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Showing 6901 - 6950Study Looks for Optimal Dosing of Single-Agent Ipilimumab in Metastatic Melanoma
There has been debate as to the optimal dose of single-agent ipilimumab (Yervoy) in metastatic melanoma. A phase III study presented at the 2016 European Society for Medical Oncology (ESMO) Congress—the first to directly compare these doses—concluded that 10 mg/kg is more effective, but also more...
Small Study Tests Dual Checkpoint Blockade in High-Risk Stage III Melanoma
As neoadjuvant or adjuvant therapy for stage III melanoma patients with palpable disease, the combination of ipilimumab (Yervoy) plus nivolumab (Opdivo) was shown to be a promising, though also toxic, combination in a phase Ib study reported at the 2016 European Society for Medical Oncology (ESMO) ...
Chemotherapy May Be Avoidable in Some Women With Early-Stage Breast Cancer Based on Clinical and Genomic Risks
In the phase III MINDACT trial reported in The New England Journal of Medicine, Fatima Cardoso, MD, of Champalimaud Clinical Center–Champalimaud Foundation, Lisbon, and colleagues found that adjuvant chemotherapy may be avoidable in women with early-stage breast cancer who are at high clinical...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the first...
Combination Strategies Harness the Power of the Oncolytic Virus Talimogene Laherparepvec
The injectable oncolytic immunotherapy talimogene laherparepvec (also known as T-VEC, Imlygic) may become a valuable component of combination immunotherapy approaches in melanoma, a strategy believed to help overcome resistance of tumors to single-agent immunotherapies. “[Talimogene laherparepvec] ...
Higher Complete Pathologic Regression Rate With Neoadjuvant Docetaxel- vs Epirubicin-Based Triplets in Gastric/Gastroesophageal Junction Cancer
In the phase II portion of a German phase II/III trial (FLOT4) reported in The Lancet Oncology, Al-Batran et al found that preoperative docetaxel-based vs anthracycline-based triplet therapy produced a higher complete histopathologic regression rate in patients with resectable gastric or...
Fulvestrant Superior to Anastrozole as Initial Therapy in Advanced Breast Cancer
Fulvestrant (Faslodex) was superior to anastrozole as initial treatment of hormone receptor–positive, endocrine therapy–naive, advanced breast cancer, significantly reducing the risk of disease progression or death, according to the results of the phase III FALCON study presented at the 2016...
KEYNOTE-045 Trial Finds Pembrolizumab Improves Survival Over Chemotherapy in Advanced Urothelial Cancer
The phase III KEYNOTE-045 trial, investigating the use of the anti–PD-1 (programmed cell death protein 1) therapy pembrolizumab (Keytruda) in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall survival, according to a news release issued by Merck. In...
Pembrolizumab, but Not Nivolumab, Improves Outcomes in Front-Line Setting for PD-L1–Positive Advanced NSCLC
Checkpoint inhibitors have revolutionized the treatment of advanced non–small cell lung cancer (NSCLC), but evidence of their benefit was restricted to the second-line setting. However, early-phase trials with both pembrolizumab (Keytruda) and nivolumab (Opdivo) demonstrated favorable results in...
Introduction
As expensive cancer biologics move off patent, biosimilar products are coming on board. These are highly similar versions of licensed biologics that demonstrate near-fingerprint identity to their reference products in terms of structure and potency. Biosimilars represent a major opportunity for...
Expert Point of View: Jean-Charles Soria, MD, PhD
Formal discussant Jean-Charles Soria, MD, PhD, of Institut Gustave Roussy, Villejuif, France, and Editor-in-Chief of Annals of Oncology (the official journal of the European Society for Medical Oncology [ESMO]), tried to put these findings into perspective. He pointed out that when applying the...
Pembrolizumab Plus Chemotherapy Improves Outcomes Over Chemotherapy Alone in Advanced NSCLC
Combining immunotherapy with a standard chemotherapy doublet appears to be an attractive option for the front-line treatment of advanced nonsquamous non–small cell lung cancer (NSCLC), according to the results of a phase II study presented at the 2016 European Society for Medical Oncology (ESMO)...
Phase III Study of Sunitinib Is First to Show Benefit in Adjuvant Setting for Treatment of Renal Cell Carcinoma
Sunitinib (Sutent) improved disease-free survival by more than 1 year when used as adjuvant treatment for high-risk locoregional renal cell carcinoma following nephrectomy, but with the cost of toxicity. S-TRAC is the first phase III trial showing a benefit for adjuvant therapy in renal cell...
Expert Point of View: Bernard Escudier, MD
Formal discussant of this trial, Bernard Escudier, MD, Chairman of the Renal Cancer Unit at Institut Gustave Roussy, Villejuif, France, said: “The main question is whether this study will change practice.” He is not so sure it will and would like more data. Dr. Escudier told listeners that the...
Notable Gains in Survival Achieved With Atezolizumab in Non–Small Cell Lung Cancer
The programmed cell death ligand 1 (PD-L1) inhibitor atezolizumab (Tecentriq) significantly improved overall survival, compared to docetaxel, in previously treated, advanced non–small cell lung cancer (NSCLC), according to preliminary results of the phase III OAK study. The findings are the first...
Ribociclib Granted FDA Priority Review for First-Line Treatment of Hormone Receptor–Positive/HER2-Negative Advanced Breast Cancer
On November 1, the U.S. Food and Drug Administration (FDA) accepted a New Drug Application (NDA) for filing and granted Priority Review for ribociclib (LEE011) as first-line treatment of postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2...
French Trial Shows Addition of Androgen Maintenance Improves Survival in Elderly Patients With Acute Myeloid Leukemia
The addition of norethandrolone as maintenance therapy improved survival in patients aged ≥ 60 years with acute myeloid leukemia (AML), according to a French phase III trial reported in the Journal of Clinical Oncology by Pigneux et al. In the open-label trial, 330 patients with de novo AML or...
Phase III SOLO-2 Trial Shows Significant Progression-Free Survival Benefit From Olaparib Treatment in BRCA-Mutated Metastatic Ovarian Cancer
Positive results were announced on October 26, 2016, from the phase III SOLO-2 trial, designed to determine the efficacy of olaparib (Lynparza) tablets (300 mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive, BRCA-mutated relapsed ovarian cancer. Results from the...
Proton Pump Inhibitors Seem to Reduce the Efficacy of Capecitabine in Advanced Gastroesophageal Cancer
In a secondary analysis of a clinical trial reported in JAMA Oncology, Chu et al found that use of proton pump inhibitors (gastric acid suppressants) reduced the effectiveness of oral capecitabine in patients with advanced gastroesophageal cancer. The study involved analysis of the effect of...
Effect of Isolated Peritoneal and Nonperitoneal Metastasis and Metastatic Sites on Survival in Patients With Colorectal Cancer
Overall survival was poorer with isolated peritoneal metastasis in colorectal cancer vs other isolated sites of metastasis in patients receiving first-line systemic therapy but similar to that in patients with peritoneal plus another metastatic site and in patients with at least two nonperitoneal...
FDA Approves Pembrolizumab as First-Line Treatment for PD-L1–Positive Non–Small Cell Lung Cancer
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the treatment of patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) as determined by an FDA-approved test. This is the...
KEYNOTE-045 Studying Pembrolizumab in Advanced Bladder Cancer Meets Primary Endpoint and Stops Early
Merck announced October 21, 2016, that the phase III KEYNOTE-045 trial investigating the use of pembrolizumab (Keytruda), the company’s anti–PD-1 (programmed cell death protein 1) therapy in patients with previously treated advanced urothelial cancer, met the primary endpoint of overall ...
Evaluating the FDA’s Approach to Cancer Clinical Trials
Since the announcement of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) on June 29, 2016, as part of the White House’s Cancer Moonshot, we’ve been working to further the FDA’s efforts to get new oncology products into the hands of patients. We are committed to...
Minimal Residual Disease Assessment and Prediction of Outcome in CLL Responders
Assessment of minimal residual disease was associated with improved prediction of outcome in responders, as well as complete responders, in patients with chronic lymphocytic leukemia (CLL) who respond to treatment. Kovacs et al reported these findings, which are based on an analysis of two phase...
Similar Functional Outcomes With Robot-Assisted Laparoscopic and Open Radical Retropubic Prostatectomy
Robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy yielded similar domain-specific quality-of-life or pathologic outcomes at 12 weeks in men with newly diagnosed, clinically localized prostate cancer, according to the results of a randomized phase III trial reported ...
Clinical Trials Actively Recruiting Patients With Metastatic Breast Cancer
Pilot Study Title: Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole-Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain Study Type: Pilot/interventional/parallel assignment Study Sponsor ...
Study Finds Nivolumab Improves Survival vs Standard Therapy in Recurrent Squamous Cell Carcinoma of the Head and Neck
In the phase III CheckMate 141 trial reported in The New England Journal of Medicine, Ferris et al found that nivolumab (Opdivo) increased overall survival vs standard therapies in patients with recurrent platinum-refractory squamous cell carcinoma of the head and neck. Study Details In this...
SGO and ASCO Clinical Practice Guideline on Neoadjuvant Chemotherapy for Newly Diagnosed Advanced Ovarian Cancer
As reported by Alexi A. Wright, MD, MPH, of Dana-Farber Cancer Institute, and colleagues in the Journal of Clinical Oncology, ASCO and the Society of Gynecologic Oncology (SGO) have released a clinical practice guideline on neoadjuvant therapy for patients with newly diagnosed stage IIIC or IV...
Expert Point of View: Olivier Michielin, MS, MD, PhD
The paper’s invited discussant was Olivier Michielin, MS, MD, PhD, Head of Personalized Analytical Oncology and the Melanoma Clinic at Lausanne University Hospital in Switzerland. He called the findings of the European Organisation for Research and Treatment (EORTC) 18071 trial a “new landmark in...
Adjuvant Ipilimumab Improves Survival in High-Risk Melanoma
Patients with stage III melanoma who were considered to be at high risk for recurrence derived an overall survival benefit from adjuvant treatment with ipilimumab (Yervoy), although it came at the price of considerable toxicity, according to updated survival results from the phase III European...
Quality Science at ESMO 2016
Andrés Cervantes, MD, PhD, Scientific Chair of the 2016 European Society for Medical Oncology (ESMO) Congress, concluded the meeting earlier this month by recognizing a number of important take-home messages. At a closing press conference, Dr. Cervantes noted that the “ESMO 2016 Congress has...
With Changing Strategies for Laryngeal Cancer, Multidisciplinary Team Approach Is Key
The treatment of cancer of the larynx has changed dramatically in recent years. With organ preservation now possible in many cases, it is more important than ever for patients to receive guidance from every corner of the field. In a recent article in the Journal of Oncology Practice (JOP),1 a...
Consensus on Defining and Measuring Lymphedema Is Needed to Advance Efforts to Intervene Early and Prevent Progression
“Early intervention might prevent lymphedema progression,” Alphonse Taghian, MD, PhD, said at the 18th Annual Lynn Sage Breast Cancer Symposium in Chicago, but the lack of a universal definition of lymphedema and agreement on how to optimally measure it impedes phase III studies to test that...
Study Finds Adjuvant Sunitinib Improves Disease-Free Survival in High-Risk Renal Cell Carcinoma After Nephrectomy
In the phase III S-TRAC trial reported at the 2016 European Society for Medical Oncology Congress and in The New England Journal of Medicine by Ravaud et al, adjuvant sunitinib (Sutent) significantly prolonged disease-free survival vs placebo in patients with high-risk renal cell carcinoma after...
ESMO 2016: Pooled Analysis Shows PD-L1 Expression as a Biomarker for Nivolumab Plus Ipilimumab Response in Advanced Melanoma
A pooled analysis from three clinical trials in advanced melanoma shows that although patients treated with nivolumab and nivolumab plus ipilimumab with ≥ 5% programmed death-ligand 1 (PD-L1) tumor expression have similar progression-free survival, durable response rates were higher for the...
ESMO 2016: Meta-analysis Confirms Superiority of Concomitant Over Induction Chemotherapy in Nonmetastatic Head and Neck Cancer
Patients with head and neck squamous cell carcinoma achieved prolonged overall survival when concomitant chemotherapy was administered with locoregional treatment or radiotherapy, according to findings from a large meta-analysis reported by Blanchard et al at the European Society for Medical...
ESMO 2016: Clinical Benefit Demonstrated With Everolimus and Pasireotide LAR Alone or in Combination in Advanced Lung and Thymic Carcinoids
In patients with advanced lung or thymus carcinoid receiving everolimus, pasireotide LAR, or the combination of the two drugs, statistically significant positive impact was seen on proportion of patients’ progression-free rate at 9 months (primary endpoint) in all three arms, more relevant in ...
Stereotactic Radiosurgery Achieves Better Quality of Life and Improved Cognition Than Whole-Brain Radiotherapy
Two separate randomized trials presented at the 58th Annual Meeting of the American Society of Radiation Oncology (ASTRO) affirmed the value of stereotactic radiosurgery as an option for postoperative treatment of the surgical cavity of resected brain metastases, potentially avoiding the cognitive...
Safety of Extreme Hypofractionation Reassuring in Intermediate-Risk Prostate Cancer
Giving patients larger fractions of radiation over shorter periods (ie, hypofractionation) is gaining ground in several types of cancers. This approach is attractive for patients’ convenience, shortening treatment and travel times, and also for resource utilization. Several studies have shown that ...
Investigational Immunotherapy Appears Safe and Somewhat Active in Advanced Melanoma
The investigational immunotherapeutic IMC-20D7S was found to be well tolerated and somewhat active in patients with advanced melanoma, including one complete response, according to the results of a phase I/Ib trial reported by Khalil et al in Clinical Cancer Research. IMD-20D7S is a...
Study Finds PFS Benefit, but No Overall Survival Benefit, for Ipilimumab in Metastatic Castration-Resistant Prostate Cancer
Ipilimumab (Yervoy) was associated with prolonged progression-free survival—but not overall survival—compared with placebo in men with asymptomatic or minimally symptomatic chemotherapy-naive metastatic castration-resistant prostate cancer without visceral metastases, according to a...
Does Adding Daratumumab to Lenalidomide/Dexamethasone Improve Outcomes in Previously Treated Multiple Myeloma?
The addition of the CD38-targeted antibody daratumumab (Darzalex) to lenalidomide (Revlimid)/dexamethasone improved progression-free survival in patients with previously treated multiple myeloma, according to the results of the phase III POLLUX trial reported by Dimopoulos et al in The New England...
Combination of Ribociclib and Letrozole Improved Progression-Free Survival in Hormone Receptor–Positive Advanced Breast Cancer
The combination of the selective CDK4/6 inhibitor ribociclib plus letrozole significantly improved progression-free survival in hormone receptor–positive advanced breast cancer. When ribociclib was added to letrozole, progression-free survival improved by 44% compared with letrozole alone,...
ESMO 2016: First-Line Pembrolizumab Plus Chemotherapy Significantly Improves Outcomes in Advanced NSCLC
The addition of the programmed cell death protein 1 (PD-1) antibody pembrolizumab (Keytruda) to standard first-line chemotherapy for treatment-naive advanced non–small cell lung cancer significantly improves response rates and progression-free survival, Langer et al reported at the 2016...
ESMO 2016: Nivolumab Maintains Function and Reduces Symptoms in Relapsed Metastatic Head and Neck Cancer
Nivolumab (Opdivo) maintains function and reduces symptoms in treatment of relapsed metastatic head and neck cancer, according to results from the CheckMate 141 trial presented by Harrington et al at the 2016 European Society for Medical Oncology (ESMO) Congress in Copenhagen, Denmark (Abstract...
Intensity-Modulated vs 3D Conformal External-Beam Radiation Therapy in Locally Advanced Non–Small Cell Lung Cancer
In a secondary analysis from the NRG Oncology RTOG 0617 trial reported in the Journal of Clinical Oncology, Chun et al found that use of intensity-modulated vs three-dimensional (3D) conformal external-beam radiation therapy was associated with a reduced risk for severe pneumonitis and reduced the...
Adjuvant Ipilimumab Prolongs Survival in High-Risk Stage III Melanoma, Phase III Study Reports
In the phase III European Organisation for Research and Treatment of Cancer (EORTC) trial 18071 reported at the recent European Society for Medical Oncology meeting and in The New England Journal of Medicine by Eggermont et al, adjuvant ipilimumab (Yervoy) was found to improve recurrence-free and...
Genetic Markers Associated With Pathologic Complete Response to Neoadjuvant Therapy Identified in HER2-Positive Breast Cancer
In an analysis reported in JAMA Oncology, Fumagalli et al identified genetic markers associated with pathologic complete response among women with early-stage HER2-positive breast cancer receiving neoadjuvant therapy in the phase III NeoALTTO trial. Study Details In the NeoALTTO trial, 455...
First-Line Pembrolizumab Improves Survival vs Platinum-Based Chemotherapy in Advanced PD-L1–Positive NSCLC
Pembrolizumab (Keytruda) significantly improved progression-free and overall survival vs platinum-based chemotherapy in patients with previously untreated advanced non–small cell lung cancer (NSCLC) with ≥ 50% PD-L1 (programmed cell death ligand 1) expression and no sensitizing EGFR...
Study Finds Niraparib Maintenance Improves Progression-Free Survival in Platinum-Sensitive Recurrent Ovarian Cancer
In a phase III trial reported at the recent European Society for Medical Oncology Congress and in The New England Journal of Medicine by Mirza et al, maintenance therapy with the PARP (poly ADP ribose polymerase) 1/2 inhibitor niraparib significantly prolonged progression-free survival vs placebo...
