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Showing 2251 - 2300Pomegranates and Other Polyphenols: New Evidence to Share With Prostate Cancer Patients
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Channing Paller, MD, explores the role of pomegranate- and grape-based...
FDA Approves Olaparib for Germline BRCA-Mutated Metastatic Breast Cancer
On January 12, 2018, 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...
2018 GI CANCERS SYMPOSIUM: First-Line Lenvatinib vs Sorafenib in Unresectable Hepatocellular Carcinoma
The results of an analysis of the phase III REFLECT trial of lenvatinib mesylate (Lenvima) vs sorafenib (Nexavar) as first-line treatment for unresectable hepatocellular carcinoma based on independent imaging review were presented during the 2018 Gastrointestinal (GI) Cancers Symposium (Abstract...
Durvalumab Takes a Giant Leap Into Stage III NSCLC
Immune checkpoint inhibitors have had a dramatic impact on survival for patients with stage IV non–small cell lung cancer (NSCLC), with whispers that a cure might be achieved in a subset of patients. In typical fashion, active new agents are evaluated in earlier stages of disease. Stage III NSCLC...
Diary of a Storm
FOR DAYS BEFORE HURRICANE HARVEY was expected to move toward Houston, Texas, on Sunday, August 27, 2017, after pummeling other cities in Texas and Louisiana, the leadership team at The University of Texas MD Anderson Cancer Center (MD Anderson) in Houston strategized on how to ensure the...
2018 GI CANCERS SYMPOSIUM: First-Line Ramucirumab in Gastric Cancer Improves Progression-Free but Not Overall Survival
The monoclonal antibody ramucirumab (Cyramza) was evaluated as first-line therapy for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma in the international phase III RAINFALL trial. Charles Fuchs, MD, of Yale New Haven Health in Connecticut, presented findings...
2018 GI CANCERS SYMPOSIUM: Cabozantinib Demonstrates Significant Overall Survival Benefit in Patients With Previously Treated Advanced HCC
Detailed results of the phase III CELESTIAL trial in patients with previously treated advanced hepatocellular carcinoma (HCC) were presented in a late-breaking oral session by Abou-Alfa et al at the 2018 ASCO Gastrointestinal (GI) Cancers Symposium (Abstract 207). Study Findings In CELESTIAL,...
NSABP B-47: No Benefit for Adjuvant Trastuzumab in HER2-Low Breast Cancer
For more than a decade, breast cancer experts have wondered whether women with low levels of HER2 might derive some benefit from trastuzumab (Herceptin), based on signals seen in earlier trastuzumab trials. Most notably, in the landmark National Surgical Adjuvant Breast and Bowel Project (NSABP) ...
ECHELON-1: A Commendable Study, but Questions Remain
“The important thing is not to stop questioning. Curiosity has its own reason for existing.” —Albert Einstein The phase III international ECHELON-1 study, designed to evaluate brentuximab vedotin (Adcetris) as part of a front-line chemotherapy regimen for previously untreated advanced classic...
Safety Information on Rolapitant Injectable Emulsion
The Oncology Center of Excellence of the U.S. Food and Drug Administration (FDA) is informing health-care providers about new safety information for rolapitant (Varubi) injectable emulsion, a substance P/neurokinin (NK-1) receptor antagonist indicated for the prevention of delayed nausea and...
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...
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...
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...
FDA Approves Denosumab for the Prevention of Skeletal-Related Events in Patients With Multiple Myeloma
Today, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for denosumab (Xgeva) to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients...
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...
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...
FDA Accepts sNDA, Grants Priority Review to Adjuvant Dabrafenib/Trametinib in BRAF V600E/K Mutation–Positive Melanoma
On December 22, the U.S. Food and Drug Administration (FDA) accepted a supplemental New Drug Application (sNDA) and granted Priority Review designation to dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with BRAF V600E...
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...
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). Approval was based on data from an open-label,...
American Association for the Advancement of Science Inducts New Fellows
The American Association for the Advancement of Science (AAAS) has recently inducted 396 members as fellows, with 21 members having oncology backgrounds. Members have been awarded this honor because of their scientifically or socially distinguished efforts to advance science or its applications....
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...
St. John’s Wort
The ASCO Post’s Integrative Oncology series is intended to facilitate the availability of evidence-based information on integrative and complementary therapies commonly used by patients with cancer. In this installment, Jun J. Mao, MD, MSCE, and Jyothirmai Gubili, MS, explore the role of St....
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. Approval was...
ASCO Resolutions Approved by AMA House of Delegates
From November 11–14, ASCO delegates participated in the American Medical Association’s (AMA) Interim Meeting of the House of Delegates (HOD), the principal policy-making body of the AMA. During the meeting, several ASCO-backed resolutions were approved, including: Medicare Part B Drugs in QPP/MIPS...
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...
Bosutinib for First-Line Use in Chronic Myeloid Leukemia: Is Three a Crowd?
BOSUTINIB ( BOSULIF) is the latest tyrosine kinase inhibitor that has shown a superior molecular response profile when compared with imatinib.1,2 An orally available dual SRC/ABL1 inhibitor, the drug was shown in preclinical studies to have a potent inhibitory activity against BCR-ABL1 and minimal ...
Reports From the Journal of Clinical Oncology
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...
Phase II Data for Venetoclax/Ibrutinib Combination in Relapsed or Refractory Chronic Lymphocytic Leukemia
THE COMBINATION of ibrutinib (Imbruvica) plus venetoclax (Venclexta) achieved favorable responses in patients with relapsed or refractory chronic lymphocytic leukemia (CLL), according to initial results of the phase II CLARITY trial presented at the 2017 American Society of Hematology (ASH) Annual ...
Nivolumab 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 ...
Updated Data in KEYNOTE-061: Pembrolizumab in Previously Treated Gastric or Gastroesophageal Junction Adenocarcinoma
The phase III KEYNOTE-061 trial investigating pembrolizumab (Keytruda) as a second-line treatment for patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma did not meet its primary endpoint of overall survival (OS) (hazard ratio [HR] = 0.82, 95% confidence interval [CI] = ...
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...
Carla Casulo, MD, on Follicular Lymphoma: Results From the FLASH Study
Carla Casulo, MD, of the James P. Wilmot Cancer Center, discusses findings on POD24 as a robust early clinical endpoint of poor survival in follicular lymphoma, using data from more than 5,000 patients in 13 clinical trials (Abstract 412).
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...
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...
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...
Immunotherapy Plus Chemotherapy in Non–Small Cell Lung Cancer: Despite the Failure of Ipilimumab, Guarded Optimism Persists
Ipilimumab (Yervoy) is a fully human monoclonal antibody that inhibits cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) and was the first checkpoint inhibitor approved after showing survival benefit in metastatic melanoma.1 Indeed, in the first-line setting for metastatic melanoma, ipilimumab ...
Follicular Lymphoma: Is the Road to Cure Paved With Gallium?
The roadside along the path to curing follicular lymphoma is riddled with the debris of failed cytotoxic regimens. For decades, clinical trials unsuccessfully pitted various chemotherapy combinations against each other. It took but a single, noncytotoxic molecule, rituximab (Rituxan), to forever...
Evidence-Based Support for Triplet Therapies in Multiple Myeloma
Over the past 15 years, multiple myeloma has garnered among the highest number of regulatory approvals by the U.S. Food and Drug Administration (FDA) for the management of all phases of the disease. This fast-expanding repertoire of treatment options has pushed the median survival of multiple...
FDA Grants Bevacizumab Full Approval in Recurrent Glioblastoma
On December 5, the U.S. Food and Drug Administration (FDA) granted full approval of bevacizumab (Avastin) for the treatment of adults with recurrent glioblastoma that has progressed following prior therapy. Bevacizumab was previously granted provisional approval in this setting under the FDA's ...
More Than One-Third of PAs in Oncology Experience Burnout, Despite High Rate of Career Satisfaction
A new physician assistant (PA)-based study finds that despite personal satisfaction in the oncology specialty, high rates of burnout—over one-third of PAs (34.8%)—are common. These findings reveal important factors that could help to decrease burnout and improve the oncology workforce...
FDA Approvals in November 2017: Novel Drugs, New Indications
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) approved a number of novel drugs and new indications in November 2017. Several of them are listed here. Fulvestrant/Abemaciclib Combination in Breast Cancer ON NOVEMBER 15 , the FDA approved fulvestrant (Faslodex) in combination with abemaciclib...
Reports From JCO and JOP
Staying up-to-date with peer-reviewed oncology literature is a daunting task. To assist readers, The ASCO Post has summarized a number of studies recently published in the Journal of Oncology Practice (JOP) and the Journal of Clinical Oncology (JCO). Survival as Quality Metric in Cancer Care In a...
Update on NCI-MATCH Precision Medicine Trial
THE NATIONAL CANCER INSTITUTE (NCI) Molecular Analysis for Therapy Choice (MATCH) clinical trial has achieved the goal of screening nearly 6,000 patients in just under 2 years, according to data presented at the 2017 American Association for Cancer Research–NCI–European Organisation for Research...
IDEA Trial: ‘Going Beyond Statistics’ in Stage III Colon Cancer
According to Alberto Sobrero, MD, Head of Medical Oncology at Ospedale San Martino in Genova, Italy, the results of the pivotal IDEA trial, which evaluated the optimal duration of adjuvant chemotherapy for stage III colon cancer, were not clear to clinicians.1 The combined analysis of six...
ASCO Election Candidates
SIXTEEN DISTINGUISHED ASCO members have been selected by the ASCO Nominating Committee as candidates for open leadership positions within the Society, including: The offices of President-Elect and Treasurer Four seats on the Society’s Board of Directors Two seats on the Nominating Committee...
ESMO Asia 2017: FLAURA Trial: Osimertinib Improves Progression-Free Survival in Asian Patients With EGFR-Mutated NSCLC
Osimertinib (Tagrisso) improves progression-free survival compared to standard first-line therapy in Asian patients with EGFR-mutated non–small cell lung cancer (NSCLC), according to the Asian subset analysis of the FLAURA trial presented at the European Society for Medical Oncology (ESMO)...
ESMO Asia 2017: AXEPT Trial: New Second-Line Therapy for Metastatic Colorectal Cancer Is Effective and Safe
A randomized trial in 650 patients has confirmed the safety and efficacy of a new second-line treatment for metastatic colorectal cancer, researchers reported at the European Society for Medical Oncology (ESMO) Asia 2017 Congress (Abstract LBA3_PR). Oral fluorinated pyrimidines have been...
