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Showing 24501 - 24550FDA Issues Draft Guidance on Biosimilar Product Development
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.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...
Facing the Future without Fear of Breast Cancer Recurrence
A year ago, I was living my dream. Married to a wonderful man, Danny, and with two young children to raise, Karl, 7, and Marcus, 4, I had given up a career in accounting to be a stay-at-home mom. At age 34, I was enjoying life, helping my children with their homework and going to their soccer and...
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...
Combination of Oncolytic Virus and Chemotherapy Holds Promise in Glioblastoma
Glioblastoma remains a uniformly lethal disease. Both the alkylating agent temozolomide and oncolytic viruses (engineered to preferentially infect and kill cancer cells) hold promise in treatment of glioblastoma. The effects of combining the two and the mechanisms of their interaction on cancer...
Six1-Eya2 Interaction a Potential Target in Blocking Breast Cancer Metastasis
The Six1 gene is a key regulator of embryonic development that requires interaction with the Eya family of proteins (Eya1-4) to activate transcription of genes involved in neurogenesis, myogenesis, and nephrogenesis. Overexpression of Six1 and Eya is observed in a number of cancers. In breast...
Significant Differences in Genetic Characteristics of Primary Colorectal Cancer and Hepatic Metastases
Vermaat and colleagues from the University Medical Center Utrecht, Hubrecht Institute, Utrecht, The Netherlands, and Hoffman-La-Roche Inc./Genentech, Nutley, New Jersey, recently showed that there was significant genetic variation between individual primary colorectal cancer tumors and their...
PI3K Inhibitors May Improve Response to Cancer Immunotherapy
The induction of antitumor immunity by vaccines or immunotherapies is inhibited by the immunosuppressive microenvironment of tumors. Toll-like receptor (TLR) agonists have the potential to increase inflammatory antitumor effects in the microenvironment, but these ligands can exert a mixture of both ...
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...
SIDEBAR: Expect Questions from Your Patients
The possibility of reexcision after breast-conservation surgery should be discussed with patients before the initial surgery, advised Laurence E. McCahill, MD, lead investigator of the JAMA study on reexcision following breast-conservation surgery, which showed wide variability in reexcision...
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...
Carfilzomib May Offer Advantages in Patients with Relapsed/Refractory Multiple Myeloma
Carfilzomib is an oral second-generation proteasome inhibitor with a mechanism of action that may increase efficacy and reduce adverse effects currently associated with proteasome inhibitor therapy. It is being investigated for use in multiple myeloma and select solid tumors, and the FDA has...
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,...
Expert Point of View: Peripheral Blood or Bone Marrow as Unrelated Donor Stem Cell Source
This large randomized, controlled trial took a lot of time and extensive resources, and yet survival was the same between the two types of unrelated donor transplant sources, noted Stephanie J. Lee, MD, Professor of Medicine at Washington University and the Fred Hutchinson Cancer Center in Seattle. ...
Which Is Better: Peripheral Blood or Bone Marrow as Unrelated Donor Stem Cell Source?
Over the past decade, the use of peripheral blood stem cells has increased, and now about 75% of unrelated living donor transplants are performed using peripheral blood stem cells without supportive data in the unrelated donor setting. This trend is called into question by results of a large phase...
Expert Point of View: Long-term Survival Benefit and Safety Confirmed for VMP Regimen in Multiple Myeloma in Patients Who Were Not Transplant Candidates
Commenting on the 5-year follow-up data of VISTA presented at the 2011 ASH meeting, Kenneth C. Anderson, MD, said, “This is the longest follow-up of protocols incorporating novel therapies into initial therapy of nontransplant candidates in myeloma. Remarkably, bortezomib with melphalan and...
Long-term Survival Benefit and Safety Confirmed for VMP Regimen in Multiple Myeloma in Patients Who Were Not Transplant Candidates
Five-year analysis of the VISTA trial confirms a survival advantage with VMP (bortezomib [Velcade], melphalan, and prednisone) for upfront treatment of multiple myeloma in patients who were not transplant candidates. At a median follow-up of 60.1 months, a 13-month improvement in overall survival...
What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication Peginterferon alfa-2b (PegIntron, Sylatron) was recently ...
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)...
A Dose of Destruction and Tough Love for Health Care
Title: The Creative Destruction of Medicine: How the Digital Revolution Will Create Better Health Care Author: Eric Topol, MD Publisher: Basic Books Publication date: February 1, 2012 Price: $27.99 / $31.00 (CAN), Hardcover, 320 pages More information: http://creativedestructionofmedicine.com/...
Starting Down the Path toward Electronic QOPI®: ASCO and US Oncology Collaborate in Quality Measurement
The Quality Oncology Practice Initiative (QOPI®), ASCO’s quality measurement program, is entering its 6th successful year and continuing to grow, both in number of participants and in quality measures evaluated. In the truest spirit of quality improvement, ASCO’s oncologist leaders have determined...
ASCO Seeks Better Access to Clinical Trials for Patients with Cancer
ASCO and other organizations submitted recommendations to the Centers for Medicare & Medicaid Services to influence development of a clinical trials coverage regulation of the Patient Protection and Affordable Care Act. The health-care law requires insurers to cover routine care costs for...
SIDEBAR: Leadership to Legacy
Through the Conquer Cancer Foundation Leadership to Legacy campaign, ASCO members and other field leaders have the opportunity to personally invest in the future of oncology by supporting the work of its most talented young researchers. Contributions to the Leadership to Legacy campaign not only...
SIDEBAR: Career Development Award
The Career Development Award (CDA) is a 3-year grant totaling $200,000 to provide funding to clinical investigators who have received their initial faculty appointment, to establish an independent clinical cancer research program. This research must have a patient-oriented focus, including a...
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...
SWOG S0226 Findings Revive Interest in Combination Hormonal Therapy
Two hormonal therapies combined are more efficacious than one when used as first-line treatment for hormone receptor–positive metastatic breast cancer in postmenopausal women, finds Southwest Oncology Group trial S0226. Results of the phase III trial, reported at the 2011 CTRC-AACR San Antonio...
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...
Genomics Projects Plumb Breast Cancer’s Inner Workings
Two large collaborative genomics projects are producing new and sometimes surprising findings about what makes breast cancers tick—information that may ultimately be applied to improve clinical outcomes. In a special session titled “Genome Data for the Masses: Presentation of TCGA and ICGC Breast...
Atypical Breast Lesions: How High Is the Cancer Risk?
Women with atypical breast lesions have approximately a 5% to 11% risk of developing breast cancer within 5 years, depending on histology, and this risk can be reduced with chemoprevention, according to a presentation at the 2011 San Antonio Breast Cancer Symposium.1 Investigators tracked the...
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...
Inefficient Markets Impede Cancer Pain Relief
The potent analgesic property of morphine was first isolated in 1804, and after more than 2 centuries morphine is still the gold standard for moderate to severe pain. It is relatively easy to produce, and compared to most pharmaceuticals, morphine is dirt-cheap. Therein lies the cruel conundrum:...
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...
Expert Point of View: Two Novel Agents Prolong Survival in Advanced Prostate Cancer
“My comment on the AFFIRM trial is ‘wow, very impressive.’ The median survival and the declines in PSA levels are impressive, and this is going to change the way we care for patients in our practices,” said Nicholas Vogelzang, MD, medical oncologist with Comprehensive Cancer Centers of Nevada 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 ...
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, ...
Surviving Cancer Means Making Many Difficult Decisions
The best advice I received after getting a diagnosis of stage I invasive lobular carcinoma in my left breast was from my radiologist, who told me, “Remember, be your own best advocate.” Those words have stayed with me through my 6-year struggle with breast cancer and its aftermath. Extraordinary...
SIDEBAR: Should ‘AYA’ Be an Oncology Subspecialty?
The lag in improvement in survival rates for adolescents and young adults (AYAs) with cancer and a greater awareness of the unique issues they face has prompted discussion about whether “AYA” should become a new oncology subspecialty.1 “Yes and no,” according to Archie Bleyer, MD. “I am going to...
SIDEBAR: Expect and Ask Questions about Sex and Fertility Preservation
What most concerns the adolescent and young adult population? “If they are worried about anything, it is sex and having families,” according to Archie Bleyer, MD. Years ago, he said, “oncologists were so worried about just getting them in remission, treating their cancers, and getting them 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...
ASH 2011 Presentations Include Novel Agents and New Strategies in Leukemia, Lymphoma, and Myeloma
Attendees at the 53rd Annual Meeting of the American Society of Hematology (ASH), held recently in in San Diego, were able to choose from a wide range of interesting and important sessions exploring hematologic malignancies. In addition to The ASCO Post’s regular news coverage from the meeting,...
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...
AACR Urges Congress to Maintain, Preferably Increase, Cancer Research Funding
December 23, 2011, marked the 40th anniversary of the National Cancer Act. To mark that occasion, on February 2, the American Association for Cancer Research (AACR) held a Congressional briefing, attended by about 100 legislative aides, to remind Congress that the war on cancer is far from over....
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...
Risk Stratification of BRCA Mutation Carriers May Help Guide Follow-up
Patient and tumor characteristics can stratify women with breast cancer and a BRCA mutation into groups having different risks of contralateral disease, which may help tailor follow-up, suggests a study of more than 5,000 women in the Netherlands. Confirming findings of other studies, the study...
Context May Affect Benefit of Adjuvant Clodronate in Breast Cancer
A benefit of the oral bisphosphonate clodronate when used as adjuvant therapy for early breast cancer may depend on factors such as the endpoint assessed and patient age, suggests the randomized B-34 trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP). The trial,...
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...
