Dune Medical Devices announced that an FDA Advisory Panel voted 10 to 1 in favor of Dune’s MarginProbe System for use in breast cancer surgery, as an adjunct to current standard methods of intraoperative surgical margin assessment. Dune submitted a Premarket Application (PMA) in April 2011 based on ...
Bayer HealthCare and Onyx Pharmaceuticals announced that the FDA has granted priority review designation to Bayer HealthCare’s New Drug Application (NDA) filed end of April 2012 for the oral multikinase inhibitor regorafenib, for the treatment of patients with metastatic colorectal cancer whose...
Mevion Medical Systems, Inc, announced that it has received FDA 510(k) clearance for its Mevion S250 Proton Therapy System. According to Mevion, the new system delivers precise, noninvasive treatment comparable to that available with larger, more complex proton therapy systems but with higher...
The FDA has granted approval to cetuximab (Erbitux) for use in combination with FOLFIRI (irinotecan, fluorouracil, leucovorin) for first-line treatment of patients with KRAS mutation–negative (wild-type), EGFR-expressing metastatic colorectal cancer as determined by FDA-approved tests for this use. ...
When asked to comment on implications of this study, lead author Frank A. Greco, MD, remarked, “The use of this gene-expression profile assay (CancerTYPE ID, bioTheranostics, Inc) on the biopsy material of patients with carcinoma of unknown primary provides a single tissue of origin diagnosis in...
Molecular gene-expression profiling is an emerging technique to determine tissue of origin in patients with carcinoma of unknown primary, although the value of predictions from such profiling in improving treatment outcomes is unclear. In a prospective trial using tumor profiling results to direct...
With three available tyrosine kinase inhibitors for the treatment of chronic myeloid leukemia (CML), attention has turned from the ability to achieve a sustained response to the possibility of “curing” patients. Updates of pivotal trials presented at ASCO may help define the role of the tyrosine...
The third-generation tyrosine kinase inhibitor ponatinib showed robust efficacy in the 10-month follow-up of the phase II PACE trial (Ponatinib Ph+ALL and CML Evaluation), which is evaluating ponatinib in treatment-refractory chronic myeloid leukemia (CML)1 At the 2012 ASCO Annual Meeting, Jorge E. ...
Richard Goldberg, MD, Physician-in-Chief of The Ohio State University Comprehensive Cancer Center – James Cancer Hospital and Solove Research Institute, presented the first Charles G. Moertel Lecture of the Alliance for Clinical Trials in Oncology during the plenary session of the group’s recent...
There is limited evidence in the literature about how oncologists should discuss bad or serious news with their patients. A recent study sought to understand what patients with cancer value when their doctors communicate news of recurrence.1 The ASCO Post spoke with the study’s lead author, Anthony ...
Additional noteworthy gastrointestinal cancer studies presented during oral abstract sessions at the 2012 ASCO Annual Meeting included the following trials in metastatic colorectal cancer. Perifosine/Capecitabine Fails in Phase III Trial Adding perifosine, an oral alkylphospholipid inhibitor that...
Over the past 10 years, agents targeting the VEGF system, such as bevacizumab, have become standard components of anticancer therapy in various malignancies. Recently, it has become increasingly evident that prolonged duration of anti-VEGF therapy is needed to optimize the therapeutic effect of...
In a study highlighted at a press briefing during the 2012 ASCO Annual Meeting, German investigators reported that prolonging treatment with bevacizumab (Avastin) beyond disease progression extends overall survival in patients with metastatic colorectal cancer.1 Patients received bevacizumab plus...
Risks associated with being a young cancer survivor were emphasized by two studies highlighted in press briefings at the 2012 ASCO Annual Meeting. Investigators from the Children’s Oncology Group (COG) reported that adolescents and young adults treated for high-risk B-precursor acute lymphoblastic ...
The American Board of Pediatrics has announced that the upcoming 2013 Pediatric Hematology-Oncology Certifying Examination will be held on April 16, 2013. Registration and other information is provided below. Examination Date: April 16, 2013 Registration for first-time applicants: August 1, 2012,...
First-line therapy with the investigational oral agent afatinib improved progression-free survival compared with standard chemotherapy (pemetrexed (Alimta)/cisplatin) in patients with advanced non–small cell lung cancer (NSCLC) harboring an EGFR mutation. Afatinib improved progression-free survival ...
At an Annual Meeting press conference, ASCO spokesperson Sylvia Adams, MD, said, “BREAK-3 confirms that BRAF targeting is effective in metastatic melanoma. The tumor shrinkage seen with dabrafenib is similar to results observed for the FDA-approved drug vemurafenib, with fewer side effects. We will ...
Metastatic melanoma was long considered untreatable and incurable. The FDA approval of ipilimumab (Yervoy) and vemurafenib (Zelboraf) ushered in a new era for this disease, and now additional treatment options are in late stages of clinical development. Dabrafenib, a novel oral BRAF inhibitor, and...
A new study comparing lung cancer death rates among women by year of birth shows dramatic differences in trends between states, likely reflecting the success or failure of tobacco control efforts. The study, published early online in the Journal of Clinical Oncology,1 finds that while lung cancer...
In light of the Supreme Court ruling, The ASCO Post asked three nationally regarded experts about how the Affordable Care Act will affect the practice of oncology. Ezekiel J. Emanuel, MD, PhD, Professor and Vice Provost for Global Initiatives, University of Pennsylvania: This is an overwhelmingly...
On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act into law—a hotly contested bill that enacted sweeping changes to the U.S. health-care system. The debate over the Affordable Care Act continued all the way to the Supreme Court, spearheaded by the case Florida...
Results of two late-breaking phase III trials presented at 2012 ASCO Annual Meeting add to the evolving understanding of how best to treat non–small cell lung cancer (NSCLC). The TAILOR trial suggested the benefit of chemotherapy over EGFR-targeted therapy as second-line treatment of patients with...
The Conquer Cancer Foundation of ASCO recently announced the recipients of its 2012 Breast Cancer Symposium Merit Awards, which recognize leading oncology professionals for their work in the area of breast cancer research. This year, the Foundation honors 16 individuals for their research in the...
For now, genomic sequencing seems to have a greater presence in the news than in the clinic. What can physicians tell their patients who ask about genetic testing to identify mutations driving cancer growth? “The real answer is that when you get down to it, genomics is like any other test,”...
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. Despite recent news reports...
The use of dietary supplements by cancer patients has risen significantly over the past 2 decades despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and the...
Jennifer Levin Carter, MD, MPH is Founder and President of N-of-One. A board-certified internist and entrepreneur, she has more than 20 years of experience evaluating existing and emerging markets, new medical technologies, and early-stage companies in the health-care field. Formerly, Dr. Carter...
In a whispered but resolute voice, Itzhak Brook, MD, MSc, led off his presentation at the 2012 ASCO Annual Meeting1 by telling the audience his voice is weak because he doesn’t have vocal cords. He spoke with the aid of a tracheoesophageal voice prosthesis. “I have practiced medicine for more than ...
Thirty years ago, when the first supportive care meeting as a forerunner of the Multinational Association of Supportive Care in Cancer (MASCC) Symposium was held in New York, supportive care was largely ignored, with little discussion at major cancer meetings, which focused primarily on...
Results of several long-running chemotherapy trials were reported at the 2012 ASCO Annual Meeting breast cancer oral session, reported in brief here. NSABP B-38 The final analysis of the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-38 trial showed that the addition of gemcitabine...
Obtaining a thorough family history of cancer should be a key component in evaluating patients and deciding whether to refer those at increased risk of either primary or second cancers for genetic counseling and testing. Many community oncology practices comply with this practice, but there is room ...
The oral antidepressant duloxetine (Cymbalta) at 60 mg/d improved chemotherapy-induced painful neuropathy in a randomized, double-blind, placebo-controlled, phase III trial.1 Overall, 59% of patients treated with duloxetine experienced some pain relief, 33% reported at least a 30% decrease in pain, ...
The ability to make a diagnosis of non–small cell lung cancer (NSCLC) with FDG-PET varies widely among centers, and this imaging modality performed more poorly in community and academic centers than in published studies.1 A secondary analysis of the prospective American College of Surgeons Oncology ...
More attention is being paid to the importance of patient preference as a factor in treatment selection. An innovative randomized, double-blind study in patients with metastatic kidney cancer demonstrates that quality of life and side effects drive patient preference.1 Results also suggest that...
Eun-Sil Shelley Hwang, MD, MPH, of Duke University Medical Center, Durham, North Carolina, who discussed both papers on ductal carcinoma in situ at the ASCO Annual Meeting, noted that better risk stratification and treatments are substantially changing the outlook for DCIS. “We are getting close to ...
Risk stratification and outcomes can be improved for women with ductal carcinoma in situ (DCIS), according to two studies presented at the 2012 ASCO Annual Meeting. RTOG 9804 Findings from the Radiation Therapy Oncology Group (RTOG) 9804 trial suggested that even for DCIS patients whose prognosis...
Eduardo Cazap, MD, PhD, is founder and first President of the Latin American and Caribbean Society of Medical Oncology (SLACOM). In 2008, he was elected to a 2-year term as President of the International Union against Cancer (UICC). The ASCO Post recently spoke with Dr. Cazap about his roots in...
Lapatinib (Tykerb) proved valuable as a component of neoadjuvant chemotherapy for HER2-positive operable breast cancer in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-41 trial presented at the 2012 ASCO Annual Meeting by Andre Robidoux, MD, of the NSABP and the University of...
Hundreds of investigators, such as 2008 Young Investigator Award and 2010 Career Development Award recipient Richard Carvajal, MD, have received seed funding from ASCO’s Conquer Cancer Foundation early in their careers—funding that supported their professional growth and helped lay the foundation...
Direct your patients to www.cancer.net/whattoknow so they can learn about ASCO’s recent guideline on sentinel lymph node biopsy for melanoma, including what it means for patients and a list of questions to ask the doctor. In addition, patients can find more information about melanoma at...
When the Supreme Court upheld the Patient Protection and Affordable Care Act on June 28, ASCO released a statement by ASCO President Sandra M. Swain, MD, Medical Director of the Washington Cancer Institute at MedStar Washington Hospital Center. Critically Important Provisions In the statement, Dr....
Did you miss one of the symposia this year and need to quickly catch up on the highlights in small, digestible portions? No problem. ASCO University’s e-Seminar series now has you covered. Or, is there a new journal article that everyone’s talking about, and you need guidance on how to interpret...
Journal of Clinical Oncology (JCO) has recently launched several new features for readers under the direction of Stephen A. Cannistra, MD, who began his tenure as Editor-in-Chief in June 2011. These initiatives include the creation of two new article types: Rapid Communications (RC) and...
The new hospital at Rush University Medical Center, Chicago, has been listed in KPMG’s recent second edition of Infrastructure 100: World Cities Edition, a report showcasing 100 of the most innovative and inspiring urban infrastructure projects from around the world. Rush is one of only 10...
Pearls in Neuro-oncology is guest edited by Tracy Batchelor, MD, Director, Division of Neuro-Oncology, Massachusetts General Hospital Cancer Center, and Professor of Neurology, Harvard Medical School, Boston. The series is intended to provide the practicing oncologist with guidance in managing...
Medivation, Inc, and Astellas Pharma, Inc, announced that the FDA has accepted for filing the New Drug Application (NDA) for enzalutamide (formerly MDV3100) for the potential treatment of men with castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy and granted...
The FDA has approved everolimus tablets (Afinitor) for use in combination with exemestane to treat postmenopausal women with advanced hormone receptor–positive, HER2-negative breast cancer after failure of treatment with letrozole or anastrozole. The approval was based on a randomized,...
Onyx Pharmaceuticals announced that the FDA has granted accelerated approval to carfilzomib (Kyprolis) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including treatment with bortezomib (Velcade) and an immunomodulatory therapy, and have...
In the 1930s and 1940s, when the American Cancer Society [ACS] first brought forth the message that early cancer detection saves lives, it was a broad brushstroke and an appropriate message. The problem now is that new technology enables us to find [tumors that would never progress to invasive...
Regorafenib, an orally administered investigational tyrosine kinase inhibitor that has shown activity in chemorefractory metastatic colorectal cancer, markedly delayed disease progression in patients with treatment-refractory metastatic gastrointestinal stromal tumor (GIST) in the phase III GRID...