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Showing 451 - 500Adjuvant Temozolomide in 1p/19q Non-codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by Martin J. van den Bent, MD, of the Brain Tumour Centre at Erasmus MC Cancer...
Addition of Tumor-Treating Fields to Maintenance Temozolomide in Glioblastoma
Final results of a phase III trial reported by Stupp and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved progression-free and overall survival in patients with previously treated glioblastoma. The...
Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...
St. John’s Wort
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....
FDA Accepts sNDA for Osimertinib in First-Line Treatment of EGFR-Mutated NSCLC
On December 18, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) for the use of osimertinib (Tagrisso)—a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor with clinical activity against central...
Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes
On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug...
FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma
On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab was previously granted provisional approval in this setting under the FDA's ...
Phase III Trial of Combination Therapy for Progressive Glioblastoma
In a phase III trial reported in The New England Journal of Medicine, Wick et al found that adding bevacizumab (Avastin) to lomustine at first disease progression did not improve overall survival in patients with progressive glioblastoma. Study Details In the trial, 437 patients with disease...
Comparison of EGFR Inhibitors in Untreated Advanced EGFR-Mutant NSCLC
As reported in The New England Journal of Medicine by Soria et al, the phase III FLAURA trial has shown a significant progression-free survival benefit with the third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) osimertinib (Tagrisso) vs standard EGFR TKIs in...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer
MORE THAN A QUARTER of patients with recurrent high-grade glioma treated with the retroviral vector Toca 511 and the prodrug of the chemotherapy fluorouracil (5-FU), Toca FC, were alive more than 3 years after treatment, according to data from a subset of patients in a phase I clinical trial, Toca ...
Axicabtagene Ciloleucel for Large B-Cell Lymphoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On October 18, 2017, the chimeric antigen receptor (CAR)...
ESMO Asia 2017: Alectinib More Effective Than Crizotinib in Asian Patients With ALK-Positive NSCLC
A subanalysis of the phase III ALEX study has shown that alectinib (Alecensa) is more effective than the standard of care, crizotinib, in Asian patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC), researchers reported at the European Society for Medical...
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
Novel Tyrosine Kinase Inhibitor for ALK- or ROS1-Rearranged NSCLC
A phase I trial has shown that the ALK and ROS1 tyrosine kinase inhibitor lorlatinib is active in patients with advanced ALK- or ROS1-positive non–small cell lung cancer (NSCLC), including those with central nervous system (CNS) metastases and failure on at least two prior tyrosine kinase...
AACR-NCI-EORTC: Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer
More than a quarter of patients with recurrent high-grade glioma treated with the retroviral vector Toca 511 (vocimagene amiretrorepvec) combined with Toca FC (an extended-release formulation of fluorocytosine, a prodrug of fluorouracil [5-FU]) were alive more than 3 years after...
Predicting Risk of Subsequent CNS Tumors in Survivors of Childhood Cancer
As reported in the Journal of Clinical Oncology, Wang et al have developed a model for predicting risk of subsequent central nervous system (CNS) tumors in survivors of childhood cancer. Study Details In the study, matched childhood cancer survivors with (n = 82) and without (n = 228) subsequent...
Expert Point of View: Luis Paz-Ares, MD
FORMAL DISCUSSANT of the ALEX and ALUR trials, Luis Paz-Ares, MD, Professor of Medicine at the Hospital Universitario 12 de Octubre, Madrid, said that the ALEX trial is “good news” for patients. “Importantly, 40% had baseline metastases. Disease progression was nicely controlled with alectinib...
Alectinib Yields Favorable Results in Phase III Trials of ALK-Positive NSCLC
RESULTS OF TWO separate phase III trials confirm the activity of alectinib (Alecensa) in the central nervous system (CNS) in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Results lend support for alectinib as the better first-line treatment option over...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
Expert Point of View: Tony Mok, MD, FASCO
“IN 2008, I presented the IPASS results. FLAURA has beaten me to the ground. The results exceeded expectations, and FLAURA is undoubtedly a positive study,” stated formal discussant Professor Tony Mok, MD, FASCO, Chair of Department of Clinical Oncology, the Chinese University of Hong Kong. “It is ...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2017, durvalumab (Imfinzi) was granted...
Cumulative Burden of Chronic Health Conditions in Childhood Cancer Survivors
In a report from the St Jude Lifetime Cohort Study published in The Lancet, Bhakta et al detailed the burden of lifetime chronic health conditions in survivors of childhood cancers. The report included retrospectively collected data on chronic health conditions in 5,522 patients treated for...
Small Steps Forward in Brain Tumor Therapy
SOME RECENT ADVANCES in the treatment of brain tumors are promising, but others are less so, according to Jeffrey J. Olson, MD, Professor of Neurosurgery at Emory University, Atlanta. At the 2017 Debates and Didactics in Hematology and Oncology Conference, held in Sea Island, Georgia, and...
FDA Approves First Biosimilar for the Treatment of Cancer
The U.S. Food and Drug Administration today approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the U.S. for the treatment of cancer. “Bringing new biosimilars to...
ESMO 2017: ALEX and ALUR Trials: Alectinib Shows CNS Benefit in ALK-Positive NSCLC
Data from two separate phase III studies presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid show the particular central nervous system (CNS) activity of alectinib (Alecensa) in patients with advanced non–small cell lung cancer involving a mutation of the...
Dinutuximab vs Temsirolimus in Combination Therapy for Children With Resistant Neuroblastoma
A randomized phase II trial (Children’s Oncology Group [COG] ANBL1221) has resulted in the selection of dinutuximab (Unituxin) plus irinotecan/temozolomide as a regimen to be further evaluated in the treatment of pediatric patients with refractory or relapsed neuroblastoma. Study results were...
Zika Virus Shows Oncolytic Activity Against Glioblastoma Stem Cells in Preclinical Trial
Although Zika virus causes devastating damage to the brains of developing fetuses, it someday may prove to be an effective treatment for glioblastoma. New research from Washington University School of Medicine in St. Louis and the University of California San Diego School of Medicine showed that...
Addition of EGFR-Targeting Vaccine to Temozolomide in EGFRvIII-Expressing Glioblastoma
The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported by Weller et al...
Expect Questions About Glioblastoma Symptoms
WITH THE MANY NEWS REPORTS about Senator John McCain being diagnosed with glioblastoma, patients may be asking if symptoms such as headaches and vision or speech problems should signal the need for screening or diagnostic tests. “There has never been any suggestion that doing routine screening,...
‘Substantial Improvements’ in the Treatment of Glioblastoma
NEWS ARTICLES about Senator John McCain’s diagnosis of glioblastoma accurately describe glioblastoma as aggressive and having a poor prognosis. But as Walter J. Curran, Jr, MD, pointed out in one of those reports, “substantial improvements in surgical approaches” have enabled more patients to...
Adjuvant Temozolomide in 1p/19q Non-Codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by van den Bent et al. Study Details In the open-label 2 x 2 factorial trial, 745...
Study Maps Mutation That May Drive Meningioma Development in Childhood Cancer Survivors
Neuroscientists may have uncovered the genetic basis for why many long-term survivors of childhood cancer develop meningiomas, the most common adult brain tumor, decades after their treatment with cranial radiation. The findings, published by Agnihotri et al in Nature Communications, show that...
Vaccine-Chemotherapy Combination in Glioblastoma
Despite highly aggressive therapy that includes maximal tumor resection, high-dose radiation, and temozolomide chemotherapy, the prognosis for patients with newly diagnosed glioblastoma is dismal, with a median survival of less than 15 months, prompting researchers to study novel approaches to...
FDA Grants Alectinib Priority Review for Initial Treatment of ALK-Positive Lung Cancer
Today, the U.S. Food and Drug Administration (FDA) accepted Genentech’s supplemental New Drug Application (sNDA) and granted Priority Review for alectinib (Alecensa) as a first-line treatment for people with anaplastic lymphoma kinase (ALK)-positive, locally advanced, or metastatic...
In Case You Missed It: Short Takes on Current Cancer Research
MOST ONCOLOGISTS are familiar with the findings of the plenary sessions featured at the 2017 ASCO Annual Meeting, with topics ranging from the duration of adjuvant oxaliplatin-based therapy in stage III colon cancer to patient-reported outcomes for symptom monitoring during routine cancer...
Effect of BRAF V600E Mutation on Outcome in Pediatric Low-Grade Gliomas
An analysis reported by Lassaletta et al in the Journal of Clinical Oncology showed that BRAF V600E mutation is associated with a poor outcome in pediatric low-grade gliomas treated with standard adjuvant therapy. Study Details The study involved patients with low-grade gliomas with long-term...
Analysis Reveals Genomic Alterations, Oncogenes Driving Medulloblastoma Subtypes
The most comprehensive analysis yet of medulloblastoma has identified genomic changes responsible for more than 75% of the brain tumors, including two new suspected cancer genes that were found exclusively in the least understood disease subgroups. The study from an international research...
Single-Center Trial of Stereotactic Radiosurgery for Completely Resected Brain Metastases
In a U.S. single-institution study reported in The Lancet Oncology, Mahajan et al found that stereotactic radiosurgery to the surgical cavity reduced local recurrence vs observation in patients with completely resected brain metastases. Study Details In the trial, 128 evaluable patients at MD...
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...
Expert Point of View: Lynn Schuchter, MD
DISCUSSANT LYNN SCHUCHTER, MD, the C. Willard Professor of Medicine at the Abramson Cancer Center at the University of Pennsylvania, Philadelphia, said the findings herald “a new era on two fronts…. Systemic therapy as initial treatment for patients with asymptomatic central nervous system (CNS)...
Drug Combinations Prove Effective Against Melanoma Brain Metastases
STUDIES PRESENTED at the 2017 ASCO Annual Meeting have shown that for melanoma that metastasizes to the brain, the combined use of checkpoint inhibitors and targeted agents can be effective. In COMBI-MB, 58% of patients responded intracranially to the BRAF inhibitor dabrafenib (Tafinlar) plus the...
Stereotactic Radiosurgery vs Whole-Brain Radiotherapy for Resected Metastatic Brain Disease
In the phase III NCCTG N107C/CEC.3 trial, stereotactic radiosurgery to the surgical cavity reduced cognitive deterioration and was associated with similar overall survival vs whole-brain radiotherapy in patients with resected brain metastasis. These results were reported by Brown et al in The...
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...
Study Demonstrates Potential for Artificial Intelligence and Whole-Genome Sequencing to Scale Access to Precision Medicine
In a study published by Wrzeszczynski et al in Neurology: Genetics, researchers at the New York Genome Center (NYGC), The Rockefeller University, and IBM illustrated the potential of IBM Watson for Genomics to analyze complex genomic data from state-of-the-art sequencing of whole genomes. The study ...
FDA Approves Aminolevulinic Acid Hydrochloride as an Optical Imaging Agent Indicated in Gliomas
ON JUNE 6, the U.S. Food and Drug Administration (FDA) approved aminolevulinic acid hydrochloride, known as ALA HCl (Gleolan), as an optical imaging agent indicated in patients with gliomas (suspected World Health Organization [WHO] grades III or IV) for preoperative imaging, as an adjunct for the...
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...
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...
Lessons Learned and to Be Learned: Reducing Risk of Subsequent Malignancies in Childhood Cancer Survivors
I recently saw a patient in our survivorship clinic. She was treated at age 15 years for Hodgkin lymphoma and is now in her early 50s. During the prior 2 decades, she had developed both bilateral breast cancer and thyroid cancer, as well as multiple basal cell carcinomas, all occurring within her...
