Alternative versions of biologic agents, ie, “biosimilars,” will presumably be getting the green light by the FDA, giving oncologists more choices for treatments that come at lower costs to patients and society. The FDA plans to issue its guidance on biosimilars by the end of this year, paving the...
With In the Clinic, The ASCO Post 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. Sunitinib Indication—The oral kinase inhibitor...
Several American and European clinical trials have yielded mixed results on the survival advantage of preoperative chemoradiotherapy for patients with locally advanced esophagogastric junction adenonocarcinoma. However, a distinguished panel at the 2011 ASTRO Annual Meeting did agree that surgery...
ASCO has just added a membership category for medical students, spurred on by—you guessed it—a medical student. Daniel G. Stover, MD, knew he wanted to go into oncology from very early on. But when he contacted ASCO to join as an intern, having just graduated from Vanderbilt School of Medicine, he...
Vismodegib is a small-molecule, orally active hedgehog pathway inhibitor that has shown considerable promise in treating basal cell carcinoma and is currently being evaluated alone and in combination in early-phase trials in medulloblastoma and a long list of other cancers.1 Owing to its...
At the 2011 Pan-Pacific Lymphoma Conference in Kauai, Hawaii, Andreas Engert, MD, Chairman of the German Hodgkin Lymphoma Study Group (GHSG) and Professor of Medicine at the University Hospital of Cologne, Germany, discussed the treatment of nodular lymphocyte-predominant Hodgkin lymphoma (NLPHL),...
Prostate cancer is the most prevalent nonskin cancer in men. An estimated 16% of men are diagnosed with prostate cancer, yet only 3% of men die from it.1 Unlike other cancers, prostate cancer is associated with a prolonged lead-time, meaning it can take anywhere from 5 to 12 years to become...
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. Cetuximab (Erbitux) was recently approved by the FDA for use in...
Women with HER2-positive advanced breast cancer are much less likely to have disease progression or die when two agents are used instead of one to target the HER2 signaling pathway, investigators for the international phase III CLEOPATRA trial found. The 808 women studied were randomly assigned to...
Following a priority review process for orphan diseases, ruxolitinb (Jakafi) recently became the first drug to receive FDA approval for the treatment of intermediate- and high-risk myelofibrosis. Discovery in 2004 of the JAK2V617F mutation in a significant proportion of patients with...
Adding an inhibitor of the mammalian target of rapamycin (mTOR) to hormonal therapy for advanced breast cancer effectively circumvents resistance, suggest updated results of the randomized BOLERO-2 trial. With a median follow-up of 12.5 months, the likelihood of disease progression or death among...
The Conquer Cancer Foundation of ASCO Merit Awards will be presented to 20 leading oncology trainees for their important contributions to gastrointestinal cancer research. This year’s recipients will be recognized at the 2012 Gastrointestinal Cancers Symposium, which takes place January 19-21 in...
Elderly Hodgkin lymphoma, typically defined as affecting individuals ≥ 60 years of age, remains a disease for which no standard treatment recommendation exists. This population is underrepresented in clinical studies, and survival rates in older patients with Hodgkin lymphoma are significantly and ...
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. Indications In September 2011, the monoclonal antibody RANKL...
“Many new frontiers exist in integrative medicine,” NIH Director Francis Collins, MD, PhD, stated in his keynote address at the Eighth International Conference of the Society for Integrative Oncology (SIO) in Cleveland. “The evidence is overwhelming that these approaches are being used by many...
When sentinel lymph node biopsy for the regional staging of melanoma was first introduced, it was recommended for any patient with a melanoma 1.0 mm in Breslow thickness or greater. Patients with thin melanomas were not thought to have a sufficiently high risk to warrant the additional cost and...
The Canadian HD.6 randomized study in patients with nonbulky early-stage Hodgkin lymphoma is mostly of historic interest.1,2 It has little relevance to current treatment standards or questions, and the risk for its inappropriate interpretation is of great concern. Radical Radiation Approach Long...
A criticism of the HD.6 trial is that current radiation techniques are probably less toxic than subtotal nodal radiation therapy, which was used in this investigation. Responding to this in an accompanying editorial in The New England Journal of Medicine,1 David J. Straus, MD, of the lymphoma...
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 Abiraterone acetate (Zytiga) (an oral agent that...
Periodic drug shortages are an unavoidable reality in our complicated pharmaceutical supply chain; however, over the past several years, drug shortages have expanded to crisis levels, putting vulnerable patients at risk. In 2010, there were 178 drug shortages reported to the FDA, 132 of which were...
The story of bisphosphonates, and their disease-modifying potential in breast cancer, is still evolving. While some studies presented at the 2011 San Antonio Breast Cancer Symposium failed to show gains, others found benefits. The theme that is emerging is that bisphosphonates may be most...
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...
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...
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,...
Keratoacanthomas and cutaneous squamous cell carcinomas are frequently observed in patients receiving the RAF inhibitor vemurafenib (Zelboraf) for treatment of BRAF-mutated melanoma. As discussed by Lacouture and colleagues in a recent Journal of Clinical Oncology article, these effects appear to...
With the aging of the population, virtually all of the subspecialties of oncology will soon be concerned primarily with the care of older patients. While there is not one precise definition of the age of “geriatric” patients, it is clear that the aging of our society has necessitated a focus on the ...
A re-analysis of the RADIANT-2 trial, which evaluated everolimus (Afinitor) in patients with advanced nonpancreatic neuroendocrine tumors, has yielded prognostic factors that identify a group of patients who are not only at high risk for recurrence but who may derive benefit from treatment with...
Eating more red meat appears to be associated with an increased risk of all-cause mortality and death from cancer and cardiovascular disease, but substituting fish, poultry, nuts, legumes, low-fat dairy products, and whole grains for red meat is associated with a lower mortality risk, according to...
“Analyses after 2 additional years of follow-up consolidated our previous finding that [prostate-specific antigen (PSA)]-based screening significantly reduced mortality from prostate cancer but did not affect all-cause mortality,” investigators from the European Randomized Study of Screening for...
Efficacy and safety of traditional anticoagulants (eg, vitamin K antagonists) are well recognized, given their long-standing use in clinical practice. However, the novel anticoagulants have several potential advantages over the vitamin K antagonists. Even so, in light of their recent introduction...
Throughout the course of medical history, we have witnessed innovations that have initially been met with skepticism but have later revolutionized our management of patients with specific disorders. The recent history of oncology drug development is full of instances where a drug that was...
Results from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial, which found no benefit for completion axillary nodal dissection in patients with breast cancer involving one to two positive sentinel nodes,1 have led to changes in breast cancer management, though points of...
The ASCO provisional clinical opinion on palliative care recently published1 was based largely on data from seven published randomized controlled trials, including a phase III lung cancer trial by Temel and colleagues, which was the trigger for the new recommendations.2 The trial’s principal...
Short-term androgen deprivation therapy does not appear to increase cardiovascular mortality in men with clinically localized prostate cancer, according to a post hoc analysis of a large Radiation Therapy Oncology Group (RTOG)-sponsored clinical trial.1 “Our study analyzes data from a large...
ASCO has released a provisional clinical opinion (PCO) addressing the integration of palliative care services into standard oncology care.1 The ASCO Post recently spoke with one of the PCO’s lead authors, Thomas J. Smith, MD, Director of Palliative Care for Johns Hopkins Medicine and the Johns...
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. In March 2012, the U.S. Preventive...
As introduced in our report on page 1 of this issue, counterfeit pharmaceuticals are an increasingly important safety concern, and three of the most prominent drug-counterfeiting episodes in recent years have involved hematology/oncology products. Counterfeit Erythropoietin Helen B., a 61-year-old...
In 2002, Tim F., a 17-year-old liver transplant patient, received 40,000 units of erythropoietin weekly, beginning immediately after his transplantation procedure.1 His family had purchased the product from the local CVS Pharmacy, upon his discharge from a Manhattan hospital. After each injection,...
A mutational analysis of 18 genes in 398 patients with acute myeloid leukemia (AML) found at least one somatic alteration in 97.3% of the patients and identified genetic predictors of outcome that improved risk stratification among patients with AML, independent of age, white-cell count, induction...
Thromboembolic disease is common in patients with cancer and increases risk of mortality. Recent studies showed that the oral factor Xa inhibitor rivaroxaban (Xarelto) was as effective and safe as standard anticoagulant therapy in treating deep-vein thrombosis, with superior efficacy of rivaroxaban ...
In an editorial accompanying the recently reported UK phase III Bladder Cancer 2001 (BC2001) trial, Shipley and Zietman, from Massachusetts General Hospital and Harvard Medical School, point out that this trial shows that “the addition of a very tolerable regimen of chemotherapy to radiotherapy...
Radiotherapy is an alternative to surgery in muscle-invasive bladder cancer, particularly in less-fit patients. However, it is associated with high rates of incomplete response or recurrence, with salvage surgery often being required. Although synchronous chemoradiotherapy has improved local...
The American Lung Association has released new interim guidelines to assist physicians, patients, and the public in their discussions about lung cancer screening. Developed by the American Lung Association’s Lung Cancer Screening Committee chaired by Jonathan Samet, MD, MS, from the University of...
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 The oral kinase inhibitor vandetanib (Caprelsa) was...
Studies assessing the effect of prostate-specific antigen (PSA) testing on prostate cancer mortality have produced conflicting results, and recommendations regarding PSA screening vary among authorities. The recently published 11-year follow-up of the European Randomized Study of Screening for...
Management of patients with cancer who have fever and a low neutrophil count is one of the most common scenarios oncologists face today. “Physicians have to be keenly aware of the infection risks, diagnostic methods, and microbial therapies required for managing febrile neutropenic patients because ...
It is said that time is perhaps the most treasured asset we have. If you are a practicing oncologist, everyone wants more and more of your time, and I’m not referring to patients. Rather, there is an increasing proliferation of folks who want to make sure we’re doing a good job, and they are...
While failure of remission-induction therapy is rare in children and adolescents with acute lymphoblastic leukemia (ALL), when it does occur it is highly adverse and heterogeneous, according to a study in The New England Journal of Medicine. “Patients who have T-cell leukemia appear to have a...
Two studies in The New England Journal of Medicine found that low-dose radioiodine is as effective as a high-dose strategy in treating patients with thyroid cancer and that recombinant human thyrotropin (thyrotropin alfa [Thyrogen]) and thyroid hormone withdrawal had similar efficacy in preparing...
Three phase III, double-blind, multicenter, randomized studies showed that lenalidomide (Revlimid) maintenance therapy for patients with multiple myeloma significantly improved progression-free survival or time to progression, the primary endpoints of the studies published in The New England...