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Rare-Cancer Expert Richard Carvajal, MD, Appointed Director of Experimental Therapeutics

Richard D. Carvajal, MD, has been named Director of the Experimental Therapeutics/Phase I program and melanoma service in medical oncology at New York-Presbyterian/Columbia University Medical Center effective November 1, 2014. Dr. Carvajal, a medical oncologist, has extensive clinical expertise in...

skin cancer

Anti–PD-1 Antibody Nivolumab in Previously Treated Unresectable or Metastatic 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.   On December 22, 2014, the anti–PD-1 (programmed cell death...

solid tumors
hematologic malignancies

FDA Drug Approvals 2014

Nivolumab (Opdivo), a monoclonal antibody, was approved for treatment of metastatic melanoma.  Approved December 22, 2014. Olaparib (Lynparza), a poly (ADP-ribose) polymerase (PARP) inhibitor, was approved for treatment of BRCA-mutated advanced ovarian cancer. Approved December 19, 2014....

Oncologists, Pathologists Partner to Improve Practice and Optimize Patient Care

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) have announced a new partnership to optimize patient care and foster excellence in the practices of pathology and oncology through interprofessional education, advocacy, quality improvement,...

FDA’s Janet Woodcock, MD, Receives Lifetime Achievement Award From the Institute for Safe Medication Practices

Janet Woodcock, MD, Director of the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, has been awarded the Institute for Safe Medication Practices Lifetime Achievement Award, which recognizes “an individual who has had a significant career history of making...

skin cancer

Treatment Paradigm in Advanced Melanoma Poised for Change… Again

In the treatment of advanced/metastatic melanoma, recent debate has focused on the choice of initial therapy: ipilimumab (Yervoy) or, for patients with BRAF-mutant cancer, a BRAF/MEK inhibitor. This issue is now taking a back seat to the emerging conversation about the positioning of antibodies...

issues in oncology
health-care policy

ASCO and AACR Call for Regulation of E-Cigarettes and Other Electronic Nicotine Delivery Systems

The American Association for Cancer Research (AACR) and ASCO have outlined steps in a joint statement to guide policymakers as they work to minimize the potential negative consequences of electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems without undermining their...

colorectal cancer

Colorectal Cancer 2015

Despite advances in detection and treatment, colorectal cancer remains the third deadliest cancer among men and women in the United States. To get a better understanding of the current state of this disease and what lies ahead, The ASCO Post recently spoke with colorectal cancer expert John L....

FDA’s Draft Guidance for Laboratory-Developed Tests

The FDA’s proposed regulatory framework is based on a test’s level of risk to the patient. Premarket approvals would be required of the tests in the highest-risk category within a year of the final guidance; that would include tests for which there is already an FDA-approved equivalent. For...

health-care policy

Molecular Pathologists vs the FDA: Proposed Regulation of Laboratory-Developed Tests Sparks Debate

The packed ballroom looked like a plenary session at any big medical research meeting. But on the dais were representatives of the Food and Drug Administration (FDA), the subject was the Agency’s proposed regulation of laboratory-developed tests, and the attendees who lined up to ask questions for...

lung cancer
issues in oncology

Overdiagnosis May Be Overblown in Lung Cancer Screening

“Overdiagnosis has been overblown” in concerns voiced about lung cancer screening with low-dose computed tomography, ­Andrea B. McKee, MD, told participants at the opening session of the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. Dr. McKee is Chair of the Department of Radiation ...

lung cancer

Top 10 Lessons Learned So Far About Treating Lung Cancer With Immunotherapy

Immunotherapy agents “really work” in treating lung cancer, but they have unique toxicities, are challenging to combine with other therapies, and questions remain about dose and duration, Roy S. Herbst, MD, PhD, stated at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology. “There are ...

issues in oncology

More Than 1.5 Million Cancer Deaths Averted During 2 Decades of Dropping Mortality

The American Cancer Society’s annual cancer statistics report found that a 22% drop in cancer mortality over 2 ­decades led to the avoidance of more than 1.5 million cancer deaths that would have occurred if peak rates had persisted. And while cancer death rates have declined in every state, the...

lung cancer

‘Clinically Meaningful Improvements’ in Survival for Patients With NSCLC When Veliparib Is Added to Carboplatin and Paclitaxel

Adding veliparib to carboplatin and paclitaxel resulted in “clinically meaningful improvements” in progression-free survival and overall survival among patients with previously untreated metastatic or advanced non–small cell lung cancer (NSCLC), particularly those with squamous histology. The...

lung cancer

Significant Improvement in Progression-Free Survival Using Sunitinib as Switch Maintenance in Advanced NSCLC

Progression-free survival was significantly improved among patients with advanced non–small cell lung cancer (NSCLC) receiving sunitinib (Sutent) as switch maintenance compared to placebo, according to results of an Alliance phase III trial (Cancer and Leukemia Group B [CALGB] 3067). The effect of...

breast cancer

Contralateral Prophylactic Mastectomy: Know the Data When Discussing the Option With Patients

Oncologists need a better understanding of why women choose contralateral prophylactic mastectomies without indication, and they need data to counter their patients’ misperceptions about this treatment choice. “Many women who choose [contralateral prophylactic mastectomy] are not at increased risk...

colorectal cancer

Vitamin D Protects Against Colorectal Cancer by Boosting the Immune System

A study by investigators at Dana-Farber Cancer Institute has demonstrated that vitamin D can protect some people with colorectal cancer by heightening the immune system’s vigilance against tumor cells. The research, released earlier this month by the journal Gut, shows a link between vitamin D and...

breast cancer

Fulvestrant Surpasses Anastrozole in First-Line Treatment of Metastatic Breast Cancer

Fulvestrant (Faslodex) at a 500-mg dose was superior to anastrozole as first-line therapy for advanced hormone receptor–positive breast cancer in the phase II FIRST study.1 Overall survival and time to disease progression were significantly better with fulvestrant than with the current standard of...

Expert Point of View: Erin Hofstatter, MD

These data do not change what we already know: Chemoprevention is slam-dunk, hands-down effective in preventing breast cancer. The effects of 5 years of chemoprevention persist for 20 years. This is great because it [could potentially] reduce the numbers of women we need to treat,” said Erin...

breast cancer

Tamoxifen Prevention of Breast Cancer Extends More Than 16 Years

The benefits of tamoxifen as primary prevention of breast cancer are well established. The good news is that the benefits live on, with a protective effect that extends up to 22 years. At a median follow-up of 16 years, women treated with 5 years of tamoxifen enjoyed a 29% reduction in the risk of...

gynecologic cancers

FDA Approves Olaparib to Treat BRCA-Mutated Advanced Ovarian Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to olaparib (Lynparza) for women with advanced ovarian cancer with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, as detected by an FDA-approved test, who have been treated with three...

lung cancer

FDA Approves Ramucirumab Combination for Non–Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) has approved ramucirumab (Cyramza) for use in combination with docetaxel for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK mutations ...

skin cancer

FDA Approves Nivolumab for Advanced Melanoma

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to nivolumab (Opdivo) for patients with unresectable or metastatic melanoma who no longer respond to other drugs. Nivolumab, a programmed cell death protein 1 (PD-1) inhibitor, is intended for patients who have been...

breast cancer

BOLERO-1: Everolimus Plus Trastuzumab/Paclitaxel Misses the Mark in First‑Line HER2-Positive Advanced Breast Cancer

The addition of everolimus (Afinitor) to weekly trastuzumab (Herceptin) plus paclitaxel in the first-line metastatic breast cancer setting did not improve outcomes in the phase III BOLERO-1/TRIO-019 but did provide a “signal” in the hormone receptor–negative subset. The study was reported at the...

Expert Point of View: Mary L. Disis, MD

Study discussant Mary L. Disis, MD, Professor of Medicine and Associate Dean of Translational Science at the University of Washington, Seattle, commented that the response rate, approaching 20%, is “in the ballpark” of those observed in melanoma, lung cancer, and renal cancer. She pointed out that...

breast cancer

Pembrolizumab Holds Promise in Breast Cancer, Early Studies Suggest

Single-agent treatment with the immunotherapy drug pembrolizumab produced a “signal of activity” and led to some durable responses in patients with metastatic triple-negative breast cancer, Rita Nanda, MD, of the University of Chicago, reported at the 2014 San Antonio Breast Cancer Symposium.1...

breast cancer

Neoadjuvant Therapy in Triple-Negative Breast Cancer: Impact of Subtype

Among women with triple-negative breast cancer, overall, basal-like and non–basal-like tumors were equally likely to demonstrate a pathologic complete response to neoadjuvant chemotherapy, but they responded differently to the addition of carboplatin and bevacizumab (Avastin) to a standard...

Expert Point of View: David Steensma, MD

Patients with Philadelphia chromosome–positive ALL have traditionally done poorly with conventional chemotherapy, but outcomes are improving in the era of tyrosine kinase inhibitors. This study reports the safety and efficacy with a combination of a targeted approach and low-intensity...

leukemia

Nilotinib With Low-Intensity Chemotherapy Useful in Elderly Patients With Philadelphia Chromosome–Positive ALL

The addition of the tyrosine kinase inhibitor nilotinib (Tasigna) to standard low-intensity chemotherapy improved outcomes in elderly patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) and may represent a new approach to this group of patients, who are ...

Expert Point of View: Brad S. Kahl, MD

AETHERA is the first study to show a significant effect of a post-transplant strategy in patients at high risk of relapse after transplant,” said Brad S. Kahl, MD, Associate Professor at the University of Wisconsin School of Medicine and Public Health, Madison. “The question remains whether...

lymphoma

Post-Transplant Brentuximab Vedotin Improved Progression-Free Survival in Hodgkin Lymphoma Patients

In patients with Hodgkin lymphoma who are at risk for disease progression following autologous stem cell transplantation, early consolidation with brentuximab vedotin (Adcetris) post-transplant significantly improved progression-free survival compared with placebo in the phase III AETHERA trial.1...

Expert Point of View: Fredrick Hagemeister, MD

As session moderator, Fredrick Hagemeister, MD, Professor of Medicine, University of Texas MD Anderson Cancer Center, Houston, commented during the discussion of Dr. Connors’ study. He first emphasized the need to establish the safety of new drugs in clinical trials before incorporating them...

lymphoma

Brentuximab Vedotin Added to Standard Therapy for Advanced-Stage Hodgkin Lymphoma May Improve Results

Several studies presented at the 2014 ASH Annual Meeting supported the use of brentuximab vedotin (Adcetris) in Hodgkin lymphoma. The Reed-Sternberg cells of classical Hodgkin lymphoma typically express CD30, which is targeted by brentuximab vedotin, an anti-CD30 monoclonal antibody conjugated by a ...

breast cancer

Ovarian Suppression Plus Hormonal Therapy May Be Practice-Changing in Premenopausal Hormone Receptor–Positive Early-Stage Breast Cancer

Results of the large International Breast Cancer Study Group (IBCSG)-coordinated SOFT trial present a convincing argument for the addition of ovarian function suppression to adjuvant hormonal therapy to reduce the risk of tumor recurrence in younger women with hormone receptor–positive early-stage...

issues in oncology

What Is a Physician? Call a Spade a Spade

Anyone who has awoken from a decades-long amnestic spell can be forgiven for thinking that physicians cannot do anything right nowadays. Compared with decades ago, when physicians did mostly right, we now seem to be nowhere close to correctness. Nearly every malady that befalls the health-care...

Expert Point of View: David H. Vesole, MD, PhD, FACP

David H. Vesole, MD, PhD, FACP, Co-Division Chief and Director of Research for the Multiple Myeloma Division at the John Theurer Cancer Center at Hackensack University Medical Center in New Jersey, commented after the presentation of the ASPIRE trial data that the findings were “impressive.” “It’s ...

multiple myeloma

Carfilzomib-Based Triplet Yields ‘Unprecedented’ Duration of Remission in Relapsed Myeloma

The phase III global ASPIRE trial documented an “unprecedented” duration of remission in relapsed multiple myeloma patients receiving carfilzomib (Kyprolis) plus a standard-of-care doublet, according to Keith Stewart, MB, ChB, Professor of Medicine at the Mayo Clinic in Scottsdale, Arizona, who...

supportive care
sarcoma

Growing Support Group for Epithelioid Hemangioendothelioma Spins the ‘Wheel of Hope’

Two years ago, my son was diagnosed with the rare vascular sarcoma epithelioid hemangioendothelioma, on which there is incredibly little reseach and knowledge (see here for more on this rare cancer). PubMed revealed a “characteristic” description: unpredictable behavior, no correlation with...

sarcoma

Unraveling the Mysteries of Epithelioid Hemangioendothelioma

Epithelioid hemangioendothelioma is a rare and devastating vascular sarcoma that affects between 100 and 200 people, mostly young adults, each year in the United States. The cancer may arise as a solitary lesion but more commonly presents with metastatic involvement, usually in the liver and lungs. ...

gastroesophageal cancer

High Genetic Propensity to Obesity Raises Risk of Esophageal Adenocarcinoma

“People with a high genetic propensity to obesity have higher risks of esophageal metaplasia and neoplasia than people with a low genetic propensity,” according to analyses of data from the Barrett’s and Esophageal Adenocarcinoma Genetic Susceptibility Study. “These analyses provide the strongest...

skin cancer

Adding Sargramostim to Ipilimumab Improved Overall Survival Among Patients With Unresectable Stage III or IV Melanoma

Patients with unresectable stage III or IV melanoma treated with ipilimumab (Yervoy) plus sargramostim (Leukine) had longer overall survival and less toxicity than did those treated with ipilimumab alone, according to a phase II randomized clinical trial conducted by the Eastern Cooperative...

breast cancer

Mammographically Dense Breasts Highly Prevalent Among American Women

A study on the prevalence of mammographically dense breasts in the United States “estimated that approximately 43% of women aged 40 to 74 years have heterogeneously or extremely dense breasts, corresponding to approximately 27.6 million U.S. women,” researchers reported in the Journal of the...

Adding CD47 to Artificial Antigen-Presenting Cells May Stimulate T-Cell Responses and Improve Functionality

Artificial antigen-presenting cells have been shown to stimulate antigen-specific T-cell responses, but their effect in vivo may be compromised by rapid macrophage clearance. In a study reported in Clinical Cancer Research, Bruns and colleagues added CD47 to classic two-signal artificial...

colorectal cancer

Therapeutic DNA Vaccination Against Colorectal Cancer via MYB Targeting

The oncoprotein and transcription factor MYB is overexpressed in colorectal cancer and critical to proliferation and tumor cell survival. In a study reported in Clinical & Translational Immunology, Cross and colleagues developed a DNA vaccine to generate an MYB-specific immune response on the...

gynecologic cancers

Zoledronic Acid Inhibits Angiogenesis in Ovarian Cancer Patients

The bisphosphonate zoledronic acid has been reported to produce antitumor effects, although the mechanisms of such effects remain unclear. In a study reported in Clinical Cancer Research, Gonzalez-Villasana and colleagues found evidence that zoledronic acid inhibited ovarian cancer angiogenesis by...

lung cancer

LAMC2 Increases the Metastatic Potential of Lung Adenocarcinoma

Mechanisms of lung cancer metastasis remain largely undefined. In a study reported in Cell Death & Differentiation that used genome-wide transcriptional analysis in a metastasis model, Moon and colleagues found that the epithelial basement membrane protein laminin γ2 (LAMC2) was significantly...

lung cancer

PEDF Improves Lung Cancer Response to Radiation via Vasculature Normalization

In a study reported in Cancer Gene Therapy, Xu and colleagues found that the addition of pigment epithelium-derived factor (PEDF) to radiation improved tumor response in a mouse model of lung cancer. Lewis lung cancer allografts in nude mice were treated with radiation, PEDF, and PEDF plus...

prostate cancer

'Bipolar' Androgen Therapy in Castration-Resistant Prostate Cancer

Resistance to castrating therapy and androgen deprivation therapy in prostate cancer is due in part to adaptive upregulation of androgen receptor levels by castration-resistant prostate cancer cells in the setting of prolonged exposure to a low-testosterone environment. In a study reported in...

Patients May Voice Concerns About Chemotherapy Effects on the Brain Even If They Have Never Heard of ‘Chemobrain’

The concept of “chemobrain” is underrecognized, noted ­Serena Wong, MD, co-investigator of a clinical trial examining the effects of chemotherapy and hormonal therapy on the brain. Dr. Wong is a medical oncologist at Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine at...

symptom management

'Chemobrain’ Study Aims to Correlate Structural Changes Within the Brain and Psychomotor Function

The novelty of our approach is that we are going to be using multiple modalities” to study the effects of chemotherapy and hormonal therapy on the brain, looking for structural changes within the brain and how these changes might affect psychomotor function, particularly upper-extremity movements...

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