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Showing 3101 - 3150‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
‘Clinically Meaningful’ Results With First-Line Osimertinib in EGFR–Positive NSCLC
OSIMERTINIB (TAGRISSO) showed encouraging results as first-line therapy for patients with epidermal growth factor receptor (EGFR)–mutated non–small-cell lung cancer (NSCLC) in the phase III FLAURA trial, according to results presented at the 2017 European Society for Medical Oncology (ESMO)...
FDA Accepts sNDA for Lenvatinib for the Treatment of Hepatocellular Carcinoma
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
Nivolumab Plus Ipilimumab vs Sunitinib Alone as First-Line Therapy for Metastatic Renal Cell Carcinoma
A CHANGE IN PARADIGM may be on the horizon for the treatment of metastatic renal cell carcinoma. According to the results of CheckMate 214, the combination of ipilimumab (Yervoy) plus nivolumab (Opdivo) outperformed the standard of care—sunitinib (Sutent)—for first-line treatment, with improved...
MSLT-II Completion Lymph Node Dissection Trial: Practice Changing but Not Likely Practice Abandoning
PROBABLY THE MOST IMPORTANT advance in the treatment of newly diagnosed primary melanoma has been the incorporation of sentinel lymph node biopsy as part of initial surgical management. The routine use of sentinel lymph node biopsy, often termed “sentinel lymphadenectomy,” in appropriately...
Abemaciclib Plus Endocrine Therapy Extends Progression-Free Survival in First-Line Therapy for Advanced Breast Cancer
THE VALUE OF cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in advanced breast cancer became ever more certain with the announcement of interim data from MONARCH 3, which evaluated abemaciclib in combination with endocrine therapy as first-line therapy for hormone receptor–positive/HER2-negative...
Study Finds 'Standard Care' Treatments in Breast Cancer Clinical Trials Not Always Standard
Historically, randomized controlled trials have served as the state-of-the-art method for determining the efficacy and safety of new, innovative treatment regimens for patients with cancer and other diseases. It is imperative that such trials are carefully designed to ensure that they are...
European Commission Approves Obinutuzumab for Previously Untreated Advanced Follicular Lymphoma
On September 22, Roche announced that the European Commission has approved obinutuzumab (Gazyvaro in Europe; available in the United States as Gazyva) in combination with chemotherapy, followed by obinutuzumab maintenance in patients achieving a response, as a new treatment for previously untreated ...
Avelumab in Locally Advanced or Metastatic Urothelial Carcinoma
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 9, 2017, avelumab (Bavencio) was granted...
Durvalumab in Advanced Urothelial Carcinoma Progressing After Platinum Therapy
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On May 1, 2017, durvalumab (Imfinzi) was granted...
Combination of Rituximab and Hyaluronidase Human for Subcutaneous Use in Lymphoma and Leukemia
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On June 22, 2017, the combination of rituximab (Rituxan)...
Clinical Trials Actively Recruiting Patients With Breast Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on patients with breast cancer. These studies highlight neoadjuvant combination therapy, cell vaccines, novel imaging techniques, radiotherapy, and more. All of the studies are...
FDA Expands Approval of Ipilimumab to Pediatric Patients 12 Years and Older
On July 24, the U.S. Food and Drug Administration (FDA) expanded the indication for ipilimumab (Yervoy) injection for intravenous use now to include the treatment of unresectable or metastatic melanoma in pediatric patients 12 years of age and older. Ipilimumab was evaluated in 2 trials of...
ASTRO 2017: Accelerated Breast Radiation Therapy Following Mastectomy Can Shorten Treatment Time While Maintaining Tumor Control
Radiation therapy following mastectomy for intermediate-stage, high-risk breast cancer can be shortened from 5 to 3 weeks while maintaining tumor control rates in the breast and surrounding region that are equivalent to conventional treatment, according to research presented by Sun et al at the...
ASTRO 2017: Aggressively Reduced Radiation Therapy May Benefit Some Patients With HPV-Related Throat Cancer
For certain patients with oropharyngeal cancer caused by the human papillomavirus (HPV), an aggressive reduction of radiation therapy after surgery may provide cancer control while simultaneously reducing post-treatment side effects, improving quality of life, and lowering treatment costs,...
ASTRO 2017: GOG-249 Confirms Adjuvant Pelvic Radiation as Standard of Care for High-Risk, Early-Stage Endometrial Cancer
In a new phase III trial report from the National Clinical Trial Network group, NRG Oncology, recurrence-free and overall survival rates for women with stage I–II high-risk endometrial cancer were not superior following adjuvant vaginal cuff brachytherapy plus chemotherapy when compared with...
FDA Approves New CDK4/6 Inhibitor for Certain Advanced or Metastatic Breast Cancers
The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
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 ...
ASTRO 2017: Radiation-Immunotherapy Combination May Benefit Some Patients With Late-Stage Cancer
A new study involving patients with stage IV cancer has found that treatment with radiation therapy and immunotherapy can slow tumor growth by stimulating the body’s immune system to attack the cancer. In the phase II trial, patients with end-stage cancer that had metastasized to the lungs or ...
ASTRO 2017: Adding Radiation to Maintenance Chemotherapy May Benefit Patients With Limited Metastatic NSCLC
For patients with limited metastatic non–small cell lung cancer (NSCLC), adding radiation therapy before maintenance chemotherapy may curb disease progression when compared to maintenance chemotherapy alone, according to a randomized phase II clinical trial reported by Iyengar et al. at the...
ASTRO 2017: IAEA Trial: Safety, Efficacy of High-Dose Brachytherapy Plus Pelvic Radiation for Cervical Cancer
Findings from a new multicenter, international clinical trial confirm the effectiveness of high-dose brachytherapy, or internal radiation therapy, for managing locally advanced cervical cancer. Tumor control was significantly better following four fractions of 7 Gy each than following two 9-Gy...
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...
WISDOM Study to Test Personalized Approach to Breast Cancer Screening
MANY health-care experts disagree about when screening mammography is appropriate and for whom. That’s what Women Informed to Screen Depending on Measures of Risk (WISDOM) seeks to remedy. The University of California (UC) Health study aims to uncover whether annual mammograms really are the best...
How Early Palliative Care May Benefit Patients With Incurable Cancer
Palliative care provided soon after a patient is diagnosed with incurable cancer not only helps improve the patient’s overall quality of life but also improves communication about the patient’s wishes for end-of-life care, according to a study by Jennifer S. Temel, MD, Clinical Director of Thoracic ...
FDA Recent Approvals Include First Oncology Biosimilar
ON SEPTEMBER 14, 2017, the U.S. Food and Drug Administration (FDA) approved bevacizumab-awwb (Mvasi) as a biosimilar to bevacizumab (Avastin) for the treatment of multiple types of cancer. Bevacizumab-awwb is the first biosimilar approved in the United States for the treatment of cancer....
Duration Studies in Oncology Have Often Been Poorly Designed and Analyzed
The ASCO Post is pleased to introduce “At Microphone 1,” an occasional column written by Steven E. Vogl, MD, of Bronx, New York. When he’s not in his clinic, Dr. Vogl can generally be found at major oncology meetings, and often at the microphone where he stands ready with important questions for...
Is Complete Lymphadenectomy Still Standard of Care in Melanoma?
DOES COMPLETE lymph node dissection for sentinel node–positive melanoma still have a role in the management of this disease? That’s debatable. Although it does not improve overall survival over observation alone, complete lymphadenectomy may have other benefits, according to a dialogue at the...
PD-L1 Inhibitor Consolidation Therapy for NSCLC: New Standard of Care?
THE PROGRAMMED CELL DEATH ligand 1 (PD-L1) inhibitor durvalumab (Imfinzi) improved progression-free survival by 11.2 months compared with placebo in patients with locally advanced, unresectable stage III non–small cell lung cancer (NSCLC) whose disease did not progress following standard treatment ...
Significant Improvement in Outcomes Reported With Adjuvant Therapy for Melanoma
FOR PATIENTS with malignant melanoma, the significant improvement in outcomes with targeted agents and antibodies against the programmed cell death protein 1 (PD-1) has now been observed in the adjuvant setting. Two landmark studies presented at the European Society for Medical Oncology (ESMO) 2017 ...
ESMO 2017: KEYNOTE-045: Updated Results Support Pembrolizumab as Second-Line Treatment in Advanced Urothelial Cancer
Mature results from the KEYNOTE-045 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA37_PR) confirmed significantly longer survival in patients with advanced urothelial cancer who received the checkpoint inhibitor pembrolizumab after initial...
ESMO 2017: Patients Struggle With Key Aspects of Clinical Trial Methodology
Clinical trials are fundamental to the development of new treatments for cancer, yet the annual accrual to cancer clinical trials worldwide is low, estimated at 3%–5%. A nationwide study in Ireland, the preliminary results of which were presented at the European Society for Medical Oncology...
ESMO 2017: KEYNOTE-040 Evaluates Pembrolizumab in Head and Neck Cancer
Immunotherapy with the checkpoint inhibitor pembrolizumab (Keytruda) may be a better option than standard treatments for patients whose head and neck cancer has spread or recurred after an initial round of chemotherapy, according to results of the KEYNOTE-040 trial presented at the European Society ...
ESMO 2017: MONARCH 3: Abemaciclib as Initial Therapy Improves Outcome in Endocrine-Sensitive Advanced Breast Cancer
The results of the MONARCH 3 trial, presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract 236O_PR), showed that adding the cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib to endocrine therapy improved progression-free survival compared to endocrine...
FDA Approves Copanlisib for Adults With Relapsed Follicular Lymphoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to copanlisib (Aliqopa) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior systemic therapies. “For patients with relapsed follicular lymphoma, the cancer often...
ESMO 2017: PACIFIC Trial: Durvalumab Improves Progression-Free Survival in Stage III Lung Cancer
Durvalumab improves progression-free survival in patients with locally advanced, unresectable stage III lung cancer, according to late-breaking results from the phase III PACIFIC trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in Madrid (Abstract LBA1_PR) and...
Adding First-Line Ipilimumab to Paclitaxel/Carboplatin in Advanced Squamous NSCLC
In a phase III trial reported by Govindan et al 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 non–small cell lung cancer (NSCLC). Study Details In the...
ESMO 2017: ICON8 Trial Reaffirms Standard Chemotherapy Dosing in Ovarian Cancer
Caucasian women with ovarian cancer can safely stick to the standard every-3-week dosing schedule for paclitaxel rather than boosting up to a weekly dose-dense regimen, according to results of the phase III ICON8 trial presented at the European Society for Medical Oncology (ESMO) 2017 Congress in...
ESMO 2017: Phase III IFCT-0302 Trial Assesses Minimal vs CT Scan–Based Follow-up for Completely Resected NSCLC
The optimal follow-up protocol for patients with completely resected non–small cell lung cancer (NSCLC) remains elusive after results of the IFCT-0302 trial, presented at the 2017 European Society for Medical Oncology (ESMO) Congress in Madrid, did not show a difference in overall survival...
First-Line Cetuximab vs Bevacizumab Plus Chemotherapy in KRAS Wild-Type Colorectal Cancer
A phase III trial has shown no significant difference in overall survival with first-line cetuximab (Erbitux) vs bevacizumab (Avastin) plus chemotherapy in patients with advanced or metastatic KRAS wild-type colorectal cancer. These study findings were reported by Alan Venook, MD, of University of ...
‘Substantial Improvements’ in the Treatment of Glioblastoma
NEWS ARTICLES about Senator John McCain’s diagnosis of glioblastoma accurately describe glioblastoma as aggressive and having a poor prognosis. But as Walter J. Curran, Jr, MD, pointed out in one of those reports, “substantial improvements in surgical approaches” have enabled more patients to...
FDA Approves Betrixaban for Prophylaxis of Venous Thromboembolism
ON JUNE 23, 2017, the U.S. Food and Drug Administration (FDA) approved betrixaban (Bevyxxa) for the prophylaxis of venous thromboembolism in adult patients hospitalized for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and...
Midostaurin in FLT3 Mutation–Positive Acute Myeloid Leukemia and Systemic Mastocytosis
ON APRIL 28, 2017, midostaurin (Rydapt) was approved for treatment of adults with newly diagnosed acute myeloid leukemia (AML) who have FLT3 mutation–positive disease, as detected by a U.S. Food and Drug Administration (FDA)-approved test, in combination with standard cytarabine and daunorubicin...
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...
Emerging Global Leaders in Biosimilar Development: Regulatory Guidance and Cost Impact
BIOLOGICS PLAY A KEY ROLE in cancer treatment and are the principal components of many therapeutic regimens.1 However, they require complex manufacturing processes, resulting in high cost and occasional shortages in supply, limiting the accessibility of cancer treatment for many patients, more so ...
Positioning Lu-177 Dotatate Therapy and 68-Ga Dotatate Scans in Management of Neuroendocrine Tumors
The results of the phase III NETTER-1 trial, recently published in The New England Journal of Medicine,1 have been met with great interest by clinicians who treat neuroendocrine tumors. In patients with advanced midgut lesions, treatment with the radiopharmaceutical lutetium Lu-177 dotatate...
Atezolizumab in Patients With Advanced Urothelial Carcinoma Who Are Ineligible for Cisplatin
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 17, 2017, the programmed cell death ligand 1 (PD-L1)...
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. The topics range from therapy for stage IV non–small cell lung cancer...
Targeted Treatments and Health-Related Quality of Life in Ovarian Cancer
Novel targeted treatment strategies and new trial endpoints in recurrent, platinum-sensitive ovarian cancer were highlighted in a gynecologic cancer session at the Best of ASCO New Orleans. At the meeting, Karen McLean, MD, PhD, of the University of Michigan Medical Center, Ann Arbor, presented...
FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia
The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with...
Phase III ALCYONE Study of Daratumumab in Front-Line Treatment of Multiple Myeloma
On August 24, positive topline results were announced from the phase III ALCYONE study of daratumumab (Darzalex) in combination with bortezomib (Velcade), melphalan, and prednisone (VMP) vs VMP alone as front-line treatment for newly diagnosed patients who are not considered candidates for...
