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Showing 7901 - 7950FDA Grants Priority Review to Lorlatinib in ALK-Positive NSCLC
On February 12, the U.S. Food and Drug Administration (FDA) accepted and granted Priority Review to Pfizer’s new drug application for lorlatinib. The Prescription Drug User Fee Act goal date for a decision by the FDA is in August 2018. Lorlatinib is an investigational, anaplastic lymphoma...
FDA Grants Premarket Approval to New HPV Assay
On February 14, Becton, Dickinson and Company (BD) announced it had received premarket approval from the U.S. Food and Drug Administration (FDA) for the BD Onclarity human papillomavirus (HPV) assay. The test detects 14 types of high-risk HPV from specimens collected for cervical cancer screening...
2018 SURVIVORSHIP: Many Young Adult Cancer Survivors Forgo Follow-up Care After Cancer Treatment Ends
Despite survivorship guidelines from ASCO and other organizations regarding follow-up care after cancer treatment ends, follow-up care is generally lacking for adolescent and young adult (AYA) cancer survivors. Since AYA cancer survivors are at an increased risk for late effects from their cancer...
2018 SURVIVORSHIP: Therapeutic Sexual Aids Frequently Not Available for Cancer Survivors Who Need Them
Cancer care guidelines recommend that cancer survivors who experience sexual dysfunction after cancer treatment use therapeutic aids to help improve their sexual health. However, a new study of 25 leading cancer centers found that 87% of the centers reported having no sexual aids available on site...
2018 SURVIVORSHIP: Exercise Speeds Improvement in Arm Mobility After Surgery for Breast Cancer
New findings from a clinical trial of women with breast cancer suggest that guided exercise with a physical therapist after lymph node dissection helps women regain their range of arm motion more quickly. These findings will be presented by Paskett et al at the upcoming 2018 Cancer Survivorship...
2018 SURVIVORSHIP: Exercising During Chemotherapy for Breast or Colon Cancer Has Long-Term Benefits
A follow-up study to a randomized clinical trial reveals that exercising during adjuvant chemotherapy helps people engage in more physical activity years later. Four years later, people with breast or colon cancer who had participated in an 18-week exercise program while receiving chemotherapy...
2018 GU CANCERS SYMPOSIUM: Combination Therapy Shows Antitumor Activity in Advanced Renal Cell Carcinoma
Combining the antiangiogenic agent axitinib (Inlyta) with the immunotherapy pembrolizumab (Keytruda) was found to have promising antitumor activity and no unexpected side effects in an early-phase clinical trial in patients with advanced kidney cancer who had not been previously treated. The full...
Viviane Tabar, MD, Named Chair of the Department of Neurosurgery at Memorial Sloan Kettering Cancer Center
VIVIANE TABAR, MD, has been named the new Chair of the Department of Neurosurgery at Memorial Sloan Kettering Cancer Center (MSK). Dr. Tabar has been a faculty member at MSK for more than 15 years and is currently the Theresa C. Feng Chair for Neurosurgical Oncology and the Vice Chair for...
Avelumab in Advanced Urothelial Carcinoma: Further Study Needed to Clarify its Role
AS REVIEWED in this issue of The ASCO Post, Patel and colleagues have presented data from the phase I JAVELIN study evaluating avelumab (Bavencio) in platinum-refractory patients with advanced urothelial carcinoma.1 The drug is active with durable responses when compared with historical...
Avelumab Active in Advanced Urothelial Carcinoma After Platinum Failure
AS REPORTED in The Lancet Oncology by Manish R. Patel, MD, of Florida Cancer Specialists/Sarah Cannon Research Institute, and colleagues, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic...
Differentiating Cancerous Prostate Tissue From Benign Tissue
Using nuclear medicine, German researchers may have found a way to accurately differentiate cancerous tissue from healthy tissue in prostate cancer patients. The research is highlighted in findings published by Rahbar et al in The Journal of Nuclear Medicine. These new findings demonstrate that...
EXPERT POINT OF VIEW: Eric P. Winer, MD, FASCO; Heikki Joensuu, MD; and Julie Gralow, MD, FASCO
IN INTERVIEWS with The ASCO Post and in discussions held during the meeting, several breast cancer experts weighed in on the findings of GeparSepto and CALGB 40502. Eric P. Winer, MD, FASCO, Chief of the Division of Women’s Cancers and the Thompson Senior Investigator in Breast Cancer Research at ...
Updates of Key Studies Differ on Relative Benefit of Nab-Paclitaxel in Breast Cancer
TWO IMPORTANT STUDIES, both updates of earlier findings and presented at the 2017 San Antonio Breast Cancer Symposium, provided different findings as to the relative benefit of nanoparticle albumin-bound (nab)-paclitaxel (Abraxane), vs solvent-based paclitaxel in breast cancer. “The two studies...
EXPERT POINT OF VIEW: C. Kent Osborne, MD, and Joseph Sparano, MD
“ONCOLOGISTS WANT to find drugs that will delay the use of chemotherapy, and cyclin-dependent kinase (CDK) 4/6 inhibitors provide that. These agents work better than chemotherapy and with less toxicity,” said press conference moderator C. Kent Osborne, MD, Director of the Duncan Cancer Center at...
CDK 4/6 Inhibitors May Be Effective but More Toxic in Older Women
OLDER WOMEN with breast cancer derive benefit from treatment with cyclin-dependent kinase (CDK) 4/6 inhibitors as part of initial endocrine-based therapy for hormone receptor–positive, HER2-negative, metastatic breast cancer, according to a retrospective pooled subgroup analysis of women aged 70 or ...
EXPERT POINT OF VIEW: William Sikov, MD, and Carlos L. Arteaga, MD
BREAST CANCER EXPERTS found the small differences in benefit for 1 year vs 9 weeks of adjuvant trastuzumab (Herceptin) in the SOLD trial to be provocative. William Sikov, MD, of Women and Infants Hospital of Rhode Island’s Breast Health Center and the Warren Alpert Medical School of Brown...
Trastuzumab for 9 Weeks Fails to Show Noninferiority in HER2-Positive Breast Cancer
ANOTHER TRIAL has validated that 1 year of adjuvant trastuzumab (Herceptin) remains the standard in HER2-positive breast cancer, but the margin of difference, compared with just 9 weeks of the drug, was slim, based on the findings of the phase III SOLD trial reported at the 2017 San Antonio Breast...
Precision Medicine: Hope or Hype?
ALTHOUGH PRECISION medicine may be a recent discovery in some fields, it is an old story in the field of breast cancer, and one that has been exceptionally important in terms of managing the disease, according to George Sledge, MD, FASCO, Professor of Medicine and Medical Oncologist at the...
EXPERT POINT OF VIEW: Neil P. Shah, MD, PhD; Joseph M. Connors, MD; and Kenneth C. Anderson, MD
NEIL P. SHAH, MD, PhD, Leader of the Hematopoietic Malignancies Program at the University of California, San Francisco, Helen Diller Family Cancer Comprehensive Cancer Center, noted that BLU- 285 could fill an “unmet medical need” for a KIT inhibitor that is “both potent and selective.” He pointed ...
Novel Agent Appears Active in Advanced or Aggressive Systemic Mastocytosis
THE INVESTIGATIONAL agent BLU-285 (avapritinib) has shown significant activity in patients with advanced or aggressive forms of systemic mastocytosis, a rare blood disorder that originates in mast cells, according to the findings of a phase I trial reported at the 2017 American Society of...
CONCORD-3: Global Surveillance of Cancer Survival Trends, 2000–2014
In an article in The Lancet, Allemani et al reported findings from the CONCORD program for global surveillance of cancer survival trends updated through 2014 (CONCORD-3). Study Details CONCORD-3 includes data on 37.5 million patients diagnosed with cancer between 2000 and 2014 from...
ASCO Clinical Practice Guideline: Treatment of Malignant Pleural Mesothelioma
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 treatment of malignant pleural mesothelioma. The guideline was informed by a systematic literature search and expert panel review ...
Patient Refusal of Esophagectomy and Long-Term Survival
Patients with esophageal cancer who refuse surgery when it is recommended are less likely to survive long term than similar groups of patients who undergo an operation, according to research presented by Ghaly et al at the 54th Annual Meeting of The Society of Thoracic Surgeons (P78). ...
2018 GU CANCERS SYMPOSIUM: Chemotherapy Added to Hormone Therapy for Prostate Cancer Improves Quality of Life
A new analysis of the ongoing STAMPEDE clinical trial found that adding docetaxel to hormone therapy for advanced prostate cancer improves quality of life and lowers the need for subsequent therapy. Docetaxel was also found to be cost-effective. These findings will be presented by James et al at...
2018 GU CANCERS SYMPOSIUM: Adding Immunotherapy to Standard Treatment Slows Growth of Advanced Kidney Cancer—With Fewer Side Effects
In a phase III clinical trial of patients with previously untreated metastatic renal cell cancer combining the immunotherapy atezolizumab (Tecentriq) with the targeted therapy bevacizumab (Avastin) delayed cancer growth by about 3 months longer than sunitinib, another targeted therapy. The benefit...
2018 GU CANCERS SYMPOSIUM: New Model Predicts Survival for People With Bladder Cancer Receiving Immunotherapy
Researchers have developed a model to predict overall survival for people with advanced urothelial cancers treated with the immune checkpoint inhibitor atezolizumab (Tecentriq). The model, which is based on six clinical factors, may help inform treatment decisions for use of atezolizumab in these...
2018 GU CANCERS SYMPOSIUM: Apalutamide Delays Prostate Cancer Metastases by More Than 2 Years
Findings from the phase III placebo-controlled SPARTAN trial suggest that apalutamide is an effective treatment for men with nonmetastatic castration-resistant prostate cancer who are at high risk for developing metastatic disease and for whom no approved treatments exist. Men who received...
EXPERT POINT OF VIEW: Stephen Leong, MD
STEPHEN LEONG, MD, of the University of Colorado Comprehensive Cancer Center, Aurora, discussed the RAINFALL findings at the symposium, commenting, “The study did meet its primary endpoint of progression-free survival; however, it was disappointing not to see a benefit in overall survival or...
Ramucirumab/Chemotherapy in Gastric Cancer: ‘Positive’ Trial but Insufficient Benefit
BASED ON EFFICACY seen in the second-line setting for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, ramucirumab (Cyramza) was evaluated as first-line therapy in the international phase III RAINFALL trial. Although the study met its primary endpoint, with a 25%...
Bone-Modifying Agents in Metastatic Breast Cancer: Time to De-escalate Dosing Intervals
AS REVIEWED in this issue of The ASCO Post, ASCO and Cancer Care Ontario (CCO) have issued an updated guideline on the role of bone-modifying agents in metastatic breast cancer.1 The updated guideline supports a change in clinical practice for our patients with breast cancer and bone metastasis....
Changing Negative Perceptions on the Impact of Clinical Trials in Brazil
CLINICAL TRIALS are an essential research tool to advance medical knowledge and patient care. Traditionally, the majority of pharmaceutical-sponsored clinical trials have been implemented in Western Europe and North America. More recently, however, large pharmaceutical companies have increased...
FDA Approves Radiopharmaceutical for Rare Gastrointestinal Cancers
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be...
Expect Questions About Necessity of Chemotherapy for Early-Stage Breast Cancer
“For patients with early-stage breast cancer, we’ve seen a significant decline in chemotherapy use over the past few years without a real change in evidence,” or in national guidelines and recommendations, reported Allison W. Kurian, MD, MSc, lead author of a study on chemotherapy recommendations ...
Steep Decline in Chemotherapy Use for Early-Stage Breast Cancer
The use of chemotherapy to treat women with early-stage breast cancer “declined markedly over time,” according to analysis of data from 2,926 women between the ages of 20 and 79. The trends documented “are remarkable for their steepness of decline, independent of clinical factors and despite no...
I’m Not a Victim of Cancer
What I thought after feeling a large, hard lump—similar to the feel of a granola bar—in my left breast was that I probably pulled a muscle while playing with my two young children, ages 7 and 5. Cancer never entered my mind until I asked my husband to feel the lump, and he immediately said, with...
The Toxicity of Time
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,...
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 ...
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...
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...
Enasidenib in IDH2-Mutant Relapsed or Refractory Acute Myeloid Leukemia
On August 1, 2017, the IDH2 inhibitor enasidenib (Idhifa) was granted regular approval for treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by a U.S. Food and Drug Administration (FDA)-approved...
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...
Potential Effect of Excess Body Weight on Detection of Cervical Precancer
In a study reported in the Journal of Clinical Oncology, Clarke et al found that increasing body mass index (BMI) was associated with lower rates of cervical precancer diagnosis and higher rates of cervical cancer diagnosis. The investigators had hypothesized that increased body mass could decrease ...
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...
The Roller Coaster
The following essay by Shaker R. Dakhil, MD, FACP, is adapted, with permission, from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Stan Winokur, MD, and Vincent Coppola and published in May 2014. The book is available on Amazon.com and...
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...
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...
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...
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...
CAP, IASLC, AMP Update Guideline for Molecular Testing and Targeted Therapies in Lung Cancer
To ensure that clinicians stay apace and provide optimal patient care, three leading medical societies—the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP)—have updated their...
High Body Fat Levels in Postmenopausal Women With Normal BMI May Be Associated With Increased Breast Cancer Risk
Among postmenopausal women with normal body mass index (BMI), those with higher body fat levels had an increased risk for invasive breast cancer, according to data presented at an American Association for Cancer Research (AACR) Special Conference titled Obesity and Cancer: Mechanisms...
