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issues in oncology

Overcoming Sexism in Academic Medicine

The troubling results from a survey1 investigating the sexual harassment and discrimination experiences of academic medical faculty show that such incidents continue to happen with unexpected frequency despite increasing awareness of the problem. The study by Reshma Jagsi, MD, DPhil, and...

cost of care

The Emperor’s New Clothes: Biosimilars and Cost in Oncology

Biosimilars are biologic products similar to the parent (branded) molecule in structure and function—such as erythropoietin and filgrastim (Neupogen).1 To truly bend the cost curve, we want to see a dramatic economic savings achieved as oncology biosimilars for rituximab (Rituxan), trastuzumab...

myelodysplastic syndromes

High-Risk Mutations Predict Poor Outcomes for Patients With Myelodysplastic Syndromes Undergoing Transplantation

Although several treatment options are available for patients with myelodysplastic syndromes (MDS), hematopoietic stem cell transplantation (HSCT) remains the only curative therapy.1 The risks of complications and death from transplantation can be substantial. Determining which patients may...

breast cancer

Pembrolizumab Moving Forward in Triple-Negative Breast Cancer

In the treatment of triple-negative breast cancer, checkpoint inhibition is making inroads in both early- and late-stage disease, and the line of treatment and expression of the programmed cell death ligand 1 (PD-L1) could be important in determining outcomes, according to studies reported at the...

myelodysplastic syndromes

Mutations in Myelodysplastic Syndrome Associated With Poorer Outcome After Stem Cell Transplantation

In a study reported in The New England Journal of Medicine, R. Coleman Lindsley, MD, PhD, of Dana-Farber Cancer Institute, and colleagues found that a number of mutations present in patients with myelodysplastic syndromes (MDS) were associated with poorer clinical outcome after allogeneic...

colorectal cancer

FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer

On June 30, 2017, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic...

multiple myeloma

FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab -(Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide ...

breast cancer

Scalp Cooling to Prevent Chemotherapy-Induced Alopecia: Is It Now Ready for Prime Time?

In oncology, sometimes we forget about the small, everyday things that can significantly impact a patient’s life. When patients are explained the side effects of chemotherapy and chemotherapy-induced alopecia, most women will cry or become visibly upset. When a woman loses her hair, it represents...

breast cancer

Two Studies Show Scalp Cooling Reduces Hair Loss in Women Receiving Chemotherapy for Breast Cancer

An interim analysis of the SCALP trial, reported in JAMA by Julie Nangia, MD, of Baylor College of Medicine, and colleagues, showed that use of a scalp-cooling device significantly reduced hair loss in women receiving chemotherapy for stage I or II breast cancer compared with no scalp cooling.1 The ...

pancreatic cancer

WCHN Launches Trial to Screen Newly Diagnosed Patients With Diabetes for Early-Stage Pancreatic Cancer

Western Connecticut Health Network (WCHN) has announced the launch of a 3-year research study that will investigate the link between new-onset diabetes and pancreatic cancer. The main goal of the study is to detect the often lethal cancer at a curable stage. The study was developed by a team of...

leukemia

Idelalisib in Resistant CLL: Benefit Shown, Questions Remain

As reported in The Lancet Oncology by Dr. Andrew Zelenetz and colleagues and reviewed in this issue of The ASCO Post, an international phase III trial in 416 patients with refractory or recurrent chronic lymphocytic leukemia (CLL) addressed the benefit of adding the first-in-class phosphoinositide...

leukemia

Adding Idelalisib to Bendamustine/Rituximab in Relapsed/Refractory CLL

As reported by Andrew D. Zelenetz, MD, of Memorial Sloan Kettering Cancer Center, and colleagues in The Lancet Oncology, interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in...

breast cancer

Interventionist-Guided Weight Loss Program for African American Breast Cancer Survivors

As reported by Stolley et al in the Journal of Clinical Oncology, a community-based interventionist-guided weight loss program for African American breast cancer survivors (Moving Forward) proved successful in achieving weight loss goals compared with a self-guided weight loss program. African...

leukemia

Adding Midostaurin to Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia With FLT3 Mutation

In a phase III trial (Cancer and Leukemia Group B 10603 [RATIFY]/Alliance) reported in The New England Journal of Medicine, Stone et al found that the addition of midostaurin (Rydapt) to standard chemotherapy improved overall survival in patients with newly diagnosed acute myeloid leukemia with...

colorectal cancer

ESMO World GI 2017: Right-Sided Colorectal Tumors: An Internal Radiation Advantage

For patients with colorectal cancer that has metastasized to the liver, having a primary tumor on the left side as opposed to the right side of the colon is known to be a significant advantage in terms of treatment response. But a new study, presented by van Hazel et al at the European Society for...

solid tumors

FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy

On July 3, the U.S. Food and Drug Administration (FDA) cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss during chemotherapy. This is the first cooling cap cleared by the agency for use in cancer patients with solid tumors. “We are pleased to expand the...

colorectal cancer

FDA Approves Panitumumab for Use in Wild-Type RAS Metastatic Colorectal Cancer

Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for panitumumab (Vectibix) for patients with wild-type RAS (defined as wild-type in both KRAS and NRAS as determined by an FDA-approved test for this use) metastatic colorectal cancer...

pancreatic cancer

ESMO World GI 2017: Pegilodecakin Plus FOLFOX in Advanced Pancreatic Cancer

Clinical data on an investigational immuno-oncology drug pegilodecakin (PEGylated human interleukin-10, also known as AM0010) was presented by Hecht et al at the ESMO 19th World Congress on Gastrointestinal Cancer in Barcelona, Spain (Abstract O-004). Pegilodecakin is being evaluated in an ongoing...

hepatobiliary cancer

ESMO World GI 2017: Phase I Data on Anti–PD-1 Antibody BGB-A317 in Hepatocellular Carcinoma

Preliminary results from patients with advanced hepatocellular carcinoma enrolled in a phase I study of the investigational anti–programmed cell death protein 1 (PD-1) antibody BGB-A317 in advanced solid tumors were presented by Yen et al at the ESMO 19th World Congress on Gastrointestinal...

head and neck cancer

Outcome by Age With Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer

As reported in the Journal of Clinical Oncology by Brose et al, a prespecified analysis of the phase III double-blind SELECT trial of lenvatinib (Lenvima) vs placebo in radioiodine-refractory differentiated thyroid cancer showed progression-free survival benefits in both older and younger...

lung cancer

First-Line Nivolumab vs Chemotherapy in Advanced NSCLC With PD-L1 Expression ≥ 5%

As reported by Carbone et al in The New England Journal of Medicine, the phase III CheckMate 026 trial has shown no progression-free survival benefit for first-line nivolumab (Opdivo) vs platinum-based chemotherapy in patients with recurrent or stage IV non–small cell lung cancer with...

leukemia

EHA 2017: Half of Chronic-Phase Philadelphia Chromosome–Positive CML Patients Stay in Treatment-Free Remission 2 Years After Stopping Nilotinib

New data from two clinical trials—ENESTfreedom and ENESTop—demonstrates that approximately half of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in the chronic phase, were able to maintain treatment-free remission after stopping treatment with ...

multiple myeloma

EHA 2017: Ixazomib Plus Lenalidomide/Dexamethasone in Newly Diagnosed Multiple Myeloma With No Stem Cell Transplant, Followed by Maintenance Ixazomib

Data from two phase I/II clinical trials evaluating ixazomib (Ninlaro) in patients with newly diagnosed multiple myeloma was presented at the 2017 European Hematology Association (EHA) Annual Meeting (Abstracts S408, S780). Both studies evaluated ixazomib plus lenalidomide (Revlimid) and...

skin cancer

Dabrafenib Plus Trametinib in BRAF V600–Mutant Melanoma Brain Metastases

A phase II trial has shown that the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinst) produces responses in brain metastases in patients with BRAF V600–mutant melanoma. These findings were reported by Davies et al in The Lancet Oncology. Study ...

lymphoma

Brentuximab Vedotin vs Physician’s Choice in CD30-Positive Cutaneous T-Cell Lymphoma

The phase III ALCANZA trial has shown that brentuximab vedotin (Adcetris) produces a higher global response rate vs physician’s choice of therapy in previously treated CD30-positive cutaneous T-cell lymphomas. These results were reported by Prince et al in The Lancet. Study Details In this...

lymphoma

ICML 2017: Nivolumab Shows Durable Response in Relapsed or Progressed Classical Hodgkin Lymphoma, Regardless of Brentuximab Vedotin History

Extended follow-up data demonstrated responses from nivolumab (Opdivo) in adult patients with relapsed or progressed classical Hodgkin lymphoma after autologous stem-cell transplant (ASCT), irrespective of brentuximab vedotin (Adcetris) therapy history. Results from the phase II CheckMate-205 study ...

leukemia

EHA 2017: Updated CTL019 ELIANA Data Show Durable Remission Rates in Children, Young Adults With Relapsed/Refractory B-Cell ALL

Updated results from the ELIANA clinical trial demonstrated CTL019 (tisagenlecleucel) remission rates are maintained at 6 months in relapsed/refractory pediatric and young adult patients with B-cell acute lymphoblastic leukemia (ALL). These data from this pivotal trial of CTL019 show that 83% (52...

lymphoma

EHA 2017: The DYNAMO Study: Duvelisib in Double-Refractory Follicular Lymphoma and Small Lymphocytic Lymphoma

Long-term follow-up data from the DYNAMO study, which met its primary endpoint of overall response rate (ORR; P = .0001) at the final analysis, was presented at the 22nd Congress of the European Hematology Association (EHA) (Abstracts S777, E1130).  DYNAMO is a phase II clinical study...

lung cancer

FDA Grants Regular Approval to Dabrafenib and Trametinib Combination for Metastatic NSCLC With BRAF V600E Mutation

On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib (Tafinlar) and trametinib (Mekinist) administered in combination for patients with metastatic non–small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test. These ...

multiple myeloma

FDA Approves Daratumumab in Combination With Pomalidomide and Dexamethasone for Relapsed or Refractory Multiple Myeloma

The U.S. Food and Drug Administration (FDA) has approved the use of the monoclonal antibody daratumumab (Darzalex) in combination with pomalidomide (Pomalyst) and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide...

palliative care

Impact of Palliative Care on End-of-Life Services for Patients Dying in a Hospital

In a single-center retrospective analysis reported in the Journal of Oncology Practice, Wiesenthal et al found that among patients dying in a hospital, those with palliative care in place at final admission received less diagnostic testing and other services not associated with promoting patient...

lung cancer

Atezolizumab as First-Line or Subsequent Treatment in PD-L1–Selected Advanced NSCLC

In the phase II BIRCH trial, atezolizumab (Tecentriq) was found to produce higher response rates as first-line or subsequent therapy in patients with advanced non–small cell lung cancer (NSCLC) with higher levels of programmed cell death ligand 1 (PD-L1) expression. Study findings were...

breast cancer

Positive Results for APHINITY, but Value of Benefit of Dual HER2 Blockade Questioned

The results of the long-awaited APHINITY trial are in, and although the phase III study met its primary endpoint, it failed to establish dual HER2 blockade as the optimal adjuvant treatment for early HER2-positive breast cancer. After 3 years of follow-up, the addition of pertuzumab (Perjeta) to...

leukemia
lymphoma

FDA Approves Rituximab Plus Hyaluronidase Combination for Treatment of Certain Hematologic Malignancies

On June 22, 2017, the U.S. Food and Drug Administration granted regular approval to the combination of rituximab and hyaluronidase human (Rituxan Hycela) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia. The approval provides a...

breast cancer

Pregnancy After Breast Cancer

Findings from a retrospective study showed that women who became pregnant after an early breast cancer diagnosis, including those with estrogen receptor–positive tumors, did not have a higher chance of cancer recurrence and death than those who did not become pregnant.1 Matteo Lambertini, MD, of...

neuroendocrine tumors

Major Breakthrough in Development of Systemic Targeted Therapy for Midgut Neuroendocrine Tumors

This issue of The ASCO Post discusses a recent trial reported by Strosberg et al in The New England Journal of Medicine that is the first phase III randomized international multicenter clinical trial evaluating lutetium Lu-177 dotatate as a peptide receptor radionuclide therapy in midgut...

neuroendocrine tumors

Lu-177 Dotatate Improves Progression-Free Survival in Advanced Progressive Midgut Neuroendocrine Tumors

In the phase III NETTER-1 trial reported in The New England Journal of Medicine, Jonathan R. Strosberg, MD, of the Moffitt Cancer Center in Tampa, Florida, and colleagues found that the addition of the targeted radiotherapeutic agent lutetium Lu-177 dotatate to the long-acting repeatable (LAR)...

colorectal cancer

ASCP/CAP/AMP/ASCO Colorectal Cancer Biomarker Guideline: A Clinician's Perspective

The joint American Society for Clinical Pathology (ASCP), College of American Pathologists (CAP), Association for Molecular Pathology (AMP), and ASCO guideline reported by Sepulveda et al, and reviewed in this issue of The ASCO Post, represents a collaboration of three pathology societies and ASCO ...

lung cancer

Alectinib vs Crizotinib in First-Line Treatment of ALK-Positive NSCLC

In 2011, crizotinib (Xalkori) became the first effective targeted therapy for anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Now data from a phase III trial show that alectinib (Alecensa), a second-generation ALK inhibitor, outperformed crizotinib, the current...

colorectal cancer

ASCP/CAP/AMP/ASCO Guideline on Molecular Biomarkers in Colorectal Cancer

As reported in the Journal of Clinical Oncology by Antonia R. Sepulveda, MD, PhD, of Columbia University, and colleagues, a joint guideline on the use of molecular biomarkers for evaluation of colorectal cancer has been developed by an expert panel from the American Society for Clinical Pathology...

issues in oncology

IASLC Endorses Tobacco Reform Report

The International Association for the Study of Lung Cancer (IASLC) has endorsed a report that outlines key action items to be taken immediately to accelerate progress toward ending cigarette smoking in adults.1  Issuing its Executive Summary Report, the Core Team for Tobacco Control and Smoking...

genomics/genetics

Identifying Genetic Basis for Extraordinary Clinical Responses May Accelerate Development of New Therapies

Accelerating the discovery of targeted cancer therapies requires defining the targets present in individual tumors, and there are two main ways to do this, David B. Solit, MD, told participants at the inaugural OncoSET Symposium: Emerging Approaches to Precision Medicine in Chicago.1 The...

leukemia

Expert Point of View: Susan O'Brien, MD

Commenting on the studies of CAR T cells in chronic lymphocytic leukemia (CLL) thus far, Susan O’Brien, MD, of the University of California at Irvine, said: “Some people are disappointed in the results, but the problem is there was too much hype to begin with. The first article on CAR T published...

leukemia

Newer Approaches With CAR T Cells Explored in CLL

Chimeric antigen receptor (CAR) T-cell therapy is a hot area of research and development in hematologic malignancies and, more recently, some solid tumors. Results have been particularly good in acute lymphocytic leukemia, and one or more CAR T-cell products may be getting close to approval by the ...

health-care policy

SWOG Clinical Trials Have Yielded Positive Return on Investment

The National Cancer Institute (NCI)-funded SWOG clinical trials program has added 3.34 million years of life for patients with cancer in the United States because of successful therapies that were validated through its trials. When analyzed, the investment for each year of life gained since the...

solid tumors

Novel Tropomyosin Receptor Kinase Inhibitor Yields High Response Rates Across Tumor Types

Larotrectinib, an oral inhibitor of tropomyosin receptor kinase, showed “striking” activity in adult and pediatric patients with the genetic aberrations known as tropomyosin receptor kinase (TRK) fusion, researchers reported at the 2017 ASCO Annual Meeting.1 Of 55 patients treated with...

breast cancer

Expert Point of View: Richard S. Finn, MD and Ingrid A. Mayer, MD

Richard S. Finn, MD, of the David Geffen School of Medicine at UCLA, Los Angeles, commented on MONARCH 2 and the field of cyclin-dependent kinase 4/6 (CDK4/6) inhibition in general in an interview with The ASCO Post. “MONARCH 2 is confirmatory for the role of CDK4/6 inhibition in estrogen...

breast cancer

Abemaciclib Plus Fulvestrant Delays Breast Cancer Progression in MONARCH 2

In the treatment of metastatic estrogen receptor–positive breast cancer, a highly significant 45% reduction in progression was achieved with abemaciclib, combined with fulvestrant (Faslodex), in the global phase III MONARCH 2 trial, reported at the 2017 ASCO Annual Meeting by George W. Sledge, MD,...

breast cancer

Olaparib Improves Progression-Free Survival in BRCA-Associated Breast Cancer

The PARP INHIBITOR olaparib (Lynparza) improved progression-free survival in women with HER2-negative metastatic breast cancer that was either hormone receptor–positive or triple-negative in patients who had a germline BRCA mutation.1,2 These results of the international, randomized, open-label,...

prostate cancer

Two Studies Show Abiraterone Plus Prednisolone/Prednisone Added to Standard Hormone Therapy Improves Survival in Advanced Prostate Cancer

The addition of abiraterone acetate (Zytiga) plus prednisolone/prednisone to standard androgen-deprivation therapy improves survival in men starting treatment for locally advanced or metastatic, hormone--naive prostate cancer, according to the results of two potentially practice-changing studies...

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