health-care policy

AMA Urges Physicians to Take Steps to Avoid Medicare Payment Penalty

The American Medical Association (AMA) is reminding physicians that the Medicare reimbursement system has changed, and, if they have not done so already, they have until December 31, 2017, to take a few simple steps to avoid a Medicare payment penalty in 2019. The changes are part of the...

legislation

Nearly 100 Leading Cancer Researchers and Physician-Scientists Urge Congress to Reach a Bipartisan Budget Agreement and Invest in Medical Research

On December 6, the American Association for Cancer Research (AACR) delivered a letter from the current AACR President and Past Presidents—as well as Fellows of the AACR Academy that include 18 Nobel Laureates—to urge leaders in the House and Senate to “move quickly to finalize a...

gynecologic cancer

FDA Accepts sNDA for Rucaparib in Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

On December 5, Clovis Oncology announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for rucaparib (Rubraca) and granted Priority Review status to the application, with a Prescription Drug User Fee Act (PDUFA) date of April 6, 2018. In...

solid tumors

Updated SCOUT Trial Data Demonstrate Response to Larotrectinib in TRK Fusion Cancers

At the Special Conference on Pediatric Cancer Research, convened in Atlanta by the American Association for Cancer Research, investigators announced updated clinical data from the larotrectinib (LOXO-101) pediatric phase I SCOUT trial. Bayer and Loxo Oncology are jointly developing larotrectinib,...

issues in oncology

Does Warfarin Have Anticancer Potential in Persons Older Than Age 50?

A Norwegian population–based cohort study indicated that the use of warfarin was associated with a reduced risk of cancer overall and site-specific cancers among patients aged > 50 years. The findings were reported in JAMA Internal Medicine by Haaland et al. As noted by the investigators,...

solid tumors

Phase I Study Finds ERK1/2 Inhibitor Safe and Active in Advanced Solid Tumors

Ulixertinib (BVD-523) is an ERK1/2 kinase inhibitor with potent preclinical activity in BRAF- and RAS-mutant cell lines. Now, a multicenter phase I study investigating its safety and efficacy in the treatment of patients with advanced solid tumors has found that ulixertinib to have an acceptable...

kidney cancer

FDA Accepts sBLA for Nivolumab Plus Ipilimumab in Intermediate- and Poor-Risk Patients With Advanced Renal Cell Carcinoma

On December 13, the U.S. Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) for priority review of nivolumab (Opdivo) plus ipilimumab (Yervoy) to treat intermediate- and poor-risk patients with advanced renal cell carcinoma. The FDA also previously...

lymphoma

ASH 2017: Acalabrutinib Demonstrates Activity in Relapsed or Refractory Mantle Cell Lymphoma

At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Wang et al presented results from the open-label, single-arm phase II ACE-LY-004 clinical trial, which served as the basis for the recent U.S. Food and Drug Administration (FDA) accelerated approval of acalabrutinib...

leukemia

ASH 2017: Dasatinib Plus Standard Chemotherapy Demonstrates 3-Year Survival Benefit in Pediatric Patients With Philadelphia Chromosome–Positive ALL

At the 59th American Society of Hematology (ASH) Annual Meeting & Exposition, Hunger et al presented data from the phase II CA180-372 study in pediatric patients with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia (ALL) treated with dasatinib (Sprycel) added ...

lymphoma

ASH 2017: ALCANZA Trial: Brentuximab Vedotin in CD30-Expressing Cutaneous T-Cell Lymphoma

Updated results from the phase III ALCANZA clinical trial evaluating brentuximab vedotin (Adcetris) in CD30-expressing cutaneous T-cell lymphoma (CTCL) were presented by Horwitz et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 1509). The presentation...

colorectal cancer

Primary Tumor Location and Outcomes in Stage III Colon Cancer According to RAS- and BRAF-Mutation Status

  In a study in the PETACC-8 trial population reported in JAMA Oncology, Taieb et al found that the risk of recurrence in patients with stage III colon cancer differed for the primary tumor location according to RAS- and BRAF-mutation status. Study Details A total of 2,559 patients were...

solid tumors

Anti–PD-L1 Antibody in Advanced Urothelial Carcinoma After Platinum Failure

As reported in The Lancet Oncology by Patel et al, the anti–programmed cell death ligand 1 (PD-L1) antibody avelumab (Bavencio) produced durable responses in patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based therapy in two expansion cohorts of...

hematologic malignancies
symptom management

ASH 2017: Low–Molecular-Weight Heparin/Edoxaban vs Dalteparin for VTE Associated With Cancer

People with cancer face an increased risk for venous thromboembolism (VTE). Under current guidelines, cancer patients who develop VTE are prescribed low–molecular-weight heparin, an anticoagulant that must be injected under the skin daily for several months. While effective, this regimen can...

hematologic malignancies

ASH 2017: HERCULES Trial: Caplacizumab Shows Dramatic Improvements for Acquired Thrombotic Thrombocytopenic Purpura

In a phase III trial, patients with acquired thrombotic thrombocytopenic purpura (TTP), a rare blood clotting disorder, who received the investigational drug caplacizumab showed significant improvements in the time it took to normalization of their platelet count compared to those receiving a...

hematologic malignancies
symptom management

ASH 2017: Abatacept Nearly Eliminates Severe Acute GVHD After Hematopoietic Stem Cell Transplant

Results from a phase II clinical trial presented by Kean et al at the 59th American Society of Hematology (ASH) Annual Meeting (Abstract 212) show that the drug abatacept (Orencia) nearly eliminated life-threatening severe acute graft-versus-host disease (GVHD) in patients receiving hematopoietic...

head and neck cancer

Number of Metastatic Lymph Nodes and Survival in Hypopharyngeal/Laryngeal Cancer

A study using National Cancer Database data has shown that the number of metastatic nodes is a primary independent factor associated with an increased mortality risk in patients with hypopharyngeal and laryngeal cancers. The study was reported in JAMA Oncology by Ho et al. Study Details The study ...

kidney cancer

Prognostic Factors in Stage III Favorable-Histology Wilms Tumor

An analysis from the Children’s Oncology Group Study AREN0532 reported in the Journal of Clinical Oncology by Fernandez et al showed that positive lymph nodes and loss of heterozygosity (LOH) at chromosome 1p or 16q are associated with poorer event-free survival in patients with stage III...

breast cancer

Hormonal Contraception and Breast Cancer Risk

As reported in The New England Journal of Medicine by Mørch et al, a Danish study has shown that the risk of breast cancer is increased in hormonal contraception users vs nonusers, with the absolute increase in risk being small. Study Details The study assessed the association between the...

leukemia

ASH 2017: MURANO Trial: Venetoclax Found Superior to Standard Chemotherapy When Combined With Rituximab in CLL

In the phase III MURANO trial, treatment with the targeted cancer drug venetoclax (Venclexta) in combination with rituximab (Rituxan) more than doubled the likelihood that patients with chronic lymphocytic leukemia (CLL) would survive for 2 years without cancer progression, compared to treatment...

multiple myeloma

ASH 2017: ALCYONE Trial: Adding Daratumumab to Bortezomib, Melphalan, and Prednisone in Multiple Myeloma

The first randomized trial to evaluate the use of a monoclonal antibody for treating newly diagnosed multiple myeloma showed that adding the drug daratumumab (Darzalex) to one of the standard treatment regimens reduced the likelihood of disease progression or death by 50%. The regimen also induced...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

ASH 2017: People Aged 75 Years and Older Are Underrepresented in Blood Cancer Clinical Trials

In the first comprehensive analysis of clinical trial enrollment among older adults with blood cancers, researchers from the U.S. Food and Drug Administration (FDA) found significant gaps in participation among those aged 75 and older when considered against the incidence of these malignancies in...

prostate cancer

Novel Clinical-Genomic Risk Group Classification for Localized Prostate Cancer

As reported in the Journal of Clinical Oncology, Spratt et al have developed an integrated clinical-genomic risk classifier for predicting distant metastasis in patients with localized prostate cancer. The classifier uses National Comprehensive Cancer Network® (NCCN) risk categories and risk...

survivorship

Prevalence of Prior Cancer in Patients With Newly Diagnosed Cancer

In a study using Surveillance, Epidemiology, and End Results (SEER) data reported in JAMA Oncology, Murphy et al found that among persons newly diagnosed with cancer, 25% of those aged ≥ 65 years and 11% of those aged < 65 years had a history of a prior primary cancer. Prevalence of Prior...

breast cancer

BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer

The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...

pancreatic cancer

Identification of Cystic Precursors to Pancreatic Cancer Using Targeted Mass Spectrometry

In a study reported in the Journal of Clinical Oncology, Jabbar et al found that mass spectroscopy proteomic analysis of the pancreatic cyst fluid biomarkers mucin-5AC (MUC5AC), mucin-2 (MUC2), and prostate stem cell antigen (PSCA) identified cystic pancreatic cancers and precursor lesions with...

lung cancer

Study Suggests Racial Differences in Lung Tumor Biology

According to research by the American Cancer Society, lung cancer is the second most common cancer in men and women in the United States and is the leading cause of cancer-related death. In addition, among all populations, African Americans tend to have the highest lung cancer incidence and...

multiple myeloma

ASH 2017: Clinical Activity Seen With Anti-BCMA CAR T-Cell Therapy in Heavily Pretreated Multiple Myeloma

A one-time infusion of an investigational chimeric antigen receptor (CAR) T-cell therapy that targets a protein found on most multiple myeloma cells elicited an 86% overall response rate in 21 patients whose disease had come back or had not responded after a median of seven prior treatments,...

lymphoma

ASH 2017: JULIET Trial: 6-Month Analysis of Tisagenlecleucel in Relapsed/Refractory DLBCL Shows Sustained Responses

Six months after receiving a single dose of tisagenlecleucel, a chimeric antigen receptor (CAR) T-cell therapy that targets CD-19, high response rates persist among adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), according to findings reported by Schuster et al at...

lymphoma

ASH 2017: ZUMA-1: Responses to CAR T-Cell Therapy Still Strong After 1 Year in Patients With Refractory NHL

Among 108 patients with fast-growing and refractory aggressive non-Hodgkin lymphoma (NHL), more than half were still alive at least a year after receiving a single infusion of a CAR T-cell therapy called axicabtagene ciloleucel that targets the CD-19 protein frequently found on cancerous lymphoma...

hematologic malignancies

ASH 2017: Rapid Responses, Few Adverse Effects Seen With Targeted Agent in Phase I Trial in Systemic Mastocytosis

In a phase I trial, patients with an advanced or aggressive form of systemic mastocytosis, a rare blood disorder, had rapid and durable responses with few adverse effects following treatment with an investigational drug that targets the genetic mutation found in more than 90% of cases. Results were ...

leukemia

ASH 2017: CLARITY Trial: Combination Treatment With Two Targeted Agents Shows Promise in Previously Treated CLL

One-third of patients with previously treated chronic lymphocytic leukemia (CLL) had no detectable disease after 6 months of combination therapy with the targeted agents ibrutinib (Imbruvica) and venetoclax (Venclexta), with no increase in the occurrence of tumor-lysis syndrome, a serious treatment ...

lymphoma

ASH 2017: Addition of Brentuximab Vedotin to Multidrug Regimen Reduces Risk of First-Line Treatment Failure in Advanced Hodgkin Lymphoma

Patients with advanced Hodgkin lymphoma (HL) who were treated with a multidrug regimen that included the targeted agent brentuximab vedotin (Adcetris) had a 23% reduction in the risk of disease progression, death, or the need for additional therapy, compared with patients who received the standard...

lymphoma

ASH 2017: Targeted Antibody Mogamulizumab Superior to Vorinostat for Previously Treated CTCL in Phase III Trial

In a large, international, randomized phase III trial presented by Kim et al at the 59th American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 817), patients with previously treated cutaneous T-cell lymphoma (CTCL) who received the investigational targeted drug...

lymphoma

ASH 2017: Sustained Benefit With Ibrutinib in Relapsed or Refractory Mantle Cell Lymphoma

The results of a pooled analysis of patients with relapsed or refractory mantle cell lymphoma (MCL) treated with ibrutinib (Imbruvica) were presented at the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition (Abstract 151). The extended follow-up data demonstrated that...

leukemia

ASH 2017: RESONATE-2 Trial: Patient-Reported Outcomes on Ibrutinib Treatment in Patients With CLL

At the 2017 American Society of Hematology (ASH) Annual Meeting & Exposition, the 3-year follow-up data from the RESONATE-2 study (PCYC-1115/1116) were presented. The investigators found that patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL)...

hematologic malignancies
leukemia
lymphoma
multiple myeloma

Watch for More From ASH 2017

Phase III ASPIRE Trial of Carfilzomib in Relapsed Multiple Myeloma Overall survival results from the phase III ASPIRE trial will be detailed for the first time in an oral presentation by Stewart et al on Monday, December 11. The addition of carfilzomib to lenalidomide and...

hematologic malignancies
issues in oncology

ASH 2017: Direct Oral Anticoagulant May Reduce Recurrence of VTE in Patients With Cancer

People with cancer have an increased risk of developing blood clots, with roughly one in five experiencing venous thromboembolism (VTE). International guidelines recommend treatment using low–molecular-weight heparin, an anticoagulant that is injected subcutaneously; however, new results from ...

breast cancer

SABCS 2017: Older Women With Hormone Receptor–Positive Breast Cancer May Receive Similar Benefit From CDK4/6 Inhibitors as Younger Women

Older women with hormone receptor–positive, HER2-negative metastatic breast cancer who were treated with cyclin-dependent kinase (CDK) 4/6 inhibitors achieved progression-free survival at a rate similar to that of younger women, according to data presented by Singh et al at the 2017 San...

breast cancer

SABCS 2017: Postmenopausal Women Who Lose Weight May Have Reduced Breast Cancer Risk

Postmenopausal women who lose weight may have a significantly reduced chance of developing breast cancer, according to data presented by Chlebowski et al at the 2017 San Antonio Breast Cancer Symposium (Abstract GS5-07). “Breast cancer is among the leading types of cancer and...

breast cancer

SABCS 2017: Circulating Tumor Cells May Predict Late Recurrence in Patients With Hormone Receptor–Positive Breast Cancer

Among patients with hormone receptor–positive HER2-negative stage II–III breast cancer without clinical evidence of recurrence, those who had circulating tumor cells (CTCs) detected in blood 5 years after diagnosis had an increased risk for late recurrence of breast cancer, according to ...

breast cancer

SABCS 2017: Phase III EMBRACA Trial Meets Primary Endpoint

Patients with advanced HER2-negative breast cancer with germline BRCA mutations had significantly prolonged progression-free survival when treated with the poly(ADP-ribose) polymerase (PARP) inhibitor talazoparib, compared with those who received chemotherapy of physician’s choice, according...

breast cancer

SABCS 2017: Combined Residual Risk Score Test and Predicting Breast Cancer Risk in Women Who Tested Negative for Hereditary Mutations

Results from a validation study to better define the risk of breast cancer in women of European ancestry who tested negative for a hereditary cancer mutation with a hereditary cancer risk test (myRisk Hereditary Cancer test) were reported earlier this week in a spotlight presentation at the 2017...

head and neck cancer

ASCO Clinical Practice Guideline Update: Use of Larynx-Preservation Strategies in the Treatment of Laryngeal Cancer

As reported in the Journal of Clinical Oncology by Arlene A. Forastiere, MD, of The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, and colleagues, ASCO has issued a clinical practice guideline update on the use of larynx-preservation strategies in the treatment of laryngeal cancer. The ...

breast cancer

SABCS 2017: 2 Years of Extended Anastrozole Therapy Proved as Effective as 5 Years in Hormone Receptor–Positive Breast Cancer

Postmenopausal women with hormone receptor–positive breast cancer who took the aromatase inhibitor anastrozole for 2 years after an initial 5 years of adjuvant endocrine therapy received an equal benefit to those who took the drug for 5 additional years. The trial results suggest that a...

breast cancer

SABCS 2017: SOLD Trial Data Support Current Standard 12-Month Adjuvant Trastuzumab for HER2-Positive Breast Cancer

Disease-free survival after 9 weeks of adjuvant trastuzumab (Herceptin) and standard chemotherapy was not comparable to disease-free survival after 12 months of adjuvant trastuzumab and standard chemotherapy for women with early-stage HER2-positive breast cancer, supporting the current...

breast cancer

SABCS 2017: Temporary Ovarian Suppression With Hormone Analog May Preserve Fertility During Breast Cancer Chemotherapy

Meta-analysis of individual patient data from five randomized clinical trials provided a high level of evidence that treatment with a gonadotropin-releasing hormone analog (GnRHa) could safely and effectively protect ovarian function and potentially preserve fertility in premenopausal women...

breast cancer
pain management

SABCS 2017: Acupuncture May Reduce Joint Pain Caused by Aromatase Inhibitor Treatment

Acupuncture significantly reduced joint pain for postmenopausal women with early-stage breast cancer receiving treatment with an aromatase inhibitor compared with both sham acupuncture and no treatment, according to data from the randomized, phase III SWOG S1200 trial presented by Hershman et al at ...

breast cancer

SABCS 2017: MONALEESA-7: Ribociclib Improved Progression-Free Survival for Pre- and Perimenopausal Women With HR-Positive Advanced Breast Cancer

Adding the cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali) to standard endocrine therapy with temporary ovarian suppression significantly improved progression-free survival for pre- and perimenopausal women with advanced hormone receptor–positive (HR-positive), HER2-negative...

breast cancer

SABCS 2017: Combination of Pembrolizumab and Trastuzumab Shows Early Promise for Patients With Trastuzumab-Resistant Breast Cancer

A combination of pembrolizumab (Keytruda) and trastuzumab (Herceptin) tested in patients with trastuzumab-resistant advanced HER2-positive breast cancer was well tolerated and had clinical benefit in patients whose tumors were positive for a biomarker for pembrolizumab, according to data presented...

hematologic malignancies

ASCO Clinical Practice Guideline Update: Platelet Transfusion for Patients With Cancer

As reported in the Journal of Clinical Oncology by Charles A. Schiffer, MD, of Karmanos Cancer Institute, Wayne State University School of Medicine, and colleagues, ASCO has issued a clinical practice guideline update on platelet transfusions in patients with cancer. The updated guideline replaces ...

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