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Showing 1151 - 1200Second-Line Lenvatinib Plus Everolimus Improves Progression-Free Survival vs Everolimus in Metastatic Renal Cell Carcinoma in Phase II Trial
In a phase II trial reported in The Lancet Oncology, Motzer et al found that the combination of the multi–tyrosine kinase inhibitor lenvatinib (Lenvima) plus the mTOR inhibitor everolimus (Afinitor) significantly improved progression-free survival vs everolimus alone in patients with...
FDA Approves Expanded Indication for Medical Device to Treat Newly Diagnosed Glioblastoma Multiforme
The U.S. Food and Drug Administration (FDA) today approved an expanded indication for the Optune tumor treating fields device to treat patients with newly diagnosed glioblastoma multiforme. It is given along with the chemotherapy drug temozolomide following standard treatments that include...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced NSCLC
On October 2, 2015, the U.S. Food and Drug Administration (FDA) granted accelerated approval for pembrolizumab (Keytruda) to treat patients with metastatic non–small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express programmed cell...
Rolapitant Reduced Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
In two phase III trials reported in The Lancet Oncology, Rapoport et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients...
Rolapitant Reduced Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy or Anthracycline/Cyclophosphamide
In a phase III study reported in The Lancet Oncology, Schwartzberg et al found that the addition of rolapitant to serotonin (5-HT3) receptor antagonist and dexamethasone treatment significantly improved complete response rates in prevention of chemotherapy-induced nausea and vomiting in patients...
Investigational Topical Gel Is Safe and Effective in Patients With Cutaneous T-Cell Lymphoma, Phase I Trial Shows
Results of a phase I trial show that an investigational topical drug, resiquimod gel, causes regression of both treated and untreated tumor lesions and may completely remove cancerous cells from both sites in patients with early-stage cutaneous T-cell lymphoma. Currently, there is no cure for...
Analysis Suggests Use of Pioglitazone for Diabetes May Increase Risk of Prostate and Pancreatic Cancers But Not Bladder Cancer
Available data suggest an increased risk of bladder cancer with pioglitazone treatment for diabetes. In an analysis of Kaiser Permanente Northern California data reported in JAMA, Lewis et al found no significantly increased risk of bladder cancer in patients with diabetes ever using pioglitazone....
Phase II Study Evaluates Neoadjuvant Eribulin vs Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Locally Advanced HER2-Negative Breast Cancer
In a randomized phase II trial (NSABP FB9) reported in Breast Cancer Research and Treatment, Abraham and colleagues found no improvement in pathologic complete response rate with neoadjuvant eribulin (Halavan) vs weekly paclitaxel followed by doxorubicin/cyclophosphamide in women with locally...
FDA Grants Orphan Drug Designation to Melphalan for Cholangiocarcinoma
Delcath Systems, Inc, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development has granted Orphan Drug designation to melphalan for the treatment of cholangiocarcinoma. Cholangiocarcinoma is recognized by the FDA as an orphan disease,...
Daratumumab Expanded Access Program Open to Eligible U.S. Patients With Heavily Pretreated Multiple Myeloma
Janssen Biotech, Inc, announced the opening of a daratumumab expanded access program for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for patients with multiple myeloma. The multicenter, open-label...
ESMO World GI 2015: Low Body Mass Index Associated With Poorer Survival in Metastatic Colorectal Cancer
Although being overweight with a high body mass index (BMI) has long been associated with a higher risk for colorectal cancer, thinner patients might not fare as well as previously expected after treatment for advanced cancer, according to a new study from Duke Medicine. The study, which was...
ASCO 2015: IMGN853 Demonstrates Single-Agent Activity for Patients With Platinum-Resistant Ovarian Cancer
In a phase I trial, the investigational agent mirvetuximab soravtansine (IMGN853) was found to be active in patients with platinum-resistant ovarian cancer. ImmunoGen, Inc, announced the first clinical findings of this folate-receptor alpha (FRα)-targeting antibody-drug conjugate at the...
16-Gene Assay Recurrence Score Predicts Recurrence After Surgery for Localized Renal Cell Carcinoma
In a study reported in The Lancet Oncology, Rini et al developed a 16-gene assay and recurrence score that predicted postsurgery outcome in patients with stage I to III clear cell renal cell carcinoma. Development Phase In the development phase, examination of the association between expression...
New Molecular Diagnostic Test Predicts Progression of Barrett's Esophagus to Esophageal Cancer
Interpace Diagnostics, a subsidiary of PDI, Inc, announced new data demonstrating the clinical value of BarreGen, a molecular diagnostic test that predicts the risk of progression from Barrett’s esophagus to esophageal cancer approximately 3 to 4 years before the cancer develops. These...
ASCO 2015: New Targeted Treatment IMMU-130 Shows Activity in Patients With Metastatic Colon Cancer
Although various drugs have improved outcomes for metastatic colon cancer patients, researchers continually strive to find new agents to improve treatment. Antibody-drug conjugates are a promising option, due to the fact that they can deliver chemotherapy directly into a targeted cell, destroy...
ASCO 2015: Entolimod May Be a Promising Treatment Option for Many Solid Tumors
A collaborative team of researchers led by Alex A. Adjei, MD, PhD, FACP, of Roswell Park Cancer Institute, shared results from the first clinical study of the anticancer effects of the novel agent entolimod on May 30 at the 2015 ASCO Annual Meeting in Chicago (Abstract 3063). Their findings confirm ...
ASCO 2015: Eribulin Extends Overall Survival for Heavily Pretreated Patients With Advanced Liposarcoma and Leiomyosarcoma
Heavily pretreated patients with intermediate- or high-grade liposarcoma or leiomyosarcoma had a 2-month increase in median overall survival when subsequently treated with eribulin (Halaven) rather than the standard drug dacarbazine. “For a disease where so few treatment options exist, a...
ASCO 2015: Complete Lymph Node Dissection Does Not Improve Survival in Patients With Melanoma and Micrometastases
For patients with melanoma and micrometastases, as shown by positive sentinel lymph node biopsy, complete lymph node dissection did not improve survival, according to results of a randomized study presented at the 2015 ASCO Annual Meeting (Abstract LBA9002). “This is the first study which...
ASCO 2015: Obinutuzumab Doubles Progression-Free Survival in Patients With Relapsed, Indolent Non-Hodgkin Lymphoma
Adding the anti-CD20 monoclonal antibody obinutuzumab (Gazyva) to standard bendamustine (Treanda) chemotherapy and then following that with single-agent obinutuzumab maintenance therapy “resulted in a statistically significant, but more importantly, a clinically meaningful increase in...
Two Studies Highlight Benefit of Stereotactic Body Radiotherapy in Locally Advanced Pancreatic Cancer
Two studies from researchers at Johns Hopkins Kimmel Cancer Center add to preliminary evidence that high-dose radiation treatment, or stereotactic body radiotherapy, appears to be safe and as effective as standard radiation treatment for certain patients with locally advanced pancreatic cancer....
FDA Grants Fast Track Designation to Evofosfamide for Advanced Pancreatic Cancer
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of evofosfamide (TH-302), administered in combination with gemcitabine, for previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer. Evofosfamide is an...
Increasing Number of Boys Vaccinated Against HPV Could Protect More People at the Same Price
Public health programs that devote a portion of their funding to encourage more boys to be vaccinated against human papillomavirus (HPV)—rather than merely attempting to raise coverage among girls—may ultimately protect more people for the same price, a study from Duke University...
Cancer Experts Find Too Many People Are Being Screened, Diagnosed, and Treated for Disease
A recent commentary published in Annals of Internal Medicine discusses the paradoxical finding that most patients are at below-average risk of disease and can expect to experience less-than-average benefits from a treatment. Yet, argue Vickers et al, too many people are being screened, diagnosed,...
Improved Quality Metrics for Robotic Pancreaticoduodenectomy With Increased Performance
In a retrospective single-institution study reported in JAMA Surgery, Boone et al found significant improvements in blood loss, incidence of conversion to open surgery, pancreatic fistula incidence, and operative time with increased number of patients treated with robotic pancreaticoduodenectomy....
Comprehensive Genomic Profiling Shows Distribution of Targetable Alterations in Carcinomas of Unknown Primary Site
In a study reported in JAMA Oncology, Ross et al found potentially targetable genomic alterations in most carcinomas of unknown primary site using comprehensive genomic profiling. Adenocarcinomas of unknown primary site frequently harbored receptor tyrosine kinase/Ras/MAPK pathway alterations....
Addition of Aprepitant to Ondansetron Effective in Preventing Chemotherapy-Induced Nausea and Vomiting in Pediatric Patients
In a phase III trial reported in The Lancet Oncology, Kang et al found that adding aprepitant to ondansetron with or without dexamethasone was effective in preventing chemotherapy-induced nausea and vomiting in pediatric patients receiving moderately or highly emetogenic chemotherapy. Study...
Age-Stratified Predictive Model May Provide Surgical Guidelines for Uterine Leiomyomas
A study by Brohl et al investigating the case incidence of unexpected uterine sarcoma following surgery for presumed benign leiomyoma (fibroids or myomas) has found that the risk of unexpected uterine sarcoma varies significantly across age groups, with a more than fivefold difference between the...
FDA Approves First Biosimilar Product Filgrastim‑Sndz
The U.S. Food and Drug Administration (FDA) today approved filgrastim-sndz (Zarxio), the first biosimilar product approved in the United States. A biosimilar product is a biologic product that is approved based on a showing that it is highly similar to an already-approved biologic. The biosimilar...
Aurora Kinase A Inhibitor Alisertib Active in Solid Tumors
In a phase II study reported in The Lancet Oncology, Melichar et al found that the oral aurora kinase A inhibitor alisertib was active in solid tumors, particularly breast cancer and small cell lung cancer. Aurora kinases play central roles in mitosis. Inhibition of aurora kinase A, which is...
No Overall Survival Benefit of Adding Orteronel to Prednisone in Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer
In the phase III ELM-PC 4 trial reported in The Lancet Oncology, Saad et al found that the addition of the CYP 17,20 lyase inhibitor orteronel to prednisone did not improve overall survival in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. Improvement in...
FDA Grants Orphan Drug Designation to Human Reovirus Formulation for the Treatment of Ovarian Cancer
Oncolytics Biotech, Inc, a clinical-stage biotechnology company focused on the development of oncolytic viruses as potential cancer therapeutics, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation for its proprietary formulation of the human reovirus...
Ibrutinib Active in Previously Untreated and Relapsed/Refractory CLL With TP53 Aberrations
In a phase II study reported in The Lancet Oncology, Farooqui et al found that single-agent ibrutinib (Imbruvica) had good activity in patients with previously untreated or relapse/refractory chronic lymphocytic leukemia (CLL) with TP53 aberrations. Study Details In this single-arm trial, 51...
Supplemental New Drug Application Submitted for Carfilzomib for Relapsed Multiple Myeloma
Amgen and its subsidiary Onyx Pharmaceuticals, Inc, announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at...
Analysis of Unexplored Part of Human Genome May Lead to Cancer Biomarker Development
A new analysis opens the door to the discovery of thousands of potential new cancer biomarkers, according to a recent study by Iyer et al published in Nature Genetics. Long Noncoding RNA Researchers at the University of Michigan Comprehensive Cancer Center analyzed the global landscape of long...
Expanded Analyses of Phase III MM-398 NAPOLI-1 Study Substantiate Positive Results of MM-398 Combined With Fluorouracil/Leucovorin
Additional analyses from the global phase III NAPOLI-1 study of MM-398 (aka PEP02), a nanoliposomal encapsulation of irinotecan, in metastatic pancreatic cancer were presented by Chen et al in an oral session at the 2015 Gastrointestinal Cancers Symposium (Abstract 234). The primary analysis ...
No Survival Difference for Adjuvant Capecitabine vs 5-FU With or Without Oxaliplatin in Stage III Colon Cancer
In an analysis reported in The Lancet Oncology, Schmoll et al found no difference in survival outcomes with adjuvant capecitabine vs fluorouracil (5-FU)/leucovorin with or without oxaliplatin in patients with stage III colon cancer and no adverse impact of adjuvant oxaliplatin on post-relapse...
ASH 2014: Oral Inhibitor Shows Clinical Activity in Poor-Prognosis AML
An oral targeted drug has shown encouraging activity and tolerable side effects in patients with treatment-resistant or relapsed acute myelogenous leukemia (AML), a poor-prognosis group with few options, reported investigators from Dana-Farber Cancer Institute and The University of Texas MD...
LINE-1 Hypomethylation Associated With Poorer Survival in Microsatellite Instability–High vs Microsatellite-Stable Tumors in Colorectal Cancer
In a study reported in the Journal of the National Cancer Institute, Inamura et al found that hypomethylation in long interspersed nucleotide element-1 (LINE-1) is associated with greater colorectal cancer–specific and overall mortality in high-degree microsatellite instability vs...
Hormone Loss Could Be Involved in Colon Cancer
Some cancers, like breast and prostate cancer, are driven by hormones such as estrogen and testosterone, but to date, there are none that are understood to be driven by the lack of a hormone. New evidence reported by researchers at Thomas Jefferson University, Philadelphia, suggests that human...
Sex Steroid Hormones May Play a Role in the Development of Aggressive Prostate Cancer
Men with higher estradiol-to-testosterone ratios had a substantially reduced risk of aggressive prostate cancer, whereas men with higher ratios of 2-hydroxyestrone to 16α-hydroxyestrone had an increased risk of such cancer, according to the study findings presented by Black et al in Cancer...
Robert S. Miller, MD, FACP, FASCO, Joins ASCO as Medical Director for Society's Institute for Quality
Robert S. Miller, MD, FACP, FASCO, Assistant Professor of Oncology and Oncology Medical Information Officer at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, has been named Medical Director of the Institute for Quality (iQ) of the American Society of Clinical Oncology (ASCO). ...
Pilot Study Evaluates Concurrent Use of Sunitinib and Radiation Therapy in Recurrent High-Grade Glioma
The combination of continuous daily-dosed sunitinib (Sutent) and hypofractionated stereotactic radiation therapy produced acceptable toxicity and “encouraging” 6-month progression-free survival in previously irradiated patients with recurrent high-grade glioma, according to the results...
Lymphatic Mapping Agent Receives Orphan Drug Designation for Head and Neck Cancers
Navidea Biopharmaceuticals, Inc, recently announced that technetium 99m tilmanocept (Lymphoseek Injection) has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for use in sentinel lymph node detection in patients with cancer of the head and neck. The designation...
mTOR Inhibitor Ridaforolimus Shows Activity in Advanced Endometrial Cancer
The oral mTOR inhibitor ridaforolimus was modestly active and reasonably tolerated in women with recurrent or metastatic endometrial cancer, according to the results of a phase II study reported in Gynecologic Oncology. Tsoref et al suggested that it may prove to be an effective therapeutic...
Promising Activity of Ibrutinib Plus Rituximab in High-Risk CLL
In a phase II trial reported in The Lancet Oncology, Burger et al found that the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) showed promising activity and an encouraging safety profile in patients with previously treated or untreated high-risk chronic lymphocytic leukemia (CLL)....
NSAID Use May Reduce Risk of Breast Cancer Recurrence in Overweight and Obese Women
Obesity is associated with a worse breast cancer prognosis and elevated levels of inflammation, including greater cyclooxygenase-2 (COX-2) expression and activity in adipose-infiltrating macrophages. Data from a new study finds that overweight and obese women who regularly used aspirin or other...
Noninvasive Image Texture Analysis May Provide Tumor Heterogeneity Information With Prognostic Potential in NSCLC
Noninvasive quantitative computed tomography–based texture analysis can accurately differentiate the presence of a KRAS mutation from pan–wild-type non–small cell lung cancer (NSCLC), based on the results of a study in PLOS ONE. Weiss et al reported that this tumor heterogeneity...
New Androgen Receptor Inhibitor Shows Activity in Metastatic Castration-Resistant Prostate Cancer
ODM-201 is a novel androgen receptor inhibitor—structurally distinct from enzalutamide (Xtandi)—that acts via high-affinity binding to the androgen receptor and inhibition of receptor nuclear translocation. In the phase I/II ARADES trial reported in The Lancet Oncology, Fizazi et al...
FDA Grants Orphan Drug Designation to ENMD-2076 for Hepatocellular Carcinoma
CASI Pharmaceuticals, Inc, announced that its investigational agent ENMD-2076 has received orphan drug designation from the U.S. Food & Drug Administration (FDA) for the treatment of hepatocellular carcinoma. ENMD-2076 is an orally active Aurora A/angiogenic kinase inhibitor with a unique...
Adding Rilotumumab to First-Line Chemotherapy May Benefit Patients With Advanced Gastric or Esophagogastric Junction Adenocarcinoma
Hepatocyte growth factor (HGF) and its receptor MET have been found to promote the proliferation, migration, and survival of tumor cells and to play a role in gastric cancer. In a phase II study reported in The Lancet Oncology, Iveson et al found evidence of benefit from adding the anti-HGF...
