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Showing 4251 - 4300Focused Ultrasound, a Young Technology, Begins to Grow
In the United States, it’s been a good 2 years for focused ultrasound. The technology, which uses multiple, intersecting ultrasound beams to treat cancer and other diseases, completed its first successful U.S. phase III oncology trial—to alleviate the pain of bone metastases—and received approval...
FDA Approves Bevacizumab Plus Chemotherapy for Platinum-Resistant, Recurrent Ovarian Cancer
The U.S. Food and Drug Administration (FDA) approved bevacizumab (Avastin) in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for the treatment of patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. The approval is ...
Optimizing HER2 Therapy in Early and Advanced Breast Cancers
Trastuzumab (Herceptin) has been the cornerstone of therapy for HER2-positive tumors, which comprise about 20% of all breast tumors. Additional therapies targeted to other HER2 pathways or other targets to be used in combination with trastuzumab are being explored in both the adjuvant and...
The Wedding Picture
The following essay by Fadlo R. Khuri, MD, FACP, is excerpted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories (May 2014), coedited by Stan Winokur, MD, and Vincent Coppola. The book is available on Amazon.com and thebigcasino.org. Life and hope are why we go...
RSNA Awards Gold Medal to Three Leaders in Radiology
The Radiological Society of North America (RSNA) awarded the Gold Medal, the organization’s highest honor, to three individuals at the RSNA 100th Scientific Assembly and Annual Meeting: Gary J. Becker, MD, of Tucson; Allen S. Lichter, MD, FASCO, of Alexandria, Virginia; and Etta D. Pisano, MD, of...
Policy Issues in Molecularly Targeted Therapy: The Science, the Money, the Applications
In the past decade, much new knowledge about the molecular underpinnings of cancer has accumulated, and the array of molecular aberrations in each individual tumor can be assessed through genomic sequencing and other tests. The rationale for and feasibility of developing molecularly targeted...
Immune-Suppressing Protein in Noncancerous Cells of Cancer Patients Offers Clue to Drug Response
A multicenter phase I study using an investigational immune therapy drug has found that the presence of the immune-suppressing protein PD-L1 in noncancerous immune cells can predict how patients with different types of advanced cancer will respond to treatment. The study, led by a Yale Cancer...
Getting the Most Out of Ipilimumab in Melanoma
Ipilimumab (Yervoy) was first approved by the U.S. Food and Drug Administration (FDA) in 2011 on the basis of an improvement in overall survival compared with gp100 vaccine in patients with advanced melanoma.1 Response rates with ipilimumab have been modest at best—10% to 15% using 3 mg/kg and 15%...
Moving a Mountain: Crizotinib in ROS1-Rearranged NSCLC
It was thousands of years ago in China. An elderly man was unhappy with the mountain that embraced his seaside village. He would need to walk for hours before he could reach the nearest town. So, as the old fable goes, he set his mind to move the mountain. Every day, he dug up basketfuls of rocks...
Choice for Metastatic Pancreatic Cancer: FOLFIRINOX or Gemcitabine/Nab-Paclitaxel?
The choice between FOLFIRINOX (fluorouracil [5-FU], leucovorin, irinotecan, oxaliplatin) vs the combination of gemcitabine and nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for first-line treatment of metastatic pancreatic cancer is not much of a contest, judging by a discussion of...
Man With Tumor of the Breast, Albumen Print, Paris, 1873
Through the Lens of Oncology History A Century of Progress The text and photographs on these pages represent the establishment of oncology as a viable medical specialty during the mid-1800s. The images and captions are excerpted from a four-volume series of books titled Oncology Tumors &...
FDA Approves Denosumab for the Treatment of Hypercalcemia of Malignancy Refractory to Bisphosphonate Therapy
The U.S. Food and Drug Administration has approved a new indication for denosumab (Xgeva) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Denosumab was approved and granted Orphan Drug designation by the FDA, which is reserved for drugs that are intended for...
Olaparib for BRCA-Mutated Previously Treated Advanced Ovarian 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 December 19, 2014, olaparib (Lynparza) was granted accelerated...
Smarter Trial Design Saves Money and Produces Better Drugs
The process of identifying a promising molecule and moving it from the laboratory through the highly complex series of clinical trials necessary to garner U.S. Food and Drug Administration (FDA) approval is a costly scientific gauntlet during which many new agents fail. New trial design,...
Blinatumomab Achieves Complete Molecular Responses in Majority of B-Cell Leukemia Patients
Results from the international phase II BLAST study show that one cycle of blinatumomab (Blincyto) immunotherapy achieved complete minimal residual disease response in 78% of patients with acute lymphoblastic leukemia.1 Complete minimal residual disease response was achieved in 80% of patients...
Complexities of Targeting HER2 in Estrogen Receptor–Positive Breast Cancers
The interactions between the estrogen receptor (ER) and HER2 pathways in breast cancers are clearly complex and remain incompletely understood. Historically, cancers that express both ER and HER2 were thought to be intrinsically resistant to endocrine therapy, likely due to HER2 being the dominant...
Nivolumab Improves Outcomes vs Dacarbazine in Previously Untreated Advanced Melanoma Without a BRAF Mutation
In a phase III trial reported in The New England Journal of Medicine, Robert and colleagues found that the programmed cell death protein-1 (PD-1) immune-checkpoint–inhibitor antibody nivolumab (Opdivo) significantly increased overall survival, progression-free survival, and objective response rate...
Nab-Paclitaxel Boosts Pathologic Complete Response in High-Risk Breast Cancer
Nab-paclitaxel (Abraxane) achieved superior results compared with conventional solvent-based paclitaxel in patients with early-stage high-risk breast cancer in the large phase III GeparSepto trial from the German Breast Group (GBG).1 The study, presented at the 2014 San Antonio Breast Cancer...
No Benefit for Adjuvant Capecitabine Monotherapy in Elderly Patients With Early-Stage Breast Cancer
Adjuvant therapy with capecitabine plus ibandronate failed to improve outcomes vs ibandronate alone in elderly patients with moderate-to-high-risk early-stage breast cancer in the ICE study—the largest study to date conducted in elderly women with breast cancer.1 “Capecitabine is frequently used in ...
Low-Fat Diet Reduces Mortality in Breast Cancer Subset
The final survival analysis of the landmark Women’s Intervention Nutrition Study (WINS) confirmed that a low-fat diet can reduce the risk of dying for a subset of breast cancer patients.1 At the San Antonio Breast Cancer Symposium, Rowan T. Chlebowski, MD, PhD, of the Los Angeles Biomedical...
Top 10 Myths About FDA’s Office of Hematology and Oncology Products
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 Gideon Blumenthal, MD, and Tatiana Prowell, MD, discuss 10 common myths about FDA’s Office of Hematology and Oncology ...
‘Clinically Meaningful Improvements’ in Survival for Patients With NSCLC When Veliparib Is Added to Carboplatin and Paclitaxel
Adding veliparib to carboplatin and paclitaxel resulted in “clinically meaningful improvements” in progression-free survival and overall survival among patients with previously untreated metastatic or advanced non–small cell lung cancer (NSCLC), particularly those with squamous histology. The...
FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer
The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...
BOLERO-1: Everolimus Plus Trastuzumab/Paclitaxel Misses the Mark in First‑Line HER2-Positive Advanced Breast Cancer
The addition of everolimus (Afinitor) to weekly trastuzumab (Herceptin) plus paclitaxel in the first-line metastatic breast cancer setting did not improve outcomes in the phase III BOLERO-1/TRIO-019 but did provide a “signal” in the hormone receptor–negative subset. The study was reported at the...
Neoadjuvant Therapy in Triple-Negative Breast Cancer: Impact of Subtype
Among women with triple-negative breast cancer, overall, basal-like and non–basal-like tumors were equally likely to demonstrate a pathologic complete response to neoadjuvant chemotherapy, but they responded differently to the addition of carboplatin and bevacizumab (Avastin) to a standard...
Post-Transplant Brentuximab Vedotin Improved Progression-Free Survival in Hodgkin Lymphoma Patients
In patients with Hodgkin lymphoma who are at risk for disease progression following autologous stem cell transplantation, early consolidation with brentuximab vedotin (Adcetris) post-transplant significantly improved progression-free survival compared with placebo in the phase III AETHERA trial.1...
Ovarian Suppression Plus Hormonal Therapy May Be Practice-Changing in Premenopausal Hormone Receptor–Positive Early-Stage Breast Cancer
Results of the large International Breast Cancer Study Group (IBCSG)-coordinated SOFT trial present a convincing argument for the addition of ovarian function suppression to adjuvant hormonal therapy to reduce the risk of tumor recurrence in younger women with hormone receptor–positive early-stage...
Expert Point of View: David H. Vesole, MD, PhD, FACP
David H. Vesole, MD, PhD, FACP, Co-Division Chief and Director of Research for the Multiple Myeloma Division at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey, commented after the presentation of the ASPIRE trial data that the findings were “impressive.” “It’s ...
Carfilzomib-Based Triplet Yields ‘Unprecedented’ Duration of Remission in Relapsed Myeloma
The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to Keith Stewart, MB, ChB, Professor of Medicine at the Mayo Clinic in Scottsdale, Arizona, who...
'Chemobrain’ Study Aims to Correlate Structural Changes Within the Brain and Psychomotor Function
The novelty of our approach is that we are going to be using multiple modalities” to study the effects of chemotherapy and hormonal therapy on the brain, looking for structural changes within the brain and how these changes might affect psychomotor function, particularly upper-extremity movements...
Clinical Trials Actively Recruiting Patients With Glioblastoma
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies for patients with newly diagnosed or recurrent glioblastoma multiforme. The studies include pilot, phase I, I/II, III, and observational trials investigating chemoradiation therapy;...
Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research
Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...
News Roundup From the 2014 San Antonio Breast Cancer Symposium
Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...
Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL
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 December 3, 2014, blinatumomab (Blincyto) was granted...
Iniparib: The Fairy Tale Dream Comes to an End
The first poly ADP ribose polymerase (PARP) inhibitor was developed in the early 1990s. Since then, the activity of PARP inhibitors has been explored in a variety of settings, including and perhaps most enthusiastically in the treatment of cancer. The greater dependence of several cancers on PARP,...
Ibrutinib for Waldenström’s Macroglobulinemia
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 January 29, 2015, the U.S. Food and Drug Administration (FDA)...
TNT Trial Supports Platinums in BRCA-Mutated Breast Cancer
The TNT trial, presented at the 2014 San Antonio Breast Cancer Symposium, provided no evidence that unselected advanced triple-negative breast cancer patients are more likely to respond to carboplatin than to docetaxel.1 However, patients with BRCA1/2 mutations do have a greater response and a...
Radiotherapy in Good-Prognosis DLBCL
Limited-stage nonbulky diffuse large B-cell lymphoma (DLBCL) carries an excellent prognosis, and radiotherapy provides no value in patients who obtain a complete response, according to the phase III 02-03 trial from the Lysa/Goelams group, presented at the 56th American Society of Hematology (ASH)...
First Randomized Trial to Show Benefit of Tyrosine Kinase Inhibitor in Newly Diagnosed Acute Myeloid Leukemia
Sorafenib (Nexavar) added to chemotherapy improved event-free survival and relapse-free survival in younger patients with acute myeloid leukemia, according to results of the randomized, controlled phase II SORAML trial.1 However, no significant improvement in overall survival has been seen to ...
Expert Point of View: David Ilson, MD
David Ilson, MD, of Memorial Sloan Kettering Cancer Center in New York, criticized the trial presented by Dr. Penniment at the 2015 Gastrointestinal Cancers Symposium for lacking a chemotherapy-alone arm. “Chemotherapy alone, in phase III trials, has achieved dysphagia relief in 70% of patients,”...
Radiotherapy Alone as Effective as Chemoradiation Therapy in Palliation of Dysphagia in Patients With Advanced Esophageal Cancer
Palliation of dysphagia associated with advanced esophageal cancer can be effectively accomplished with radiotherapy alone, without the addition of chemotherapy, according to a multinational phase III study presented at the 2015 Gastrointestinal Cancers Symposium.1 “There was no significant...
Expert Point of View
Commenting on the RAISE study at a press briefing held during the 2015 Gastrointestinal Cancers Symposium, moderator Smitha S. Krishnamurthi, MD, Associate Professor of Medicine at Case Western Reserve University School of Medicine, Cleveland, acknowledged that improvements of 1 to 2 months in...
Ramucirumab Added to FOLFIRI Yields Results Similar to Bevacizumab or Aflibercept in Second‑Line Colorectal Cancer
The phase III international RAISE trial found that ramucirumab (Cyramza) extends survival when given with chemotherapy to metastatic colorectal cancer patients who progress on treatment,1 but some experts commented that “financial toxicity” might be an issue, given the modest benefit. “The RAISE...
Kay Research and Care Center Opens at St. Jude Children’s Research Hospital
St. Jude Children’s Research Hospital in Memphis has officially opened the Kay Research and Care Center. The new $198 million center houses the Eric Trump Foundation Surgery and ICU Center, and the Marlo Thomas Center for Global Education and Collaboration. The St. Jude Red Frog Events Proton...
FDA Approves Lenalidomide in Combination With Dexamethasone for Newly Diagnosed Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has expanded the existing indication for lenalidomide (Revlimid) in combination with dexamethasone to include patients newly diagnosed with multiple myeloma. Lenalidomide plus dexamethasone was previously approved in June 2006 for use in multiple myeloma...
Crizotinib Crosses Another Finish Line in Lung Cancer
Treatment of anaplastic lymphoma kinase (ALK)–positive lung cancer has been one of the great success stories in oncology in the past decade. First discovered in lung cancer in 2007, ALK rearrangements are found in 3% to 5% of patients and define a distinct molecular subgroup of the disease with...
First-Line Crizotinib Improves Progression-Free Survival vs Chemotherapy in ALK-Positive NSCLC
In a phase III trial (PROFILE 1014) reported in The New England Journal of Medicine, Benjamin J. Solomon, MB, BS, PhD, of Peter MacCallum Cancer Centre, Melbourne, and colleagues found that the ALK inhibitor crizotinib (Xalkori) improved progression-free survival vs standard chemotherapy in...
FDA Grants Cobimetinib Priority Review for Use in Combination With Vemurafenib in Advanced Melanoma
The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review for Genentech’s New Drug Application (NDA) for cobimetinib in combination with vemurafenib (Zelboraf) for the treatment of people with BRAF V600 mutation–positive advanced melanoma. The FDA will make a decision on...
FDA Approves Palbociclib in Combination With Letrozole for Advanced Breast Cancer
The U.S. Food and Drug Administration has granted accelerated approval to palbociclib (Ibrance) in combination with letrozole for the treatment of postmenopausal women with estrogen receptor–positive, HER2-negative metastatic breast cancer who have not yet received an endocrine-based therapy....
HIV-Related Lymphoma Can Be Safely Treated With Transplant
Human immunodeficiency virus (HIV)-positive patients with relapsed/refractory lymphoma can safely undergo autologous hematopoietic cell transplantation, according to results of a phase II multicenter trial presented at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition in...
