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Showing 13801 - 13850FDA Issues Draft Guidance on Biosimilar Product Development
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at...
2012 Oncology Meetings
MARCH ACR 5th Annual PET/CT SymposiumMarch 1-4 • Stowe, Vermont For more information: www.acr.org 3rd Asian Breast Cancer CongressMarch 3-4 • Bangalore, India For more information: http://abcconline.net TAT 2012 (International Congress on Targeted AntiCancer Therapies)March 8-10 • Amsterdam, The...
Nearly Identical Survival for Laparoscopy vs Laparatomy in Patients with Stage I/IIA Disease
Building on previously reported results that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay endpoints, the Gynecologic Oncology Group reported small and lower than anticipated potential for increase risk of cancer recurrence with laparoscopy...
Addition of Bevacizumab to Neoadjuvant Chemotherapy Increases Pathologic Complete Response Rate in HER2-negative Disease
Two studies reported in The New England Journal of Medicine showed that the addition of bevacizumab (Avastin) to neoadjuvant chemotherapy significantly increased the pathologic complete response rate in women with HER2-negative breast cancer. In one study, from the German Breast Group, the benefit...
A Patient with Cancer Saw a Need and Left a Living Legacy
It is well documented that the rigors of delivering cancer care can unintentionally supersede valuable doctor-patient communication. Before he died in 1995, Kenneth B. Schwartz, a patient with cancer at Massachusetts General Hospital, recognized this phenomenon and founded the Kenneth B. Schwartz...
Reexcision Rates Following Breast-conservation Surgery Vary Widely
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Reexcision rates for women with...
Similar Morbidity, Higher Costs for Robotic vs Laparoscopic Hysterectomy in Women with Endometrial Cancer
A population-based analysis comparing laparoscopic hysterectomy and robotic hysterectomy for endometrial cancer “found similar morbidity but increased cost compared with laparoscopic hysterectomy,” investigators reported in the Journal of Clinical Oncology.1 After adjusting for patient, surgeon,...
Challenges, Progress, and Future Directions in Head and Neck Cancer
Although head and neck cancer remains a major therapeutic challenge, significant advances have been made over the past few decades. The ASCO Post recently spoke with Marshall R. Posner, MD, Medical Director of the Head and Neck Oncology Program, Mount Sinai Medical Center, New York, about the...
Adding Thalidomide to Chemoradiation Increases Toxicities but Not Survival for Stage III Non–Small Cell Lung Cancer
Adding thalidomide (Thalomid) to the third-generation chemotherapy doublet of paclitaxel and carboplatin and radiation for patients with stage III non–small cell lung cancer (NSCLC) increased toxicities but did not improve survival. These results from the Eastern Cooperative Oncology Group (ECOG)...
Career Development Award Recipient Susan K. Parsons, MD, Supports Next Generation of Researchers
Like all pediatric oncologists, Susan K. Parsons, MD, MRP, knows that when a child is diagnosed with cancer, it happens to the whole family. Siblings must cope with everything from disruption of routine to reduced parental attention, to the often-new possibility of mortality. Parents must navigate...
Expert Point of View: Genomics Projects Plumb Breast Cancer’s Inner Workings
Charles M. Perou, PhD, the May Goldman Shaw Distinguished Professor of Molecular Oncology at the University of North Carolina, Chapel Hill, commented on the research being conducted by The Cancer Genome Atlas (TCGA) and the International Cancer Genome Consortium (ICGC). “The TCGA and ICGC efforts...
Important News Briefs: New Data Reported in Gastric, Colorectal, and Hepatocellular Cancers
Findings presented at the 2012 Gastrointestinal Cancers Symposium will impact the future care of patients with these malignancies. The ASCO Post has summarized some of the most newsworthy data in the following briefs. In the phase III GRANITE-1 trial (n = 656), single-agent treatment with...
What Were the Take-home Messages from the 2012 Gastrointestinal Cancers Symposium?
Richard M. Goldberg, MD, of The Ohio State University Medical Center, chaired the steering committee of the 2012 Gastrointestinal Cancers Symposium in San Francisco, which attracted approximately 4,000 registrants who viewed data from some 700 scientific abstracts. The ASCO Post asked Dr. Goldberg...
Lung Cancer Alliance Announces National Framework for Lung Cancer Screening Excellence
The Lung Cancer Alliance (LCA) moved lung cancer screening to a national platform by announcing a Framework for Lung Cancer Screening Excellence, which includes a bill of rights for the at-risk public and guiding principles for lung cancer screening sites. “The science is indisputable: Screening...
A Visionary Call for the ‘Creative Destruction’ of Medicine
According to nationally regarded cardiologist and geneticist Eric Topol, MD, Chief Academic Officer of Scripps Health, the next frontier of the digital revolution can create exponentially better health care. Dr. Topol, who is also Director of the Scripps Translational Science Institute and...
Two Novel Agents Prolong Survival in Advanced Prostate Cancer
Two novel agents with distinct mechanisms of action join ranks of treatments that extend survival for patients with castration-resistant prostate cancer: MDV3100 and radium-223. Both drugs achieved a survival advantage compared with placebo, with relatively benign side-effect profiles, according to ...
2012 Oncology Meetings
MARCH Hematology/Oncology Pharmacy Association 8th Annual Meeting March 21-24 • Orlando, Florida For more information: www.hoparx.org 65th Society of Surgical Oncology Annual Meeting March 21-24 • Orlando, Florida For more information: www.surgonc.org Society of Interventional Radiology 37th...
VEGFR Tyrosine Kinase Inhibitors Linked to Increased Risk of Fatal Adverse Events
A meta-analysis of 10 randomized controlled trials involving 4,679 patients showed that the use of vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitors was associated with an increased risk of fatal adverse events. “The crude incidence of [fatal adverse events] in patients ...
Survival Advantage of Oxaliplatin Extends to Diverse Group of Patients
The survival advantage conferred by adding oxaliplatin to adjuvant chemotherapy with fluorouracil (5-FU), as previously shown in randomized controlled trials, extends to patients in the general population, including older and minority group patients and those with higher comorbidity. These results, ...
Cost of Cancer Therapy: The Elephant in the Room?
I am distressed by your coverage of innovative therapies, such as dual HER2 blockade (see The ASCO Post, January 1, 2012, and Supplement to February 15, 2012), without mentioning that these therapies will never be cost-effective given the current pricing of the agents involved. If we wish to...
Adolescents and Young Adults with Cancer: A Distinct Population of Patients Who Need to Be Treated Differently
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Cancer among adolescents and young...
Some Patients Using Complementary and Alternative Therapies May Be Receiving ‘Parallel’ Rather Than Integrative Care
Most patients with cancer receiving complementary and alternative medicine do so not as part of integrative care, but rather as “parallel care,” according to Lynda Balneaves, RN, PhD, Associate Professor, University of British Columbia, School of Nursing in Vancouver. Dr. Balneaves is lead...
Research Funding Key to Continued Progress in Cancer Care
American Association for Cancer Research (AACR) President and ASCO member Judy Garber, MD, MPH, recently spoke with The ASCO Post about the findings of AACR’s landmark Cancer Progress Report,1 In addition, she offered her perspective on the current and future state of cancer research. Project...
Expert Point of View: Maintenance with Lenalidomide or Bortezomib Prolongs Remission in Elderly Patients with Multiple Myeloma
David S. Siegel, MD, PhD, of the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey, commented to The ASCO Post that essentially all patients with multiple myeloma could be candidates for maintenance therapy. “But I don’t know that we have established that maintenance...
Researchers Map Potential Genetic Origins, Pathways of Lung Cancer in Never-smokers
Findings from a small study on potential gene mutations and pathway alterations that could lead to lung cancer in never-smokers were presented in a poster at the American Association for Cancer Research–International Association for the Study of Lung Cancer Joint Conference on Molecular Origins of...
FDA Drug Approvals, January–March 2012
Imatinib mesylate tablets (Gleevec) approved for the adjuvant treatment of adult patients following complete gross resection of Kit (CD117) positive gastrointestinal stromal tumors (GIST). Accelerated approval for this indication was granted in December 2008. Vismodegib (Erivedge) capsules...
First Urine-based Molecular Test to Gauge Need for Repeat Prostate Biopsies
Gen-Probe announced the FDA has approved its PROGENSA PCA3 (prostate cancer gene 3) assay, the first molecular test to help determine the need for repeat prostate biopsies in men who have had a previous negative biopsy. “Overexpression of the PCA3 gene is highly specific to cancerous prostate...
Ki-67 Image Analysis and Digital Read Applications Cleared
Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image...
ODAC Votes against Denosumab to Delay Bone Metastasis in Men with Castration-resistant Prostate Cancer
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12 to 1 that the risk-benefit ratio was insufficient for an expanded use of denosumab (Xgeva) to delay the spread of prostate cancer to the bone in men with castration-resistant disease. The panel was not asked specifically whether it...
New Colonoscopy System Cleared by FDA
A developer of endoscopy products based in New York and Kissing, Germany, invendo medical, announced that the company received 510(k) clearance by the FDA of the company’s new C20 colonoscopy system, including the SC20 single-use colonoscope. The invendoscope SC20 has several features that are...
FDA Acts to Bolster Supply of Critically Needed Cancer Drugs
The FDA has announced a series of steps to increase the supply of critically needed cancer drugs and build on President Obama’s Executive Order to help prevent future drug shortages. The President’s order, issued last October 31, directed the FDA to take action to help further prevent and reduce...
Eating Problems and Pain Prevalent in Survivors of Head/Neck Cancer
“Eating problems due to poor oropharyngeal functioning and persistent pain are the most prevalent problems” faced by patients 5 years after being treated for head and neck cancer, according to a study published online by the Archives of Otolaryngology–Head & Neck Surgery.1 More than 50% of...
Rising Costs in Radiation Oncology Linked to Medicare Coverage
In the ongoing debate over how to control rising cancer care costs, it is vital to identify usage patterns of expensive new technologies. A recent study examined the relationship between Medicare reimbursement and the increasing use of intensity-modulated radiation therapy (IMRT).1 The ASCO Post...
Expert Point of View: Answer to Secondary Cancers with RAF Inhibitors May Be Concomitant MEK Inhibition
“The development of nonmelanoma skin cancers secondary to RAF inhibitor treatment has been recognized since 2005, having been seen initially with sorafenib (Nexavar),” noted Mario E. Lacouture, MD, of Memorial Sloan-Kettering Cancer Center. Commenting on recently published studies in this setting,...
Expert Point of View: Next-generation Sequencing in Metastatic Triple-negative Breast Cancer Yields Rewards
Hope Rugo, MD, of the University of California, San Francisco, commented on Dr. O’Shaughnessy’s presentation on molecular pathways in triple-negative breast cancer at the 2011 San Antonio Breast Cancer Symposium. “The really exciting thing is that we have moved from intrinsic subtyping of breast...
Searching for Quality in an Increasingly Complex Health-care Environment
With the Presidential election just around the corner, the health-care debate will undoubtedly heat up. The ASCO Post spoke with Sean R. Tunis, MD, MSc, Founder and Director, Center for Medical Technology Policy, and former Chief Medical Officer for the Centers for Medicare & Medicaid Services, ...
GU Symposium 2016: Even After Antiandrogen Therapy, Docetaxel Remains Useful in Prostate Cancer
A study presented at the 2016 Genitourinary Cancers Symposium showed that 40% of patients with metastatic castration-resistant prostate cancer treated with docetaxel following abiraterone (Zytiga) had at least a 50% reduction in prostate-specific antigen (PSA), demonstrating the activity of...
Radiation Therapy Lowers Risk of Cancer Recurrence in Patients Undergoing Pancreatic Surgery
Radiation therapy was associated with a lower risk of cancer recurrence in pancreatic cancer surgery patients, making it, like chemotherapy, an important addition to treatment, Mayo Clinic research found. Whether radiotherapy helps patients after pancreatic cancer surgery has been a long-standing...
GU Symposium 2016: Updated Results of IMvigor 210 Show Durable Response Rates With Atezolizumab in Advanced Bladder Cancer
In the pivotal phase II IMvigor 210 study, the investigational cancer immunotherapy atezolizumab (MPDL3280A) showed encouraging response rates in patients with locally advanced or metastatic urothelial carcinoma, Roche announced. These data were presented by Hoffman-Censits et al at the 2016...
GU Symposium 2016: New Blood Test Technology Shows Promise for Guiding Prostate Cancer Treatment Decisions
An early study suggests that an experimental blood test may help guide individualized decisions on the most appropriate treatments for patients with prostate cancer. The new noninvasive “liquid biopsy” scans the entire landscape of different kinds of cancer cells in blood and analyzes...
GU Symposium 2016: Cabozantinib Improves Upon the Standard of Care for Advanced Kidney Cancer
New analyses from a phase III clinical trial of patients with previously treated advanced kidney cancer demonstrated that patients of all risk levels experience more benefit from cabozantinib (Cometriq) than from the current standard of care, everolimus (Afinitor). The greater activity of...
GU Symposium 2016: Regular Aspirin Use May Reduce Risk of Dying From Prostate Cancer
A large observational study has found that men who take aspirin regularly may have a lower risk of dying from prostate cancer. Men who took aspirin regularly after their prostate cancer diagnosis were less likely to die from the disease. However, aspirin did not affect the overall incidence of...
Long-Term Follow-up of Risk of Cancer Among Twins
In a long-term follow-up study among approximately 200,000 Nordic twin individuals, there was an increased cancer risk in twins whose co-twin was diagnosed with cancer, with an increased risk for cancer overall and for specific types of cancer, including prostate, melanoma, breast, ovary, and...
Palliative Care Offers Greater Cost Savings for Cancer Patients With Multiple Chronic Conditions
Patients with incurable cancer and numerous other serious health conditions who consulted with a palliative care team within 2 days of hospitalization had significant savings in hospital costs, according to a new study led by researchers at the Icahn School of Medicine at Mount Sinai. Published by...
2012 Oncology Meetings
APRIL 3rd European Lung Cancer ConferenceApril 18-21 • Geneva, Switzerland For more information: www.esmo.org Diagnosis and Treatment of Advanced Forms of Prostate Cancer, Bladder Cancer and Kidney CancerApril 20-21 • Kiev, Ukraine For more information: http://nbscience.com Organisation for...
Report to the Nation Finds Continuing Declines in Cancer Death Rates
Death rates from all cancers combined for men, women, and children continued to decline in the United States between 2004 and 2008, according to the Annual Report to the Nation on the Status of Cancer, 1975-2008. Overall cancer incidence rates among men decreased by an average of 0.6% per year...
SIDEBAR: Oocyte Preservation
For oocyte cryopreservation, eggs removed from a woman’s body are not fertilized with sperm to create embryos before being frozen. For this reason, oocyte cryopreservation may be a suitable option for women who do not have a partner, do not want to use donor sperm, or have religious or ethical...
SIDEBAR: Internet Tool to Calculate ‘Risks to Fertility'
The risk calculator available at the Fertile Hope website (www.fertilehope.org) lets patients know whether specific treatment regimens would put them at high, intermediate, low, very low/no risk, or unknown risk for azoospermia or amenorrhea. Both Fertile Hope and the ASCO fertility recommendations ...
Options for Preserving Fertility Should Be Considered Early to Maximize the Likelihood of Success
Most cancer survivors prefer to have biologic offspring despite concerns about the possible effects of cancer treatment on the child, the child’s lifetime cancer risk, or their own longevity, according to an ASCO panel that developed guidelines on fertility preservation in patients with cancer.1...
Higher Intake of Red Meat Associated with Increased Risk of Mortality
Eating more red meat appears to be associated with an increased risk of all-cause mortality and death from cancer and cardiovascular disease, but substituting fish, poultry, nuts, legumes, low-fat dairy products, and whole grains for red meat is associated with a lower mortality risk, according to...
