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Showing 10251 - 10300FDA Accepts sBLA, Grants Priority Review for Tisagenlecleucel in Adults With DLBCL
Today, the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental Biologics License Application (sBLA) for tisagenlecleucel (Kymriah) suspension for intravenous infusion (formerly CTL019) for the treatment of adult patients with relapsed or refractory diffuse large...
Treatment Outcomes in Patients With Bone Metastasis From Advanced RCC
In a subgroup analysis of the phase III METEOR trial of advanced renal cell carcinoma (RCC) patients with with bone metastases, cabozantinib was associated with improved outcomes vs everolimus. The analysis was reported by Escudier et al in the Journal of Clinical Oncology. Study Details In the...
Cell-Free DNA Tumor Fraction and Somatic Copy Number Alterations May Affect Survival in Metastatic Triple-Negative Breast Cancer
In a study reported in the Journal of Clinical Oncology, Stover et al found that cell-free (cf) DNA tumor fraction ≥ 10% was associated with worse survival in metastatic triple-negative breast cancer, and that several somatic copy number alterations are enriched and prognostic in metastatic...
Study Finds Association Between Breast Implants and Risk of Anaplastic Large Cell Lymphoma
In a Dutch study reported in JAMA Oncology, de Boer et al found that breast implants were associated with an increased risk of anaplastic large cell lymphoma (ALCL) in the breast, although the absolute risk was small. Study Details In the study, all patients diagnosed with primary non-Hodgkin...
2018 GI CANCERS SYMPOSIUM: Liquid Biopsy Test May Detect Early-Stage Colorectal Cancer
A new study has found that a test that identifies circulating tumor cells (CTCs) present in the bloodstream can detect colorectal cancer at an early stage, with accuracy ranging from 84% to 88%. Most prior studies using CTCs have been able to detect late-stage colorectal cancer, and this study is...
FDA Approves Afatinib for Previously Untreated, Metastatic NSCLC With Other Nonresistant EGFR Mutations
On January 12, 2018, the U.S. Food and Drug Administration (FDA) granted approval to afatinib (Gilotrif) for a broadened indication in first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have nonresistant epidermal growth factor receptor (EGFR)...
Passive Scattering Proton Therapy vs Intensity-Modulated Photon Radiotherapy for Locally Advanced NSCLC
In a study reported in the Journal of Clinical Oncology, Liao et al found that passive scattering proton radiotherapy (PSPT) improved heart—but not lung—radiation dose-volume indices vs intensity-modulated photon radiotherapy (IMRT) in patients with advanced non–small cell lung...
CAP Guideline Details HPV Testing in Head and Neck Carcinomas
Patients with certain head and neck cancers who test positive for high-risk types of human papillomavirus (HPV) have a better prognosis and may need less aggressive treatment. To help ensure that patients with these cancers are accurately diagnosed and effectively treated, the College of...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to olaparib (Lynparza), a poly ADP-ribose polymerase (PARP) inhibitor, for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative metastatic breast cancer who have been...
Brentuximab Vedotin Plus Bendamustine in Relapsed/Refractory Hodgkin Lymphoma
A phase I/II trial has shown that the addition of brentuximab vedotin (Adcetris) to bendamustine is active in relapsed or refractory Hodgkin lymphoma. Study findings were reported in The Lancet Oncology by O’Connor et al. Study Details In the study, 64 patients with Hodgkin lymphoma and 1...
Out-of-Pocket Costs and Prescription Abandonment of Novel Oral Anticancer Agents
In a retrospective claims-based study reported in the Journal of Clinical Oncology, Doshi et al found that higher out-of-pocket costs were associated with increased rates of prescription abandonment for novel oral anticancer agents. Study Details The study involved data on 38,111 patients from...
PSA at 7 Months and Prognosis in Metastatic Hormone-Sensitive Prostate Cancer Treated With ADT With or Without Chemotherapy
In a study reported in the Journal of Clinical Oncology, Harshman et al found that a prostate-specific antigen (PSA) level ≤ 0.2 ng/mL at 7 months after the start of androgen-deprivation therapy (ADT) was significantly associated with longer overall survival in metastatic...
Chemoradiation in Elderly Patients With Stage III NSCLC Improves Overall Survival
Elderly patients with stage III non–small cell lung cancer (NSCLC) showed improved overall survival when treated with chemoradiation compared to definitive radiation alone, according to findings published by Miller et al in the Journal of Thoracic Oncology. NSCLC constitutes between...
Study Finds Gene-Expression Profile Testing for Breast Cancer Less Cost-Effective in Real-World Practice
The most commonly used gene expression profile test used to help predict breast cancer recurrence may not be as cost-effective as once thought, say a team of researchers led by scientists from Georgetown Lombardi Comprehensive Cancer Center. Their study, published by Chandler et al in the Journal...
Durable Complete Responses After Discontinuation of Immunotherapy in Metastatic Melanoma
As reported in the Journal of Clinical Oncology by Robert and colleagues, a high proportion of patients with metastatic melanoma achieving complete response on pembrolizumab (Keytruda) in the phase Ib KEYNOTE-001 trial maintained complete response for prolonged durations after treatment...
Comparison of Chemoradiation Treatment Schedules in Locally Advanced Head and Neck Cancer
In an Indian phase III trial reported in the Journal of Clinical Oncology, Noronha and colleagues found that curative-intent adjuvant chemoradiotherapy with cisplatin at 100 mg/m2 every 3 weeks produced better locoregional control than cisplatin at 30 mg/m2 every week in patients with locally...
Adjuvant Pembrolizumab Improves Recurrence-Free Survival in Stage III Resected High-Risk Melanoma
On January 8, Merck and the European Organisation for Research and Treatment of Cancer (EORTC) announced that the phase III EORTC1325/KEYNOTE-054 trial investigating pembrolizumab (Keytruda) as monotherapy for surgically resected high-risk melanoma met its primary endpoint of recurrence-free...
Everolimus in Previously Treated Thymoma and Thymic Carcinoma
In an Italian phase II study reported in the Journal of Clinical Oncology, Zucali et al found that everolimus was active in cisplatin-pretreated thymoma and thymic carcinoma; however, a high rate of fatal pneumonitis was observed. Study Details In the study, 51 patients with advanced/recurrent...
Bipolar Androgen Therapy After Progression on Enzalutamide in Metastatic Castration-Resistant Prostate Cancer
In a single-center phase II study reported in The Lancet Oncology, Teply et al found that bipolar androgen therapy can induce prostate-specific antigen (PSA) response and resensitization to enzalutamide (Xtandi) in men with metastatic castration-resistant prostate cancer who progressed on...
New Cancer Model Shows Genomic Link Between DCIS and IDC Breast Cancer Types
A new genetic-based model may explain how ductal carcinoma in situ (DCIS) progresses to a more invasive form of cancer, say researchers at The University of Texas MD Anderson Cancer Center. The study provides new insight into how DCIS leads to invasive ductal carcinoma (IDC) and provides a clearer...
Cancer Statistics 2018: U.S. Cancer Mortality Continues Decades-Long Drop
The cancer death rate dropped 1.7% from 2014 to 2015, continuing a drop that began in 1991 and has reached 26%, resulting in nearly 2.4 million fewer cancer deaths during that time. The data is reported in “Cancer Statistics, 2018,” the American Cancer Society’s...
Radioiodine Treatment of Well-Differentiated Thyroid Cancer and Hematologic Malignancy Risk
In a study reported in the Journal of Clinical Oncology, Molenaar et al found that radioiodine treatment for well-differentiated thyroid cancer was associated with an increased risk of acute myeloid leukemia (AML) and chronic myeloid leukemia (CML) compared with thyroidectomy alone. Study Details ...
Patients With SCLC Face Barriers to Receiving Standard-of-Care Treatment
Despite decades of clinical research establishing chemotherapy with thoracic radiation as the standard of care for the initial management of nonmetastatic small cell lung cancer (SCLC), a large percentage of U.S. patients do not receive these treatments, and in turn have lower overall survival,...
Surveillance vs Metastasis-Directed Therapy in Recurrent Oligometastatic Prostate Cancer
In a Belgian phase II study reported in the Journal of Clinical Oncology, Ost et al found that androgen deprivation therapy (ADT)-free survival was prolonged with metastasis-directed therapy vs surveillance in recurrent oligometastatic prostate cancer. Study Details Sixty-two patients with...
Ribociclib Receives FDA Breakthrough Therapy Designation in Premenopausal Women With Hormone Receptor–Positive, HER2-Negative Breast Cancer
On January 3, ribociclib (Kisqali) received U.S. Food and Drug Administration (FDA) Breakthrough Therapy designation for initial endocrine-based treatment of pre- or perimenopausal women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer in combination with...
Association of Tumor-Infiltrating Lymphocytes With Prognosis in Breast Cancer Subtypes
In a study reported in The Lancet Oncology by Denkert et al, increased levels of tumor-infiltrating lymphocytes (TILs) in women receiving neoadjuvant chemotherapy were associated with improved prognosis in HER2-positive breast cancer and triple-negative breast cancer, but poorer outcome in luminal...
FDA Accepts sBLA, Grants Priority Review for Brentuximab Vedotin in Advanced Hodgkin Lymphoma
On January 2, the U.S. Food and Drug Administration (FDA) accepted for filing a supplemental Biologics License Application (sBLA) for brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The FDA also...
Activity of Hypoxia-Inducible Factor-2α Antagonist in Advanced Renal Cell Carcinoma
In a phase I trial reported in the Journal of Clinical Oncology, Courtney et al found that a first-in-class hypoxia-inducible factor-2α (HIF-2α) antagonist (PT2385) was active in patients with previously treated advanced clear cell renal cell carcinoma (RCC). Study Details In the...
Addition of PEGPH20 to Nab-Paclitaxel/Gemcitabine in Pancreatic Ductal Adenocarcinoma
In a phase II study reported in the Journal of Clinical Oncology, Hingorani et al found that the addition of pegvorhyaluronidase alfa (PEGPH20) to nab-paclitaxel (Abraxane)/gemcitabine improved progression-free survival in patients with previously untreated metastatic pancreatic ductal...
Long-Term Outcomes With Neoadjuvant vs Adjuvant Chemotherapy in Early Breast Cancer
A meta-analysis reported in The Lancet Oncology by the Early Breast Cancer Trialists’ Collaborative Group indicates that neoadjuvant chemotherapy is associated with a higher local recurrence risk vs the same chemotherapy given postoperatively after breast-conserving therapy. Study Details...
FDA Updates Nilotinib Label With Information on Discontinuing Treatment in Certain Patients With Early-Phase CML After Sustained Response
On December 22, the U.S. Food and Drug Administration (FDA) updated the product label for nilotinib (Tasigna) to include information for providers about how to discontinue the drug in certain patients. Nilotinib, first approved by the FDA in 2007, is indicated for the treatment of patients with...
Harborside Partners With MAZ to Launch OncologyGo, Cancer Resource for Mobile Devices and TV
Media technology company, MAZ, has partnered with Harborside, a medical communications company based in Huntington, New York, to launch OncologyGo, a streaming-event coverage and video content app for specialists in oncology health care available on Apple TV, Roku, FireTV, and iOS. Harborside...
Is Medical Assistance in Dying Compassionate Care?
Suicidal ideation while receiving end-of-life cancer care is not unusual but can often be reversed by palliative and psychosocial oncology interventions. That said, there are patients who, even after intensive interventions, request medical assistance in dying. Physician-assisted death has been a...
Durvalumab Consolidation After Chemoradiotherapy Improves Progression-Free Survival in Stage III Non–Small Cell Lung Cancer
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1) ...
Durvalumab Consolidation After Chemoradiotherapy Improves Progression-Free Survival in Stage III Non–Small Cell Lung Cancer
As reported by Scott J. Antonia, MD, PhD, of the H. Lee Moffitt Cancer Center and Research Institute, and colleagues in The New England Journal of Medicine, an interim analysis of the phase III -PACIFIC trial showed improved progression-free survival with the programmed cell death protein 1 (PD-1)...
Lower Dose of Cabazitaxel in Prostate Cancer
On September 14, 2017, the microtubule inhibitor cabazitaxel (Jevtana) was approved at the lower dose of 20 mg/m2 every 3 weeks in combination with prednisone for treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen.1,2...
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 members were...
Expert Point of View: Eduardo Bruera, MD, FAAHPM
Eduardo Bruera, MD, FAAHPM, Medical Director, Department of Supportive Care Center, The University of Texas MD Anderson Cancer Center, in Houston, called the dyadic intervention “highly innovative.” “We all talk about movement, exercise, and the importance of physical activity for our patients,...
Dyadic Yoga Program for Patients With Lung Cancer and Their Caregivers May Optimize Treatment Response
Yoga therapy delivered to patients with lung cancer and their caregivers together appears to be a feasible and beneficial supportive care strategy. According to data presented at the 2017 Palliative and Supportive Care in Oncology Symposium,1 the dyadic intervention resulted in a clinically and...
Adding First-Line Radiotherapy to Chemotherapy for Liver Metastases From Colorectal Cancer
A meta-analysis of three randomized trials (FOXFIRE, SIRFLOX, and FOXFIRE-Global) indicates no overall survival benefit of adding first-line selective internal radiotherapy to chemotherapy in patients with liver metastases from colorectal cancer. The findings were reported by Wasan and colleagues...
Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer
As reported in The Lancet by Krishnansu S. Tewari, MD, of the University of California-Irvine Medical Center, and colleagues, the final overall survival results of the phase III Gynecologic Oncology Group 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in...
Samuel Oschin Comprehensive Cancer Institute Receives 3-Year Accreditation From ACS
The Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai has been honored with a 3-year accreditation with commendation from the American College of Surgeons (ACS). The accreditation is recognized by the National Cancer Institute, Centers for Medicare & Medicaid Services, the Joint...
Oncologists Urged to Be Proactive in Advising Patients to Reduce Risk of Alcohol-Related Cancers
A recently released ASCO statement summarizing extensive evidence linking alcohol use to an increased risk of several leading cancers, including breast, colon, and head and neck, called on oncologists “as front-line providers for cancer patients” to help patients reduce excessive alcohol use.1...
Medical Oncologist Takes the Paths Less Traveled to Unwind and Reboot
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 in the Living a Full Life series of articles, Andrew D. Seidman, MD, of Memorial Sloan Kettering Cancer ...
FCC, NCI Working to Improve Rural Cancer Care via Broadband Access
The Connect2Health Task Force, an initiative of the Federal Communmications Commission (FCC), has announced that the FCC and the National Cancer Institute (NCI) have joined forces, signing a memorandum of understanding that will focus on how increasing broadband access and adoption in rural areas...
The Puzzle Table
The ASCO Post is pleased to reproduce installments of the “Art of Oncology” as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays,...
Data Must Be Generated to Support Cross-Labeling of Combination Therapies for Cancer
Combinations of targeted therapies (triple, quadruple, or even more) are part of the future of cancer treatment, which means that traditional clinical trials will have to be streamlined and updated to enable greater flexibility and to extract adequate safety and efficacy data. Problems inherent in...
FDA Helps Streamline Approval Process for Supplemental Drug Indications
As researchers learn more about the natural history of cancers, as more drugs are effective for more types of the disease, and as the number and complexity of combination therapies increase, the more important it is that new drugs and permutations of old ones be available to patients. The U.S. Food ...
Neratinib Is Approved: Should We Reject It Anyway?
The U.S. Food and Drug Administration (FDA) approved 1 year of extended adjuvant neratinib (Nerlynx) after chemotherapy and a year of trastuzumab (Herceptin) for HER2-positive breast cancer this summer on the basis of the ExteNET trial. Many were surprised at the approval, since the evidence of...
Mount Sinai Surgeons Remove Cancerous Lymph Nodes Using Novel Robot-Assisted Procedure
A team of surgeons at Mount Sinai Beth Israel, led by Hyunsuk Suh, MD, Assistant Professor in the Department of Surgery at the Icahn School of Medicine at Mount Sinai, has performed the first robot-assisted radical neck dissection in the United States using the bilateral axillo-breast approach, a...
