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Showing 11951 - 12000FDA Issues Guidance for Diagnostic Tests Used with Targeted Therapies
The FDA issued a new draft guidance to facilitate the development and review of “companion diagnostics”—tests used to help health-care professionals determine whether a patient with a particular disease or condition should receive a particular drug therapy or how much of the drug to give. The draft ...
Intermittent or Continuous Androgen Suppression Produces Comparable Survival after Radical Therapy in Prostate Cancer
Men with prostate cancer who receive intermittent courses of androgen-suppressing therapy can live as long as those who are treated with continuous therapy, according to results of a recently concluded study. Until now, standard treatment has consisted of continuous therapy, but this is expected to ...
Expert Point of View: Bevacizumab Makes Inroads against Ovarian Cancer
Formal discussant, Anil Sood, MD, The University of Texas MD Anderson Cancer Center, Houston, said that both studies presented important information, but several issues should be considered, including the best combination with bevacizumab, whether the benefits accrue from bevacizumab alone or...
Second Primary Malignancies Explored in Multiple Myeloma
Three randomized controlled trials presented at the 2010 Annual Meeting of the American Society of Hematology (ASH) suggested that treating multiple myeloma with lenalidomide (Revlimid) increased the risk of second primary malignancies; of particular concern is transformation to acute myeloid...
Patients with Early Breast Cancer Benefit from Regional Nodal Irradiation
Findings from a Canadian study presented at the 2011 ASCO Annual Meeting may expand the pool of patients with lymph node–positive breast cancer offered extended-field irradiation.1 “Results from MA.20 suggest that all women with node-positive disease following breast-conserving surgery be offered...
Surgical Site Infections after Colectomy More Likely in Obese Patients
Obese patients appear to have a significantly increased risk of developing a surgical site infection after segmental or total colectomy for colon cancer, diverticulitis, or inflammatory bowel disease, and the presence of infection increases the cost associated with the procedure, according to a...
‘Unrealistic Optimism’ Poses Ethical Challenges, May Affect Informed Consent Process
Does a patient’s optimistic expectation of reaping a health benefit from participating in phase I and phase II oncology studies, even when he understands that these early trials are not designed to provide direct therapeutic benefit, compromise the informed consent process? And, does that...
Updated Drug Label Approved for Pioglitazone after Safety Review
The FDA recently approved updated drug labels for pioglitazone (Actos) and other pioglitazone-containing medicines (in combination with metformin, Actoplus Met and Actoplus Met XR; and with glimepiride, Duetact) to include safety information that the use of pioglitazone for more than 1 year may be...
SIDEBAR: The Anonymity Advantage
This study has the advantage of not only being patient-reported but also of patient anonymity; the questionnaires were not administered or discussed with the patients by any of the treating physicians,” the study authors reported. “I know that patients often want to please their doctor. They don’t ...
Circulating Tumor Cell Assay Shows Potential for Predicting Prognosis in Head and Neck Carcinoma
According to the NCI, an estimated 49,260 new cases of oral cavity, pharyngeal, and laryngeal cancers occurred in the United States in 2010, and approximately 11,480 deaths were attributed to these cases. It is estimated that 95% or more of these cases are squamous cell carcinomas. Currently, the...
A Conversation with Constance M. Chen, MD, MPH
Although incidence data vary widely, breast cancer–related lymphedema may affect as many as 54% of the 2.3 million survivors of breast cancer in the United States. The condition is often disabling and can result in both long-term devastating physical consequences for survivors, including the loss...
Congressional Hearing Highlights Oncology Drug Shortages
Some oncology drugs are in such short supply that the situation is now critical, with almost 200 drugs affected—triple that of 2003. This was the background described by speakers at a July 2011 congressional briefing sponsored by the Association of Community Cancer Centers (ACCC), ASCO, and other...
A Conversation with Samuel Silver, MD, PhD
Over the past 2 decades, significant therapeutic advances have led to greater survival rates and quality of life for patients with cancer. During the same period there has been a transformation in the way oncology services are both perceived and delivered. In a recent conversation with The ASCO...
Expert Point of View: World Conference on Lung Cancer
The EURTAC study provides additional evidence of the efficacy of the oral EGFR inhibitors in the first-line treatment of patients with mutated EGFR—and, importantly, in Western patients, rather than Asians, for whom data are more abundant. “The findings speak to the fact that all patients with...
World Conference on Lung Cancer: Personalized Approaches to Treatment
The 14th World Conference on Lung Cancer hosted more than 7,000 attendees in Amsterdam recently, with the theme “Better Care through Personalized Medical Approaches.” The following are brief summaries of key data presented at the conference, with perspective provided by Roy S. Herbst, MD, PhD, of...
Pathways Reconsidered: Let’s Not Stop ‘Thinking Outside the Box’
I read “Are Clinical Pathways Inevitable in Oncology’s Future?” (The ASCO Post, July 15, 2011) including Lesli Lord’s interview with great interest and agree with most everything said in the article. However, I do want to make one comment: There is no specialty for which the 80/20 rule applies more ...
Unexpected Results May Push Breast Cancer Research toward More Productive Approaches
Two recent articles on breast cancer prognostic factors in the Journal of Clinical Oncology “do not jibe with accepted—and profoundly influential—notions of malignant progression,” according to an editorial accompanying the articles in the Journal of Clinical Oncology. One of the articles found...
Long-term Data Show Benefit of Degarelix Beyond 3 Years in Advanced Hormone-dependent Prostate Cancer
Degarelix (Firmagon) is effective and well tolerated beyond 3 years in patients with advanced prostate cancer, according to a recent study published in The Journal of Urology.1 The new study (CS21A) extends the conclusions of the pivotal phase III study (CS21) in which the risk of prostate-specific ...
SIDEBAR: Higher Postmastectomy Radiotherapy Rates at NCCN Institutions
While the investigators reported that overall only 54.8% of patients with high-risk breast cancer received postmastectomy radiation therapy, they also cited a report that 83.6% of high-risk patients treated at National Comprehensive Cancer Network (NCCN) institutions received such treatment....
SIDEBAR: Expect Questions from Your Patients
Women who have already undergone mastectomy and chemotherapy may question why additional breast cancer treatment is needed. Benjamin D. Smith, MD, of MD Anderson Cancer Center in Houston said that he frequently has patients referred to him who initially express their preference to avoid radiation...
Many Women Treated for High-risk Breast Cancer Do Not Receive Recommended Postmastectomy Radiation Therapy
Despite major studies showing that postmastectomy radiation therapy improves survival for women with high-risk breast cancer and evidence-based guidelines supporting the use of postmastectomy radiotherapy, 45% of these patients do not receive such treatment, according to an analysis of data from...
Crizotinib plus Companion Diagnostic Test Approved in NSCLC
On August 26, 2011, the FDA granted accelerated approval to Pfizer’s crizotinib (Xalkori) for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. The FDA approved the...
Treating Cancer in Japan: A Conversation with Kensei Tobinai, MD
In this installment of Oncology Worldwide, internationally regarded lymphoma expert and cancer survivor, Kensei Tobinai, MD, Chief, National Cancer Center Hospital, Tokyo, sheds light on the Japanese oncology experience. Medical Education What was the medical school experience in Japan like? When...
Integrative Oncology Modalities Supported by Varying Levels of Evidence, but More Research Needed Overall
Over the past couple of decades, unregulated nonstandard oncology approaches have gained growing popularity among cancer patients. The relatively new field of integrative oncology was established to promote a more holistic and multidisciplinary approach to cancer care and to encourage scientific...
Lifestyle Changes Can Benefit Patients with Cancer
Oncologists may successfully manage their patients with cancer by following treatment guidelines, but they come up short when it comes to prescribing simple measures to enhance their patients’ health, according to Ann Partridge, MD, MPH, of Dana-Farber Cancer Institute, Boston, who spoke on the...
FDA Clears Genetic FISH Panel for Leukemia Patient Prognosis
Abbott announced it has received 510k clearance from the FDA for a new in vitro diagnostic test to aid in determining the prognosis of patients with chronic lymphocytic leukemia (CLL). Abbott’s Vysis CLL FISH Probe Kit is the first FDA-cleared CLL test to aid in prognosis. The test detects genetic...
Developing Targeted-agent Combinations: Business and Regulatory Issues, and Legal Obstacles
The Institute of Medicine’s National Cancer Policy Forum recently convened a public workshop, “Facilitating Collaborations to Develop Combination Investigational Cancer Therapies,” to address the promises and challenges involved in the development of combination oncologic drug therapies. In the...
A Conversation with Monica Morrow, MD, FACS
Over the past 15 years, practice guidelines have become an accepted tool to help physicians optimize patient care by offering informed assessment of the benefits and potential harms associated with various care options. However, a plethora of new guidelines have entered the market, many of which...
Using the New Melanoma Drugs in the Clinic
With two effective new treatments for advanced melanoma, the question has become how to best use them and how to manage their toxicities. Vemurafenib (Zelboraf) and ipilimumab (Yervoy)1 have different pharmacokinetics, which lend themselves to different patient types. Omid Hamid, MD, of The...
We Can Conduct Clinical Trials of Protons
A great deal has been written about proton therapy, with a good deal of heat and only a modest amount of light. I would like to comment on an aspect of the proton vs photon controversy that I believe has not been adequately addressed: Should we run clinical trials that would allow us to prove that...
Palliative Care, Quality of Life, and Cost
More than half of our nation’s patients with cancer are Medicare beneficiaries, making the entitlement program ground zero in the heated debate on health-care spending. Total Medicare expenditures attributable to beneficiaries in their last year of life runs upward of 30%; this statistic serves as...
LETTER TO THE EDITOR: ‘Unrealistic Optimism’ or Losing Sight of the Forest for the Trees?
The article: “Unrealistic Optimism Poses Ethical Challenges, May Affect Informed Consent Process” (The ASCO Post, September 1, 2011, page 35) seems to be delving into a subject with an intent that is unclear. I agree fully with Dr. Jimmie Holland that discrimination between “optimism” and...
Cancer Information on Wikipedia as Accurate as on PDQ but Harder to Understand
A comparison of cancer information on Wikipedia and the patient version of information on the NCI’s Physician Data Query (PDQ) “found that although Wikipedia had similar accuracy and depth to the PDQ, the written style was more complex and thus might be less understandable to patients.” According...
‘Hot Chemotherapy’ Generates Heated Debate about Its Use with Cytoreductive Surgery to Manage Peritoneal Metastases
"Hot chemotherapy” has become the common term for hyperthermic intraperitoneal chemotherapy (HIPEC), which together with cytoreductive surgery is being used by some surgeons to treat patients with carcinomatosis from colorectal cancer. While HIPEC is not considered the most important component of...
ASCO Issues Policy Statement to Reduce Cancer Care Disparities
Last August, ASCO issued the policy statement, “Opportunities in the Patient Protection and Affordable Care Act to Reduce Cancer Care Disparities” in the Journal of Clinical Oncology.1 The statement builds on ASCO’s policy on disparities in cancer care released in 2009. It calls on both the...
SIDEBAR: Who Should Manage Survivorship Care?
It has been suggested that after completing their treatment, cancer patients can be transitioned to primary care providers for continued “survivorship” care. But at the Best of ASCO meeting, speakers and audience members alike felt survivorship care is the domain of the treating oncologist. Few...
Yoga, Geriatric Assessment, and Nausea/Vomiting Addressed in Session on Supportive Care and Survivorship Issues
Marie E. Wood, MD, of the Familial Cancer Program at the University of Vermont, Burlington, addressed clinically relevant issues in supportive care and survivorship at the Best of ASCO® Annual Meeting ‘11 in Miami. Delayed Nausea and Vomiting Two studies addressed the problem of...
Improvements Highlighted in Treatment of Leukemias and Preleukemias
Certain preleukemic conditions and leukemia in high-risk patients have remained challenging to treat despite advances in hematology, according to Wendy Stock, MD, of the University of Chicago. But studies reported at the Best of ASCO® Annual Meeting ‘11 in Seattle show progress even in these ...
Novel Drugs Ipilimumab and Vemurafenib for Advanced Melanoma
In this introductory installment of In the Clinic, The ASCO Post provides an overview of two new melanoma agents recently approved by FDA, with discussion on pivotal data leading to approval, dosage and administration, and managing drug-related toxicities. Watch for more on clinical use of novel...
JCO Implements Rapid Review Program
In an effort to support the practice-changing or time-dependent results of select articles submitted to the Journal of Clinical Oncology, the publication has introduced a new Rapid Review program. This fast-paced track gives authors an opportunity to have their important findings accelerated...
Help Inform ASCO Policy with New Oncology Practice Survey
As part of ongoing efforts to respond to a rapidly evolving oncology practice environment, ASCO is conducting a groundbreaking national survey to better understand the challenges facing oncology practices brought on by the current economic, legislative, and regulatory changes. Under the guidance of ...
New ASCO Focused Update Recommendation on Maintenance Treatment of Stage IV Non–Small Cell Lung Cancer
A focused update to the 2009 ASCO Clinical Practice Guideline Update on Chemotherapy for Stage IV Non-Small-Cell Lung Cancer reflects new evidence on maintenance therapy in patients with response or stable disease after four cycles of first-line cytotoxic chemotherapy.1 The 2009 update...
Can Bayesian Design Streamline Our Sluggish Clinical Trial System?
The randomized controlled clinical trial has long been the gold standard for new cancer drugs to demonstrate worthiness of FDA approval; however, many experts contend that that our method of bringing drugs to the market is plagued by undue costs, long delays, and overregulation. According to Donald ...
Expert Point of View: International Prostate Cancer Studies Report Inroads in Managing Bone Metastases
"Radium-223 chloride is an effective, well tolerated, and convenient treatment, and it has a survival benefit. These favorable characteristics may well promote its use in clinical practice,” said formal discussant of this abstract, Wim J.G. Oyen, MD, Radboud University Nijmegen Medical Center,...
International Prostate Cancer Studies Report Inroads in Managing Bone Metastases
Treatment and prevention of bone metastases in patients with prostate cancer is coming of age, according to several studies presented at the European Multidisciplinary Cancer Congress (ECCO/ESMO/ESTRO). Among the most impressive studies reported was an international phase III trial of radium-223,...
Health-care Policy: A Three-act Play
The health of Americans, the economy, the debt crisis, and the action or inaction in Washington are all seriously interrelated. Decades ago, the bank robber Willie Sutton was asked why he robs banks. His famous answer, “Because that’s where the money is,” succinctly describes the approach that...
SIDEBAR: Expert Q and A
D. Neil Hayes, MD, MPH, of the University of North Carolina, Chapel Hill, discusses the role of HPV status in head and neck cancer. Are you convinced human papillomavirus (HPV) positivity is associated with better prognosis? Dr. D. Neil Hayes: The HPV story influences almost everything we do in...
New Therapies and Prognostic Techniques Highlighted in Head and Neck Cancer
D. Neil Hayes, MD, MPH, of the University of North Carolina at Chapel Hill, described efforts to position the epidermal growth factor receptor (EGFR) inhibitor cetuximab (Erbitux) in head and neck cancer treatment. Surprisingly negative results came from the phase III Radiation Therapy Oncology...
Novel Approaches and Agents Making Headway against Sarcoma
Novel approaches and agents reported at the ASCO 2011 Annual Meeting are improving outcomes in sarcoma, a heterogeneous disease with historically poor outcomes, according to William D. Tap, MD, Section Chief of Sarcoma Oncology at Memorial Sloan-Kettering Cancer Center in New York. Dr. Tap...
Adjuvant Treatment Still Standard in Melanoma, but New Drugs Prolong Life in Metastatic Setting
At the Best of ASCO® Miami meeting, Omid Hamid, MD, The Angeles Clinic and Research Institute (www.theangelesclinic.org), Los Angeles, California, reviewed abstracts that received a great deal of attention at this year’s Annual Meeting—the new treatments for metastatic melanoma. He also described...
