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Showing 1101 - 1150Adjuvant Temozolomide in 1p/19q Non-codeleted Anaplastic Glioma
Interim results of the phase III CATNON trial (EORTC study 26053-22054) indicate a survival benefit of adjuvant temozolomide in 1p/19q non-codeleted anaplastic glioma. These findings were reported in The Lancet by Martin J. van den Bent, MD, of the Brain Tumour Centre at Erasmus MC Cancer...
Pembrolizumab in Advanced Urothelial Carcinoma
On May 18, 2017, pembrolizumab (Keytruda) was granted regular approval for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant...
2018 GI CANCERS SYMPOSIUM: KEYNOTE-224 Trial: Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib
Findings from the phase II KEYNOTE-224 trial investigating the use of pembrolizumab (Keytruda) in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar) were presented by Zhu et al at the 2018 Gastrointestinal (GI) Cancers Symposium in San Francisco...
Carfilzomib-Based Treatment and Transplant in Smoldering Myeloma
Can aggressive treatment of high-risk smoldering multiple myeloma patients prevent disease worsening? A carfilzomib (Kyprolis)-based regimen and autologous stem cell transplant (ASCT) plus maintenance produced encouraging outcomes in the phase II GEM-CESAR study by the Spanish Myeloma Group. The...
Proof-of-Principle Study of Combination Checkpoint Inhibitor Plus Trastuzumab in HER2-Positive Advanced Breast Cancer
The combination of pembrolizumab (Keytruda) plus trastuzumab (Herceptin) may turn out to be a good treatment option for patients with trastuzumab-resistant advanced HER2-positive breast cancer, according to the results of an early study presented at the 2017 San Antonio Breast Cancer Symposium...
Improved Overall and Progression-Free Survival With First-Line Pembrolizumab in Combination With Pemetrexed and Cisplatin or Carboplatin in NSCLC
The phase III KEYNOTE-189 trial—investigating pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and cisplatin or carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC)—met its dual primary endpoints of...
Lenvatinib and Pembrolizumab Combination Receives Breakthrough Therapy Designation for Advanced Renal Cell Carcinoma
On January 9, Eisai and Merck announced that they received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for Eisai's multiple receptor tyrosine kinase inhibitor lenvatinib (Lenvima) in combination with Merck's anti–programmed cell death protein 1...
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...
Addition of Tumor-Treating Fields to Maintenance Temozolomide in Glioblastoma
Final results of a phase III trial reported by Stupp and colleagues in JAMA indicate that adding antimitotic treatment with tumor-treating fields to maintenance temozolomide is associated with improved progression-free and overall survival in patients with previously treated glioblastoma. The...
Gemtuzumab Ozogamicin in CD33-Positive Acute Myeloid Leukemia
On September 1, 2017, gemtuzumab ozogamicin (Mylotarg) was approved for treatment for newly diagnosed CD33-positive acute myeloid leukemia (AML) in adults and for treatment of relapsed or refractory CD33-positive AML in adults and pediatric patients aged ≥ 2 years.1,2 It may be used in combination...
Providing a Safe Haven for Patients With Advanced Lung Cancer
In 1996, Jimmie C. Holland, MD, the Wayne E. Chapman Chair in Psychiatric Oncology at Memorial Sloan Kettering Cancer Center (MSK) in New York, decided to launch the cancer center’s Lung Cancer Survivorship Program after she had a startling encounter with a patient. “The woman said to me, ‘Would...
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] = ...
BELLE-3 Trial: Combination Therapy in Resistant Advanced Breast Cancer
The phase III BELLE-3 trial has shown prolonged progression-free survival but a worse safety profile with the addition of the pan-phosphoinositide 3-kinase inhibitor buparlisib to fulvestrant (Faslodex) in postmenopausal women with hormone receptor–positive, HER2-negative advanced breast...
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...
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...
First-Line Pembrolizumab in Cisplatin-Ineligible Advanced Urothelial Cancer
As reported in The Lancet Oncology by Arjun V. Balar, MD, of Perlmutter Cancer Center of New York York Langone Medical Center, and colleagues, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic...
Tandem Autologous/Allogeneic HCT With Maintenance Therapy in High-Risk Myeloma
In a phase II study reported in Blood Advances, Green et al found that tandem autologous/allogeneic hematopoietic cell transplantation (HCT) followed by bortezomib (Velcade) maintenance produced good results in patients with newly diagnosed high-risk multiple myeloma. Poorer outcomes were observed...
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 ...
Recent Study Findings in 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 clonal myeloid disorders, acute lymphoblastic leukemia, lymphoma, and plasma cell dyscrasias. Clonal Myeloid Disorders STUDY:...
Tackling the High Cost of Cancer Care
AT THE 2017 ASCO ANNUAL MEETING, the leaders of the newly formed Value in Cancer Care Consortium (vi3c; vi3c.org) met to discuss the group’s plan to study how to improve the affordability of cancer drugs and make them more accessible to patients. The goal of the Value in Cancer Care Consortium is...
Huntsman Cancer Institute Names New Clinical Research Director
Huntsman Cancer Institute (HCI) at the University of Utah has announced David Gaffney, MD, PhD, as Senior Director for Clinical Research. In this position, Dr. Gaffney will oversee Huntsman Cancer Institute’s clinical research efforts, which include more than 200 active clinical cancer trials at...
Pembrolizumab in Advanced Gastric Cancer
On September 22, 2017, pembrolizumab (Keytruda) was granted accelerated approval for treatment of recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma with tumors expressing programmed cell death ligand 1 (PD-L1), as determined by a U.S. Food and Drug...
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...
Neratinib for Extended Adjuvant Treatment of Early-Stage HER2-Positive Breast Cancer
On July 17, 2017, neratinib (Nerlynx) a dual inhibitor of HER2 and epidermal growth factor receptor (EGFR), was approved for extended adjuvant treatment of adults with early-stage HER2-overexpressed/amplified breast cancer following adjuvant trastuzumab (Herceptin)-based therapy.1,2 Supporting...
Abemaciclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer
On September 28, 2017, the cyclin-dependent kinases 4 and 6 (CDK4/6) inhibitor abemaciclib (Verzenio) was approved for use in combination with fulvestrant (Faslodex) for women with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer with disease progression following...
Adding Antibody-Drug Conjugate to First-Line Treatment of Advanced Classical Hodgkin Lymphoma
As reported by Eichenauer et al in The Lancet Oncology, the final results of a phase II German Hodgkin Study Group trial showed similar efficacy but a better toxicity profile for BrECADD (brentuximab vedotin [Adcetris], etoposide, doxorubicin, cyclophosphamide, dacarbazine, dexamethasone) vs...
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...
Novel Tyrosine Kinase Inhibitor for ALK- or ROS1-Rearranged NSCLC
A phase I trial has shown that the ALK and ROS1 tyrosine kinase inhibitor lorlatinib is active in patients with advanced ALK- or ROS1-positive non–small cell lung cancer (NSCLC), including those with central nervous system (CNS) metastases and failure on at least two prior tyrosine kinase...
Carfilzomib May Be a Strong Candidate for Salvage Therapy in Relapsed/Refractory Multiple Myeloma—but Questions Remain
WITH THE INCLUSION of proteasome inhibitors and immunomodulatory agents first into salvage and then as components of first-line, consolidation, and maintenance regimens, response rates, depth of response, and median progression-free and overall survival have all improved for patients suffering...
Expert Point of View: Alexander Eggermont, MD, PhD
BASED ON THE RESULTS of COMBI-AD1 and CheckMate 238,2 invited discussant Alexander Eggermont, MD, PhD, Professor of Oncology at Gustave Roussy in Paris, commented: “It’s a good day for melanoma!” In COMBI-AD, treatment with the combination of dabrafenib (Tafinlar) and trametinib (Mekinist)...
Second-Line Pembrolizumab Extends Survival in Urothelial Cancer
PEMBROLIZUMAB (KEYTRUDA) extended survival by about 3 months in patients with advanced urothelial cancer whose disease progressed on platinum-based chemotherapy vs investigator’s choice of therapy, according to the mature results of the KEYNOTE-045 trial presented at the European Society for...
Immunotherapy for Advanced Soft-Tissue and Bone Sarcoma
The phase II SARC028 trial has shown activity of pembrolizumab (Keytruda) in some subtypes of advanced sarcoma. These findings were reported by Tawbi et al in The Lancet Oncology. Study Details In the study, 84 patients with advanced soft-tissue sarcoma aged ≥ 18 years (n = 42) or bone sarcoma ...
Results From the Phase III JUNIPER Trial Evaluating Abemaciclib in KRAS-Mutated, Advanced NSCLC
On October 10, Eli Lilly and Company announced that its phase III JUNIPER study evaluating abemaciclib (Verzenio), a cyclin-dependent kinase (CDK) 4 and CDK6 inhibitor, as monotherapy in KRAS-mutated, advanced non–small lung cancer (NSCLC) did not meet its primary endpoint of overall...
First-Line Immunotherapy for Cisplatin-Ineligible Patients With Advanced Urothelial Cancer
As reported in The Lancet Oncology by Balar et al, first-line pembrolizumab (Keytruda) produced durable responses in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer in the phase II KEYNOTE-052 trial. The trial supported the accelerated approval...
Journal of Clinical Oncology Literature Update
STAYING UP-TO-DATE in the fast-paced world of oncology literature is a daunting task at best. To assist with that task, The ASCO Post has assembled an assortment of studies recently published in the Journal of Clinical Oncology. Sorafenib Dosing and Outcomes in Hepatocellular Cancer IN A...
Momelotinib vs Ruxolitinib in Janus Kinase Inhibitor–Naive Myelofibrosis
In the phase III SIMPLIFY-1 noninferiority trial reported in the Journal of Clinical Oncology, Mesa et al found that the selective Janus kinase (JAK) 1 and 2 inhibitor momelotinib was noninferior to ruxolitinib (Jakafi) in spleen response, but not symptom response, in JAK inhibitor–naive...
Integrative Therapies in Palliative Care Project
Palliative care professionals are invited to participate in a unique project sponsored by the National Cancer Institute. Collinge and Associates, Inc, is seeking interdisciplinary professionals to help develop and evaluate a new online continuing education (CE/CME) course on the use of integrative...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as ...
ASTRO 2017: RTOG 0617: Long-Term Survival Rates Improve Previous Estimates for Locally Advanced Lung Cancer
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. At 5 years following treatment with a standard dose of ...
MicroRNA-Loaded Minicells in Recurrent Malignant Pleural Mesothelioma
An Australian phase I first-in-human trial has shown early activity of microRNA-loaded minicells in patients with malignant pleural mesothelioma. These findings were reported in The Lancet Oncology by van Zandwijk et al. The minicells (TargomiRs) are loaded with miR-16–based mimic microRNA...
Addition of Motesanib to Paclitaxel/Carboplatin in East Asian Patients With Advanced NSCLC
The phase III MONET-A trial has shown that the addition of the multikinase/vascular endothelial growth factor receptor inhibitor motesanib to paclitaxel and carboplatin did not significantly improve progression-free survival in East Asian patients with stage IV/recurrent nonsquamous non–small ...
FDA Grants Accelerated Approval to Pembrolizumab for Advanced Gastric Cancer
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express programmed cell death ligand 1 (PD-L1) as...
NCI-COG Pediatric MATCH Trial to Test Targeted Drugs in Childhood Cancers
Investigators at the National Cancer Institute (NCI) and the Children’s Oncology Group (COG) have announced the opening of enrollment for a unique precision medicine clinical trial. NCI-COG Pediatric Molecular Analysis for Therapy Choice (Pediatric MATCH) is a nationwide trial to explore whether...
Olaparib Receives Positive pCODR Recommendation for Treatment of BRCA-Mutated Ovarian Cancer
The pan-Canadian Oncology Drug Review (pCODR) has provided a positive clinical recommendation for the reimbursement of olaparib (Lynparza), a first-of-its-kind treatment for BRCA-mutated ovarian cancer. Lynparza is an oral, potent inhibitor of poly (ADP-ribose) polymerase (PARP) available as a...
Does Reducing the Starting Dose of Sorafenib Affect Outcomes in Hepatocellular Carcinoma?
In a retrospective study reported in the Journal of Clinical Oncology, Reiss et al found that reducing the starting dose of sorafenib (Nexavar) was associated with noninferior overall survival, reduced cost, and lower risk of discontinuing treatment in patients with advanced hepatocellular...
Addition of EGFR-Targeting Vaccine to Temozolomide in EGFRvIII-Expressing Glioblastoma
The phase III ACT IV study has shown no survival benefit of adding rindopepimut, a vaccine targeting the epidermal growth factor receptor (EGFR) deletion mutation EGFRvIII, to temozolomide in patients with newly diagnosed EGFRvIII-positive glioblastoma. These findings were reported by Weller et al...
A Doctor’s Call to Arms About the Overuse of Antibiotics
On September 3, 1928, Scottish biologist Alexander Fleming returned to London from a vacation and sorted through some petri dishes containing colonies of Staphylococcus. He noticed something unusual in one dish: It was dotted with colonies except for one area where a patch of mold grew....
Pembrolizumab in Classical Hodgkin Lymphoma
On March 14, 2017, pembrolizumab (Keytruda) was granted accelerated approval for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma or those who have relapsed after three or more prior lines of therapy.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
