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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 ...

Grace Lu-Yao, PhD, Receives SIOG Nursing Award

Grace Lu-Yao, PhD, Associate Director of Population Science at the Sidney Kimmel Cancer Center–Jefferson Health (SKCC), has been honored with the International Society of Geriatric Oncology (SIOG) 2018 Nursing and Allied Health Investigator Award at the SIOG 2018 Annual Conference. Dr. Lu-Yao...

Jonathan Chernoff, MD, PhD, Receives Grant to Investigate RAC1-Mutant Melanoma

Jonathan Chernoff, MD, PhD, Chief Scientific Officer and Stanley P. Reimann Chair in Oncology Research at the Fox Chase Cancer Center, has received a grant from the Melanoma Research Foundation to support research on RAC1-mutant melanoma. The grant will provide $200,000 over 2 years. With this...

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...

Rishi Jain, MD, MS, DABOM, Joins Fox Chase GI Program

Rishi Jain, MD, MS, DABOM, has joined Fox Chase Cancer Center as Assistant Professor in the Gastrointestinal (GI) Medical Oncology Program. After graduating from Fox Chase/Temple University Fellowship Training Program, Dr. Jain moved on to the Gastrointestinal Medical Oncology Program at The Ohio...

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...

breast cancer

Association Between Pathologic Complete Response After Neoadjuvant Chemotherapy and Breast Cancer Outcomes

A large comprehensive patient-level meta-analysis showed that achieving pathologic complete response after neoadjuvant chemotherapy correlates with significantly improved event-free survival and overall survival in patients with localized breast cancer. These findings were particularly robust in...

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...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC

Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...

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...

head and neck cancer
immunotherapy

Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...

breast cancer

Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer

In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...

symptom management

FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia

On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...

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...

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...

colorectal cancer
issues in oncology

Does Tailored Lifestyle Feedback Given During Colorectal Cancer Screening Improve Disease-Preventive Behaviors?

A program that provided individually tailored lifestyle recommendations for patients undergoing screening for colorectal cancer helped encourage healthy behavior, according to results published by Knudsen et al in Cancer Epidemiology, Biomarkers & Prevention. “It is well known that...

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...

issues in oncology
symptom management

Apixaban Thromboprophylaxis in Patients With Cancer

In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...

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 ...

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