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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...

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and class labeling of in vitro companion diagnostics for classes of oncology therapeutic products: “With a new draft guidance document that the FDA issued … our aim is to make it easier to get class labeling ...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

CDC Foundation Launches Virtual Tool to Prevent Infections in Patients With Cancer

The Centers for Disease Control and Prevention (CDC) Foundation recently launched an educational tool using virtual human technology to improve patient-provider conversations about neutropenia as a side effect of chemotherapy. This new resource is part of the Preventing Infections in Cancer...

Expert Point of View: Carlos L. Arteaga, MD, Laura J. Esserman, MD, MBA, and Joseph Sparano, MD

“This study supports the use of neoadjuvant chemotherapy,” commented press conference moderator Carlos L. Arteaga, MD, of the Simmons Cancer Center at UTSouthwestern Medical Center in Dallas. “It did not matter whether patients received adjuvant therapy, as long as they had achieved a pathologic...

issues in oncology
health-care policy
legislation
cost of care

Will the Trump Administration’s Plan to Reduce Cancer Drug Prices Work?

High drug prices are the number one health-care concern of many Americans. The average price of a cancer drug rose from less than $10,000/yr before 2000 to more than $170,000/yr in 2017.1-3 Between 1995 and 2013, the launch price of cancer drugs increased by 10% to 12% every year, and the average...

Expert Point of View: Aaron T. Gerds, MD, MS

At a press conference where the ECOG-ACRIN E1912 presentation and related issues were discussed, session moderator Aaron T. Gerds, MD, MS, of the Cleveland Clinic Taussig Cancer Center, was quite enthusiastic about these results. “I believe these results should change clinical practice....

hematologic malignancies
leukemia

First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL

First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...

Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD

Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...

breast cancer

KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer

In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...

leukemia

MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...

skin cancer
immunotherapy

ESMO Immuno-Oncology 2018: Does Proton Pump Inhibitor Therapy Impact the Efficacy of Nivolumab Plus Ipilimumab?

Patients with melanoma receiving proton pump inhibitors for comorbidities derived approximately half the clinical benefit from immunotherapy consisting of nivolumab (Opdivo) plus ipilimumab (Yervoy) as patients receiving the same combination but not treated with proton pump inhibitors, according to ...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: MYSTIC: First-Line Durvalumab With or Without Tremelimumab in Metastatic NSCLC

First-line immunotherapy with durvalumab (Imfinzi) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late-breaking results from the MYSTIC trial presented by Rizvi et al at the European Society for Medical...

head and neck cancer

Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma

In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...

issues in oncology

ASCO and ESMO Publish Joint Assessment of Their Value Frameworks

To better understand the performance characteristics of ASCO’s Value Framework Net Health Benefit Score version 2 (ASCO-NHB v2) and the European Society for Medical Oncology’s (ESMO’s) Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1), ASCO and ESMO undertook a...

gastroesophageal cancer

Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer

A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...

sarcoma

Regorafenib in Previously Treated Metastatic Osteosarcoma

In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...

skin cancer

Aggressive Squamous Cell Carcinoma in Solid Organ Transplant Recipients

Squamous cell carcinoma (SCC) is the most frequently diagnosed cancer in recipients of a solid organ transplant. When organ transplant recipients are diagnosed with SCC, they are also at higher risk for a more aggressive disease course, metastasis, and death than the general population. Researchers ...

colorectal cancer
gynecologic cancers

CIMRA Assay for Detection of Gene Variants in Lynch Syndrome

An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...

hematologic malignancies

Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE

Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism. Readers of The ASCO Post are invited to participate in this research by...

breast cancer

RSNA 2018: Mammography Screening Beyond Age 75

Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....

breast cancer

RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women

A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...

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