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ASCO and ESMO Publish Joint Assessment of Their Value Frameworks

To better understand the performance characteristics of ASCO’s Value Framework Net Health Benefit Score version 2 (ASCO-NHB v2) and the European Society for Medical Oncology’s (ESMO’s) Magnitude of Clinical Benefit Scale version 1.1 (ESMO-MCBS v1.1), ASCO and ESMO undertook a...

head and neck cancer
immunotherapy

Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...

Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer

In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...

FDA Approves Romiplostim for Pediatric Patients With Immune Thrombocytopenia

On December 14, 2018, the U.S. Food and Drug Administration (FDA) approved romiplostim (Nplate) for pediatric patients at least 1 year old with immune thrombocytopenia for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. Approval was based ...

FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer

On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...

Genetic Assay May Help Predict Disease Relapse in Patients With Gastroesophageal Cancer

A seven-gene assay could improve care for patients with gastroesophageal cancer by predicting their likelihood of relapse after chemotherapy and surgery. These findings were published by Smyth et al in Annals of Oncology. A team at The Institute of Cancer Research (ICR), London, and The Royal...

colorectal cancer
issues in oncology

Does Tailored Lifestyle Feedback Given During Colorectal Cancer Screening Improve Disease-Preventive Behaviors?

A program that provided individually tailored lifestyle recommendations for patients undergoing screening for colorectal cancer helped encourage healthy behavior, according to results published by Knudsen et al in Cancer Epidemiology, Biomarkers & Prevention. “It is well known that...

Regorafenib in Previously Treated Metastatic Osteosarcoma

In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...

issues in oncology
symptom management

Apixaban Thromboprophylaxis in Patients With Cancer

In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...

Aggressive Squamous Cell Carcinoma in Recipients of Solid Organ Transplant Recipients

Squamous cell carcinoma (SCC) is the most frequently diagnosed cancer in recipients of a solid organ transplant. When organ transplant recipients are diagnosed with SCC, they are also at higher risk for a more aggressive disease course, metastasis, and death than the general population. Researchers ...

colorectal cancer
gynecologic cancers

CIMRA Assay for Detection of Gene Variants in Lynch Syndrome

An international team of researchers has developed, calibrated, and validated a novel tool for identifying the genetic changes in Lynch syndrome genes that are likely to be responsible for causing symptoms of the disease. The results were published by Drost et al in Genetics in Medicine. ...

Addition of Veliparib to Cisplatin/Etoposide in Extensive-Stage SCLC

In the phase II ECOG-ACRIN 2511 trial reported in the Journal of Clinical Oncology, Owonikoko et al found that the addition of the poly (ADP ribose) polymerase (PARP) inhibitor veliparib to cisplatin/etoposide was associated with a modest but statistically significant improvement in...

Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3

An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...

lymphoma
immunotherapy

ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma

As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...

hematologic malignancies

Alexander B. Pine, MD, PhD, on Practices and Preferences for Anticoagulant Therapy in Treating VTE

Alexander B. Pine, MD, PhD, of Yale School of Medicine, discusses a survey gathering data on health-care providers’ practices and preferences in using direct oral anticoagulant therapy to treat venous thromboembolism.

RSNA 2018: Mammography Screening Beyond Age 75

Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....

RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women

A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...

RSNA 2018: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers

Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01). “If the positive preliminary findings are maintained as the ...

SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC

In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non­–small cell lung cancer (NSCLC).  In the study, 100 patients with ...

leukemia
issues in oncology

Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy

In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...

Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas

In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...

breast cancer

Hope S. Rugo, MD, on Metastatic Breast Cancer: Treatment for Pretreated Hormone Receptor–Positive Disease

Hope S. Rugo, MD, of the University of California, San Francisco, discusses how treatment with a lower dose of palbociclib (100 mg vs 125 mg) in combination with fulvestrant or tamoxifen is associated with a lower rate of high-grade neutropenia (Abstract PD2-12).

Vitamin D Supplementation and Cancer Risk

In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...

colorectal cancer
immunotherapy

Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer and Misdiagnosis of MSI or dMMR Status

In a study reported in JAMA Oncology, Cohen et al found evidence that primary resistance to immune checkpoint inhibitor treatment in metastatic colorectal cancer (CRC) can be explained in some cases by misdiagnosis of microsatellite instability (MSI) or defective mismatch repair (dMMR) status....

breast cancer
survivorship

POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause

In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...

ASCO and Friends of Cancer Research Applaud NCI’s Expansion of Clinical Trial Eligibility Criteria

ASCO and Friends of Cancer Research (Friends) applaud the National Cancer Institute's (NCI) recent revision of its clinical trial protocol template to broaden eligibility criteria for cancer clinical trials. The protocol template was expanded to help increase the opportunity for ...

breast cancer
solid tumors
leukemia
lung cancer
lymphoma
multiple myeloma
issues in oncology
immunotherapy

FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...

Every Cancer Treatment Plan Is Different—Help Your Patients Learn About What to Expect

YOUR PATIENTS can be active partners in their treatment. Address patient concerns and questions about core types of treatment with affordable printed materials from ASCO Answers. Topics include oral chemotherapy, understanding immunotherapy, understanding blood test results, and much more. Many of ...

2019 Medicare Physician Fee Schedule and Quality Payment Program Final Rule Released

AT THE BEGINNING of November, the Centers for Medicare & Medicaid Services (CMS) released the final rule for the Medicare Physician Fee Schedule and Quality Payment Program (QPP) outlining reimbursement changes for 2019. CMS estimates that the overall impact will be a 1% reimbursement cut for...

Calling ASCO Members: Join ASCO’s Research Survey Pool Today to Help Inform Research in Oncology

  ASCO IS assembling a cohort of its members who are willing to participate in survey-based research projects of ASCO members for noncommercial purposes. The immense knowledge and experience of ASCO’s membership can help to accelerate the development of new insights that may help to improve cancer...

Oncology Care Team Reduces Opioid Use After Surgery by Using Quality Improvement Approach

IN A QUALITY improvement project that was featured in the Quality Care Symposium press program,1 members of an oncology care team achieved a 46% reduction in opioid use among patients who underwent a range of urologic surgeries. They did this by using a systemic approach that identified multiple...

Scientific and Career Development Retreat: Networking and Collaborating With Promising Researchers

ASCO’s Conquer Cancer Foundation is committed to supporting the research and career development of young researchers through its Grants & Awards Program. On October 10–11, 2018, Conquer Cancer hosted its 4th Scientific and Career Development Retreat at ASCO headquarters in Alexandria,...

genomics/genetics

Role of Genomic Profiling in Younger Patients With Cancer

Although overall cancer survival rates continue to improve among all age groups in the United States—there are currently an estimated 15.5 million cancer survivors, and that number is expected to increase to 20.3 million by 20261—survival rates for adolescents and young adults with cancer (AYAs)...

Oncology Researcher Catherine J. Wu, MD, Always Knew She Wanted to Be a Doctor

Catherine J. Wu, MD, Professor at Dana-Farber Cancer Institute, was reared in a medical environment, which shaped her career path as a physician-scientist. “Both of my parents are physicians and were trained in internal medicine. Medicine was always part of my life as I grew up, and it seemed like...

leukemia

Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia

ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...

skin cancer

Encorafenib and Binimetinib: A New Benchmark in Metastatic Melanoma Therapy?

IN JULY 2018, the U.S. Food and Drug Administration (FDA) approved the combination of the oral BRAF inhibitor encorafenib (Braftovi) and the oral MEK inhibitor binimetinib (Mektovi) for BRAF V600E– or V600K– positive metastatic melanoma. The FDA approval was based on the results of the COLUMBUS...

skin cancer

Encorafenib Plus Binimetinib vs Vemurafenib in Advanced BRAF-Mutant Melanoma

AS REPORTED in The Lancet Oncology by Reinhard Dummer, MD, of the University Hospital Zurich Skin Cancer Center, and colleagues, the phase III COLUMBUS trial has shown a significant improvement in overall survival with the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK...

leukemia
lymphoma

Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular Lymphoma

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 September 24, 2018, duvelisib (Copiktra) was granted...

bladder cancer
immunotherapy

Bladder Cancer: Strategies to Address Checkpoint Inhibitor Failure

CHECKPOINT INHIBITORS have rapidly become the standard of care as second-line treatment, and in some patients first-line treatment, of advanced bladder cancer. However, the majority of patients do not respond and eventually experience disease progression; these patients will need subsequent...

prostate cancer

Shedding Light on Mechanisms of Resistance to Treatment of Metastatic Castration-Resistant Prostate Cancer

ONE OF the pressing issues in metastatic castration-resistant prostate cancer is the development of resistance to therapies directed at the androgen receptor (AR), such as enzalutamide (Xtandi) and abiraterone acetate (Zytiga). Research is ongoing to identify mechanisms of resistance in the hope of ...

breast cancer

Management of HER2-Positive Breast Cancer: Business as Usual?

MANAGEMENT OF HER2-positive breast cancer changed after the introduction of trastuzumab (Herceptin), the first anti-HER2 therapy to be approved by the U.S. Food and Drug Administration (FDA) for this type of cancer. Recent studies have more clearly defined the role of pertuzumab (Perjeta) and...

breast cancer

Expert Point of View: Rebecca Dent, MD, and Suzette Delaloge, MD, MSc

FORMAL DISCUSSANT of the ACE trial, Rebecca Dent, MD, of the National Cancer Center in Singapore, commented that the phase II ENCORE 301 study provided proof of concept that a histone deacetylase (HDAC) inhibitor can reprogram epigenetic changes.1 In that randomized, double-blind,...

breast cancer

HDAC Inhibitor May Overcome Endocrine Resistance in Advanced Breast Cancer

EPIGENETIC CHANGES are associated with the development of cancer, and epigenetic therapy is an attractive strategy for targeting the tumor microenvironment. One approach targeted to epigenetic changes is using histone deacetylase (HDAC) inhibition, which has antitumorigenic effects including growth ...

colorectal cancer
immunotherapy

Expert Point of View: Julien Taieb, MD

JULIEN TAIEB, MD, Professor of Medicine at Paris Descartes University in France, said the MODUL cohort was based on a clear rationale for adding atezolizumab (Tecentriq) to bevacizumab (Avastin) in the metastatic colorectal cancer setting. In immunodeficient mice, the combination of an...

colorectal cancer
immunotherapy

No Benefit for Atezolizumab Plus Standard of Care for Maintenance in Colorectal Cancer Subset

ADDING ATEZOLIZUMAB (Tecentriq) to a fluoropyrimidine plus bevacizumab (Avastin) did not improve outcomes for patients with BRAF wild-type metastatic colorectal cancer enrolled in the umbrella MODUL trial.1 “Despite activity in other, immune-responsive tumor types, there was no improvement in...

skin cancer
immunotherapy

Expert Point of View: Reinhard Dummer, MD

KEYNOTE-022’S invited discussant, Reinhard Dummer, MD, Professor of Dermatologic Oncology at the University Hospital Zurich Skin Cancer Center in Switzerland, told attendees, “We’ve been waiting for this small prospective randomized phase II trial, and the initial results appear very promising.”...

skin cancer
immunotherapy

Pembrolizumab Triplet Shows Activity in BRAF-Mutant Melanoma

AS FIRST-LINE treatment of advanced BRAF-mutant melanoma, pembrolizumab (Keytruda) added to dabrafenib (Tafinlar) and trametinib (Mekinist) produced a nonsignificant improvement in progression-free survival. It also increased the rate of grade 3 to 5 treatment-related adverse events in the phase II ...

prostate cancer

Expert Point of View: Joaquin Mateo, MD, PhD

FORMAL DISCUSSANT Joaquin Mateo, MD, PhD, of the Prostate Cancer Translational Research Group, Vall d’Hebron Institute of Oncology, Barcelona, said that the TRITON2 findings were encouraging, although still preliminary. “We should interpret these results with caution, because this interim analysis ...

prostate cancer

PARP Inhibitor Active in BRCA1/2-Mutated Metastatic Castration-Resistant Prostate Cancer

THE SEARCH for biomarkers in prostate cancer has proved frustrating, partly due to the complexity of the disease and its heterogeneity. A preliminary analysis of a phase II (TRITON2) study suggests that rucaparib (Rubraca), a poly (ADP-ribose) polymerase (PARP) inhibitor, may be active in men with...

kidney cancer

Expert Point of View: Manuela Schmidinger, MD

“TARGETED AGENTS were a breakthrough in the treatment of renal cell carcinoma, and immunotherapy also works well, improving survival. In the past 2 years, combining a checkpoint inhibitor with targeted agents appears to work even better, and multiple combination trials are underway. The outcomes...

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