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breast cancer

Study Questions Use of Partial Breast Brachytherapy in Older Women

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...

breast cancer

AVEREL Trial Shows Benefit of Bevacizumab in HER2-positive Locally Recurrent or Metastatic Breast Cancer

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...

hematologic malignancies

Subcutaneous Bortezomib Approved

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...

health-care policy

FDA Completes Work on Three Drug User Fee Programs

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...

pain management

Shared REMS Approved for all Transmucosal Immediate-release Fentanyl Products

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...

skin cancer

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...

kidney cancer

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

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,...

issues in oncology
health-care policy

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...

lymphoma

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...

multiple myeloma

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...

multiple myeloma

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...

multiple myeloma

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, ...

multiple myeloma

Monoclonal Antibody Promising in Multiple Myeloma

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...

leukemia

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...

leukemia

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,...

leukemia

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 ...

leukemia

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...

leukemia

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...

lymphoma

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...

lymphoma

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...

breast cancer

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...

breast cancer

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...

breast cancer

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 ...

breast cancer

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...

breast cancer

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...

breast cancer

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 ...

breast cancer

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...

breast cancer

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 ...

breast cancer

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,...

breast cancer

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...

breast cancer

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...

gynecologic cancers

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...

breast cancer

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...

cns cancers

Combination of Oncolytic Virus and Chemotherapy Holds Promise in Glioblastoma

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...

colorectal cancer

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...

solid tumors

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 ...

issues in oncology

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...

breast cancer

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...

multiple myeloma

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...

gynecologic cancers

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,...

Expert Point of View: Peripheral Blood or Bone Marrow as Unrelated Donor Stem Cell Source

This large randomized, controlled trial took a lot of time and extensive resources, and yet survival was the same between the two types of unrelated donor transplant sources, noted Stephanie J. Lee, MD, Professor of Medicine at Washington University and the Fred Hutchinson Cancer Center in Seattle. ...

issues in oncology

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...

multiple myeloma

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...

skin cancer

What You Should Know about Peginterferon Alfa-2b for Adjuvant Treatment of Melanoma

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 ...

head and neck cancer

Challenges, Progress, and Future Directions in Head and Neck Cancer

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...

lung cancer

Adding Thalidomide to Chemoradiation Increases Toxicities but Not Survival for Stage III Non–Small Cell Lung Cancer

Adding thalidomide (Thalomid) to the third-generation chemotherapy doublet of paclitaxel and carboplatin and radiation for patients with stage III non–small cell lung cancer (NSCLC) increased toxicities but did not improve survival. These results from the Eastern Cooperative Oncology Group (ECOG)...

issues in oncology

Starting Down the Path toward Electronic QOPI®: ASCO and US Oncology Collaborate in Quality Measurement

The Quality Oncology Practice Initiative (QOPI®), ASCO’s quality measurement program, is entering its 6th successful year and continuing to grow, both in number of participants and in quality measures evaluated. In the truest spirit of quality improvement, ASCO’s oncologist leaders have determined...

SIDEBAR: Career Development Award

The Career Development Award (CDA) is a 3-year grant totaling $200,000 to provide funding to clinical investigators who have received their initial faculty appointment, to establish an independent clinical cancer research program. This research must have a patient-oriented focus, including a...

Career Development Award Recipient Susan K. Parsons, MD, Supports Next Generation of Researchers

Like all pediatric oncologists, Susan K. Parsons, MD, MRP, knows that when a child is diagnosed with cancer, it happens to the whole family. Siblings must cope with everything from disruption of routine to reduced parental attention, to the often-new possibility of mortality. Parents must navigate...

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