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multiple myeloma

Phase III BOSTON Study Finds Selinexor Improves Outcomes in Myeloma

When added to bortezomib and dexamethasone in patients with multiple myeloma, selinexor significantly improved progression-free survival and response rates, with a lower incidence of peripheral neuropathy, compared with bortezomib/dexamethasone alone, according to results from the global phase III...

lung cancer

Addition of Pemetrexed vs Vinorelbine to Adjuvant Cisplatin for Nonsquamous NSCLC

In the Japanese phase III JIPANG trial reported in the Journal of Clinical Oncology, Kenmotsu et al found that adjuvant therapy with pemetrexed/cisplatin did not result in superior recurrence-free survival but was better tolerated than vinorelbine/cisplatin in patients with completely resected...

breast cancer
immunotherapy

Updates From Selected Clinical Trials in Breast Cancer

Each year, The ASCO Post asks Jame Abraham, MD, FACP, Chairman of the Department of Hematology and Medical Oncology at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at 2019 San...

breast cancer
immunotherapy

End-of-Study Results From CLEOPATRA: Pertuzumab, Trastuzumab, and Docetaxel in HER2-Positive Metastatic Breast Cancer

As reported in The Lancet Oncology by Sandra M. Swain, MD, and colleagues, long-term follow-up of the phase III CLEOPATRA trial has shown maintained overall survival benefit with the addition of pertuzumab to trastuzumab plus docetaxel in patients with previously untreated HER2-positive metastatic...

covid-19

A Message From the FDA OCE for Patients With Cancer and Health-Care Providers on COVID-19

On March 23, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) issued the following statement: The FDA OCE recognizes that patients with cancer constitute a vulnerable population at risk of contracting the coronavirus disease (COVID-19). While everyone’s daily lives...

issues in oncology

Update on Project Facilitate at the Oncology Center of Excellence

OCE Insights is an occasional department developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mitchell Chan, PharmD, BCPS, Regulatory Project Manager; Tamy Kim, PharmD, Associate Director of Regulatory ...

lung cancer
immunotherapy

Patient-Reported Outcomes With Addition of Pembrolizumab vs Placebo to Pemetrexed/Platinum for Nonsquamous NSCLC

As reported in The Lancet Oncology by Marina C. Garassino, MD, and colleagues, global health status/quality of life was maintained or improved with the addition of pembrolizumab vs placebo to pemetrexed/platinum therapy for previously untreated metastatic nonsquamous non–small cell lung cancer...

breast cancer

Oral Paclitaxel Outperforms Intravenous Formulation in Phase III Trial

In the first reported phase III study of an oral taxane, an investigational oral form of paclitaxel yielded a higher overall response rate and produced less neuropathy than standard intravenous paclitaxel, researchers reported at the 2019 San Antonio Breast Cancer Symposium.1 “Oral paclitaxel...

breast cancer

SABCS 2019: Oral vs Intravenous Paclitaxel for Patients With Metastatic Breast Cancer

Patients with metastatic breast cancer who received an oral formulation of paclitaxel had better response and survival and less neuropathy than patients who received intravenous paclitaxel, according to results of a phase III trial presented at by Umanzor et al at the San Antonio Breast Cancer...

issues in oncology

Project Facilitate: FDA’s Plan to Ease Expanded Access to Novel Therapies

The U.S. Food and Drug Administration (FDA) plans to provide oncologists with greater help in acquiring expanded access to investigational therapies. Deemed Project Facilitate, the pilot program was announced at a press briefing during the 2019 ASCO Annual Meeting. Project Facilitate is essentially ...

issues in oncology

Richard Pazdur, MD, on the Launch of Project Facilitate

Richard Pazdur, MD, Director of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence and Acting Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, discusses the launch of Project Facilitate, a new pilot program to...

issues in oncology

FDA Announces Project Facilitate

Today, the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence announced a new pilot program to assist oncology health-care professionals in requesting access to unapproved therapies for patients with cancer. A new call center designated Project Facilitate will be a single point...

issues in oncology

2019 ASCO: Sexual Harassment and Gender Disparities: Survey of Gynecologic Oncologists

A recent survey of U.S.-based physician members of the Society of Gynecologic Oncology found that 64% of respondents experienced sexual harassment in training or practice; among women, the rate was 71% and among men, it was 51%. Only 10% reported the incident(s) to officials. In addition, women...

Expert Point of View: Irene Ghobrial, MD, and Monica M. Bertagnolli, MD, FACS, FASCO

Irene Ghobrial, MD, of Dana-Farber Cancer Institute and Harvard Medical School, Boston, who has conducted seminal trials in smoldering myeloma, commented on the phase III E3A06 study. Asked by The ASCO Post whether E3A06 settles the issue of treating smoldering disease, Dr. Ghobrial responded,...

immunotherapy
multiple myeloma

Multiple Myeloma Pipeline Filled With CAR T-Cell Therapies

The burgeoning pipeline of chimeric antigen receptor (CAR) T-cell therapies targeting B-cell maturation antigen (BCMA) in multiple myeloma was on full display at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition. A bispecific antibody also made its debut in this busy...

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...

lymphoma
immunotherapy

More Antibody-Drug Conjugates Expected to Impact Treatment of Lymphoma

FOR THE TREATMENT of lymphoma, antibody-drug conjugates (ADCs) are becoming an important class of drugs, as described at the 2018 Pan Pacific Lymphoma Conference by Brad Kahl, MD, Professor of Medicine at Washington University School of Medicine, St. Louis.1  “We have one ADC—brentuximab vedotin...

integrative oncology

Acupressure for Cancer-Related Fatigue

Difficult-to-treat, cancer-related fatigue is a common, distressing clinical issue. It impedes daily activities, severely affecting patients’ quality of life. Compounding the problem is a lack of consensus on an effective pharmacologic intervention. Acupressure is a traditional Chinese medicine...

lung cancer
immunotherapy

Addition of Atezolizumab to Bevacizumab and Chemotherapy in First-Line Treatment of Metastatic Nonsquamous NSCLC

As reported at the 2018 ASCO Annual Meeting and in The New England Journal of Medicine by Socinski et al, the phase III IMpower150 trial has shown that the addition of atezolizumab (Tecentriq) to bevacizumab (Avastin) plus chemotherapy significantly improved progression-free and overall survival in ...

head and neck cancer

Concurrent Chemoradiotherapy With Nedaplatin vs Cisplatin in Nasopharyngeal Carcinoma

As reported in The Lancet Oncology by Tang et al, a Chinese phase III noninferiority trial has shown similar progression-free survival with nedaplatin- vs cisplatin-based chemoradiotherapy in patients with stage II to IVB nasopharyngeal carcinoma, with nedaplatin being associated with fewer severe...

breast cancer
immunotherapy

Neoadjuvant Trastuzumab Biosimilar vs Trastuzumab in HER2-Positive Early Breast Cancer

In a phase III trial reported in the Journal of Clinical Oncology, Pivot et al found equivalence of the trastuzumab biosimilar SB3 and the reference trastuzumab (Herceptin) in producing breast pathologic complete response in the neoadjuvant treatment of patients with HER2-positive early breast...

hematologic malignancies

Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma

Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...

solid tumors
lung cancer

Dyadic Yoga Program for Patients With Lung Cancer and Their Caregivers May Optimize Treatment Response

Yoga therapy delivered to patients with lung cancer and their caregivers together appears to be a feasible and beneficial supportive care strategy. According to data presented at the 2017 Palliative and Supportive Care in Oncology Symposium,1 the dyadic intervention resulted in a clinically and...

palliative care
lung cancer

2017 ASCO Palliative Care: Yoga Can Be an Effective Supportive Therapy for People With Lung Cancer and Their Caregivers

In a feasibility trial of people with advanced lung cancer receiving radiation therapy and their caregivers, yoga was beneficial to both parties. These findings will be presented by Milbury et al at the upcoming 2017 Palliative and Supportive Care in Oncology Symposium in San Diego (Abstract 125). ...

breast cancer

What Is the Most Important Factor Women Consider in Deciding on SERM Use to Reduce Their Risk of Breast Cancer?

Currently, two medications have been approved by the U.S. Food and Drug Administration to reduce the risk of breast cancer: tamoxifen and raloxifene. Both medications, selective estrogen receptor modulators (SERMs), have been shown to reduce the risk for breast cancer by up to 50% in prevention...

lymphoma

ICML 2017: ADCT-402 Demonstrates Encouraging Antitumor Activity in Relapsed/Refractory Non-Hodgkin Lymphoma

Clinical data from an ongoing phase I clinical trial evaluating ADCT-402 for the treatment of relapsed or refractory non-Hodgkin lymphoma was presented at the 14th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland. ADCT-402 is a novel antibody-drug conjugate composed of a ...

lung cancer

ASTRO Issues Guideline for Use of Stereotactic Radiation in Early-Stage Lung Cancer

The American Society for Radiation Oncology (ASTRO) has issued a new clinical guideline for the use of stereotactic body radiation therapy (SBRT) in early-stage lung cancer. While SBRT is the current standard of care for peripherally located tumors in patients who cannot undergo surgery, the new...

breast cancer
symptom management

OPTIMIZE-2 Trial Offers Reassuring Data on Deescalation of Bisphosphonate Therapy for Breast Cancer–Related Bone Metastases

Bisphosphonates were first synthesized more than a century ago, with their initial usage restricted to a range of industrial processes until their potential clinical relevance was appreciated in the late 1960s.1 Then, following development for the treatment of osteoporosis and Paget’s disease of...

gastrointestinal cancer
colorectal cancer
issues in oncology

Increased Recognition of Colorectal Cancer in Young Adults, Even Those Aged 20 to 29, as Evidence Continues to Accumulate

The incidence of colorectal cancer continues to increase among young adults, with the sharpest increase among those aged 20 to 29, according to a recent article in the Journal of the National Cancer Institute.1 This trend has been called disturbing and ominous, but the widely reported results of...

skin cancer

Binimetinib vs Dacarbazine: Which Was More Effective in NRAS-Mutant Melanoma?

In the phase III NEMO trial reported in The Lancet Oncology, Dummer et al found that treatment with the MEK inhibitor binimetinib improved progression-free survival vs dacarbazine in patients with advanced NRAS-mutant melanoma. Study Details In the open-label trial, 402 patients from 118 sites in ...

Honoring the Life of Nancy E. Armitage

The University of Nebraska community mourns the loss of dedicated community leader and volunteer Nancy E. Armitage of Omaha. She died February 27, 2017, from complications associated with pancreatic cancer. Nancy is remembered for the support and encouragement she offered to others over the years...

colorectal cancer

Germline Cancer Susceptibility Mutations in Early-Onset Colorectal Cancer

In a study reported in JAMA Oncology, Pearlman et al found that 16% of patients with early-onset colorectal cancer had germline cancer susceptibility mutations, with a wide array of such mutations being identified. Heather Hampel, MS, CGC, of The Ohio State University Comprehensive Cancer Center,...

colorectal cancer

Germline Cancer Susceptibility Mutations in Early-Onset Colorectal Cancer

In a study reported in JAMA Oncology, Pearlman et al found that 16% of patients with early-onset colorectal cancer had germline cancer susceptibility mutations, with a wide array of such mutations being identified. The study involved 450 patients diagnosed with colorectal cancer at age < 50...

issues in oncology

Computer-Assisted Decision Support in Medical Oncology: We Need It Now

Today’s medical oncologist is increasingly challenged to stay current with the latest developments in cancer treatment. I have been fortunate to speak with many oncologists over the past quarter-century on how professional life has evolved since the 1990s. These conversations have left me with a...

integrative oncology

Mistletoe

The use of dietary supplements by patients with cancer has increased significantly over the past 20 years despite insufficient evidence of safety and effectiveness. Finding reliable sources of information about dietary supplements can be daunting. Patients typically rely on family, friends, and...

breast cancer

Dual HER2 Blockade Substantially Delays Disease Progression

There is an emerging theme in HER2-positive breast cancer: The greater the pathway inhibition, the better the outcome. The latest evidence comes from the phase III Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) trial of 808 patients with previously untreated metastatic disease. The...

ASCO Launches Oncology Practice Census

How many oncologists are in private practice and how many are employed by hospitals and academic medical centers in the United States? No one knows the answer for sure, but ASCO is undertaking an ambitious national effort to determine where oncologists are practicing these days. Online Survey...

breast cancer

Pertuzumab: New Drug for HER2-positive Metastatic Breast Cancer

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indication In June 2012, pertuzumab (Perjeta) was approved for use...

breast cancer
skin cancer
multiple myeloma
supportive care
gastroesophageal cancer

New Research Presented in Breast, Gastric, Esophageal Cancers, Melanoma, and Multiple Myeloma, plus Supportive Care 

Attendees at the ASCO Annual Meeting are faced with a major challenge of trying to attend as many important sessions as they can over a 4-day period. Our challenge is to feature the major news in The ASCO Post. In addition to our regular comprehensive coverage of key presentations, the following...

multiple myeloma

New Strategies for Relapsed/Refractory Multiple Myeloma Explored 

Although upfront therapy can achieve remission in multiple myeloma, most patients will ultimately relapse. Newer targeted therapies and genomic analysis are moving the management of relapsed/refractory multiple myeloma forward, according to Kenneth C. Anderson, MD, Director, Jerome Lipper Multiple...

survivorship

Ongoing Clinical Trials Actively Recruiting Adolescent and Young Adult Survivors of Childhood Cancer

ADOLESCENT AND YOUNG ADULT CHILDHOOD CANCER SURVIVORS Study Type: Randomized/interventional Study Title: A Randomized Web-Based Physical Activity Intervention in Adolescent Survivors of Childhood Cancer Study Sponsor and Collaborators: St. Jude Children’s Research Hospital Purpose: Five-year...

gynecologic cancers

Desensitization Protocols May Allow Reintroduction of Chemotherapeutic Agents After Hypersensitivity Reactions

Hypersensitivity reactions to chemotherapeutic agents used to treat ovarian cancer are “increasingly common and can greatly limit their use,” according to an article published in the Journal of the National Comprehensive Cancer Network. “Drug desensitization has emerged as a safe and effective way...

leukemia

Ofatumumab Plus Chlorambucil for Previously Untreated CLL in Patients Not Treatable With Fludarabine-Based Regimens

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2014, ofatumumab (Arzerra) received regular approval...

prostate cancer

Beyond the Cystoscope: Thinkers and Technicians

I have spent my career working with urologists. Over a long period of time, I have concluded that they are fine and interesting people who work hard, live well, support interesting hobbies, generally take good care of their families, and are very enjoyable company at parties. The recent discussion...

leukemia

Tissue Microenvironment Affects Activity of PTEN in Leukemia

The tumor suppressor PTEN, which is underexpressed in many cancers, dephosphorylates phosphatidylinositol (3,4,5)-triphosphate and thus inhibits activity of phosphatidylinositol 3-kinases involved in growth factor and survival factor signaling through effectors such as Akt and mTOR. As reported in...

multiple myeloma

Experts Debate the Need for Upfront vs Late Stem Cell Transplant in Multiple Myeloma

With powerful new drugs capable of achieving sustained and deep remissions in multiple myeloma, the role of upfront stem cell transplantation is being questioned by experts, who debated the pros and cons at the National Comprehensive Cancer Network (NCCN) 9th Annual Congress on Hematologic...

multiple myeloma

Impact of High-Dose Melphalan/Autologous Stem Cell Transplant and Lenalidomide Maintenance in Myeloma Patients ≤ Age 65

In a phase III trial reported in The New England Journal of Medicine, Antonio Palumbo, MD, Chief of the Myeloma Unit at the University of Turin, Italy, and colleagues found that high-dose melphalan plus autologous stem cell transplantation improved progression-free survival and overall survival...

prostate cancer

Genomic Score Predicts Aggressiveness of Prostate Cancer in Biopsy Specimens

A prospectively designed study establishes the17-gene Oncotype DX prostate cancer test as a robust and independent predictor of the aggressiveness of prostate cancer based on a patient’s diagnostic specimen. Tumor aggressiveness, as measured by the test’s Genomic Prostate Score, was similar in...

hematologic malignancies
solid tumors

Clinical Trials Actively Recruiting Children and Young Adults With Cancer

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies of children and young adult cancer survivors. The studies include phase I, I/II, III, observational, and interventional trials investigating genomic profiling to personalize treatment;...

bladder cancer

Treating Bladder Cancer in 2015

Treatment of advanced bladder cancer continues to prove challenging, and therapies that offer long-term survival remain elusive. The ASCO Post recently spoke with Derek Raghavan, MD, PhD, FACP, FRACP, FASCO, President of the Levine Cancer Center, Charlotte, North Carolina, about the current state...

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