New ESMO Tumor DNA Scale Helps Match Patients to Optimal Targeted Treatments

A new scale for tumor DNA mutations called ESCAT (European Society for Medical Oncology [ESMO] Scale for Clinical Actionability of Molecular Targets) is aiming to simplify and standardize choices for targeted cancer treatment. Information about the development and use of the scale in practice was...

Outcomes for Rural Patients With Cancer Enrolled in Clinical Trials

The disparity in survival rates between rural and urban patients is reduced when patients in both settings are enrolled in clinical trials, SWOG study results show. The study results were published in JAMA Network Open by a team led by Joseph Unger, PhD, a SWOG biostatistician...

FDA Grants Orphan Drug Designation to ASLAN003 in Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) has granted ASLAN003 Orphan Drug designation as a treatment for acute myeloid leukemia (AML). ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be a first-in-class drug in AML. The FDA...

MUC16 Mutation, Tumor Mutation Load, and Prognosis in Gastric Cancer

In a study reported in JAMA Oncology, Li et al found that MUC16 mutation was associated with increased tumor mutation load and improved prognosis in gastric cancer. The study involved analysis of genomic data from 437 gastric cancer samples from The Cancer Genome Atlas (TCGA; discovery set) and...

Neoadjuvant Chemoradiotherapy in Locally Advanced Esophageal Cancer

In a Chinese phase III trial reported in the Journal of Clinical Oncology, Yang et al found that adding neoadjuvant chemoradiotherapy to surgery improved survival in locally advanced squamous cell carcinoma of the esophagus. Study Details In the open-label trial, 451 patients with potentially...

Active Surveillance of Lung Subsolid Nodules May Reduce Unnecessary Surgery and Overtreatment

Subsolid nodules can be considered a biomarker of lung cancer risk, and should be managed with long-term active surveillance. Conservative management of these nodules may reduce unnecessary surgery and overtreatment in patients with multiple comorbidities and aggressive lung cancer arising from...

skin cancer
immunotherapy

Gene-Expression Predictor for Immunotherapy Response in Melanoma

In a new study, researchers developed a gene expression predictor that can indicate whether melanoma in a specific patient is likely to respond to treatment with immune checkpoint inhibitors. Their research was published by Auslander et al in Nature Medicine. “There is a critical need to be...

FDA Grants Orphan Drug Designation to CPI-613 for the Treatment of Peripheral T-Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to CPI-613 for the treatment of peripheral T-cell lymphoma. CPI-613 is a novel lipoic acid analog with an anticancer activity that inhibits multiple enzyme targets within the tricarboxylic acid cycle. This drug is...

Adding Sorafenib to Topotecan in Platinum-Resistant Ovarian Cancer

In a German phase II trial reported in The Lancet Oncology, Chekerov et al found that the addition of sorafenib (Nexavar) to topotecan improved progression-free survival in women with platinum-resistant ovarian cancer. Study Details In the multicenter investigator-initiated double-blind trial,...

head and neck cancer
immunotherapy

Induction Chemotherapy Followed by Cetuximab and Radiotherapy vs Concurrent Chemoradiotherapy in Head and Neck Cancer

As reported in the Journal of Clinical Oncology by Geoffrois et al, the European phase III GORTEC (Groupe Oncologie Radiothèrapie Tête et Cou) 2007-02 trial has shown no improvement in progression-free survival with induction chemotherapy followed by cetuximab and radiotherapy (RT) vs...

lung cancer
immunotherapy

FDA Approves Pembrolizumab in Combination With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC

Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum as first-line treatment of patients with metastatic, nonsquamous non–small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Pembrolizumab...

bladder cancer
immunotherapy

FDA Updates Prescribing Information for Pembrolizumab and Atezolizumab in Urothelial Carcinoma

On August 16, 2018, the U.S. Food and Drug Administration (FDA) updated the prescribing information for pembrolizumab (Keytruda) and atezolizumab (Tecentriq) to require the use of an FDA-approved companion diagnostic test to determine programmed cell death ligand 1 (PD-L1) levels in tumor tissue...

issues in oncology
survivorship

Impact of Doctor-Patient Communication on Outcomes in Cancer Survivors

A new study from the American Cancer Society has found that patients with cancer who reported greater satisfaction in the way their provider communicated with them received more efficient care, with fewer office visits and better health outcomes. These findings were published by Rai et al in...

head and neck cancer
immunotherapy

Cetuximab With Radiotherapy Found to Be Inferior to Standard Treatment in HPV-Positive Oropharyngeal Cancer

An interim analysis of data from a randomized clinical trial of patients with human papillomavirus (HPV)-positive oropharyngeal cancer found that treatment with radiation therapy and cetuximab (Erbitux) is associated with worse overall and progression-free survival compared to the current standard...

Addition of Vincristine and Irinotecan to Vincristine, Dactinomycin, and Cyclophosphamide in Pediatric Intermediate-Risk Rhabdomyosarcoma

In a phase III Children’s Oncology Group study reported in the Journal of Clinical Oncology, Hawkins et al found that substituting vincristine and irinotecan (VI) for half of vincristine, dactinomycin, and cyclophosphamide (VAC) courses did not improve event-free survival in pediatric...

cns cancers
immunotherapy

Bevacizumab and Temozolomide in First Recurrence of Glioma Without 1p/19q Codeletion

In a phase II trial funded by the European Organisation for Research and Treatment of Cancer and reported in The Lancet Oncology, van den Bent et al found no evidence of a survival benefit with the addition of bevacizumab (Avastin) to temozolomide in patients with a first recurrence of World Health ...

lung cancer
immunotherapy

FDA Approves Nivolumab for Certain Patients With Previously Treated Small Cell Lung Cancer

Today, nivolumab (Opdivo) received approval from the U.S. Food and Drug Administration (FDA) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been...

breast cancer
gynecologic cancer
issues in oncology

BRCA Testing in Medically Underserved Women in Southeastern United States

Medically underserved women in the Southeast region of the United States diagnosed with breast cancer or ovarian cancer may have not received genetic testing that could have helped them and their relatives make important decisions about their health, according to new research from Vanderbilt-Ingram ...

FDA Accepts Biologics License Application, Grants Priority Review for Tagraxofusp in Rare Hematologic Malignancy

The U.S. Food and Drug Administration (FDA) has accepted for filing a biologics license application (BLA) for tagraxofusp (Elzonris, formerly SL-401) for the treatment of patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic malignancy. The FDA also granted Priority ...

cns cancers
survivorship

Functional and Social Independence in Survivors of Pediatric CNS Tumors

In a report from the St. Jude Lifetime Cohort Study published in the Journal of Clinical Oncology, Brinkman et al found that 60% of adult survivors of pediatric central nervous system (CNS) tumors do not achieve full functional or social independence in adult life. In the study, functional and...

leukemia
immunotherapy

Bendamustine Followed by Obinutuzumab Plus Venetoclax in Treatment-Naive and Relapsed/Refractory CLL

In a German phase II trial reported in The Lancet Oncology, Cramer et al found promising response rates with bendamustine followed by obinutuzumab (Gazyva) plus venetoclax (Venclexta) in both treatment-naive and relapsed/refractory chronic lymphocytic leukemia (CLL). In the trial, patients with an ...

FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...

lung cancer
issues in oncology

Small Study Looks at Physician-Patient Discussions About Lung Cancer Screening

National guidelines advise doctors to discuss the benefits and harms of lung cancer screening with high-risk patients. A small study (n = 14) by researchers from the University of North Carolina Lineberger Comprehensive Cancer Center reported there is a gap between what guidelines...

VB4-845 Granted Fast Track Designation by FDA for Treatment of Non–Muscle Invasive Bladder Cancer

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to VB4-845 for the treatment of bacillus Calmette-Guérin (BCG)–unresponsive, high-grade, non–muscle invasive bladder cancer. VB4-845 is currently being evaluated in a phase III registration...

Basal Cell Carcinoma and Risk for Development of Other Cancers

Patients who develop frequent cases of basal cell carcinoma appear to be at significantly increased risk for the development of other cancers, according to a study published by Cho et al in JCI Insight. Methods Researchers studied 61 people treated at Stanford Health Care for frequent...

Broad-Based Genomic Sequencing in Advanced NSCLC in the Community Oncology Setting

In a study reported in JAMA, Presley et al found that use of broad-based genomic sequencing vs routine testing for EGFR mutations or ALK rearrangements alone directed treatment in a minority of patients with advanced non–small cell lung cancer (NSCLC) in the community oncology setting and was ...

Drug Combination Design for Multiple Myeloma Using an AI Platform

A multidisciplinary team of researchers from the National University of Singapore (NUS) has developed an artificial intelligence (AI) technology platform that could potentially change the way drug combinations are being designed, hence enabling doctors to determine the most effective drug...

FDA Grants Clearance of PowerLook Density Assessment for Digital Breast Tomosynthesis

iCAD has announced U.S. Food and Drug Administration (FDA) clearance of its artificial intelligence software program, PowerLook Density Assessment Version 3.4, which provides an automated method of determining breast density. The software is compatible with iCAD’s digital breast...

Definitive Pelvic Radiation Therapy Plus Chemotherapy and Survival in Newly Diagnosed Metastatic Cervical Cancer

In a study using National Cancer Database data reported in JAMA Oncology, Wang et al found that definitive pelvic radiation therapy plus chemotherapy was associated with improved survival vs chemotherapy alone in newly diagnosed metastatic cervical cancer. The study included data from 3,169...

Impact of Peer-Review Intervention on Radiotherapy Schedules for Palliative Treatment of Bone Metastases

In a single-center study reported in the Journal of Oncology Practice, Walker et al found that institution of a peer-review process resulted in shorter fractionation schedules for palliation of bone metastases, consistent with current guidelines. As stated by the authors, “Shorter...

gynecologic cancer
pancreatic cancer

FDA Grants Breakthrough Device Designation for Cancer Detection Liquid Biopsy

PapGene, Inc, has announced their cancer detection test has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA). The PapGene test is a multianalyte test that uses a combination of circulating tumor DNA...

breast cancer
issues in oncology

Cardiac Monitoring in Patients With Breast Cancer

Although heart failure is an uncommon complication of breast cancer treatment, the risk may be higher in patients treated with certain types of chemotherapy and lower in younger patients, according to a study published by Henry et al in JACC: Cardiovascular Imaging. Researchers studied 16,456...

colorectal cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation for Encorafenib Plus Binimetinib and Cetuximab in BRAF V600E–Mutant Metastatic Colorectal Cancer

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for encorafenib (Braftovi) in combination with binimetinib (Mektovi) and cetuximab (Erbitux) for the treatment of patients with BRAF V600E–mutant metastatic colorectal cancer (mCRC), as detected by...

Prognostic Model for Treatment Outcomes in BRAF V600–Mutated Metastatic Melanoma

In a study reported in JAMA Oncology, Hauschild et al identified baseline lactate dehydrogenase (LDH), performance status, disease burden, and gene signature as potential determinants of treatment outcomes in BRAF V600–mutant metastatic melanoma treated with BRAF and/or MEK inhibitors. Study ...

Apatinib and Oral Etoposide in Platinum-Resistant/Refractory Ovarian Cancer

In a Chinese single-center phase II study reported in The Lancet Oncology, Lan et al found a high response rate with oral apatinib plus oral etoposide in patients with platinum-resistant or refractory ovarian cancer. Study Details The study included 35 patients with progression within 6 months...

Cory Wiegert Named New CEO of CancerLinQ LLC

Cory Wiegert has been named Chief Executive Officer (CEO) of CancerLinQ LLC, a wholly owned nonprofit subsidiary of ASCO. Mr. Wiegert, a proven expert in building and successfully launching innovative technology solutions, began his new role today (August 13, 2018), overseeing the continued...

ESR1 Fusions and Metastasis in Estrogen Receptor–Positive Breast Cancer

Estrogen receptor–positive breast cancer is the most common type of breast cancer, but resistance to therapy is common, and eventual development of metastatic disease is a leading cause of death. In research published by Lei et al in Cell Reports, researchers from Baylor College of...

Assay Uses Big Data to Predict Responses to Immunotherapy

In the age of big data, cancer researchers are discovering new ways to monitor the effectiveness of immunotherapy treatments. Researchers at the Johns Hopkins Bloomberg~Kimmel Institute for Cancer Immunotherapy developed a new way to use bioinformatics as a gathering tool to determine how ...

FDA Grants 510(k) Clearance to SRT-100+ Superficial Radiation Therapy for Treating Nonmelanoma Skin Cancer and Keloids

Sensus Healthcare, Inc, a medical device company specializing in the noninvasive treatment of nonmelanoma skin cancers and keloids with image-guided superficial radiation therapy, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its new...

CNS Activity of EGFR Tyrosine Kinase Inhibitor in T790M-Positive Advanced NSCLC

In a planned subgroup analysis of the phase III AURA3 trial reported in the Journal of Clinical Oncology, Wu et al found that the third-generation EGFR tyrosine kinase inhibitor osimertinib (Tagrisso) produced higher central nervous system (CNS) response rates vs platinum plus pemetrexed (Alimta)...

Circulating Tumor Cells and Late Recurrence in Hormone Receptor–Positive Breast Cancer

In a study reported in JAMA Oncology, Sparano et al found that a single circulating tumor cell (CTC) assessment was predictive of late recurrence in patients with hormone receptor–positive, HER2-negative breast cancer. The study involved patients from a phase III trial of doxorubicin and...

health-care policy
issues in oncology

ASCO Statement: Step Therapy Creates Barriers to Care for Medicare Advantage Beneficiaries With Cancer

Monica M. Bertagnolli, MD, FACS, FASCO, ASCO President, released the following statement today: “ASCO strongly opposes the Centers for Medicare & Medicaid Services (CMS) decision to allow Medicare Advantage plans to employ step therapy across physician-administered and self-administered...

ASCO and Friends Submit Recommendations to FDA Aimed at Reducing Barriers to Clinical Trial Participation

ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO...

leukemia
issues in oncology
immunotherapy

Guidelines for Pediatric CAR T-Cell Therapy Developed

Almost 1 year after the U.S. Food and Drug Administration (FDA) approval of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia (ALL), researchers at The University of Texas MD Anderson Cancer Center and the Pediatric Acute Lung Injury and...

Utilization of Hypofractionated Radiation Therapy in Breast Cancer

Researchers at the Feinstein Institute for Medical Research and Northwell Health’s Department of Radiation Medicine have identified methods to increase use of the radiation therapy hypofractionation in patients with breast cancer. These findings, published by Gilbo et al...

lung cancer
issues in oncology

Lung Cancer Screening Guidelines May Be Inadequate for High-Risk Minorities

Data from a lung cancer screening program at the University of Illinois at Chicago (UIC) provides evidence that national lung cancer screening guidelines, which were developed based on the National Lung Screening Trial (NLST) in 2011 and recommend screening based on age and smoking history, may be...

lung cancer
immunotherapy

Osimertinib Resistance Mechanisms in EGFR T790M–Positive NSCLC

In a study reported in JAMA Oncology, Oxnard et al found early resistance and a number of competing resistance mechanisms in acquired osimertinib (Tagrisso) resistance associated with loss of the T790M mutation conferring resistance to prior EGFR tyrosine kinase inhibitor (TKI) treatment in...

Long-Term Pooled Safety Data for Palbociclib Combined With Endocrine Therapy in HR-Positive, HER2-Negative Breast Cancer

In an analysis of pooled safety data from the PALOMA trials of palbociclib (Ibrance) plus endocrine therapy in hormone receptor (HR)-positive, HER2-negative advanced breast cancer reported in the Journal of the National Cancer Institute, Diéras et al found no evidence of specific cumulative...

lymphoma
skin cancer

FDA Approves Mogamulizumab-kpkc for Two Rare Types of Non-Hodgkin Lymphoma

Today, the U.S. Food and Drug Administration approved mogamulizumab-kpkc (Poteligeo) injection for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides or Sézary syndrome after at least one prior systemic therapy. This approval provides a new...

solid tumors
hematologic malignancies

FDA Warns of Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Allogeneic Stem Cell Transplant

The U.S. Food and Drug Administration (FDA) is warning that the antibiotic azithromycin should not be given on a long-term basis to prevent the inflammatory lung condition bronchiolitis obliterans syndrome in patients with cancers of the blood or lymph nodes who undergo a donor stem cell...

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