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issues in oncology

Assuming the Role of NCI Director: Working to Accelerate Progress

    I’m not sure anything can prepare a person to become director of the National Cancer Institute (NCI), but I can honestly say that I am humbled to have been appointed to this position and am excited to have this unique opportunity. As many of you may know, I come to NCI from the University of...

Giving Back After Cancer

My diagnosis of neuroblastoma when I was 14 happened rather accidentally. I was a competitive dancer and very active in sports my first year in high school and had no symptoms of cancer or any illness. It wasn’t until my mother, who is a nurse, came into my room one morning to wake me for school...

Medical Oncologist Takes the Paths Less Traveled to Unwind and Reboot

GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. For this installment in the Living a Full Life series of articles, Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer ...

American Association for the Advancement of Science Inducts New Fellows

The American Association for the Advancement of Science (AAAS) has recently inducted 396 members as fellows, with 21 members having oncology backgrounds. Members have been awarded this honor because of their scientifically or socially distinguished efforts to advance science or its applications....

FCC, NCI Working to Improve Rural Cancer Care via Broadband Access

The Connect2Health Task Force, an initiative of the Federal Communmications Commission (FCC), has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas...

The Puzzle Table

The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...

Alectinib in ALK-Positive Metastatic Non–Small Cell Lung Cancer

On November 6, 2017, alectinib (Alecensa) received regular approval for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by a U.S. Food and Drug Administration–approved test.1,2 Supporting Efficacy Data Approval was...

Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer

Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...

issues in oncology

FDA Helps Streamline Approval Process for Supplemental Drug Indications

As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...

WHAT SHOULD PUMA DO?

Puma should invest in developing an escalating-dose schedule for neratinib (Nerlynx). If one plans on giving a drug for a year, and starts after finishing a year of effective adjuvant therapy, there is no hurry to begin at full, intolerable doses. Starting at a lower dose and escalating slowly as...

solid tumors
breast cancer

Neratinib Is Approved: Should We Reject It Anyway?

The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...

supportive care
lung cancer

Providing a Safe Haven for Patients With Advanced Lung Cancer

In 1996, Jimmie C. Holland, MD, the Wayne E. Chapman Chair in Psychiatric Oncology at Memorial Sloan Kettering Cancer Center (MSK) in New York, decided to launch the cancer center’s Lung Cancer Survivorship Program after she had a startling encounter with a patient. “The woman said to me, ‘Would...

St. John’s Wort

The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....

Katherine E. Reeder-Hayes, MD, Sees Equity as Next Big Challenge in Breast Cancer Care

Breast cancer specialist Katherine E. Reeder-Hayes, MD, MBA, was born on a farm in Morgan County, Alabama. “My family grew soybeans and cotton and raised cattle. None of my family members were in the medical field, but I always felt comfortable around people who were sick or had emergencies and...

global cancer care

Slovenia’s First Medical Oncology Resident Reflects on His Career in a Rapidly Changing Field

Bostjan Seruga, MD, PhD, is a medical oncology consultant at the Insitute of Oncology Ljubljana and Associate Professor at the University of Ljubljana, Slovenia. He has published on barriers in global cancer research. The ASCO Post spoke with him recently about his career path, cancer care in...

Fulvestrant Monotherapy for Postmenopausal Women With Advanced Breast Cancer

On August 28, 2017, fulvestrant (Faslodex) was approved at 500 mg as monotherapy for expanded use in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast cancer who have not received previous endocrine therapy.1 Supporting Efficacy Data Approval was based on improved...

A Letter of Thanks From the Conquer Cancer Foundation

Small victories matter when you are conquering cancer.  Listen to a patient’s loved one detail the progress of treatment. You will hear the value they give to accomplishments that otherwise seem minor: She rested well last night. He managed to eat. The scan showed no new growth! It is easy,...

NIH Research Program Partners With National Library of Medicine to Advance Precision Medicine

THE NATIONAL INSTITUTES OF HEALTH’S All of Us Research Program and the National Library of Medicine (NLM) have teamed up to raise awareness about the program, a landmark effort to advance precision medicine. Through this 3-year pilot program, the National Network of Libraries of Medicine has...

ASCO Kicks Off Strategic Planning to Support Women in Oncology

Women in oncology aren’t ascending the leadership ladder at rates anywhere close to their male counterparts—and ASCO wants to fix that. The most recent report on “The State of Women in Academic Medicine” from the Association of American Medical Colleges (AAMC) said that although women make up...

lymphoma

Another PI3K Inhibitor Welcome For Use in Indolent Lymphoma

PHOSPHATIDYLINOSITOL 3-KINASE (PI3K) signaling is important for the proliferation and survival of malignant B cells. Copanlisib (Aliqopa) is a novel pan-class PI3K inhibitor with predominant activity against PI3K-alpha and PI3K-delta isoforms. As reviewed in this issue of The ASCO Post, a phase II ...

Conquer Cancer Researcher Spotlight: Dr. Xiuning Le

Xiuning Le, MD, PhD Assistant Professor The University of Texas MD Anderson Cancer CenterSpecialty: Thoracic/head & neck cancer, breast cancer Of all the adjectives used to describe cancer, one in particular can be surprising: smart. In fact, one of the reasons cancer can be so hard to treat...

Deadline Approaching: Give a Year-End Gift by December 31

The New Year is almost here—and what better way to close out 2017 than by donating to Conquer Cancer, ASCO’s affiliate organization? Your tax-deductible year-end gift will help fuel advances in prevention, treatment, and cures for all types of cancer.  Give now at CONQUER.ORG/Year-End to end 2017...

ASCO Resolutions Approved by AMA House of Delegates

From November 11–14, ASCO delegates participated in the American Medical Association’s (AMA) Interim Meeting of the House of Delegates (HOD), the principal policy-making body of the AMA. During the meeting, several ASCO-backed resolutions were approved, including: Medicare Part B Drugs in QPP/MIPS...

lung cancer

European Union Expert Group Releases Position Statement on Lung Cancer Screening in Europe

AS REPORTED in The Lancet Oncology by Matthijs Oudkerk, MD, of the University of Groningen, the Netherlands, and colleagues, a European Union (EU) expert group has issued a position statement on low-dose computed tomography (CT) screening for lung cancer, proposing a near-term phased implementation ...

breast cancer

Exercise Counteracts Fatigue, Pain in Women With Advanced Breast Cancer

A SUPERVISED and individualized exercise program can reduce fatigue and pain while improving cardiovascular health and quality of life in women being treated for advanced breast cancer, according to research presented by Eduardo Oliveira, PhD, Professor of Exercise Physiology and Exercise Cancer...

geriatric oncology

Broadening the Evidence Base for Older Patients: FDA-ASCO Workshop Explores Emerging Strategies

In the not-so-distant past, clinical trials were considered an option only for the young and fit. Enrolling older people “used to be thought unethical,” said Janet Woodcock, MD, Director of the U.S. Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER), as she opened...

breast cancer

Disease Progression and Deterioration of Health-Related Quality of Life in Advanced Breast Cancer

IN PATIENTS WITH estrogen receptor–positive, HER2-negative advanced or metastatic breast cancer, better quality of life may be prolonged by delaying the progression of the disease, according to an ongoing quality-of-life assessment from the PALOMA-2 study, presented by Nadia Harbeck, MD, PhD, of...

colorectal cancer
survivorship

Fiber Is Only One Component in Improving Outcomes in Cancer Survivors

SINCE 2003, every iteration of the American Cancer Society’s Nutrition Guidelines for Cancer Survivors has advocated for a plant-based diet with ample quantities of whole grains, as well as vegetables and fruits.1-3 This recommendation has been based primarily on data that such foods play in...

issues in oncology
legislation

Medical Aid in Dying: When Legal Safeguards Become Burdensome Obstacles

In 2017, the District of Columbia (DC) became the seventh jurisdiction in the United States to legalize medical aid in dying,1 which gives terminally ill patients the option of how and when they die. The new DC statute is nearly identical to earlier enacted medical aid in dying statutes in...

Balancing Opioid Use to Relieve Cancer-Related Pain and Protecting Patients From Addiction and Death

According to the Centers for Disease Control and Prevention (CDC), from 1999 to 2015, more than 183,000 people have died in the United States from overdoses related to prescription opioids, including methadone, oxycodone, and hydrocodone.1 To stem the epidemic in prescription opioid–related use and ...

breast cancer

Dose-Dense Chemotherapy in Early Breast Cancer: A ‘Win-Win’ Treatment Approach

INCREASING THE DOSE density of chemotherapy lowers the risk of recurrence and breast cancer death by about 15% in women with early breast cancer, according to a large, meticulously conducted meta-analysis by the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG).1 The trials included in...

breast cancer

Extended Endocrine Therapy in Postmenopausal Women With Breast Cancer: 2 Years as Effective as 5 Years

An additional 5 years of aromatase inhibitor therapy after 5 years of adjuvant endocrine therapy failed to improve disease-free survival compared with an additional 2 years of aromatase inhibitor therapy in postmenopausal women with hormone receptor–positive breast cancer, according to the results ...

breast cancer

Ribociclib Doubles Progression-Free Survival in Premenopausal Breast Cancer

PREMENOPAUSAL WOMEN with hormone receptor–positive, HER2-negative advanced breast cancer benefited substantially from the addition of ribociclib (Kisqali) to first-line endocrine therapy plus medical ovarian suppression, according to results from the MONALEESA-7 study.1 At the 2017 San Antonio...

lymphoma

Front-Line Brentuximab Plus AVD vs Standard ABVD in Advanced Hodgkin Lymphoma

FRONT-LINE TREATMENT of advanced Hodgkin lymphoma with brentuximab vedotin (Adcetris) plus doxorubicin/ vinblastine/dacarbazine (A+AVD) achieved superior outcomes compared with the standard four-drug regimen of doxorubicin/bleomycin/vinblastine/dacarbazine (ABVD). The substitution of brentuximab...

gynecologic cancers
hepatobiliary cancer
gastroesophageal cancer
leukemia

Reports From the Journal of Clinical Oncology

Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...

leukemia

Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia

THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...

lymphoma

Updated Follow-up of ZUMA-1 Confirms Benefit of CAR T-Cell Therapy in Aggressive B-Cell Lymphoma

POSITIVE DATA about chimeric antigen receptor (CAR) T-cell therapy in lymphoma continue to accrue. Long-term follow-up of the pivotal ZUMA-1 trial shows that patients with refractory diffuse large B-cell lymphoma (DLBCL) continue to have durable responses to the CD19-directed CAR T-cell therapy...

issues in oncology

FCC, NCI Working to Improve Rural Cancer Care via Broadband Access

The Federal Communications Commission’s Connect2Health Task Force (C2HFCC) has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas can improve...

lymphoma

CAR T-Cell Therapy in Refractory B-Cell Lymphomas

As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...

health-care policy

AMA Urges Physicians to Take Steps to Avoid Medicare Payment Penalty

The American Medical Association (AMA) is reminding physicians that the Medicare reimbursement system has changed, and, if they have not done so already, they have until December 31, 2017, to take a few simple steps to avoid a Medicare payment penalty in 2019. The changes are part of the...

legislation

Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research

On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...

gynecologic cancers

FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...

solid tumors

Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers

At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...

solid tumors

Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors

Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...

hematologic malignancies
symptom management

ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer

People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...

hematologic malignancies

ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura

In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...

hematologic malignancies
symptom management

ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant

Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials

In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...

prostate cancer

Novel Clinical-Genomic Risk Group Classification for Localized Prostate Cancer

As reported in the Journal of Clinical Oncology, Spratt et al have developed an integrated clinical-genomic risk classifier for predicting distant metastasis in patients with localized prostate cancer. The classifier uses National Comprehensive Cancer Network® (NCCN) risk categories and risk...

pancreatic cancer

Identification of Cystic Precursors to Pancreatic Cancer Using Targeted Mass Spectrometry

In a study reported in the Journal of Clinical Oncology, Jabbar et al found that mass spectroscopy proteomic analysis of the pancreatic cyst fluid biomarkers mucin-5AC (MUC5AC), mucin-2 (MUC2), and prostate stem cell antigen (PSCA) identified cystic pancreatic cancers and precursor lesions with...

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