The findings of the National Lung Screening Trial (NLST), reported in 2011, revealed that participants who received low-dose helical computed tomography (CT) scans had a 20% lower risk of dying of lung cancer than participants who received standard chest x-rays. Despite these results,...
In the international phase III LION study reported in The New England Journal of Medicine, Harter et al found that lymphadenectomy did not improve progression-free or overall survival vs no lymphadenectomy in women with advanced ovarian cancer. Study Details The trial enrolled 647 women with...
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
In a German phase III trial (CeTeG/NOA–09) reported in The Lancet, Herrlinger et al found that the addition of adjuvant lomustine to temozolomide and radiotherapy improved overall survival in newly diagnosed glioblastoma with methylated MGMT promoter. The researchers noted that findings...
As reported in the Journal of Clinical Oncology by Flinn et al, 5-year follow-up of the phase III BRIGHT trial has shown improved outcomes with first-line bendamustine/rituximab vs R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone) or R-CVP (rituximab plus...
Two studies presented at the 2018 San Antonio Breast Cancer Symposium validated a small benefit of extending adjuvant aromatase inhibitor therapy beyond thestandard 5 years for postmenopausal women with hormone receptor–positive breast cancer. In a meta-analysis of 24,912 patients from 12...
As reported by Gnant et al in The Lancet Oncology, disease-free survival (DFS) was improved with adjuvant denosumab vs placebo in postmenopausal women with hormone receptor–positive, early-stage breast cancer receiving aromatase inhibitor treatment. A primary analysis of the phase III...
Darolutamide—an investigational androgen receptor inhibitor—significantly improved metastasis-free survival in men with high-risk nonmetastatic castration-resistant prostate cancer vs placebo in the large phase III ARAMIS trial.1 Men treated with darolutamide had a median metastasis-free survival...
The checkpoint inhibitor pembrolizumab plus the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor axitinib significantly improved overall survival, progression-free survival, and objective response rates vs sunitinib as first-line therapy for clear cell metastatic renal cell...
In the phase III TROG 09.02 CHISEL trial reported in The Lancet Oncology, Ball et al found that stereotactic ablative body radiotherapy improved local disease control vs standard radiotherapy in peripherally located, inoperable stage I non–small cell lung cancer (NSCLC). The open-label trial ...
On February 28, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for subcutaneous injection for the treatment of certain patients with HER2-positive early breast cancer (node-positive, or node-negative and estrogen receptor/progesterone...
In the phase III ERA 223 trial reported in The Lancet Oncology, Smith et al found that the addition of radium-223 to abiraterone acetate and prednisone or prednisolone did not improve symptomatic skeletal event-free survival and was associated with increased risk of fracture in patients with...
A recent study by the American Cancer Society (ACS) has found that while colorectal cancer incidence in the United States is rapidly declining overall, colorectal cancer rates are increasing among young adults. According to the study, compared with adults born in the 1950s, those born in the 1990s...
In a French phase III trial reported in JAMA Oncology, Oudard et al found that the addition of docetaxel to androgen-deprivation therapy (ADT) did not improve prostate-specific antigen (PSA) progression-free survival in men with high-risk prostate cancer with rising PSA after primary local therapy. ...
On February 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or...
FIRST-LINE therapy with the combination of ibrutinib and rituximab reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to the late-breaking...
IN THE RANDOMIZED, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.8% of patients remained...
IN A PHASE III TRIAL reported during the Plenary Session at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition and published in The New England Journal of Medicine, single-agent ibrutinib and ibrutinib/rituximab were associated with superior progression-free survival vs...
In sunny San Diego, the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition welcomed nearly 30,000 attendees who were eager to present, learn, network, and cheer the joint achievements of many researchers. The packed meeting was filled with important information from...
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 October 30, 2018, pembrolizumab in combination with...
THE JOURNAL of Clinical Oncology’s (JCO) author-friendly submission programs are taking time off the publication process for health-care professionals. JCO’s quick review process programs, Fast Track Presubmission and Rapid Review, aim to make the journal submission and review process easier for...
SOME PATIENTS with advanced head and neck cancer may achieve durable responses with immunotherapy, and recent trial results suggest first-line immunotherapy may increase survival among patients with recurrent or metastatic disease. However, concerns remain about selecting patients most likely to...
TISAGENLECLEUCEL IS an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1,2 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the 2018 American Society of...
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
INVITED STUDY discussant Michael J. Overman, MD, Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, is a co-investigator on CheckMate 142, which led to the approval of another immunotherapy doublet—nivolumab plus ipilimumab—in patients...
THE COMBINATION of durvalumab and tremelimumab prolonged median overall survival by 2.5 months compared with best supportive care alone in patients with advanced treatment-refractory colorectal cancer. These findings, which are from the randomized phase II Canadian Cancer Trials Group (CCTG) CO.26...
ANDREW X. ZHU, MD, PhD, of Massachusetts General Hospital Cancer Center and Harvard Medical School, noted that Prep-02/ JSAP-05 is the first study to show the value of neoadjuvant chemotherapy in patients with resectable pancreatic adenocarcinoma. However, the findings are applicable only to Asian ...
SEVERAL STUDIES presented at the 2019 Gastrointestinal Cancers Symposium evaluated the benefits of neoadjuvant treatment in patients with pancreatic cancer—and in patients deemed fully resectable, not just “borderline” resectable.1-3 Although the standard of care for resectable pancreatic ductal...
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...
As reported by Tombal et al in The Lancet Oncology, treatment with enzalutamide was associated with clinically meaningful delays in pain progression, symptom worsening, and deterioration in functional status vs placebo in the phase III PROSPER trial in nonmetastatic, castration-resistant prostate...
As reported at the 2019 Genitourinary Cancers Symposium (Abstract 543) and in The New England Journal of Medicine, Rini et al found significant benefits in overall and progression-free survival with the combination of pembrolizumab plus axitinib vs sunitinib in the first-line treatment of advanced...
In a study reported in the Journal of the National Cancer Institute, Stephanie B. Wheeler, MPH, PhD, of the Department of Health Policy and Management, University of North Carolina, Chapel Hill, and colleagues found that black women reported nonadherence to endocrine therapy for breast cancer more ...
As reported in The Lancet Oncology by Fabrice Barlesi, MD, and colleagues, the phase III JAVELIN Lung 200 trial has shown no overall survival benefit with avelumab vs docetaxel in patients with platinum pretreated programmed cell death ligand 1 (PD-L1)–positive advanced non–small cell lung cancer ...
Younger women who have been treated for breast cancer have a higher risk for osteopenia and osteoporosis than do their cancer-free peers, and that risk seems to rise when treatment involves chemotherapy plus hormone therapy or aromatase inhibitors alone. Researchers from Johns Hopkins Bloomberg...
In the phase III RAINFALL trial reported in The Lancet Oncology, Fuchs et al found no apparent benefit of the addition of the VEGFR-2 inhibitor ramucirumab to first-line cisplatin and fluoropyrimidine treatment in metastatic gastric or gastroesophageal junction adenocarcinoma. Study Details The...
Thomas Powles, MD, PhD, of Queen Mary University of London, discusses phase III study findings on ramucirumab plus docetaxel vs placebo plus docetaxel in patients with advanced platinum-refractory urothelial carcinoma (Abstract 353).
Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, discusses phase III findings on a comparison of tivozanib and sorafenib in patients with refractory advanced renal cell carcinoma (Abstract 541).
Silke Gillessen, MD, of Cantonal Hospital St. Gallen, discusses data from a phase III study on the incidence of hypocalcemia in patients with castration-resistant prostate cancer treated with denosumab. The trial was designed to assess prevention of symptomatic skeletal events with denosumab...
Ignacio Duran, MD, PhD, of the Hospital Universitario Marqués de Valdecilla, discusses an overall survival analysis of the phase III METEOR trial of cabozantinib vs everolimus in advanced renal cell carcinoma (Abstract 550).
Brian C. Baumann, MD, of Washington University School of Medicine, discusses phase III study findings on adjuvant sequential chemotherapy plus radiotherapy vs adjuvant radiotherapy alone for locally advanced bladder cancer after radical cystectomy (Abstract 351).
Karim Fizazi, MD, PhD, of the University of Paris-Sud and Gustave Roussy, discusses final phase III findings on men with newly diagnosed, high-risk, metastatic, castration-naive prostate cancer who were treated with abiraterone acetate plus prednisone added to androgen-deprivation therapy (Abstract ...
A phase III Egyptian trial presented by Zaghloul et al (Abstract 351) at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy. Researchers compared postoperative radiotherapy ...
In the phase III ARAMIS trial reported by Fizazi et al at the 2019 Genitourinary Cancers Symposium (Abstract 140) and simultaneously published in The New England Journal of Medicine, researchers found that the androgen receptor antagonist darolutamide significantly prolonged metastasis-free...
On February 15, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following complete resection. Approval was based on the phase III EORTC1325/KEYNOTE-054 trial, a randomized, double-blind,...
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews: Pembrolizumab in Combination With Axitinib as First-Line Treatment for Advanced Renal Cell Carcinoma Today, the FDA accepted and granted Priority Review for a new supplemental biologics license...
It is estimated that 20% to 33% of patients undergoing cancer treatment are concomitantly using a gastric acid suppressant, most commonly a proton pump inhibitor (including omeprazole and esomeprazole magnesium) or a histamine H2-receptor blocker (such as ranitidine). A study by Mir et al...
In the phase II TBCRC026 study reported in the Journal of Clinical Oncology, Connolly et al found that early changes in tumor maximum standardized uptake values corrected for lean body mass (SULmax) on [18F]fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) were...
In the phase III Lumiere trial reported in the Journal of Clinical Oncology, O’Connor et al found that the Aurora A kinase inhibitor alisertib did not improve outcomes vs investigator’s choice of single-agent treatment in relapsed or refractory peripheral T-cell lymphoma (PTCL). Study...
In a French phase III trial (PRODIGE 12-ACCORD 18-UNICANCER GI) reported in the Journal of Clinical Oncology, Edeline et al found that adjuvant gemcitabine plus oxaliplatin (GEMOX) did not significantly improve relapse-free survival vs surveillance following resection for localized biliary tract...
Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of pembrolizumab and axitinib extended both overall survival (OS) and progression-free survival (PFS) for patients with clear cell metastatic renal cell carcinoma compared with the...