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Showing 15201 - 15250Omacetaxine Mepesuccinate Receives Full FDA Approval for CML
The U.S. Food and Drug Administration (FDA) has granted full approval to omacetaxine mepesuccinate (Synribo) for injection. The full approval was based on the final analysis of two phase II trials that evaluated the efficacy and tolerability data of omacetaxine. The agent received an accelerated...
Crizotinib Proves Effective in ALK-Positive Lymphoma
Crizotinib (Xalkori) produced promising results in patients with ALK-positive lymphoma in two small studies presented at the 2013 American Society of Hematology (ASH) Annual Meeting. Crizotinib exerted potent antitumor activity in advanced ALK-positive lymphoma and achieved durable responses in...
Gemtuzumab Ozogamicin Reduces Relapse, Improves Event-Free Survival in Pediatric AML
The monoclonal antibody gemtuzumab ozogamicin (Mylotarg) improved event-free survival and reduced the risk of relapse in children with acute myeloid leukemia (AML) in a study from the Children’s Oncology Group, presented at the 55th American Society of Hematology (ASH) Annual Meeting and Exposition ...
Idelalisib Achieves High Response Rates in ‘Double-Refractory’ Indolent NHL
In patients with indolent B-cell non-Hodgkin lymphoma (NHL) refractory to both rituximab (Rituxan) and an alkylating agent, monotherapy with the selective oral PI3K-delta inhibitor idelalisib produced a high response rate, with responses persisting for 1 year in the average patient, according to...
Idelalisib Plus Rituximab in Heavily Pretreated Relapsed CLL: ‘Dawn of a New Age’?
Idelalisib plus rituximab (Rituxan) improved progression-free survival, overall response rates, and overall survival compared with rituximab alone in heavily pretreated patients with relapsed chronic lymphocytic leukemia (CLL). Moreover, the combination provided effective, durable disease control...
Promising Results Demonstrated for Brentuximab Vedotin in Cutaneous T-Cell Lymphoma
Phase II results suggest that brentuximab vedotin (Adcetris) has encouraging activity in CD30-positive cutaneous T-cell lymphomas and lymphoproliferative disorders, including mycosis fungoides, the most common type of cutaneous T-cell lymphoma. High levels of responses were achieved in a 48-patient ...
Zoledronic Acid Fails to Benefit Women With Chemoresistant Breast Cancer
Zoledronic acid does not improve outcomes in patients with early breast cancer who do not have a full response to neoadjuvant anthracycline/taxane–based chemotherapy, according to results of the Neo-Adjuvant Trial Add-On (NATAN) study presented at the 2013 San Antonio Breast Cancer Symposium.1 A...
Adding Bevacizumab to Adjuvant Chemotherapy/Trastuzumab Fails to Improve Survival in HER2-Positive Breast Cancer
The addition of bevacizumab (Avastin) to adjuvant chemotherapy did not improve invasive disease-free survival or overall survival in patients with high-risk HER2-positive breast cancer in the large randomized phase III BETH trial. Although not specifically designed to answer this question, BETH...
Immune Modulation May Aid Some Breast Cancer Subtypes
There may be an immunogenic phenotype in breast cancer that could benefit from immune modulation as part of treatment, according to results from studies that correlated high levels of tumor-infiltrating lymphocytes with both pathologic complete responses and long-term outcomes. Studies presented at ...
Novel Therapies May Help Wipe Out Residual Acute Lymphoblastic Leukemia
Minimal residual disease after induction and consolidation for the treatment of acute leukemia might be eradicated by novel therapies, thus obviating the need for stem cell transplantation. That is the prediction of Matthew J. Wieduwilt, MD, PhD, Assistant Clinical Professor of Medicine at the...
Minimal Residual Disease Before and After Transplant: What Does It Mean?
In patients with acute leukemia, outcomes after hematopoietic stem cell transplantation are negatively impacted by the presence of minimal residual disease. However, transplant can prolong survival in patients with minimal residual disease after consolidation, according to two studies presented at...
For Progressive Neuroendocrine Tumors, Clinical Benefit Is High With Capecitabine Plus Temozolomide
In an interim analysis of a phase II trial, 97% of patients with progressive metastatic neuroendocrine tumors achieved clinical benefit with the combination of capecitabine and temozolomide (CAPTEM). The results were reported at the 2014 Gastrointestinal Cancers Symposium by Robert L. Fine, MD,...
Colorectal Cancer Survivors Face Challenges With Bowel Regulation
The fight against colorectal cancer leaves many survivors with battle wounds, according to studies that show a high incidence of assorted morbidities that can affect quality of life. Clinicians, in fact, may be unaware of the struggles with bowel function that occur during survivorship, researchers ...
Outcomes in Metastatic Colorectal Cancer: Studies Examine Relative Merits, Cost-Effectiveness
Targeted biologic agents have improved long-term outcomes in metastatic colorectal cancer, but debate continues as to their relative efficacy and proper sequencing. At the 2014 Gastrointestinal Cancers Symposium, a number of studies attempted to answer these questions by interrogating the clinical...
More Support for ‘All-RAS’ Testing in Metastatic Colorectal Cancer
Multiple studies reported at the 2014 Gastrointestinal Cancers Symposium add further support for widening the genetic analysis of colorectal cancer tumors. In fact, experts predict that more extensive genetic testing for RAS gene mutations (in KRAS and NRAS) beyond the routine analysis of KRAS exon ...
Aspirin Use Not Associated With Survival in PIK3CA-Mutant Colorectal Cancer
Contrary to emerging data from other studies, the regular use of aspirin was not associated with improved survival in patients with PIK3CA-mutant metastatic colorectal cancer in a study reported at the 2014 Gastrointestinal Cancers Symposium in San Francisco.1 Large Dataset “We did not validate...
Fine-Tuning Bladder-Preservation Trimodality Therapy for Patients With Muscle-Invasive Bladder Cancer
Organ preservation is a hallmark of progress in the world of cancer management. For patients with muscle-invasive bladder cancer, the bladder-sparing approach is a well-established alternative to radical cystectomy. Patients undergo cystoscopic evaluation between the induction and consolidation...
Five Key Studies in Prostate Cancer and Renal Cell Carcinoma
The 10th Genitourinary Cancers Symposium, sponsored by ASCO, the American Society for Radiation Oncology, and the Society of Urologic Oncology, was held January 29–February 1, 2014, in San Francisco. The more than 630 abstracts presented addressed essential research in genitourinary malignancies,...
Role of Immunotherapy Explored in Metastatic Castration-Resistant Prostate Cancer
Ipilimumab (Yervoy) failed to meet the primary endpoint of improving overall survival in the randomized, phase III CA184-043 trial. However, the immunotherapy did improve progression-free survival and prostate-specific antigen (PSA) response compared with placebo in postdocetaxel metastatic...
The Evolution of U.S. Cooperative Group Trials: Publicly Funded Cancer Research at a Crossroads
Over the past 5 decades, National Cancer Institute (NCI) Clinical Trials Cooperative Groups have played an enormous role in the fight against cancer, tackling a broad social agenda, including cancer prevention, quality-of-life issues for patients with cancer, and comparison of benefits among...
I Refuse to Capitulate to Cancer
Early last year, just as I returned to my residency in neurologic surgery at Stanford University after completing 2 years of my postdoctoral fellowship in a laboratory developing optogenetic techniques, I started losing weight—dropping from 180 lb to 160 lb in just 6 months—and I was having fairly...
State-of-the-Art Update on Prostate Cancer
The 2014 Genitourinary Cancers Symposium, held in San Francisco from January 29 to February 1, brought together more than 3,100 participants from around the world involved in the care of patients with genitourinary malignancies. The abstract presentations and plenary discussions offered the latest...
Transition From Busy Oncologist to Retiree: Challenges and Opportunities
Oncology is a demanding field that requires special qualities to care for very sick patients, many of whom will die prematurely of their disease. Research indicates that years of facing life-and-death decisions in the clinic can be associated with oncology burnout syndrome, which effects physician...
Bendamustine/Rituximab May Be Important Alternative for Indolent NHL or MCL
Results from the BRIGHT study combined with long-term safety data from other studies suggest that bendamustine (Treanda) plus rituximab (Rituxan) “may be an important alternative treatment option” for the initial treatment of patients with low-grade non-Hodgkin lymphoma (NHL) and mantle cell...
Adding Idelalisib to Rituximab Improved Survival in Patients With Relapsed CLL
Receiving rituximab (Rituxan) with idelalisib, rather than rituximab with placebo, “significantly improved progression-free survival, response rate, and overall survival” among patients with relapsed chronic lymphocytic leukemia (CLL) who were less able to undergo chemotherapy because of clinically ...
Long-Term Benefit With Dasatinib After Imatinib Failure in Chronic-Phase Chronic Myeloid Leukemia
Patients with chronic myeloid leukemia (CML) in the chronic phase who are resistant or intolerant to imatinib (Gleevec) can experience long-term benefit with dasatinib (Sprycel), according to long-term results of a randomized phase III study. The CA180-034 study also found that early molecular and...
Expect Questions From Patients
Results from the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4), showing that men with early-stage prostate cancer, particularly men under 65 years old, treated with radical prostatectomy had increased survival compared to those assigned to watchful waiting, has raised concerns among...
Prostate Cancer Study Showing Increased Survival for Younger Men Undergoing Prostatectomy Not Expected to Increase Surgeries
Extended follow-up in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG4), reported recently in The New England Journal of Medicine,1 found that men with early-stage prostate cancer, particularly those under 65 years old, who were treated with radical prostatectomy had increased survival...
Have You Heard?
“It’s not a matter of if a child will be seriously poisoned or killed. It’s a matter of when.” Lee Cantrell, PharmD, Director of the San Diego Division of the California Poison Control System and Professor of Clinical Pharmacy at the University of California, San Francisco, commenting on the...
MD Anderson Honors Two Champions for Women in Medicine and Research
Two champions of gender equality in medicine and research were recently honored by The University of Texas MD Anderson Cancer Center. Laurie Glimcher, MD, the Stephen and Suzanne Weiss Dean of Weill Cornell Medical College and Provost for Medical Affairs of Cornell University since 2012, received...
Mutation Predicts Benefit From Alkylating Chemotherapy in Oligodendroglial Tumors
Patients in the Radiation Therapy Oncology Group (RTOG) 9402 study with 1p/19q codeleted anaplastic oligodendroglial tumors had markedly prolonged overall survival after chemoradiotherapy (with procarbazine, lomustine, and vincristine) compared with radiation therapy alone. Some patients with...
The FDA’s Bad Ad Program
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this installment, Robert Dean, MBA, Director, and Michael Sauers, Deputy Director, of Division II in the FDA’s Office of Prescription Drug Promotion discuss the FDA’s Bad Ad program. The...
The CoMMpass Trial in Multiple Myeloma
When I was diagnosed with multiple myeloma in 2008, at just 47, I was lucky. I was asymptomatic, my cancer was detected through a routine blood test, and I had the smoldering type, so I didn’t need immediate treatment. Plus, I knew that recent advances in more effective therapies were making it...
Unraveling the Molecular Complexity of Multiple Myeloma
In 2011, the Multiple Myeloma Research Foundation (MMRF) announced the launch of CoMMpass (Relating Clinical Outcomes in Multiple Myeloma to Personal Assessment of Genetic Profile), a clinical study at the heart of its Personalized Medicine Initiative. CoMMpass will follow 1,000 newly diagnosed...
Does ‘Specialist Bias’ Contribute to Overtreatment of Prostate Cancer?
Specialist bias, in which specialists recommend the therapy that they are capable of delivering, is thought to influence the treatment of patients with localized prostate cancer and to contribute to overtreatment of men with limited life expectancy,” Ayal A. Aizer, MD, MPH, and colleagues, from the ...
Shaw T. Chen, MD, PhD, Joins Polaris Pharmaceuticals
Shaw T. Chen, MD, PhD, has been appointed Executive Vice-President of Regulatory Affairs at Polaris Pharmaceuticals, a subsidiary of Polaris Group. Dr. Chen had previously been with the U.S. Food & Drug Administration (FDA) for over 26 years in new drug development. Most recently he served as...
Decision Time for Lung Cancer Screening in High‑Risk Populations
For decades, dedicated members of the oncology community have fought to increase the nation’s focus on lung cancer prevention and treatment. Although smoking cessation initiatives have reduced cigarette consumption, lung cancer 5-year survival has remained stagnant at 15%, lagging far below most...
Study Shows Pathologic Complete Response to Neoadjuvant Therapy for Breast Cancer of Prognostic Value but Not for Use as Surrogate for Survival
Pathologic complete response to neoadjuvant therapy has been proposed as a surrogate endpoint for long-term clinical benefit in breast cancer. The U.S. Food and Drug Administration (FDA) established the international Collaborative Trials in Neoadjuvant Breast Cancer (CTNeoBC) working group to...
Association of Community Cancer Centers Honors Researcher and Community Oncologist With National Award
In recognition of his dedication to cancer research and education, and for promoting the goals of cancer prevention, early detection, and quality cancer treatment, John Powderly II, MD, Certified Physician Investigator, President and Founder of Carolina BioOncology Institute, Huntersville, North...
Determining Why Younger Women With Breast Cancer Are Less Likely to Survive Than Their Older Counterparts
Although cancer survival rates among pediatric and older adult patients continue to rise, survival rates for adolescents and young adults (AYAs), defined by the National Cancer Institute as those between the ages of 15 and 39, have remained stagnant for decades. In breast cancer especially, AYAs...
Amended 2013 Conflicts of Interest Policy Expands Requirements for Financial Disclosures
The Society’s 2013 Policy for Relationships with Companies is scheduled to go into effect on April 22, with one large change to its original requirements. The policy will still require the full disclosure of all financial relationships by all authors; however, since announcing the new policy in...
Raj Mantena, RPh, Makes $1 Million Donation to Conquer Cancer Foundation to Help Build the Future of Cancer Care
It is a challenge faced time and time again by oncologists: how to achieve the best possible outcomes for patients while simultaneously controlling costs, providing care that is both high quality and high value. Raj Mantena, RPh, the first individual to donate $1 million dollars to the Conquer...
Cancer Research Funding Still Tight—and Getting Tighter
Margaret Foti, PhD, MD (hc), CEO of the American Association for Cancer Research (AACR), welcomed about 150 congressional staffers to a March briefing in Washington, DC, with a plea for increased federal funding. “Extraordinary progress is being made in cancer research today, as evidenced by the...
Individualized Care Key to Cancer Pain Management at Sidney Kimmel Comprehensive Cancer Center
Learning about the particulars of each cancer patient’s pain and treating each case uniquely is the key to keeping pain manageable. That is the goal of the Duffey Pain and Palliative Care Program at The Sidney Kimmel Comprehensive Cancer Center in Baltimore. The team consists of physicians, nurse...
Electronic Cigarette Use and Smoking Among Adolescents
Use of e-cigarettes does not discourage, and may encourage, conventional cigarette use among U.S. adolescents.” This was the conclusion of a cross-sectional analysis of survey data from a representative sample of middle and high school students who completed the National Youth Tobacco Survey (NYTS) ...
Recent Study Finds Tripling in Thyroid Cancer
According to a recent report by Davies and Welch,1 the incidence of thyroid cancer in the United States has nearly tripled since 1975, from 4.9 to 14.3 per 100,000 persons, with most of the increase due to papillary thyroid cancer, which has increased from 3.4 to 12.5 per 100,000 persons. The...
Overcoming Physician Bias in Recommending Palliative Care
In 2010, Jennifer S. Temel, MD, published her landmark study in The New England Journal of Medicine showing that the introduction of palliative care early after a diagnosis of metastatic non–small cell lung cancer, along with cancer therapy, not only provided patients with a better quality of life...
Targeting Cancer Stem Cells in Breast Cancer: A Potential Clinical Strategy
Preclinical models have suggested that cancer stem cells play a role in tumor recurrence and metastasis following adjuvant therapy, and Max S. Wicha, MD, and his research team are deciphering the mechanisms by which this might happen. A true understanding of cancer stem cells will have important...
Detecting Accelerated Aging in Adult Survivors of Childhood Cancer
Last fall, Kirsten K. Ness, PhD, published her study1 on the prevalence of frailty as a sign of accelerated aging in adult survivors of childhood cancer, and the results are startling. Among the 1,922 participants in the study, the prevalence of prefrailty was 31.5% among women and 12.9% among men; ...
Complications Other Than Incontinence or Erectile Dysfunction After Prostatectomy or Radiotherapy for Prostate Cancer
Studies of complications of surgery or radiotherapy for prostate cancer generally focus on incontinence and erectile dysfunction. In a population-based cohort study reported in The Lancet Oncology, Robert Nam, MD, MSc, FRCS(C), Professor of Surgery, Sunnybrook Health Sciences Centre, University of...
