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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....

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 ...

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

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...

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...

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...

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 ...

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...

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. ...

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...

head and neck cancer

Cancer Has Given Me More Than It Has Taken Away

In the fall of 2010, I developed a sore throat and tonsillitis while on a hike in North Carolina. Although it was not uncommon for me to have sore throats accompanied by some swelling on my tonsils, this time much of the inflammation and swelling were centered on just my left tonsil. After 7 days...

Friends of Cancer Research Holds Annual Conference on Clinical Cancer Research

Friends of Cancer Research, in conjunction with the Engelberg Center for Health Care Reform at Brookings, recently held the seventh annual Conference on Clinical Cancer Research in Washington, DC. The panels that comprised the daylong meeting discussed a future that has already begun. The most...

health-care policy

Transitioning From Volume to Value in Cancer Care

In an oncology health-care system that is increasingly changing its delivery and payment models, how do busy oncologists successfully bridge the transition from a volume- to value-based, patient-centric model? This, and other topics on value fueled a robust discussion at the Association of...

hematologic malignancies
leukemia

New Choosing Wisely List, Leukemia Quick-Takes From ASH

Nearly 5,000 scientific abstracts were presented at the 2014 American Society of Hematology (ASH) Annual Meeting and Exhibition in San Francisco. Along with our targeted coverage of the meeting’s key newsmakers, The ASCO Post provides you with these brief reports of other interesting...

Expert Point of View: Matthew J. Ellis, MB, BChir, PhD

Matthew J. Ellis, MB, BChir, PhD, Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine, Houston, commented on endocrine resistance and the potential of the four-gene panel for assessing resistance for The ASCO Post. Endocrine response and resistance is a research focus...

lung cancer

Ramucirumab in Metastatic Non–Small Cell Lung Cancer

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. In December 12, 2014, ramucirumab (Cyramza) was approved for use in ...

health-care policy

ASCO Policy Statement Urges Removal of Barriers to Patient Participation in Phase I Clinical Trials

ASCO has released a policy statement calling for greater access to and education about phase I clinical trials, the first-in-human studies of new agents designed to fight cancer. In “The Critical Role of Phase I Trials in Cancer Research and Treatment” ASCO policy statement, the Society stresses...

bladder cancer

Molecular Classification Predicts Postcystectomy Recurrence in High-Risk Bladder Cancer

Radical cystectomy is the standard therapeutic option for patients with muscle-invasive bladder cancer. However, 5-year overall survival for high-risk patients with pT3, pT4, pN-negative, and pN-positive M0 bladder cancer after radical cystectomy is only about 50% and ranges from 32% in patients...

bladder cancer

Novel Genomic Signature Predicts Postcystectomy Recurrence in High-Risk Bladder Cancer

As reported in the Journal of the National Cancer Institute, Anirban P. Mitra, MD, PhD, of the University of Southern California, and colleagues identified a novel genome-based signature that improves prediction of postcystectomy recurrence in patients with high-risk bladder cancer.1 Use of the...

bladder cancer

Treating Bladder Cancer in 2015

Treatment of advanced bladder cancer continues to prove challenging, and therapies that offer long-term survival remain elusive. The ASCO Post recently spoke with Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, President of the Levine Cancer Center, Charlotte, North Carolina, about the current state...

hematologic malignancies

Ruxolitinib for Polycythemia Vera

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 4, 2014, ruxolitinib (Jakafi) was approved for the...

gastrointestinal cancer

Minimally Invasive Techniques Used to Address Small GIST Lesions

Surgeons at the cutting edge are offering minimally invasive resection to patients with small gastrointestinal stromal tumors (GISTs) deemed to be low-risk, according to panelists at a session of the American College of Surgeons 2014 Clinical Congress in San Francisco. “We are seeing more small...

lymphoma

FDA Expands Approved Use of Ibrutinib for Waldenström’s Macroglobulinemia

The U.S. Food and Drug Administration (FDA) today expanded the approved use of ibrutinib (Imbruvica) for patients with Waldenström’s macroglobulinemia, a rare, indolent type of B-cell lymphoma. Ibrutinib is the first therapy indicated specifically for Waldenström’s macroglobulinemia and previously...

leukemia

CAR T Cells Impressive in Acute Lymphocytic Leukemia

As more experience is gained with the use of genetically engineered chimeric antigen receptor (CAR) T cells in patients with leukemia, the data continue to be highly encouraging. Three different groups using slightly different modifications of CAR T cells reported positive experiences in treating...

breast cancer

News Roundup From the 2014 San Antonio Breast Cancer Symposium

Highlighted here are summaries of four abstracts presented at the 2014 San Antonio Breast Cancer Symposium: They focus on the EPO-ANE-3010 clinical trial of epoetin alfa (Epogen, Procrit) in anemic patients with metastatic breast cancer, a New York Cancer Consortium trial of fulvestrant (Faslodex)...

colorectal cancer

Observation Appropriate for Some Patients With Rectal Cancer Following Neoadjuvant Therapy

Some patients with rectal cancer who achieve a complete response to neoadjuvant chemoradiation therapy can be monitored for tumor recurrence and may never need surgery, according to a retrospective review from patients at Memorial Sloan Kettering Cancer Center, New York, presented at the 2015...

colorectal cancer

More on Ramucirumab in Metastatic Colorectal Cancer

I am writing in regard to the report and commentary in this issue on the RAISE Trial. To begin, a discussion of this phase III clinical trial presented at the 2015 Gastrointestinal Cancers Symposium (RAISE study) may not be the most appropriate forum to air legitimate views on finances and...

Expect Questions About Atypical Hyperplasia as an Important Risk Factor for Breast Cancer

A special report in The New England Journal of Medicine concluded that atypical hyperplasia of the breast “confers an absolute risk of later breast cancer of 30% at 25 years of follow-up.1” This is higher than previously recognized, and the report’s authors urged “more intensive screening and...

breast cancer

Atypical Hyperplasia as a Predictor of Future Breast Cancer: Focus on Chemoprevention and Screening

Atypical hyperplasia of the breast has “special importance as a predictor of future breast cancer,” according to a special report in The New England Journal of Medicine.1 That special importance is based on the high incidence of atypical hyperplasia—found in around 10% of the 1 million breast...

breast cancer
colorectal cancer
hepatobiliary cancer
lung cancer

Twenty Years After a Diagnosis …  and Counting

In 1995, I was diagnosed with advanced colorectal cancer and given little chance to live. The dire diagnosis came years after being assured by several physicians that the problem I was having with rectal bleeding and anemia was nothing more than the result of an internal hemorrhoid. Busy raising...

lung cancer
issues in oncology
health-care policy

At Long Last: CMS Will Cover Lung Cancer Screening

Few issues in health-care debates are more contentious and polarizing than population screening for the early detection of cancer. After a decades-long battle, lung cancer screening advocates have just received what they have long sought: The Centers for Medicare & Medicaid Services (CMS) has...

integrative oncology

Capsaicin

Scientific name: 8-methyl-N-vanillyl-6-nonenamide Brand names: Zostrix cream 0.025% or 0.075%, Salonpas Gel-Patch Hot, Sinus Buster (homeopathic intranasal spray). The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence ...

leukemia

Blinatumomab in Philadelphia Chromosome–Negative Relapsed/Refractory B-Cell Precursor ALL

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 3, 2014, blinatumomab (Blincyto) was granted...

breast cancer

Iniparib: The Fairy Tale Dream Comes to an End

The first poly ADP ribose polymerase (PARP) inhibitor was developed in the early 1990s. Since then, the activity of PARP inhibitors has been explored in a variety of settings, including and perhaps most enthusiastically in the treatment of cancer. The greater dependence of several cancers on PARP,...

hematologic malignancies

Ibrutinib for Waldenström’s Macroglobulinemia

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 January 29, 2015, the U.S. Food and Drug Administration (FDA)...

issues in oncology

Pharmacokinetics and Exposure Response in Drug Development

INSIDE THE BLACK BOX is an occasional column offering insight into the U.S. Food and Drug Administration (FDA) and its policies and procedures. In this installment, former clinical pharmacology team leader Julie Bullock, PharmD, and current team leader Nitin Mehrotra, PhD, discuss how...

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