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Showing 4751 - 4800FDA 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...
BTK Inhibitor in Relapsed or Refractory Mantle Cell Lymphoma
A phase II study (ACE-LY-004) reported in The Lancet by Wang et al showed durable responses with the Bruton tyrosine kinase inhibitor acalabrutinib (Calquence) in patients with relapsed or refractory mantle cell lymphoma. The study supported the recent approval of acalabrutinib in this setting....
California Trends in Cancer Survival by Health Insurance Status
A study using California Cancer Registry data showed that survival improvements in patients with cancer between 1997 and 2014 have largely been limited to those with private or Medicare insurance. These findings were reported in JAMA Oncology by Libby et al. Study Details The study involved...
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: 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 ...
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...
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: 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...
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...
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: 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: 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)...
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 &...
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...
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...
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...
Ibrutinib in Chronic Graft-vs-Host Disease
On August 2, 2017, ibrutinib (Imbruvica) was approved for treatment of adult patients with chronic graft-vs-host disease after failure of one or more lines of systemic therapy.1,2 This is the first U.S. Food and Drug Administration (FDA)-approved therapy for treatment of chronic graft-vs-host...
Acalabrutinib in Previously Treated Mantle Cell Lymphoma
On October 31, 2017, the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib (Calquence) was granted accelerated approval for treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.1,2 Supporting Efficacy Data Approval was based on objective response...
Barbara Savoldo, MD, PhD, Awarded Grant for Immunotherapy Research
University of North Carolina Lineberger Comprehensive Cancer Center researcher Barbara Savoldo, MD, PhD, has been awarded a $600,000, 3-year grant from to support research of an immunotherapy being developed. The grant will help fund clinical research into an investigational chimeric antigen...
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...
Future Directions for CAR T-Cell Therapy
Chimeric antigen receptor (CAR) T-cell therapy burst upon the scene as an innovative approach to the treatment of hematologic malignancies, mainly for patients who have exhausted all other treatment options. Recently two CAR T-cell products were approved by the U.S. Food and Drug Administration...
Olaparib Tablets for Maintenance Treatment in Ovarian Cancer
On August 17, 2017, olaparib -(Lynparza) in tablet form was granted regular approval for maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.1,2 Olaparib...
Immunotherapy Has Indelibly Changed the Treatment Paradigm in Urothelial Carcinoma
Cisplatin-based combination chemotherapy is the preferred first-line therapy for metastatic urothelial cancer and the only treatment shown to improve survival in patients with previously untreated disease for many years. This chemotherapy also has proven to be beneficial in the neoadjuvant and...
CMS Finalizes 340B Cuts, Part B Drugs in Quality Payment Program, 2018 Physician Fee Schedule
The Centers for Medicare & Medicaid Services (CMS) released its final rule on the 2018 Hospital Outpatient Prospective Payment System (PPS). In the rule, CMS finalized a proposal to cut reimbursement for separately paid drugs under the 340B Drug Pricing Program (340B) from average sales price...
Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia
On November 9, 2017, dasatinib (Sprycel) was granted regular approval for treatment of pediatric patients with Philadelphia chromosome–positive chronic myeloid leukemia (CML) in chronic phase.1,2 Supporting Efficacy Data Approval was based on findings among 97 pediatric patients with chronic-phase...
Obinutuzumab-Based First-Line Treatment Improves Progression-Free Survival vs Rituximab-Based Treatment in Follicular Lymphoma
In the phase III GALLIUM trial reported in The New England Journal of Medicine by Robert Marcus, MBBS, of University College London, and colleagues, obinutuzumab (Gazyva)-based therapy significantly prolonged progression-free survival vs rituximab (Rituxan)-based therapy in patients with previously ...
Vemurafenib in Erdheim-Chester Disease
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 6, 2017, vemurafenib (Zelboraf) was granted...
Shifting Landscape of Oncology Drug Development and Approvals
Future oncology drug development and approvals will be faster and more efficient as well as take the patient experience more into account, said Richard Pazdur, MD, Director of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA). The Center was established as part of...
Cancer and Obesity: Not Such a Linear Relationship
Obesity has been established as a strong risk factor for the development of cancer. African Americans and Hispanics are particularly at risk, and their access to health care is often poor. How do racial and ethnic disparities in the development of obesity as well as access to care intersect to...
Caring for the Frail, Older Patient With Cancer: Four Practical Approaches
Cancer may be a disease of aging, but data suggest that older patients with cancer are undertreated, especially with respect to chemotherapy. One analysis showed that approximately 40% of patients in their 70s—and 60% of patients in their 80s—do not receive adjuvant therapy after surgery for colon...
Concurrent Palliative Care: Recommendations From the ASCO Clinical Practice Guideline
Updated in 2016, the ASCO clinical practice guideline on the integration of palliative care into standard oncology care provides evidence-based recommendations to oncology clinicians, patients, family and friend caregivers, and palliative care specialists about providing high-quality care for...
Preparing for Steep Increase in Breast Cancer Among the Elderly
“We are in the midst of a steep increase” in the incidence of breast cancer among women aged 65 years and older, Arti Hurria, MD, reported at the 19th Annual Lynn Sage Breast Cancer Symposium, Chicago.1 “Are we prepared as a health-care system and as providers to address this burgeoning need?” she...
Managing Neurotoxicity in Advanced Breast Cancer
Neurotoxicity in advanced breast cancer is not limited to chemotherapy-induced peripheral neuropathy, according to Matti Aapro, MD, of IMO Clinique de Genolier, Switzerland. Surgery, radiation therapy, and medical therapy can all have detrimental effects on either the central or peripheral nervous ...
Managing Low-Dose CT Screening for Lung Cancer
As low-dose computed tomography (CT) screening for lung cancer has moved from clinical trials to clinical practice, management issues are growing more urgent for screening centers around the country: for instance, how to support referrals from and to other providers; how to ensure the quality of...
Durvalumab Therapy Improves Outcomes in Patients With Unresectable Stage III NSCLC
The PACIFIC study showed that the addition of the programmed cell death ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) following chemoradiotherapy for patients with unresectable stage III non–small cell lung cancer (NSCLC) dramatically improved progression-free survival compared with placebo....
How ASCO’s New Initiatives Are Helping Oncologists Transition to MACRA
This year has been an important transitional period for oncology providers to start collecting their performance data to meet the requirements of the Quality Payment Program outlined in the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The Quality Payment Program is a...
SABCS 2017: Increasing the Dose Intensity of Chemotherapy May Lower the Risk of Breast Cancer Recurrence and Death
Increasing the dose intensity of chemotherapy—by either shortening the intervals between the cycles or by sequential administration instead of concurrent administration of the drugs—reduced the risk of early-stage breast cancer recurrence and death compared with standard chemotherapy...
FGFR Kinase Inhibitor in FGFR-Altered Advanced Cholangiocarcinoma
In a phase II trial reported in the Journal of Clinical Oncology, Javle et al found that the oral pan-fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 was active in FGFR-altered advanced cholangiocarcinoma. It is estimated that FGFR2 fusions/translocations are present in 13% to 17%...
Combination Therapy for Previously Untreated Stage IV NSCLC
As reported in The Lancet Oncology by Herbst et al, the phase III SWOG S0819 trial showed no overall benefit of adding cetuximab (Erbitux) to carboplatin/paclitaxel both with and without bevacizumab (Avastin) in patients with previously untreated stage IV non–small cell lung cancer (NSCLC). A ...
FDA Approves Biosimilar for the Treatment of Certain Breast and Stomach Cancers
The U.S. Food and Drug Administration (FDA) today approved trastuzumab-dkst (Ogivri) as a biosimilar to trastuzumab (Herceptin) for the treatment of patients with breast or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors overexpress the HER2 gene. The drug is the first...
Extended Intermittent vs Continuous Adjuvant Therapy for Postmenopausal Women With Breast Cancer
The phase III SOLE trial has shown no disease-free survival benefit with extended intermittent vs continuous adjuvant letrozole in postmenopausal women with breast cancer. These findings were reported by Colleoni et al in The Lancet Oncology. As noted by the investigators, the findings suggest an...
FDA Announces Approval, CMS Proposes Coverage of First Breakthrough-Designated Test to Detect Extensive Number of Cancer Biomarkers
On November 30, the U.S. Food and Drug Administration (FDA) approved the FoundationOne CDx (F1CDx), the first 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 ...
Update on Phase III JAVELIN Gastric 300 Trial of Avelumab in Pretreated Advanced Gastric Cancer
On November 28, Merck KGaA and Pfizer announced that the phase III JAVELIN Gastric 300 trial did not meet its primary endpoint of superior overall survival with single-agent avelumab (Bavencio) compared with physician's choice of chemotherapy. The trial investigated avelumab as a third-line...
Quality of Life With Neoadjuvant Chemoradiotherapy in Esophageal/Esophagogastric Junction Cancer
An analysis in the Dutch Chemoradiotherapy for Esophageal Cancer Followed by Surgery Study (CROSS) reported by Noordman et al in the Journal of Clinical Oncology showed no adverse effect of neoadjuvant chemoradiotherapy vs surgery alone on postsurgery health-related quality of life in patients with ...
Patients With CLL May Be Willing to Trade Treatment Efficacy for Reduced Side Effects
When choosing their preferred treatment, patients with chronic lymphocytic leukemia (CLL) place the highest value on treatments that deliver the longest progression-free survival, but they are willing to swap some drug efficacy for a reduced risk of serious adverse events, according to a study...
Climbing Costs for Treating Breast Cancer Poised to Strain Medicare in the Near Future
With cancer care costs projected to increase 32% from 2010 to 2020, researchers are working to determine the main drivers of costs for treating breast cancer. In a study led by Ami Vyas, PhD, MS, MBA, of the University of Rhode Island, published in the November issue of JNCCN–Journal of the...
Health-Related Quality of Life With Immediate vs Delayed ADT in Prostate Cancer
In a health-related quality-of-life study among patients in the phase III TOAD trial, immediate vs delayed androgen-deprivation therapy (ADT) was associated with early worsening of androgen-deprivation therapy–related symptoms but few other comparative adverse effects on functioning or quality of...
Adverse Pathologic Findings in Low-Volume Intermediate-Risk Prostate Cancer
In a single-center analysis reported in JAMA Oncology, Hiten D. Patel, MD, MPH, of The James Buchanan Brady Urological Institute, Johns Hopkins University School of Medicine, and colleagues found that among men undergoing elective radical prostatectomy, those with low-volume intermediate-risk...
A Vivid Look Back, a Cogent Look Forward
Cancer memoirs come in a variety of literary styles and voices. Not surprisingly, the most poignant cancer memoirs are by those who are writing, in essence, their final words before departing this earth. The most widely read of that variety has been the beautifully written best seller When Breath...
