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Showing 6501 - 6550Regorafenib Improves Survival in Patients With Hepatocellular Carcinoma Progressing on Sorafenib
In the phase III RESORCE trial reported in The Lancet, Jordi Bruix, MD, Head of the Barcelona Clinic Liver Cancer Group, University of Barcelona, and colleagues found that regorafenib (Stivarga) improved overall survival vs placebo in patients with hepatocellular carcinoma who had progressed on...
Bright Future for Osimertinib in EGFR T790M–Positive Lung Cancer
The AURA3 study—reported by Mok and colleagues and reviewed in this issue of The ASCO Post—confirms the dramatic activity of osimertinib (Tagrisso) in patients with advanced epidermal growth factor receptor (EGFR)-mutant non–small cell lung cancer (NSCLC) and acquired resistance to prior EGFR...
Osimertinib Improves Progression-Free Survival vs Platinum/Pemetrexed in EGFR T790M–Positive NSCLC
In the phase III AURA3 trial reported in The New England Journal of Medicine by Tony S. Mok, MD, of the Chinese University of Hong Kong, and colleagues, osimertinib (Tagrisso) significantly improved progression-free survival vs platinum/pemetrexed (Alimta) among patients with epidermal growth...
Radiotherapy vs Temozolomide in Low-Grade Glioma: The Importance of Molecular Classification
The optimal treatment strategy for low-grade glioma has yet to be established, and practice patterns vary in regard to the timing of treatment, as well as the chosen treatment modality. It was against this backdrop, at a time when the benefits of radiation and chemotherapy remained uncertain but ...
Tailoring Treatment for Older Adults With Colorectal Cancer
Nearly 60% of colorectal cancer cases are diagnosed in patients ≥ 65 years, with a median age at diagnosis of 68 years,1 but this population makes up only 34% of clinical trial participants.2 In addition, the older adults enrolled on clinical trials are traditionally the most-fit older adults....
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Chinese Trial Adds Utidelone to Capecitabine in Heavily Pretreated Patients With Metastatic Breast Cancer
In a Chinese phase III trial reported in The Lancet Oncology, Zhang et al found that adding the epothilone analog utidelone to capecitabine prolonged progression-free survival in women with heavily pretreated metastatic breast cancer refractory to both anthracycline and taxane treatment. Study...
Myeloablative vs Reduced-Intensity HCT for Acute Myeloid Leukemia and Myelodysplastic Syndromes
In a phase III trial reported in the Journal of Clinical Oncology, Scott et al found that myeloablative conditioning for allogeneic hematopoietic cell transplantation was associated with a reduced risk of relapse and a nonsignificant overall survival advantage vs reduced-intensity conditioning in...
ASCO-SITC Clinical Immuno-Oncology Symposium: Utility of Biomarkers for Predicting Colorectal Cancer Survival Depends on Tumor Location
A large population-based study suggests that the utility of particular types of tumor-infiltrating lymphocytes (TILs) to predict colorectal cancer survival depends on where the tumor originates in the body. Although prior research has shown an association between high TIL density and longer...
Olaparib Meets Primary Endpoint in OlympiAD Trial in BRCA-Mutated Metastatic Breast Cancer
On February 17, positive results were announced from the phase III OlympiAD trial comparing olaparib (Lynparza) tablets to physician’s choice of a standard-of-care chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harboring germline BRCA1 or BRCA2...
2017 GU Cancers Symposium: Atezolizumab Plus Bevacizumab Shows Potential in Metastatic Renal Cell Carcinoma
Results from the phase II IMmotion150 study that compared atezolizumab (Tecentriq) plus bevacizumab (Avastin) and atezolizumab monotherapy to sunitinib (Sutent) alone in patients with previously untreated, locally advanced or metastatic renal cell carcinoma were presented at the 2017 Genitourinary...
2017 GU Cancers Symposium: Updated Efficacy and Tolerability of Durvalumab in Locally Advanced or Metastatic Urothelial Carcinoma
At the 2017 Genitourinary Cancers Symposium, Powles et al presented updated efficacy and safety data for durvalumab in patients with locally advanced or metastatic urothelial cancer (Abstract 286). Updated results from the phase I/II trial showed an objective response rate of 20.4% in all...
Exploring the Opportunities and Challenges of Seamless Drug Development
The traditional three-phase clinical trial process for testing new drugs does not necessarily make sense when it comes to targeted therapies, according to many experts, including regulators, academic researchers, industry chief executive officers, and patient advocates alike. Instead of three...
Combination Immunotherapy for Lung Cancer: The Wave of the Future
Increasing experience with immunotherapy for lung cancer in both the lab and the clinic is helping to refine treatment approaches and point the way forward, according to Naiyer Rizvi, MD, Director of both Thoracic Oncology and Immunotherapeutics at Columbia University Medical Center in New York....
Selected Abstracts From the 2016 ASH Annual Meeting
Here are several abstracts selected from the proceedings of this year’s American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics in high-grade, aggressive B-cell non-Hodgkin lymphomas (NHLs), including newly diagnosed as well as relapsed or refractory...
Ongoing Phase III Clinical Trials of Immunotherapy in Advanced Non–Small Cell Lung Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy in lung cancer. All of the studies are listed on the National Institutes of Health website at ClinicalTrials.gov. Study Title: A Randomized, Double-Blind, Phase...
New Analysis of CheckMate 057: Search Continues for Predictors of Outcome With Nivolumab
Prognostic factors and tumor expression of programmed cell death ligand 1 (PD-L1) predict early mortality among patients with previously treated nonsquamous advanced non–small cell lung cancer (NSCLC) who receive nivolumab instead of docetaxel. But these features are not reliable for excluding...
KEYNOTE-010 Update Shows ‘Striking’ Durability of Second-Line Pembrolizumab in NSCLC
Pembrolizumab’s benefit in previously treated advanced non–small cell lung cancer (NSCLC) that expresses programmed cell death ligand 1 (PD-L1) is long lasting, persisting even after therapy ends, suggests an update of the KEYNOTE-010 trial.1 Initial results of the randomized phase II/III trial,...
Expert Point of View: Vincent J. Picozzi, MD
Vincent J. Picozzi, MD, a pancreatic cancer specialist at Virginia Mason Hospital in Seattle, commented on the findings by Chan et al presented at the 2017 Gastrointestinal Cancers Symposium. Dr. Picozzi first acknowledged that there is a strong biologic rationale for evaluating cabozantinib...
Cabozantinib Elicits Responses in Neuroendocrine and Carcinoid Tumors
In a phase II study reported at the 2017 Gastrointestinal Cancers Symposium, the tyrosine kinase inhibitor cabozantinib (Cometriq) was evaluated in advanced carcinoid and pancreatic neuroendocrine tumors. Radiographic responses to therapy were observed in both tumor subtypes, and compared to other ...
Health-Related Quality of Life in Pivotal Trial of Adjuvant Ipilimumab in Stage III Melanoma
As reported in The Lancet Oncology by Coens et al, there was little difference between adjuvant ipilimumab (Yervoy) vs placebo in health-related quality of life in patients with high-risk stage III melanoma in the phase III EORTC 18071 trial supporting the 2014 approval of ipilimumab in this...
Study Finds Suboptimal Use of Adjuvant Endocrine Therapy in Breast Cancer
In a retrospective cohort study reported in JAMA Oncology, Daly et al found that recommended use of adjuvant endocrine therapy for breast cancer improved in the United States between 2004 and 2013 but remains suboptimal. The study included data on 981,729 women with stage I to III breast cancer...
Durvalumab Shows Activity in Heavily Pretreated Patients With Non–Small Cell Lung Cancer
The immune checkpoint inhibitor durvalumab (also known as MEDI4736) is active and achieves durable responses in patients with heavily pretreated advanced non–small cell lung cancer (NSCLC) that does not have any epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)...
Atezolizumab Benefits Survival vs Docetaxel Across Multiple Subtypes of Non–Small Cell Lung Cancer
A wide range of patients with advanced non–small cell lung cancer (NSCLC) see a survival advantage from second- or third-line atezolizumab (Tecentriq) as compared with docetaxel, according to new data from the OAK trial.1 The main results of the randomized phase III trial, previously reported,...
Quality-of-Life Data From KEYNOTE-024: First-Line Pembrolizumab vs Chemotherapy in Advanced NSCLC
When used as first-line therapy for advanced non–small cell lung cancer (NSCLC), pembrolizumab (Keytruda) yields better health-related quality of life than platinum-based chemotherapy, suggest new data from the randomized phase III KEYNOTE-024 trial.1 After 15 weeks of treatment, changes in scores...
Clinical Trials Study the Role of Immunotherapy in the First-Line Setting of Non–Small Cell Lung Cancer
In 2016, the KEYNOTE-024 trial set the bar for first-line immunotherapy in non–small cell lung cancer (NSCLC). Trial results showed that pembrolizumab (Keytruda), an antibody to programmed cell death protein 1 (PD-1), reduced the risk of disease progression or death by 50% and the risk of death by...
Adding Bevacizumab to Perioperative Chemotherapy in Esophagogastric Adenocarcinoma
In the UK Medical Research Council ST03 phase II/III trial reported in The Lancet Oncology, Cunningham et al found that adding bevacizumab (Avastin) to perioperative chemotherapy did not improve survival in patients with operable esophagogastric cancer and may have been associated with impaired...
Patients With Breast Cancer With Dense Breast Tissue More Likely to Develop Contralateral Disease
Patients with breast cancer with dense breast tissue have almost a twofold increased risk of developing disease in the contralateral breast, according to new research from The University of Texas MD Anderson Cancer Center. The study, published by Brewster et al in the journal Cancer, is among the...
Zoledronic Acid Every 12 Weeks vs Every 4 Weeks in Women With Breast Cancer and Bone Metastases
In the phase III OPTIMIZE-2 trial reported in JAMA Oncology, Hortobagyi et al found that an every-12-week schedule of zoledronic acid was noninferior to an every-4-week schedule in terms of skeletal-related event rate in women with bone metastases from breast cancer who were currently receiving...
Residual Cancer Burden, Breast Cancer Phenotype, and Long-Term Prognosis After Neoadjuvant Chemotherapy
In a study reported in the Journal of Clinical Oncology, Symmans et al found that residual cancer burden (RCB) after neoadjuvant chemotherapy was significantly prognostic for long-term outcome across breast cancer subtypes. Study Details The study included 5 patient cohorts from The University of ...
Italian Trial Adds Bevacizumab to Cisplatin/Etoposide in Extensive-Disease Small Cell Lung Cancer
In an Italian phase III trial reported in the Journal of Clinical Oncology, Tiseo et al found that adding first-line bevacizumab (Avastin) to cisplatin/etoposide did not prolong overall survival in patients with extensive-disease small cell lung cancer. Study Details In the open-label trial, 204...
Adding Idelalisib to Bendamustine/Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
As reported by Zelenetz et al in The Lancet Oncology, an interim analysis of a phase III trial has shown the superiority of adding the phosphoinositide-3-kinase δ inhibitor idelalisib (Zydelig) to bendamustine/rituximab (Rituxan) in patients with relapsed or refractory chronic lymphocytic...
Retinoic Acid and Arsenic Trioxide vs Retinoic Acid and Chemotherapy in APL
As reported in the Journal of Clinical Oncology by Platzbecker et al, the final results of the Italian-German phase III APL0406 trial indicate that the combination of all-trans retinoic acid (ATRA) and arsenic trioxide (ATO [Trisenox]) is associated with better outcomes than standard ATRA plus...
Clinical Trials Actively Recruiting Patients With Cancer-Related Pain
Phase I Study Title: Qigong Mind-Body Exercise for Persistent Post-Surgical Pain in Breast Cancer Survivors: A Pilot Study Study Type: Phase I/interventional/single-group assignment Study Sponsor and Collaborators: Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Spaulding...
Telotristat Ethyl: A Novel Therapy for Carcinoid Syndrome—Not a Panacea but a Step in the Right Direction
The multihumoral manifestations of neuroendocrine tumors include diarrhea, cutaneous flushing, wheezing, and right-sided valvular heart disease.1 Serotonin, a biogenic amine and product of tryptophan metabolism,2 mediates several of these symptoms.3,4 Diarrhea is a cardinal and often disabling...
Telotristat Ethyl Reduces Frequency of Bowel Movements in Patients With Metastatic Neuroendocrine Tumors and Carcinoid Syndrome
In the phase III TELESTAR trial reported in the Journal of Clinical Oncology by Matthew H. Kulke, MD, of Dana-Farber Cancer Institute, and colleagues, telotristat ethyl, an investigational tryptophan hydroxylase inhibitor, significantly reduced the frequency of bowel movements in patients with...
ASCEND-4 Study Shows 45% Reduction in Risk of Disease Progression for NSCLC Patients on First-Line Ceritinib
Compared to chemotherapy, the use of first-line ceritinib (Zykadia) resulted in a statistically significant and clinically meaningful improvement in median progression-free survival, with an estimated 45% reduction in disease progression risk, as well as significant improvements in quality of...
FDA Accepts Two sBLAs for Pembrolizumab in Locally Advanced or Metastatic Urothelial Cancer
On February 3, the U.S. Food and Drug Administration (FDA) accepted for review two supplemental Biologics License Applications (sBLAs) for pembrolizumab (Keytruda) in patients with locally advanced or metastatic urothelial cancer. Specifically, the application for first-line use was accepted and...
Increased Risk of Cardiac Events With High Heart Dose in High-Dose Thoracic Radiotherapy
In a single-center pooled analysis reported in the Journal of Clinical Oncology, Wang et al found that a higher dose of radiation to the heart was associated with an increased risk of cardiac events in patients receiving high-dose radiation therapy for stage III non–small cell lung cancer...
Accelerated Partial-Breast vs Whole-Breast Irradiation After Breast-Conserving Surgery
As reported in The Lancet Oncology by Polgár et al, 5-year late side effects and cosmetic results were similar with accelerated partial-breast irradiation (APBI) with interstitial brachytherapy vs whole-breast irradiation (WBI) after breast-conserving surgery for low-risk invasive and in...
Adding Antiandrogen Therapy to Radiation Therapy in Recurrent Prostate Cancer
As reported in The New England Journal of Medicine by Shipley et al in the NRG Oncology Radiation Therapy Oncology Group (RTOG), the final analysis of the phase III RTOG 9601 trial showed that the addition of antiandrogen therapy with bicalutamide to radiation therapy significantly improves overall ...
Study Finds Durvalumab of Benefit in Advanced and Metastatic Non–Small Cell Lung Cancer
Durvalumab was active and led to long-lasting response in a cohort of heavily pretreated patients with epidermal growth factor receptor/anaplastic lymphoma kinase (EGFR/ALK) wild-type locally advanced and metastatic non–small cell lung cancer (NSCLC), particularly among patients whose tumors...
Early Success Reported With Two New Agents for High-Risk Myelodysplastic Syndromes
At the 2016 American Society for Hematology (ASH) Annual Meeting & Exposition, researchers reported early success with two new experimental agents for high-risk myelodysplastic syndromes—enasidenib (also known as AG-221), a potent oral inhibitor of the isocitrate dehydrogenase 2 (IDH2) enzyme,...
Selected Abstracts From the 2016 ASH Annual Meeting
Here are several abstracts selected from the proceedings of this year’s American Society of Hematology (ASH) Annual Meeting & Exposition, highlighting newer therapeutics in several different types of non-Hodgkin lymphomas (NHLs), including mantle cell lymphoma and marginal zone lymphoma. For...
Studies Advance the Use of PD-1 Blockade in Classical Hodgkin Lymphoma
Classical Hodgkin lymphoma is one of the malignancies most susceptible to treatment with monoclonal antibodies targeting the programmed cell death protein (PD-1). Nivolumab (Opdivo) has been approved by the U.S. Food and Drug Administration (FDA) for use in patients with relapsed/refractory...
Expert Point of View: Virginia Kaklamani, MD, and Melinda L. Telli, MD
Moderator of the press conference on this study, Virginia Kaklamani, MD, of the University of Texas Health Science Center at San Antonio, agreed that an improvement in response is important. “If you are a patient with symptoms, such as a cough from lung metastases, and I give you a combination...
Veliparib Improves Reponse but Not Progression-Free Survival in BRCA-Mutation Carriers
A randomized phase II study in women with metastatic breast cancer who have mutations in BRCA1 or BRCA2 evaluated the addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to combination chemotherapy. The trial did not meet its primary endpoint.1 Hyo Sook Han, MD, of Moffitt...
Adjuvant Letrozole vs Anastrozole in Hormone Receptor–Positive Node-Positive Early Breast Cancer
As reported in the Journal of Clinical Oncology by Smith et al, the final results of the phase III FACE trial showed no difference in disease-free or overall survival for adjuvant letrozole vs anastrozole in postmenopausal women with hormone receptor–positive node-positive early breast...
Tumor-Infiltrating Lymphocytes Prognostic in the Metastatic and Neoadjuvant Breast Cancer Settings
Studies presented at the 2016 San Antonio Breast Cancer Symposium added to growing evidence that tumor-infiltrating lymphocytes are important prognostic factors in breast cancer. One investigation evaluated their impact in advanced HER2-positive breast cancer, finding a linear relationship between...
Nivolumab, as Salvage, Improves Overall Survival in Gastric Cancer
Gastric cancer can apparently be added to the growing list of malignancies for which drugs targeting the programmed cell death protein 1 (PD‑1) receptor are effective, according to the results of the phase III ONO-4538 investigation conducted in Asia and presented at the 2017 Gastrointestinal...
