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Showing 6751 - 6800FDA Programs to Expedite Drug and Biologic Product Development
With the advent of Breakthrough Therapy designation, there are now four FDA programs to expedite the development of promising new agents: Fast Track, Breakthrough Therapy, Priority Review, and Accelerated Approval (Table 1). These programs complement one another and serve a common goal: to speed...
Trametinib and Dabrafenib in Combination for Unresectable or Metastatic Melanoma With BRAF V600E or V600K Mutations
On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved...
NIH Makes Palliative Care More Attainable for Pediatric Patients and Their Families
A campaign “Palliative Care: Conversations Matter” recently launched by the National Institute of Nursing Research (NINR) aims to increase the use of palliative care for children with serious illness. Palliative care can reduce a child’s pain, help manage other distressing symptoms, and provide...
ASCO Turns Attention to Community Researchers With Community Research Forum
The implementation of clinical trials and quality research programs by community-based investigators and research staff is one of the most effective weapons available in the fight against cancer. The ASCO Community Research Forum was designed in support of this mission and to aid these...
HER2 Testing: The Next Chapter
Late last year, the American Society of Clinical Oncology and College of American Pathologists published a comprehensive update of guidelines for HER2 testing,1 the first such update since their initial landmark publication in 2007.2 This new report, summarized in this issue of The ASCO Post,...
ASCO and College of American Pathologists Guideline Update: Recommendations for HER2 Testing in Breast Cancer
The American Society of Clinical Oncology (ASCO) and College of American Pathologists (CAP) recently convened an Update Committee to conduct a systematic literature review and update recommendations for optimal HER2 testing. In particular, the Committee identified criteria and areas requiring...
Longer-Term Follow-up of Breast Implant–Associated Anaplastic Large Cell Lymphoma: More Certainty About Certain Uncertainties
When what is now called breast implant–associated anaplastic large cell lymphoma was first recognized and initially described, a number of uncertainties prevailed—mainly, was the association with breast implants real, and was this a true lymphoma? Through the significant efforts of those who...
ASH Studies Confirm Benefit of Rituximab Maintenance in Follicular Lymphoma
Findings from two major studies presented at the 2013 American Society of Hematology Annual Meeting not only confirm the benefit of rituximab (Rituxan) maintenance in follicular lymphoma, but also indicate that the longer the maintenance period, the greater the impact on progression-free survival....
Addition of Novel Antiangiogenic Agent of No Benefit in Metastatic Breast Cancer
Ramucirumab added to first-line docetaxel failed to improve progression-free survival in patients with metastatic breast cancer in the large, randomized, placebo-controlled ROSE/TRIO-12 trial.1 An interim analysis of overall survival showed no advantage for the addition of ramucirumab. This study,...
Postmastectomy Pain Effectively Treated With a Simple Injection
For postmastectomy neuropathic pain, perineural infiltration with a combination of bupivacaine and dexamethasone is a “simple, effective, practice-changing treatment that any surgeon can do,” according to Laura J. Esserman, MD, MBA, Professor of Surgery and Radiology at the University of...
SABCS Highlights Include Findings in Triple-Negative Disease, Protective Effects of Exercise, and the Adherence-Copay Link
The San Antonio Breast Cancer Symposium brings together specialists from all over the world who focus on management of breast cancer. We have covered many of the important presentations in the pages of The ASCO Post and in our online Evening News. Below are summaries of additional noteworthy...
Maintenance Treatment With Capecitabine and Bevacizumab Is Effective in Metastatic Colorectal Cancer
In patients with metastatic colorectal cancer, maintenance treatment with capecitabine plus bevacizumab (Avastin) after induction treatment with capecitabine, oxaliplatin, and bevacizumab (CAPOX-B) significantly delayed disease progression, compared to observation, according to the final results of ...
The Surgeon General’s Report on Tobacco Turns 50: Much Success, Much Work Ahead
On January 11, 2014, the nation commemorated the 50th anniversary of a document that transformed our public health landscape and has saved millions of lives: Smoking and Health: Report of the Advisory Committee to the Surgeon General of the Public Health Service. This groundbreaking report, which...
Nintedanib Combined With Docetaxel Is Effective Second-Line Option for Advanced NSCLC
The combination of nintedanib and docetaxel “is an effective second-line option” for patients with advanced non–small cell lung cancer (NSCLC) who have received previous treatment with one line of platinum-based therapy, according to results from the phase III LUME-Lung 1 study published in The...
Overdiagnosis of Breast Cancer: New Research Directions
Currently, one of the most challenging problems in oncology is to accurately predict whether neoplastic lesions detected by screening tests will progress. The focus on developing ever-more sensitive cancer screening tests has produced the clinical dilemma of overdiagnosis. Overdiagnosis occurs when ...
The Canadian National Breast Screening Trial Had So Many Flaws That Its Results Should Not Be Used to Guide Screening Recommendations
If a randomized, controlled trial of therapy for breast cancer was submitted for publication in which 1. The drug being tested was old and ineffective, and 2. prior to randomization, the women underwent a clinical breast examination and the study coordinators knew who had the largest cancers, and...
Flaws in CNBSS Are Vast, Impact on Screening Recommendations Is Nil
The recent report from the Canadian National Breast Screening Study (CNBSS)—published in BMJ and reviewed in The ASCO Post, early release online—concluded that annual mammography in women aged 40 to 59 does not result in a reduction in mortality from breast cancer beyond that of physical...
Leaders of ASCO, ASH, ASTRO, and NCCN Embrace Collaboration With Advanced Practitioners
Nearly 250 advanced practitioners assembled at the first annual JADPRO Live educational symposium in St. Petersburg, Florida, hosted by the Journal of the Advanced Practitioner in Oncology (JADPRO). Leaders from four prominent oncology organizations championed collaborative practice as not only...
Expert Point of View: Jennifer R. Brown, MD, PhD
Commenting on the CLL 11 trial in chronic lymphocytic leukemia (CLL), Jennifer R. Brown, MD, PhD, Director of the CLL Center at Dana-Farber Cancer Institute, Boston, said she agreed with first author Valentin Goede, MD, that in this study, replacing rituximab (Rituxan) with obinutuzumab (Gazyva) in ...
Expert Point of View: C. Kent Osborne, MD
At the San Antonio Breast Cancer Symposium, press briefing moderator C. Kent Osborne, MD, Director of the Dan Duncan Cancer Center at Baylor College of Medicine, Houston, predicted the findings of the study by Badwe et al could be practice-changing. “This is not to say that we shouldn’t perform...
In Stage IV Breast Cancer, the Primary May Not Need to Be Removed
Mastectomy is unnecessary in many women with stage IV breast cancer, according to a study from Indian investigators, reported at the 2013 San Antonio Breast Cancer Symposium.1 The study randomly assigned 350 patients with metastatic breast cancer to mastectomy, complete axillary dissection, plus...
ASCO Applauds CVS Caremark’s Move to Stop Selling Tobacco
CVS Caremark recently announced that it will stop selling cigarettes and other tobacco products at its more than 7,600 CVS/pharmacy stores across the United States by October 1, 2014, making CVS/pharmacy the first national pharmacy chain to take this step in support of the health and well-being of...
Irinotecan Drug-Eluting Beads Improve Outcomes in Colorectal Cancer Patients With Liver Metastases
Irinotecan drug-eluting beads (DEBIRI) given simultaneously with FOLFOX (leucovorin, fluorouracil, oxaliplatin) and bevacizumab (Avastin) in patients with unresectable colorectal liver metastasis improved response rates, increased resectability, and prolonged hepatic progression–free survival in a...
Sequencing Sorafenib and Sunitinib in Either Order Does Not Affect Survival in Metastatic Renal Cell Carcinoma
The explosion of new therapies for metastatic renal cell carcinoma is a welcome advance, but studies have not yet defined optimal sequencing of the newer therapies. According to the phase III SWITCH trial, it matters little whether therapy for metastatic renal cell carcinoma begins with sorafenib...
PREVAIL Trial Shows Enzalutamide to Be a Promising Option for Metastatic Castration-Resistant Prostate Cancer
Encouraging results of the large phase III PREVAIL trial represent another positive milestone for men with metastatic castration-resistant prostate cancer. Enzalutamide (Xtandi) improved overall survival by 29% and reduced the risk of radiographic progression of disease by 81% in men who had not...
Cancer Has Allowed Me to Put My Goals First
Despite my family history of cancer—my father had colorectal cancer, his father had gallbladder cancer, and my father’s mother died of what was believed to be uterine cancer—when I complained to my gynecologist about postmenopausal bleeding in the spring of 2011, I was told not to worry about it....
St. Jude Children’s Research Hospital Committee Identifies Eight Palliative Care Priorities in Pediatric Oncology
About 2½ years ago, St. Jude Children’s Research Hospital in Memphis conducted a series of focus groups to better understand the palliative care priorities of bereaved parents. Their findings were never intended to be generalized, but rather to be used to formulate a strategic plan for an...
Affordable Care Act to Cover Chemoprevention for Women at High Risk for Breast Cancer
On January 9, 2014, Kathleen Sebelius, Secretary of the Department of Health and Human Services, announced that under the Patient Protection and Affordable Care Act, women at increased risk of breast cancer will be entitled to preventive medications without incurring out-of-pocket costs (with the...
ASCO Addresses Changes in Medicare for 2014
Medicare patients make up 61% of new cancer cases in the United States, and as the population ages, that proportion is expected to rise to 70% by 2030. Over the past decade, the oncology community has been financially challenged by alterations in the Medicare payment system. To address the changes...
Ibrutinib for Previously Treated Chronic Lymphocytic Leukemia
On February 12, 2014, ibrutinib (Imbruvica) was granted accelerated approval for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.1,2 Ibrutinib previously received accelerated approval for the treatment of patients with mantle cell...
Impact of Delayed Initiation of Adjuvant Chemotherapy for Breast Cancer Varies by Tumor Subtype
The optimal time interval between surgery and initiation of adjuvant chemotherapy for early-stage breast cancer is not well established. Although most physicians aim to initiate adjuvant chemotherapy within a few weeks of surgery, clinical factors may cause delay. The influence of delay on relapse...
Brigham and Women’s Hospital Tumor Staging for Cutaneous Squamous Cell Carcinoma Outperforms AJCC and UICC Staging
In a study reported in the Journal of Clinical Oncology, Pritesh S. Karia, MPH, and Chrysalyne D. Schmults, MD, MSCE, of Brigham and Women’s Hospital, Boston, and colleagues compared Brigham and Women’s Hospital, American Joint Committee on Cancer (AJCC), and International Union Against Cancer...
Higher Copayment Associated With Greater Discontinuation of and Nonadherence to Tyrosine Kinase Inhibitor Treatment in CML
The availability of the tyrosine kinase inhibitor imatinib (Gleevec) has dramatically increased survival in chronic myeloid leukemia (CML). Nonadherence to therapy with imatinib and other tyrosine kinase inhibitors is associated with disease progression and treatment resistance. In a study reported ...
FDA Orders Cessation of Sale, Distribution of Four Tobacco Products
FDA has issued orders to stop the further sale and distribution of four tobacco products currently on the market. The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco...
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...
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...
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...
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 ...
Expert Point of View: Neal J. Meropol, MD
Neal J. Meropol, MD, Chief of Hematology and Oncology at University Hospitals Case Medical Center at Case Western Reserve University, Cleveland, discussed the various findings in RAS mutations at the Gastrointestinal Cancers Symposium. “RAS mutations beyond exon 2 are common, occurring in about 15% ...
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 ...
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...
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...
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...
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...
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...
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...
