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Showing 1151 - 12002012 In Review: Oncology Drugs/Indications Newly Approved by FDA
At press time, the FDA had granted approval for the following new agents and indications for cancer treatment in 2012. Cabozantinib (Cometriq) for the treatment of progressive metastatic medullary thyroid cancer. Cabozantinib is a small molecule that inhibits the activity of multiple tyrosine...
Persistent Survival Benefit in Patients with Untreated Disease Treated with Bortezomib Added to Melphalan and Prednisone
A final analysis of the phase III VISTA trial (Velcade as Initial Standard Therapy in Multiple Myeloma: Assessment with Melphalan and Prednisone) found a persistent significant benefit in overall survival with VMP (bortezomib, melphalan, prednisone) vs MP (melphalan, prednisone) in patients with...
NCI Director Assesses Barriers to Faster Progress in Cancer Research
At a National Press Club media event in Washington, DC, on September 25, 2012, National Cancer Institute (NCI) Director Harold E. Varmus, MD, addressed a group of 75 reporters and officials. His discussion focused on impediments—biologic, economic, institutional, and cultural—to faster cancer...
Oral Proteasome Inhibitor May Be a Game-changer in Myeloma
An investigational oral proteasome inhibitor currently known as MLN9708 could make the treatment of multiple myeloma much more convenient and possibly less neurotoxic, according to the results of a phase I/II study of treatment-naive multiple myeloma patients presented at the 54th Annual Meeting of ...
Overall Survival Benefit Achieved with Pomalidomide in Advanced Myeloma
Support for the oral immunomodulatory agent pomalidomide for multiple myeloma took a step forward when the phase III MM-003 trial showed a survival advantage in patients with advanced disease, in addition to a doubling in progression-free survival, when pomalidomide was given with low-dose...
SIDEBAR: Ibrutinib in Other Hematologic Tumors
At the 2012 ASH Annual Meeting, researchers also reported preliminary results for ibrutinib in diffuse large B-cell lymphoma, follicular lymphoma, and multiple myeloma. A multicenter phase II study in 70 heavily pretreated patients with relapsed or refractory diffuse large B-cell lymphoma in two...
Survival Benefit Achieved with Four Drugs plus Maintenance in Myeloma
An overall survival benefit in newly diagnosed multiple myeloma was attained with a four-drug induction regimen followed by a duet for maintenance in a study from the Italian GIMEMA network. Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Torino in Italy, reported the findings...
Hematology/Oncology Team Joins NewYork-Presbyterian Hospital/Columbia University Medical Center
The Herbert Irving Comprehensive Cancer Center (HICCC) at NewYork-Presbyterian Hospital/Columbia University Medical Center has welcomed five new clinician-scientists specializing in leukemia. These practitioners joined the HICCC faculty in early January 2013. The new staff members are Mark G....
ASH Highlights Included New Data in Myeloma, Lymphoma, and Leukemia, plus Studies of Mucositis and Graft-vs-Host Disease
The 54th Annual Meeting of the American Society of Hematology (ASH) featured about 5,000 abstracts, including oral sessions and posters, as well as named lectures and symposia. In addition to our regular news coverage from the meeting, below are capsule summaries of a few news highlights that we...
We Need Gemtuzumab Available Again to Treat AML
The word “revival” signifies a renewed use or acceptance after a period of inactivity; similarly, the word “resurrection” refers to the concept of an entity coming back to life after death. In the past year, these terms have been used frequently by us (and others) in articles calling for the return ...
More Brief Reports from ASH, Including New Data in Leukemia, Lymphoma, and Myelodysplastic Syndrome
At the 54th Annual Meeting of the American Society of Hematology (ASH), held in Atlanta, nearly 5,000 abstracts were presented in oral sessions and posters. As part of our ongoing comprehensive coverage from the meeting, here are several more studies of note. New Targets in Acute Myeloid Leukemia...
FDA Approves Pomalidomide for Advanced Multiple Myeloma
The FDA approved pomalidomide (Pomalyst) an oral immunomodulatory agent, to treat patients with multiple myeloma whose disease progressed after being treated with other cancer drugs. Pomalidomide is intended for patients who have received at least two prior therapies, including lenalidomide...
Study Shows Little Association of Multidisciplinary Tumor Boards with Measures of Care
A survey of Veterans Affairs (VA) medical centers recently reported by Nancy L. Keating, MD, MPH, and colleagues at Harvard Medical School in the Journal of the National Cancer Institute showed that the presence of multidisciplinary tumor boards had little association with rates of recommended...
High Infection Rates Found in Multiple Myeloma Patients, With High Mortality
A large Swedish study using population-based data to estimate the risk of bacterial and viral infections among 9,610 patients with multiple myeloma (9,253 eligible for analysis) found that the myeloma patients had a 7-fold risk of developing any infection compared to 34,931 matched controls from...
Pomalidomide 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. Indication On February 8, 2013, the immunomodulatory agent...
Thalidomide/Prednisone Maintenance after Stem Cell Transplant Improves Progression-free but Not Overall Survival
Maintenance therapy with thalidomide (Thalomid) and prednisone after autologous stem cell transplantation in patients with multiple myeloma improved progression-free survival but not overall survival, according to results of a phase III trial reported in Blood. Patients receiving maintenance...
New ACCC Officers and Trustees
Results of the election of new officers and trustees (2013–2014) for the Association of Community Cancer Centers (ACCC) were announced recently at the ACCC Annual National Meeting. First Nonphysician ACCC President Elected Virginia Vaitones, MSW, became ACCC President at the 39th Annual National...
AACR Briefs Congressional Staffers on Importance of Continued Funding for Research
As we all now know, the start of the sequestration prescribed by the Budget Control Act of 2011 was delayed until March 1, 2013, by the American Taxpayer Relief Act of 2012. With Congress unable to strike a deal, the mandatory reductions in Federal spending were triggered on March 1. Those...
Gene Transfer Therapy Is Producing Prolonged Remissions in Patients with Advanced Leukemia
In August 2011, researchers from the University of Pennsylvania published their breakthrough findings of a pilot study showing sustained remissions of up to 1 year in a small number of patients with advanced chronic lymphocytic leukemia (CLL) who had been treated with genetically engineered...
New NCCN Guidelines for Patients Available for Adolescents and Young Adults with Cancer
The National Comprehensive Cancer Network (NCCN), with support from the NCCN Foundation and the LIVESTRONG Foundation and through collaboration with Critical Mass: The Young Adult Cancer Alliance (Critical Mass), recently announced the availability of the NCCN Guidelines for Patients: Caring for...
Control of Autophagic Cell Death by Caspase-10 in Multiple Myeloma
Multiple myeloma subtypes are driven by a variety of genetic abnormalities. Given the genetic diversity of the disease, identification of oncogenic mechanisms common to all subtypes is highly desirable. In a study reported in Cancer Cell, Lamy and colleagues found that that all multiple myeloma...
SIDEBAR: NCCN Patient Guidelines for Adolescents and Young Adults
NCCN Patient Guidelines for Adolescents and Young Adults with Cancer are now available. Visit www.nccn.com to view these and other NCCN guidelines for patients. Patient versions of the NCCN Guidelines are available in the following categories: Adolescents and young adults Breast cancer Chronic...
NCCN Patient Guidelines for Adolescents and Young Adults
The National Comprehensive Cancer Network (NCCN) has issued new NCCN Guidelines for Patients, titled “Caring for Adolescents and Young Adults [AYA].” These guidelines fill an unmet need in oncology, as Peter F. Coccia, MD, Chair of the NCCN Guidelines Panel for Young Adult Oncology and a member of...
Daratumumab Receives Breakthrough Therapy Designation in Multiple Myeloma
FDA has granted daratumumab breakthrough therapy designation for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double refractory to a proteasome inhibitor and...
NCCN Clinical Practice Guidelines in Oncology: 2013 Updates
At the 18th Annual Conference of the National Comprehensive Cancer Network (NCCN), representatives of NCCN Guidelines panels presented two new sets of guidelines along with updates for several tumor types, summarized in this issue of The ASCO Post. New NCCN Guidelines for Survivorship “The...
Tailored Intervention Protocol for Oral Chemotherapy Adherence Studied
In a study testing the effectiveness of three strategies to improve oral chemotherapy adherence, tailored coaching was beneficial for some patients, reducing barriers to adherence, reported Susan M. Schneider, PhD, RN, AOCN, ACNS-BC, FAAN, Associate Professor and Director of Oncology Nursing...
A New Center for Lymphoid Malignancies Aims to Provide Precision Patient Care
In January, New York-Presbyterian Hospital/Columbia University Medical Center opened the Center for Lymphoid Malignancies, a 3,700 square foot outpatient clinic, in the heart of Midtown Manhattan. The Center is solely focused on the treatment of all forms of Hodgkin and non-Hodgkin lymphoma,...
Newly Approved Drugs and Indications
FDA has approved the following new drugs and/or indications in 2013: Denosumab (Xgeva subcutaneous injection) for giant cell tumor of bone. Lenalidomide (Revlimid capsules) for relapsed/refractory mantle cell lymphoma FDA approved. Trametinib (Mekinist tablets) for unresectable or metastatic...
Venous Thromboembolism in Patients with Cancer: Real-world Challenges for the Practicing Oncologist
The close association between cancer and thrombosis has been recognized now for more than 150 years.1 Not only is it now known that patients with cancer are at substantially increased risk of developing venous thromboembolism, even prior to the diagnosis of cancer, but the association between...
Updated ASCO Clinical Practice Guideline for Venous Thromboembolism Prophylaxis and Treatment
ASCO has released a new evidence-based clinical practice guideline for venous thromboembolism prophylaxis and treatment, updating the 2007 practice guideline.1 The update is based on a systematic review of literature published from December 2007 to December 2012. An Update Committee reviewed...
Lenalidomide Induces Long-lasting Responses in Elderly Patients
Treatment with lenalidomide (Revlimid) as initial therapy induced long-lasting responses in a phase II study of 60 patients with chronic lymphocytic leukemia (CLL). “Overall, 35 patients (58%) patients had responses lasting more than 36 months and were considered long-term responders,” the...
New Guidelines Issued in the Treatment of Multiple Myeloma-Related Bone Disease
The International Myeloma Working Group (IMWG) has developed clinical practice recommendations for the management of multiple myeloma-related bone disease based on published study data through August 2012. Consensus of the interdisciplinary panel of clinical experts on the plasma-cell cancer was...
Barriers to Successful Hematopoietic Stem Cell Transplantation
The Center for International Blood and Marrow Transplant Research is a combined research program of the National Marrow Donor Program and the Medical College of Wisconsin, Milwaukee. At the forefront of research to increase access to hematopoietic stem cell transplantation and improve outcomes, the ...
Denosumab in Adults and Skeletally Mature Adolescents with Giant Cell Tumor of Bone
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. Indication On June 13, 2013, denosumab (Xgeva) was approved for the ...
ACCC Institutes Network to Provide Assistance in Treating Uncommon Cancers
Among the more than 200 types of cancer are those called “forgotten” or “orphan” cancers, with fewer than 40,000 new cases each year. They present treatment challenges in community cancer centers. Because of the low incidence of these diseases, such as chronic myeloid leukemia, acute promyelocytic...
New Research Presented in Breast, Gastric, Esophageal Cancers, Melanoma, and Multiple Myeloma, plus Supportive Care
Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...
SIDEBAR: Societies Call for Protection of Patient Access to Clinical Trials
American Academy of NeurologyAmerican Association for Cancer ResearchAmerican Cancer Society Cancer Action NetworkAmerican Childhood Cancer FoundationAmerican Diabetes AssociationAmerican Epilepsy SocietyAmerican Heart Association/American Stroke AssociationAmerican Lung AssociationAmerican Society ...
Lenalidomide in Relapsed/Progressed Mantle Cell Lymphoma after Two Prior Therapies Including Bortezomib
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. Indication On June 5, 2013, lenalidomide (Revlimid) was approved...
New Guidelines Issued in the Treatment of Multiple Myeloma-Related Bone Disease
The International Myeloma Working Group (IMWG) has developed clinical practice recommendations for the management of multiple myeloma-related bone disease based on published study data through August 2012. Consensus of the interdisciplinary panel of clinical experts on the plasma cell cancer was...
Tecemotide Vaccine Warrants Further Study in Unresectable Stage III Non–Small Cell Lung Cancer
Results of the START trial suggest that maintenance therapy with the investigational immunotherapy tecemotide (formerly known as L-BLP25) may have a role in the treatment of patients with unresectable stage III non–small cell lung cancer (NSCLC). Although there was no significant overall survival...
Dr. Julie Vose Finds the Best of Both Worlds—Patient Care and Cutting-Edge Research—in Academic Medicine
Julie M. Vose, MD, MBA, is the Neumann M. and Mildred E. Harris Professor and Chief of the Division of Hematology/Oncology at the University of Nebraska Medical Center. She grew up in Mitchell, South Dakota, a small town nestled on the banks of the James River. Mitchell is home to the Corn Palace,...
Access to and Appropriate Use of Oncology Drugs Called Into Question by ASCO Studies
Studies presented at this year’s ASCO Annual Meeting suggest that despite the wealth of amazing oncolytics on the market, drug shortages persist, drug substitutions are common, off-label use of drugs occurs frequently, and patients find their costs burdensome. Drug Shortage Persists The shortage of ...
Panobinostat Combined With Bortezomib and Dexamethasone Can Recapture Responses in Heavily Pretreated Patients
The combination of the investigational histone deacetylase inhibitor panobinostat (Faridak) with bortezomib (Velcade) and dexamethasone was able to recapture responses in 34.5% of heavily pretreated, bortezomib-refractory patients with multiple myeloma in the phase II PANORAMA 2 trial. The 55...
The Direction of Immunotherapy Over the Next Decade
The use of immunotherapy to target malignant cells in a variety of cancers—especially the PD-1 inhibitors lambrolizumab and nivolumab in the treatment of metastatic melanoma and the anti–PD-L1 agent MPDL3280A in the treatment of melanoma and lung, kidney, colorectal, and gastric cancers—made...
Pomalidomide In Patients With Disease Progression Who Are Refractory to Bortezomib and Lenalidomide
The second-generation immunomodulatory drug pomalidomide (Pomalyst) “has shown impressive results in patients with multiple myeloma who are refractory to lenalidomide [Revlimid] and bortezomib [Velcade],” according to a review of clinical data leading to the drug’s approval by the FDA. In February, ...
View From a Cancer Ward in Botswana
Julie Livingston, PhD, MPH, is a Professor of History at Rutgers University. She is also an African historian with interdisciplinary training in public health and anthropology. Among other issues, her work considers the challenges of delivering oncology services in southern Africa, where there is a ...
Myeloma Foundation Launches Open Access Gateways to Accelerate Drug Development
The Multiple Myeloma Research Foundation (MMRF) has announced two open access gateways, the MMRF Researcher Gateway, which will upload genomic data as it becomes available and make it accessible to all researchers, and the MMRF CoMMunity Gateway, which will aggregate subtypes of myeloma patients...
SIDEBAR: 2013 New Drug/Indication Approvals*
1. September 30, 2013: Pertuzumab (Perjeta) Accelerated approval in combination with trastuzumab and docetaxel for the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory, or early-stage breast cancer. 2. September 6, 2013: Paclitaxel protein-bound particles (albumin-bound)...
SIDEBAR: IMWG Recommendations
The International Myeloma Working Group (IMWG) recommends intravenous zoledronic acid as first-line therapy and intravenous pamidronate as second-line therapy for all patients being treated for multiple myeloma, regardless of imaging findings.1 These drugs are given monthly for 2 years and can be...
Options for Management of Bone Health in Patients With Multiple Myeloma
Bone health is critical in patients with multiple myeloma, since up to 85% will suffer bone damage. Options for management include two FDA-approved bisphosphonates—pamidronate and zoledronic acid—and possibly the RANK-L inhibitor denosumab (Xgeva, investigational use). Importance of Supportive ...
