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issues in oncology

2018 ASCO: Geriatric Assessment Improves Communication Between Oncologists and Older Patients

A federally funded randomized study demonstrated that the use of geriatric assessment in routine care of older adults with advanced cancer significantly improved doctor-patient communication about age-related concerns as well as patient satisfaction with the communication. The study was featured in ...

lung cancer
symptom management
immunotherapy

Safety of PD-1/PD-L1 Inhibitors in Patients With NSCLC and Preexisting Autoimmune Disorders

In a study reported in the Journal of Clinical Oncology, Leonardi et al found that programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) inhibitor monotherapy in patients with non–small cell lung cancer (NSCLC) and autoimmune disorders worsened such disorders in a...

solid tumors
hematologic malignancies

FDA Oncology Drug Approvals Granted Between June 2017 and May 16, 2018

Over the past year (June 2017–May 2018), the U.S. Food and Drug Administration (FDA) granted approval to a number of new oncology drug products, including several biosimilar products. Here we provide the labeling approved for these novel drugs and new indications.  EPOETIN ALFA-EPBX (RETACRIT)...

lymphoma

Pioneering Researcher and Oncologist Volker S. Diehl, MD, Helped Unlock the ‘Black Box’ of Hodgkin Lymphoma

Volker S. Diehl, MD, the internationally renowned hematologist and researcher, was born in Berlin, Germany, on February 28, 1938—arguably one of the most tumultuous periods in world history. Germany had just invaded Austria, signaling the dark intentions of the Third Reich. In 1943, the air raids...

prostate cancer

AUA 2018: Is Prostate Cancer Screening and Risk Stratification Moving Beyond the PSA Test?

New diagnostic tests for prostate cancer, as well as new information about the impact of the U.S. Preventive Services Task Force recommendations on prostate cancer screening, were presented at the 113th Annual Meeting of the American Urological Association (AUA). PSA Screening of African American...

Roger Lo, MD, PhD, Receives American Skin Association Award for Skin Cancer Research

THE AMERICAN SKIN ASSOCIATION (ASA) recently announced Roger Lo, MD, PhD, of the David Geffen School of Medicine at the University of California (UCLA), as the recipient of the Abby S. and Howard P. Milstein Innovation Award for Melanoma/Non-Melanoma Skin Cancer Research.  The award is available...

lung cancer

Stage IV Lung Cancer Did Not Stop Me From Climbing Mera Peak

A veteran mountain climber and skier, I’ve been healthy for most of my 61 years, so it was especially shocking to experience a bout of shortness of breath during a moderately intense mountain bike ride with my wife, Jan, in the spring of 2014. A never-smoker, I was used to climbing up high mountain ...

colorectal cancer

BRAF Mutations, Survival, and Recurrence in Patients Undergoing Surgery for Colorectal Cancer Liver Metastases

In a study reported in JAMA Surgery, Margonis et al found that presence of a BRAF V600E mutation was associated with higher risk of recurrence and poorer overall survival among patients undergoing surgical resection of liver metastases from colorectal cancer. Study Details The cohort study...

sarcoma

Trametinib Treatment for Histiocytic Sarcoma With an Activating MAP2K1 Mutation

In a letter to the editor in The New England Journal of Medicine, Gounder et al described the successful treatment of a patient with histiocytic sarcoma and an activating MAP2K1 (MEK1) mutation with the MAPK kinase 1 and 2 inhibitor trametinib (Mekinist). As noted by the authors, patients with...

lung cancer

Treatment of Malignant Pleural Mesothelioma: ASCO Clinical Practice Guideline

As reported by Hedy L. Kindler, MD, of the University of Chicago, and colleagues in the Journal of Clinical Oncology, ASCO has released a clinical practice guideline on the treatment of malignant pleural mesothelioma.1 The guideline was based on a systematic literature search and expert panel...

hematologic malignancies
immunotherapy

Logistics of CAR T-Cell Therapy in Real-World Practice

With the U.S. Food and Drug Administration (FDA) approvals of tisagenlecleucel (Kymriah)1 and axicabtagene ciloleucel (Yescarta),2 chimeric antigen receptor (CAR) T-cell therapy has moved into real-world practice, offering new potentially curative options for incurable hematologic malignancies. Its ...

leukemia

Molecular Minimal Residual Disease Detection Shows Further Promise in Acute Myeloid Leukemia

Extended next-generation sequencing genomic profiling in acute myeloid leukemia (AML) has revealed remarkable heterogeneity and molecular complexity of the disease and provided critical insights into the genetic mechanisms underpinning of preleukemic and leukemic pathogenesis.1,2 Despite...

lung cancer
skin cancer
issues in oncology
immunotherapy

Survival in Male vs Female Patients Receiving Immune Checkpoint Inhibitors

In a systematic review and meta-analysis reported in The Lancet Oncology, Conforti et al found a significant difference in overall survival benefit favoring male vs female patients receiving immune checkpoint inhibitor therapy for advanced cancers. Study Details The study involved database...

lymphoma

PET-Guided Therapy for Aggressive Non-Hodgkin Lymphomas

In a German phase III trial (PETAL) reported in the Journal of Clinical Oncology, Dührsen et al found that interim 18F-FDG positron emission tomography (PET) findings were associated with  survival in patients with aggressive non-Hodgkin lymphomas receiving R-CHOP (rituximab [Rituxan]...

breast cancer

Circulating Tumor Cells and Benefit of Adjuvant Radiotherapy in Early Breast Cancer

In a study reported in JAMA Oncology, Goodman et al found that adjuvant radiotherapy was associated with better outcome in patients with early breast cancer who had detectable circulating tumor cells (CTCs). Study Details The analysis included data from patients with stage pT1 to pT2 and pN0 to...

leukemia

Targeted Sequencing Detection of Molecular Minimal Residual Disease and Prognosis in Acute Myeloid Leukemia

In a study reported in The New England Journal of Medicine, Mojca Jongen-Lavrencic, MD, PhD, of Erasmus MC Cancer Institute, and colleagues found that molecular minimal residual disease identified by next-generation sequencing during complete remission was associated with an increased risk of...

Treatment Centers Authorized to Administer CAR T-Cell Therapy

The following medical facilities are certified, as of March 2020, to administer the U. S. Food and Drug Administration-approved chimeric antigen receptor (CAR) T-cell therapy: axicabtagene ciloleucel (Yescarta or “A”) for eligible patients with non-Hodgkin lymphoma, and tisagenlecleucel (Kymriah or ...

issues in oncology
cost of care
immunotherapy

Weighing the Cost and Value of CAR T-Cell Therapy

This past year’s approval by the U.S. Food and Drug Administration (FDA) of two chimeric antigen receptor (CAR) T-cell therapies heralded a new era in both effective cancer treatments and the most expensive cancer drugs ever. Tisagenlecleucel (Kymriah) was initially approved for the treatment of...

solid tumors
immunotherapy

New Data on ALK Inhibitors and CAR T-Cell Therapies

The 2018 American Association for Cancer Research (AACR) Annual Meeting was abuzz with more than 22,000 attendees from around the world who came to Chicago to hear the latest in basic science and clinical trial results. Here we present summaries of a few of the highlights from the AACR meeting...

solid tumors

First Selective RET Inhibitor Shows Efficacy in Multiple Cancers

A first-in-human study provides proof of concept that a novel oral agent targeted to RET genetic alterations is safe and active in RET-driven cancers. The agent, called BLU-667, achieved durable disease control in patients with lung and thyroid cancers harboring the RET oncogene, according to the...

colorectal cancer
breast cancer
hepatobiliary cancer
lung cancer
kidney cancer
prostate cancer
cns cancers
leukemia

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®): 2018 Guidelines Updates

In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) covering 8 tumor types. Guidelines are now published for more than 60 tumor types and topics. Some of the key updates were presented at NCCN’s 23rd...

lymphoma
immunotherapy

FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, 2018, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade...

breast cancer
immunotherapy

For Adjuvant Trastuzumab, 6 Months Is Noninferior to 12 Months

The noninferiority phase III Persephone trial could shake up the standard of care for adjuvant trastuzumab (Herceptin), showing that patients with early-stage HER2-positive breast cancer derived as much benefit from 6 months of trastuzumab as 12 months, according to research from the United Kingdom ...

lung cancer

2018 ASCO: Upfront, Comprehensive Genetic Testing in Advanced Lung Cancer Is Cost-Effective

An economic model comparing different types of genetic testing in metastatic non–small cell lung cancer (NSCLC) found that using next-generation sequencing to test for all known lung cancer–related gene changes at the time of diagnosis was more cost-effective and faster than testing one ...

bladder cancer

Dose-Dense Neoadjuvant Chemotherapy in Muscle-Invasive Bladder Cancer

In a phase II trial reported in the Journal of Clinical Oncology, Iyer et al found that dose-dense neoadjuvant gemcitabine plus cisplatin produced a high response rate and was generally well tolerated in patients with planned radical cystectomy for muscle-invasive bladder cancer. Study Details In ...

palliative care
lung cancer

Racial/Ethnic Disparities in the Quality of End-of-Life Care Among Patients With Lung Cancer

Significant disparities in the quality of end-of-life lung cancer care were found among racial/ethnic minorities, with higher odds of experiencing potentially preventable medical encounters during end of life as compared with non-Hispanic whites. These findings were published by Karanth et al in...

leukemia

Clearance of Somatic Mutations at Remission and Outcomes in AML

In a study reported in the Journal of Clinical Oncology, Morita et al found that clearance of somatic mutations at complete remission—particularly those in nonpreleukemic genes—was associated with improved outcomes in previously untreated patients with acute myeloid leukemia (AML)....

lung cancer

Afatinib in Previously Untreated Metastatic NSCLC With Nonresistant EGFR Mutations

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 January 12, 2018, afatinib (Gilotrif) was approved...

breast cancer

Can Some Patients With Early Breast Cancer Avoid Surgery?

RESEARCHERS AT The University of Texas MD Anderson Cancer Center are testing the possibility of safely eliminating surgery in patients with breast cancer who are “exceptional responders” to neoadjuvant therapy, according to Henry M. Kuerer, MD, PhD, a breast cancer surgeon who described this...

solid tumors
issues in oncology
symptom management

NCCN Debuts Three New Sets of Guidelines

THE NATIONAL Comprehensive Cancer Network® (NCCN®) debuted three sets of completely new guidelines for treating patients with uveal melanoma, for treating patients who have cancer and the human immunodeficiency virus (HIV), and for managing immune-related toxicities.  Cancer in People Living With...

leukemia
genomics/genetics

Minimal Residual Disease in Acute Myeloid Leukemia: Mutation Matters

A RECENT article in The New England Journal of Medicine explored the nuances of minimal/measurable residual disease testing after induction treatment of acute myeloid leukemia (AML)1 and David P. Steensma, MD, and Benjamin L. Ebert, MD, PhD, of Dana-Farber Cancer Institute and Harvard Medical...

lung cancer

Expert Point of View: Roy S. Herbst, MD, PhD

FORMAL DISCUSSANT of the KEYNOTE-189 trial, Roy S. Herbst, MD, PhD, Chief of Medical Oncology at Smilow Cancer Hospital, Yale Cancer Center, New Haven, heartily endorsed the new triplet combination of pembrolizumab, pemetrexed, and a platinum in advanced nonsquamous non– small cell lung cancer...

lung cancer
immunotherapy

Pembrolizumab Plus Standard Chemotherapy Improves Survival in Newly Diagnosed Metastatic Non–Small Cell Lung Cancer

ADDING THE IMMUNE checkpoint inhibitor pembrolizumab (Keytruda) to standard chemotherapy with pemetrexed (Alimta) and a platinum as first-line therapy was superior to chemotherapy alone in the KEYNOTE-189 trial.1 Induction and maintenance therapies with the new triplet therapy improved overall...

cns cancers

Early-Phase Trial of Carboxyamidotriazole Orotate and Temozolomide in Glioblastoma

In a phase Ib trial reported in the Journal of Clinical Oncology, Omuro et al found evidence of activity of carboxyamidotriazole orotate plus temozolomide in patients with recurrent anaplastic gliomas or glioblastoma and previously untreated glioblastoma. Carboxyamidotriazole orotate is an...

lung cancer
immunotherapy

FDA Accepts sBLA, Grants Priority Review to Atezolizumab for Initial Treatment of Metastatic Nonsquamous NSCLC

The U.S. Food and Drug Administration (FDA) recently accepted a supplemental biologics license application (sBLA) and granted Priority Review for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin), paclitaxel, and carboplatin for the first-line treatment of metastatic nonsquamous...

solid tumors
skin cancer

FDA Approves Drug Combination for Adjuvant Treatment of BRAF V600–Mutant Melanoma

On April 30, 2018, the U.S. Food and Drug Administration (FDA) approved dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and lymph node involvement following...

solid tumors

FDA Approves Dabrafenib/Trametinib Combination for BRAF-Positive Anaplastic Thyroid Cancer

Today, the U.S. Food and Drug Administration approved dabrafenib (Tafinlar) and trametinib (Mekinist), administered together, for the treatment of unresectable, metastatic, BRAF V600E mutation–positive anaplastic thyroid cancer. Anaplastic thyroid cancer accounts for about 1% to 2% of all...

lung cancer

Disparities Found in Lung Cancer Care, Survival in United States vs England

Despite steady declines in death rates in recent years, lung cancer remains the leading cause of cancer deaths in wealthy countries. In a study published by Andreano et al in the Journal of Thoracic Oncology, Yale researchers collaborated with investigators in Europe to examine lung cancer care and ...

issues in oncology
legislation

Decision Aids Reflect Patients’ Values and Preferences for Care: So Why Aren’t More Oncologists Using Them?

Overwhelming evidence shows that patient decision aids, such as educational booklets, videos, or Web-based tools that take into account patients’ values and personal preferences, hold enormous promise for improving the informed consent process. Patient decision aids both reduce unwanted medical...

skin cancer
immunotherapy

Nivolumab in Adjuvant Treatment of Melanoma

On December 20, 2017, nivolumab (Opdivo) was granted regular approval for adjuvant treatment of patients with melanoma with lymph node involvement or metastatic disease who have undergone complete resection.1,2 Nivolumab was previously approved for the treatment of patients with unresectable or...

solid tumors
prostate cancer

Should We Treat Rising PSA in Men With Castrate Androgen Levels?

In rapid succession, the SPARTAN study results were presented at the 2018 Genitourinary Cancers Symposium, the data were published in The New England Journal of Medicine,1 and the drug apalutamide -(Erleada) was approved by the U.S. Food and Drug Administration (FDA) for men with previously...

lung cancer
immunotherapy

IL-15 Superagonist Plus Nivolumab in Advanced NSCLC

In a phase Ib trial reported in The Lancet Oncology, Wrangle et al found evidence of activity of the combination of nivolumab (Opdivo) and the interleukin (IL)-15 superagonist ALT-803 in patients with previously treated advanced non–small cell lung cancer (NSCLC). ALT-803 targets the shared...

lung cancer
immunotherapy

FDA Accepts sBLA, Grants Priority Review for Pembrolizumab Plus Pemetrexed and Platinum Chemotherapy in Metastatic Nonsquamous NSCLC

On April 30, the U.S. Food and Drug Administration (FDA) accepted for review a supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) based on results of the phase III KEYNOTE-189 trial. The application seeks approval for pembrolizumab in combination with pemetrexed (Alimta) ...

lung cancer
prostate cancer

By 2030, Prostate and Lung Cancers Are Expected to Be the Most Common Cancer Types Among HIV-Infected Adults

While effective antiretroviral therapy, which suppresses HIV replication and improves immune function, has resulted in increased longevity for people living with HIV and reduced the risk of certain cancers, including Kaposi sarcoma and non-Hodgkin lymphoma, other cancers are expected to become more ...

lymphoma
immunotherapy

FDA Expands Tisagenlecleucel Approval to Include Relapsed or Refractory Large B-Cell Lymphoma

On May 1, the U.S. Food and Drug Administration (FDA) approved tisagenlecleucel (Kymriah) suspension for intravenous infusion for the treatment of adult patients with relapsed or refractory large B-cell lymphoma—including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma, and...

issues in oncology

Characteristics of FDA-Designated Breakthrough and Nonbreakthrough Cancer Drugs

In a study reported in the Journal of Clinical Oncology, Hwang et al found little difference in the efficacy and safety of U.S. Food and Drug Administration (FDA)-designated breakthrough vs nonbreakthrough cancer drugs and found that breakthrough drugs were not more likely to represent a novel...

lung cancer
immunotherapy

Results From the ARCTIC Trial in Third-Line Treatment of NSCLC

AstraZeneca and MedImmune have announced high-level results from the phase III ARCTIC trial in patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) who have received at least two prior treatments. This randomized, open-label, multicenter trial assessed the efficacy...

solid tumors
hematologic malignancies

Update Regarding Tazemetostat Clinical Program

On April 23, Epizyme, Inc, announced that U.S.-based enrollment of new patients into tazemetostat clinical trials is temporarily on hold. Following a safety report of a pediatric patient who developed a secondary lymphoma, the U.S. Food and Drug Administration (FDA) issued a partial clinical hold...

prostate cancer

Concordance of Non–Low-Risk Prostate Cancer Among Brother Pairs

In a Swedish study reported in the Journal of Clinical Oncology, Jansson et al identified an increased risk of non–low-risk prostate cancer among men with prostate cancer who had with brothers diagnosed with non–low-risk disease. Study Details The study involved 4,262 pairs of...

lung cancer
gastroesophageal cancer

ESTRO 37: Positioning for Radiotherapy and Impact on Survival in Patients With Lung or Esophageal Cancers

Very small differences in the way a patient lies during radiotherapy treatment for lung or esophageal cancer can have an impact on survival, according to research presented at the European Society for Radiotherapy & Oncology (ESTRO) 37 Conference (Abstract OC-0322). These differences of only a...

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