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Showing 3051 - 3100FDA 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...
Clinical Trials Actively Recruiting Patients With Lung Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with lung cancer. These studies highlight combinations of chemotherapy, mutation-specific treatments, stereotactic body radiation therapy, metastatic control, cancer...
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...
FDA Approves Alectinib for ALK-Positive Metastatic NSCLC
On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to alectinib (Alecensa) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non–small cell lung cancer (NSCLC), as detected by an FDA-approved test. In December 2015,...
Norman E. Sharpless, MD, Sworn in as Director of the National Cancer Institute
Norman E. “Ned” Sharpless, MD, took the oath of office late Tuesday, October 17, 2017, to become the 15th Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). He succeeds Harold E. Varmus, MD, who stepped down as Director in March 2015. Douglas R. Lowy, ...
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...
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...
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...
FDA Approves Novel Therapies for Lymphoma Indications
IN OCTOBER, the U.S. Food and Drug Administration (FDA) approved two novel agents for lymphoma indications: -acalabrutinib (Calquence), a kinase inhibitor, for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy; and axicabtagene ciloleucel (Yescarta), a...
In Patients With Non–Small Cell Lung Cancer, Tumor Mutation Load Emerging as Biomarker for Immunotherapy
Tumor mutation burden is emerging as a biomarker for selecting non–small cell lung cancer (NSCLC) patients for immunotherapy, according to Naiyer Rizvi, MD, the Price Family Chair of Clinical Translational Medicine, Professor of Medicine, and Director of Thoracic Oncology at Columbia University,...
Tumor Mutation Burden Shows Promise as a Response Biomarker in Small Cell Lung Cancer
Patients with small cell lung cancer (SCLC) and a high tumor mutation burden had a near doubling in response rate and 1-year overall survival when ipilimumab (Yervoy) was combined with nivolumab (Opdivo), vs nivolumab alone, new findings from CheckMate 032 have shown. Regardless of the treatment...
No Additional Benefit Found for Routine, Early Palliative Care in Mesothelioma
Early routine specialist palliative care for patients recently diagnosed with malignant pleural mesothelioma did not impact quality of life, an international multicenter study has found.1 “Regular early specialist palliative care for patients was not associated with improved quality of life, as...
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...
FDA Approves New Treatment for Adults With Mantle Cell Lymphoma
The U.S. Food and Drug Administration (FDA) today granted accelerated approval to acalabrutinib (Calquence) for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy. “Mantle cell lymphoma is a particularly aggressive cancer,” said Richard...
AACR-NCI-EORTC: NCI-MATCH Reaches Central Patient-Screening Goal
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 by Chen et al at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer...
FDA Approves Axicabtagene Ciloleucel for Large B-Cell Lymphoma
On October 18, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to axicabtagene ciloleucel (Yescarta) for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma...
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...
Potential Risk Activities and Breast Cancer–Related Lymphedema in Patients Undergoing Bilateral Surgery
In a study reported in the Journal of Clinical Oncology, Asdourian et al found that several factors considered to pose an increased risk of lymphedema were not significantly associated with the occurrence of lymphedema among women undergoing bilateral breast cancer surgery. Study Details In the...
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...
2017 ASCO Palliative Care: Resilience Intervention Improves Quality of Life for Adolescents and Young Adults With Cancer
Although a cancer diagnosis is daunting at any age, adolescents and young adults (AYAs) with the disease often face unique challenges and are at risk for poor psychosocial outcomes than older patients. A randomized study investigating whether a brief, age-appropriate, skills-based intervention...
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...
Phase III Trial Shows No Survival Benefit to Adding First-Line Ipilimumab to Chemotherapy in Advanced Squamous NSCLC
IN A PHASE III trial reported by Ramaswamy Govindan, MD, of Washington University School of Medicine, and colleagues in the Journal of Clinical Oncology, the addition of first-line ipilimumab (Yervoy) to paclitaxel/carboplatin did not improve overall survival in patients with advanced squamous...
Standard of Care Upheld for Locally Advanced Cervical Cancer
THE FIRST FORMAL comparison of two acceptable approaches to locally advanced cervical cancer has concluded that standard chemoradiotherapy is preferable to neoadjuvant chemotherapy plus surgery. The findings confirm what most specialists have believed to be the optimal treatment. The results came ...
CheckMate 238: Nivolumab Shows Benefit as Adjuvant Melanoma Treatment
IN THE TREATMENT of malignant melanoma, immune checkpoint inhibitors are no longer just for metastatic disease, and the best type may be agents targeting the programmed cell death protein 1 (PD-1), according to results of CheckMate 238, presented at the European Society for Medical Oncology (ESMO)...
Adjuvant BRAF/MEK Inhibition Improves Survival in Resectable Melanoma
FOR PATIENTS with locally advanced, resectable melanoma harboring BRAF mutations, adjuvant treatment with BRAF/ MEK inhibition significantly improves overall survival, results of the COMBI-AD trial have shown. The study was presented at the European Society for Medical Oncology (ESMO) 2017...
Alectinib Yields Favorable Results in Phase III Trials of ALK-Positive NSCLC
RESULTS OF TWO separate phase III trials confirm the activity of alectinib (Alecensa) in the central nervous system (CNS) in patients with anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC). Results lend support for alectinib as the better first-line treatment option over...
Abiraterone or Docetaxel: Which Is Optimal for Hormone-Sensitive High-Risk Prostate Cancer?
ABIRATERONE ACETATE (Zytiga) plus prednisone and docetaxel have moved up from the castrate-resistant metastatic setting to earlier in the course of disease as treatment of high-risk hormone-sensitive prostate cancer in men who are initiating androgen-deprivation therapy, based on level 1 evidence...
Positive Early Data on Second-Line Ramucirumab/Docetaxel in Platinum-Refractory Advanced Urothelial Cancer
RAMUCIRUMAB (CYRAMZA) added to docetaxel improved progression-free survival and almost doubled the overall response rate compared with docetaxel alone in patients with advanced or metastatic urothelial cancer that has progressed on platinum-based chemotherapy. These results of the phase III RANGE...
Immunotherapy Plus Radiation Appears Active in Patients With Solid Tumors and Lung or Liver Metastases
THE NOVEL COMBINATION of immunotherapy with ipilimumab (Yervoy) plus radiation achieved a clinical benefit in up to 57% of patients with solid tumors and metastases to the lungs or liver, according to evidence from a phase II trial presented at the 2017 Annual Meeting of the American Society for...
Consolidative Radiation Therapy: New Paradigm for Limited Metastatic NSCLC?
ADDING CONSOLIDATIVE RADIATION therapy to maintenance chemotherapy had a robust effect on preventing disease progression compared with maintenance chemotherapy alone in patients with limited metastatic non–small cell lung cancer (NSCLC), according to a late-breaking study presented at the 2017...
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...
Norman E. Sharpless, MD, Sworn in as Director of the National Cancer Institute
Norman E. “Ned” Sharpless, MD, took the oath of office late Tuesday, October 17, 2017, to become the 15th Director of the National Cancer Institute (NCI), part of the National Institutes of Health (NIH). He succeeds Harold E. Varmus, MD, who stepped down as Director in March 2015....
IASLC 2017: REVEL Trial Subgroup Analysis Further Clarifies Outcomes With Ramucirumab Plus Docetaxel in Advanced Non–Small Cell Lung Cancer
New subgroup analysis from the phase III REVEL trial of ramucirumab (Cyramza) in advanced non–small cell lung cancer (NSCLC) was presented at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer in Yokohama, Japan. Specifically, these...
IASLC 2017: Brigatinib in ALK-Positive Non–Small Cell Lung Cancer
Data from the phase II ALTA clinical trial evaluating brigatinib (Alunbrig) in patients with locally advanced or metastatic anaplastic lymphoma kinase (ALK)-positive non–small cell lung cancer (NSCLC) who have disease progression on crizotinib were presented at the International...
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...
Osimertinib Granted Breakthrough Therapy Designation for First-Line Treatment of EGFR Mutation–Positive NSCLC
On October 9, AstraZeneca announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for osimertinib (Tagrisso) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation–positive non–small cell lung ...
Brentuximab Vedotin Granted FDA Breakthrough Therapy Designation in Front-Line Advanced Hodgkin Lymphoma
On October 2, Seattle Genetics, Inc, announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to brentuximab vedotin (Adcetris) in combination with chemotherapy for the front-line treatment of patients with advanced classical Hodgkin lymphoma. The positive ...
Immunotherapy for Metastatic Mismatch Repair–Deficient Colorectal Cancer: Game-Changer for Small Group of Patients
PATIENTS WITH DNA mismatch repair–deficient (dMMR) metastatic colorectal cancer display a high level of microsatellite instability (MSI-H)1 and demonstrate poor chemosensitivity and shorter overall survival than patients with mismatch repair–proficient (pMMR) metastatic metastatic colorectal...
Selective PI3K Inhibitor Boosts Effect of Letrozole in Neoadjuvant Setting
FOR THE first time, an inhibitor of the phosphoinositide 3-kinase (PI3K) pathway (taselisib) used in combination with endocrine therapy in the neoadjuvant setting improved response rates over endocrine therapy alone—with good tolerability—in women with early breast cancer, according to the phase...
Strong Showing for Rucaparib Maintenance Therapy for Platinum-Sensitive Ovarian Cancer
EVIDENCE CONTINUES to mount for the benefits of poly (ADP-ribose) polymerase (PARP) inhibition in ovarian cancer. Rucaparib (Rubraca) maintenance therapy after response to platinum-containing therapy significantly improved progression-free survival in patients with recurrent ovarian cancer compared ...
FDA Approves Copanlisib for Relapsed Follicular Lymphoma
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) has granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. Copanlisib is a kinase inhibitor that works by blocking several enzymes that...
Expert Point of View: Paul Baas, MD, PhD
INVITED DISCUSSANT Paul Baas, MD, PhD, of The Netherlands Cancer Institute, called the MAPS2 trial an “excellent example of how studies in mesothelioma should be run.” As Dr. Baas pointed out, both arms performed well as second- and third-line treatment, with median progression-free survival with ...
Relapsed Mesothelioma Controlled by Checkpoint Inhibition
IN PATIENTS with malignant pleural mesothelioma, combination immunotherapy with two checkpoint inhibitors in the second or third line of treatment extended survival to at least 15 months in the MAPS2 trial,1 sponsored by the Intergroupe Francophone de Cancérologie Thoracique (IFCT) and reported at ...
