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Showing 12451 - 12500Nivolumab for Adjuvant Treatment of Melanoma Granted Regular Approval by FDA
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to the anti–programmed cell death protein 1 (PD-1) monoclonal antibody nivolumab (Opdivo) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes, or in patients with...
FDA Grants Regular Approval to Pertuzumab for Adjuvant Treatment of HER2-Positive Breast Cancer
On December 20, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to pertuzumab (Perjeta) for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. APHINITY...
FDA Approves Cabozantinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to cabozantinib (Cabometyx) for treatment of patients with advanced renal cell carcinoma (RCC). The FDA previously approved cabozantinib in 2016 for treatment of patients with advanced RCC who have received...
FDA Grants Accelerated Approval to Bosutinib for Treatment of Newly Diagnosed Philadelphia Chromosome–Positive CML
On December 19, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to bosutinib (Bosulif) for treatment of patients with newly diagnosed chronic-phase Philadelphia chromosome–positive chronic myelogenous leukemia (CML). BFORE Trial Approval was based on data from ...
Combination Agent in Asian Patients With Previously Treated Metastatic Colorectal Cancer
In the Asian phase III TERRA trial, trifluridine/tipiracil (Lonsurf) produced a significant improvement in overall survival vs placebo among patients with metastatic colorectal cancer refractory or intolerant of standard chemotherapies with or without exposure to biologic therapies. These findings...
Howard A. ‘Skip’ Burris III, MD, FACP, FASCO, Elected ASCO President for 2019–2020 Term
Howard A. “Skip” Burris III, MD, FACP, FASCO, a long-time member and volunteer, has been elected to serve as the President of ASCO for the term beginning in June 2019. He will take office as President-Elect during the ASCO Annual Meeting in Chicago in June 2018. Additionally, five...
CAR T-Cell Therapy in Refractory B-Cell Lymphomas
As reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine, Schuster et al found that chimeric antigen receptor (CAR) T-cell therapy produced responses in a high proportion of patients with B-cell lymphomas refractory to or...
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...
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...
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...
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,...
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...
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 ...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
Maria-Victoria Mateos, MD, PhD, on Multiple Myeloma: Results From the ALCYONE Trial
Maria-Victoria Mateos, MD, PhD, of the University Hospital of Salamanca, discusses phase III study findings on daratumumab plus bortezomib, melphalan, and prednisone vs bortezomib, melphalan, and prednisone in patients ineligible for transplant who have been newly diagnosed with multiple myeloma...
Michael Unterhalt, MD, on Mantle Cell Lymphoma: Long-Term Follow-up Results
Michael Unterhalt, MD, of the University Hospital Grosshadern, discusses study findings on rituximab maintenance after first-line immunochemotherapy among older patients who are not candidates for autologous stem cell transplantation (Abstract 153).
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,...
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...
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...
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 ...
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...
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...
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...
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)...
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 ...
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...
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...
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 ...
FDA Announces Approval, CMS Proposes Coverage of Diagnostic Test for Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved CDx (F1CDx), a breakthrough-designated, next-generation sequencing–based in vitro diagnostic test that can detect genetic mutations in 324 genes and 2 genomic signatures in any solid tumor type. The Centers for Medicare &...
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...
AKT Inhibitor Ipatasertib in Metastatic Triple-Negative Breast Cancer
The randomized phase II LOTUS trial has shown improved progression-free survival with the addition of the AKT inhibitor ipatasertib to paclitaxel in the first-line treatment of metastatic triple-negative breast cancer. These results were reported by Sung-Bae Kim, MD, of the University of Ulsan...
Partial-Breast and Reduced-Dose Radiotherapy After Breast-Conserving Surgery
The UK IMPORT LOW phase III trial has shown noninferiority in local relapse for partial-breast and reduced-dose vs standard whole-breast radiotherapy after breast-conserving surgery in early breast cancer. These study results were reported by Charlotte E. Coles, PhD, of the University of...
Asparaginase-Associated Pancreatitis in Childhood Acute Lymphoblastic Leukemia
An observational study reported in The Lancet Oncology by -Wolthers et al in the Ponte di Legno Toxicity Working Group identified characteristics and the course of asparaginase-associated pancreatitis in childhood acute lymphoblastic leukemia. Kjeld Schmiegelow, MD, of The University Hospital...
Untangling the Controversies of Hematopoietic Cell Transplantation
BOOKMARK Title: Hematopoietic Cell Transplants: Concepts, Controversies, and Future DirectionsEditors: Hillard M. Lazarus, MD; Robert Peter Gale, MD, PhD, DSc (hon), FACP; Armand Keating, MD, FRCP(C); Andrea Bacigalupo, MD; Reinhold Munker, MD; Kerry Atkinson, MBBS, MD, DTM&H, FRCP, FRACP; and...
Radiation Oncologist Gives Clear Advice to Patients With Cancer
BOOKMARK Title: Cancer: What You Need to Know: Overcome the 10 Common Mistakes Patients MakeAuthor: Stephen A. Rosenberg, MDPublisher: Stephen Rosenberg, MDYear Published: November 2017Price: $9.99, paperback, 248 pages Stephen A. Rosenberg, MD, is Chief Resident in Radiation Oncology at the...
Old and New Perspectives on the Theory of Cancer
BOOKMARK Title: Tripping Over the Truth: How the Metabolic Theory of Cancer Is Overturning One of Medicine’s Most Entrenched ParadigmsAuthor: Travis Christofferson, MSPublisher: Chelsea Green PublishingPublication Date: February 2017Price: $24.95, hardcover; 288 pages Bringing a book to market is...
Achieving One’s Childhood Dreams While Facing Pancreatic Cancer
BOOMARK Title: The Last LectureAuthor: Randy Pausch with Jeffrey ZaslowPublisher: HyperionDate: April 2008Price: $21.95, hardcover; 206 pages Faced with imminent death, how does one chose to live out the remainder of one’s life? Such is the question at the heart of The Last Lecture, a memoir...
Love Triumphs Amid a Battle With Cancer
BOOKMARK Title: The Red Devil: To Hell With Cancer—and BackAuthor: Katherine Russell RichPublisher: CrownDate Published: October 1999Price: $23.95, hardcover, 256 pages Over the past year or so, there have been several best-selling memoirs of people fighting and ultimately losing their battle with ...
Clinical Trials Actively Recruiting Patients With Pediatric Leukemia
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on pediatric leukemia. These studies highlight quality-of-life reporting; neutropenia management; combination chemotherapy; chimeric antigen receptor (CAR) T-cell therapy and some...
Gratitude
The following essay by Stan Winokur, MD, is adapted from The Big Casino: America’s Best Cancer Doctors Share Their Most Powerful Stories, which was coedited by Dr. Winokur and -Vincent Coppola and published in May 2014. The book is available on Amazon.com and thebigcasino.org. I looked into her...
Liposome-Encapsulated Daunorubicin and Cytarabine for AML Subtypes
On August 3, 2017, a liposome-encapsulated combination of daunorubicin and cytarabine (Vyxeos) was approved for treatment of adults with newly diagnosed therapy-related acute myeloid leukemia (AML) or AML with myelodysplasia-related changes.1,2 This is the first U.S. Food and Drug...
