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issues in oncology

The FDA Ensures Quality and Safety of Generic Drugs in the United States

The U.S. Food and Drug Administration’s (FDA) generic drug program has substantially increased the availability of affordable, high-quality drugs in the United States. It is arguably the only really effective health-care cost–containment program. The more than 10,000 generic drugs currently...

kidney cancer

Clinical Trials Actively Recruiting Patients With Renal Cell Carcinoma

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy as treatment for renal cell carcinoma. These studies are researching combination chemotherapies; immunotherapies; radiosurgery techniques; stereotactic body...

solid tumors
breast cancer

Fergus J. Couch, PhD, and Max S. Wicha, MD, Recognized for Significant Contributions to Breast Cancer Research at 2016 SABCS

The American Association for Cancer Research (AACR) honored two renowned researchers for their work in breast cancer at the 2016 San Antonio Breast Cancer Symposium (SABCS), held December 6–10 in San Antonio, Texas. Fergus J. Couch, PhD, of the Mayo Clinic, will receive the 9th Annual AACR...

issues in oncology

Concerns About Safety of Generic Oncology Drugs Made in Developing Countries

In an article in The Lancet Oncology, Y. Tony Yang, ScD, of George Mason University, Charles L. Bennett, MD, PhD, MPP, of the University of South Carolina and colleagues from the United States, Europe, and Japan examined clinical, policy, safety, and regulatory considerations for generic oncology...

breast cancer

SABCS 2016: Extended Letrozole Therapy Showed Limited Benefit in Postmenopausal Women With Early-Stage, Hormone Receptor–Positive Breast Cancer

Five additional years of hormone therapy with letrozole following an initial 5 years of aromatase inhibitor-based adjuvant hormone therapy did not demonstrate a statistical improvement in disease-free survival or overall survival in postmenopausal women with early-stage hormone...

breast cancer

SABCS 2016: Adding Everolimus to Fulvestrant Improved Outcomes for Postmenopausal Patients With Hormone Receptor–Positive Breast Cancer

Progression-free survival was more than doubled for patients with metastatic hormone receptor–positive, HER2-negative breast cancer resistant to aromatase inhibitor therapy by adding everolimus (Afinitor) to treatment with the endocrine therapeutic fulvestrant (Faslodex), according to data...

breast cancer

SABCS 2016: Genomic Sequencing of Treatment-Resistant Metastatic Breast Cancer Reveals Clinically Relevant Genetic Alterations

Genomic sequencing of estrogen receptor–positive metastatic breast cancer that had become resistant to therapies revealed multiple genomic and molecular alterations that were not present in the primary tumor samples, with implications for choice of next therapy, clinical trial eligibility,...

lung cancer

New Treatments for Lung Cancer in 2016

With drug approvals for immunotherapy in the first- and second-line settings, breakthroughs in targeting epidermal growth factor receptor (EGFR) mutations, and the rapid evolution of therapies that target anaplastic lymphoma kinase (ALK) rearrangements, 2016 has been an extraordinary year for lung...

solid tumors

Mutanome-Directed Immunotherapy: Finding the Best Treatment Match

Oncologists may be accustomed to looking for commonalities in patients, but highly personalized therapies are now being developed based on mutational analysis of tumors. According to data presented at the Cedars-Sinai annual symposium on New Therapeutics in Oncology: The Road to Personalized...

solid tumors

Noteworthy Antitumor Activity Seen in Phase I Studies of PDGFRα and KIT Mutation Inhibitors

Two studies presented at the 28th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Munich focused on the inhibition of mutations in the KIT and PDGFRα oncogenes. These genes encode receptor tyrosine kinases, and when they are mutated, cell signaling malfunctions, leading to...

skin cancer

Novel Immunotherapy Combinations May Be the Future of Melanoma Treatment

The future treatment of melanoma may rely on combinations of immunotherapy agents beyond the current checkpoint inhibitors, and they are entering clinical trials, according to Jeffrey Weber, MD, PhD, Deputy Director of the Laura and Isaac Perlmutter Cancer Center at New York University Langone...

lung cancer

Experts Consider the New Immunotherapy Paradigm in Advanced Lung Cancer

One immune checkpoint inhibitor has now moved to the front of the line for treating advanced non–small cell lung cancer (NSCLC). Based on pivotal studies presented at the 2016 European Society for Medical Oncology (ESMO) Congress, pembrolizumab (Keytruda) became a first-line option, and it is...

lymphoma

‘Clinically Useful’ Findings for Brentuximab Vedotin in CTCL, Rituximab Maintenance in MCL

Positive studies about brentuximab vedotin ­(Adcetris) in cutaneous T-cell lymphoma1 and rituximab (Rituxan) maintenance therapy in mantle cell lymphoma (MCL)2 were reported at the 2016 Annual Meeting of the American Society for Hematology (ASH). “These abstracts each focus on approved agents and...

breast cancer

Equivalent Response Rates With Trastuzumab or Trastuzumab Biosimilar Plus Taxane in HER2-Positive Metastatic Breast Cancer

In part 1 of a phase III equivalence trial reported in JAMA, Rugo et al found that treatment with trastuzumab (Herceptin) or a proposed trastuzumab biosimilar in combination with a taxane produced similar overall response rates in patients with previously untreated metastatic HER2-positive breast...

multiple myeloma

ASH 2016: Additions to Standard Multiple Myeloma Therapy Do Not Appear to Yield Additional Benefit

Trial results presented by Stadtmauer during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-1) suggest two therapies that are often added to standard therapy in patients with multiple myeloma do not improve rates of progression-free survival ...

leukemia

ASH 2016: Children With Down Syndrome and ALL Fare as Well as Other Children Treated on ALL Consortium Protocols

Despite an elevated risk of toxicity from chemotherapy, children with Down syndrome and acute lymphoblastic leukemia (ALL) did not experience higher rates of relapse or treatment-related mortality compared with other children treated on Dana-Farber Cancer Institute ALL Consortium Protocols,...

leukemia
lymphoma

ASH 2016: Ibrutinib and TGR-1202 Combination Yields Encouraging Results in Patients With Relapsed Forms of Leukemia or Lymphoma

A combination of two targeted agents has demonstrated safety as well as encouraging signs of effectiveness in a phase I clinical trial in patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL). Davids et al reported the findings at the 58th American ...

leukemia

ASH 2016: IKZF1 Gene Mutations Found to Increase Hereditary Risk for Acute Lymphocytic Leukemia in Children

A late-breaking abstract being presented by Churchman et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-2) identifies inherited genetic mutations in the gene IKZF1 that confer a higher likelihood of developing pediatric...

hematologic malignancies
symptom management

ASH 2016: Ibrutinib Found Helpful in Treating Graft-vs-Host Disease After Stem Cell Transplant

A late-breaking abstract presented by Miklos et al during the 58th American Society of Hematology (ASH) Annual Meeting & Exposition in San Diego (Abstract LBA-3) showed patients who experience graft-vs-host disease (GVHD) after stem cell transplantation that is not resolved by corticosteroid...

prostate cancer

Does Androgen-Deprivation Therapy Increase the Risk for Dementia in Patients With Prostate Cancer?

In a UK population–based study reported in the Journal of Clinical Oncology, Khosrow-Khavar et al found no significant association between the use of androgen-deprivation therapy and the risk for dementia in patients with prostate cancer. The study involved a cohort of 30,903 men with newly...

leukemia

ASH 2016: Cessation of Tyrosine Kinase Inhibitor Treatment in Chronic Myeloid Leukemia Patients With Deep Molecular Response

In one of the largest-ever trials to assess the safety of stopping tyrosine kinase inhibitor therapy—the Euro-Ski trial—about half of 821 patients with chronic myeloid leukemia (CML) showed no evidence of relapse 2 years after treatment cessation, suggesting that some patients can...

leukemia

ASH 2016: Phase I Trial of Vadastuximab Talirine in Combination With 7+3 Induction Therapy for Patients With AML

In a clinical trial presented by Erba et al at the 58th American Society of Hematology (ASH) AnnualMeeting & Exposition (Abstract 211), vadastuximab talirine was found to be safe when used in combination with standard chemotherapy treatment for patients with acute myeloid leukemia (AML). The...

leukemia

ASH 2016: Biomarker May Predict Which Patients Previously Treated for Cancer Will Develop Highly Fatal Form of Leukemia

Patients successfully treated for breast, colon, and other cancers can go on to develop an often-fatal form of leukemia, sometimes years after completion of treatment, due to a genetic mutation leading to secondary malignancies known as therapy-related myeloid neoplasms. A study conducted by...

hematologic malignancies
supportive care

ASH 2016: Preventative Antibiotics Could Prevent Clostridium difficile Among Stem Cell Transplant Recipients

It may be possible to safely prevent one of the most common—and costly to treat—infections contracted by hospitalized patients undergoing bone marrow transplantation for the treatment of blood cancers, according to a study from the Abramson Cancer Center at the University of...

lymphoma

FDA Grants sBLA to Pembrolizumab for the Treatment of Relapsed or Refractory Classical Hodgkin Lymphoma

The U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, for the treatment of patients with refractory classical Hodgkin lymphoma or for...

breast cancer
issues in oncology
survivorship

Psychotropic and Opioid Medication Use in Older Patients With Breast Cancer Across the Care Trajectory

A new McGill University study published by Syrowatka et al in JNCCN – Journal of the National Comprehensive Cancer Network found that most patients with breast cancer aged 65 and older use psychotropic and opioid medications during active treatment, often in the first year of...

leukemia

High Frequency and Poor Outcome of Philadelphia Chromosome–Like ALL Reported in Adults

In a study reported in the Journal of Clinical Oncology, Roberts et al found a high frequency of Philadelphia chromosome (Ph)–like acute lymphoblastic leukemia (ALL) in adults with B-cell ALL and poorer outcome with conventional therapy in these patients. Frequency of Disease The frequency...

gastrointestinal cancer

EORTC-NCI-AACR 2016: Liquid Biopsies Identify Molecular Alterations Driving GI Cancer Drug Resistance in Nearly 80% of Patients

Ryan Corcoran, MD, PhD, Translational Research Director of the Center for Gastrointestinal Cancers at Massachusetts General Hospital (MGH) Cancer Center, described to attendees of the 2016 EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics the results of a program at MGH focused...

breast cancer

RSNA 2016: Large Study Finds No Evidence for Age-Based Mammography Cutoff

In the largest-ever study on screening mammography outcomes, researchers found that there is no clear cutoff age to stop breast cancer screening. The findings were presented November 28, 2016, at the 2016 Annual Meeting of the Radiological Society of North America (RSNA). This research adds support ...

cns cancers

Association of Extent of Surgeon-Assessed Resection on Outcome in High-Risk Neuroblastoma

In an analysis of patients with high-risk neuroblastoma from the Children’s Oncology Group A3973 study reported in the Journal of Clinical Oncology, von Allmen et al found that surgeon-assessed resection of at least 90% was associated with improved event-free survival and a reduced cumulative ...

leukemia

FDA Grants Full Approval and Label Update for Ponatinib in CML and ALL

The U.S. Food and Drug Administration (FDA) has granted ponatinib (Iclusig) full approval for the treatment of adult patients with chronic-phase, accelerated-phase, or blast-phase chronic myeloid leukemia (CML) or Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) for whom no ...

solid tumors

FDA Grants Priority Review to Pembrolizumab for New Indication in Microsatellite Instability–High Cancer

On November 28, the U.S. Food and Drug Administration (FDA) accepted for review the supplemental Biologics License Application (sBLA) for pembrolizumab (Keytruda) for the treatment of previously treated patients with advanced microsatellite instability–high (MSI-H) cancer. The FDA granted...

prostate cancer

Can Mindfulness-Based Cognitive Therapy Reduce Distress in Patients With Advanced Prostate Cancer?

Chambers et al found that a mindfulness-based cognitive therapy intervention did not improve measures of distress or anxiety vs minimally enhanced usual care among men with advanced prostate cancer, according to an Australian study reported in the Journal of Clinical Oncology. In the study, 189...

issues in oncology

AMA Statement on Opening Day Court Case Against Anthem-Cigna Deal

Andrew W. Gurman, MD, President of the American Medical Association (AMA), issued the following statement on November 21: “The nation’s slide toward health insurance monopolies will be contested in federal court today as the U.S. Department of Justice (DOJ) and a bipartisan group of...

breast cancer

Study Shows Modestly Reduced Breast Cancer Recurrence Risk With Increased Protein Intake Independent of Tumor Insulin Receptor Status

In an analysis in the Nurses’ Health Study population reported in the Journal of Clinical Oncology, Holmes et al found modest reductions in the risk for distant recurrence of breast cancer with greater protein intake. No associations with intake of essential amino acids, branched-chain amino...

American Society of Hematology Honors David Grimwade, PhD, Posthumously With the 2016 Exemplary Service Award

The American Society of Hematology (ASH) will recognize the late David Grimwade, PhD, formerly of King’s College London and Guy’s and St. Thomas’ NHS Foundation Trust with the 2016 Exemplary Service Award for his exceptional years of service and dedication to the Society’s global programs that...

ASH Reports Highest-Scoring Abstracts by Early-Career Researchers for Annual Meeting

The American Society of Hematology (ASH) recently announced that the following trainees received the highest-scoring abstracts in the categories of undergraduate student, medical student, graduate student, resident physician, and postdoctoral fellow for the 58th ASH Annual Meeting, December...

lymphoma

Center for Leukemia and Lymphoma Research at UNMC Renamed Dr. James O. Armitage Center for Leukemia and Lymphoma Research

The University of Nebraska Board of Regents voted to rename an area of the University of Nebraska Medical Center (UNMC) in honor of a longtime professor who has made extraordinary contributions to the institution. The Center for Leukemia and Lymphoma Research, established in 2003, was renamed by...

skin cancer

Safety Profile of Nivolumab Monotherapy in Advanced Melanoma

As reported in the Journal of Clinical Oncology, Weber et al performed a pooled analysis of the safety profile of nivolumab (Opdivo) monotherapy in advanced melanoma, including a focus on potential immune-related (select) adverse events. The analysis pooled safety data from 576 patients receiving...

Shirley A. Johnson, RN, MS, MBA, Joins Roswell Park Cancer Institute

Shirley A. Johnson, RN, MS, MBA, has been appointed as Roswell Park Cancer Institute’s Senior Vice President of Nursing and Patient Care Services and Chief Nursing Officer. Ms. Johnson officially joined the Roswell Park staff on October 31, 2016, bringing with her nearly 25 years of experience in...

Zhu Chen, MD, PhD, and Hugues de Thé, MD, PhD, to Present 2016 ASH Ernest Beutler Lecture

The American Society of Hematology (ASH) will honor Zhu Chen, MD, PhD, of Shanghai Institute of Hematology, and Hugues de Thé, MD, PhD, of Collège de France, with the 2016 Ernest Beutler Lecture and Prize for their significant research advances in the area of acute promyelocytic leukemia (APL)....

integrative oncology

Sleep Disruption in Cancer Survivors: Yoga Offers a Low-Risk Intervention With High Potential for Benefit

Impaired sleep quality is a concerning problem for many patients with cancer, and pharmacologic treatments come with many negative effects. Several small studies indicate that yoga improves persistent fatigue, sleep disturbance, anxiety, and quality of life, in addition to reducing the need for ...

kidney cancer

Study Finds Cabozantinib of Clinical Benefit vs Sunitinib in Advanced Renal Cell Carcinoma

A randomized phase II clinical trial evaluating cabozantinib (Cabometyx) compared with standard-of-care sunitinib (Sutent) as first-line therapy for patients with advanced renal cell carcinoma has found that cabozantinib reduced the rate of disease progression or death by 34% compared with...

kidney cancer

Adjuvant Sunitinib for Renal Cell Carcinoma: Not Ready for Prime Time

In renal cell carcinoma and other cancer types, a consistent paradigm in drug development exists: Observe efficacy of a drug in the metastatic setting and move quickly to explore the agent in the adjuvant setting. In the cytokine era, there were multiple efforts to characterize whether adjuvant...

kidney cancer

Adjuvant Sunitinib Improves Disease-Free Survival in High-Risk Renal Cell Carcinoma After Nephrectomy

In the phase III S-TRAC trial reported at the recent European Society for Medical Oncology meeting and in The New England Journal of Medicine by Alain Ravaud, MD, PhD, of Bordeaux University Hospital, and colleagues, adjuvant sunitinib (Sutent) significantly prolonged disease-free survival vs...

lung cancer
skin cancer

Numerous ESMO Presentations Focused on Anti–PD-1 Therapy in Lung Cancer and Melanoma

The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...

breast cancer

Androgen Receptor Antagonists May Meet ‘Unmet Need’ in Triple-Negative Breast Cancer

Although there are no androgen receptor antagonists currently approved for the treatment of breast cancer, clinical trials indicate that these agents benefit some patients with triple-negative breast cancer, Tiffany A. Traina, MD, told participants at the 18th Annual Lynn Sage Breast Cancer...

lymphoma
skin cancer

Lack of Standardized Definitions of Cutaneous T-Cell Lymphomas Hampers the Collection of Reliable Data

Cutaneous T-cell lymphomas are a heterogeneous group of cancers. Some subtypes of cutaneous T-cell lymphomas are often misdiagnosed as benign skin diseases, making it challenging to gather reliable epidemiologic data. At the 3rd World Congress of Cutaneous Lymphomas (sponsored by the International...

Skin Cancer Foundation President Perry Robins, MD, Announces Retirement, Names Deborah S. Sarnoff, MD, His Successor

Perry Robins, MD, Founder and President of the Skin Cancer Foundation, was honored at the organization’s Champions for Change Gala, held October 18 at the Mandarin Oriental New York. Dr. Robins was honored at the event as a “Champion for Change” for his lifetime commitment to decreasing the...

cns cancers

Activation of WNT5A May Drive Glioblastoma Stem Cell Differentiation and Invasive Growth

Glioblastoma multiforme remains the most common and highly lethal brain cancer, known for its tendency to recur. Researchers at The University of Texas MD Anderson Cancer Center have identified a pathway by which cancer cells aggressively spread and grow in the brain, opening up new possibilities...

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