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Showing 3551 - 3600FDA’s First Site-Agnostic Drug Approval Marks a Paradigm Shift in Regulatory Criteria
IN MAY, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with solid tumors that have the microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) biomarker, which disrupts the ability of cells to repair DNA. The...
Tissue Specimens in Clinical Trials: A Double-Edged Sword
AN INCREASING number of clinical trials require the submission of tissue specimens, either from archived specimens or increasingly from fresh biopsies taken after enrollment into the trial. These specimens can be either mandatory, required to determine whether a given patient has the required...
A New Triumvirate in Estrogen Receptor–Positive Metastatic Breast Cancer
THE BODY OF EVIDENCE supporting the use of cell-cycle inhibitors in combination with endocrine therapy for estrogen receptor–positive metastatic breast cancer now has another agent in the spotlight. The phase III MONARCH 2 trial—reported at the 2017 ASCO Annual Meeting and by Sledge et al in the...
FDA Grants Durvalumab Breakthrough Therapy Designation for Patients With Locally Advanced Unresectable NSCLC
On July 31, AstraZeneca and MedImmune (AstraZeneca’s global biologics research and development arm) announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for durvalumab (Imfinzi) for the treatment of patients with locally advanced,...
Initial Progression-Free Survival Results From the MYSTIC Trial in Stage IV NSCLC
On July 27, researchers announced the progression-free survival (PFS) results for the phase III MYSTIC trial, a randomized, open-label, multicenter, global trial of durvalumab (Imfinzi) monotherapy or durvalumab in combination with tremelimumab vs platinum-based standard-of-care chemotherapy in...
NCI-COG Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers
Today, investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore...
Concurrent Chemotherapy, Proton Therapy May Improve Survival in Patients With Advanced Lung Cancer
For patients with advanced, inoperable stage III lung cancer, concurrent chemotherapy and proton-beam radiotherapy offers improved survival compared to historical data for standard of care, according to a new study from The University of Texas MD Anderson Cancer Center. The research, published by...
Neoadjuvant Ado-trastuzumab Emtansine vs Trastuzumab in Early HER2-Positive, HR-Positive Breast Cancer
A West German Study Group phase II trial, reported by Harbeck et al in the Journal of Clinical Oncology, has shown a higher pathologic complete response rate with neoadjuvant ado-trastuzumab emtansine (formerly known as T-DM1; Kadcyla) with or without endocrine therapy vs trastuzumab (Herceptin)...
Pembrolizumab and Cetuximab-Treated Head and Neck Cancer: Activity Confirmed But No Surprises
WITH THE RECENT efficacy findings, improvements in survival, and resultant U.S. Food and Drug Administration (FDA) approvals of programmed cell death protein 1 (PD-1) immune checkpoint inhibitors across multiple solid tumor indications, the publication of yet another positive trial adds to the...
Pembrolizumab in Second-Line Therapy for Advanced Urothelial Carcinoma
THE TREATMENT OF metastatic urothelial carcinoma experienced a long period of stagnation until the recognition that targeting the programmed cell death protein 1 (PD-1) pathway could yield deep and durable responses.1-3 Cisplatin-based combination chemotherapy has been the reference standard for...
Breast Cancer and Brain Metastases: Whole-Brain Radiotherapy May Not Be the Answer
FOR PATIENTS WITH BREAST CANCER who have metastases to the central nervous system (CNS), clinicians should think twice before administering whole-brain radiotherapy, according to Kimberly Blackwell, MD, Professor of Medicine and Assistant Professor of Radiation Oncology at Duke University Medical...
Are Wearable Physical Activity Monitors Coming of Age in Oncology?
COMMERCIALLY AVAILABLE wearable physical activity monitors have been making their way into clinical research in recent years; however, most studies on these devices have been related to non-cancer conditions including obesity, depression, and physical activity. Their application in the field of...
Radiation Therapy for Spinal Cord Compression: One Treatment Is Sufficient
SPINAL CORD COMPRESSION associated with metastatic cancer can be effectively treated with a single dose of radiotherapy, according to the results of a phase III British study that showed multiple radiotherapy doses to be no better than one treatment.1 Up to 10% of all patients with cancer will...
Maintaining Predictable Increases in NIH Funding for Cancer Research
CONGRESS RECENTLY passed its fiscal year (FY) 2017 spending bill, which contains an additional $2 billion for the National Institutes of Health (NIH). This marks the first time in more than a dozen years that Congress funded back-to-back increases for the NIH, demonstrating the bipartisan...
Edus H. Warren, MD, PhD, Named Leader of Fred Hutch Global Oncology Program
Immunotherapy researcher and oncologist Edus H. Warren, MD, PhD, has been selected to lead the Fred Hutchinson Cancer Research Center (Fred Hutch) program in Global Oncology in its effort to transform cancer care in sub-Saharan Africa, China, and other regions by providing greater access to the...
Advance Care Planning: Ensuring Patients’ End-of-Life Wishes Are Honored
When Amy Berman, BSN, LHD (aged 58), stood in front of the mirror to perform a routine breast self-exam and saw redness and dimpling on her right breast, she feared they were the telltale signs of inflammatory breast cancer. “I have never self-diagnosed myself before, but I had recently read an...
ASTRO Updates Insurance Coverage Recommendations for Proton Therapy
The American Society for Radiation Oncology (ASTRO) has issued an update to its recommendations for medical insurance coverage regarding the use of proton beam therapy to treat cancer. The updated Proton Beam Therapy Model Policy provides guidance to payers on clinical indications that are...
Impact of Health Insurance and Sociodemographic Status on Survival for AYAs With Cancer
According to the National Cancer Institute, cancer is the leading cause of disease-related death among adolescents and young adults (AYAs) between the ages of 15 and 39. And although cancer survival among this age group is more than 80%, AYAs have not experienced the same improvements in relative...
FDA Approves First Companion Diagnostic Test to Simultaneously Screen for Multiple NSCLC Therapies
On June 22, the U.S. Food and Drug Administration (FDA) granted premarket approval to Thermo Fisher Scientific for the first next-generation sequencing–based test that simultaneously screens tumor samples for biomarkers associated with three FDA-approved therapies for non–small cell...
Has a New Standard Really Been Established for the Adjuvant Treatment of Pancreatic Cancer?
THE PAST YEAR has undoubtedly been a disappointing one as far as clinical advances in pancreatic cancer go. No fewer than five high-profile randomized phase II or III trials in this setting reported negative results in 2016, ranging from next-generation cytotoxic agents1 to novel immunotherapeutic ...
Preparing for Future Challenges in Geriatric Surgical Oncology
In the past decade, advances in surgical oncology have been echoed in the field of geriatric oncology. The current literature regarding older people with cancer includes mainly retrospective cohort studies, focusing on alternatives to radical surgery in comorbid patients. More recently, work has...
Second Cancers May Be Deadlier in Child, Adolescent, and Young Adult Patients
Second cancers in children and adolescents and young adults (AYAs) are far deadlier than they are in older adults and may partially account for the relatively poor outcomes of cancer patients between the ages of 15 and 39 overall, a new study by researchers at the University of California, Davis...
Autologous and Allogeneic Hematopoietic Cell Transplantation
HERE ARE SEVERAL ABSTRACTS selected from the proceedings of the 2016 American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting clinical trials on autologous and allogeneic hematopoietic cell transplantation for various hematologic malignancies. Additional selected...
Potent PARP Inhibitor Moves Ahead in BRCA-Mutated Breast Cancer
TALAZOPARIB, a novel inhibitor of poly (ADP-ribose) polymerase (PARP), showed encouraging efficacy in breast cancer patients with BRCA1/2 mutations in the phase II ABRAZO trial, presented at the 2017 ASCO Annual Meeting by Nicholas C. Turner, MD, of the Royal Marsden Hospital and The Institute of...
Retreatment With Checkpoint Inhibitors May Be Feasible for Some Patients With NSCLC
INCREASING NUMBERS of patients are being treated with checkpoint inhibitors, and about one-quarter to one-third will develop immune-related adverse events. One question on the minds of oncologists is can these patients be safely re-treated once their adverse events resolve? One of the first...
Expert Point of View: John Heymach, MD
"TO PUT THESE RESULTS into context, currently we have three approved epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors for EGFR-positive non–small cell lung cancer (NSCLC): gefitinib (Iressa), erlotinib (Tarceva), and afatinib (Gilotrif). Not many studies have compared these drugs ...
Dacomitinib Outperforms Gefitinib in EGFR-Positive NSCLC
DACOMITINIB, a second-generation epidermal growth factor receptor (EGFR)-targeted tyrosine kinase inhibitor, outperformed gefitinib (Iressa) as first-line treatment for EGFR-positive advanced non–small cell lung cancer (NSCLC) in the phase III ARCHER 1050 study.1 Dacomitinib improved...
Annual Report to the Nation: Cancer Death Rates Continue to Decline
Overall cancer death rates continue to decrease in men, women, and children for all major racial and ethnic groups, according to the latest Annual Report to the Nation on the Status of Cancer, 1975–2014, published by Jemal et al in the Journal of the National Cancer Institute.1 The report finds...
FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer
On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...
Idelalisib in Resistant CLL: Benefit Shown, Questions Remain
As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...
FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
On June 29, the U.S. Food and Drug Administration (FDA) allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency-authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas, including chronic leukemia, acute leukemia, non-Hodgkin...
European Commission Expands Use of Ceritinib for First-Line Use in ALK-Positive Advanced NSCLC
On June 29, the European Commission approved expanding the use of ceritinib (Zykadia) to include the first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)–positive. Approval follows a positive opinion granted...
First-Line Nivolumab vs Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 5%
As reported by Carbone et al in The New England Journal of Medicine, the phase III CheckMate 026 trial has shown no progression-free survival benefit for first-line nivolumab (Opdivo) vs platinum-based chemotherapy in patients with recurrent or stage IV non–small cell lung cancer with...
EHA 2017: The DYNAMO Study: Duvelisib in Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma
Long-term follow-up data from the DYNAMO study, which met its primary endpoint of overall response rate (ORR; P = .0001) at the final analysis, was presented at the 22nd Congress of the European Hematology Association (EHA) (Abstracts S777, E1130). DYNAMO is a phase II clinical study...
FDA Grants Regular Approval to Dabrafenib and Trametinib Combination for Metastatic NSCLC With BRAF V600E Mutation
On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib (Tafinlar) and trametinib (Mekinist) administered in combination for patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These ...
Atezolizumab as First-Line or Subsequent Treatment in PD-L1–Selected Advanced NSCLC
In the phase II BIRCH trial, atezolizumab (Tecentriq) was found to produce higher response rates as first-line or subsequent therapy in patients with advanced non–small cell lung cancer (NSCLC) with higher levels of programmed cell death ligand 1 (PD-L1) expression. Study findings were...
Expert Point of View: John V. Heymach, MD, PhD
“This is a watershed moment in the treatment of anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Often studies show only incremental improvements with a new treatment. This is different. Alectinib [Alecensa] shows a dramatic increase in efficacy that is also accompanied ...
ASCP/CAP/AMP/ASCO Colorectal Cancer Biomarker Guideline: A Clinician's Perspective
The joint American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and ASCO guideline reported by Sepulveda et al, and reviewed in this issue of The ASCO Post, represents a collaboration of three pathology societies and ASCO ...
Alectinib vs Crizotinib in First-Line Treatment of ALK-Positive NSCLC
In 2011, crizotinib (Xalkori) became the first effective targeted therapy for anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Now data from a phase III trial show that alectinib (Alecensa), a second-generation ALK inhibitor, outperformed crizotinib, the current...
Newer Approaches With CAR T Cells Explored in CLL
Chimeric antigen receptor (CAR) T-cell therapy is a hot area of research and development in hematologic malignancies and, more recently, some solid tumors. Results have been particularly good in acute lymphocytic leukemia, and one or more CAR T-cell products may be getting close to approval by the ...
ICML 2017: Data From the TRANSCEND Trial of JCAR017 in Relapsed and Refractory Aggressive B-Cell Non-Hodgkin Lymphoma
Data from the TRANSCEND trial of JCAR017 in relapsed and refractory aggressive B-cell non-Hodgkin lymphoma (NHL) was presented at the 2017 International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. JCAR017 is Juno Therapeutics’ investigative chimeric antigen receptor (CAR) ...
ICML 2017: ADCT-402 Demonstrates Encouraging Antitumor Activity in Relapsed/Refractory Non-Hodgkin Lymphoma
Clinical data from an ongoing phase I clinical trial evaluating ADCT-402 for the treatment of relapsed or refractory non-Hodgkin lymphoma was presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. ADCT-402 is a novel antibody-drug conjugate composed of a ...
ICML 2017: Triplet Combination of Umbralisib, Ublituximab, and Ibrutinib in CLL/SLL/NHL
Data from the chemotherapy-free triple combination of umbralisib, an oral, next generation PI3K delta inhibitor; ublituximab, a novel glycoengineered anti-CD20 monoclonal antibody; and ibrutinib (Imbruvica) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and...
ICML 2017: Phase II Trial of Tazemetostat in Relapsed or Refractory Follicular Lymphoma and DLBCL
Positive interim efficacy data from an ongoing phase II clinical trial of tazemetostat, a first-in-class, oral enhancer of zeste homolog 2 (EZH2) inhibitor, as a single-agent treatment for relapsed or refractory patients with follicular lymphoma or diffuse large B-cell lymphoma (DLBCL) grouped by...
Impact of Subsidies on Use of Oral Immunomodulatory Drugs in Medicare Beneficiaries With Myeloma
According to a study by Olszewski and colleagues in the Journal of Clinical Oncology, Medicare Part D beneficiaries without a low-income subsidy may face daunting barriers in affording oral immunomodulatory drugs for myeloma. The low-income subsidy markedly reduces out-of-pocket costs for...
Ceritinib vs Chemotherapy in Previously Treated ALK-Rearranged NSCLC
The phase III ASCEND-5 trial has shown a significant improvement in progression-free survival with ceritinib (Zykadia) vs chemotherapy in advanced ALK-rearranged non–small cell lung cancer (NSCLC) previously treated with crizotinib (Xalkori) and chemotherapy. Trial results were reported in...
ASTRO Issues Guideline for Use of Stereotactic Radiation in Early-Stage Lung Cancer
The American Society for Radiation Oncology (ASTRO) has issued a new clinical guideline for the use of stereotactic body radiation therapy (SBRT) in early-stage lung cancer. While SBRT is the current standard of care for peripherally located tumors in patients who cannot undergo surgery, the new...
PD-L2 Expression and Clinical Response to Pembrolizumab in Head and Neck Cancer
A study assessing the prevalence and distribution of programmed cell death ligand 2 (PD-L2) in human tumor samples across seven cancer indications, including renal cell carcinoma, bladder, melanoma, non–small cell lung cancer, triple-negative breast cancer, gastric carcinoma, and head and...
Sacituzumab Govitecan in Previously Treated Patients With Metastatic NSCLC
As reported by Heist et al in the Journal of Clinical Oncology, the antibody-drug conjugate sacituzumab govitecan showed activity in patients with previously treated metastatic non–small cell lung cancer (NSCLC). Sacituzumab targets Trop-2, present on many solid tumors; govitecan is the...
Androgen Blockade and Salvage Radiation Therapy in Prostate Cancer: Cautious Optimism Amid Unanswered Questions
The recent report of results of RTOG 9601 by Shipley et al in The New England Journal of Medicine1—reviewed in this issue of The ASCO Post—strongly supports the variably used practice of adding “androgen blockade” to salvage radiation therapy in men with a rising prostate-specific antigen (PSA)...
