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Showing 1351 - 1400Evaluation of Plasmid DNA Vaccine Encoding HER2 Intracellular Domain in Patients With Advanced HER2-Positive Breast Cancer
In a single-institution phase I study reported in JAMA Oncology, Disis et al found that a plasmid DNA vaccine encoding the HER2 intracellular domain (ICD) was associated with primarily low-grade toxicity and induced HER2-specific type 1 T-cell responses in patients with advanced HER2-positive...
POSEIDON Trial: First-Line Durvalumab With or Without Tremelimumab Plus Chemotherapy in Metastatic NSCLC
As reported in the Journal of Clinical Oncology by Melissa L. Johnson, MD, and colleagues, the pivotal phase III POSEIDON trial has shown significantly improved progression-free and overall survival with the addition of tremelimumab and durvalumab to platinum-based chemotherapy in the first-line...
Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation
On June 22, 2022, dabrafenib in combination with trametinib was granted accelerated approval for treatment of adult and pediatric patients (aged 6 and older) with unresectable or metastatic solid tumors with BRAF V600E mutation whose disease progressed following prior treatment and who have no...
Margetuximab-cmkb vs Trastuzumab With Chemotherapy in Previously Treated Advanced HER2-Positive Breast Cancer: Final Overall Survival Analysis of the SOPHIA Trial
As reported in the Journal of Clinical Oncology by Hope S. Rugo, MD, FASCO, and colleagues, the final overall survival results of the pivotal phase III SOPHIA trial have shown no significant difference between margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in previously...
Cemiplimab-rwlc in Combination With Platinum-Based Chemotherapy in Advanced NSCLC With No EGFR, ALK, or ROS1 Aberrations
On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1aberrations.1 Supporting Efficacy Data Approval was supported by findings in the...
Teclistamab-cqyv in the Treatment of Relapsed or Refractory Multiple Myeloma
On October 25, 2022, the bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager teclistamab-cqyv was granted accelerated approval for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome...
Prophylactic Bilateral Mastectomy Among Women With Breast Cancer and Pathogenic Variants in High-Penetrance and Moderate-Penetrance Genes
In a study reported in JAMA Oncology, Reid et al found that undergoing prophylactic bilateral mastectomy was as common in women with breast cancer with pathogenic/likely pathogenic variants in ATM and CHEK2 (moderate-penetrance genes) as in those with variants in BRCA1, BRCA2, or PALB2...
Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements
On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy ...
Sodium Thiosulfate to Reduce the Risk of Cisplatin-Related Ototoxicity in Pediatric Patients With Localized Solid Tumors
On September 20, 2022, sodium thiosulfate was approved to reduce the risk of ototoxicity associated with cisplatin in pediatric patients (aged ≥ 1 month) with localized, nonmetastatic solid tumors.1 Supporting Efficacy Data Approval was based on findings in the multicenter open-label SIOPEL 6...
Selpercatinib Approved for Advanced RET Fusion–Positive Solid Tumors and Advanced RET Fusion–Positive NSCLC
On September 21, 2022, selpercatinib was granted accelerated approval for adults with locally advanced or metastatic solid tumors with RET gene fusion whose disease has progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.1 On the same day,...
Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer
On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (ClinicalTrials.gov...
Prevalence of Tumor Thrombus at RCC Diagnosis and Risk of Venous Thromboembolism
In a Dutch single-institution retrospective cohort study reported in JACC: CardioOncology, Kaptein et al identified the prevalence of venous tumor thrombus at diagnosis in patients with renal cell carcinoma (RCC) and the associated risk of venous thromboembolism. Study Details The study included...
Addition of Fluorouracil to Adjuvant Chemotherapy and Comparison of Standard vs Dose-Dense Treatment in Node-Positive Early Breast Cancer
As reported in The Lancet Oncology by Lucia Del Mastro, MD, and colleagues, end-of-study findings from the Italian phase III GIM2 trial after a median follow-up of 15 years indicate that the addition of fluorouracil to adjuvant epirubicin, cyclophosphamide, and paclitaxel did not improve outcomes...
Fracture Risk Among Older Cancer Survivors
In a study reported in JAMA Oncology, Rees-Punia et al found that the risk of frailty-related bone fractures among older cancer survivors was significantly greater vs that among older adults without a history of cancer. Study Details The longitudinal cohort study used data from 92,431 older adults...
Proposed Threshold for Circulating Tumor Plasma Cells to Define Plasma Cell Leukemia–Like Multiple Myeloma
In a study reported in the Journal of Clinical Oncology, Jelinek et al provided evidence that a threshold of ≥ 2% circulating tumor plasma cells (CTCs) defines the presence of plasma cell leukemia (PCL)-like multiple myeloma. As stated by the investigators, “Primary PCL is the most aggressive...
Cancer Clinical Trial Participation Among Medicare Fee-for-Service Beneficiaries With Cancer
In a retrospective cohort study reported in JAMA Oncology, Green et al found that only 1% to 2% of Medicare fee-for-service beneficiaries aged ≥ 65 years with cancer were enrolled in interventional cancer clinical trials. Study Details The study assessed clinical trial participation among patients...
Early Discontinuation of Full Treatment Regimen or Oxaliplatin Alone in Patients Receiving Adjuvant Oxaliplatin/Fluoropyrimidine Therapy for Stage III Colon Cancer
In a pooled analysis reported in the Journal of Clinical Oncology, Gallois et al found that early discontinuation of adjuvant oxaliplatin/fluoropyrimidine regimens—consisting of FOLFOX (infusional fluorouracil, leucovorin, and oxaliplatin) or CAPOX (capecitabine and oxaliplatin)—was associated...
Cost-Effectiveness of COG Breast Cancer Screening Guidelines for Hodgkin Lymphoma Survivors Who Received Chest Irradiation
In a cost-effective analysis reported in the Journal of Clinical Oncology, Wong et al found that only the mammography component of the Children’s Oncology Group (COG) breast cancer screening guidelines for chest-irradiated Hodgkin lymphoma survivors was cost-effective; magnetic resonance imaging...
Management of Severe Immune-Related Adverse Events With Ipilimumab/Nivolumab and Survival in Advanced Melanoma
In a Dutch study reported in JAMA Oncology, van Not et al found that management of grade ≥ 3 immune-related adverse events with steroids alone vs steroids plus second-line immunosuppressants was associated with better survival outcomes among patients receiving first-line combination ipilimumab and...
Prevalence of Mismatch Repair Deficiency in Rectal Adenocarcinoma in a Prospective Screening Program
As reported in a letter published in The New England Journal of Medicine by Papke et al, data from a prospective biopsy screening program at a large gastrointestinal pathology group indicate that approximately 3% of rectal adenocarcinomas are mismatch repair (MMR)-deficient. Study Background As...
Rare Germline ATM Variants in Chronic Lymphocytic Leukemia
In a single-institution analysis reported in the Journal of Clinical Oncology, Benjamin L. Lampson, MD, and colleagues found a higher prevalence of rare germline ATM variants in chronic lymphocytic leukemia (CLL) vs other lymphoid and myeloid disorders. They also determined that patients with CLL...
First-Line Pembrolizumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC Without EGFR/ALK Alterations
As reported in the Journal of Clinical Oncology by Gilberto de Castro, Jr, MD, PhD, and colleagues, 5-year follow-up of the KEYNOTE-042 trial showed a maintained overall survival benefit with first-line pembrolizumab vs chemotherapy in patients with non–small cell lung cancer (NSCLC) with a PD-L1...
CNS-Directed Therapy and Neurocognitive Outcomes in Survivors of Childhood ALL Receiving No Cranial Irradiation
In a single-institution study reported in the Journal of Clinical Oncology, Jacola et al found that survivors of childhood acute lymphoblastic leukemia (ALL) who received central nervous system (CNS)-directed therapy excluding cranial irradiation had poorer outcomes in numerous neurocognitive...
Comparison of Two Chemotherapy Regimens for Newly Diagnosed Ewing Sarcoma
As reported in The Lancet by Brennan et al, the European phase III EURO EWING 2012 trial found improved event-free survival with a standard U.S. chemotherapy regimen vs a standard European regimen in newly diagnosed patients with Ewing sarcoma. As stated by the investigators, “Internationally, a...
Lisocabtagene Maraleucel Improves Event-Free Survival in Second-Line Treatment of Relapsed or Refractory LBCL
As reported in The Lancet by Manali Kamdar, MD, of the University of Colorado Cancer Center, Aurora, and colleagues, an interim analysis of the phase III TRANSFORM trial has shown significantly improved event-free survival with second-line lisocabtagene maraleucel vs standard-of-care salvage...
Lutetium Lu-177 Vipivotide Tetraxetan for PSMA-Positive Metastatic Castration-Resistant Prostate Cancer
On March 23, 2022, the radioligand therapeutic agent lutetium Lu-177 vipivotide tetraxetan was approved for treatment of patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer who have been treated with an androgen receptor pathway inhibitor ...
Addition of Brentuximab Vedotin to Chemotherapy in Pediatric High-Risk Hodgkin Lymphoma
As reported in The New England Journal of Medicine by Castellino et al, the phase III Children’s Oncology Group (COG) AHOD1331 trial showed improved event-free survival with brentuximab vedotin plus chemotherapy vs standard chemotherapy in previously untreated pediatric patients with high-risk...
Association of FLT3-ITD Measurable Residual Disease With Outcomes in Newly Diagnosed AML
In a study reported in the Journal of Clinical Oncology, Grob et al found that next-generation sequencing detection of FLT3-internal tandem duplication (FLT3-ITD) measurable residual disease (MRD) in complete remission was associated with markedly increased risk of relapse and poorer overall...
Effect of Smartphone Psychotherapy Apps on Fear of Recurrence Among Young Breast Cancer Survivors
In a Japanese trial (J-SUPPORT 1703) reported in the Journal of Clinical Oncology, Akechi et al found that 8-week use of smartphone psychotherapy apps was associated with significant benefits in reducing the fear of recurrence in breast cancer survivors aged 20 to 49 years. Study Details In the...
Indian Trial Explores Addition of Low-Dose Nivolumab to Chemotherapy in Advanced Head and Neck Cancer
In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Vijay Patil, MBBS, MD, DM, and colleagues found that the addition of low-dose nivolumab to triple metronomic chemotherapy significantly improved overall survival in patients with newly diagnosed or recurrent...
Sequencing of Short-Duration ADT With Radiotherapy in Nonmetastatic Prostate Cancer
In a pooled analysis (SANDSTORM) reported in the Journal of Clinical Oncology, Ma et al found that concurrent/adjuvant short-term androgen-deprivation therapy (ADT) with prostate-only radiotherapy (PORT) was associated with better outcomes in multiple measures vs neoadjuvant/concurrent ADT with...
PET-Adapted Therapy for Bulky Stage I/II Classical Hodgkin Lymphoma
As reported in the Journal of Clinical Oncology by Ann S. LaCasce, MD, MMSc, and colleagues, the phase II CALGB 50801/Alliance trial has shown that a positron-emission tomography (PET)-adapted treatment strategy allowed many patients with bulky stage I/II classical Hodgkin lymphoma to avoid...
Avoidance of Surgery in Patients With Invasive Breast Cancer and Exceptional Response to Neoadjuvant Systemic Therapy
In a phase II trial reported in The Lancet Oncology, Henry Kuerer, MD, PhD, FACS, and colleagues found radiotherapy alone among women with triple-negative or HER2-positive invasive breast cancer who had pathologic complete response on percutaneous image-guided, vacuum-assisted core biopsy (VACB)...
Mosaic Chromosomal Alterations and Risk of Lung Cancer
In a study reported in The Lancet Oncology, Qin et al found that the presence of mosaic chromosomal alterations detected in blood-derived DNA was associated with an increased risk of lung cancer among persons of Chinese and European heritage. Study Details The study involved two cohorts:...
Ciltacabtagene Autoleucel in Relapsed or Refractory Multiple Myeloma
In a Chinese phase II trial (CARTIFAN-1) reported in the Journal of Clinical Oncology, Mi et al found that the anti–B-cell maturation antigen chimeric antigen receptor (CAR) T-cell therapy ciltacabtagene autoleucel was active in patients with relapsed or refractory multiple myeloma. Study Details...
Concurrent Olaparib and Radiotherapy for Triple-Negative Breast Cancer
In a French phase I trial reported in JAMA Oncology, Loap et al found that concurrent olaparib and radiotherapy was well tolerated in patients with triple-negative breast cancer who had incomplete pathologic response or unresectable disease after neoadjuvant chemotherapy. Survival outcomes with the ...
KEYNOTE-716: Distant Metastasis–Free Survival With Adjuvant Pembrolizumab in Resected Stage IIB or IIC Melanoma
As reported in The Lancet Oncology by Georgina V. Long, MBBS, PhD, and colleagues, an analysis from the phase III KEYNOTE-716 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival with adjuvant pembrolizumab vs placebo in resected stage IIB or IIC...
Telisotuzumab Vedotin Plus Erlotinib in c-Met Protein–Expressing NSCLC
In a phase Ib trial reported in the Journal of Clinical Oncology, D. Ross Camidge, MD, PhD, and colleagues found that the combination of telisotuzumab vedotin and erlotinib showed activity in c-Met protein–expressing advanced non–small cell lung cancer (NSCLC), including those with an EGFR mutation ...
Biomarker Assessment for Benefit of LuPSMA vs Cabazitaxel in Metastatic Castration-Resistant Prostate Cancer
In a prespecified analysis from the Australian phase II TheraP trial reported in The Lancet Oncology, Buteau et al found that higher gallium-68–labeled PSMA-11 positron-emission tomography (PSMA-PET) mean standardized uptake values (SUVmean) were associated with a greater likelihood of...
Effect of Invitation to Colonoscopy Screening on Risk of Colorectal Cancer and Risk of Mortality: The NordICC Trial
In a pragmatic trial reported in The New England Journal of Medicine, Bretthauer et al, on behalf of the Nordic-European Initiative on Colorectal Cancer (NordICC) Study Group, found a reduced risk of colorectal cancer diagnosis but no significant reduction in disease-specific mortality among...
Managing Primary Prophylactic Colony-Stimulating Factor Use in Patients Receiving Regimens Associated With Intermediate Risk for Febrile Neutropenia
In a study reported in the Journal of Clinical Oncology, Dawn L. Hershman, MD, MS, FASCO, and colleagues found that a standing order entry (SOE) for vs an alert against use of primary prophylactic colony-stimulating factor (PP-CSF) for patients receiving first-line regimens for cancer associated...
Focal Adhesion Kinase Inhibitor in Patients With Meningioma and Somatic NF2 Mutations
As reported in the Journal of Clinical Oncology by Priscilla K. Brastianos, MD, PhD, and colleagues, the phase II Alliance A071401 trial showed activity of the focal adhesion kinase (FAK) inhibitor GSK2256098 in patients with recurrent or progressive grade 1 to 3 meningioma and somatic NF2...
PSA Screening Rates and Incidence of Metastatic Prostate Cancer at VHA Facilities
In a retrospective cohort study reported in JAMA Oncology, Bryant et al found that prostate-specific antigen (PSA) screening rates at Veterans Health Administration (VHA) facilities declined between 2005 and 2019—and that diagnoses of metastatic prostate cancer increased over the same time period....
Addition of Capecitabine to Temozolomide in Advanced Pancreatic Neuroendocrine Tumors
As reported in the Journal of Clinical Oncology by Pamela L. Kunz, MD, and colleagues, the phase II ECOG-ACRIN E2211 trial has shown significantly prolonged progression-free survival with the addition of capecitabine to temozolomide in patients with advanced pancreatic neuroendocrine tumors. Study ...
Genomic Microsatellite Signature Assay to Identify Germline MMRD in Patients With CMMRD
In an analysis reported in the Journal of Clinical Oncology, Chung et al described the performance of a newly developed assay using genomic microsatellite signatures (LOGIC; low-pass genomic instability characterization) in detecting germline mismatch repair deficiency (MMRD) in patients with the...
Increased Mortality From Comorbid Cancer and Cardiovascular Disease Associated With Increased Social Vulnerability
In a U.S.-based cross-sectional study reported in JACC: CardioOncology, Sarju Ganatra, MD, of Lahey Hospital & Medical Center, Burlington, Massachusetts, and colleagues found that mortality from comorbid cancer and cardiovascular disease (CVD) was significantly higher in counties with higher...
Chemotherapy Outcomes in Noninfant Childhood ALL With 11q23/KMT2A Rearrangements
In a retrospective study reported in the Journal of Clinical Oncology, Attarbaschi et al described outcomes in patients with noninfant childhood acute lymphoblastic leukemia (ALL) and 11q23/KMT2A rearrangements treated with chemotherapy regimens between 1995 and 2010. Study Details The study...
Identifying Patients With Ovarian Cancer With Greatest Potential Benefit From First-Line Bevacizumab
In a study reported in the Journal of Clinical Oncology, Benoit You, MD, PhD, and colleagues found that an unfavorable CA-125 elimination rate constant K (KELIM) score, indicating poorer tumor chemosensitivity, was associated with derived benefit from first-line bevacizumab when given with...
Addition of Bemarituzumab to mFOLFOX in FGFR2b-Selected Gastric or Gastroesophageal Junction Adenocarcinoma
In the phase II FIGHT trial reported in The Lancet Oncology, Zev A. Wainberg, MD, and colleagues found numerically better progression-free survival with the addition of the anti-FGFR2b antibody bemarituzumab to mFOLFOX (modified fluorouracil, leucovorin, and oxaliplatin) in patients with...
Rogaratinib vs Chemotherapy in Previously Treated Patients With Advanced Urothelial Carcinoma and FGFR1/3 mRNA Overexpression
As reported in the Journal of Clinical Oncology by Cora N. Sternberg, MD, and colleagues, interim analysis of the phase II portion of the phase II/III FORT-1 trial has shown similar objective response rates with the oral FGFR1–4 inhibitor rogaratinib vs chemotherapy in previously treated patients...
