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Showing 3801 - 3850Time to Biochemical Failure as Surrogate Endpoint in Locally Advanced Prostate Cancer
As reported in the Journal of Clinical Oncology by Dignam et al, analysis of outcomes in the phase III NRG/RTOG 9202 trial indicates that the time interval to biochemical failure (IBF) could serve as a surrogate endpoint for clinical outcomes in patients receiving radiotherapy plus long-term...
Regorafenib vs Lomustine in Relapsed Glioblastoma
In the Italian phase II REGOMA trial reported in The Lancet Oncology, Lombardi et al found that regorafenib was associated with improved overall survival vs lomustine in patients with relapsed glioblastoma. In the open-label trial, 119 patients from 10 Italian sites were randomly assigned between...
RADAR Trial: Short- vs Intermediate-Term Androgen Suppression and Zoledronic Acid in Locally Advanced Prostate Cancer
As reported by Denham et al in The Lancet Oncology, 10-year results of the phase III TROG 03.04 RADAR trial have shown that 18 months of androgen suppression plus radiotherapy is more effective than 6 months of androgen suppression plus radiotherapy in locally advanced prostate cancer, but no...
Adjuvant FOLFIRINOX vs Gemcitabine in Pancreatic Cancer
In a phase III Canadian and French trial reported in The New England Journal of Medicine, Conroy and colleagues in the Canadian Cancer Trials Group and the Unicancer-GI–PRODIGE Group found that adjuvant modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) produced better...
Fecal Microbiota Transplantation May Help Restore Beneficial Bacteria in Patients With Cancer
Researchers have shown that autologous fecal microbiota transplantation may be a safe and effective way to help replenish beneficial gut bacteria in patients with cancer who require intense antibiotics during allogeneic hematopoietic stem cell transplantation. Their findings were published by Ying ...
Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma
ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...
Venetoclax in Combination Regimens for Older Patients With AML or Those With Comorbidities Precluding Intensive Induction
On November 21, 2018, venetoclax (Venclexta) was granted accelerated approval for use in combination with azacitidine or decitabine or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients aged ≥ 75 years or who have comorbidities that preclude the use of ...
Lorlatinib in Second- or Third-Line Treatment of ALK-Positive Metastatic Non–Small Cell Lung Cancer
On November 2, 2018, lorlatinib (Lorbrena) was granted accelerated approval for the treatment of patients with ALK-positive metastatic non–small cell lung cancer (NSCLC) whose disease has progressed on crizotinib (Xalkori) and at least one other ALK inhibitor for metastatic disease or whose disease ...
Durvalumab Improves Overall Survival After Chemoradiotherapy in Unresectable, Stage III NSCLC
AS REPORTED in The New England Journal of Medicine by Scott J. Antonia, MD, PhD, of H. Lee Moffitt Cancer Center and Research Institute, and colleagues, the phase III PACIFIC trial has shown significantly improved overall survival, a coprimary endpoint, with the programmed cell death ligand 1...
Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early-Stage Cervical Cancer
TWO STUDIES recently reported in The New England Journal of Medicine indicate that minimally invasive radical hysterectomy is associated with poorer survival outcomes than open abdominal radical hysterectomy in women with early-stage cervical cancer. As reported by Pedro T. Ramirez, MD, of The...
Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy
As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...
Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer
As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...
Larotrectinib for Solid Tumors With NTRK Gene Fusions
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 November 26, 2018, larotrectinib (Vitrakvi) was...
First-Line Ibrutinib With or Without Rituximab vs Rituximab/Bendamustine in Older Patients With CLL
In a phase III trial reported at the recent American Society of Hematology Annual Meeting & Exposition and in The New England Journal of Medicine by Woyach et al, ibrutinib (Imbruvica) and ibrutinib/rituximab (Rituxan) were associated with superior progression-free survival vs...
MURANO Trial Follow-up: MRD and Prognosis With Fixed Duration of Venetoclax/Rituximab in Relapsed or Refractory CLL
As reported in the Journal of Clinical Oncology by Kater et al, high undetectable minimal residual disease (MRD) rates persisted after the end of venetoclax (Venclexta)/rituximab (Rituxan) treatment in the phase III MURANO trial in relapsed or refractory chronic lymphocytic leukemia (CLL), and were ...
Radiotherapy Plus Cetuximab or Cisplatin in HPV-Positive Oropharyngeal Carcinoma
In a noninferiority phase III trial (NRG Oncology RTOG 1016) reported in The Lancet, Gillison et al found that radiotherapy plus cetuximab (Erbitux) was associated with poorer overall survival vs radiotherapy plus cisplatin in patients with human papillomavirus (HPV)-positive oropharyngeal...
Pembrolizumab vs Standard of Care in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma
In the phase III KEYNOTE-040 trial reported in The Lancet, Cohen et al found that pembrolizumab (Keytruda) was associated with a “clinically meaningful prolongation of overall survival” vs investigator’s choice of standard therapies in patients with previously treated recurrent or ...
Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer
In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...
Regorafenib in Previously Treated Metastatic Osteosarcoma
In a phase II trial reported in The Lancet Oncology, Duffaud et al found evidence of activity of regorafenib (Stivarga) in a cohort of adult patients with previously treated metastatic osteosarcoma. This noncomparative, double-blind trial involves 4 cohorts of patients, consisting of those with...
Apixaban Thromboprophylaxis in Patients With Cancer
In the Canadian phase III AVERT trial reported in The New England Journal of Medicine, Carrier et al found that the oral factor Xa inhibitor apixaban reduced the risk of venous thromboembolism vs placebo among intermediate- to high-risk ambulatory patients with cancer starting chemotherapy but was...
Addition of Veliparib to Cisplatin/Etoposide in Extensive-Stage SCLC
In the phase II ECOG-ACRIN 2511 trial reported in the Journal of Clinical Oncology, Owonikoko et al found that the addition of the poly (ADP ribose) polymerase (PARP) inhibitor veliparib to cisplatin/etoposide was associated with a modest but statistically significant improvement in...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
ECHELON-2: Brentuximab Vedotin Plus Chemotherapy in CD30-Positive Peripheral T-Cell Lymphoma
As reported by Horwitz et al in The Lancet, the phase III ECHELON-2 trial showed that brentuximab vedotin (Adcetris) plus cyclophosphamide, doxorubicin, and prednisone (CHP) improved progression-free and overall survival vs cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) in...
SELECT Trial: Adjuvant Erlotinib in Resected EGFR-Mutant NSCLC
In a phase II trial reported in the Journal of Clinical Oncology, Pennell et al found that adjuvant erlotinib (Tarceva) improved disease-free survival over historical controls in patients with resected EGFR-mutant non–small cell lung cancer (NSCLC). In the study, 100 patients with ...
Reducing Infections in Patients With AML Receiving Induction and Reinduction Chemotherapy
In a report in the Journal of Oncology Practice, Morris et al described an initiative that has been successful in reducing the incidence of invasive fungal infections in patients with acute myeloid leukemia (AML) receiving induction and reinduction therapy at the University of Virginia Health...
Eicosapentaenoic Acid and Aspirin in Preventing Colorectal Adenomas
In a UK trial (seAFOod Polyp Prevention) reported in The Lancet by Hull et al, no differences in adenoma prevention were found after treatment with omega-3 polyunsaturated fatty acid eicosapentaenoic acid (EPA), aspirin, both, or placebo in patients with high-risk findings on colonoscopy. On the...
Vitamin D Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, vitamin D supplementation was found to have no benefit in reducing risk of invasive cancer vs placebo over 5 years of follow-up. Study Details The trial was a randomized, placebo-controlled trial, with a two-by-two...
Primary Resistance to Immune Checkpoint Inhibitors in Metastatic Colorectal Cancer and Misdiagnosis of MSI or dMMR Status
In a study reported in JAMA Oncology, Cohen et al found evidence that primary resistance to immune checkpoint inhibitor treatment in metastatic colorectal cancer (CRC) can be explained in some cases by misdiagnosis of microsatellite instability (MSI) or defective mismatch repair (dMMR) status....
POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause
In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...
Moxetumomab Pasudotox-tdfk for Relapsed or Refractory Hairy Cell Leukemia
ON SEPTEMBER 13, 2018, moxetumomab pasudotox-tdfk (Lumoxiti), a CD22-directed cytotoxin, was approved for the treatment of adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including with a purine nucleoside analog.1,2 Supporting...
Encorafenib Plus Binimetinib vs Vemurafenib in Advanced BRAF-Mutant Melanoma
AS REPORTED in The Lancet Oncology by Reinhard Dummer, MD, of the University Hospital Zurich Skin Cancer Center, and colleagues, the phase III COLUMBUS trial has shown a significant improvement in overall survival with the combination of the BRAF inhibitor encorafenib (Braftovi) and the MEK...
Duvelisib for Relapsed or Refractory CLL/SLL and for Relapsed or Refractory Follicular Lymphoma
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 September 24, 2018, duvelisib (Copiktra) was granted...
Pembrolizumab With Chemotherapy for First-Line Treatment of Metastatic Nonsquamous NSCLC
On August 20, 2018, pembrolizumab (Keytruda) in combination with pemetrexed (Alimta) and platinum was granted regular approval as first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma...
Talazoparib for Germline BRCA-Mutated HER2-Negative Advanced Breast Cancer
On October 16, 2018, the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib (Talzenna) was approved for the treatment of patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer.1,2 Patients must be selected for...
Lenvatinib in Unresectable Hepatocellular Carcinoma
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...
Factors Affecting Use of Outpatient Specialty Palliative Care Clinics Among Patients With Advanced Cancer
In a study reported in the Journal of Oncology Practice, Yu et al identified factors affecting use of outpatient specialty palliative care (OSPC) among patients with advanced cancer in the University of Pittsburgh Medical Center Hillman Cancer Center Network (UPMC-HCCN). Study Details The...
Marine Omega-3 Fatty Acid Supplementation and Cancer Risk
In a trial reported in The New England Journal of Medicine by Manson et al, marine n-3 (omega-3) fatty acid supplementation was found to have no benefit in reducing the risk for invasive cancer vs placebo over 5 years of follow-up. Higher intake of n-3 fatty acids has been associated with a reduced ...
Adding Genomic Factors to MSKCC Risk Model in Metastatic Renal Cell Carcinoma
In a study reported in The Lancet Oncology, Voss et al found that adding the mutation status of prognostic genes to the Memorial Sloan Kettering Cancer Center (MSKCC) risk model improved the prognostic performance of the model in patients with advanced renal cell carcinoma. The study involved...
Radiotherapy With Cisplatin or Cetuximab in Low-Risk, HPV-Positive Oropharyngeal Cancer
In the phase III De-ESCALaTE trial reported in The Lancet, Mehanna et al found no difference in severe toxicity with cisplatin vs cetuximab (Erbitux) plus radiotherapy in low-risk human papillomavirus (HPV)-positive oropharyngeal cancer. Cetuximab was associated with poorer recurrence and survival...
Bladder-Sparing Treatment Regimens for Muscle-Invasive Bladder Cancer
In a phase II trial (NRG/RTOG 0712) reported in the Journal of Clinical Oncology, Coen et al found that bladder-sparing treatment with twice-daily radiation plus fluorouracil/cisplatin (FCT) or once-daily radiation plus gemcitabine (GD) produced similar distant metastasis-free survival in patients...
Cardiovascular Toxicities Associated With Immune Checkpoint Inhibitor Treatment
In a pharmacovigilance study reported in The Lancet Oncology, Salem et al found that immune checkpoint inhibitors can cause “severe and disabling inflammatory cardiovascular immune-related adverse events” that need to be considered in patient care and clinical trial design. Study...
Discontinuation of Follow-up Care Among Women With Early-Stage Breast Cancer
In a study using linked Surveillance, Epidemiology, and End Results (SEER)-Medicare data reported in the Journal of Oncology Practice, Quyyumi et al found that 21% of women with early-stage breast cancer discontinued follow-up care within 5 years after diagnosis. Study Details The study involved...
MRD-Guided Azacitidine Treatment in Myelodysplastic Syndrome and Acute Myeloid Leukemia
In a German phase II trial (RELAZA2) reported in The Lancet Oncology, Platzbecker et al found that minimal residual disease (MRD)–guided treatment with azacitidine was successful in preventing hematologic relapse in patients with myelodysplastic syndrome (MDS) and acute myeloid leukemia...
Multigene Classifier Test for Thyroid Nodules With Indeterminate Cytology
In a study reported in JAMA Oncology, Steward et al found that the use of a multigene genomic classifier test (ThyroSeq v3) could reduce the need for diagnostic surgery in a substantial proportion of patients with thyroid nodules with indeterminate cytology. The blinded prospective cohort...
ELOQUENT-3: Addition of Elotuzumab to Pomalidomide and Dexamethasone in Previously Treated Multiple Myeloma
As reported in The New England Journal of Medicine by Dimopoulos et al, the phase II ELOQUENT-3 trial has shown that the addition of elotuzumab (Empliciti) to pomalidomide (Pomalyst) and dexamethasone significantly prolonged progression-free survival in patients with relapsed and/or refractory...
Risk of Chronic Health Conditions in Survivors of Childhood Cancer Diagnosed From 1970 to 1999
In a report from the Childhood Cancer Survivor Study cohort published in The Lancet Oncology, Gibson et al found that more recently treated survivors of childhood cancer had reduced risk of chronic health conditions compared to those diagnosed early in the study period. The study involved data...
Ultrasonography Findings and Risk of Ovarian Cancer
In a study reported in JAMA Internal Medicine, Smith-Bindman et al found that the appearance of ovarian masses on ultrasonography was highly associated with risk of ovarian cancer in a large unselected population of women undergoing pelvic ultrasonography. Study Details The study was a nested...
Addition of Interleukin-2 to Dinutuximab Beta in High-Risk Neuroblastoma
In an international phase III trial (HR-NBL1/SIOPEN) reported in The Lancet Oncology, Ladenstein et al found that the addition of interleukin (IL)-2 to dinutuximab beta did not improve event-free survival in children and young people with high-risk neuroblastoma. Study Details The current report...
Phase III Trial of Minimally Invasive vs Open Abdominal Radical Hysterectomy in Early Cervical Cancer
In a phase III trial (Laparoscopic Approach to Cervical Cancer [LACC]) reported in The New England Journal of Medicine, Ramirez et al found that minimally invasive radical hysterectomy was associated with poorer disease-free and overall survival vs open abdominal radical hysterectomy in women with...
Causes of Inferior Outcomes in AYAs With Leukemia
Despite survival gains for children diagnosed with acute lymphoblastic leukemia (ALL), adolescents and young adults (AYAs)— those between the ages of 15 and 39— diagnosed with the disease have seen only modest improvements in survival. A study by Julie A. Wolfson, MD, MSHS, Assistant Professor and ...
