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Showing 4151 - 4200Ado-Trastuzumab Emtansine as a Late Treatment for HER2-Positive Metastatic Breast Cancer—Better and Less Toxic Than Physician’s Choice
TH3RESA is a randomized phase III open-label study, reported in The Lancet Oncology and summarized in this issue of The ASCO Post, which examined the activity of ado-trastuzumab emtansine (Kadcyla) in heavily pretreated HER2-positive metastatic breast cancer.1 Formerly known as T-DM1,...
Strong Showing for Anti–PD-1 Agents in Non–Small Cell Lung Cancer
Monoclonal antibodies targeting the programmed death receptor-1 (PD-1) pathway are expected to answer an unmet need in non–small cell lung cancer (NSCLC). With first-line platinum-doublets, 1-year overall survival is 30% to 50%, and while treatments targeting sensitizing mutations are more...
Ipilimumab Reduces Recurrences as Adjuvant Treatment of Melanoma
Ipilimumab (Yervoy) has transformed the treatment of metastatic melanoma, producing long-term responses in about 20% of patients. A phase III study has now evaluated its impact in the adjuvant setting, and the results are a bit less striking. Primary Endpoint The European Organisation for Research...
'Impressive' Outcomes Achieved With Pembrolizumab in Advanced Melanoma
The latest bit of good news for the programmed death receptor-1 (PD-1)–targeting antibodies in advanced melanoma comes for pembrolizumab (MK-3475). While the results came from only a phase I study, they were among those chosen for presentation at an ASCO press briefing during the Annual Meeting....
Avoiding Antioxidant-Drug Interactions During Cancer Treatment
Many potential drug-nutrient interactions can affect cancer treatment. It is important to consider these interactions given the significant use of supplements and other self-treatment options during cancer care. Antioxidants account for a large portion of the $32 billion in supplement industry...
Lung-MAP Trial Debuts—Other Personalized Studies Will Follow
Oncologists now have a means of bringing personalized medicine to advanced squamous cell carcinoma, and it involves a biomarker-driven clinical trial that maximizes the chance of successful treatment and new drug approvals. Lung-MAP (Lung Cancer Master Protocol) is a unique concept in which the...
Belinostat for Relapsed/Refractory Peripheral T-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 3, 2014, belinostat (Beleodaq) was granted accelerated...
Progress in Differentiated Thyroid Cancer
Treatment of differentiated thyroid cancer has been slow to advance. Three decades lapsed between the description of the first differentiated thyroid cancer patient being cured by radioactive iodine in the 1940s1 and the report of the study that led to the approval of doxorubicin in the 1970s.2 The ...
Sorafenib Improves Progression-Free Survival in Progressive Radioactive Iodine–Refractory Differentiated Thyroid Cancer
Patients with radioactive iodine–refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis. In the double-blind phase III DECISION trial reported in The Lancet, Marcia S. Brose, MD, PhD, of Abramson Cancer Center of the University of Pennsylvania, and colleagues ...
Federally Funded Trials Praised—and Underfunded
All four studies presented at the 2014 ASCO Annual Meeting Plenary Session were at least partially funded by federal dollars, bringing long overdue attention to the value of federally supported cancer research. Perhaps because of this high visibility, ASCO leaders took to the soapbox to sound the...
Investigational Immunotherapy Demonstrates Response in Patients With PD-L1–Positive Metastatic Bladder Cancer
The investigational immunotherapy agent MPDL3280A (also known as anti-PDL1) produced an overall response rate of 43% in a phase I study of patients previously treated for metastatic urothelial bladder cancer whose tumors were characterized as programmed death ligand 1 (PD-L1)-positive. Results of...
FDA Approves Belinostat for Relapsed or Refractory Peripheral T-Cell Lymphoma
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to belinostat (Beleodaq), a histone deacetylase inhibitor, for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma (NHL). “This is the...
Breast Cancer–Related Benefits of Weight Loss
Obesity and physical inactivity are associated with an increased risk of developing and dying of breast cancer via several proposed mechanisms. Two studies presented at the 2014 ASCO Annual Meeting explored the relationships among exercise, weight loss, and breast cancer risk. One study was...
Impressive Delay in Thyroid Cancer Progression Achieved With Lenvatinib
The investigational tyrosine kinase inhibitor lenvatinib reduced disease progression by 79%, as compared to placebo, in patients with metastatic differentiated thyroid cancer that is refractory to radioactive iodine in the phase III SELECT trial. These findings were presented at the 2014 ASCO...
Intralesional Injections Trigger Immune Responses in Melanoma
The emerging approach to treating metastatic melanoma is a full-throttle effort to stimulate an immune response. One of the components of this strategy could be intralesional injections, according to studies presented at the 2014 ASCO Annual Meeting. T-VEC Oncolytic Immunotherapy Talimogene...
Neoadjuvant Chemotherapy Less Invasive Option for Advanced Ovarian Cancer, but Jury Still Out
Neoadjuvant chemotherapy followed by interval debulking surgery may be a better strategy for the initial treatment of advanced ovarian cancer than the current standard of care, suggest results of a phase III trial. Neoadjuvant chemotherapy followed by interval debulking surgery led to fewer...
Expert Point of View: Philip McCarthy, MD
Melphalan, prednisone, and thalidomide (Thalomid), or MPT, was a widely accepted regimen in newly diagnosed multiple myeloma when the E1A06 trial was launched, noted Philip McCarthy, MD, Director of the Blood and Marrow Transplant Program at the Roswell Park Cancer Institute, Buffalo, New York....
Multiple Myeloma Studies Explore Roles of Panobinostat in Relapsed/Refractory Disease and Thalidomide Compared to Lenalidomide as Part of Initial Therapy
At the 2014 ASCO Annual Meeting, one phase III trial confirmed the promise of a novel agent in advanced multiple myeloma, while another cooperative group trial returned some rather surprising results in newly diagnosed myeloma patients. Panobinostat Doubles Response, Prolongs Remission The phase...
Cancer Survivor and Patient Advocate Michael S. Katz, MBA, Has Helped Alter the Standard of Care for Myeloma Survivors
Michael S. Katz, MBA, has lived longer than any of his doctors thought he would. A two-time cancer survivor, Mr. Katz was diagnosed, first with multiple myeloma in 1990 and then with colorectal cancer in 2008, and has spent the past 2 decades tirelessly advocating for patients with cancer. The...
Ibrutinib in Previously Treated CLL and CLL With 17p Deletion
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 28, 2014, the approved use of ibrutinib (Imbruvica) in...
Idelalisib for Relapsed CLL in Combination With Rituximab and for Relapsed Follicular Lymphoma or Small Lymphocytic Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On July 23, 2014, idelalisib (Zydelig) was approved for use in...
Circulating Tumor Cells in Metastatic Breast Cancer: Are We Afraid of the Truth?
All truths are easy to understand once they are discovered; the point is to discover them.” —Galileo Galilei There are several “truths” in breast oncology that have been discovered over the years, become widely understood, and changed the way we practice. Prospective randomized studies have...
FDA Approval of Ceritinib for the Treatment of ALK-Positive Non–Small Cell Lung Cancer
INSIDE THE BLACK BOX is an occasional column providing insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, FDA oncologists Sean Khozin, MD, MPH, and Dikran Kazandjian, MD, discuss anaplastic lymphoma kinase (ALK)-positive non–small cell...
FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women with ovarian...
FDA Grants Bevacizumab Priority Review for Certain Types of Cervical Cancer
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy in the treatment of women with persistent, recurrent, or metastatic cervical cancer. The designation of Priority...
Enzalutamide and the Landscape of Castration-Resistant Prostate Cancer: Integrating New Indications With Existing Agents
The androgen receptor axis is a validated target for the treatment of castration-resistant prostate cancer. Several perturbations in this pathway are postulated to lead to androgen-independent growth, including androgen receptor mutation and amplification as well as the autocrine production of...
NEPA for Chemotherapy-Induced Nausea and Vomiting: Key Endpoints and Additional Analyses Show Strong Efficacy
For the prevention of chemotherapy-induced nausea and vomiting, NEPA, a novel combination of a neurokinin-1 (NK1) receptor antagonist and the 5-HT3 receptor antagonist palonosetron (Aloxi), has been studied in three pivotal trials that were recently published in the Annals of Oncology.1-3 Further...
Tackling the Heterogeneity of Triple-Negative Breast Cancer
Triple-negative breast cancer is now recognized as a very complex subtype for which one treatment will not be applicable to all, according to Mohammad Jahanzeb, MD, Professor of Clinical Medicine at the University of Miami and Director of the UM Sylvester Deerfield Campus, who gave an update on...
New Research Presented in Wilms Tumor, Pediatric Sarcoma, Head and Neck Cancer, and Non–Small Cell Lung Cancer
In the past few months, numerous presentations from this year’s ASCO Annual Meeting have been covered in depth in the pages of The ASCO Post and online at ASCOPost.com. The brief summaries below capture additional important highlights that have not been covered thus far. We hope you will find them...
Mixed Results for Targeting MET in Non–Small Cell Lung Cancer
Two different abstracts explored the potential for MET as a therapeutic target in patients with metastatic non–small cell lung cancer (NSCLC), with different results. A phase III study found that onartuzumab, an antibody that targets the MET receptor, combined with erlotinib (Tarceva) was not as...
Studies Assess Response to Platinum Therapy in Triple-Negative Breast Cancer
Studies in triple-negative breast cancer presented at the 2014 ASCO Annual Meeting sought to determine predictors of response to platinum agents. One identified a subset of responders to neoadjuvant chemotherapy, but prediction proved more elusive in metastatic disease. Neoadjuvant Carboplatin The...
Expert Point of View: Lauren C. Harshman, MD
In her discussion of the renal cell carcinoma studies at the ASCO Annual Meeting, Lauren C. Harshman, MD, Assistant Professor of Medical Oncology at Dana-Farber Cancer Institute, Boston, suggested, “Given the plateau in efficacy with current treatments, there is space and need for agents with new...
Anti–PD-1 Agent Shows Activity in Renal Cell Carcinoma
Renal cell carcinoma can be added to the growing list of tumors that respond to programmed death (PD)-1 immune checkpoint inhibitors, according to the results of the CheckMate trials, presented at the 2014 ASCO Annual Meeting. The phase II CheckMate-010 trial evaluated three doses of nivolumab as a ...
Recent FDA Drug Approvals Foster Growing Treatment Armamentarium for Chronic Lymphocytic Leukemia and Rare B-Cell Lymphomas
Recent approvals announced by the U.S. Food and Drug Administration (FDA) have led to increased treatment options for managing several difficult-to-treat hematologic B-cell cancers. The newly approved drugs and/or their indications include the oral PI3K delta inhibitor idelalisib (Zydelig) for the...
Failure of IGF-1R Inhibitor Figitumumab in Advanced Nonadenocarcinoma Non–Small Cell Lung Cancer
The vast majority of non–small cell lung cancer (NSCLC) patients present with advanced disease, and many will develop metastases after primary curative therapy. Until recently, despite its low efficacy, chemotherapy remained the only treatment modality in metastatic NSCLC. Within the past decade,...
Palbociclib Expanded Access Program Open to Eligible Breast Cancer Patients
Pfizer Inc announced that the company has initiated a multicenter, open-label expanded access program in the United States for the investigational oral CDK 4/6 inhibitor, palbociclib. Through the program, palbociclib is being made available for use in combination with letrozole for postmenopausal...
Bortezomib Retreatment in Multiple Myeloma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On August 8, 2014, the approved use of bortezomib (Velcade) in...
FDA Approves Bortezomib Retreatment in Patients With Multiple Myeloma
The U.S. Food and Drug Administration has approved bortezomib (Velcade) for the retreatment of adult patients with multiple myeloma who had previously responded to bortezomib therapy and relapsed at least 6 months following completion of prior bortezomib treatment. The labeling update includes...
Understanding the Impact of Results From CALGB/ SWOG 80405 and Other New Data in Colorectal Cancer
The Cancer and Leukemia Group B (CALGB)/Southwest Oncology Group (SWOG) 80405 trial, presented during the Plenary Session at this year’s ASCO Annual Meeting, demonstrated that cetuximab (Erbitux) and bevacizumab (Avastin) confer similar benefits as first-line treatment with chemotherapy for KRAS...
Treating Multiple Myeloma in 2014
The field of multiple myeloma is rapidly changing, and the shifts that are occurring impact the management of these patients, from initial diagnosis through multiple relapses. At the 9th Annual New Orleans Summer Cancer Meeting, Sergio A. Giralt, MD, Chief of the Adult Bone Marrow Transplant...
Targeting KRAS Mutations in Lung Cancer: No Longer Impossible
The KRAS mutation has long been considered “undruggable,” but new approaches in drug development may change this. The end result could be effective new treatment options for KRAS-mutated non–small cell lung cancer (NSCLC), according to David R. Gandara, MD, who described the emerging findings at...
Stereotactic Body Radiation Therapy an Effective Option for Early-Stage Lung Cancer Patients
Stereotactic body radiation therapy (SBRT) is safe and effective in early-stage non–small cell lung cancer (NSCLC), as it confers local control in 90% or more patients with T1 disease, according to Roy Decker, MD, PhD, Associate Professor in the Department of Therapeutic Radiology at Yale Cancer...
No Survival Benefits With Erlotinib and Whole-Brain Radiotherapy for NSCLC With Multiple Brain Metastases
“To exploit the potential radiosensitizing properties, the direct effect on brain metastases, and systemic activity of erlotinib,” researchers from the United Kingdom tested concurrent erlotinib and whole-brain radiotherapy followed by maintenance erlotinib in patients with of non–small cell lung...
Ongoing Clinical Trials Actively Recruiting Patients With Intraocular Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of children and adults with intraocular cancers. The studies include pilot, phase 0, phase I, phase II, and observational trials evaluating new combination therapies, vaccines, optical...
National Cancer Institute Launches the National Clinical Trials Network to Expedite Scientific Advances
In March, the National Cancer Institute (NCI) transformed its Cooperative Group Program into the National Clinical Trials Network (NCTN). Spurred by recommendations in the Institute of Medicine (IOM) 2010 report, A National Cancer Clinical Trials System for the 21st Century: Reinvigorating the NCI...
Complications No Different Between Open and Robot-Assisted Radical Cystectomy When Open Urinary Diversion Performed
We read the letter to the editor in the July 24, 2014, issue of The New England Journal of Medicine entitled, “A Randomized Trial of Robot-Assisted Laparoscopic Radical Cystectomy,” with great interest.1 Provocative Results In the letter, reviewed in this issue of The ASCO Post, Bochner and...
Lung Cancer Webinar Highlights Brain Metastases and Thoracic Radiotherapy
Postoperative radiation therapy, given after adjuvant chemotherapy, significantly increased overall survival in non–small cell lung cancer (NSCLC) compared to chemotherapy alone, according to a study reported at ASCO’s 2014 Annual Meeting.1 That study, an analysis of records in the National Cancer...
Optimal Chemoradiotherapy Dosing and Recurrence After Stereotactic Body Radiotherapy Explored in Lung Cancer Webinar
Cetuximab (Erbitux) added no survival benefit to chemoradiation in stage III non–small cell lung cancer (NSCLC), according to results reported in a Plenary Session of the 2013 World Conference on Lung Cancer in Sydney, Australia.1 It was the second surprise result from the Radiation Therapy...
Angiogenesis in Ovarian Cancer: Are We Missing the Clinical Target?
Production of vascular endothelial growth factor (VEGF) is increased during normal ovulation, and can account for much of the reversible toxicity associated with ovarian hyperstimulation.1,2 We also have compelling data from multiple clinical trials to validate the importance of tumor-associated...
‘Paradigm-Shifting’ Results in Treatment of Hematologic Disorders
The three leukemia/lymphoma studies selected from the many 2014 ASCO Annual Meeting abstracts for presentation at the recent Best of ASCO meeting in Chicago “are really paradigm-shifting,” noted Lucy A. Godley, MD, PhD, of the University of Chicago. These studies, she said, “give great promise for...
