A5079242757- Breast Cancer Treatment Studies
- Cancer Treatment and Pharmacology
- HER2/EGFR in Cancer Research
- Advanced Breast Cancer Therapies
- Cancer Genomics and Diagnostics
- Colorectal Cancer Treatments and Studies
- Intraperitoneal and Appendiceal Malignancies
- Occupational and environmental lung diseases
- Pancreatic and Hepatic Oncology Research
- Prostate Cancer Treatment and Research
- Lung Cancer Research Studies
- Monoclonal and Polyclonal Antibodies Research
- Lung Cancer Treatments and Mutations
- Neuroendocrine Tumor Research Advances
- Statistical Methods in Clinical Trials
- Health Systems, Economic Evaluations, Quality of Life
- Peptidase Inhibition and Analysis
- Estrogen and related hormone effects
- Breast Lesions and Carcinomas
- Chronic Myeloid Leukemia Treatments
- Neuroblastoma Research and Treatments
- Chemotherapy-induced cardiotoxicity and mitigation
- Economic and Financial Impacts of Cancer
- Chronic Lymphocytic Leukemia Research
- Multiple and Secondary Primary Cancers
Roche (United States)
2023
United States Food and Drug Administration
2009-2020
Orlando Health
2013-2019
University of Pittsburgh
2012-2019
NRG Oncology
2019
Allegheny Health Network
2019
Sana Klinikum Offenbach
2019
Charité - Universitätsmedizin Berlin
2019
Q.D. Research
2018
American Society of Clinical Oncology
2014-2017
See accompanying editorial on page 1186 Lee M. Ellis, University of Texas MD Anderson Cancer Center, Houston, TX; David S. Bernstein and Richard L. Schilsky, American Society Clinical Oncology, Alexandria, VA; Emile E. Voest, Medical Center Utrecht, the Netherlands; Jordan D. Berlin, Vanderbilt-Ingram Nashville, TN; Daniel Sargent, Mayo Clinic, Rochester, MN; Patricia Cortazar, US Food Drug Administration, Silver Spring, MD; Elizabeth Garrett-Mayer, South Carolina, Charleston, SC; Roy Herbst...
On February 22, 2013, the FDA licensed ado-trastuzumab emtansine (Kadcyla; Genentech, Inc.) for use as a single agent treatment of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) who previously received trastuzumab and taxane, separately or in combination. The clinical basis licensure was phase III trial 991 HER2-positive MBC that randomly allocated to receive (n=495) lapatinib combination capecitabine (n=496). coprimary endpoints were...
The achievement of pathologic complete response (pCR) is strongly prognostic for event-free survival (EFS) and overall (OS) in patients with early breast cancer (EBC), adapting postneoadjuvant therapy improves long-term outcomes HER2-positive disease not achieving pCR. We sought to investigate factors EFS OS among without pCR after neoadjuvant systemic treatment consisting chemotherapy plus anti-HER2 therapy.We used individual data from 3,710 randomly assigned 11 trials EBC ≥100 enrolled,...
Purpose Patients with organ dysfunction, prior or concurrent malignancies, and comorbidities are often excluded from clinical trials. Excluding patients on the basis of these factors results in trial participants who healthier younger than overall population cancer. Methods ASCO Friends Cancer Research established a multidisciplinary working group that included experts design conduct to examine how eligibility criteria could be more inclusive. The analyzed current criteria; conducted...
Abstract On May 20, 2011, the U.S. Food and Drug Administration (FDA) approved sunitinib malate capsules (Sutent®; Pfizer, Inc., New York) for treatment of progressive, well-differentiated pancreatic neuroendocrine tumors (pNETs) in patients with unresectable locally advanced or metastatic disease. In a phase III randomized trial, 171 received either (37.5 mg) placebo once daily. The progression-free survival (PFS) interval was primary efficacy endpoint. Secondary endpoints included overall...
On June 8, 2012, the U.S. Food and Drug Administration (FDA) approved pertuzumab (Perjeta, Genentech) for use in combination with trastuzumab (Herceptin, docetaxel treatment of patients HER2-positive metastatic breast cancer (MBC) who have not received prior anti-HER2 therapy or chemotherapy disease. Approval was based on results a randomized, double-blind, placebo-controlled trial conducted 808 MBC. Patients were randomized (1:1) to receive (n = 402) placebo 406) docetaxel. The primary...
Malignant peritoneal mesothelioma (MPeM) is a rare but aggressive malignancy with limited treatment options. VEGF inhibition enhances efficacy of immune-checkpoint inhibitors by reworking the immunosuppressive tumor milieu. Efficacy and safety combined PD-L1 (atezolizumab) (bevacizumab) blockade (AtezoBev) was assessed in 20 patients advanced unresectable MPeM progression or intolerance to prior platinum-pemetrexed chemotherapy. The primary endpoint confirmed objective response rate per...
Pathologic complete response (pCR) has prognostic importance and is frequently used as a primary end point, but doubts remain about its validity surrogate for event-free survival (EFS) overall (OS) in human epidermal growth factor receptor 2 (HER2)-positive, early breast cancer.We obtained individual-patient data from randomized trials of neoadjuvant anti-HER2 therapy that enrolled at least 100 patients, had pCR, EFS, OS, median follow-up 3 years. We quantified the patient-level association...
Abstract Withdrawn by Author Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-14-20.
Article Tools SPECIAL DEPARTMENTS OPTIONS & TOOLS Export Citation Track Add To Favorites Rights Permissions COMPANION ARTICLES No companion articles ARTICLE CITATION DOI: 10.1200/JCO.2001.19.14.3439 Journal of Clinical Oncology - published online before print September 21, 2016 PMID: 11454894 Developing Drugs to Decrease the Toxicity Chemotherapy Grant WilliamsxGrant WilliamsSearch for by this author , Patricia CortazarxPatricia CortazarSearch Richard PazdurxRichard PazdurSearch Gerald...
Exposure-response (E-R) analyses for ado-trastuzumab emtansine (T-DM1, Kadcyla) were performed using data from a randomized, active control (lapatinib plus capecitabine) trial in patients with human epidermal growth factor 2-positive metastatic breast cancer. Kaplan-Meier survival stratified by T-DM1 trough concentration on day 21 of cycle 1 (Cmin,C1D21) overall (OS) and progression-free (PFS). E-R indicated that after adjusting baseline risk factors, higher exposure is associated improved...
Abstract Learning Objectives After completing this course, the reader will be able to: Consider tumor histology when making treatment decisions for patients with NSCLC.Identify NSCLC who may appropriate candidates maintenance therapy pemetrexed. This article is available continuing medical education credit at CME.TheOncologist.com. On July 2, 2009, U.S. Food and Drug Administration approved pemetrexed injection (Alimta® Injection; Eli Lilly Company, Indianapolis, IN) of locally advanced or...
619 Background: Neuroendocrine tumors (NETs) are relatively rare and heterogeneous arising throughout the aerodigestive tract, which incurable life-limiting when metastatic. Prior studies of checkpoint inhibitors in NET patients have yielded minimal evidence efficacy. Historically, effective therapies for advanced, progressive yield response rates less than 10% progression-free survival (PFS) durations approximately 11 months, as compared to 4.5 months with placebo. Methods: We undertook a...
The standard-of-care for patients with pathological complete response (pCR) after neoadjuvant human epidermal growth factor receptor 2 (HER2)-targeted therapy plus chemotherapy is continuation of HER2-targeted in the adjuvant setting. Our objective was to evaluate risk recurrence or death these and determine if outcomes differed by regimen received each We analyzed patient-level data from five randomized trials evaluating trastuzumab, pertuzumab, both as part systemic HER2-positive early...
Abstract On December 19, 2008, the U.S. Food and Drug Administration approved imatinib mesylate tablets for oral use (Gleevec®; Novartis Pharmaceuticals Corporation, East Hanover, NJ) adjuvant treatment of adult patients following complete gross resection Kit+ (CD117+) gastrointestinal stromal tumor (GIST). A randomized, double-blind, placebo-controlled study enrolling 713 was submitted. The primary objective clinical trial to compare recurrence-free survival (RFS) intervals two groups....
Abstract Background: Pathologic complete response (pCR) is a proposed surrogate endpoint for predicting long-term clinical benefit on endpoints such as disease-free survival (DFS), event-free (EFS), or overall (OS). A meta-analysis needed to establish the magnitude of pCR improvement trial level that results in improved DFS, EFS, OS. Methods: We identified 12 neoadjuvant randomized trials (N = 13,125) with clearly defined and follow-up available EFS Trials included AGO 1 (n 668), ECTO 1355),...
Group sequential designs (GSD), which provide for interim monitoring of efficacy data and allow potential early trial termination while preserving the type I error rate, have become commonplace in oncology clinical trials. Although ethically appealing, GSDs tend to overestimate true treatment effect size at analyses. Overestimation may exaggerate benefit a drug imprecise information physicians their patients about drug's effect. The cause such phenomenon are generally not well understood by...
61 Background: There is limited information on LRR rates in pts treated with NAC. Methods: 12 large NAC BC trials (11,955 pts) pCR and long-term F/U for LRR, EFS OS were included. Primary aims to assess by pCR, tumor subtype, surgery type other clinico-pathologic factors. Main definition of was ypT0/is ypN0. Results: Median F/U: 5.4 years. age: 49, T2 tumors: 61%, Inflammatory BC: 4%; Clinically(+) nodes: 47%. Overall LRR: 6.8% (95% CI: 6.3, 7.2). 5.5% (ypT0/isypN0) vs. 7.1% without. After...