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Showing 6651 - 6700Pembrolizumab in First-Line Treatment of Metastatic Non–Small Cell Lung Cancer
On October 24, 2016, pembrolizumab (Keytruda) was approved for use in patients with metastatic non–small cell lung cancer (NSCLC) whose tumors have high programmed cell death ligand 1 (PD-L1) expression (tumor proportion score ≥ 50%) as determined by a U.S. Food and Drug Administration...
At ESMO 2016, Many Phase III Trials Fail to Meet Primary Endpoints
The 2016 European Society for Medical Oncology (ESMO) Congress revealed many important positive findings from key trials in a number of tumor types, but many highly anticipated phase III trials in advanced disease failed to meet their primary endpoints. The ASCO Post has summarized several of these ...
Expert Point of View: Florian Lordick, MD
Florian Lordick, MD, Professor of Oncology and Director of the University Cancer Center in Leipzig, Germany, offered some critical evaluation of the two studies. AGITG Phase II Trial For the AGITG’s phase II DOCTOR trial, he emphasized the need to show the impact on survival outcomes for...
Locally Advanced Esophageal Cancer Outcomes Improved With Neoadjuvant Therapy
In studies presented at the 2016 European Society for Surgical Oncology (ESMO) Congress, two different neoadjuvant treatment approaches improved the outcomes of patients with esophageal cancer. Investigators from the Australasian Gastro-Intestinal Trials Group (AGITG) reported that the addition of...
Numerous ESMO Presentations Focused on Anti–PD-1 Therapy in Lung Cancer and Melanoma
The 2016 European Society for Medical Oncology (ESMO) Congress was jam-packed with studies of the anti–programmed cell death protein 1 (PD-1) antibodies in non–small cell lung cancer and melanoma, where they have clearly changed the treatment paradigm. Here is a roundup of some of those trials,...
Clinical Strategies for Improving Endocrine Therapy in Metastatic Breast Cancer
Most women with hormone receptor–positive breast cancer receive endocrine therapy as part of their treatment, but “the reality is that patients who receive antihormone therapy in the metastatic disease setting ultimately develop disease progression, ” William J. Gradishar, MD, stated at the 18th...
Androgen Receptor Antagonists May Meet ‘Unmet Need’ in Triple-Negative Breast Cancer
Although there are no androgen receptor antagonists currently approved for the treatment of breast cancer, clinical trials indicate that these agents benefit some patients with triple-negative breast cancer, Tiffany A. Traina, MD, told participants at the 18th Annual Lynn Sage Breast Cancer...
Phase III Trial Shows Ado-Trastuzumab Emtansine Noninferior to Trastuzumab/Taxane in HER2-Positive Breast Cancer
In the phase III MARIANNE trial reported in the Journal of Clinical Oncology, Perez et al found that ado-trastuzumab emtansine (formerly known as T-DM1; Kadcyla) was associated with noninferior progression-free survival compared with trastuzumab (Herceptin) plus taxane in patients with...
Christian U. Blank, MD, PhD, on Melanoma: Initial Data From the OpACIN Trial (German Language Version) 
Christian U. Blank, MD, PhD, of the Netherlands Cancer Institute, discusses in German study findings on neoadjuvant ipilimumab plus nivolumab in patients with palpable stage III melanoma. (Abstract LBA39)
Updated ASTRO Guideline Expands Pool of Suitable Candidates for Accelerated Partial-Breast Irradiation
On November 17, the American Society for Radiation Oncology (ASTRO) issued an updated clinical practice statement for accelerated partial-breast irradiation for early-stage breast cancer. The updated guideline reflects recent evidence that greater numbers of patients can benefit from accelerated...
Cautious Optimism About Olaratumab in Soft-Tissue Sarcoma
The current plethora of drugs in development for oncology is leading to the testing of novel agents in common as well as rare diseases. Targeted therapies have been a focus of great interest in soft-tissue sarcomas, with testing of a variety of oral tyrosine kinase inhibitors leading to the...
Expert Point of View: Alice T. Shaw, MD, PhD
Commenting on ASCEND-5, Alice T. Shaw, MD, PhD, Director of Thoracic Oncology at the Massachusetts General Hospital Cancer Center, Boston, noted that it is the first randomized study to examine how a second-generation anaplastic lymphoma kinase (ALK) inhibitor compares to standard second-line...
Studies Confirm Ceritinib’s Benefit in ALK-Positive Patients
For patients with advanced non–small cell lung cancer (NSCLC) harboring the ALK gene rearrangement, ceritinib (Zykadia) provided longer progression-free survival than chemotherapy in patients previously treated with chemotherapy and crizotinib (Xalkori), but gastrointestinal toxicity was...
Immunotherapy Clinical Trials Actively Recruiting Patients With Non–Small Cell Lung Cancer
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on immunotherapy as treatment for non–small cell lung cancer (NSCLC). These studies are researching programmed cell death ligand 1 (PD-L1) antibody therapy; hypofractionated...
Vaccine Therapy in Metastatic Renal Cell Carcinoma: Past, Present, and Future
As reviewed in this issue of The ASCO Post, Brian Rini, MD, and colleagues recently reported results from the phase III IMPRINT trial,1 which randomized HLA-A*02–positive patients with treatment-naive metastatic clear cell variant renal cell carcinoma, in favorable- and intermediate- risk...
Phase III Trial Shows No Survival Benefit of Adding First-Line IMA901 Vaccine to Sunitinib in Advanced Renal Cell Carcinoma
In the phase III IMPRINT trial reported in The Lancet Oncology, Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues found no overall survival benefit of adding the multipeptide cancer vaccine IMA901 to sunitinib (Sutent) in the first-line treatment of locally...
‘Breakthrough’ in Recurrent Ovarian Cancer: Niraparib Extends Progression-Free Survival in Platinum-Sensitive Disease
A landmark study showed that the investigational PARP (poly ADP-ribose polymerase) 1/2 inhibitor niraparib, when used as maintenance therapy, significantly improves the outcome of platinum-sensitive recurrent ovarian cancer. Specifically, niraparib significantly prolonged progression-free survival ...
Recent Progress and Concepts in Pancreatic Cancer
November is National Pancreatic Cancer Awareness Month, the impetus for this article. Pancreatic cancer is a huge health challenge. It's the eighth most common cancer in the United States and the fourth most common cause of cancer deaths but is expected to become the second most common cause of...
Pembrolizumab as First-Line Therapy in Metastatic NSCLC: Practice-Changing Implications of KEYNOTE-024 Trial
We are in the midst of a paradigm shift in lung cancer. In the past 2 years, the anti–programmed cell death protein 1 (anti–PD-1) inhibitors nivolumab (Opdivo) and pembrolizumab (Keytruda) were found to improve overall survival in the second-line setting compared with docetaxel for patients with...
Pembrolizumab Improves Outcomes vs Platinum-Based Chemotherapy in Advanced PD-L1–Positive NSCLC
In the phase III KEYNOTE-024 trial reported in The New England Journal of Medicine by Martin Reck, MD, PhD, of the German Center of Lung Research, Grosshansdorf, and colleagues, pembrolizumab (Keytruda) significantly improved progression-free and overall survival vs platinum-based chemotherapy in...
Update on Neoplastic Hematology: Review of Recent Clinical Trials
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 myelodysplastic syndromes, multiple myeloma, and chronic lymphocytic leukemia. Myelodysplastic Syndromes Clinical Trial:...
Phase III Trial Shows Improved PFS With Addition of Palbociclib to Letrozole in ER-Positive, HER2-Negative Breast Cancer
In the phase III PALOMA-2 trial reported in The New England Journal of Medicine, Finn et al found that the addition of palbociclib (Ibrance) to letrozole significantly improved progression-free survival in postmenopausal women with previously untreated advanced estrogen receptor–positive,...
Does Telotristat Ethyl Reduce the Frequency of Bowel Movements in Patients With Metastatic NETs and Carcinoid Syndrome?
In the phase III TELESTAR trial reported in the Journal of Clinical Oncology by Kulke et al, telotristat ethyl, a tryptophan hydroxylase inhibitor, significantly reduced the frequency of bowel movements in patients with metastatic neuroendocrine tumors and carcinoid syndrome. Telotristat ethyl...
Improved Outcomes Reported With 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...
No Benefit Reported With Addition of Palifosfamide to Doxorubicin in Metastatic Soft-Tissue Sarcoma
In the phase III PICASSO III trial reported in the Journal of Clinical Oncology, Ryan et al found that adding palifosfamide to doxorubicin did not prolong progression-free survival among patients with metastatic soft-tissue sarcoma. Palifosfamide is the active metabolite of ifosfamide. In the...
Living With Metastatic Breast Cancer Is Like Walking a Tightrope
I’ve always had fibrocystic breasts and was steadfast in performing monthly breast self-exams, so I could become familiar with the terrain of my breasts and spot any subtle changes. So, in November 2002, when I felt something in my left breast that seemed different from my usual lumps, I made a...
Study Suggests Benefit of Adjuvant Radiation Therapy but Not Chemotherapy in Some Patients With Merkel Cell Carcinoma
In an analysis of National Cancer Data Base data reported in the Journal of the National Cancer Institute, Shailender Bhatia, MD, of the University of Washington/Fred Hutchinson Cancer Research Center, and colleagues found that adjuvant radiotherapy was associated with a survival benefit in...
Higher Baseline Metabolic Tumor Volume and Poorer Outcomes in Patients With High Tumor Burden Follicular Lymphoma
In a pooled analysis reported in the Journal of Clinical Oncology, Michel Meignan, MD, PhD, of the Université Paris-Est Créteil, and colleagues found that higher baseline total metabolic tumor volume measured by 18F-fluorodeoxyglucose (18F-FDG) positron-emission tomography–computed tomography (FDG...
Enrollment Completed for Phase III ECHELON-2 Clinical Trial Evaluating Front-Line Brentuximab Vedotin in Mature T-Cell Lymphoma
Seattle Genetics, Inc, and Takeda Pharmaceutical Company Limited have announced completion of patient enrollment in the ECHELON-2 clinical trial. ECHELON-2 is a global phase III randomized trial evaluating brentuximab vedotin (Adcetris) as part of a front-line combination chemotherapy regimen in...
Forging Collaboration Between Children’s and Adult Oncology Groups in Designing Trials for Adolescents and Young Adults
Nonrhabdomyosarcoma soft-tissue sarcomas account for about 5% of all childhood malignancies and are also diagnosed in adolescents and young adults, as well as in older adults, and can require different approaches to treatment based on a patient’s age and stage of disease. These sarcomas comprise...
Research Community Forum 2016 Annual Meeting: Using Collective Wisdom to Improve Cancer Research
The ASCO Research Community Forum held its 2016 Annual Meeting from September 25–26, at ASCO headquarters in Alexandria, Virginia. Nearly 100 physician investigators and research staff from all types of research sites across the United States attended the meeting. Each year, the ASCO Research...
Study 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...
