On May 17, 2016, nivolumab (Opdivo) was granted accelerated approval for treatment of patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation and post-transplantation brentuximab vedotin (Adcetris).1,2 Continued approval for ...
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.On May 18, 2016, the PD-L1 (programmed cell death ligand 1)...
On June 2, 2016, U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement on the release of the final individual patient expanded access form. “Today, the FDA finalized its efforts to streamline the process used by physicians to request expanded...
Session moderator, Michael O. Koch, MD, Professor of Urology and Chairman of the Department of Urology at Indiana University School of Medicine, Indianapolis, described the drug as a “game-changer for metastatic disease.” “The last [development] that was even similar to this was when the MVAC...
Seattle Children’s announced that 39 of 42 patients treated in a phase I clinical trial using genetically reprogrammed T cells to treat relapsed or refractory acute lymphoblastic leukemia (ALL) have achieved complete remission, showing no detectable leukemia cells. Phase II of this trial, known as...
A new U.S. Department of Veterans Affairs (VA) study suggests that African American men and men with a higher tumor stage may benefit from adjuvant chemotherapy following radical prostatectomy.1 According to prespecified analysis of these two “high–risk” subgroups, patients with ≥ T3b disease had a ...
In 2012–2013, members of the President’s Cancer Panel (prescancerpanel.cancer.gov) focused their efforts on accelerating widespread acceptance of and use of approved human papillomavirus (HPV) vaccines to prevent cancer. The topic is important, because HPVs cause most cases of cervical cancer and...
The American Association for Cancer Research (AACR) congratulates Saverio Candido, PhD, on receiving the fourth Margaret Foti Scholar-in-Training Award from the University of Catania in Italy. Dr. Candido is being recognized for his research on biomarkers of bladder cancer development and...
Breast surgeon Deanna Attai, MD, is a virtual mighty mouse as a spokesperson for her professional organization, the American Society of Breast Surgeons (ASBrS). She is as big on ideas as she is petite in stature and for actively tweeting on medical topics (@DrAttai). Assistant Clinical Professor...
Last year, five organizations introduced new methods to compare cancer treatments. For more on ASCO’s Value Framework, see page 120. The NCCN Evidence Blocks™ use a simple graphic to show experts’ ratings of systemic therapies in five areas: efficacy, safety, quality and quantity of evidence,...
Value framework tools made a splash in 2015, with five different groups unveiling methods to help physicians and patients compare therapies based on efficacy, toxicity, and/or cost. Now these potential users are beginning to examine and debate the tools, including how and whether they will work in...
An adjuvant chemotherapy regimen improved overall survival in early-stage pancreatic cancer patients, in the large phase III European ESPAC-4 study reported at the 2016 ASCO Annual Meeting.1 The combination of gemcitabine and capecitabine almost doubled the 5-year survival rate, compared to...
Formal discussant of this trial Stuart A. Grossman, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins University, Baltimore, commented that the trial did not include a best standard-of-care arm. The pivotal trial defined optimal radiotherapy as 60 Gy over 6 weeks, but this...
The combination of short-course radiotherapy and temozolomide followed by maintenance with temozolomide significantly improved survival compared with short-course radiotherapy alone in newly diagnosed elderly patients with glioblastoma, according to the results of a global cooperative group trial...
Fred Hutchinson Cancer Research Center has announced the hiring of Steve Stadum as Executive Vice President and Chief Operating Officer. Mr. Stadum, currently the Chief Operating Officer (COO) of the Oregon Health & Science University (OHSU) Knight Cancer Institute, will join Fred Hutchinson as ...
The incidence of new cases of breast cancer in low- and middle-income countries, particularly in sub-Saharan Africa, is rising, and it will take a concerted effort from the international cancer community to counteract this troubling upward trend. It has been estimated that of the 15 million cancer ...
Five years of aromatase inhibitor as upfront therapy or after tamoxifen is the current standard of care for postmenopausal women with early hormone receptor–positive breast cancer. A new trial suggests that extending aromatase inhibitor therapy with letrozole for an additional 5 years may improve...
It can be easy to miss the forest for the trees in the interpretation of clinical trials. In particular, trials for the treatment of cancer are exceedingly complex, with long lists of inclusion and exclusion criteria, designs with hidden biases, drugs with unpronounceable names (if not cumbersome...
On June 27, 2016, Clifford A. Hudis, MD, FACP, FASCO, will begin his tenure as Chief Executive Officer of ASCO, succeeding Allen S. Lichter, MD, FASCO, who presided over the Society and the Conquer Cancer Foundation of ASCO since 2006. Dr. Hudis’ dedication to ASCO dates back more than 25 years...
For relapsed or refractory multiple myeloma, daratumumab (Darzalex), combined with bortezomib (Velcade) and dexamethasone, reduced relapses by 61% in the phase III CASTOR study reported at the 2016 ASCO Annual Meeting.1 “The results are unprecedented in a randomized study comparing a novel...
During the 2016 Annual Meeting, ASCO announced the creation of the Allen S. Lichter Visionary Leader Award to recognize ASCO members who have transformed the oncology field or significantly advanced the mission of ASCO, the Conquer Cancer Foundation, or CancerLinQ, LLC, through their leadership,...
The global economic crisis has been associated with increased unemployment and reduced public-sector expenditure on health care. In a study reported in The Lancet, Maruthappu et al found that the global economic crisis beginning in 2008 was also associated with a large excess in cancer mortality...
Duke Cancer Institute researchers have found that a hypothetical leukemia patient buying the life-extending drug therapy for his condition would reach his annual out-of-pocket maximum in a month on most of the bronze policies and half of the silver policies offered through the Affordable Care Act...
Skin cancer screenings performed by primary care physicians during routine office visits improve the detection of potentially deadly melanomas and find them in earlier stages, according to new research from the University of Pittsburgh School of Medicine. The results were presented by Ferris et al...
Lung cancer patients with oligometastases, defined as three or fewer sites of metastasis, may benefit from aggressive local therapy, surgery, or radiation, after standard chemotherapy, according to research led by The University of Texas MD Anderson Cancer Center. If validated in larger studies,...
Treatment with nivolumab (Opdivo) doubled overall survival and improved quality of life, with fewer side effects, in a treatment-resistant and rapidly progressing form of head and neck carcinoma, reported a large, randomized international trial co-led by investigators at the University of...
An experimental CDK inhibitor, abemaciclib, yielded encouraging and durable results against several different types of cancers, including breast cancer, lung cancer, glioblastoma, and melanoma, according to a report published by Patnaik et al in Cancer Discovery. The results of the trial supported ...
ASCO announced that a total of 58 practices in 39 states and the District of Columbia have joined CancerLinQ, ASCO’s big data initiative to rapidly improve the quality of care for people with cancer. CancerLinQ is already up and running in a number of practices and drawing on approximately...
A pilot study revealed large differences in median retail prices for 23 cancer drugs in 7 different countries, with the highest retail prices identified in the United States and the lowest, in India and South Africa. Notably, after the monthly drug price is expressed as a percentage of domestic...
For breast cancer survivors who carry mutations in BRCA genes, preventive surgery may substantially reduce the risk of future breast and ovarian cancers. However, it appears that black women are far less likely to receive these widely recommended procedures than white or Hispanic...
An analysis of health claims data from 2007–2014 on more than 28,000 patients under the age of 65 found that a large proportion of patients with advanced solid tumors received at least one form of aggressive care within the last 30 days of life. The study was presented by Chen et al at...
A Web-mediated follow-up application (app; Moovcare™) improved advanced lung cancer survival, according to a French multicenter randomized phase III study. Researchers analyzed the association and evolution of self-reported clinical symptoms over time. The median overall survival of patients...
Findings from the European phase II FAST study showed that the novel, first-in-class antibody IMAB362 can significantly extend median survival when added to standard chemotherapy (13.2 vs 8.4 months) for patients with advanced gastric cancer. This therapy targets a protein called claudin-18 splice...
Initial findings from a pivotal phase III trial showed that daratumumab (Darzalex) added to a standard two-drug regimen (bortezomib [Velcade] and dexamethasone) markedly improved outcomes for patients with recurrent or refractory multiple myeloma. The daratumumab combination reduced the risk of...
The anti–programmed cell death ligand 1 (PD-L1) immunotherapy atezolizumab (Tecentriq) is effective in patients with previously untreated advanced bladder cancer who are not eligible for the standard treatment with cisplatin. According to a nonrandomized phase II trial, atezolizumab shrank...
The targeted PARP inhibitor rucaparib, which has demonstrated robust clinical activity in patients with ovarian cancer who have a BRCA mutation, also showed promise in previously treated patients with pancreatic cancer who have the mutation, according to results from a phase II clinical study...
Several clinical trials have demonstrated that maintenance therapy with lenalidomide (Revlimid) after autologous hematopoietic stem cell transplant reduces the risk of disease progression in patients with multiple myeloma, but there have been no definitive results regarding overall...
An innovative project launched in October 2015 may help expedite metastatic breast cancer genomics research and provide leads for development of new treatments. In the 7 months since the launch, more than 2,000 patients have enrolled in the research study designed to collect and...
A large-scale genomic analysis found that patterns of genetic changes detected in blood samples (liquid biopsy) closely mirror those identified in traditional tumor biopsy. With blood samples from more than 15,000 patients and 50 different tumor types, this is one of the largest cancer genomics...
Researchers reported encouraging early results from a phase II trial that matches patients with molecular abnormalities in the tumor to corresponding targeted treatments. Twenty-nine of 129 patients with 12 different types of advanced cancers responded to drugs outside of U.S. Food and Drug...
For a more in-depth look at these data, please click here. Patients with anaplastic glioma without 1p/19q codeletion benefit from adjuvant chemotherapy, according to early results from a European phase III trial. The estimated 5-year survival rates were 56% with radiation therapy and...
A biosimilar trastuzumab antibody (MYL-1401O) is comparable in efficacy and safety to trastuzumab (Herceptin) in women with HER2-positive advanced breast cancer, according to a randomized phase III study. The response rates were comparable among women who received trastuzumab and among...
“Today, the U.S. Food and Drug Administration (FDA) finalized its efforts to streamline the process used by physicians to request expanded access, often called ‘compassionate use,’ to investigational drugs and biologics for their patients. As a physician, I understand the...
The U.S. Food and Drug Administration (FDA) today approved the cobas EGFR Mutation Test v2, a blood-based companion diagnostic for the epidermal growth factor receptor (EGFR) inhibitor erlotinib (Tarceva). This is the first FDA-approved, blood-based genetic test that can detect EGFR gene mutations...
Nearly 20% of women with ovarian cancer do not undergo surgery, despite it being a standard part of treatment recommendations, according to new research from the Perelman School of Medicine at the University of Pennsylvania. The findings, which suggest that women may live four times longer with...
As reported by Hope S. Rugo, MD, of the University of California San Francisco Comprehensive Cancer Center, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on endocrine therapy for hormone receptor–positive metastatic breast cancer. The...
ASCO today published an updated framework for assessing the relative value of cancer therapies that have been compared in clinical trials. The framework, published by Schnipper et al in the Journal of Clinical Oncology, defines value as a combination of clinical benefit, side effects, and...
An analysis of the phase III adjuvant ALTTO trial showed that early rash was associated with better clinical outcome with lapatinib (Tykerb) treatment of HER2-positive breast cancer, as reported by Sonnenblick et al in the Journal of the National Cancer Institute. It had been previously found that...
A new study shows the rate of colorectal cancer continues to increase in individuals under 50 years old, despite the fact that the overall rate of the disease has been declining in recent years. Following examination of more than 1 million colorectal cancer patient records over 10 years,...
On May 25, ASCO issued its first clinical practice guideline on invasive cervical cancer. This resource-stratified guideline is the first of its kind from ASCO, offering treatment recommendations tailored to resource availability. Access to cervical cancer care varies between regions of the...