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issues in oncology
immunotherapy

Immunotherapy-Related Toxicities May Be More Common Than Originally Reported

Immunotherapy has significantly improved the overall survival of patients with non–small cell lung cancer (NSCLC) and is generally better tolerated than traditional chemotherapies, but the results of a retrospective study suggested that immunotherapy side effects may be more common than initially...

breast cancer
supportive care

Has Scalp Cooling Reached the Level of Standard of Care?

Does evidence of the effectiveness and safety of scalp cooling to reduce hair loss among women being treated for breast cancer mean that scalp cooling is a new standard of care? “I would suggest that it is,” stated Mikel Ross, MSN, RN, AGNP-BC, of the Breast Medicine Service, Memorial Sloan...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: Second-Line Nivolumab vs Chemotherapy in SCLC

Treatment with nivolumab (Opdivo) did not improve response rates or survival over standard chemotherapy in patients with metastatic small cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented by Reck et al at the European Society for Medical...

skin cancer
immunotherapy

ESMO Immuno-Oncology 2018: OpACIN Trial: Neoadjuvant Ipilimumab Plus Nivolumab in Stage III Melanoma

Updated data of the OpACIN study, which studied combined ipilimumab (Yervoy) plus nivolumab (Opdivo) administered as neoadjuvant or adjuvant therapy in patients with high-risk stage III melanoma, demonstrated high response rates upon neoadjuvant therapy and promising long-term clinical outcome,...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: OAK Trial: Fast Progression in Patients With NSCLC Treated With Atezolizumab vs Chemotherapy

Overall survival (OS) was improved across all subgroups of patients with non–small cell lung cancer (NSCLC) who received atezolizumab (Tecentriq) compared with chemotherapy, including poor prognostic factors that were evaluated in an analysis of data from the OAK trial. Additionally, this...

hematologic malignancies
multiple myeloma
immunotherapy

Front-Line Daratumumab Combination Regimen Improves Outcomes in Multiple Myeloma

In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab (Darzalex) to lenalidomide (Revlimid) and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract...

breast cancer

Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy

As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...

hematologic malignancies
leukemia

Fixed-Duration Venetoclax Plus Rituximab in Relapsed or Refractory CLL

In patients with relapsed or refractory chronic lymphocytic leukemia (CLL), fixed-duration venetoclax -(Venclexta) combined with rituximab (Rituxan) reduced the risk of disease progression or death compared with standard-of-care bendamustine/rituximab, according to longer-term follow-up of the...

breast cancer

Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer

As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...

hematologic malignancies
immunotherapy

Combining a Checkpoint Inhibitor With CAR T-Cell Therapy May Augment Immune Response

Chimeric antigen receptor (CAR) T-cell therapy is a revolutionary approach to treating hematologic malignancies. As experience with this strategy is gained, researchers are learning more about how to optimize responses, especially in patients with “immune exhaustion,” who have a suboptimal initial...

hematologic malignancies
leukemia
immunotherapy

Early Studies of Ibrutinib Plus CAR T-Cell Combination in Chronic Lymphocytic Leukemia

Researchers are combining chimeric antigen receptor (CAR) T-cell therapy with ibrutinib (Imbruvica) as a means of augmenting and deepening responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Two pilot studies presented at the 2018 American Society of Hematology...

solid tumors

Larotrectinib for Solid Tumors With NTRK Gene Fusions

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 November 26, 2018, larotrectinib (Vitrakvi) was...

global cancer care
hepatobiliary cancer

Controlling the Global Burden of Liver Cancer

The burden of mortality related to liver cancer is increasing worldwide. Prevention and control of viral hepatitis will be vital in combating this burden, but curbing the growing epidemic of obesity must also be seen as a key part of liver cancer prevention, according to Rosmawati Mohamed, MD, of...

lung cancer

Low-Dose CT Lung Screening: New Developments Support Increased Quality, More Data, Deep Learning

Two years ago, Rick Avila, MS, Chief Executive Officer (CEO) of Accumetra, LLC, was using rolls of Scotch tape as a research tool. The Scotch tape was a phantom, or reference object, and his company was working with computed tomography (CT) lung screening sites around the world to determine the...

leukemia

Nuclear Excision Repair as a Possible Predictor of Early Relapse in Pediatric ALL

Researchers recently discovered that by testing the level of nucleotide excision repair (NER) gene expression, pediatric oncologists may be able to determine the likelihood of early relapse (less than 3 years) in patients with acute lymphoblastic leukemia (ALL). These findings were published by...

leukemia

First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL

In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...

skin cancer

FDA Approves Pembrolizumab for Merkel Cell Carcinoma

Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. The FDA’s approval was based on Cancer Immunotherapy Trials Network protocol 9...

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...

hematologic malignancies
leukemia

First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL

First-line therapy with the combination of ibrutinib (Imbruvica) and rituximab (Rituxan) reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to...

Expert Point of View: Eric P. Winer, MD, and Jame Abraham, MD

Commenting on the findings of the KATHERINE trial were Eric P. Winer, MD, Director of the Breast Oncology Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber Cancer Institute and the Thompson Senior Investigator in Breast Cancer Research andProfessor of Medicine at Harvard...

breast cancer

KATHERINE Trial: Adjuvant T-DM1 Reduces Invasive Disease Risk by 50% vs Trastuzumab in HER2-Positive Early Breast Cancer

In patients with HER2-positive early breast cancer and residual disease after neoadjuvant chemotherapy, adjuvant treatment with trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease by 50% over trastuzumab (Herceptin).1 The phase III KATHERINE study was presented at the 2018...

leukemia

MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL

As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: MYSTIC: First-Line Durvalumab With or Without Tremelimumab in Metastatic NSCLC

First-line immunotherapy with durvalumab (Imfinzi) or the combination of durvalumab and tremelimumab does not improve overall survival in unselected patients with lung cancer, according to late-breaking results from the MYSTIC trial presented by Rizvi et al at the European Society for Medical...

lung cancer
immunotherapy

ESMO Immuno-Oncology 2018: KEYNOTE-010: Long-Term Treatment With Pembrolizumab in Previously Treated NSCLC

Patients with previously treated, advanced non–small cell lung cancer (NSCLC) who received pembrolizumab (Keytruda) showed significantly longer overall survival (OS) compared to those treated with docetaxel, Herbst et al reported at the ESMO Immuno-Oncology Congress 2018 in Geneva,...

head and neck cancer

Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma

In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...

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 ...

breast cancer

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...

symptom management

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 ...

sarcoma

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...

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. ...

lung cancer

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...

breast cancer

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. Readers of The ASCO Post are invited to participate in this research by...

breast cancer

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)....

breast cancer

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...

breast cancer

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 ...

lung cancer

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 ...

colorectal cancer

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...

issues in oncology

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...

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...

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)...

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...

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