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Showing 8251 - 8300Carfilzomib-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...
Adding Sargramostim to Ipilimumab Improved Overall Survival Among Patients With Unresectable Stage III or IV Melanoma
Patients with unresectable stage III or IV melanoma treated with ipilimumab (Yervoy) plus sargramostim (Leukine) had longer overall survival and less toxicity than did those treated with ipilimumab alone, according to a phase II randomized clinical trial conducted by the Eastern Cooperative...
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;...
Supplemental New Drug Application for Carfilzomib
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) carfilzomib (Kyprolis) to seek approval for the treatment of patients with relapsed multiple myeloma who have received at least...
CPX-351 Receives Fast Track Designation for Secondary Acute Myeloid Leukemia in Elderly Patients
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Celator Pharmaceuticals’ investigational agent CPX-351, a liposomal formulation of cytarabine:daunorubicin, for the treatment of elderly patients with secondary acute myeloid leukemia. The FDA established the Fast...
New Choosing Wisely List, Leukemia Quick-Takes From ASH
Nearly 5,000 scientific abstracts were presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exhibition in San Francisco. Along with our targeted coverage of the meeting’s key newsmakers, The ASCO Post provides you with these brief reports of other interesting...
Ramucirumab in Metastatic Non–Small Cell Lung 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. In December 12, 2014, ramucirumab (Cyramza) was approved for use in ...
Treating Bladder Cancer in 2015
Treatment of advanced bladder cancer continues to prove challenging, and therapies that offer long-term survival remain elusive. The ASCO Post recently spoke with Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, President of the Levine Cancer Center, Charlotte, North Carolina, about the current state...
Ruxolitinib for Polycythemia Vera
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 4, 2014, ruxolitinib (Jakafi) was approved for the...
Strong Showing for Anti-CD38 Antibodies in Multiple Myeloma
An investigational class of agents in multiple myeloma, the anti-CD38 monoclonal antibodies, could be the next blockbusters in this malignancy, myeloma experts predicted at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition. Anti-CD38 antibodies target multiple myeloma...
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)...
E1199 Update: It’s Weekly Paclitaxel for Triple‑Negative Breast Cancer
An update of clinical trial E1199 showed that weekly paclitaxel and every-3-week docetaxel were both more effective than every-3-week paclitaxel in preventing deaths and tumor recurrences, according to Joseph Sparano, MD, Professor of Medicine and Women’s Health at the Albert Einstein College of...
Modified Nab-Paclitaxel/Gemcitabine in Pancreatic Cancer: Efficacious, Less Toxic, Less Costly
A less intensive regimen of nab-paclitaxel (Abraxane) plus gemcitabine appears to be as efficacious as the standard regimen in first-line treatment for metastatic pancreatic cancer, but less toxic and far less expensive, according to a study that earned a Merit Award at the 2015 Gastrointestinal...
Observation Appropriate for Some Patients With Rectal Cancer Following Neoadjuvant Therapy
Some patients with rectal cancer who achieve a complete response to neoadjuvant chemoradiation therapy can be monitored for tumor recurrence and may never need surgery, according to a retrospective review from patients at Memorial Sloan Kettering Cancer Center, New York, presented at the 2015...
More on Ramucirumab in Metastatic Colorectal Cancer
I am writing in regard to the report and commentary in this issue on the RAISE Trial. To begin, a discussion of this phase III clinical trial presented at the 2015 Gastrointestinal Cancers Symposium (RAISE study) may not be the most appropriate forum to air legitimate views on finances and...
Primary Surgical Therapy Results in Higher 5-Year Survival for Patients With Advanced-Stage Disease
Bucking national trends toward preserving the larynx in patients with advanced laryngeal cancer, treatment of patients for stage IV disease at Louisiana State University (LSU) Health-Shreveport were more likely to involve primary surgical therapy, including total laryngectomy, and more likely to...
First-Line Crizotinib Superior to Pemetrexed‑Plus‑Platinum Chemotherapy in Patients With ALK‑Positive NSCLC
Crizotinib (Xalkori) treatment “was superior to pemetrexed-plus-platinum chemotherapy with respect to progression-free survival, objective response rate, reduction in lung-cancer symptoms, and improvement in quality of life” in patients with previously untreated advanced anaplastic lymphoma kinase...
Capsaicin
Scientific name: 8-methyl-N-vanillyl-6-nonenamide Brand names: Zostrix cream 0.025% or 0.075%, Salonpas Gel-Patch Hot, Sinus Buster (homeopathic intranasal spray). The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence ...
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,...
No Benefit of Adding Iniparib to Gemcitabine/Carboplatin in Metastatic Triple‑Negative Breast Cancer
In a phase III trial reported in Journal of Clinical Oncology, Joyce O’Shaughnessy, MD, of Baylor Charles A. Sammons Cancer Center, Dallas, and colleagues found that the addition of iniparib to gemcitabine and carboplatin did not improve overall survival or progression-free survival in patients...
Tailoring Therapy for Diffuse Large B-Cell Lymphoma by Interim PET May Be Problematic
In a study that reflected clinical practice, treatment of diffuse large B-cell lymphoma based on the results of interim positron-emission tomography (PET) was feasible; however, switching PET-positive patients to an alternative treatment still resulted in inferior treatment outcomes, and the...
Oral Proteasome Inhibitors Advancing in Multiple Myeloma Trials
Two orally administered proteasome inhibitors—oprozomib and ixazomib—looked encouraging in multiple myeloma studies presented at the 2014 ASH Annual Meeting and Exposition. Study Details for Oprozomib Oprozomib, given as a single agent in a dose-escalation study of heavily pretreated patients,...
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)...
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...
Pancreatic Cancer: Latest Drug Development Hits and Misses
Targeting one of the deadliest cancers and seeking to fill an unmet need, drug development in pancreatic cancer is an area of high interest. This was certainly the case at the 2015 Gastrointestinal Cancers Symposium, where results were impressive for some novel agents but disappointing for several...
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...
Cutaneous Adverse Effects Associated With Tyrosine Kinase Inhibitors May Impact Quality of Life and Adherence to Treatment
Tyrosine kinase inhibitors “are associated with numerous adverse effects, many of which are cutaneous and can affect patients’ quality of life and impede their adherence to long-term treatment,” National Cancer Institute (NCI) investigators concluded after studying the adverse effects of the...
Cancer Was My Wake-Up Call to a Healthier Life
I come from strong physical stock and inherited a sort of “tough it out mentality” when it comes to coping with the usual aches and pains that creep up as you age. So by the time I realized that my legs had become so swollen and my breathing so labored it was difficult for me to walk, I could...
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...
Treating Head and Neck Cancer in 2015
Each year in the United States, about 55,000 people will be diagnosed with head and neck cancer, and of them, about 12,000 will die of the disease. Although advances have been made in the treatment of head and neck cancer, this disease remains persistently problematic, due, in part, to the complex...
The Search for Optimal Adjuvant Breast Cancer Chemotherapy: The End of an Era?
Using a complex and innovative study design, Budd and colleagues from the Southwest Oncology Group (SWOG) addressed, in a randomized multicenter trial,1 an issue that has been under evaluation for over 40 years—namely, what are the optimal dose and schedule for adjuvant breast cancer chemotherapy?...
Combination Treatment Every 2 Weeks May Benefit Some Women With High-Risk Early-Stage Breast Cancer
In a phase III trial (SWOG S0221) reported in the Journal of Clinical Oncology, George T. Budd, MD, of Taussig Cancer Center, Cleveland Clinic, and colleagues found no difference in disease-free survival among four different combinations of continuous or every-other-week...
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 Approves Lenvatinib for Progressive Radioiodine-Refractory Differentiated Thyroid Cancer
The U.S. Food and Drug Administration (FDA) has granted approval to lenvatinib (Lenvima) to treat patients with progressive, differentiated thyroid cancer whose disease progressed despite receiving radioactive iodine therapy. Lenvatinib is a tyrosine kinase inhibitor that binds to multiple sites...
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...
Nivolumab in Previously Treated Metastatic Renal Cell Cancer
The approval of multiple inhibitors of either the VEGF or mTOR pathway provided an incremental advance in the treatment of metastatic clear cell renal cancer. However, the agents have several important limitations: For example, the optimal clinical effect appears to be dependent on chronic...
Nivolumab Shows Activity in Previously Treated Metastatic Renal Cell Carcinoma
In a randomized phase II trial reported in the Journal of Clinical Oncology, Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues found that the programmed cell death protein-1 (PD-1) immune checkpoint inhibitor antibody nivolumab (Opdivo) was associated with...
Lanreotide Evaluated in Pancreatic Neuroendocrine Subgroup
The somatostatin analog lanreotide (Somatuline) depot extended the time to disease progression in patients with pancreatic neuroendocrine tumors, in a planned subgroup analysis of the CLARINET trial, Alexandria T. Phan, MD, of The Houston Methodist Hospital in Texas, reported at the 2015...
New Data Reported in Colorectal, Gastric, and Pancreatic Cancers
The 2015 Gastrointestinal Cancers Symposium, held January 15–17 in San Francisco, attracted almost 4,000 attendees, who heard or viewed data from nearly 800 scientific abstracts and lectures. Here are our summaries of some of the many important developments from the meeting. Bevacizumab Plus...
Addressing the Global Cancer Burden
Since 1990, the annual global death toll from cancer has risen about 40%, and that number is projected to increase from the current level of approximately 8 million cancer deaths per year to more than 13 million by 2030. The poorer, resource-challenged regions of the world will suffer a...
Clinical Trials Actively Recruiting Patients With Esophageal Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting observational, interventional, phase I, phase II, and phase III clinical studies for patients with newly diagnosed or recurrent esophageal cancer. All of the studies are listed on the National Institutes...
Five Questions Can Guide the Treatment of Relapsed Myeloma
Joseph Mikhael, MD, MEd, myeloma expert at the Mayo Clinic in Arizona, Scottsdale, and Associate Dean of the Mayo School of Graduate Medical Education, considers five questions when selecting treatment for patients with multiple myeloma who relapse. “With prolonged survival, which approaches 10...
Panobinostat in Combination With Bortezomib‑Dexamethasone in Previously Treated Multiple Myeloma
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 February 23, 2015, panobinostat (Farydak) was granted...
Development and Approval of Biosimilar 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, Leah Christl, PhD, and Albert Deisseroth, MD, PhD, answer questions about biosimilar products. Dr. Christl is the Associate Director...
Lenalidomide in Combination With Dexamethasone in Newly Diagnosed Multiple Myeloma
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 February 18, 2015, the indication for lenalidomide (Revlimid)...
Adjuvant Ovarian Suppression May Benefit Women With Premenopausal Breast Cancer Who Received Prior Chemotherapy
In a phase III trial (SOFT) reported in The New England Journal of Medicine, Prudence A. Francis, MD, of Peter MacCallum Cancer Centre, Melbourne, Australia, Meredith M. Regan, ScD, of IBCSG Statistical Centre at Dana-Farber Cancer Institute, Boston, and colleagues found that the addition of...
Priority Review Granted for Trabectedin in Advanced Soft-Tissue Sarcoma
The U.S. Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for trabectedin to treat patients with advanced soft-tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have received prior chemotherapy including an anthracycline. The NDA ...
Expert Point of View: Jonathan Rosenberg, MD
Formal discussant of both trials, Jonathan Rosenberg, MD, of the Genitourinary Division at Memorial Sloan Kettering Cancer Center in New York, agreed that both studies move the field of antiangiogenesis in advanced bladder cancer forward. “The very high overall response rates in the pazopanib plus...
