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genomics/genetics

Human Gene Therapy: Progress and Oversight

The early debate over the social and ethical implications of gene therapy led the National Institutes of Health (NIH) to establish the Recombinant DNA Advisory Committee in 1974. However, the risks of human gene therapies were largely unknown until 1999, when a patient died of a massive immune...

breast cancer

Advanced HER2-Positive Breast Cancer: All Eyes on These Novel Agents

NEW AGENTS for the treatment of advanced HER2-positive breast cancer should be coming soon to your clinic, according to Sara A. Hurvitz, MD, Director of the Breast Cancer Clinical Research Program and Associate Professor of Medicine at the David Geffen School of Medicine at the University of...

issues in oncology
cns cancers

Fine-Tuning an ‘Airport Diagnosis’

HIS HEAD WAS DIFFERENT from those of the other people in line. He bore a matrix of white rows of circular patches on his shaved scalp like a wig. The patches were electrodes, connected by cords to a power supply in a satchel around his shoulder. I was able to make an instant and unfortunate...

issues in oncology

Full Disclosure: What Oncologists Must Tell Patients About Their Experience and Training

Informed consent is an important part of delivering quality cancer care. Traditional ethical and legal rules require clinicians to disclose three types of information: (1) the patient’s diagnosis; (2) the nature of the proposed intervention and its intended benefits, risks, and adverse effects;...

hematologic malignancies
immunotherapy

Allogeneic Hematopoietic Cell Transplantation and Cell Therapy

As part of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several studies of allogeneic hematopoietic cell transplantation (allo-HCT) and cellular therapy, as used in myelodysplastic syndromes (MDS), acute...

Expert Point of View: Christopher L. Hallemeier, MD, and Andrew S. Kennedy, MD

Christopher L. Hallemeier, MD, Associate Professor in Radiation Oncology at the Mayo Clinic, Rochester, and Andrew S. Kennedy, MD, Physician in Chief of Radiation Oncology at Sarah Cannon, Nashville, and Director of Radiation Oncology Research, Sarah Cannon Research Institute, commented on the...

colorectal cancer
gastrointestinal cancer

Study Finds Shorter Treatment Course for Rectal Cancer May Actually Improve Outcomes

In patients with locally advanced rectal cancer, the delivery of all radiotherapy and chemotherapy neoadjuvantly—with a shorter course of radiation—may improve the chance of complete response and downstaging over conventional treatment, according to investigators from Washington University, St....

kidney cancer
immunotherapy

Study Finds Pembrolizumab Active in Advanced Non–Clear Cell Kidney Cancer

IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Response rates were...

prostate cancer
immunotherapy

Nivolumab Combined With Ipilimumab Shows Activity in Prostate Cancer Subsets

In contrast with melanoma, lung cancer, and kidney cancer, immune checkpoint inhibitor therapy has been disappointing in prostate cancer thus far. Because of success in treating other tumor types, interest remains high in exploring the effect of immunotherapy with checkpoint inhibition in prostate...

prostate cancer

Enzalutamide Plus ADT Extends Progression-Free Survival in Metastatic Hormone-Sensitive Prostate Cancer

Adding enzalutamide to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of disease progression or death by 61% compared with ADT plus placebo, according to the results of the ...

gastroesophageal cancer

KEYNOTE-181: Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Esophageal Cancer

IN THE GLOBAL phase III KEYNOTE-181 trial, pembrolizumab as second-line therapy for advanced esophageal cancer did not improve overall survival in the whole population, vs chemotherapy, but did improve survival for patients with strong expression of programmed cell death ligand 1 (PD-L1),...

pancreatic cancer

Trends in Neoadjuvant Therapy for Resectable Pancreatic Cancer

SEVERAL STUDIES at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...

bladder cancer

Antibody-Drug Conjugate Shows Activity in Heavily Pretreated Bladder Cancer

PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...

prostate cancer
immunotherapy

CheckMate 650: Nivolumab and Ipilimumab in Metastatic, Castration-Resistant Prostate Cancer

SOME PATIENTS with metastatic prostate cancer may respond to a combination of immune checkpoint inhibitors after treatment with hormonal therapy and chemotherapy is not successful, according to early results from the phase II CheckMate 650 trial. Principal Investigator Padmanee Sharma, MD, PhD,...

prostate cancer

Interim Analysis of the ARCHES Trial: Enzalutamide Plus Androgen-Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer

ADDING ENZALUTAMIDE to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of progression or death by 61% compared with ADT plus placebo, according to results of the phase III...

prostate cancer

ARAMIS Trial: Darolutamide in High-Risk Nonmetastatic Prostate Cancer

THE INVESTIGATIONAL androgen receptor inhibitor darolutamide significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer vs placebo in the large phase III ARAMIS trial.1 Men treated with darolutamide had a median metastasis-free survival...

kidney cancer
immunotherapy

Pembrolizumab/Cabozantinib Shows Activity in Previously Treated Renal Cell Carcinoma

THE COMBINATION of pembrolizumab and cabozantinib demonstrated antitumor activity in patients with previously treated metastatic renal cell carcinoma and both drugs were tolerable at their approved doses, according to data from a dose-escalation cohort of a phase I study.1 Among eight patients with ...

kidney cancer
immunotherapy

JAVELIN Renal 101: Avelumab Plus Axitinib vs Sunitinib in the First-Line Treatment of Advanced Kidney Cancer

THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri,...

kidney cancer
bladder cancer
prostate cancer
hepatobiliary cancer

Conference Highlights From the 2019 Gastrointestinal and Genitourinary Cancers Symposiums

THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...

skin cancer

Patient-Reported Outcomes in the COMBI-AD Trial

In a study focused on the phase III COMBI-AD trial reported in The Lancet Oncology, Schadendorf et al found no difference in patient-reported outcomes with adjuvant dabrafenib plus trametinib vs placebo in patients with resected BRAF V600E– or BRAF V600K–mutant stage III melanoma. The...

gastroesophageal cancer

AACR 2019: Small Study of Virotherapy Plus Radiotherapy for Patients With Esophageal Cancer Unable to Receive Standard Treatments

The experimental oncolytic adenovirus telomelysin in combination with radiotherapy was safe and showed early clinical efficacy in vulnerable patients with esophageal cancer, according to results from a phase I clinical trial presented by Fujiwara et al at the American Association for ...

gynecologic cancers
immunotherapy

Lenvatinib Plus Pembrolizumab in Advanced Endometrial Cancer

In an interim analysis of a phase II study reported in The Lancet Oncology, Makker et al found that lenvatinib plus pembrolizumab was active in advanced endometrial cancer. Study Details In the study, 54 patients from 11 sites with metastatic endometrial cancer unselected for microsatellite...

issues in oncology
symptom management

Differences in Medical Cannabis Use in Patients With and Without Cancer

People with and without cancer are more likely, over time, to use a more potent form of medical marijuana with increasingly higher amounts of tetrahydrocannabinol (THC), a new study published by Kim et al in the Journal of Palliative Medicine has shown. “Although there is growing...

pancreatic cancer

AACR 2019: Maintenance Rucaparib Treatment in BRCA- or PALB2-Mutated Pancreatic Cancer

Maintenance treatment with the PARP inhibitor rucaparib was well tolerated and showed activity among patients with advanced BRCA- or PALB2-mutated pancreatic cancer sensitive to platinum-based chemotherapy, according to results from an interim analysis of an ongoing phase II clinical...

skin cancer
immunotherapy

AACR 2019: Entinostat Plus Pembrolizumab in Patients With Melanoma Previously Treated With Anti–PD-1 Therapy

A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...

pancreatic cancer
immunotherapy

AACR 2019: CD40 Antibody Combined With Chemotherapy in Advanced Pancreatic Cancer

An interim analysis of a small phase Ib study by O’Hara et al evaluating the CD40 agonistic monoclonal antibody APX005M in combination with gemcitabine and nab-paclitaxel with or without the programmed cell death protein 1 (PD-1) inhibitor nivolumab in untreated patients with metastatic...

lung cancer
immunotherapy

AACR 2019: Data Analysis Shows Activity of Pembrolizumab in Pretreated Patients With Advanced Small Cell Lung Cancer

The results of an analysis of pooled data from the phase Ib KEYNOTE-028 trial and the phase II KEYNOTE-158 study of the anti–programmed cell death protein 1 monoclonal antibody pembrolizumab in the treatment of advanced small cell lung cancer has found that the therapy provided antitumor...

FDA Oncology Center of Excellence Issues Annual Report

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) has issued its 2018 Annual Report, including updates on regulatory reviews and initiatives, OCE programs, guidances, and more. Regulatory Reviews The OCE is tasked with clinical medical oncology reviews, irrespective...

ASCO Multidisciplinary Cancer Management Course in Azerbaijan: A Well-Attended Success

The National Center of Oncology (NCO) in Azerbaijan partnered with ASCO, the American Society for Clinical Pathology (ASCP), and the Oncology Nursing Society (ONS) to conduct a highly successful Multidisciplinary Cancer Management Course (MCMC) in September 2018 in Baku, Azerbaijan. The conference...

prostate cancer

ASCO Endorses Active Surveillance Guideline for Low-Risk Prostate Cancer

ASCO ENDORSES and reinforces the evidence-based American Urological Association (AUA), American Society for Radiation Oncology (ASTRO), and the Society of Urologic Oncology (SUO) Guideline published in 2018 in the Journal of Urology. ASCO’s endorsement of a guideline on clinically localized...

prostate cancer

Prostatectomy vs Watchful Waiting: Clinical Dilemma Centers on Aggressive vs Indolent Disease

THE MANAGEMENT of localized prostate cancer remains controversial. Although the widespread use of prostate-specific antigen (PSA) testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer, many men do not benefit from intervention because the disease is either...

National Cancer Institute Designates Comprehensive Cancer Center Status to NYU Langone’s Perlmutter Cancer Center

NYU LANGONE Health’s Laura and Isaac Perlmutter Cancer Center has been designated a Comprehensive Cancer Center by the National Cancer Institute (NCI). Perlmutter Cancer Center is now among 50 cancer centers across the country to earn this distinction. Perlmutter Cancer Center received an overall...

immunotherapy
multiple myeloma

ASH Reports Show Benefit of Adding Daratumumab to Initial Therapy in Multiple Myeloma

DARATUMUMAB APPEARS to be the “gift that keeps on giving” to the myeloma community. “It seems we can add daratumumab to almost anything and make the regimen better. It’s got good activity and a good safety profile,” said Kenneth Shain, MD, PhD, Director of the Myeloma Working Group at Moffitt...

prostate cancer

PARP Inhibitors Moving Ahead in Prostate Cancer

MULTIPLE POLY (ADP-ribose) polymerase (PARP) inhibitors are under study in metastatic prostate cancer and no clear winner has emerged yet. Some studies suggest that the best use of PARP inhibitors may be in patients whose cancers harbor DNA-repair defects and BRCA1/2 mutations, but other data...

bladder cancer

Antibody-Drug Conjugate Shows Activity in Heavily Pretreated Bladder Cancer

PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...

colorectal cancer
neuroendocrine tumors
gastrointestinal cancer
hepatobiliary cancer

New Data in Colorectal, Neuroendocrine, Gastric, and Hepatocellular Cancers

THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...

lung cancer
immunotherapy

CheckMate 384 Supports More Convenient Dosing of Nivolumab in Advanced NSCLC

PATIENTS WITH advanced non–small cell lung cancer (NSCLC) may no longer have to come to the clinic every 2 weeks for treatment. According to a descriptive analysis of the phase IIIb/IV CheckMate 384 study, a more convenient dosing option of nivolumab has demonstrated convincing short-term safety...

breast cancer

Breast Density Assessment Variation by Screening Modality

Fewer women are assigned to a dense-breast category when evaluated with advanced mammographic screening technologies compared to standard digital mammography, according to a new study published by Gastounioti et al in Radiology. Density Assessment A woman’s breast density is assessed during ...

lung cancer

Ultradeep Next-Generation Sequencing in Patients With Lung Cancer

A new method of determining the sequence of molecules in DNA can be used to detect small fragments of cancerous genetic material in blood samples from patients with lung cancer with a high degree of accuracy, according research published by Li et al in Annals of Oncology. Liquid Biopsies and...

gynecologic cancers
survivorship

Persistent Long-Term Fatigue and Impact on Quality of Life Among Epithelial Ovarian Cancer Survivors

A study among epithelial ovarian cancer survivors from 25 cooperative Gynecologic Cancer Intergroup centers in France showed similar quality of life compared to healthy controls who were randomly selected from the electoral rolls, but persistent long-term fatigue. The researchers found depression,...

issues in oncology

Infertility in Women and Low Absolute Risk of Cancer

A study of over 64,000 women of childbearing age in the United States has found that infertility is associated with a higher risk of developing cancer compared to a group of over 3 million women without fertility problems—although the absolute risk is very low, at just 2%. These findings ...

prostate cancer

AR-V7 Assay Findings and Outcomes With Hormone Therapy in High-Risk Castration-Resistant Prostate Cancer

In the PROPHECY study, reported in the Journal of Clinical Oncology, Armstrong et al found that positive findings on 2 assays for circulating tumor cell (CTC) androgen receptor splice variant 7 (AR-V7) were associated with poorer outcomes for abiraterone and enzalutamide therapy in men with...

gynecologic cancers

SGO 2019: Post Hoc Exploratory Analyses From the ARIEL3 Trial in Recurrent Ovarian Cancer

Data from post hoc exploratory analyses from the phase III ARIEL3 clinical study of rucaparib in recurrent ovarian cancer was presented during oral plenary and poster sessions at the Society of Gynecologic Oncology’s (SGO) 50th Annual Meeting on Women’s Cancer. These analyses...

prostate cancer

Docetaxel Plus Androgen-Deprivation Therapy After Primary Local Therapy in High-Risk Prostate Cancer

In a French phase III trial reported in JAMA Oncology, Stéphane Oudard, MD, PhD, of Hôpital Européen Georges Pompidou, and colleagues found that the addition of docetaxel to androgen-deprivation therapy (ADT) did not improve prostate-specific antigen (PSA) progression-free survival in men with...

Use Technology and Appreciate the Importance of Partners

Most oncologists are comfortable treating lesbian, gay, bisexual, transgender, and queer/questioning (LGBTQ) patients with cancer, according to a survey of 149 oncologists from 45 National Cancer Institute–designated Comprehensive Cancer Centers, but not as confident in their knowledge of the...

breast cancer

Restarting My Life After Terminal Cancer

At the end of 2015, I was dying. I was just 50 years old and a wife and mother of 2 teenage boys. Twelve years earlier, I had been diagnosed with ductal carcinoma in situ in my left breast. Despite a modified radical mastectomy and removal of nearly all of the lymph nodes in my left underarm—which ...

palliative care
supportive care

Sweet Surrender

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,...

WebMD Recognizes Seven Cancer Innovators With Its Health Heroes Award

On January 15, 2019, WebMD, an online and print health-care resource for consumers, presented its 2018 Health Heroes Award in New York City to 7 people who are making a difference in oncology care. The honorees include Karen M. Winkfield, MD, PhD, Associate Professor of Radiation Oncology at Wake...

issues in oncology

The Risks of Drug Approval Based on Shaky Evidence

Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...

solid tumors
bladder cancer

Johns Hopkins Greenberg Bladder Cancer Institute Awards Research Grants to Women’s Bladder Cancer Projects

The Johns Hopkins Greenberg Bladder Cancer Institute awarded research grants to four projects that focus on bladder cancer treatments in women and how biology could offer new targets for cancer therapy.The Institute awards grants of $25,000 to $50,000. David McConkey, PhD, Director of the...

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