive, human epidermal growth factor receptor 2–negative, axillary node–negative breast cancer, in whom an assay of 21 genes had been performed, and we classified the clinical risk of recurrence of breast cancer as low or high on the basis of the tumor size and histologic grade. The effect of clinical risk was evaluated by calculating hazard ratios for distant recurrence with the use of Cox proportional-hazards models. The initial endocrine therapy was tamoxifen alone in the majority of the premenopausal women who were 50 years of age or younger. RESULTS: The level of clinical risk was prognostic of distant recurrence in women with an intermediate 21-gene recurrence score of 11 to 25 (on a scale of 0 to 100, with higher scores indicating a worse prognosis or a greater potential benefit from chemotherapy) who were randomly assigned to endocrine therapy (hazard ratio for the comparison of high vs. low clinical risk, 2.73; 95% confidence interval [CI], 1.93 to 3.87) or to chemotherapy plus endocrine (chemoendocrine) therapy (hazard ratio, 2.41; 95% CI, 1.66 to 3.48) and in women with a high recurrence score (a score of 26 to 100), all of whom were assigned to chemoendocrine therapy (hazard ratio, 3.17; 95% CI, 1.94 to 5.19). Among women who were 50 years of age or younger who had received endocrine therapy alone, the estimated (±SE) rate of distant recurrence at 9 years was less than 5% (≤1.8±0.9%) with a low recurrence score (a score of 0 to 10), irrespective of clinical risk, and 4.7±1.0% with an intermediate recurrence score and low clinical risk. In this age group, the estimated distant recurrence at 9 years exceeded 10% among women with a high clinical risk and an intermediate recurrence score who received endocrine therapy alone (12.3±2.4%) and among those with a high recurrence score who received chemoendocrine therapy (15.2±3.3%). CONCLUSIONS: Clinical-risk stratification provided prognostic information that, when added to the 21-gene recurrence score, could be used to identify premenopausal women who could benefit from more effective therapy. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, .)

Published
2019

8. Is Her2 of value in identifying patients who particularly benefit from anthracyclines during adjuvant therapy? A qualified yes

Author

Ravdin, Peter Marcus

Subjects
Breast cancer, Anthracyclines -- Evaluation, Health
Abstract

Data from several large adjuvant breast cancer chemotherapy trials suggest that anthracycline-based chemotherapies relative to non-anthracycline-based adjuvant therapies are particularly effective in patients whose tumors overexpress Her2. Most trials show some evidence of this effect, but the interaction generally has not been confirmed statistically, perhaps because the trials are underpowered. In addition, there have been a multiplicity of Her2 immunohistochemistry techniques used in these studies, which are clearly not of equivalent utility in detecting this effect. Thus, while there is good evidence that further work in this area will be of value, at this time the results are inconclusive and not ready for clinical application. [J Natl Cancer Inst Monogr 2001;30: 80-4]

Published
2001

9. Tumor Marker Utility Grading System: a framework to evaluate clinical utility of tumor markers

Author

Hayes, Daniel F., Bast, Robert C., Desch, Christopher E., Fritsche, Herbert, Jr., Kemeny, Nancy E., Jessup, J. Milburn, Locker, Gershon Y., Macdonald, John S., Mennel, Robert G., Norton, Larry, Ravdin, Peter, Taube, Sheila, and Winn, Rodger J.

Subjects
Tumor markers -- Physiological aspects, Cancer -- Diagnosis, Health
Abstract

Introduction of tumor markers into routine clinical practice has been poorLY controlled, with few criteria or guidelines as to how such markers should be used. We propose a Tumor Marker Utility Grading System (TMUGS) to evaluate the clinical utility of tumor markers and to establish an investigational agenda for evaluation of new tumor markers. A Tumor Marker Utility Grading Worksheet has been designed. The initial portion of this worksheet is used to clarify the precise characteristics of the marker in question. These characteristics include the marker designation, the molecule and/or substance and the relevant alteration from normalcy the assay format and reagents, the specimen type, and the neoplastic disease for which the marker is being evaluated. To determine the clinical utility of each marker, one of several potential uses must be designated, including risk assessment, screening, differential diagnosis, prognosis, and monitoring clinical course. For each of these uses, associations between marker assay results and expected biologic process and end points must be determined. However, knowledge of tumor marker data should contribute to a decision in practice that results in a more favorable clinical outcome for the patient, including increased overall survival, increased disease-free survival, improvement in quality of life, or reduction in cost of care. Semiquantitative utility scales have been developed for each end point. The only markers recommended for use in routine clinical practice are those that are assigned utility scores of '++ or '+++' on a 6-point scale (ranging from 0 to +++) in the categories relative to more favorable clinical outcomes. Each utility score assignment should be supported by documentation of the level of evidence used to evaluate the marker. TMUGS will establish a standardized analytic technique to evaluate clinical utility of known and future tumor markers. It should result in improved patient outcomes and more cost-efficient investigation and application of tumor markers. [J Natl Cancer Inst 1996;88:1456-66

Published
1996

11. Nitric oxide synthase (NOS3) variants and disease-free survival among treated and untreated breast cancer patients in a SWOG Clinical Trial (S8897)

Author

Choi, Ji-Yeob, Barlow, William E., Albain, Kathy S., Hong, Chi-Chen, Blanco, Javier G., Livingston, Robert B., Davis, Warren, Rae, James M., Yeh, I-Tien, Hutchins, Laura F., Ravdin, Peter M., Martino, Silvana, Lyss, Alan P., Osborne, C. Kent, Abeloff, Martin D., Hayes, Daniel F., and Ambrosone, Christine B.

Subjects
Adult, Aged, 80 and over, Clinical Trials as Topic, Polymorphism, Genetic, Nitric Oxide Synthase Type III, Carcinoma, Breast Neoplasms, Middle Aged, Medical Oncology, Prognosis, Article, Disease-Free Survival, Methotrexate, Doxorubicin, Antineoplastic Combined Chemotherapy Protocols, Southwestern United States, Humans, Female, Fluorouracil, Cisplatin, Cyclophosphamide, Algorithms, Aged
Abstract

Numerous chemotherapeutic agents are cytotoxic through generation of reactive species, and variability in genes related to oxidative stress may influence disease-free survival (DFS). We examined relationships between DFS and variants in NOS3, as well as NQO1, NQO2, and CBR3, among treated and untreated breast cancer patients in a Southwest Oncology Group clinical trial (S8897).In the parent trial, women were assigned according to prognostic features; the high-risk group was randomized to cyclophosphamide, i.v. methotrexate, and 5-fluorouracil or to cyclophosphamide, i.v. doxorubicin, and 5-fluorouracil +/- tamoxifen, and the low-risk group did not receive adjuvant therapy. We extracted DNA from normal lymph node tissue and examined functional polymorphisms in NOS3, NQO1, NQO2, and CBR3, in relation to DFS, using Cox proportional hazard model.There were significant interactions between DFS, adjuvant therapy, and NOS3 Glu298Asp and -786 polymorphisms, alone and in combination (P for interaction = 0.008). When NOS3 genotypes were combined, women with genotypes encoding for lower nitric oxide who received chemotherapy had a2-fold increase in hazard of progression (hazard ratio, 2.32; 95% confidence interval, 1.26-4.25), whereas there was reduced risk for those who did not receive adjuvant therapy (hazard ratio, 0.42; 95% confidence interval, 0.19-0.95). There were no associations between the other genotypes and DFS in either group.Variants encoding lower activity of NOS3 may affect outcomes in breast cancer patients, with the direction of risk differing depending on chemotherapy status. These results may mirror the known dual functions of nitric oxide and nitric oxide synthase, depending on oxidative environment.

Published
2009

12. Gene Polymorphisms in Cyclophosphamide Metabolism Pathway,Treatment-Related Toxicity, and Disease-Free Survival in SWOG 8897 Clinical Trial for Breast Cancer

Author

Yao, Song, primary, Barlow, William E., additional, Albain, Kathy S., additional, Choi, Ji-Yeob, additional, Zhao, Hua, additional, Livingston, Robert B., additional, Davis, Warren, additional, Rae, James M., additional, Yeh, I-Tien, additional, Hutchins, Laura F., additional, Ravdin, Peter M., additional, Martino, Silvana, additional, Lyss, Alan P., additional, Osborne, C. Kent, additional, Abeloff, Martin, additional, Hortobagyi, Gabriel N., additional, Hayes, Daniel F., additional, and Ambrosone, Christine B., additional

Published
2010
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14. Nitric Oxide Synthase Variants and Disease-Free Survival among Treated and Untreated Breast Cancer Patients in a Southwest Oncology Group Clinical Trial

Author

Choi, Ji-Yeob, primary, Barlow, William E., additional, Albain, Kathy S., additional, Hong, Chi-Chen, additional, Blanco, Javier G., additional, Livingston, Robert B., additional, Davis, Warren, additional, Rae, James M., additional, Yeh, I-Tien, additional, Hutchins, Laura F., additional, Ravdin, Peter M., additional, Martino, Silvana, additional, Lyss, Alan P., additional, Osborne, C. Kent, additional, Abeloff, Martin D., additional, Hayes, Daniel F., additional, and Ambrosone, Christine B., additional

Published
2009
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16. Poor-Prognosis Estrogen Receptor–Positive Breast Cancer Identified by Histopathologic Subclassification

Author

Webster, Lucy R., primary, Lee, Shu-Fen, additional, Ringland, Clare, additional, Morey, Adrienne L., additional, Hanby, Andrew M., additional, Morgan, Graeme, additional, Byth, Karen, additional, Mote, Patricia A., additional, Provan, Pamela J., additional, Ellis, Ian O., additional, Green, Andrew R., additional, Lamoury, Gillian, additional, Ravdin, Peter, additional, Clarke, Christine L., additional, Ward, Robyn L., additional, Balleine, Rosemary L., additional, and Hawkins, Nicholas J., additional

Published
2008
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20. Mammograms and Mortality: How Has the Evidence Evolved?

Author

Kowalski, Amanda E.

Subjects
TASK forces, AGEISM, MAMMOGRAMS, MEDICAL personnel
Abstract

Randomized controlled trials of radiotherapy show that it increases lung and esophageal cancer mortality among women treated for early-stage breast cancer (Early Breast Cancer Trialists' Collaborative Group 2005). Latest Mortality Results across Trials Latest Mortality Results across Trials The meta-analysis by Nelson et al. (2016) that informs the US Preventive Services Task Force mammography guidelines primarily considers the relative risk of breast cancer mortality at the latest available date for each trial. In all age groups, the relative risk of breast cancer mortality is less than one, indicating that the ratio of the breast cancer mortality rate in intervention to control is less than one. As summarized in Table 2, the most recent mortality results from the Canadian National Breast Screening Study (Miller et al. 2014) show an imprecise increase in breast cancer mortality for women in their 40s and an imprecise decrease in breast cancer mortality for women in their 50s. Based on these results, it is not surprising that the literature, which focuses on breast cancer mortality as the primary outcome at various points in time, does not identify a compelling trend in breast cancer mortality as follow-up length increases. [Extracted from the article]

Published
2021
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21. Breast Cancer Decline Mirrors Fall in Hormone Use, Spurs Both Debate and Research.

Author

McNeil, Caroline

Subjects
*BREAST cancer research, *HORMONES, *HORMONE therapy for menopause
Abstract

The article reports on the debate and research spurred by decline in breast cancer due to decline in use of hormone. A study presented at a breast cancer symposium reported that the decline in incidence of breast cancer from 2002 to 2003 may have resulted form the fall in postmenopausal hormone use in the same period. Peter Ravdin of University of Texas and his colleagues have used data from the Surveillance, Epidemiology, and End Result (SEER) database.

Published
2007
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22. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age.

Abstract

The MINDACT trial showed excellent 5-year distant metastasis-free survival of 94·7% (95% CI 92·5-96·2) in patients with breast cancer of high clinical and low genomic risk who did not receive chemotherapy. We present long-term follow-up results together with an exploratory analysis by age., info:eu-repo/semantics/published

Published
2021

23. FAM222A encodes a protein which accumulates in plaques in Alzheimer's disease.

Author

Yan, Tingxiang, Liang, Jingjing, Gao, Ju, Wang, Luwen, Fujioka, Hisashi, The Alzheimer Disease Neuroimaging Initiative, Weiner, Michael W., Schuff, Norbert, Rosen, Howard J., Miller, Bruce L., Perry, David, Aisen, Paul, Toga, Arthur W., Jimenez, Gustavo, Donohue, Michael, Gessert, Devon, Harless, Kelly, Salazar, Jennifer, Cabrera, Yuliana, and Walter, Sarah

Subjects
ALZHEIMER'S disease, CEREBRAL atrophy, AMYLOID plaque, PROTEINS, PROTEIN expression, CENTRAL nervous system physiology
Abstract

Alzheimer's disease (AD) is characterized by amyloid plaques and progressive cerebral atrophy. Here, we report FAM222A as a putative brain atrophy susceptibility gene. Our cross-phenotype association analysis of imaging genetics indicates a potential link between FAM222A and AD-related regional brain atrophy. The protein encoded by FAM222A is predominantly expressed in the CNS and is increased in brains of patients with AD and in an AD mouse model. It accumulates within amyloid deposits, physically interacts with amyloid-β (Aβ) via its N-terminal Aβ binding domain, and facilitates Aβ aggregation. Intracerebroventricular infusion or forced expression of this protein exacerbates neuroinflammation and cognitive dysfunction in an AD mouse model whereas ablation of this protein suppresses the formation of amyloid deposits, neuroinflammation and cognitive deficits in the AD mouse model. Our data support the pathological relevance of protein encoded by FAM222A in AD. In this study the authors identify a possible link between the gene FAM222A and brain atrophy. The protein it encodes is found to accumulate in plaques seen in Alzheimer's disease, and functional analysis suggests it interacts with amyloid-beta. [ABSTRACT FROM AUTHOR]

Published
2020
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24. ki67 nuclei detection and ki67-index estimation: a novel automatic approach based on human vision modeling.

Author

Barricelli, Barbara Rita, Casiraghi, Elena, Gliozzo, Jessica, Huber, Veronica, Leone, Biagio Eugenio, Rizzi, Alessandro, and Vergani, Barbara

Subjects
HIGH resolution imaging, VISION, TUMOR markers, SOURCE code, CELL nuclei
Abstract

Background: The protein ki67 (pki67) is a marker of tumor aggressiveness, and its expression has been proven to be useful in the prognostic and predictive evaluation of several types of tumors. To numerically quantify the pki67 presence in cancerous tissue areas, pathologists generally analyze histochemical images to count the number of tumor nuclei marked for pki67. This allows estimating the ki67-index, that is the percentage of tumor nuclei positive for pki67 over all the tumor nuclei. Given the high image resolution and dimensions, its estimation by expert clinicians is particularly laborious and time consuming. Though automatic cell counting techniques have been presented so far, the problem is still open. Results: In this paper we present a novel automatic approach for the estimations of the ki67-index. The method starts by exploiting the STRESS algorithm to produce a color enhanced image where all pixels belonging to nuclei are easily identified by thresholding, and then separated into positive (i.e. pixels belonging to nuclei marked for pki67) and negative by a binary classification tree. Next, positive and negative nuclei pixels are processed separately by two multiscale procedures identifying isolated nuclei and separating adjoining nuclei. The multiscale procedures exploit two Bayesian classification trees to recognize positive and negative nuclei-shaped regions. Conclusions: The evaluation of the computed results, both through experts' visual assessments and through the comparison of the computed indexes with those of experts, proved that the prototype is promising, so that experts believe in its potential as a tool to be exploited in the clinical practice as a valid aid for clinicians estimating the ki67-index. The MATLAB source code is open source for research purposes. [ABSTRACT FROM AUTHOR]

Published
2019
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25. Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.

Abstract

PURPOSE: MINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen. PATIENTS AND methods: R-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety. RESULTS: Of 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]). CONCLUSION: Although underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy. TRIAL REGISTRATION: ClinicalTrials.gov NCT00433589.

Published
2020

26. Author Correction: FAM222A encodes a protein which accumulates in plaques in Alzheimer's disease.

Author

Yan, Tingxiang, Liang, Jingjing, Gao, Ju, Wang, Luwen, Fujioka, Hisashi, The Alzheimer Disease Neuroimaging Initiative, Weiner, Michael W., Schuff, Norbert, Rosen, Howard J., Miller, Bruce L., Perry, David, Aisen, Paul, Toga, Arthur W., Jimenez, Gustavo, Donohue, Michael, Gessert, Devon, Harless, Kelly, Salazar, Jennifer, Cabrera, Yuliana, and Walter, Sarah

Subjects
ALZHEIMER'S disease, PROTEINS
Abstract

This image incorrectly showed the same sample as shown in the original Figure 4g, top row (A 1-42), under "0.5h". In the original version of the manuscript, the image shown in Figure 4g, bottom row (A 1-42 + rAggregatin), under "6h" was incorrect. [Extracted from the article]

Published
2022
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31. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer.

Abstract

BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e., the noninferiority boundary) or higher. RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemotherapy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the r

Published
2016

32. 70-Gene signature as an aid to treatment decisions in early-stage breast cancer

Abstract

BACKGROUND: The 70-gene signature test (MammaPrint) has been shown to improve prediction of clinical outcome in women with early-stage breast cancer. We sought to provide prospective evidence of the clinical utility of the addition of the 70-gene signature to standard clinical-pathological criteria in selecting patients for adjuvant chemotherapy. METHODS: In this randomized, phase 3 study, we enrolled 6693 women with early-stage breast cancer and determined their genomic risk (using the 70-gene signature) and their clinical risk (using a modified version of Adjuvant! Online). Women at low clinical and genomic risk did not receive chemotherapy, whereas those at high clinical and genomic risk did receive such therapy. In patients with discordant risk results, either the genomic risk or the clinical risk was used to determine the use of chemotherapy. The primary goal was to assess whether, among patients with high-risk clinical features and a low-risk gene-expression profile who did not receive chemotherapy, the lower boundary of the 95% confidence interval for the rate of 5-year survival without distant metastasis would be 92% (i.e. the noninferiority boundary) or higher. RESULTS: A total of 1550 patients (23.2%) were deemed to be at high clinical risk and low genomic risk. At 5 years, the rate of survival without distant metastasis in this group was 94.7% (95% confidence interval, 92.5 to 96.2) among those not receiving chemotherapy. The absolute difference in this survival rate between these patients and those who received chemother apy was 1.5 percentage points, with the rate being lower without chemotherapy. Similar rates of survival without distant metastasis were reported in the subgroup of patients who had estrogen-receptor-positive, human epidermal growth factor receptor 2-negative, and either node-negative or node-positive disease. CONCLUSIONS: Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the r, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2016

34. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase.

Abstract

The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included., Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2011

35. The EORTC 10041/BIG 03-04 MINDACT trial is feasible: results of the pilot phase.

Abstract

The MINDACT (Microarray In Node-negative and 1-3 node positive Disease may Avoid ChemoTherapy) trial investigates the clinical utility of the 70-gene profile (MammaPrint) for the selection of breast cancer patients for adjuvant chemotherapy (CT) together with standard clinicopathological criteria. We present the results of the pilot phase consisting of first 800 patients included., Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2011

36. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller.

Abstract

PURPOSE: To evaluate the risk of recurrence in women diagnosed with T1a and T1b, node-negative, human epidermal growth factor receptor 2 (HER2) -positive breast cancer. METHODS: We reviewed 965 T1a,bN0M0 breast cancers diagnosed at our institution between 1990 and 2002. Dedicated breast pathologists confirmed HER2 positivity if 3+ by immunohistochemistry or if it had a ratio of 2.0 or greater by fluorescence in situ hybridization (FISH). Patients who received adjuvant chemotherapy or trastuzumab were excluded. Kaplan-Meier product was used to calculate recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were fit to determine associations between HER2 status and survival after adjustment for patient and disease characteristics. Additionally, 350 breast cancers from two other institutions were used for validation. RESULTS: Ten percent of patients had HER2-positive tumors. At a median follow-up of 74 months, there were 72 recurrences. The 5-year RFS rates were 77.1% and 93.7% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). The 5-year DRFS rates were 86.4% and 97.2% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). In multivariate analysis, patients with HER2-positive tumors had higher risks of recurrence (hazard ratio [HR], 2.68; 95% CI, 1.44 to 5.0; P = .002) and distant recurrence (HR, 5.3; 95% CI, 2.23 to 12.62; P < .001) than those with HER2-negative tumors. Patients with HER2-positive tumors had 5.09 times (95% CI, 2.56 to 10.14; P < .0001) the rate of recurrences and 7.81 times (95% CI, 3.17 to 19.22; P < .0001) the rate of distant recurrences at 5 years compared with patients who had hormone receptor-positive tumors. CONCLUSION: Patients with HER2-positive T1abN0M0 tumors have a significant risk of relapse and should be considered for systemic, anti-HER2, adjuvant therapy., Journal Article, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

Published
2009

37. High risk of recurrence for patients with breast cancer who have human epidermal growth factor receptor 2-positive, node-negative tumors 1 cm or smaller.

Abstract

PURPOSE: To evaluate the risk of recurrence in women diagnosed with T1a and T1b, node-negative, human epidermal growth factor receptor 2 (HER2) -positive breast cancer. METHODS: We reviewed 965 T1a,bN0M0 breast cancers diagnosed at our institution between 1990 and 2002. Dedicated breast pathologists confirmed HER2 positivity if 3+ by immunohistochemistry or if it had a ratio of 2.0 or greater by fluorescence in situ hybridization (FISH). Patients who received adjuvant chemotherapy or trastuzumab were excluded. Kaplan-Meier product was used to calculate recurrence-free survival (RFS) and distant recurrence-free survival (DRFS). Cox proportional hazard models were fit to determine associations between HER2 status and survival after adjustment for patient and disease characteristics. Additionally, 350 breast cancers from two other institutions were used for validation. RESULTS: Ten percent of patients had HER2-positive tumors. At a median follow-up of 74 months, there were 72 recurrences. The 5-year RFS rates were 77.1% and 93.7% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). The 5-year DRFS rates were 86.4% and 97.2% in patients with HER2-positive and HER2-negative tumors, respectively (P < .001). In multivariate analysis, patients with HER2-positive tumors had higher risks of recurrence (hazard ratio [HR], 2.68; 95% CI, 1.44 to 5.0; P = .002) and distant recurrence (HR, 5.3; 95% CI, 2.23 to 12.62; P < .001) than those with HER2-negative tumors. Patients with HER2-positive tumors had 5.09 times (95% CI, 2.56 to 10.14; P < .0001) the rate of recurrences and 7.81 times (95% CI, 3.17 to 19.22; P < .0001) the rate of distant recurrences at 5 years compared with patients who had hormone receptor-positive tumors. CONCLUSION: Patients with HER2-positive T1abN0M0 tumors have a significant risk of relapse and should be considered for systemic, anti-HER2, adjuvant therapy., Journal Article, Research Support, N.I.H. Extramural, Research Support, Non-U.S. Gov't, info:eu-repo/semantics/published

Published
2009

38. Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial.

Abstract

This Review describes the work conducted by the TRANSBIG consortium in the development of the MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) trial. The goal of the trial is to provide definitive evidence regarding the clinical relevance of the 70-gene prognosis signature, and to assess the performance of this signature compared with that of traditional prognostic indicators for assigning adjuvant chemotherapy to patients with node-negative breast cancer. We outline the background work and the key questions in node-negative early-stage breast cancer, and then focus on the MINDACT trial design and statistical considerations. The challenges inherent in this trial in terms of logistics, implementation and interpretation of the results are also discussed. We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment., Journal Article, Review, info:eu-repo/semantics/published

Published
2006

39. Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial.

Abstract

This Review describes the work conducted by the TRANSBIG consortium in the development of the MINDACT (Microarray In Node negative Disease may Avoid ChemoTherapy) trial. The goal of the trial is to provide definitive evidence regarding the clinical relevance of the 70-gene prognosis signature, and to assess the performance of this signature compared with that of traditional prognostic indicators for assigning adjuvant chemotherapy to patients with node-negative breast cancer. We outline the background work and the key questions in node-negative early-stage breast cancer, and then focus on the MINDACT trial design and statistical considerations. The challenges inherent in this trial in terms of logistics, implementation and interpretation of the results are also discussed. We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment., Journal Article, Review, info:eu-repo/semantics/published

Published
2006

40. Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer.

Author

Shuford, Stephen, Wilhelm, Christine, Rayner, Melissa, Elrod, Ashley, Millard, Melissa, Mattingly, Christina, Lotstein, Alina, Smith, Ashley M., Guo, Qi Jin, O'Donnell, Lauren, Elder, Jeffrey, Puls, Larry, Weroha, S. John, Hou, Xiaonan, Zanfagnin, Valentina, Nick, Alpa, Stany, Michael P., Maxwell, G. Larry, Conrads, Thomas, and Sood, Anil K.

Subjects
OVARIAN cancer diagnosis, OVARIAN cancer patients, OVARIAN cancer treatment, LAPAROSCOPIC surgery, CANCER chemotherapy
Abstract

Although 70–80% of newly diagnosed ovarian cancer patients respond to first-line therapy, almost all relapse and five-year survival remains below 50%. One strategy to increase five-year survival is prolonging time to relapse by improving first-line therapy response. However, no biomarker today can accurately predict individual response to therapy. In this study, we present analytical and prospective clinical validation of a new test that utilizes primary patient tissue in 3D cell culture to make patient-specific response predictions prior to initiation of treatment in the clinic. Test results were generated within seven days of tissue receipt from newly diagnosed ovarian cancer patients obtained at standard surgical debulking or laparoscopic biopsy. Patients were followed for clinical response to chemotherapy. In a study population of 44, the 32 test-predicted Responders had a clinical response rate of 100% across both adjuvant and neoadjuvant treated populations with an overall prediction accuracy of 89% (39 of 44, p < 0.0001). The test also functioned as a prognostic readout with test-predicted Responders having a significantly increased progression-free survival compared to test-predicted Non-Responders, p = 0.01. This correlative accuracy establishes the test's potential to benefit ovarian cancer patients through accurate prediction of patient-specific response before treatment. [ABSTRACT FROM AUTHOR]

Published
2019
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41. Active research on CTRC-AACR San Antonio Breast Cancer Symposium

Subjects
Oncology, Experimental -- Conferences, meetings and seminars, Breast cancer -- Conferences, meetings and seminars, Cancer -- Research, Business, international
Abstract

Contract Awarded for Active research on CTRC-CR San Antonio Breast Cancer Symposium Contract Value : $10,000 Contract No. : CA165625-01 Contract Investigator : RAVDIN, PETER MARCUS Contractor name : UNIVERSITY [...]

Published
2013

42. Reduction in HRT May Have Led to Breast-Cancer Drop.

Subjects
*HORMONE therapy for menopause, *BREAST cancer, *CANCER in women, *HEALTH of older women
Abstract

The article looks at how the decline in the number of older women using hormone replacement therapy (HRT) may have led to the drop in the incidence of breast cancer. The Women's Health Initiative study of women using HRT was prematurely stopped when the hormones were found to significantly increase the risk of breast cancer. Comments from Peter Ravdin, a research professor in the Department of Biostatistics at M.D. Anderson, are presented.

Published
2007

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