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Showing 23901 - 23950Ingenol Mebutate Approved for Topical Actinic Keratosis Therapy
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...
FDA Approves Vismodegib for Basal Cell Carcinoma
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...
Axitinib Receives FDA Approval in Advanced Renal Cell Carcinoma
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 ...
Cost of Care: A Multidisciplinary Responsibility
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,...
Drug Shortages Hit Oncology Hard: Experts Weigh in on Challenges and Solutions
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...
Expert Point of View: Maintenance Rituximab vs Retreatment Rituximab in Patients with Low–Tumor-Burden Follicular Lymphoma
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...
Maintenance Rituximab vs Retreatment Rituximab in Patients with Low–Tumor-Burden Follicular Lymphoma
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...
New Immunomodulatory Drug Produces Impressive Phase II Results in Multiple Myeloma
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...
Expert Point of View: Next-generation Proteasome Inhibitors Will Improve Outcomes in Bortezomib-refractory Myeloma Patients
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...
Next-generation Proteasome Inhibitors Will Improve Outcomes in Bortezomib-refractory Myeloma Patients
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...
Expert Point of View: Monoclonal Antibody Promising in Multiple Myeloma
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, ...
A Second Chance for Gemtuzumab in Acute Myeloid Leukemia
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...
Novel Agent Efficacious in Chronic Lymphocytic Leukemia
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,...
Three Novel Agents Show Promise in Acute Lymphoblastic Leukemia
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 ...
Expert Point of View: Ponatinib Continues to Impress in Patients with Leukemia
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...
Ponatinib Continues to Impress in Patients with Leukemia
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...
Expert Point of View: BELA Trial Reborn: Bosutinib Produces Improved Results in Chronic Myeloid Leukemia
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...
BELA Trial Reborn: Bosutinib Produces Improved Results in Chronic Myeloid Leukemia
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...
Expert Point of View: Post-CHOP Radioimmunotherapy Comparable to Rituximab Given along with CHOP in Previously Untreated Follicular Lymphoma
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...
Post-CHOP Radioimmunotherapy Comparable to Rituximab Given along with CHOP in Previously Untreated Follicular Lymphoma
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...
Expert Point of View: Everolimus plus Exemestane Significantly Prolongs Remission in BOLERO-2
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...
Everolimus plus Exemestane Significantly Prolongs Remission in BOLERO-2
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...
Expert Point of View #2: Can Molecular Profiling Identify ER-positive Patients Destined for Relapse?
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 ...
Expert Point of View: Can Molecular Profiling Identify ER-positive Patients Destined for Relapse?
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...
Can Molecular Profiling Identify ER-positive Patients Destined for Relapse?
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...
Expert Point of View: Benefits of Some Bisphosphonates Confirmed in Breast Cancer Outcomes, but Questions Remain
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 ...
Benefits of Some Bisphosphonates Confirmed in Breast Cancer Outcomes, but Questions Remain
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...
Expert Point of View: Bevacizumab Progression-free Survival Benefit Upheld in AVEREL Trial
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 ...
Bevacizumab Progression-free Survival Benefit Upheld in AVEREL Trial
Bevacizumamb (Avastin) added to trastuzumab (Herceptin) and docetaxel as first-line therapy for HER2-positive advanced breast cancer moderately improved progression-free survival in the phase III AVEREL trial, presented at the 2011 San Antonio Breast Cancer Symposium by Luca Gianni, MD, of the San ...
SIDEBAR: Lessons Learned from Other HER2 trials
From studies presented at the San Antonio Breast Cancer Symposium and elsewhere, important observations have emerged that will eventually advance our understanding of HER2-positive disease. According to C. Kent Osborne, MD, of Baylor College of Medicine, Houston, key findings include the following: ...
Expert Point of View: Dual HER2 Blockade Substantially Delays Disease Progression
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,...
Dual HER2 Blockade Substantially Delays Disease Progression
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...
Special Supplement: Reports from the 34th San Antonio Breast Cancer Symposium and the 53rd American Society of Hematology Annual Meeting
The ASCO Post presents this special supplement with comprehensive coverage of important data from the 34th Annual San Antonio Breast Cancer Symposium and the 53rd American Society of Hematology Annual Meeting. In addition to news about the individual abstracts, experts offer their perspectives on...
Pertuzumab Gets Priority Review for Metastatic Breast Cancer
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 ...
FDA Issues Draft Guidance on Biosimilar Product Development
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...
2012 Oncology Meetings
MARCH ACR 5th Annual PET/CT SymposiumMarch 1-4 • Stowe, Vermont For more information: www.acr.org 3rd Asian Breast Cancer CongressMarch 3-4 • Bangalore, India For more information: http://abcconline.net TAT 2012 (International Congress on Targeted AntiCancer Therapies)March 8-10 • Amsterdam, The...
Facing the Future without Fear of Breast Cancer Recurrence
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...
Nearly Identical Survival for Laparoscopy vs Laparatomy in Patients with Stage I/IIA Disease
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...
Addition of Bevacizumab to Neoadjuvant Chemotherapy Increases Pathologic Complete Response Rate in HER2-negative Disease
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...
Six1-Eya2 Interaction a Potential Target in Blocking Breast Cancer Metastasis
The Six1 gene is a key regulator of embryonic development that requires interaction with the Eya family of proteins (Eya1-4) to activate transcription of genes involved in neurogenesis, myogenesis, and nephrogenesis. Overexpression of Six1 and Eya is observed in a number of cancers. In breast...
Significant Differences in Genetic Characteristics of Primary Colorectal Cancer and Hepatic Metastases
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...
PI3K Inhibitors May Improve Response to Cancer Immunotherapy
The induction of antitumor immunity by vaccines or immunotherapies is inhibited by the immunosuppressive microenvironment of tumors. Toll-like receptor (TLR) agonists have the potential to increase inflammatory antitumor effects in the microenvironment, but these ligands can exert a mixture of both ...
A Patient with Cancer Saw a Need and Left a Living Legacy
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...
SIDEBAR: Expect Questions from Your Patients
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...
Reexcision Rates Following Breast-conservation Surgery Vary Widely
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 May Offer Advantages in Patients with Relapsed/Refractory Multiple Myeloma
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...
Similar Morbidity, Higher Costs for Robotic vs Laparoscopic Hysterectomy in Women with Endometrial Cancer
A population-based analysis comparing laparoscopic hysterectomy and robotic hysterectomy for endometrial cancer “found similar morbidity but increased cost compared with laparoscopic hysterectomy,” investigators reported in the Journal of Clinical Oncology.1 After adjusting for patient, surgeon,...
Which Is Better: Peripheral Blood or Bone Marrow as Unrelated Donor Stem Cell Source?
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...
Expert Point of View: Long-term Survival Benefit and Safety Confirmed for VMP Regimen in Multiple Myeloma in Patients Who Were Not Transplant Candidates
Commenting on the 5-year follow-up data of VISTA presented at the 2011 ASH meeting, Kenneth C. Anderson, MD, said, “This is the longest follow-up of protocols incorporating novel therapies into initial therapy of nontransplant candidates in myeloma. Remarkably, bortezomib with melphalan and...
Long-term Survival Benefit and Safety Confirmed for VMP Regimen in Multiple Myeloma in Patients Who Were Not Transplant Candidates
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...
