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Showing 8051 - 8100Sorafenib 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 ...
Second-Line Regorafenib Improves Survival in Metastatic Colorectal Cancer
In the phase III double-blind, placebo-controlled CONCUR trial,1 previously treated patients with stage IV adenocarcinoma of the colon or rectum had increased overall survival, the primary endpoint, when treated with regorafenib (Stivarga). Regorafenib also improved progression-free survival, a...
Adding Novel Agent to Standard Therapy Improves Survival in Patients With Pancreatic Cancer After Prior Gemcitabine-Based Therapy
The addition of the novel agent MM-398 to standard treatment improved overall survival in patients with metastatic pancreatic cancer who have already received gemcitabine, according to a phase III trial reported at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.1 “Patients...
Expert Point of View: Jean-Yves Douillard, MD, PhD
Commenting on the RECOURSE data,1 ESMO spokesperson Jean-Yves Douillard, MD, PhD, Professor of Medical Oncology, Institut de Cancérologie de l’Ouest (ICO) René Gauducheau, Saint-Herblain, France, said, “The phase III trial of TAS-102 is a global study and confirms the results of the phase II study...
Phase III Trial Shows Improved Survival With TAS‑102 in Metastatic Colorectal Cancer Refractory to Standard Therapies
The new combination agent TAS-102 can improve overall survival compared to placebo in patients whose metastatic colorectal cancer is refractory to standard therapies, researchers reported at the ESMO 16th World Congress on Gastrointestinal Cancer in Barcelona.1 “Around 50% of patients with...
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...
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...
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...
Benefit Confirmed for Adjuvant Oxaliplatin in Rectal Cancer
Patients with curatively resected rectal cancer are more likely to be disease-free at 3 years after treatment with an oxaliplatin-containing regimen than with fluorouracil (5-FU)/leucovorin, Korean investigators of the phase II multicenter ADORE trial reported at the ASCO Annual Meeting.1 Study...
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...
Considerable Extension of Survival Achieved With Conventional Treatment in Grade 2 Glioma
Long-term results from the Radiation Therapy Oncology Group (RTOG) 9802 study in high-risk grade 2 gliomas were presented at the 2014 ASCO Annual Meeting. The study’s mature analysis showed a 41% reduction in mortality at 5 years with combination radiation therapy followed by six cycles of PCV...
What Do Humans and Laboratory Rats Have in Common?
The requirements for sound evidence of a drug’s therapeutic benefit have translated laboratory experience to human testing. In the laboratory, experimental animals give their lives to lethal testing of drugs and scientific analysis. LD50, the terminology denoting an anticipated 50% death rate of...
Everolimus Did Not Improve Survival in Hepatocellular Cancer After Progression on Sorafenib
“Despite the strong scientific rationale and preclinical data, everolimus [Afinitor] plus best supportive care failed to improve survival over placebo plus best supportive care” among patients with advanced hepatocellular cancer that progressed during or after receiving sorafenib (Nexavar), or who...
High False-Positive Rate of Elevated CEA Seen in Patients With Resected Colorectal Cancer
A retrospective study finding a 49% false-positive of carcinoembryonic antigen (CEA) testing among patients with a history of resected colorectal cancer, “suggests that confirmation of an ongoing increase in CEA level should be universal practice before an extensive workup is initiated,” Anya...
Ongoing Clinical Trials Actively Recruiting Patients With Bladder Cancer
The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with bladder cancer. The list includes randomized and nonrandomized phase 0 to III studies as well as observational clinical trials evaluating new therapies, surgical techniques, and...
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...
Taking Charge of Your Care
The first sign I had that something might be wrong was an uncontrollable itch all over my body. Although I had never had anything like that before, the problem was easy to initially dismiss. I’m a respiratory therapist and visit patients in their homes daily, so I chalked up the itchiness to an...
Pioneering Medical Oncologist Remembers a Time Before the Subspecialty Was Created
While the first written record of cancer dates back to ancient Egypt, the history of modern oncology is fairly short, dating back only slightly more than half a century. Clinical trials in the early days of the National Cancer Institute (NCI) and the emerging cooperative groups were led by a...
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...
Michael Bookman, MD, Joins US Oncology Research as Medical Director of Gynecology Research Program
Michael Bookman, MD, of the University of Arizona Cancer Center will join Arizona Oncology, a practice in The US Oncology Network, and serve as Medical Director of the US Oncology Research Gynecology Research Program. In his new role, effective October 6, 2014, Dr. Bookman will use his extensive...
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...
Early Change in Chemotherapy Based on Elevated Circulating Tumor Cells Does Not Improve Outcome in Metastatic Breast Cancer
Elevated circulating tumor cells are associated with poor prognosis in metastatic breast cancer. In a phase III trial (Southwest Oncology Group [SWOG] S0500) reported in Journal of Clinical Oncology, Jeffrey B. Smerage, MD, PhD, Clinical Associate Professor in Medical Oncology at the University of...
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...
Study Finds New Genetic Risk Markers in Pancreatic Cancer
A large DNA analysis of people with and without pancreatic cancer has identified several new genetic markers that signal increased risk of developing the disease, report scientists from Dana-Farber Cancer Institute and other institutions worldwide. The markers are variations in the inherited DNA...
PREVAIL Trial: Enzalutamide Before Chemotherapy Prolongs Survival in Metastatic Prostate Cancer
The androgen-receptor inhibitor enzalutamide (Xtandi) has been shown to prolong survival in men with metastatic castration-resistant prostate cancer with progressive disease after chemotherapy. In the phase III PREVAIL trial reported in The New England Journal of Medicine, Tomasz M. Beer, MD, of...
EGFR as a Therapeutic Target for Gastroesophageal Cancer—or Is It Really?
The epidermal growth factor receptor (EGFR) gene is often amplified and its protein overexpressed in upper gastrointestinal cancers—and overexpression has prognostic value. With the advent of monoclonal antibodies and tyrosine kinase inhibitors against EGFR, we have witnessed a rash of randomized...
No Overall Survival Improvement but Some Palliative Benefit With Gefitinib in Esophageal Cancer Progressing Postchemotherapy
In what may be the first randomized trial of systemic therapy in this setting, Susan J. Dutton, MSc, of University of Oxford, United Kingdom, and colleagues evaluated the epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor gefitinib vs placebo in patients with esophageal cancer...
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...
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...
Patient, Tumor Characteristics Associated With BRAF and KRAS Mutations
KRAS and BRAF V600E mutations were nearly mutually exclusive and associated with specific patient and tumor characteristics, such as age and smoking status, according to an analysis of data from the N0147 phase III trial for stage III colon cancer. Primary tumors were assessed for KRAS and BRAF...
Survival Benefit of Contralateral Prophylactic Mastectomy Less Than 1% at 20 Years, but Numbers of Procedures Have Increased
For women with stage I and II breast cancer without BRCA mutations, the absolute 20-year survival benefit from contralateral prophylactic mastectomy was less than 1%, regardless of age, estrogen receptor status, and cancer stage, according to a decision analysis study using a Markov model to...
Ongoing Clinical Trials Actively Recruiting Patients With Kidney Cancer
The information in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with kidney cancer. The list includes a pilot study and observational, randomized, and nonrandomized phase II and phase III studies evaluating new therapies, combination therapies,...
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,...
Phase III Trial of Figitumumab Plus Chemotherapy in Advanced NSCLC Stopped Early for Futility and Increased Harm
In the first phase III trial assessing the combination of an insulin-like growth factor 1 receptor (IGF-1R) inhibitor with chemotherapy as first-line treatment for advanced nonadenocarcinoma non–small cell lung cancer (NSCLC), the addition of the fully human immunoglobulin G2 monoclonal antibody...
Bevacizumab in Persistent, Recurrent, or Metastatic Cervical Cancer
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 14, 2014, bevacizumab (Avastin) was approved for the...
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...
Protocol Modifications Decrease Toxicity, Increase Event-Free Survival in Children With Down Syndrome Treated for ALL
Protocol modifications to address increased risk of toxicity and excess early mortality among children with Down syndrome being treated for B-cell acute lymphoblastic leukemia (ALL) proved safe for patients with Down syndrome, and these patients had event-free survival similar to those without Down ...
FDA Grants Fast Track Designation to Novel JAK2 Inhibitor for the Treatment of Myelofibrosis
The U.S. Food and Drug Administration has granted Fast Track designation to pacritinib for the treatment of intermediate- and high-risk myelofibrosis, including patients with disease-related thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are suboptimally...
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...
