Leading up to FDA’s resolution to revoke the breast cancer indication for bevacizumab (Avastin), the debate over the drug’s clinical value was imbued with contentious ideologic overtones, which culminated in a 2-day public hearing that exposed deep divisions not only in the scientific community,...
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...
A phase III trial among patients with locally advanced or metastatic medullary thyroid cancer met its primary objective of progression-free survival prolongation among patients receiving vandetanib compared to placebo. The secondary efficacy endpoints of objective response rate, disease control...
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. “Depression is a very dangerous...
Personalized medicine: It’s a phrase that reverberates across all cancer meetings. “Matching the right drug to the right patient” will be accomplished, in the not too distant future, through genomic sequencing of the tumor and targeted, less toxic therapy. This much has been established—or has it?...
The World Health Organization system organizes myeloid malignancies into five major categories, which are subsequently further subclassified using a combination of bone marrow morphology and cytogenetic/molecular information (Table 1).1 JAK2 and MPL mutations are not disease-specific and occur...
Accelerated partial breast irradiation using brachytherapy (APBIb) as an alternative to whole-breast irradiation (WBI) after breast-conserving surgery has been rapidly adopted in the United States, but the majority of patients receiving APBIb may not be considered suitable for it. A retrospective...
Mortality rates for breast cancer have declined steadily in the United States since 1990, resulting in an improvement in survival. Multiple factors have contributed to this positive trend, one of which is the combination of earlier detection and more sophisticated surgical techniques. The ASCO Post ...
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...
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...
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 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...
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...
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, ...
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 ...
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...
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...
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 ...
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 ...
The availability of effective therapies for HER2-positive tumors has made breast cancer a better managed disease, but outcomes could be further enhanced through the targeting of other players in this pathway, emerging data suggest. C. Kent Osborne, MD, of Baylor College of Medicine, Houston,...
There is an emerging theme in HER2-positive breast cancer: The greater the pathway inhibition, the better the outcome. The latest evidence comes from the phase III Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) trial of 808 patients with previously untreated metastatic disease. The...
The FDA has accepted Roche’s Biologics License Application for pertuzumab (Omnitarg) and granted Priority Review. The proposed indication is pertuzumab in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable ...
The FDA recently issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States. “When it comes to getting new biosimilar products on the market, FDA has taken an innovative approach to supporting their development at...
A year ago, I was living my dream. Married to a wonderful man, Danny, and with two young children to raise, Karl, 7, and Marcus, 4, I had given up a career in accounting to be a stay-at-home mom. At age 34, I was enjoying life, helping my children with their homework and going to their soccer and...
Building on previously reported results that laparoscopic surgical management of uterine cancer is superior for short-term safety and length-of-stay endpoints, the Gynecologic Oncology Group reported small and lower than anticipated potential for increase risk of cancer recurrence with laparoscopy...
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...
Glioblastoma remains a uniformly lethal disease. Both the alkylating agent temozolomide and oncolytic viruses (engineered to preferentially infect and kill cancer cells) hold promise in treatment of glioblastoma. The effects of combining the two and the mechanisms of their interaction on cancer...
Vermaat and colleagues from the University Medical Center Utrecht, Hubrecht Institute, Utrecht, The Netherlands, and Hoffman-La-Roche Inc./Genentech, Nutley, New Jersey, recently showed that there was significant genetic variation between individual primary colorectal cancer tumors and their...
It is well documented that the rigors of delivering cancer care can unintentionally supersede valuable doctor-patient communication. Before he died in 1995, Kenneth B. Schwartz, a patient with cancer at Massachusetts General Hospital, recognized this phenomenon and founded the Kenneth B. Schwartz...
The possibility of reexcision after breast-conservation surgery should be discussed with patients before the initial surgery, advised Laurence E. McCahill, MD, lead investigator of the JAMA study on reexcision following breast-conservation surgery, which showed wide variability in reexcision...
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. Reexcision rates for women with...
Carfilzomib is an oral second-generation proteasome inhibitor with a mechanism of action that may increase efficacy and reduce adverse effects currently associated with proteasome inhibitor therapy. It is being investigated for use in multiple myeloma and select solid tumors, and the FDA has...
Over the past decade, the use of peripheral blood stem cells has increased, and now about 75% of unrelated living donor transplants are performed using peripheral blood stem cells without supportive data in the unrelated donor setting. This trend is called into question by results of a large phase...
Five-year analysis of the VISTA trial confirms a survival advantage with VMP (bortezomib [Velcade], melphalan, and prednisone) for upfront treatment of multiple myeloma in patients who were not transplant candidates. At a median follow-up of 60.1 months, a 13-month improvement in overall survival...
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 Peginterferon alfa-2b (PegIntron, Sylatron) was recently ...