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issues in oncology

Up-to-Date Labels for Older Drugs Essential for Appropriate Use

  Oncology drug labels, especially those that have been on the market for more than 15 years, may not always be up-to-date. Critical data about safety, efficacy, or prescribing information may be missing. Modernizing the labeling process can correct inaccurate information, add data for indications ...

hematologic malignancies
multiple myeloma
immunotherapy

Daratumumab in Previously Treated Multiple Myeloma

  On June 16, 2017, daratumumab -(Darzalex) was approved for use in combination with pomalidomide (Pomalyst) and dexamethasone for treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.1,2 Supporting...

solid tumors
immunotherapy

Pembrolizumab in MSI-H or dMMR Solid Tumors: ‘First Tissue/Site-Agnostic’ Approval by FDA

  On May 23, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) solid tumors progressing following prior treatment and who have no...

hematologic malignancies
leukemia
immunotherapy

Blinatumomab in Relapsed or Refractory B-Cell Precursor ALL

On July 11, 2017, blinatumomab (Blincyto) was approved for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.1,2 Blinatumomab received accelerated approval in December 2014 for the treatment of Philadelphia chromosome (Ph)-negative...

breast cancer

Evaluating the Need for Biopsies During Follow-up Care in Early Breast Cancer

In an analysis of more than 120,000 women diagnosed with and treated for early-stage breast cancer, researchers from The University of Texas MD Anderson Cancer Center determined the rate of additional breast biopsies needed for these patients during their follow-up care. The findings, reported by...

genomics/genetics
issues in oncology

Making Personalized Medicine a Reality for More Patients With Cancer

  This past September, Olivier Elemento, PhD, Associate Director of the Institute for Computational Biomedicine and Director of the Laboratory of Cancer Systems Biology at Weill Cornell Medicine in New York, was named Director of Weill Cornell’s Englander Institute for Precision Medicine. In this...

supportive care
integrative oncology

The State of Integrative Oncology: A New Era

Now that we have entered 2018, let’s take a moment to reflect on how far we have come and what lies ahead in integrative oncology care. Overview To cope with the physical, emotional, and spiritual effects of cancer, and in search of relief from symptoms that their conventional treatments have not...

leukemia
immunotherapy

Updated Analysis of ELIANA Trial Shows Longer-Term Durable Remissions With Tisagenlecleucel in Children, Young Adults With Relapsed/Refractory ALL

Updated results from the ELIANA clinical trial of tisagenlecleucel (Kymriah), formerly CTL019, in relapsed or refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL) have been published by Maude et al in The New England Journal of Medicine. New data include...

issues in oncology

FDA Takes Steps to Improve Transparency in Clinical Trial Information Related to New Drugs

  As part of the U.S. Food and Drug Administration’s (FDA) efforts to enhance transparency around its drug-approval decisions, the FDA is exploring new ways to build on its obligation to share information about product approvals, as announced by FDA Commissioner Scott Gottlieb, MD. The FDA is...

supportive care

For Holly G. Prigerson, PhD, Psychosocial Issues Are at the Heart of End-of-Life Cancer Care

Holly G. Prigerson, PhD, Co-Director of the Weill Cornell Medicine’s Center for Research on End-of-Life Care, was born in Maimonides Hospital in Brooklyn, where her father had been a resident. Her family moved to Long Island, first living in Islip, where Dr. Prigerson’s father practiced medicine...

gastrointestinal cancer

Incidence of Noncardia Gastric Cancer Increasing Among Americans Under 50

A type of cancer that occurs in the lower stomach has been increasing among some Americans under the age of 50, even though in the general population, the incidence of all stomach cancers has been declining for decades. These findings were published by Anderson et al in the Journal of the National...

issues in oncology

Obstetric and Neonatal Outcomes With Cancer Diagnosed During Pregnancy

As reported by de Haan et al in The Lancet Oncology, data from the International Network on Cancer, Infertility and Pregnancy (INCIP) registry indicate that use of chemotherapy during pregnancy has increased over a 20-year period, and that infants exposed to antenatal chemotherapy may be more...

immunotherapy

CAR T-Cell Immunotherapy Named Advance of the Year in ASCO’s Clinical Cancer Advances 2018

A new and unique new way to treat cancer—chimeric antigen receptor (CAR) T-cell therapy—is poised to transform the outlook for children and adults with certain otherwise incurable cancers. ASCO named this type of adoptive-cell immunotherapy the Advance of the Year in its annual...

pancreatic cancer
gastrointestinal cancer

FDA Approves Lutetium Lu-177 Dotatate for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...

breast cancer
colorectal cancer
gynecologic cancers
hepatobiliary cancer
lung cancer
pancreatic cancer
gastroesophageal cancer

Detecting and Localizing Eight Cancer Types With One Multianalyte Blood Test

Johns Hopkins Kimmel Cancer Center researchers developed a single blood test that screens for eight common cancer types and also helps identify the location of the cancer. The test, called CancerSEEK, is a unique noninvasive, multianalyte test that simultaneously evaluates levels of eight cancer...

multiple myeloma

Role of Bone-Modifying Agents in Multiple Myeloma: ASCO Clinical Practice Guideline Update

As reported in the Journal of Clinical Oncology by Kenneth Anderson, MD, of Dana-Farber Cancer Institute, and colleagues, ASCO has issued a clinical practice guideline update on the role of bone-modifying agents in multiple myeloma. The update was informed by an expert panel systematic literature...

multiple myeloma
immunotherapy

FDA Grants Priority Review for Daratumumab in Front-Line Multiple Myeloma Setting

On January 19, the U.S. Food and Drug Administration (FDA) granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone for the treatment of patients with newly diagnosed...

prostate cancer

Internationally Renowned Prostate Cancer Expert Gerald E. Hanks, MD, Dies

FROM WILHELM RÖNTGEN’S groundbreaking discovery of x-rays in 1895, the history of radiotherapy has been rich with colorful paradigm-changing researchers and physicians who over the past century have transformed the field into one of the pillars of cancer treatment. One such trailblazer who...

palliative care

Working Together to Help Pediatric Patients With Cancer Live and Live Well

While many patients with cancer can benefit from palliative care to ease symptoms from the disease or its treatment, for children with cancer, especially critically ill children, palliative care can provide an additional layer of medical and emotional support for both young patients and their...

prostate cancer

Pomegranates and Other Polyphenols: New Evidence to Share With Prostate Cancer Patients

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, Channing Paller, MD, explores the role of pomegranate- and grape-based...

leukemia

FDA Approves Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia

ON JANUARY 15, 2018, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly diagnosed low-risk acute promyelocytic leukemia whose disease is characterized by the presence of the...

solid tumors
breast cancer

FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who...

solid tumors
lung cancer

ASCO Endorsement of ASTRO Guideline on Stereotactic Body Radiotherapy for NSCLC Highlights Shared Patient Decision-Making

As reviewed in this issue of The ASCO Post, a recent ASCO panel, chaired by Bryan Schneider, MD, and Brendon Stiles, MD, has provided an endorsement of a recently published guideline on the use of stereotactic body radiotherapy for non–small cell lung cancer.1 The original guideline,2 developed and ...

solid tumors
lung cancer

ASCO Endorses ASTRO Guideline on Stereotactic Body Radiotherapy for Early-Stage NSCLC

As reported in the Journal of Clinical Oncology by Bryan J. Schneider, MD, of the University of Michigan, Ann Arbor, and colleagues, ASCO has endorsed the recently released American Society for Radiation Oncology (ASTRO) evidence-based guideline on stereotactic body radiotherapy (SBRT) in early...

Diary of a Storm

FOR DAYS BEFORE HURRICANE HARVEY was expected to move toward Houston, Texas, on Sunday, August 27, 2017, after pummeling other cities in Texas and Louisiana, the leadership team at The University of Texas MD Anderson Cancer Center (MD Anderson) in Houston strategized on how to ensure the...

bladder cancer
immunotherapy

Pembrolizumab in Advanced Urothelial Carcinoma

On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...

lung cancer

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

 On May 26, 2017, ceritinib (Zykadia) was granted regular approval for treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by a U.S. Food and Drug Administration–approved test.1,2 In 2014, the drug received ...

supportive care

Mackenzi Pergolotti, PhD, OTR/L: A Leader in the Emerging Field of Occupational Therapy in Oncology

Oncology occupational therapist Mackenzi Pergolotti, PhD, OTR/L, was born in Buffalo, New York. “I lived there until I was 6,” she shared. “Then my family moved around the state a bit, finally settling in the small town of Bath, situated near the Finger Lakes—a beautiful area in central New ...

ASCO Calls for Streamlining of Adverse Events Reporting for Cancer Clinical Trials

ASCO HAS released recommendations to streamline serious adverse events reporting for cancer clinical trials. The ASCO research statement, published last month in the Journal of Clinical Oncology (JCO), discusses strategies to address the high volume of uninformative adverse events reports submitted ...

pancreatic cancer
immunotherapy

Steven D. Leach, MD, on Pancreatic Cancer: Keynote Lecture

Steven D. Leach, MD, of Dartmouth University’s Norris Cotton Cancer Center, discusses the personalized approach that GI cancers will require to make rational use of immunotherapy—including a subset of pancreatic cancers, which appear to be highly immunogenic and are associated with long-term...

gastrointestinal cancer

2018 GI CANCERS SYMPOSIUM: First-Line Ramucirumab in Gastric Cancer Improves Progression-Free but Not Overall Survival

The monoclonal antibody ramucirumab (Cyramza) was evaluated as first-line therapy for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma in the international phase III RAINFALL trial. Charles Fuchs, MD, of Yale New Haven Health in Connecticut, presented findings...

gastrointestinal cancer
immunotherapy

2018 GI CANCERS SYMPOSIUM: KEYNOTE-224 Trial: Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib

Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...

issues in oncology
survivorship

Preserving Sexual Function in Women Treated for Cancer

“There is huge potential to positively influence a patient’s experience and outcomes” by addressing concerns about sexual function after cancer treatment early in the course of treatment planning, Stacy Tessler Lindau, MD, MA, stated in her keynote address at the 11th Annual Oncofertility...

Expert Point of View: Robert Brodsky, MD and Henry Fung, MD, FACP, FRCPE

“Several new drugs that have been approved for the treatment of chronic lymphocytic leukemia (CLL) are changing the landscape of this disease. CLL is associated with a long survival, so we will need longer follow-up to see how deep the responses are,” said Robert Brodsky, MD, Director of...

hematologic malignancies
lymphoma
immunotherapy

Update on CAR T-Cell ‘Breakthrough’ Therapy in Lymphoma

Primary analysis of the JULIET trial adds to mounting evidence that chimeric antigen receptor (CAR) T-cell therapy is effective for the treatment of lymphoma in patients with no other good treatment options. A single infusion of CAR T cells (CTL019) achieved durable remissions in almost 40% of...

hematologic malignancies
lymphoma

Best Outcomes to Date in Older Patients With Hodgkin Lymphoma

  Older patients with Hodgkin lymphoma typically do not fare as well as younger patients on standard regimens. A phase II study reported the best outcomes to date in older patients with Hodgkin lymphoma who were treated with sequential brentuximab vedotin (Adcetris) before and after a regimen of...

lung cancer
issues in oncology

Barriers to Treatment in Limited-Stage Small Cell Lung Cancer

In a study reported in JAMA Oncology, Pezzi et al found that lack of health insurance, including Medicare and Medicaid, was associated with not receiving combined-modality therapy in limited-stage small cell lung cancer (SCLC). They also found that lack of insurance was associated with poorer...

hematologic malignancies

Study Findings on Novel Therapies for Hematologic Malignancies

  Here is an update on five different studies featured at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition. Topics center on possible newer treatment regimens in both Hodgkin and Burkitt lymphomas, relapsed or refractory chronic lymphocytic leukemia, and newly...

solid tumors
immunotherapy

Trastuzumab-dkst Approved as Biosimilar to Trastuzumab

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 December 1, 2017, trastuzumab-dkst (Ogivri) was...

Expert Point of View: C. Kent Osborne, MD, FASCO and Lisa Carey, MD

C. Kent Osborne, MD, FASCO, Director of the Dan L. Duncan Comprehensive Cancer Center at Baylor College of Medicine, Houston, who moderated a press briefing where the results were presented, called the findings “intriguing” but too premature for the clinic. “We don’t know what to do with the data ...

Expert Point of View: Virginia Kaklamani, MD and Harold Burstein, MD, PhD, FASCO

Press briefing moderator Virginia Kaklamani, MD, Professor of Medicine at The University of Texas Health Science Center, San Antonio, along with Harold Burstein, MD, PhD, FASCO, Associate Professor of Medicine at Harvard Medical School, commented on the National Surgical Adjuvant Breast and Bowel ...

hematologic malignancies
lymphoma

Mogamulizumab in Cutaneous T-Cell Lymphoma

The anti-CCR4 monoclonal antibody mogamulizumab may answer an unmet need in providing an effective treatment of cutaneous T-cell lymphoma. In the phase III MAVORIC trial reported at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, treatment with mogamulizumab was...

hematologic malignancies
lymphoma
immunotherapy

ECHELON-1: A Commendable Study, but Questions Remain

“The important thing is not to stop questioning. Curiosity has its own reason for existing.” —Albert Einstein The phase III international ECHELON-1 study, designed to evaluate brentuximab vedotin (Adcetris) as part of a front-line chemotherapy regimen for previously untreated advanced classic...

symptom management

Safety Information on Rolapitant Injectable Emulsion

The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...

leukemia

Arsenic Trioxide With Tretinoin for First-Line Treatment of Acute Promyelocytic Leukemia Approved by the FDA

On January 15, the U.S. Food and Drug Administration (FDA) approved the use of arsenic trioxide (Trisenox) injection in combination with tretinoin for the treatment of adults with newly-diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17)...

colorectal cancer

2018 GI CANCERS SYMPOSIUM: Liquid Biopsy Test May Detect Early-Stage Colorectal Cancer

A new study has found that a test that identifies circulating tumor cells (CTCs) present in the bloodstream can detect colorectal cancer at an early stage, with accuracy ranging from 84% to 88%. Most prior studies using CTCs have been able to detect late-stage colorectal cancer, and this study is...

lung cancer
issues in oncology

Study Finds Adolescents Using Alternative Tobacco Products Are More Likely to Smoke 1 Year Later

Nonsmoking adolescents who use e-cigarettes, smokeless tobacco, or tobacco water pipes are more likely to start smoking conventional cigarettes within a year, according to new research by the University of California, San Francisco (UCSF). Findings were published by Watkins et al in JAMA...

head and neck cancer

CAP Guideline Details HPV Testing in Head and Neck Carcinomas

Patients with certain head and neck cancers who test positive for high-risk types of human papillomavirus (HPV) have a better prognosis and may need less aggressive treatment. To help ensure that patients with these cancers are accurately diagnosed and effectively treated, the College of...

breast cancer

FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer

Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...

issues in oncology
cost of care

Out-of-Pocket Costs and Prescription Abandonment of Novel Oral Anticancer Agents

In a retrospective claims-based study reported in the Journal of Clinical Oncology, Doshi et al found that higher out-of-pocket costs were associated with increased rates of prescription abandonment for novel oral anticancer agents. Study Details The study involved data on 38,111 patients from...

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