The news that she is both pregnant and has been found to have a potentially lethal malignancy is one of the most emotionally wrenching events any young woman ever faces. Understandably, the patient, her partner, their families, and even their caregivers find this experience fraught with anxiety and ...
For clinicians and health service researchers striving to improve care for people living with life-threatening conditions, September was a sobering month. The Dartmouth Atlas group released a brief report on Trends in Cancer Care Near the End of Life1 showing that while the proportion of patients...
In a study reported in The Lancet Oncology, Dennis C. Sgroi, MD, of Massachusetts General Hospital, and colleagues compared the ability of the breast-cancer index (BCI) assay, 21-gene recurrence score (Oncotype DX), and an immunohistochemical prognostic model (IHC4) to predict early and late...
Interim data from a Phase IB trial evaluating the investigational anti-PD-1 immunotherapy, MK-3475, in patients with previously treated non-small cell lung cancer (NSCLC) were presented recently at the 15th World Conference on Lung Cancer in Sydney, Australia. Edward Garon, MD, Director of Thoracic ...
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 September 30, 2013, pertuzumab injection (Perjeta)...
The U.S. Food and Drug Administration (FDA) is taking two actions to further enhance the agency’s ongoing efforts to prevent and resolve drug shortages. The FDA has released a strategic plan called for in the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 to improve the...
In the Prostate Cancer Prevention Trial (PCPT), initially reported in 2003, finasteride significantly reduced the risk of prostate cancer by 24.8% but was associated with a relative 26.9% increase in risk of high-grade disease compared with placebo. In a study reported in The New England Journal of ...
INSIDE THE BLACK BOX is an occasional column providing insight into the FDA and its policies and procedures. In this first installment, FDA Clinical Reviewers Laleh Amiri-Kordestani, MD, and Suparna Wedam, MD, discuss FDA’s recent approval of pertuzumab (Perjeta) for the neoadjuvant treatment of...
Hepatocellular carcinoma is a devastating disease worldwide. Although advances in liver transplantation, surgery, and locoregional therapies have made tumor control or even cure possible for a minority of patients, the majority of patients diagnosed with hepatocellular carcinoma will develop...
The investigational drug brivanib is a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, both implicated in hepatocellular carcinoma. The agent was recently evaluated in two phase III trials, one comparing first-line brivanib with sorafenib (Nexavar) in...
Both pemetrexed (Alimta) and gefitinib (Iressa) are standard second-line treatments for advanced nonsquamous non–small cell lung cancer (NSCLC) in East Asia. In a phase II trial (CTONG 0806) reported at the International Association for the Study of Lung Cancer’s 15th World Conference on Lung...
Colonoscopy and sigmoidoscopy have been shown to provide protection against colorectal cancer, but the magnitude and duration of protection, particularly against proximal colon cancer, remain undefined. A study of long-term colorectal cancer incidence and mortality after lower endoscopy reported in ...
Results from the Costa Rica HPV 16/18 Vaccine Trial indicate that 4-year efficacy against 12-month HPV 16/18 persistent infection was similarly high among women who received one, two, or the recommended three doses of the bivalent HPV16/18 L1 virus-like particle vaccine (Cervarix). The findings...
In general, we have come to think of mismatch repair–deficient colon cancer as having a more favorable prognosis, being less likely to metastasize to regional nodes or distant sites, and being resistant to fluoropyrimidines. Much of our data, however, come from trials combining stage II and III...
The 2013 European Cancer Congress (ECC), held September 27 to October 1 in Amsterdam, was jointly sponsored by the European Society of Medical Oncology, the European Cancer Organization, and the European Society of Radiation Oncology. With the Congress theme being “Reinforcing Multidisciplinarity,” ...
The optimal use of bevacizumab (Avastin) in ovarian cancer appears to be in high-risk subgroups and in patients with platinum-resistant ovarian cancer, according to results of two phase III trials presented at the 2013 European Cancer Congress (ECC) in Amsterdam. AURELIA investigated the safety and ...
Trebananib, an investigational antiangiogenesis inhibitor with a different mechanism of action than bevacizumab (Avastin), significantly improved progression-free survival in recurrent platinum-resistant and partially platinum-sensitive ovarian cancer in the phase III TRINOVA-1 trial. The addition...
The investigational oral vascular endothelial growth factor (VEGF) inhibitor cediranib extended progression-free survival when given with platinum-based chemotherapy and improved overall survival when given as maintenance therapy in patients with recurrent ovarian cancer. Experts are hopeful that...
Results of the phase III TH3RESA trial show that the antibody-conjugate ado-trastuzumab emtansine (Kadcyla), formerly known as T-DM1, extends progression-free survival in women with advanced HER2-positive breast cancer that progressed on two or more previous HER2-directed therapies including...
Only nodal status and tumor size provided statistically significant prognostic information for predicting recurrences 5 to 10 years after diagnosis for postmenopausal women with early estrogen receptor–positive breast cancer enrolled in the monotherapy arms of the ATAC (Arimidex, Tamoxifen, Alone...
I was diagnosed with stage IVB squamous cell carcinoma of the tongue in 2007, when I was just 33 years old, but the cancer had started to show itself long before then. I first noticed a white dot on the left side of my tongue in 2002, and as time went on, the sore became annoying and hurt when it...
For women with BRCA1 or BRCA2 mutations who choose to have salpingo-oophorectomy to reduce their risks of ovarian and breast cancer, also choosing to have a hysterectomy is “reasonable but not required,” noted Noah D. Kauff, MD, Director of the Ovarian Cancer Screening and Prevention Program and...
The addition of zalutumumab, an investigational epidermal growth factor receptor (EGFR) inhibitor, to primary chemoradiotherapy did not increase locoregional control or improve survival at 3 years in patients with squamous cell carcinoma of the head and neck compared with chemoradiotherapy alone,...
Five recent articles in JAMA Otolaryngology–Head & Neck Surgery1-5 span a spectrum of issues related to head and neck cancers. These include risk factors, concentration of care to teaching hospitals, avoiding venous thromboembolism, and encouraging patients to eat and do swallowing exercises to ...
In an editorial accompanying the article by Boughey et al, Monica Morrow, MD, and Chau T. Dang, MD, of Memorial Sloan-Kettering Cancer Center, New York, question whether sentinel lymph node biopsy can be considered a part of standard management in patients with initial clinically node-positive...
Sentinel lymph node surgery provides reliable nodal staging information and is associated with less morbidity than axillary lymph node dissection in patients with clinically node-negative (cN0) breast cancer. The American College of Surgeons Oncology Group (ACOSOG) Z1071 (Alliance) trial examined...
According to data from the Surveillance, Epidemiology, and End Results Program (SEER) and the U.S. Census Bureau registries,1 there are currently about 13.7 million cancer survivors in the United States, and that number is projected to grow to 18 million by 2022. In addition, 64% of this population ...
The effect of bisphosphonate treatment in early breast cancer is controversial, with some data indicating survival benefit in the adjuvant setting. In a study reported in the Journal of Clinical Oncology (German Adjuvant Intergroup Node-Positive Study, GAIN), Gunter von Minckwitz, MD, PhD, Chairman ...
In a retrospective analysis of German High-Grade Non-Hodgkin Lymphoma Study Group trials reported in the Journal of Clinical Oncology, Gerhard Held, MD, of Saarland University Medical School in Homburg, and colleagues assessed the impact of rituximab (Rituxan) and radiotherapy on outcome in...
Oncologists are getting a handle on BRCA1/2 in breast cancer, becoming more adept at treating and counseling patients with these mutations. But the BRCA mutation is only one example of a host of genetic variations that can increase breast cancer risk, according to James M. Ford, MD, Associate...
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 November 1, 2013, obinutuzumab (Gazyva) was approved...
Seven years ago, Teresa K. Woodruff, PhD, coined the term “oncofertility” to describe the melding of two medical specialties, oncology and reproductive endocrinology, with the goal of maximizing the reproductive potential of patients with cancer. Today, with Dr. Woodruff’s establishment of the...
The U.S. Food and Drug Administration has authorized the marketing of the UroLift system, a permanent implant to relieve low or blocked urine flow in men age 50 and older with benign prostatic hyperplasia. As men age, the prostate can become enlarged, also known as benign prostatic hyperplasia....
Vascular endothelial growth factor (VEGF)– and VEGF receptor-2 (VEGFR-2)–mediated signaling and angiogenesis seem to have an important role in the pathogenesis of gastric cancer. In the phase III REGARD trial reported in Lancet, Charles S. Fuchs, MD, MPH, of Dana-Farber Cancer Institute, Boston,...
For a number of years following the approval of gemcitabine for advanced pancreatic cancer, one phase III clinical trial after the next failed to demonstrate a survival benefit of combination chemotherapy compared to gemcitabine alone. Even the one positive study from the mid-2000s—the PA.3 trial...
From 12% to 15% of the approximately 45,000 patients diagnosed with pancreas adenocarcinoma undergo a potentially curative resection each year in North America, translating into roughly 5,000 to 7,000 patients who are candidates for adjuvant therapy. About 80% of these patients will relapse and...
In one study presented at ASCO’s second annual Quality Care Symposium in San Diego, patients receiving chemotherapy with palliative care intent were at high risk of side-effect–related hospitalization, which defeats the clinical purpose and adds preventable costs to health care.1 “There is an...
The FIRE-3 study compared the two epidermal growth factor receptor (EGFR) antibodies, on top of chemotherapy, in the first-line treatment of metastatic colorectal cancer. A preplanned analysis of KRAS wild-type patients without RAS mutations, ie, “all-RAS wild-type,” showed overall survival to be...
Excitement continues to build in the metastatic melanoma arena, as novel agents keep upping the ante for efficacy. The following news from the 2013 European Cancer Congress has added to the buzz. New MEK Inhibitor In the phase IB BRIM7 study, cobimetinib, a novel MEK inhibitor, when combined with...
Relapsed and refractory transplant-eligible Hodgkin lymphoma patients who achieve complete responses after treatment with brentuximab vedotin (Adcetris) can often avoid more toxic salvage chemotherapy, according to investigators from Memorial Sloan-Kettering Cancer Center, New York....
For the front-line treatment of advanced Hodgkin lymphoma, ABVD is a standard treatment, but not all patients have good outcomes with this regimen. The addition of brentuximab vedotin (Adcetris), or its substitution for bleomycin, produces high complete response rates but with a moderate increase...
Nationally regarded health-care expert Lee N. Newcomer, MD, MHA, began his presentation at this year’s ASCO Quality Care Symposium with a rhetorical question. “Why are we talking about money when we’re gathered in San Diego for 2 days to discuss some wonderful ways to impact the quality of cancer...
GeparTrio was an innovative phase III trial conducted by the German Breast Group, enrolling over 2,000 women with early breast cancer who were candidates for neoadjuvant chemotherapy. Patients with evidence of early response, defined as reduction in clinical tumor size by 50% or more, following two ...
In an exploratory analysis of long-term survival data from the GeparTrio trial reported in the Journal of Clinical Oncology, Gunter von Minckwitz, MD, PhD, of the German Breast Group in Neu-Isenburg and the University of Frankfurt, Germany, and colleagues found that response-guided neoadjuvant...
A phase II trial to evaluate the combination of bendamustine (Treanda) with bortezomib (Velcade) and dexamethasone in patients with relapsed/refractory multiple myeloma “showed a remarkable response rate of 60.9%,” and when minor responses were included, 75.9%,” researchers reported in Blood. “The...
Disease-free survival is an acceptable surrogate for overall survival in trials of cytotoxic agents for gastric cancer in the adjuvant setting, the GASTRIC group concluded after conducting a meta-analysis of data from 3,288 individual patients enrolled in 14 randomized clinical trials. The trials...
City of Hope has selected Steven T. Rosen, MD, the Director of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University Feinberg School of Medicine, as its first Provost and Chief Scientific Officer. Dr. Rosen will set the scientific direction of City of Hope as it embarks on a...
The Massachusetts Society of Clinical Oncologists (MSCO) is among the oldest and largest of ASCO’s State Affiliates. Based in the same building as the Massachusetts Medical Society in Waltham, MSCO was founded in 1985 and has a growing membership of 160 members, including medical, surgical, and...
Dr. Mason states that I implied that Dr. Telli supports the routine application of chemosensitivity assays. I have no knowledge regarding Dr. Telli’s views on this subject, nor did I in any way attempt to represent her views, much less imply that she was supportive of anything relating to...
The National Institutes of Health recently announced several changes in leadership on the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents. The panel, a working group of the NIH Office of AIDS Research Advisory Committee (OARAC), consists of...