Steven Shak

ORCID: 0000-0002-0692-8227
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Research Areas
  • Breast Cancer Treatment Studies
  • HER2/EGFR in Cancer Research
  • Advanced Breast Cancer Therapies
  • Cancer Genomics and Diagnostics
  • Cancer Treatment and Pharmacology
  • Breast Lesions and Carcinomas
  • Estrogen and related hormone effects
  • Molecular Biology Techniques and Applications
  • Cystic Fibrosis Research Advances
  • Colorectal Cancer Treatments and Studies
  • BRCA gene mutations in cancer
  • Multiple and Secondary Primary Cancers
  • Radiomics and Machine Learning in Medical Imaging
  • Lung Cancer Treatments and Mutations
  • Peptidase Inhibition and Analysis
  • Neonatal Respiratory Health Research
  • Genetic factors in colorectal cancer
  • Gene expression and cancer classification
  • Colorectal Cancer Surgical Treatments
  • Monoclonal and Polyclonal Antibodies Research
  • Lung Cancer Research Studies
  • Bioinformatics and Genomic Networks
  • Medical Imaging Techniques and Applications
  • Global Cancer Incidence and Screening
  • Prostate Cancer Treatment and Research

Exact Sciences (United States)
2020-2024

University of Pittsburgh
2006-2023

University of California, San Francisco
1983-2023

Genomic Health (United States)
2013-2023

Kaiser Permanente
1999-2023

Allegheny General Hospital
2005-2023

Research Network (United States)
1999-2023

University of Southern California
2002-2023

Sidney Kimmel Cancer Center
2002-2023

Tel Aviv University
2021

The HER2 gene, which encodes the growth factor receptor HER2, is amplified and overexpressed in 25 to 30 percent of breast cancers, increasing aggressiveness tumor.

10.1056/nejm200103153441101 article EN New England Journal of Medicine 2001-03-15

The likelihood of distant recurrence in patients with breast cancer who have no involved lymph nodes and estrogen-receptor-positive tumors is poorly defined by clinical histopathological measures.We tested whether the results a reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay 21 prospectively selected genes paraffin-embedded tumor tissue would correlate node-negative, tamoxifen-treated were enrolled National Surgical Adjuvant Breast Bowel Project trial B-14. levels expression...

10.1056/nejmoa041588 article EN New England Journal of Medicine 2004-12-11

PURPOSE: To evaluate the efficacy and safety of first-line, single-agent trastuzumab in women with HER2-overexpressing metastatic breast cancer. PATIENTS AND METHODS: One hundred fourteen cancer were randomized to receive first-line treatment 4 mg/kg loading dose, followed by 2 weekly, or a higher 8 weekly. RESULTS: The objective response rate was 26% (95% confidence interval [CI], 18.2% 34.4%), seven complete 23 partial responses. Response rates 111 assessable patients 3+ 2+ HER2...

10.1200/jco.20.3.719 article EN Journal of Clinical Oncology 2002-02-01

PURPOSE: Overexpression of the HER2 protein occurs in 25% to 30% human breast cancers and leads a particularly aggressive form disease. Efficacy safety recombinant humanized anti-HER2 monoclonal antibody as single agent was evaluated women with HER2-overexpressing metastatic cancer that had progressed after chemotherapy for PATIENTS AND METHODS: Two hundred twenty-two women, one or two regimens, were enrolled. Patients received loading dose 4 mg/kg intravenously, followed by 2-mg/kg...

10.1200/jco.1999.17.9.2639 article EN Journal of Clinical Oncology 1999-09-01

Purpose The 21-gene recurrence score (RS) assay quantifies the likelihood of distant in women with estrogen receptor–positive, lymph node–negative breast cancer treated adjuvant tamoxifen. relationship between RS and chemotherapy benefit is not known. Methods was measured tumors from tamoxifen-treated tamoxifen plus chemotherapy–treated patients National Surgical Adjuvant Breast Bowel Project (NSABP) B20 trial. Cox proportional hazards models were utilized to test for interaction treatment...

10.1200/jco.2005.04.7985 article EN Journal of Clinical Oncology 2006-05-24

PURPOSE: To evaluate the efficacy and safety of first-line, single-agent trastuzumab in women with HER2-overexpressing metastatic breast cancer. PATIENTS AND METHODS: One hundred fourteen cancer were randomized to receive first-line treatment 4 mg/kg loading dose, followed by 2 weekly, or a higher 8 weekly. RESULTS: The objective response rate was 26% (95% confidence interval [CI], 18.2% 34.4%), seven complete 23 partial responses. Response rates 111 assessable patients 3+ 2+ HER2...

10.1200/jco.2002.20.3.719 article EN Journal of Clinical Oncology 2002-02-01

PURPOSE: This study sought to estimate cardiac dysfunction (CD) risk for patients receiving trastuzumab; characterize observed CD by severity, treatment, and clinical outcome; assess effects of baseline factors on CD; cumulative doses anthracyclines trastuzumab CD. PATIENTS AND METHODS: A retrospective review records enrolled onto any seven phase II III trials was performed. Predefined criteria were used the diagnosis, New York Heart Association functional classification system document...

10.1200/jco.2002.20.5.1215 article EN Journal of Clinical Oncology 2002-03-01

Purpose To determine whether the Recurrence Score (RS) provided independent information on risk of distant recurrence (DR) in tamoxifen and anastrozole arms Arimidex, Tamoxifen, Alone or Combination (ATAC) Trial. Patients Methods RNA was extracted from 1,372 tumor blocks postmenopausal patients with hormone receptor–positive primary breast cancer monotherapy ATAC. Twenty-one genes were assessed by quantitative reverse transcriptase polymerase chain reaction, RS calculated. Cox proportional...

10.1200/jco.2009.24.4798 article EN Journal of Clinical Oncology 2010-03-09

Respiratory distress and progressive lung destruction in cystic fibrosis can be attributed to bacterial persistence the accumulation of viscous purulent secretions airways. More than 30 yr ago it was suggested that large amounts DNA contribute its viscosity bovine pancreatic DNase I could reduce viscosity. To evaluate potential clinical utility recombinant human (rhDNase) treatment fibrosis, we have cloned, sequenced, expressed rhDNase. Catalytic rhDNase greatly sputum, transforming within...

10.1073/pnas.87.23.9188 article EN Proceedings of the National Academy of Sciences 1990-12-01

Purpose We sought to identify gene expression markers that predict the likelihood of chemotherapy response. also tested whether response is correlated with 21-gene Recurrence Score assay quantifies recurrence risk. Methods Patients locally advanced breast cancer received neoadjuvant paclitaxel and doxorubicin. RNA was extracted from pretreatment formalin-fixed paraffin-embedded core biopsies. The 384 genes quantified using reverse transcriptase polymerase chain reaction pathologic complete...

10.1200/jco.2005.02.0818 article EN Journal of Clinical Oncology 2005-09-07

The 21-gene OncotypeDX recurrence score (RS) assay quantifies the risk of distant in tamoxifen-treated patients with node-negative, estrogen receptor (ER)-positive breast cancer. We investigated association between RS and for locoregional (LRR) ER-positive cancer from two National Surgical Adjuvant Breast Bowel Project (NSABP) trials (NSABP B-14 B-20).RS was available 895 (from both trials), 355 placebo-treated B-14), 424 chemotherapy plus B-20). primary end point time to first LRR. Distant...

10.1200/jco.2009.23.7610 article EN Journal of Clinical Oncology 2010-01-12

The Oncotype DX assay was recently reported to predict risk for distant recurrence among a clinical trial population of tamoxifen-treated patients with lymph node-negative, estrogen receptor (ER)-positive breast cancer. To confirm and extend these findings, we evaluated the performance this 21-gene node-negative from community hospital setting. A case-control study conducted 4,964 Kaiser Permanente diagnosed invasive cancer 1985 1994 not treated adjuvant chemotherapy. Cases (n = 220) were...

10.1186/bcr1412 article EN cc-by Breast Cancer Research 2006-05-31

We developed quantitative gene expression assays to assess recurrence risk and benefits from chemotherapy in patients with stage II colon cancer.We sought validation by using RNA extracted fixed paraffin-embedded primary tumor blocks 1,436 cancer the QUASAR (Quick Simple Reliable) study of adjuvant fluoropyrimidine versus surgery alone. A score (RS) a treatment (TS) were calculated levels 13 cancer-related genes (n = 7 n 6 benefit genes) five reference prespecified algorithms. Cox...

10.1200/jco.2010.32.8732 article EN Journal of Clinical Oncology 2011-11-08

Adjuvant! is a standardized validated decision aid that projects outcomes in operable breast cancer based on classical clinicopathologic features and therapy. Genomic classifiers offer the potential to more accurately identify individuals who benefit from chemotherapy than features.A sample of 465 patients with hormone receptor (HR) -positive zero three positive axillary nodes did (n = 99) or not have recurrence after chemohormonal therapy had tumor tissue evaluated using 21-gene assay....

10.1200/jco.2007.14.4501 article EN Journal of Clinical Oncology 2008-08-05

The recurrence score based on the 21-gene breast-cancer assay has been clinically useful in predicting a chemotherapy benefit hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, axillary lymph-node-negative breast cancer. In women with positive lymph-node disease, role of respect to adjuvant is unclear.In prospective trial, we randomly assigned HER2-negative cancer, one three lymph nodes, and 25 or lower (scores range from 0 100, higher scores indicating...

10.1056/nejmoa2108873 article EN New England Journal of Medicine 2021-12-01

These studies were conducted to determine the relationship between quantitative tumor gene expression and risk of cancer recurrence in patients with stage II or III colon treated surgery alone plus fluorouracil (FU) leucovorin (LV) develop multigene algorithms quantify as well likelihood differential treatment benefit FU/LV adjuvant chemotherapy for individual patients.We performed reverse transcription polymerase chain reaction (RT-qPCR) on RNA extracted from fixed, paraffin-embedded (FPE)...

10.1200/jco.2010.28.9538 article EN Journal of Clinical Oncology 2010-08-03

The 21-gene Recurrence Score (RS) assay is a validated prognostic/predictive tool in early hormone receptor-positive breast cancer (BC); however, only few prospective outcome results have been available so far. In the phase III PlanB trial, RS was prospectively used to define subset of patients who received endocrine therapy. We present 3-year data and concordance analysis (among biomarkers/RS).Central tumor bank established from (intermediate high-risk, locally human epidermal growth factor...

10.1200/jco.2015.63.5383 article EN Journal of Clinical Oncology 2016-03-01

Validated biomarkers are needed to improve risk assessment and treatment decision-making for women with ductal carcinoma in situ (DCIS) of the breast. The Oncotype DX® DCIS Score (DS) was shown predict local recurrence (LR) individuals low-risk treated by breast-conserving surgery (BCS) alone. Our objective confirm these results a larger population-based cohort individuals. We used an established diagnosed BCS alone from 1994 2003 validation outcomes. Central pathology excluded cases...

10.1007/s10549-015-3464-6 article EN cc-by-nc Breast Cancer Research and Treatment 2015-06-28

The prospective phase 3 PlanB trial used the Oncotype DX® Recurrence Score® (RS) to define a genomically low-risk subset of clinically high-risk pN0-1 early breast cancer (EBC) patients for treatment with adjuvant endocrine therapy (ET) alone. Here, we report five-year data evaluating prognostic value RS, Ki-67, and other traditional clinicopathological parameters. A central tumour bank was prospectively established within PlanB. Following an amendment, hormone receptor (HR)+ , RS ≤ 11 were...

10.1007/s10549-017-4358-6 article EN cc-by-nc Breast Cancer Research and Treatment 2017-06-29

PURPOSE The 21-gene recurrence score (RS) assay quantifies the likelihood of distant in women with estrogen receptor–positive, lymph node–negative breast cancer treated adjuvant tamoxifen. relationship between RS and chemotherapy benefit is not known. METHODS was measured tumors from tamoxifen-treated tamoxifen plus chemotherapy–treated patients National Surgical Adjuvant Breast Bowel Project (NSABP) B20 trial. Cox proportional hazards models were utilized to test for interaction treatment...

10.1200/jco.22.02570 article EN Journal of Clinical Oncology 2023-07-05

Overexpression of the HER2 protein occurs in 25% to 30% human breast cancers and leads a particularly aggressive form disease. Efficacy safety recombinant humanized anti-HER2 monoclonal antibody as single agent was evaluated women with HER2-overexpressing metastatic cancer that had progressed after chemotherapy for

10.1200/jco.22.02510 article EN Journal of Clinical Oncology 2023-03-07

To our knowledge, WSG-ADAPT-HR+/HER2- (ClinicalTrials.gov identifier: NCT01779206; n = 5,625 registered) is the first trial combining 21-gene expression assay (recurrence score [RS]) and response to 3-week preoperative endocrine therapy (ET) guide systemic in early breast cancer.Baseline postendocrine Ki67 (Ki67post) were evaluated centrally. In trial, all patients received exclusively ET: with pathologic regional lymph node status (pN) 0-1 (ie, 0-3 involved nodes) entered control arm if RS...

10.1200/jco.21.02759 article EN Journal of Clinical Oncology 2022-04-11
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