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Showing 5951 - 6000Survival as Quality Metric in Cancer Care
In a National Cancer Data Base study reported in the Journal of Oncology Practice, Shulman et al found little difference in risk-adjusted cancer mortality rates among individual hospitals, suggesting survival may not be an ideal quality metric at the individual hospital level. However, survival was ...
FDA Approves Brentuximab Vedotin for Primary Cutaneous Anaplastic Large Cell Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted regular approval to brentuximab vedotin (Adcetris) for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides who have received prior systemic therapy. ALCANZA...
FDA Approves Letermovir for Prophylaxis of Cytomegalovirus Infection and Disease in Allogeneic Stem Cell Transplant Patients
Today, the U.S. Food and Drug Administration (FDA) approved letermovir (Prevymis) once-daily tablets for oral use and injection for intravenous infusion. Letermovir is indicated for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic...
ARIEL3 Investigators Clarify the Effects of Rucaparib on the Liver
PRIMARY RESULTS from the randomized, placebo-controlled, phase III study ARIEL3—presented at the European Society for Medical Oncology (ESMO) 2017 Congress and published recently in The Lancet1—demonstrated that maintenance treatment with the poly(ADP-ribose) polymerase (PARP) inhibitor rucaparib ...
Ovarian Function Recovery During Anastrozole Therapy in Postmenopausal Patients With Breast Cancer
In the phase III DATA trial reported in the Journal of the National Cancer Institute by Vivianne C.G. Tjan-Heijnen, MD, PhD, of the Maastricht University Medical Centre, the Netherlands, and colleagues, 12% of women with breast cancer who had chemotherapy-induced ovarian function failure...
10-Year Follow-up on Adjuvant Therapy in Postmenopausal Early Breast Cancer
The 10-year follow-up of the phase III TEAM trial has shown that exemestane alone and sequential tamoxifen/exemestane provide similar outcomes as adjuvant endocrine therapy in postmenopausal women with hormone receptor–positive early breast cancer. The findings were reported in The Lancet Oncology ...
Association of Tumor HER3 Expression With Treatment Outcome in Advanced Colorectal Cancer
In a study reported in JAMA Oncology, Seligmann et al found that higher tumor HER3 messenger RNA expression among patients with RAS wild-type tumors was associated with a better outcome with panitumumab (Vectibix) plus irinotecan vs irinotecan alone among patients with advanced colorectal cancer in ...
Internal Radiotherapy vs Kinase Inhibitor in Advanced Hepatocellular Carcinoma
A French phase III trial has shown no significant survival difference between selective internal radiotherapy with yttrium-90 resin microspheres vs sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma. The findings were reported by Vilgrain et al in The Lancet Oncology. Study...
National Cancer Institute Awards Dr. Ruth Etzioni 5-Year Grant to Fill Gaps in Cancer-Recurrence Data
RUTH ETZIONI, PhD, a Biostatistician at Fred Hutchinson Cancer Research Center’s Public Health Sciences Division, has received a 5–year National Institutes of Health grant to advance the science of cancer surveillance by developing, validating, and deploying a scalable and automated approach for...
FDA Approves Intravenous Rolapitant for Prevention of Delayed Chemotherapy-Induced Nausea and Vomiting
ON OCTOBER 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including...
Balancing Immune-Related Adverse Events With Efficacy of Dual Checkpoint Inhibitor Therapy in Melanoma
MUCH PROGRESS has been made in the past decade in the treatment of patients with newly diagnosed metastatic melanoma. In the front-line setting, programmed cell death protein 1 (PD-1) monotherapy (nivolumab [Opdivo] and pembrolizumab [Keytruda]) and combined PD-1 plus cytotoxic...
Long-Term Survival Rates More Than Double Previous Estimates for Locally Advanced Lung Cancer
THE LONG-TERM RESULTS of a phase III clinical trial indicate that survival rates for patients receiving chemoradiation for unresectable, locally advanced non–small cell lung cancer (NSCLC) may be more than twice as high as previous estimates, setting a new benchmark of survival for patients with...
Pelvic Radiation Therapy Preferred Over Brachytherapy Plus Chemotherapy in Treatment of High-Risk Endometrial Cancer
VAGINAL CUFF BRACHYTHERAPY plus chemotherapy failed to show superiority over pelvic radiation therapy for women with high-risk stage I–II endometrial cancer in a phase III trial.1 Furthermore, vaginal cuff brachytherapy plus chemotherapy led to more pelvic and para-aortic nodal recurrences and...
Dacomitinib vs Gefitinib in Advanced NSCLC: Improving Upon Established First-Line Targeted Therapy
THE RESULTS FROM the ARCHER 1050 study—reported by Wu et al1 and reviewed in this issue of The ASCO Post—highlight the recent optimism about improved outcomes in metastatic non–small cell lung cancer (NSCLC) harboring mutations in the epidermal growth factor receptor (EGFR) gene. This trial...
Dacomitinib Prolongs Progression-Free Survival vs Gefitinib in First-Line Treatment of EGFR-Mutant NSCLC
THE PHASE III ARCHER 1050 trial has shown superior progression-free survival with the second-generation irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor dacomitinib vs gefitinib (Iressa) in the first-line treatment of advanced EGFR-mutant non–small-cell lung cancer...
Characteristics of Recurrence in Stage I to III Midgut Neuroendocrine Tumors
In a study reported in the Journal of the National Cancer Institute, Cives et al found that postsurgical relapse occurred in 31% of patients with stage I to III midgut neuroendocrine tumors over long-term follow-up, with liver, mesentery, and pelvic lymph nodes being the main sites of relapse....
FDA Accepts sBLA for Bevacizumab as a Front-Line Treatment for Advanced Ovarian Cancer
On October 25, Genentech announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for bevacizumab (Avastin) in combination with chemotherapy (carboplatin and paclitaxel), followed by bevacizumab alone, for the front-line ...
Recent Clinical Trials in Hematopoietic Cell Transplantation Setting for Hematologic Malignancies
Here is a brief look at the study findings and clinical implications of several recent and important clinical trials in neoplastic hematology. Attention is focused on hematopoietic cell transplantation in a variety of hematologic malignancies, with investigations addressing the role of maintenance ...
Management of Newly Diagnosed Multiple Myeloma in Transplant-Eligible Patients
The treatment paradigm for multiple myeloma has changed dramatically in the past decade with the availability of several efficacious agents in various drug classes. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic Malignancies™, Shaji K. Kumar, MD, Professor...
Immunotherapeutic Approaches for B-Cell Acute Lymphocytic Leukemia
New therapeutic agents for acute lymphocytic leukemia (ALL) have led to dramatic improvement in remission rates, but questions concerning the proper sequencing and combination of these agents remain. At the National Comprehensive Cancer Network® (NCCN®) 13th Annual Congress: Hematologic...
Pembrolizumab Benefits Patients With Recurrent Metastatic Head and Neck Cancer, Mainly High PD-L1–Expressing Tumors
Pembrolizumab (Keytruda) may be a better choice than standard of care for patients with recurrent or metastatic head and neck squamous cell carcinoma, especially those whose tumors express programmed cell death ligand 1 (PD-L1) in 50% or more of cells, suggest results of the phase III KEYNOTE-040...
Resectable Pancreatic Cancer: Neoadjuvant or Adjuvant Therapy?
For potentially curable treatment of resectable pancreatic cancer, adjuvant therapy remains the standard “for now,” but evidence is growing that neoadjuvant therapy may be more beneficial, at least in certain patient subsets, according to Thomas Seufferlein, MD, PhD, Professor of Medicine at the...
More Data From ESMO 2017
In GEICAM 2006-10, the addition of fulvestrant at 250 mg/d to anastrozole did not improve 5-year disease-free survival over anastrozole alone (91.0% vs 90.8%). “Immune induction” with chemotherapy or radiotherapy appeared to enhance response to nivolumab in women with metastatic triple-negative...
International Trials Reveal New Findings in the Management of Breast and Ovarian Cancers
The European Society for Medical Oncology (ESMO) 2017 Congress, held in Madrid, featured important news including at least seven practice-changing or potentially practice-changing trials, which are covered in recent issues of The ASCO Post. Here we present additional highlights of studies in breast ...
Quick Takes on Studies in Noncolorectal Gastrointestinal Cancers
In this roundup, The ASCO Post offers a glance at key findings from studies in noncolorectal gastrointestinal malignancies presented at the European Society for Medical Oncology (ESMO) 2017 Congress from investigators around the world. Docetaxel-Based Triplet in Gastric Cancer The superiority of...
Anti–PD-1 Agents Gaining Momentum in Gastric Cancer
In updates of two important studies in metastatic gastric cancer reported at the European Society for Medical Oncology (ESMO) 2017 Congress, nivolumab -(Opdivo) and pembrolizumab (Keytruda) demonstrated activity—but to varying degrees and with some nuances. “Anti-PD [programmed cell death protein]...
Factors Associated With Outcome in Pediatric Adrenocortical Tumors
In a St. Jude Adrenocortical Tumor Registry and Children’s Oncology Group study reported in the Journal of Clinical Oncology, Pinto et al found that a positive Ki67 labeling index was associated with a poorer outcome in children with adrenocortical tumors independent of germline TP53 mutation ...
ENDEAVOR Trial Endeavors to Make Case for Carfilzomib: Despite Survival Advantage, Should We Be Surprised?
LOCATION! LOCATION! LOCATION! That’s what home buyers are frequently cautioned about before purchasing a property. For trialists, and more importantly, practicing oncologists, a study’s design, akin to a property’s location, must be taken into account prior to buying into the results and changing ...
EXPERT POINT OF VIEW: Joan H. Schiller, MD
JOAN H. SCHILLER, MD, Deputy Director of Inova Schar Cancer Institute in Fairfax, Virginia, pointed out that no one particular chemotherapy regimen has been shown to improve overall survival vs other standard regimens. “So if we can’t identify one best chemotherapy, what else can we do to make...
Treatment Based on BRCA1 Expression Did Not Improve Survival in NSCLC
IN PATIENTS with early-stage non–small cell lung cancer (NSCLC), the use of expression of BRCA1 failed as an approach to customize chemotherapy, investigators from the Spanish Lung Cancer Cooperative Group reported at the 2017 International Association for the Study of Lung Cancer (IASLC) World...
Results From Phase III ARROW Study of Once-Weekly Carfilzomib in Relapsed/Refractory Multiple Myeloma
On October 23, topline results of the phase III ARROW trial were announced, showing carfilzomib (Kyprolis) administered once weekly at 70 mg/m2 with dexamethasone allowed relapsed and refractory multiple myeloma patients to live 3.6 months longer without their disease worsening than...
Adjuvant Dabrafenib/Trametinib Combination Granted FDA Breakthrough Therapy Designation for Stage III Melanoma With BRAF V600 Mutation
On October 23, Novartis announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for dabrafenib (Tafinlar) in combination with trametinib (Mekinist) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following...
Final Results of German Trial of PET-Guided Treatment in Advanced Hodgkin Lymphoma
Final results of the German Hodgkin Study Group phase III HD18 trial, reported in The Lancet by Borchmann et al, showed no benefit of adding rituximab (Rituxan) to escalated BEACOPP (eBEACOPP; bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone) in...
ASCO/CCO Focused Guideline Update on Role of Bone-Modifying Agents in Metastatic Breast Cancer
As reported by Catherine Van Poznak, MD, of the University of Michigan, Ann Arbor, and colleagues in the Journal of Clinical Oncology, ASCO and Cancer Care Ontario (CCO) have collaborated in providing a focused update for the ASCO clinical practice guideline on the role of bone-modifying agents in...
AACR-NCI-EORTC: Rising Number of Seamless Clinical Trials in Oncology
The number of early-phase trials in oncology that adopted a seamless approach—as opposed to a traditional trial approach with defined phase I, II, and III plans—is rising, with data from the majority of them presented after 2014, according to a study presented by Barata et al at the...
AACR-NCI-EORTC: Tazemetostat as Treatment for Certain Pediatric Relapsed or Refractory Solid Tumors
Children with relapsed or refractory malignant rhabdoid tumors, epithelioid sarcomas, or poorly differentiated chordomas with a particular genetic defect tolerated treatment with the investigational drug tazemetostat well, and some had objective and durable responses, according to data from a phase ...
AACR-NCI-EORTC: Gene Therapy Shows Early Efficacy Against Recurrent Brain Cancer
More than a quarter of patients with recurrent high-grade glioma treated with the retroviral vector Toca 511 (vocimagene amiretrorepvec) combined with Toca FC (an extended-release formulation of fluorocytosine, a prodrug of fluorouracil [5-FU]) were alive more than 3 years after...
2-Year Survival Outcomes With Immunotherapy in Advanced NSCLC
Analysis of 2-year overall survival with nivolumab (Opdivo) vs docetaxel in the phase III CheckMate 017 and 057 trials showed a continued survival benefit with nivolumab in patients with previously treated advanced non–small cell lung cancer (NSCLC). The findings were reported by Horn et al...
Combination Therapy for Docetaxel-Pretreated Metastatic Castration-Resistant Prostate Cancer
The phase III AFFINITY trial has shown no survival benefit with the addition of the antisense oligonucleotide custirsen to cabazitaxel (Jevtana)/prednisone in patients with metastatic prostate cancer previously treated with docetaxel. These findings were reported in The Lancet Oncology by Beer et...
FDA Accepts sBLA for Nivolumab in Resected, High-Risk, Advanced Melanoma
On October 16, Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for nivolumab (Opdivo) to treat patients with melanoma who are at high risk of disease recurrence following complete...
FDA Approves Intravenous Rolapitant for Delayed Chemotherapy-Induced Nausea and Vomiting
On October 25, the U.S. Food and Drug Administration (FDA) approved intravenous (IV) rolapitant (Varubi) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including,...
CELESTIAL Trial: Cabozantinib Meets Primary Endpoint of Overall Survival in Patients With Advanced Hepatocellular Carcinoma
On October 16, Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib (Cabometyx) providing a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with...
Anti–T-Lymphocyte Globulin and Chronic GVHD-Free Survival in Unrelated Myeloablative HCT
A double-blind phase III trial has shown no benefit of anti–T-lymphocyte globulin (ATLG) vs placebo on chronic graft-vs-host disease (GVHD)-free survival in patients undergoing human leukocyte antigen (HLA)-matched unrelated myeloablative hematopoietic cell transplantation (HCT). The study...
Extended Aromatase Inhibitor Therapy After Sequential Endocrine Therapy
In the Dutch phase III DATA trial reported in The Lancet Oncology by Tjan-Heinjen et al, a nonsignificant disease-free survival advantage was found for 6 vs 3 years of adjuvant aromatase inhibitor therapy after 2 to 3 years of tamoxifen in hormone receptor–positive early breast cancer....
FDA Grants Priority Review for Olaparib in Metastatic Breast Cancer
On October 18, AstraZeneca and Merck & Co announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a supplemental New Drug Application (sNDA) for the use of olaparib (Lynparza) tablets in patients with germline BRCA-mutated, HER2-negative...
MAF Amplification and Outcomes With Adjuvant Zoledronic Acid in Early Breast Cancer
An analysis from the phase III AZURE trial has shown that MAF-negative status was associated with a benefit and MAF-positive status, with a detriment of adjuvant zoledronic acid in early breast cancer. The analysis was reported by Coleman et al in The Lancet Oncology. Study Details The current...
Effectiveness of Sentinel Lymph Node Biopsy in Patients With Newly Diagnosed Melanoma
Research presented at the 9th World Congress of Melanoma supports the updated guideline recommendation that sentinel lymph node biopsy be performed in more patients newly diagnosed with melanoma, as it has the potential to save lives due to the information the procedure provides. This biopsy can...
Intratumoral Plasmid IL-12 With Electroporation in Stage III/IV Melanoma
OncoSec Medical Incorporated presented new clinical data on ImmunoPulse IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid] with electroporation) at the 9th World Congress of Melanoma. “We are excited to share updated data from our phase II clinical monotherapy trial with ImmunoPulse ...
FDA Accepts sBLA for Durvalumab in Locally Advanced Unresectable NSCLC
On October 17, the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for durvalumab (Imfinzi) for the treatment of patients with locally advanced (stage III) unresectable non–small cell lung cancer (NSCLC) whose disease has not progressed ...
FDA Awards Grants for Clinical Trials to Stimulate Product Development for Rare Diseases
THE U.S. FOOD and Drug Administration (FDA) has awarded numerous new clinical trial research grants, totaling more than $22 million over the next 4 years, to boost the development of products for patients with rare diseases. These new grants were awarded to principal investigators from academia and ...
