FDA has approved the following new drugs and/or indications in 2013: Denosumab (Xgeva subcutaneous injection) for giant cell tumor of bone. Lenalidomide (Revlimid capsules) for relapsed/refractory mantle cell lymphoma FDA approved. Trametinib (Mekinist tablets) for unresectable or metastatic...
The amino acid imaging agent, O-(2-[18F]-fluoroethyl)-L-tyrosine (F-18 FET), may improve upon standard magnetic resonance imaging (MRI) and its diagnostic benefit for imaging pediatric gliomas when conventional MRI is not sufficient, said researchers at the Society of Nuclear Medicine and Molecular ...
The phase III open-label AXIS trial comparing axitinib (Inlyta) vs sorafenib (Nexavar) as second-line treatment for metastatic renal cell carcinoma has shown a significant difference in median progression-free survival (8.3 months in the axitinib group vs 5.7 months in the sorafenib group; hazard...
A Surveillance, Epidemiology, and End Results (SEER) database analysis reported by Ravi Shridhar, MD, PhD, and colleagues in Cancer indicates that patients receiving surgery and radiation therapy for metastatic gastric cancer have prolonged survival compared with those receiving either alone or...
The Cancer Genome Atlas (TCGA) Research Network recently reported the results of an integrated analysis of the genomic features of 373 endometrial carcinomas.1 This report joins previously published results of similar analyses in ovarian, breast, and colorectal cancers, squamous cell carcinoma of...
The U.S. Food and Drug Administration (FDA) has expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s...
Management of metastatic breast cancer requires monitoring of tumor burden to assess response to treatment, and there is a need for biomarkers that can measure tumor burden with high sensitivity and specificity. Assays measuring serum cancer antigen (CA) 15-3 and circulating tumor cells have been...
The Conquer Cancer Foundation and ASCO International have just launched a new research funding opportunity, the Conquer Cancer Foundation of ASCO International Innovation Grant, which directly supports research being conducted by investigators in low- and middle-income countries. Advancing Cancer...
Building on ASCO’s longstanding commitment to drive quality, value, and accountability in cancer care, the Institute for Quality’s initiatives provide oncologists with resources to ensure that every patient receives the highest level of cancer care. Established in 2011, the Institute for Quality...
In a study by the Cancer Genome Atlas Research Network reported in The New England Journal of Medicine, genomes of 200 adult cases of de novo acute myeloid leukemia (AML) were analyzed by whole-genome sequencing (n = 50) or whole-exome sequencing (n = 150) to identify mutations and relationships...
In patients with advanced colorectal cancer, it remains unclear which biologic agent added to standard chemotherapy is best, even after a head-to-head comparison of two commonly used agents. In the phase III FIRE-3 trial, conducted by the German AIO CRC Study Group, the addition of cetuximab...
At least 12 different genetic tests for prostate cancer are under development. The two tests currently available are Oncotype DX (Genomic Health, Redwood City, California) and Prolaris (Myriad Genetic Laboratories, Salt Lake City). Both tests can identify which low-risk patients are “truly” at low...
As a neoadjuvant regimen for HER2-positive early breast cancer, the use of two HER2-directed agents was no more effective than trastuzumab (Herceptin) alone in producing pathologic complete responses, although one subset of patients did benefit from this approach, according to the results of the...
A trio of presentations at the ASCO Annual Meeting focused on two promising investigational drugs for the treatment of chronic lymphocytic leukemia (CLL). These two drugs—idelalisib and obinutuzumab—join a list of new approaches showing potential. Idelalisib Alone A phase I dose-ranging study of...
The investigational heat shock protein (Hsp)90 inhibitor ganetespib plus docetaxel extended overall survival compared with docetaxel alone as second-line therapy in patients with advanced non–small cell adenocarcinoma of the lung that had progressed on first-line therapy in the randomized phase II...
This is the first time I’m going public with the fact that I have advanced ovarian cancer. I thought I could avoid the fate of my mother and her mother, both of whom died of ovarian cancer in their 50s, and live well past my 60s and even 70s. But at 58, I’ve had to accept that that is not likely. I ...
Given the results of the AVAglio trial, we feel that a more balanced discussion about the role of bevacizumab (Avastin) in patients with newly diagnosed glioblastoma is in order. The accompanying article in The ASCO Post suggests that bevacizumab has no benefit in newly diagnosed glioblastoma; data ...
Treatment with lenalidomide (Revlimid) as initial therapy induced long-lasting responses in a phase II study of 60 patients with chronic lymphocytic leukemia (CLL). “Overall, 35 patients (58%) patients had responses lasting more than 36 months and were considered long-term responders,” the...
Two studies published in Journal of Clinical Oncology indicate that treatment-related symptoms and mammographic density reduction may predict whether a woman with hormone receptor–positive breast cancer will benefit from adjuvant endocrine therapy. In one study, women who had specific adverse...
The use of advanced treatment technologies, such as intensity-modulated radiotherapy and robotic prostatectomy, has increased among men unlikely to die from prostate cancer, according to a retrospective analysis of data from almost 56,000 men diagnosed with prostate cancer between 2004 and 2009....
I found out that I had stage III pancreatic cancer on Valentine’s Day in 2011, but I think the disease may have been brewing for a long time. For 19 years, I had experienced intermittent pain in the right upper quadrant of my abdomen. I had gallbladder surgery to relieve a bile duct obstruction,...
Despite his fame as co-discoverer—along with Francis Crick, PhD—of the double-helix structure of deoxyribonucleic acid (DNA) in 1953, that accomplishment is not what James Dewey Watson, PhD, came to talk about during a recent presentation he gave at the World Science Festival in New York. Instead,...
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...
On July 12, 2013, the FDA approved the tyrosine kinase inhibitor afatinib (Gilotrif) for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations...
The Center for International Blood and Marrow Transplant Research is a combined research program of the National Marrow Donor Program and the Medical College of Wisconsin, Milwaukee. At the forefront of research to increase access to hematopoietic stem cell transplantation and improve outcomes, the ...
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 On June 13, 2013, denosumab (Xgeva) was approved for the ...
For the first time since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the authority to regulate tobacco products, the agency has authorized the marketing of two new tobacco products and denied the marketing of four others through the substantial equivalence pathway....
Two drugs were recently given Priority Review designation by FDA. Obinutuzumab (GA101) was granted Priority Review for the treatment of chronic lymphocytic leukemia, based on final stage 1 data from the pivotal CLL11 trial. The FDA confirmed the action date is December 20, 2013. FDA also granted...
In 1989, Denardo and associates reported the results of intensive care unit (ICU) therapy in a series of patients who developed acute respiratory failure and required mechanical ventilation after bone marrow transplantation. Of those on mechanical ventilatory support longer than 4 days, not one...
Nearly half the surgical procedures for sarcoma done at 85 academic medical centers were performed by surgeons untrained in oncology, according to national data analyzed by researchers from the University of California Davis Medical Center, Sacramento. Orthopedic oncologists and surgical...
Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...
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 On June 5, 2013, lenalidomide (Revlimid) was approved...
The 12th International Conference on Malignant Lymphoma was held June 19-22, 2013, in Lugano, Switzerland. Over 3,000 hematologists, clinical oncologists, pathologists, and leading researchers attended the meeting, which featured new research on B-cell malignancies, follicular lymphoma, as well as...
Roche recently announced it has submitted a Premarket Approval (PMA) supplement to the FDA seeking the addition of a cervical cancer primary screening indication for the cobas HPV Test. Approval of the expanded indication would mean the cobas HPV Test could be used as the first-line test rather...
Pharmacyclics, Inc, recently announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational oral Bruton’s tyrosine kinase inhibitor ibrutinib, for two relapsed/refractory B-cell malignancy indications: mantle cell lymphoma (MCL)...
In the treatment of early breast cancer, outcomes are equivalent whether paclitaxel is delivered weekly or every 2 weeks, though the weekly schedule may be better tolerated, according to the results of a phase III trial presented at the 2013 ASCO Annual Meeting.1 “The progression-free survival...
With the approval of a number of different drugs for the treatment of metastatic renal cell carcinoma, a major issue is how to sequence these drugs to optimize outcome. A large, randomized phase II study called RECORD-3 shows that the standard sequence of the multitargeted tyrosine kinase inhibitor ...
For poor-prognosis patients with germ-cell tumors, dose intensification of chemotherapy based on slow decline of tumor markers can increase progression-free survival, according to the first randomized trial of a “personalized” treatment strategy for this tumor.1 At the 2013 ASCO Annual Meeting,...
Men with localized high-risk prostate cancer treated with adjuvant radiotherapy had similar overall and disease-free survival when treated with 18 months of androgen deprivation therapy vs 36 months of androgen deprivation therapy, the current standard of care in this setting. These results were...
Hedy Lee Kindler, MD, Associate Professor of Medicine at the University of Chicago, the invited discussant of three of these presentations, emphasized the persistent lethality of advanced pancreatic cancer. She predicted that within this decade, pancreatic cancer will become the second leading...
The challenge of treating pancreatic cancer inched forward with studies reported at the 2013 ASCO Annual Meeting, though some important studies proved disappointing. Nab-paclitaxel Improves Overall Survival In treatment-naive metastatic patients, the addition of nanoparticle albumin-bound...
Joseph M. Connors, MD, authored a commentary in the June 25 issue of The ASCO Post inspired by a recent New England Journal of Medicine publication on dose-adjusted EPOCH-R chemotherapy (etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, and rituximab) for primary mediastinal B-cell ...
My feature interview in the August 15, 2012, issue of The ASCO Post, entitled “Rethinking the Role of PSA Screening in Public Health”1 drew swift reaction from well-known figures in the prostate cancer field. The subsequent Letters to the Editor, three in all, constituted a two-pronged attack. They ...
I am the Outreach Administrator/Newsletter Editor at Support for People with Oral and Head and Neck Cancer (SPOHNC). SPOHNC is a national nonprofit organization involved in the development of support programs. As such, it can have an enormous positive impact on meeting the psychosocial needs of...
“Ridaforolimus delayed tumor progression to a small statistically significant degree in patients with metastatic sarcoma who experienced benefit with prior chemotherapy,” according to results of an international phase III trial. The large randomized placebo-controlled phase III trial evaluated the...
Adding cetuximab (Erbitux) to cisplatin doubled the overall response rate and appeared to prolong progression-free and overall survival in a randomized phase II study among patients with metastatic triple-negative breast cancer. Although the trial did not meet its primary endpoint of overall...
Doctors at Cornell University Hospital for Animals in Ithaca, New York, reported what they believe may be the first case of a pig being treated for lymphoma. The animal was described as a 730-pound black-and-white Hampshire pig that was diagnosed with presumptive B-cell lymphoma. The 4-year-old...
An “alarming difference” in survival outcomes between young, non-Hispanic white males and females with primary invasive melanoma (see accompanying article) is one of several skin cancer–related study findings in the news this summer. Other studies have concerned the rising rates of melanoma among...
The addition of tomosynthesis to standard digital mammography resulted in a 30% reduction in overall recall rates among women being screened for breast cancer, according to a new study published online in Radiology.1 The results demonstrate that digital tomosynthesis is an effective tool in...
Cedars-Sinai in Los Angeles, California, recently named Christine R. Carico the 2013 recipient of the Medical Center’s Pauletta and Denzel Washington Family Gifted Scholars Program in Neuroscience award. Ms. Carico will spend the next year researching brain disorders like the one that took the life ...