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...
Laparoscopic resection of primary and metastatic liver cancers can be safe and oncologically efficient and reduce postoperative length of stay, a single-center study from the United Kingdom found.1 The investigators cautioned, however, that “adequate patient selection and extensive experience in...
Targeted therapies have markedly improved outcomes in patients with advanced renal cell carcinoma, with median overall survival of greater than 2 years having been observed with sunitinib (Sutent) treatment. Objective responses, consisting mostly of partial responses, are observed in approximately...
Patients with a previously diagnosed cancer have an increased risk of developing cutaneous melanoma, with the highest risk among patients who have had a prior diagnosis of melanoma, according to a report published in the Archives of Dermatology.1 Key Findings Using Surveillance, Epidemiology, and...
The 2012 Genitourinary Cancers Symposium takes place February 2–4 in San Francisco. Direct your patients to www.cancer.net/GUsymposium to find written summaries for patients and a podcast that highlights the research presented at the meeting, on prostate, bladder, kidney, testicular, and other...
If your work touches those who have cancer, you have a place within ASCO. That’s the message that the organization, during its 48 years, has gotten across in many ways, not the least of which is its membership categories, which have expanded right along with the field of cancer care. “ASCO is...
By working to improve oncology care in practices in Michigan through integration of ASCO’s Quality Oncology Practice Initiative (QOPI) into its Physician Group Incentive Program, Blue Cross Blue Shield of Michigan (BCBSM) has been selected as a 2011 “Best of Blue Clinical Distinction Award” winner...
Less than 2 years since launching the first national program to help oncology practices deliver the highest quality of cancer care, ASCO and its affiliate, the Quality Oncology Practice Initiative (QOPI®) Certification Program, announced that more than 100 practices have achieved QOPI...
A small phase I/II clinical study from Johns Hopkins University in Baltimore found that epigenetic therapy with a combination of azacitidine (Vidaza) and entinostat (an investigational agent) produced responses in some patients with refractory advanced non–small cell lung cancer. The study results, ...
Although lung cancer is the leading cause of cancer death in the United States for both men and women—nearly 157,000 deaths from lung cancer occurred in 2011, according to the American Cancer Society—survey results from the Lung Cancer Research Foundation (LCRF) show that 60% of Americans are...
When intermittent chest pains sent me to the emergency room nearly a decade ago, I worried that I was having some kind of cardiac event. The ER doctor wanted to make sure that I didn’t have a pulmonary embolism, so in addition to ordering a complete cardiac workup, she also ordered a chest x-ray to ...
Local treatment of breast cancer is trending toward less invasive procedures that achieve comparable outcomes to standard interventions. What will the next step along this continuum be? According to Michael S. Sabel, MD, a surgical oncologist at the University of Michigan Comprehensive Cancer...
Previous studies of gemtuzumab ozogamicin (Mylotarg) had variable results in acute myeloid leukemia (AML). Before trials reported at the 2011 ASH Annual Meeting, two major studies had compared chemotherapy with or without gemtuzumab in patients with AML, said Martin Tallman, MD, Chief of the...
A study presented at the Plenary Session of the 53rd Annual Meeting of the American Society of Hematology (ASH) breathes new life into an older drug for acute myeloid leukemia (AML) that is no longer available in the United States.1 Gemtuzumab ozogamicin (Mylotarg) appears to be a promising...
The new anti-CD20 monocolonal antibody obinutuzumab is being studied in the treatment of patients with relapsed CD20-positive indolent B-cell non-Hodgkin lymphoma. GAUSS is the first clinical trial to compare obinutuzumab head-to-head against rituximab (Rituxan) induction therapy. “In this first...
Partial breast brachytherapy is less effective and more toxic than whole-breast irradiation when used after lumpectomy, suggests an analysis of Medicare claims data. In the 2000–2007 study of more than 130,000 older women with breast cancer—the largest of its kind to date—the rate of mastectomy in...
In findings likely to intensify the debate about the role of bevacizumab (Avastin) in advanced breast cancer, the AVEREL trial concludes that adding this antiangiogenic antibody to standard therapy prolongs progression-free survival by about 3 months in women with HER2-positive locally recurrent...
The FDA has approved a supplemental new drug application for bortezomib (Velcade), updating the label to include the subcutaneous administration in all indications approved for intravenous administration, ie, multiple myeloma and mantle cell lymphoma after at least one prior therapy. The approval...
The FDA recently completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biologic products to patients, according to FDA Commissioner Margaret A. Hamburg, MD. The programs include the fifth authorization of...
The FDA has approved a new transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy (REMS) access program. The REMS is a single shared system for all transmucosal immediate-release fentanyl products. Among the goals of the REMS access program are to mitigate the risk of...
The FDA has approved intravenous glucarpidase (Voraxaze) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. Glucarpidase is an enzyme that rapidly reduces methotrexate levels by breaking down the chemotherapy drug to a form that can be eliminated from the...
The FDA has approved ingenol mebutate (Picato) gel for the topical treatment of actinic keratosis. At a concentration of 0.015%, the gel is used once daily on the face and scalp for 3 consecutive days, whereas a 0.05% dosage form is used once daily on the trunk and extremities for 2 consecutive...
The FDA has approved vismodegib (Erivedge) to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients with metastatic...
The FDA has approved the kinase inhibitor axitinib (Inlyta) for the treatment of advanced renal cell carcinoma after failure of one prior systemic therapy. The approval is based on an international, randomized, open-label trial that enrolled 723 patients: 361 were assigned to receive axitinib at 5 ...
I read the interview with Dr. Ezekiel Emanuel (The ASCO Post, December 15, 2011) with much interest, as the health-care policy problems that America is currently experiencing have plagued other countries for some time. Despite proactive measures and attempts to amend those situations elsewhere,...
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 findings of RESORT1 have tremendous implications, both clinically and economically, commented Andrew D. Zelenetz, MD, Chief of the Lymphoma Service at Memorial Sloan-Kettering Cancer Center, New York, in an interview. “The maintenance arm received rituximab [Rituxan] every 3 months...
For patients with low–tumor-burden follicular lymphoma treated upfront with rituximab (Rituxan), retreating upon disease progression was as effective as extended dosing, or maintenance therapy, in a randomized phase III study that compared the approaches.1 Given the excellent outcomes, lack of a...
Data on pomalidomide, the novel oral immunomodulatory drug for multiple myeloma, was a major highlight of the 2011 ASH Annual Meeting, according to Kenneth D. Anderson, MD, of Dana-Farber Cancer Institute, Boston, who called the drug “very, very exciting.” Paul Richardson, MD, also of Dana-Farber...
Myeloma experts agree that the new proteosome inhibitors are particularly welcome because they are at least as effective as bortezomib (Velcade) but produce much less neuropathy. Dramatic Results “The activity of MLN 9708 is very encouraging,” said Paul G. Richardson, MD, of Dana-Farber Cancer...
The next-generation proteasome inhibitor carfilzomib is expected to gain FDA approval in the near future, offering a treatment option that may be as effective as and less neurotoxic than bortezomib (Velcade). Studies presented at the ASH Annual Meeting upheld benefits of the drug observed in...
With a wealth of new agents of various classes in the pipeline, “myeloma is going to become a chronic illness, with sustained complete responses achieved in a significant fraction of patients,” according to Kenneth C. Anderson, MD, of Dana-Farber Cancer Institute and Harvard Medical School, ...
Elotuzumab, a humanized IgG1 monoclonal antibody targeting human CS1, a cell-surface glycoprotein expressed on 95% of myeloma cells, elicited responses in 82% of relapsed/refractory myeloma patients in a phase II study reported at the ASH Annual Meeting.1 Objective response rates exceeded 90% in...
Gemtuzumab ozogamicin (Mylotarg) may have a second chance for regulatory acceptance, as studies presented at ASH 2011 demonstrated that gemtuzumab can be safely and effectively given by adjusting the dosing and treatment schedule. Gemtuzumab ozogamicin was approved for the treatment of acute...
A novel inhibitor of B-cell receptor signaling produced high rates of remission and was well tolerated in patients with chronic lymphocytic leukemia (CLL) who were refractory to at least two previous treatments, reported Susan O’Brien, MD, of The University of Texas MD Anderson Cancer Center,...
Susan O’Brien, MD, Professor in the Department of Leukemia at The University of Texas MD Anderson Cancer Center, Houston, has a special interest in novel developments in the treatment of acute lymphoblastic leukemia (ALL). At the 2011 ASH Annual Meeting, she discussed her picks of top newsmakers in ...
At the 2011 ASH Annual Meeting, Pierre Laneuville, MD, Director of Hematology at McGill University in Montreal, predicted that ponatinib may be “the drug that will replace them all” in the treatment of chronic myeloid leukemia. Dr. Laneuville explained his rationale, recalling that in the pivotal...
Initial results from the PACE (Ponatinib Ph+ ALL and CML Evaluation) trial added to accumulating evidence that the tyrosine kinase inhibitor ponatinib should soon be considered for front-line treatment of chronic myeloid leukemia (CML). “Robust responses were observed in all patient cohorts,” said...
Given the results of the BELA trial, with the problems of treatment side-effect management realized and seemingly resolved, Elias Jabbour, MD, Assistant Professor of Medicine at The University of Texas MD Anderson Cancer Center, Houston, assumes bosutinib will be approved in chronic myeloid...
The initial reports of the BELA trial (Bosutinib Efficacy and safety in chronic myeloid LeukemiA), presented at ASH 2010, were deflating. At 12-month follow-up, bosutinib failed to meet BELA’s primary endpoint. Things have since turned around, however, and results from the 24-month analysis...
SWOG S0016, which compared treatment with CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, plus rituximab [Rituxan]) and CHOP-RIT (CHOP plus tositumomab/iodine-131 tositumomab [Bexxar]) in patients with follicular lymphoma, was one of the most important studies at the 2011 ASH...
In patients with previously untreated follicular lymphoma, similar outcomes were achieved with CHOP-R (cyclophosphamide, doxorubicin, vincristine, prednisone, plus six doses of rituximab [Rituxan]) and CHOP-RIT (CHOP plus one dose of tositumomab/iodine-131 tositumomab [Bexxar]) in a phase III...
Signaling of mammalian target of rapamycin (mTOR) is required for estrogen-induced breast tumor cell proliferation, and hyperactivation of the mTOR pathway is observed in endocrine-resistant breast cancer cells. Clinically, this makes for a rational one-two punch in endocrine-resistant breast...
Adding an inhibitor of mammalian target of rapamycin (mTOR) to an aromatase inhibitor more than doubled the time to disease progression in patients with advanced, treatment-refractory breast cancer in the phase III BOLERO-2 trial, whose updated results were presented at the San Antonio Breast...
Understanding the different relapse patterns within estrogen receptor (ER)-positive breast cancer is important for guiding treatment decisions, said Laura Esserman, MD, of the University of California, San Francisco, Medical Center. Women who fall into the two separate categories may have different ...
Eastern Cooperative Oncology Group (ECOG) trials have demonstrated that recurrence patterns are different for estrogen receptor (ER)-positive vs ER-negative breast cancer. While ER-negative disease carries a high risk for early recurrence—peaking around year 1.5 from diagnosis—risk steadily...
Estrogen receptor (ER)-positive breast cancer often recurs years after the initial diagnosis, and understanding the patterns of timing regarding relapse could identify patients needing more aggressive treatment. At the 2011 San Antonio Breast Cancer Symposium, several investigative teams reported...
James Ingle, MD, of the Mayo Clinic, Rochester, Minnesota, formally discussed the ABCSG-12 and ZO-FAST bisphosphonate studies presented at the 2011 San Antonio Breast Cancer Symposium, noting, “There is a lot of interest in the effect of bisphosphonates on the tumor microenvironment and the impact ...
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...
Modest benefit reported from AVEREL1 triggered comments among trialists about the future of bevacizumab (Avastin) in breast cancer. “Although there’s controversy about the recent revoking of FDA approval of bevacizumab for metastatic breast cancer, I think there is a consensus in our disappointment ...