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Showing 1601 - 1650Importing Oncology Trials From China, or Other Single Foreign Countries, for Consideration of U.S. Regulatory Approvals
In a commentary published recently in The Lancet Oncology,1 Harpreet Singh, MD, and Richard Pazdur, MD, both of the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA), warned against the increasing number of oncology drug development programs based wholly or predominantly...
Lenvatinib/Pembrolizumab Improves Progression-Free and Overall Survival vs Chemotherapy in Previously Treated Advanced Endometrial Cancer
As reported in The New England Journal of Medicine by Vicky Makker, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the phase III Study 309/KEYNOTE-775 trial has shown prolonged progression-free and overall survival with lenvatinib plus pembrolizumab vs physician’s choice of...
SBRT in Combination With Pembrolizumab/Trametinib vs Gemcitabine in Locally Recurrent Pancreatic Cancer
In a Chinese single-institution phase II trial reported in The Lancet Oncology, Zhu et al found that stereotactic body radiotherapy (SBRT) followed by pembrolizumab plus trametinib improved overall survival vs SBRT followed by gemcitabine in patients with postresection, KRAS-mutant, PD-L1–positive...
Risk of COVID-19 Infection and Complications Among Survivors of Childhood, Adolescent, and Young Adult Cancers
In a Canadian population-based study reported in the Journal of Clinical Oncology, Gupta et al found that survivors of childhood, adolescent, and young adult cancers were not at a greater risk of COVID-19 infection or severe complications of infection compared with matched controls without cancer....
Comparison of Multiparametric Ultrasound and Multiparametric MRI for the Diagnosis of Prostate Cancer
In the prospective paired-cohort CADMUS study reported in The Lancet Oncology, Grey et al found that patients at risk of prostate cancer had a similar likelihood of being diagnosed with clinically significant cancer with the use of multiparametric ultrasound vs multiparametric magnetic resonance...
Symptom Monitoring Intervention for Hospitalized Patients With Advanced Cancer
In a single-institution study reported in JAMA Oncology, Nipp et al found that a symptom monitoring intervention for patients hospitalized with advanced cancer did not increase proportions of days with improved symptoms, nor reduce length of hospital stay or unplanned readmission rates. Study...
Risk of Major Adverse Cardiovascular Events With Combined Immune Checkpoint Inhibition and VEGFR Inhibition in Patients With Advanced RCC
As reported in the Journal of Clinical Oncology by Brian I. Rini, MD, and colleagues, prospective cardiovascular monitoring in the phase III JAVELIN Renal 101 trial in advanced renal cell carcinoma (RCC) showed that patients with higher baseline troponin T levels receiving the combination of the...
Elective Upper-Neck vs Whole-Neck Irradiation in Nasopharyngeal Carcinoma
In a Chinese phase III trial reported in The Lancet Oncology, Tang et al found that elective upper-neck irradiation sparing the uninvolved neck was noninferior in regional relapse–free survival vs standard whole-neck irradiation in previously untreated patients with nasopharyngeal carcinoma. Study...
(Epi)genetic Predisposing Factors in Wilms Tumor
In a Dutch study reported in the Journal of Clinical Oncology, Janna A. Hol, MD, and colleagues found that (epi)genetic predisposing factors could be identified in one-third of children diagnosed with Wilms tumor. As stated by the investigators, “Wilms tumor is associated with (epi)genetic...
Pathologic Response of Index Lymph Node and Concordance With Total Nodal Basin Pathologic Response in Stage III Melanoma
In a retrospective analysis reported in JAMA Surgery, Reijers et al found that pathologic response in largest lymph node metastasis (index lymph node [ILN]) was highly concordant with response in the total lymph node bed in patients with stage III melanoma receiving neoadjuvant...
How Does Intake of Unprocessed Red Meat and Processed Meat Impact Risk of Disease Recurrence and Mortality in Patients With Colon Cancer?
In a prospective cohort study reported in JAMA Network Open, Erin L. Van Blarigan, ScD, and colleagues found that higher intake of unprocessed red meat or processed meat was not associated with poorer recurrence-free or overall survival in patients with stage III colon cancer. As stated by the...
Mutations Associated With Resistance to Noncovalent BTK Inhibitors in Patients With CLL
In a study reported in The New England Journal of Medicine, Wang et al identified mutations that conferred resistance to noncovalent Bruton’s tyrosine kinase (BTK) inhibitors in patients with chronic lymphocytic leukemia (CLL) and found that some also conferred resistance to covalent BTK...
Addition of Selumetinib to Adjuvant Radioactive Iodine in High-Risk Differentiated Thyroid Cancer
As reported in the Journal of Clinical Oncology by Ho et al, the phase III ASTRA trial showed no improvement in complete remission rate with the addition of selumetinib to adjuvant radioactive iodine (RAI) in patients with high-risk differentiated thyroid cancer. As stated by the investigators,...
Addition of BCL-XL/BCL-2 Inhibitor Navitoclax to Ongoing Ruxolitinib in Patients With Myelofibrosis With Disease Progression or Suboptimal Response
In a phase II trial reported in the Journal of Clinical Oncology, Harrison et al found that the BCL-XL/BCL-2 inhibitor navitoclax showed activity in patients with myelofibrosis with disease progression or suboptimal response during ongoing ruxolitinib treatment. As stated by the investigators,...
Effect of Secondary Cytoreductive Surgery on Survival in Patients With Platinum-Sensitive Recurrent Ovarian Cancer
In a meta-analysis reported in the Journal of Clinical Oncology, Baek et al found that increased rates of complete and optimal cytoreduction with secondary cytoreductive surgery were associated with improved overall survival in patients with platinum-sensitive recurrent ovarian cancer. Study...
Potential Contribution of Nonmalignant Etiologies to Back Pain in Patients With Metastatic Prostate Cancer
In a single-institution study reported in JCO Oncology Practice, Ruppert et al found that nonmalignant etiologies contribute to back pain in many men with metastatic prostate cancer who experience pain in areas where spinal metastases are known to occur. Study Details The study consisted of...
AI Model May Aid in Screening, Staging, and Treatment Planning for Thyroid Cancer
A new study has found that an artificial intelligence (AI) model incorporating multiple methods of machine learning accurately detects thyroid cancer and predicts pathological and genomic outcomes through analysis of routine ultrasound images. The AI model could present a low-cost, noninvasive...
Upfront Peptide Receptor Radionuclide Therapy for Enteropancreatic Neuroendocrine Tumors
In an Italian retrospective cohort study reported in JAMA Network Open, Pusceddu et al found that upfront peptide receptor radionuclide therapy (PRRT) was associated with better progression-free survival vs upfront chemotherapy or targeted therapy in patients with advanced well-differentiated...
Minority Enrollment in U.S. Phase II and III Trials in Genitourinary Cancers
In a study reported in the Journal of Clinical Oncology, Owens-Walton et al found that minority populations are underrepresented in phase II and III trials targeting prostate, kidney, and bladder cancers taking place in the United States. Study Details In the analysis, the ClinicalTrials.gov...
MRI and Mammography Breast Cancer Screening Strategies for Women With ATM, CHEK2, and PALB2 Pathogenic Variants
In an analysis reported in JAMA Oncology, Lowry et al found that a strategy of annual magnetic resonance imaging (MRI) screening starting at age 30 to 35 years—followed by annual MRI and mammography at age 40—could reduce the risk of breast cancer mortality by more than 50% in women with ATM,...
Esophagus-Sparing vs Standard Palliative Radiation for Patients With Advanced Central NSCLC
As reported in JAMA Oncology by Louie et al, the Canadian phase III PROACTIVE trial showed that esophagus-sparing intensity-modulated radiotherapy (ES-IMRT) did not significantly improve esophageal quality of life vs standard radiotherapy in patients with advanced central non–small cell lung cancer ...
Effect of Screening Initiative on Disparity in Colorectal Cancer Mortality Between Black and White Patients
In an analysis reported in a letter to the editor in The New England Journal of Medicine, Doubeni et al found that a sustained Kaiser Permanente Northern California (KPNC) colorectal cancer screening initiative resulted in increased screening, increased identification of colorectal cancer, and a...
Pain and Quality of Life in the PROfound Trial: Olaparib vs Next-Generation Hormonal Agent in Metastatic Castration-Resistant Prostate Cancer With HRR Gene Alterations
In an analysis from the phase III PROfound trial reported in The Lancet Oncology, Thiery-Vuillemin et al found that olaparib was associated with better pain outcomes and preservation of health-related quality of life (QOL) vs enzalutamide or abiraterone plus prednisone in a cohort of men with...
Prediction Model for BRCA Mutation–Carrying Status in Asian Patients With Breast Cancer
In an Asian study reported in the Journal of Clinical Oncology, Ang et al developed a model for predicting carrier status of pathogenic variants in BRCA1 or BRCA2 among Asian women with breast cancer. As stated by the investigators, “With the development of poly (ADP-ribose) polymerase inhibitors...
Do Diagnostic Delays Impact Overall Survival in Patients With NSCLC?
In a Surveillance, Epidemiology, and End Results (SEER)-Medicare Database analysis reported in JCO Oncology Practice, Romine et al found that longer time from suspicion to histologic diagnosis of non–small cell lung cancer (NSCLC) was associated with better overall survival; however, this effect...
Racial Disparities in Outcomes for Patients With Early HR-Positive Breast Cancer After Adjustment for Insurance Status and Neighborhood Deprivation Index
In a post hoc analysis published in JAMA Oncology from the TAILORx trial of adjuvant therapy in early hormone receptor (HR)-positive, HER2-negative, axillary node–negative breast cancer, Sadigh et al found that Black women had a poorer relapse-free interval and overall survival vs White women. This ...
Axicabtagene Ciloleucel vs Standard of Care as Second-Line Treatment for Large B-cell Lymphoma
As reported in The New England Journal of Medicine by Frederick L. Locke, MD, and colleagues, the phase III ZUMA-7 trial of patients with large B-cell lymphoma has shown improved event-free survival with second-line axicabtagene ciloleucel vs chemoimmunotherapy with high-dose chemotherapy and...
Interim Analysis of Overall Survival in ICARIA-MM: Addition of Isatuximab to Pomalidomide/Dexamethasone in Relapsed or Refractory Multiple Myeloma
As reported in The Lancet Oncology by Paul G. Richardson, MD, and colleagues, a prespecified interim overall survival analysis of the phase III ICARIA-MM trial showed that the addition of isatuximab to pomalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma produced...
Abemaciclib for Previously Treated Patients With p16ink4A-Deficient Mesothelioma
As reported in The Lancet Oncology by Dean A. Fennell, FRCP, and colleagues, a phase II trial (MiST2) showed the activity of abemaciclib in previously treated patients with p16ink4A-deficient malignant mesothelioma. As stated by the investigators, “Genetically stratified therapy for malignant...
Prediction Model for BRCA Mutation–Carrying Status in Asian Patients With Breast Cancer
In a study reported in the Journal of Clinical Oncology, Ang et al developed a model for predicting carrier status of pathogenic variants in BRCA1 or BRCA2 among Asian women with breast cancer. As stated by the investigators: “With the development of poly (ADP-ribose) polymerase [PARP] inhibitors...
Pembrolizumab Plus Trastuzumab and Chemotherapy in Previously Untreated Advanced HER2-Positive Gastric Adenocarcinoma
As reported in Nature by Yelena Y. Janjigian, MD, and colleagues, the first interim analysis of the phase III KEYNOTE-811 trial has shown a significantly higher objective response rate with the addition of pembrolizumab to trastuzumab and chemotherapy in patients with previously untreated advanced ...
Long-Term Rates of Hospital Readmission for Venous Thromboembolism After Complex Cancer Surgery
In a U.S. retrospective cohort study reported in JAMA Surgery, Mallick et al found that hospital readmission for venous thromboembolism events (VTEs) continued beyond 30 days after complex cancer surgery. As stated by the investigators: “…VTE is a major cause of preventable morbidity and mortality...
Addition of Autologous Dendritic Cell–Based Immunotherapy to Chemotherapy in Metastatic Castration-Resistant Prostate Cancer
In a phase III trial (VIABLE) reported in JAMA Oncology, Nicholas J. Vogelzang, MD, and colleagues found that the addition of an autologous dendritic cell–based immunotherapy directed against prostate cancer (DCVAC/PCa) to chemotherapy did not improve overall survival in metastatic...
Predictive Models for Outcomes With Immune Checkpoint Inhibitor Treatment in Metastatic Melanoma
In a study reported in the Journal of Clinical Oncology, Pires da Silva et al developed predictive models for objective response and progression-free and overall survival among patients receiving anti–PD-1 antibodies with or without ipilimumab for metastatic melanoma. The analyses involved data...
Incidental Findings on Low-Dose CT Lung Cancer Screening in the NLST and Risk of Respiratory Disease Mortality
In an analysis of data from the National Lung Screening Trial (NLST) reported in Chest, Pinsky et al found that incidental respiratory disease–related findings on low-dose computed tomography (CT) screening were common and associated with an increased risk of mortality from respiratory diseases....
ARASENS Trial: Addition of Darolutamide to Androgen-Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer
As presented at the 2022 ASCO Genitourinary Cancers Symposium and reported in The New England Journal of Medicine by Smith et al, the phase III ARASENS trial has shown significantly improved overall survival with the addition of darolutamide to androgen-deprivation therapy and docetaxel in men with ...
First-Line Blinatumomab and POMP Maintenance in Older Patients With Philadelphia Chromosome–Negative B-Cell ALL
In the phase II SWOG 1318 trial reported in the Journal of Clinical Oncology, Advani et al found that blinatumomab induction and consolidation followed by maintenance with POMP (prednisone, vincristine, mercaptopurine, and methotrexate) produced good outcomes in patients aged ≥ 65 years with newly...
Study Investigates the Risk of Breast Cancer Mortality After Late Breast Cancer Recurrence
In a Danish study reported in the Journal of Clinical Oncology, Pedersen et al identified risk of breast cancer mortality among women with breast cancer recurrence at ≥ 10 years after primary diagnosis and found that mortality risk was reduced after late vs early recurrence. Study Details The study ...
KEYNOTE-522: Event-Free Survival With Neoadjuvant and Adjuvant Pembrolizumab in Triple-Negative Breast Cancer
As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, and colleagues, a preplanned interim analysis of the phase III KEYNOTE-522 trial has shown improved event-free survival with the addition of pembrolizumab to neoadjuvant chemotherapy, followed by adjuvant pembrolizumab, in ...
Adagrasib in Advanced KRAS G12C–Mutant Solid Tumors
In a first-in-human phase I/Ib study (KRYSTAL-1) reported in the Journal of Clinical Oncology, Ou et al identified the phase II dose of the oral small-molecule KRAS G12C inhibitor adagrasib and found that the agent was active in patients with advanced KRAS G12C–mutant solid tumors. Study Details...
GOG 281/LOGS: Trametinib vs Standard of Care in Recurrent Low-Grade Serous Ovarian Carcinoma
In a phase II/III trial reported in The Lancet, David M. Gershenson, MD, and colleagues found that trametinib improved progression-free survival vs standard of care treatment in women with low-grade serous ovarian carcinoma. As stated by the investigators, “Low-grade serous carcinoma of the ovary...
Tebentafusp-tebn for Unresectable or Metastatic Uveal Melanoma
On January 25, 2022, tebentafusp-tebn, a bispecific gp100 peptide-HLA–directed CD3 T-cell engager, was approved for treatment of adults with HLA-A*02:01–positive, unresectable or metastatic uveal melanoma.1 Supporting Efficacy Data Approval was based on findings in the open-label, multicenter...
Copanlisib in Patients With PIK3CA-Mutated Tumors
In a phase II trial reported in the Journal of Clinical Oncology, Damodaran et al found that the phosphoinositide 3-kinase (PI3K) inhibitor copanlisib exhibited activity in patients who have tumors with PIK3CA mutations. The study is a subprotocol (Z1F) of the NCI-MATCH ECOG-ACRIN trial (EAY131), a ...
Meta-Analysis of Aromatase Inhibitors vs Tamoxifen in Premenopausal Women With ER-Positive Early-Stage Breast Cancer Receiving Ovarian Suppression
In a patient-level meta-analysis reported in The Lancet Oncology, researchers from the Early Breast Cancer Trialists’ Collaborative Group found that use of an aromatase inhibitor vs tamoxifen reduced the risk of recurrence in premenopausal women with estrogen receptor (ER)-positive early breast...
Tofacitinib for Rheumatoid Arthritis: Cancer and Cardiovascular Event Risks
In a phase IIIb/IV safety endpoint trial (ORAL Surveillance) reported in The New England Journal of Medicine, Ytterberg et al found that treatment with the JAK inhibitor tofacitinib for rheumatoid arthritis was associated with higher rates of cancer and major cardiovascular events compared with...
Web-Based Intervention to Manage Symptoms and Quality of Life in Women With Recurrent Ovarian Cancer
In an NRG Oncology/GOG study (GOG-0259) reported in the Journal of Clinical Oncology, Donovan et al found that both nurse-led (Nurse-WRITE) and self-directed (SD-WRITE) Web-based symptom self-management interventions (WRITE Symptoms) improved symptom control vs enhanced usual care alone in women...
Niraparib in Previously Treated Patients With Metastatic Castration-Resistant Prostate Cancer and DNA Repair Gene Defects
In the phase II GALAHAD trial reported in The Lancet Oncology, Matthew R. Smith, MD, and colleagues found that the poly (ADP-ribose) polymerase (PARP) inhibitor niraparib showed activity in patients with metastatic castration-resistant prostate cancer and DNA repair gene defects whose disease had...
Differences in Risk of Severe Adverse Events in Women vs Men Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials
In a study reported in the Journal of Clinical Oncology, Joseph M. Unger, PhD, and colleagues found that women in clinical trials of chemotherapy, immunotherapy, or targeted therapy had a significantly greater risk for severe adverse events overall—and, particularly, with immunotherapy. As stated...
Potential Use of FDG-PET Findings in Reducing Duration of Immunotherapy in Patients With Advanced Melanoma
In a Danish retrospective study reported in the International Journal of Cancer, Ellebaek et al found that patients with advanced melanoma responding to PD-1 inhibitor therapy who stopped treatment within 18 months had improved survival outcomes when fluorodeoxyglucose (F-18) positron-emission...
H1-Antihistamine Use and Risk of Hepatocellular Carcinoma in Persons With Hepatitis B Virus, Hepatitis C Virus, or Dual Infection
In a Taiwanese study reported in the Journal of Clinical Oncology, Shen et al found that use of H1-antihistamines was associated with reduced risk of hepatocellular carcinoma in patients with hepatitis B virus (HBV), hepatitis C virus (HCV), or dual HBV/HCV infection. Study Details The study...
