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Showing 18651 - 18700Phase III ASTRAL-1 Study of Guadecitabine in Patients With Treatment-Naive AML Ineligible to Receive Intensive Induction Chemotherapy
Results were recently announced from the ASTRAL-1 study evaluating the efficacy and safety of guadecitabine in adults with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive induction chemotherapy. The study did not meet its co-primary endpoints: complete...
FDA Grants Breakthrough Therapy Designation to Lenvatinib Plus Pembrolizumab in Endometrial Carcinoma
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lenvatinib (Lenvima) in combination with pembrolizumab (Keytruda) for the potential treatment of patients with advanced and/or metastatic non–microsatellite instability high (MSI-H)/proficient...
Adjuvant Bevacizumab in High-Risk HER2-Negative Breast Cancer
In an article in the Journal of Clinical Oncology, Miller et al reported final results of the Eastern Cooperative Oncology Group phase III E5103 trial, initiated in 2007, which showed no benefit of adding bevacizumab (Avastin) to adjuvant therapy in patients with HER2-negative, node-positive or...
Treatment Intensification for Childhood B-Cell Lymphoblastic Leukemia With IKZF1 Deletion
In an analysis of Asian trials reported in the Journal of Clinical Oncology, Yeoh et al found evidence that treatment intensification improved outcomes in childhood B-cell acute lymphoblastic leukemia (B-ALL) with IKZF1 deletion (del). The analysis compared outcomes in the Malaysia-Singapore ALL...
FDA Approves Ivosidenib for Relapsed or Refractory Acute Myeloid Leukemia
On July 20, 2018, the U.S. Food and Drug Administration approved ivosidenib (Tibsovo) for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. Approval was based on an open-label, single-arm, multicenter...
Clinical Cancer Researcher Gini Fleming, MD, Firmly Believes in the Power of Ideas
Gini Fleming, MD, had a peripatetic path to her destination as a gynecologic and breast cancer expert. As a child, she moved around a lot, living in about 10 or 12 different places, so she had no real sense of being born and reared in any particular place. “My parents married young, when my father ...
Academic Oncology and Industry Offer the Best of Both Worlds for Mace L. Rothenberg, MD
GUEST EDITOR Dr. Abraham is the Director of the Breast Oncology Program at Taussig Cancer Institute, and Professor of Medicine, Lerner College of Medicine, Cleveland Clinic. For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, interviewed Mace L. Rothenberg, MD,...
Real-World Evidence Gaining Credibility and Practicality in Treatment Evaluation
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends...
Abemaciclib as Initial Therapy for Hormone Receptor–Positive, HER2-Negative Advanced or Metastatic Breast Cancer
Early in 2018, abemaciclib (Verzenio) in combination with an aromatase inhibitor was approved as initial endocrine-based therapy for postmenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.1,2 Supporting Efficacy Data Approval was based on findings in ...
American Cancer Society Outlines Blueprint for Cancer Control in the 21st Century
The American Cancer Society (ACS) is outlining its vision for cancer control in the decades ahead in a series of articles that began publishing in early July in CA: A Cancer Journal for Clinicians. The series of articles forms the basis of a national cancer control plan, with a blueprint toward the ...
Lung Cancer Mortality Among Women Projected to Increase by 43% Worldwide by 2030
According to a report by the International Agency for Research on Cancer, cancer is among the leading causes of morbidity and mortality worldwide, with an estimated incidence of 14 million new cases of the disease and 8.2 million cancer deaths in 2012. A study analyzing breast and female lung...
FDA Grants Orphan Drug Designation to SRF231 for Treatment of Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to SRF231 for the treatment of patients with multiple myeloma. SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells, which prevents them from being...
Two Phase III Trials of KX2-391 in Actinic Keratosis Achieve Primary Endpoints
Two phase III studies—KX-AK-003 and KX-AK-004—achieved their primary endpoint of 100% clearance of actinic keratosis lesions at day 57 within the face or scalp treatment areas, with each study achieving statistical significance (P < .0001). Statistical significance (P < .001) ...
Response to Ibrutinib in Symptomatic Untreated Waldenström’s Macroglobulinemia
In a study reported in the Journal of Clinical Oncology, Treon et al found that ibrutinib monotherapy was highly active in patients with previously untreated Waldenström’s macroglobulinemia, with better response in patients without CXCR4 mutation. Ibrutinib has been shown to be active in ...
Monthly High-Dose Vitamin D and Cancer Risk
In a study reported in JAMA Oncology, Scragg et al found that monthly high-dose vitamin D supplementation, without calcium, was not associated with a reduced risk of developing cancer. Study Details The current analysis is a post hoc analysis of the Vitamin D Assessment (ViDA) study, which...
‘Super-Resolution’ MRI May Help Plan Radiotherapy Treatment in Lung Cancer
Physicists from The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust combined standard two-dimensional magnetic resonance imaging (MRI) images of the chests of healthy volunteers to create 'super-resolution' videos, showing the lungs expanding and contracting. The...
Dabrafenib/Trametinib Combination Receives CHMP Recommendation for the Adjuvant Treatment of BRAF V600 Mutation–Positive Melanoma
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of adult patients with stage III melanoma...
KEYNOTE-048: Pembrolizumab Monotherapy in Head and Neck Squamous Cell Carcinoma
The phase III KEYNOTE-048 trial, which is investigating pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC), met a primary endpoint of overall survival (OS) as monotherapy in patients whose tumors expressed programmed cell death ...
Use of Analgesics and Ovarian Cancer–Specific Survival
In a prospective cohort study reported in The Lancet Oncology, Merritt et al found evidence that recent use of aspirin or nonaspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after diagnosis appears to improve ovarian cancer–specific survival. Study Details The study involved...
No Benefit of Adding Abiraterone to Enzalutamide in Metastatic Castration-Resistant Prostate Cancer With Increasing PSA
The PLATO trial failed to show benefit of adding abiraterone (Zytiga)/prednisone to ongoing enzalutamide (Xtandi) vs abiraterone/prednisone in men with metastatic castration-resistant prostate cancer exhibiting rising prostate-specific antigen (PSA) during enzalutamide treatment. Results of the...
Forum of International Respiratory Societies Issues Statement on World Lung Cancer Day
On World Lung Cancer Day (August 1), the members of the Forum of International Respiratory Societies (FIRS) commemorate, celebrate, and support those impacted by lung cancer. FIRS continues to support the grassroots efforts of the lung cancer community to raise awareness about lung cancer and its...
European Commission Approves Trastuzumab Biosimilar
The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval...
New Tool for Assessing Frailty May Aid in Predicting Survival in Newly Diagnosed Multiple Myeloma
A new frailty index may aid in predicting overall survival for patients newly diagnosed with multiple myeloma, according to a study published by Mian et al in JCO Clinical Cancer Informatics. This tool is important because frailty is a critical factor in treatment decision-making for ...
ALTA-1L Trial of Brigatinib vs Crizotinib in ALK-Positive Advanced NSCLC Meets Primary Endpoint
The global, randomized, phase III ALTA-1L (ALK in Lung Cancer Trial of AP26113 in 1st Line) trial met its primary endpoint at the first prespecified interim analysis, with brigatinib (Alunbrig) demonstrating a statistically significant improvement in progression-free...
Childbearing Potential in Women With Hodgkin Lymphoma
In a Swedish study reported in the Journal of Clinical Oncology, Weibull et al found that childbearing potential in young women treated for Hodgkin lymphoma in more recent years is similar to that in the general population. Study Details The study included 449 women aged 18 to 40 years identified ...
CPX-351 Liposome in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia
In a pivotal phase III trial reported in the Journal of Clinical Oncology, Lancet et al found that cytarabine and daunorubicin liposome (CPX-351, Vyxeos) significantly improved overall survival vs standard cytarabine plus daunorubicin (7+3 regimen) in older patients with newly diagnosed secondary...
FDA Approves Lusutrombopag for Thrombocytopenia in Adults With Chronic Liver Disease
Today, the U.S. Food and Drug Administration (FDA) approved lusutrombopag (Mulpleta) for thrombocytopenia in adults with chronic liver disease who are scheduled to undergo a medical or dental procedure. L-PLUS 1 and L-PLUS 2 Approval was based on two randomized, double-blind, placebo-controlled...
SPOP-Mutant Prostate Cancer Subtype, High PSA, and Prognosis
Conventional wisdom suggests that a high level of the protein prostate-specific antigen (PSA) in men with prostate cancer means a poor prognosis. However, this may not always be the case in men with a particular subtype of prostate cancer, according to a new study from Weill Cornell Medicine and...
Study Examines Right-Sided vs Left-Sided Colon Cancer Survival Rates
Patients with colorectal cancer tumors on the right side may have poorer 5-year survival rates than those whose tumors are located on the left side. However, a new large-scale retrospective study is the first to demonstrate a potential improvement of these outcomes. Study results show that nearly...
Psychosocial Effects of Contralateral Prophylactic Mastectomy Among Women With Nonhereditary Breast Cancer
In a prospective study reported in the Journal of Clinical Oncology, Parker et al found that among women with nonhereditary breast cancer electing contralateral prophylactic mastectomy (CPM), fear and worry over breast cancer may be dominant at the time of surgical decisions without sufficient...
Adding Cisplatin to First-Line Treatment of Elderly Patients With Advanced NSCLC
A joint analysis of parallel phase III trials reported in the Journal of Clinical Oncology by Gridelli et al found no overall survival benefit of adding cisplatin to first-line treatment of elderly patients with advanced non–small cell lung cancer (NSCLC) without an EGFR mutation. Study...
FDA Approves Iobenguane I-131 for Rare Adrenal Gland Tumors
On July 30, the U.S. Food and Drug Administration (FDA) approved iobenguane I-131 (Azedra) injection for adult and pediatric patients (12 years and older) with iobenguane scan–positive, unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL) who require systemic...
Peggy Burhenn, MS, RN-BC, AOCNS, on Lymphoma: Managing Older Adults
Peggy Burhenn, MS, RN-BC, AOCNS, of the City of Hope National Medical Center, discusses the challenges of working with older lymphoma patients and the importance of effective geriatric assessments.
Indocyanine Green in Sentinel Lymph Node Biopsy for Merkel Cell Carcinoma
High rates of regional lymph node involvement and metastases are not uncommon in Merkel cell carcinoma. National Comprehensive Cancer Network (NCCN) Guidelines recommend sentinel lymph node biopsy (SLNB) for staging purposes in this malignancy. In a study by Knanckstedt et al in ...
FDA Grants Fast Track Designation to Galinpepimut-S in Multiple Myeloma
The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to galinpepimut-S for the treatment of multiple myeloma. Galinpepimut-S is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms tumor 1 (WT1) protein, which is present in an array of tumor types....
Quality of Life With Niraparib Maintenance vs Placebo in Patients With Recurrent Ovarian Cancer
In a study reported in The Lancet Oncology, Oza et al found that quality of life (QOL) based on patient-reported outcomes (PROs) was not worsened with niraparib (Zejula) maintenance vs placebo in the phase III ENGOT-OV16/NOVA trial in women with recurrent ovarian cancer who were in response to...
Ado-Trastuzumab Emtansine in HER2-Mutant Lung Cancer
As reported by Li and colleagues in the Journal of Clinical Oncology, the HER2-targeted antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla) showed activity in advanced HER2-mutant lung adenocarcinoma. Study Details The current report involves a cohort of patients with HER2-mutant lung...
Following a Healthy Diet and Avoiding Alcohol May Reduce Overall Cancer Risk
The World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) has estimated that in developed countries, about 35% of breast cancers and 45% of colorectal cancers could be prevented with a better adherence to nutritional recommendations. A large prospective study evaluating...
FDA Approves Magnetic Device System for Guiding Sentinel Lymph Node Biopsies in Patients With Breast Cancer
The U.S. Food and Drug Administration (FDA) recently approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The Magtrace and Sentimag Magnetic Localization System uses magnetic detection during sentinel lymph node biopsy procedures to ...
Ability of Assay to Predict Response to Immunotherapy in Patients With Advanced Gastric Cancer
Researchers from Samsung Medical Center and Guardant Health, Inc have demonstrated the feasibility of determining a measure analogous to tumor mutation burden, a promising biomarker that may predict patient response to certain immunotherapies, utilizing the Guardant360 assay, a...
Surgeon Attitudes Toward the Omission of Axillary Dissection in Early Breast Cancer
In a study reported in JAMA Oncology, Morrow and colleagues found that surgeon acceptance of more limited surgery in early breast cancer was more likely among high-volume surgeons and those preferring a surgical margin of “no ink on tumor.” As noted by the authors, the American College ...
Biomarker-Integrated Risk Model for Lung Cancer
As reported in JAMA Oncology by the Integrative Analysis of Lung Cancer Etiology and Risk (INTEGRAL) Consortium for Early Detection of Lung Cancer, incorporating biomarkers into a lung cancer risk prediction model may improve performance compared with risk based on age and smoking exposure alone....
New Study Calls for Continued Aggressive Treatment for Breast Cancer in Women Under 40
A new study from the Stanford Cancer Institute found that young women who are treated with chemotherapy for breast cancer but have residual tumor in either the breast or lymph nodes have higher chances of recurrence compared to those with no evidence of any residual invasive...
Robot-Assisted Laparoscopic Prostatectomy vs Open Radical Retropubic Prostatectomy in Newly Diagnosed Prostate Cancer
In an Australian phase III trial reported in The Lancet Oncology, Coughlin et al found similar functional outcomes at 2 years with robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy in men with newly diagnosed clinically localized prostate cancer. Study Details In ...
Complementary Therapy for Cancer and Refusal of Conventional Treatment
People who received complementary therapy for curable cancers were more likely to refuse at least one component of their conventional cancer treatment, and were more likely to die as a result, according to researchers from Yale Cancer Center and the Cancer Outcomes, Public Policy and Effectiveness...
IMpower 132: Atezolizumab in Combination With Pemetrexed and Platinum-Based Chemotherapy in Advanced Nonsquamous NSCLC
The phase III IMpower132 study met its co-primary endpoint of progression-free survival and demonstrated that the combination of atezolizumab (Tecentriq) plus chemotherapy (cisplatin or carboplatin plus pemetrexed [Alimta]) reduced the risk of disease worsening or death compared to chemotherapy...
Quality-of-Life and Patient-Centered Outcomes With Olaparib Maintenance in Relapsed Ovarian Cancer
In the phase III SOLO2 trial reported in The Lancet Oncology, Friedlander et al found that olaparib maintenance therapy did not worsen health-related quality of life vs placebo in patients with platinum-sensitive relapsed ovarian cancer and a BRCA1 or BRCA2 mutation. In the study, maintenance...
Julie M. Vose, MD, MBA, and David G. Maloney, MD, PhD, on NHL: Update on CAR T-Cell Therapies
Julie M. Vose, MD, MBA, of the University of Nebraska Medical Center, and David G. Maloney, MD, PhD, of Fred Hutchinson Cancer Research Center and winner of this year’s Oliver Press Memorial Award, discuss three CAR T-cell products for lymphoma treatment, comparing their efficacy, toxicity, ease of ...
Jonathan W. Friedberg, MD, on Follicular Lymphoma: Novel Combination Therapies
Jonathan W. Friedberg, MD, of the University of Rochester Medical Center, discusses treatments that enhance progression-free and overall survival and clear minimal residual disease—obinutuzumab plus chemotherapy, lenalidomide, and rituximab—and the types of lymphoma patients who may benefit.
Bruce D. Cheson, MD, and Richard I. Fisher, MD, on Lymphoma: Treatment Considerations
Bruce D. Cheson, MD, of Georgetown University Hospital, and Richard I. Fisher, MD, of Fox Chase Cancer Center, discuss ways to incorporate PET and CT scanning into standard of care for and research studies on lymphoma.
