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supportive care
palliative care

Improving Palliative Care in Low-Resource Settings

In 2016, ASCO published an update to its Clinical Practice Guideline, “Integration of Palliative Care Into Standard Oncology Care,” which provides evidence-based recommendations for symptom management, clarification of treatment goals, support of coping and distress management, and coordination of...

hematologic malignancies

Study Findings on Myeloproliferative Neoplasms Including Systemic Mastocytosis

HERE IS AN UPDATE on six different studies featured at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics focused on novel treatments for myelofibrosis, polycythemia vera and essential thrombocythemia, as well as systemic mastocytosis. Myelofibrosis ABSTRACT...

lung cancer

Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer

On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...

issues in oncology

How to Build a Clinical Trial Infrastructure in the Community Oncology Setting

HISTORICALLY, CLINICAL research has been viewed as an entity belonging to academic settings alone. With the advent of the Community Clinical Oncology Program (CCOP) in the 1980s and later with the Cancer Trials Support Unit, cancer clinical trials have begun to emerge in the community setting....

lung cancer

New Data Reported From International Studies of Lung Cancer Treatment

At the European Society for Medical Oncology (ESMO) 2018 Congress, important studies were presented for every cancer type. Here, The ASCO Post offers some snapshots of lung cancer studies that may inform approaches to treating this common cancer, which—despite the advances in recent years—remains...

breast cancer

FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer

On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2-overexpressing, node-positive or node-negative (estrogen...

leukemia

FDA Approves Calaspargase Pegol-mknl for Pediatric and Young Adult Patients With ALL

On December 20, 2018, the U.S. Food and Drug Administration (FDA) approved calaspargase pegol-mknl (Asparlas), an asparagine-specific enzyme, as a component of a multiagent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients aged 1 month to...

lung cancer
immunotherapy

Durvalumab Improves Overall Survival After Chemoradiotherapy in Unresectable, Stage III NSCLC

AS REPORTED in The New England Journal of Medicine by Scott J. Antonia, MD, PhD, of H. Lee Moffitt Cancer Center and Research Institute, and colleagues, the phase III PACIFIC trial has shown significantly improved overall survival, a coprimary endpoint, with the programmed cell death ligand 1...

issues in oncology

Statement From FDA Commissioner on In Vitro Companion Diagnostics

FDA Commissioner Scott Gottlieb, MD, recently issued the following statement on developing and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...

lung cancer

Priority Review for Atezolizumab in Combination With Chemotherapy for Small Cell Lung Cancer

The U.S. Food and Drug Administration (FDA) accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with carboplatin and etoposide for the first-line treatment of patients with extensive-stage small cell lung cancer. The...

Should I Have Lied?

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,...

breast cancer

International Trials Present New Findings in Treatment of Breast Cancer

The European Society for Medical Oncology (ESMO) 2018 Congress featured an assortment of study findings, many with far-reaching clinical implications for the treatment of patients with various cancers. Many of these trials were covered in-depth in recent issues of The ASCO Post. Here, we present...

immunotherapy
skin cancer

Optimal Duration of Checkpoint Inhibition in Melanoma Is No More Than 2 Years

For patients with advanced melanoma, the concept of treating to disease progression does not always apply. With many patients responding to checkpoint inhibition for years, when can treatment be safely discontinued? This important clinical question was addressed at the European Society for Medical...

gynecologic cancers

Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early-Stage Cervical Cancer

TWO STUDIES recently reported in The New England Journal of Medicine indicate that minimally invasive radical hysterectomy is associated with poorer survival outcomes than open abdominal radical hysterectomy in women with early-stage cervical cancer. As reported by Pedro T. Ramirez, MD, of The...

Expert Point of View: Charles G. Drake, MD, PhD

“Bringing pembrolizumab (Keytruda) early into therapy is a bold move,” commented the invited discussant of this trial, Charles G. Drake, MD, PhD, Professor of Oncology and Immunology at the Herbert Irving Cancer Center at Columbia University, New York. The study enrolled patients who can be cured...

head and neck cancer
immunotherapy

Pembrolizumab Plus Chemoradiotherapy in HPV-Positive Head and Neck Cancer

The addition of pembrolizumab (Keytruda) to a chemoradiotherapy regimen yielded complete response rates of 85% in patients with human papillomavirus (HPV)-positive advanced squamous cell carcinoma of the head and neck. These findings from a phase Ib study were presented at the 2018 Society for...

issues in oncology
prostate cancer
geriatric oncology

Overscreening for Prostate Cancer in Older Men Remains an Issue

Although most major cancer organizations agree on the guidelines for prostate cancer screening, there is still uneven application of the test, such as in the older patient population, resulting in overdiagnosis and waste in an already fiscally challenged health-care system. Researchers from the...

Researchers at The University of Texas at Dallas Receive Funding for Assorted Cancer Projects

MORE THAN $4.5 million in new funding from state and federal agencies will support cancer-related research over the next 5 years at The University of Texas at Dallas. Two projects related to brain cancer, each totaling $200,000 over 2 years, recently received High-Impact/High-Risk Research...

immunotherapy

Update on Immune Checkpoint Inhibitors

Checkpoint inhibitors have moved the field of immuno-oncology to the forefront of cancer treatment and research. However, these agents come with the risk of serious adverse events. To shed light on the toxicities associated with checkpoint inhibitors and other timely issues in the field of...

supportive care
palliative care

The Great Opioid Debate: Treating Cancer Pain Safely

As the number of opioid-related deaths continues to rise in the United States, stakeholders are struggling to make sense of the crisis. At the 2018 Palliative and Supportive Care in Oncology Symposium, two experts in the field, Charles F. von Gunten, MD, PhD, and Leslie J. Blackhall, MD,...

issues in oncology
immunotherapy

Immunotherapy-Related Toxicities May Be More Common Than Originally Reported

Immunotherapy has significantly improved the overall survival of patients with non–small cell lung cancer (NSCLC) and is generally better tolerated than traditional chemotherapies, but the results of a retrospective study suggested that immunotherapy side effects may be more common than initially...

New NCCN Member Institution: Abramson Cancer Center of the University of Pennsylvania

In November, the National Comprehensive Cancer Network® (NCCN) announced that Abramson Cancer Center (ACC) of the University of Pennsylvania will become the organization’s 28th Member Institution. The Abramson Cancer Center’s membership will include the Hospital of the University of Pennsylvania...

breast cancer
supportive care

Has Scalp Cooling Reached the Level of Standard of Care?

Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: Second-Line Nivolumab vs Chemotherapy in SCLC

Treatment with nivolumab (Opdivo) did not improve response rates or survival over standard chemotherapy in patients with metastatic small cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented by Reck et al at the European Society for Medical...

AACR Remembers George H.W. Bush for Role in Cancer Research Support

The Board of Directors of the American Association for Cancer Research (AACR) released an announcement expressing sadness upon the passing of former President George H.W. Bush, on November 30 at the age of 94. Once elected, President Bush appointed Bernadine Healy, MD, in 1991 to lead the National ...

skin cancer
immunotherapy

ESMO Immuno-Oncology 2018: OpACIN Trial: Neoadjuvant Ipilimumab Plus Nivolumab in Stage III Melanoma

Updated data of the OpACIN study, which studied combined ipilimumab (Yervoy) plus nivolumab (Opdivo) administered as neoadjuvant or adjuvant therapy in patients with high-risk stage III melanoma, demonstrated high response rates upon neoadjuvant therapy and promising long-term clinical outcome,...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy

Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...

Expert Point of View: Kenneth Shain, MD, PhD, and Vincent Rajkumar, MD

In interviews with The ASCO Post, Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt Cancer Center, Tampa, Florida, and Vincent Rajkumar, MD, Professor of Medicine at the Mayo Clinic in Rochester, Minnesota, commented on the findings of the MAIA trial. “The study shows that...

FDA Issues Guidance on Endpoints for Cancer Clinical Trials

This week, the U.S. Food and Drug Administration (FDA) issued a guidance titled Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics. The guidance provides recommendations to applicants on endpoints for cancer clinical trials submitted to the FDA to support effectiveness claims...

hematologic malignancies
multiple myeloma
immunotherapy

Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma

In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...

breast cancer

Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy

As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...

hematologic malignancies
leukemia

Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL

In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...

breast cancer

AI Technology for Digital Breast Tomosynthesis Receives FDA Clearance for Clinical Use

A deep-learning, cancer detection software built on artificial intelligence (AI) called ProFound AI received clearance by the U.S. Food and Drug Administration (FDA) for commercial sales and clinical use in the United States. The announcement was made in a news release from iCAD, Inc., a global...

Expert Point of View: Joseph C. Alvarnas, MD

“When people don’t respond [to chimeric antigen receptor (CAR) T-cell therapy] as well as they should, it may be that the T cells are depleted and functionally exhausted. The mechanism of exhaustion is in part mediated by checkpoint-related killing. By thwarting that process with pembrolizumab...

breast cancer

Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer

As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...

hematologic malignancies
immunotherapy

Combining a Checkpoint Inhibitor With CAR T-Cell Therapy May Augment Immune Response

Chimeric antigen receptor (CAR) T-cell therapy is a revolutionary approach to treating hematologic malignancies. As experience with this strategy is gained, researchers are learning more about how to optimize responses, especially in patients with “immune exhaustion,” who have a suboptimal initial...

Expert Point of View: Joseph C. Alvarnas, MD, and Henry Fung, MD

Commenting on the ibrutinib (Imbruvica)/chimeric antigen receptor (CAR) T-cell approach at a press conference, Joseph C. Alvarnas, MD, said: “Patients with CLL do not do as well on CAR T-cell therapy as those with B-cell acute lymphoblastic leukemia, and by combining ibrutinib with CAR T cells,...

hematologic malignancies
leukemia
immunotherapy

Early Studies of Ibrutinib Plus CAR T-Cell Combination in Chronic Lymphocytic Leukemia

Researchers are combining chimeric antigen receptor (CAR) T-cell therapy with ibrutinib (Imbruvica) as a means of augmenting and deepening responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Two pilot studies presented at the 2018 American Society of Hematology...

solid tumors

Larotrectinib for Solid Tumors With NTRK Gene Fusions

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On November 26, 2018, larotrectinib (Vitrakvi) was...

Frederick National Laboratory Names Leonard P. Freedman, PhD, Chief Science Officer

Leonard P. Freedman, PhD, has been named Chief Science Officer at the Frederick National Laboratory for Cancer Research. He joins the Frederick National Laboratory after 6 years as Founding President of the Global Biological Standards Institute, a nonprofit organization dedicated to advancing life ...

global cancer care
hepatobiliary cancer

Controlling the Global Burden of Liver Cancer

The burden of mortality related to liver cancer is increasing worldwide. Prevention and control of viral hepatitis will be vital in combating this burden, but curbing the growing epidemic of obesity must also be seen as a key part of liver cancer prevention, according to Rosmawati Mohamed, MD, of...

Prevent Cancer Foundation Award Goes to Big Tobacco Foe, Sharon Y. Eubanks, JD

One Friday afternoon in March 1999, Pat Glynn, an attorney and manager at the Department of Justice, called a colleague, Sharon Y. Eubanks, JD, to talk about a newly formed Tobacco Task Force. Full of enthusiasm, he described plans to bring a federal suit against the major tobacco companies on...

lung cancer

Low-Dose CT Lung Screening: New Developments Support Increased Quality, More Data, Deep Learning

Two years ago, Rick Avila, MS, Chief Executive Officer (CEO) of Accumetra, LLC, was using rolls of Scotch tape as a research tool. The Scotch tape was a phantom, or reference object, and his company was working with computed tomography (CT) lung screening sites around the world to determine the...

gynecologic cancers

FDA Approves Olaparib for Maintenance Treatment of BRCA-Mutated, Advanced Ovarian Cancer

On December 19, 2018, the U.S. Food and Drug Administration (FDA) approved olaparib (Lynparza) for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer...

leukemia

Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL

Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...

leukemia

First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL

In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...

skin cancer

FDA Approves Pembrolizumab for Merkel Cell Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9...

breast cancer
issues in oncology

Increased Risk for Breast Cancer After Childbirth May Last More Than 2 Decades

Although parity—time since most recent birth— is recognized as a protective factor against breast cancer, an analysis of data from 15 prospective cohort studies to assess breast cancer risk in relation to recent childbirth has found that compared to women of the same age who had never...

immunotherapy

Cornelis Melief, MD, PhD, Receives 2018 ESMO Immuno-Oncology Award

The European Society for Medical Oncology (ESMO) has selected Cornelis Melief, MD, PhD, to receive the ESMO 2018 Immuno-Oncology Award in recognition of his work studying the interactions of the immune system with cancer. Dr. Melief is Professor Emeritus in Tumor Immunology at the Leiden...

Nicholas J. Petrelli, MD, FACS, Receives Commendation for Excellence Award From Christiana Care Health System

Nicholas J. Petrelli, MD, FACS, Bank of America Endowed Medical Director of the Christiana Care Health System’s Helen F. Graham Cancer Center & Research Institute in Newark, Delaware, recently received the Annual Commendation for Excellence from Christiana Care’s Medical-Dental Staff. An expert ...

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