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Showing 3351 - 3400Alpelisib for PIK3CA-Mutated Advanced Breast Cancer
On May 24, 2019, alpelisib was approved for use in combination with fulvestrant for postmenopausal women, and men, with hormone receptor–positive, HER2-negative, PIK3CA-mutated advanced or metastatic breast cancer, as detected by a U.S. Food and Drug Administration (FDA)-approved test following...
Pembrolizumab in Advanced Esophageal Squamous Cell Cancer With PD-L1 Expression of CPS ≥ 10
On July 30, 2019, pembrolizumab was approved for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express programmed cell death ligand 1 (PD-L1; Combined Positive Score [CPS] ≥ 10), as determined by a U.S. Food and Drug...
Pembrolizumab in First-Line Treatment of Head/Neck Squamous Cell Carcinoma
On June 10, 2019, pembrolizumab was approved for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma.1,2 Pembrolizumab was approved for use in combination with platinum and fluorouracil (5-FU) for all patients and as a single agent...
Daratumumab-Based Therapy for Patients With Newly Diagnosed Multiple Myeloma Who Are Ineligible for Transplantation
On June 27, 2019, daratumumab was approved for use in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase...
Lenalidomide for Previously Treated Follicular and Marginal Zone Lymphomas
On May 28, 2019, lenalidomide was approved for use in combination with a rituximab product for previously treated follicular lymphoma and previously treated marginal zone lymphoma.1,2 Supporting Efficacy Data Approval was based on the findings of two clinical trials: AUGMENT (ClinicalTrials.gov...
Physical Activity Level and Outcomes in Metastatic Colorectal Cancer
A prospective cohort study within the phase III Cancer and Leukemia Group B (Alliance)/SWOG 80405 trial found that increased physical activity at baseline was associated with nonsignificant improvement in overall survival, a significant improvement in progression-free survival, and a reduced risk...
Germline BRCA2 Mutation and Risk of Pediatric or Adolescent Lymphoma
In a study reported in a research letter in JAMA Oncology,1Zhaoming Wang, PhD, and colleagues at St. Jude Children’s Research Hospital, Memphis, found that the presence of a germline BRCA2 mutation increased the risk of development of pediatric or adolescent non-Hodgkin lymphoma. As noted by the...
2019 Quality Care: Intervention to Improve Rates of Resident Advanced Care Planning Documentation
In a single-center study reported at the ASCO Quality Care Symposium and simultaneously published in the Journal of Oncology Practice, Switzer et al found that an intervention consisting of a resident training module and use of a best practice alert (BPA) in electronic medical records (EMRs)...
2019 Quality Care: Improving Documentation of Pain and Constipation Assessment and Management
In a study reported at the ASCO Quality Care Symposium and simultaneously published in the Journal of Oncology Practice, Chineke et al found that a Quality Oncology Practice Initiative (QOPI) initiated in collaboration with ASCO at the Georgia Cancer Center for Excellence (GCCE) at Grady Health...
2019 Quality Care: Improving Caregiver Identification and Support in a Gynecologic Oncology Practice
In a study reported at the ASCO Quality Care Symposium and simultaneously published in the Journal of Oncology Practice, Campbell et al found that an ASCO Quality Training Program Project—the Plan-Do-Study-Act (PDSA) initiative—resulted in improvement in primary caregiver identification and...
Avelumab for Mismatch Repair–Deficient and Mismatch Repair–Proficient Endometrial Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Panagiotis A. Konstantinopoulos, MD, PhD, and colleagues found evidence of promising activity of the programmed cell death ligand 1 (PD-L1) inhibitor avelumab in mismatch repair–deficient (MMRD) recurrent or persistent endometrial...
Tumor Immune Infiltration and Disease Progression in Follicular Lymphoma
In a study reported in the Journal of Clinical Oncology, Tobin et al found that low tumor immune infiltration—indicated by low programmed cell death ligand 2 (PD-L2) expression—was associated with earlier disease progression in follicular lymphoma. As stated by the investigators, “Understanding the ...
Menopausal Hormone Therapy Use and Risk of Breast Cancer
In a study reported in The Lancet, the Collaborative Group on Hormonal Factors in Breast Cancer found that the use of menopausal hormone therapy is associated with an increased risk of breast cancer, with risk increasing as the duration of use increases, in both current and past users. Study...
Does the Addition of Bevacizumab to Erlotinib in Advanced EGFR-Mutant NSCLC Improve PFS?
In a phase II trial reported in JAMA Oncology, Thomas E. Stinchcombe, MD, and colleagues found that the addition of bevacizumab to erlotinib did not significantly improve progression-free survival (PFS) in patients with advanced EGFR-mutant non–small cell lung cancer (NSCLC). Study Details The...
Neoadjuvant Talazoparib for Operable BRCA-Mutated Breast Cancer
In a study reported in the Journal of Clinical Oncology, Jennifer K. Litton, MD, and colleagues found that 6 months of neoadjuvant talazoparib therapy resulted in a high rate of residual cancer burden (RCB) of 0 (pathologic complete response) in patients with stage I–III breast cancer with germline ...
Solid Organ Transplantation in Aging Survivors of Childhood Cancer
A retrospective analysis from the Childhood Cancer Survivor Study reported in The Lancet Oncology by Dietz et al found that the need for solid organ transplantation was infrequent in aging survivors of childhood cancer, with greater organ-specific risk being associated with particular therapeutic...
Individualized Axitinib Regimens After Immunotherapy for Advanced Renal Cell Carcinoma
In a phase II study reported in The Lancet Oncology, Ornstein et al found that individualized axitinib regimens showed activity in patients with locally recurrent or metastatic renal cell carcinoma who had previously received immune checkpoint inhibitor therapy, although the progression-free...
Addition of Apalutamide to Androgen-Deprivation Therapy in Metastatic Castration-Sensitive Prostate Cancer
As reported in The New England Journal of Medicine by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the first analysis of the phase III TITAN trial has shown that the addition of apalutamide to androgen-deprivation therapy improved radiographic progression-free and...
Risk of Infections in Survivors of Childhood Leukemia
In a study reported in the Journal of Clinical Oncology, Pelland-Marcotte et al found that survivors of childhood leukemia remained at significantly increased risk of infection compared with matched controls during an extended period following completion of treatment. Study Details The...
Reducing Time to Chemotherapy Initiation in Patients Electively Admitted to a Hematologic Malignancy Service
In a single-institution study reported in the Journal of Oncology Practice, Galeas et al found that intervention in key drivers in the care process could reduce the time to initiation of chemotherapy in patients with elective admission to a hematologic malignancy service. Study Details The goal of...
Key Predictors of Response Rates to PD-1/PD-L1 Inhibitor Therapy Across Cancer Types
In a study reported in JAMA Oncology, Lee and Ruppin found that CD8-positive T-cell abundance, tumor mutational burden, and high PD1 gene expression were the strongest predictors of response to anti–programmed cell death protein 1/programmed cell death ligand 1 (PD-1/PD-L1) treatment across cancer...
Pyrotinib or Lapatinib With Capecitabine in Previously Treated HER2-Positive Metastatic Breast Cancer
In a Chinese phase II trial reported in the Journal of Clinical Oncology by Ma et al, the combination of the pan-ErbB inhibitor pyrotinib and capecitabine improved response rate vs lapatinib/capecitabine in women with HER2-positive relapsed or metastatic breast cancer previously treated with...
Chromosomal Abnormalities and Prognosis in NPM1-Mutant AML
In a study reported in the Journal of Clinical Oncology, Angenendt et al found that adverse-risk cytogenetics were associated with significantly poorer outcomes vs normal karyotype among patients with acute myeloid leukemia (AML) with a nucleophosmin 1 (NPM1) mutation. As stated by the...
Enzalutamide Improves Survival vs Standard First-Line Treatment in Hormone-Sensitive Metastatic Prostate Cancer
As reported in The New England Journal of Medicine by Ian D. Davis, MBBS, PhD, FRACP, FAChPM, of Monash University and Eastern Health in Melbourne, and colleagues, the phase III ENZAMET trial has shown that the androgen receptor inhibitor enzalutamide improved progression-free and overall survival ...
High-Deductible Health Plans, Access to Care, and Emergency Department Use Among Cancer Survivors
In a study reported in the Journal of Oncology Practice, Zheng et al found that patients with cancer and high-deductible health plans had increases in delayed/forgone care, an effect that was attenuated for those with health savings accounts. Emergency department use was similar across insurance...
Risks of Cardiovascular Diseases in Survivors of Adult Cancers
In a study reported in The Lancet, Strongman et al found that survivors of most site-specific cancers had an increased risk for one or more cardiovascular diseases during follow-up compared with a matched control group of patients without cancer. This population-based cohort study employed multiple ...
Extended Follow-up of CheckMate 214: Nivolumab/Ipilimumab vs Sunitinib as First-Line Treatment for Advanced RCC
As reported in The Lancet Oncology by Robert J. Motzer, MD, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown a maintained survival benefit for first-line nivolumab/ipilimumab vs sunitinib in patients with previously untreated intermediate- or poor-risk advanced...
Phase Ib Trial of Toripalimab/Axitinib in Asian Patients With Advanced Mucosal Melanoma
In a Chinese phase Ib study reported in the Journal of Clinical Oncology, Sheng et al reported activity with the combination of the anti–programmed cell death protein 1 (PD-1) agent toripalimab plus axitinib in patients with metastatic mucosal melanoma. As stated by the investigators, whereas...
Prognostic Tool for Advanced, Well-Differentiated Neuroendocrine Tumors Treated With a Somatostatin Analog
In the GETNE-TRASGU study (Spanish Group of Neuroendocrine and Endocrine Tumors Treated With Analog of Somatostatin in Gastroenteropancreatic and Unknown Primary NETs) reported in the Journal of Clinical Oncology, Carmona-Bayonas et al developed a predictive model for progression-free survival in...
Selinexor/Dexamethasone in Triple-Class Refractory Multiple Myeloma
In the phase IIb STORM Part 2 study reported in The New England Journal of Medicine, Chari et al found that the combination of oral selinexor and dexamethasone produced responses in patients with multiple myeloma refractory to prior treatment with an alkylating agent, immunomodulatory agent, and...
Darolutamide for Nonmetastatic Castration-Resistant Prostate Cancer
On July 30, 2019, darolutamide was approved for the treatment of patients with nonmetastatic castration-resistant prostate cancer.1,2 Approval was based on findings in the double-blind phase III ARAMIS trial (ClinicalTrials.gov identifier NCT02200614), in which 1,509 patients were randomly assigned ...
Selinexor in Relapsed or Refractory Multiple Myeloma
In the Clinic provides overviews of novel hematology and 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 July 3, 2019, the oral nuclear export...
Addition of Pemetrexed/Carboplatin to Gefitinib in Advanced EGFR-Mutant NSCLC
In an Indian single-center phase III trial reported in the Journal of Clinical Oncology, Noronha et al found that the addition of pemetrexed/carboplatin to gefitinib improved progression-free and overall survival in first-line treatment of advanced EGFR-mutant non–small cell lung cancer...
Swallowing-Related Quality of Life After Radiotherapy vs Surgery for Oropharyngeal Squamous Cell Carcinoma
In the phase II ORATOR trial reported in The Lancet Oncology, Nichols et al found a statistical but not clinically meaningful improvement in swallowing-related quality of life outcomes 1 year after treatment with radiotherapy vs transoral robotic surgery and neck dissection in patients with...
USPSTF Recommendation on Screening for Pancreatic Cancer in Asymptomatic Adults
As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF), in a reaffirmation of its 2004 recommendation, has recommended against screening for pancreatic cancer in asymptomatic adults (a grade D recommendation).1 In developing the current recommendation, the USPSTF reviewed evidence on ...
Adjuvant Chemoradiotherapy vs Radiotherapy Alone in High-Risk Endometrial Cancer
As reported in The Lancet Oncology by Stephanie de Boer, MD, and colleagues, a post hoc updated survival analysis of the phase III PORTEC-3 trial has shown a significant overall survival benefit of adjuvant chemoradiotherapy vs radiotherapy alone in women with high-risk endometrial cancer. A...
Long-Term Follow-up of Patients With Melanoma, Kidney Cancer, and Lung Cancer Receiving Nivolumab
As reported by Suzanne L. Topalian, MD, and colleagues in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell...
5-Year Follow-Up of KEYNOTE-006 Trial of Immunotherapy Regimens in Advanced Melanoma
In a post hoc 5-year follow-up of the KEYNOTE-006 trial reported in The Lancet Oncology, Caroline Robert, MD, PhD, and colleagues found that pembrolizumab maintained overall and progression-free survival benefits over ipilimumab in patients with advanced melanoma. In the primary analysis from the...
Pexidartinib for Tenosynovial Giant Cell Tumor
On August 2, the oral colony-stimulating factor 1 receptor inhibitor pexidartinib was approved for treatment of adult patients with symptomatic tenosynovial giant cell tumor associated with severe morbidity or functional limitations and not amenable to improvement with surgery.1,2 It is the first...
Gemcitabine/Eribulin in Cisplatin-Ineligible Metastatic Urothelial Carcinoma
In the final analysis from a phase II California Cancer Consortium trial (NCI-9653) reported in the Journal of Clinical Oncology, Sadeghi et al found the combination of gemcitabine and eribulin showed activity in cisplatin-ineligible patients with metastatic urothelial carcinoma. Study Details...
Deintensified Chemoradiotherapy for HPV-Associated Oropharyngeal Squamous Cell Carcinoma
In a phase II trial reported in the Journal of Clinical Oncology, Chera et al found that deintensified chemoradiotherapy produced favorable outcomes in human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma. Study Details In the multicenter trial, 114 patients were recruited...
USPSTF Recommendation on Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer
As reported in JAMA, the U.S. Preventive Services Task Force (USPSTF) recommended risk assessment and, if indicated, genetic counseling and testing for potentially harmful BRCA1/2 mutations in women with a personal or family history of breast, ovarian, tubal, or peritoneal cancer or who have...
Atezolizumab Plus Chemotherapy and Bevacizumab in First-Line Treatment of Metastatic Lung Cancer
In late 2018, atezolizumab was approved for use in combination with bevacizumab, paclitaxel, and carboplatin for the first-line treatment of patients with metastatic nonsquamous non–small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberration.1,2 Supporting Efficacy Data Approval was ...
Adavosertib Plus Gemcitabine and Radiotherapy in Locally Advanced Pancreatic Cancer
In a phase I dose-escalation trial reported in the Journal of Clinical Oncology, Cuneo et al established the phase II dose of the Wee1 kinase inhibitor adavosertib in combination with gemcitabine and radiotherapy in locally advanced pancreatic cancer. Wee1 inhibition impedes DNA damage response and ...
Risk of Cardiovascular Adverse Events in Patients With Melanoma Treated With Combined BRAF and MEK Inhibition vs BRAF Inhibition Alone
In a meta-analysis reported in JAMA Network Open, Mincu et al found that the risk of some types of cardiovascular adverse events was higher with combined BRAF and MEK inhibitor treatment vs BRAF inhibitor monotherapy in patients with melanoma. The meta-analysis included 2,317 patients in five...
Nivolumab/Brentuximab Vedotin in Relapsed or Refractory Primary Mediastinal Large B-Cell Lymphoma
As reported in the Journal of Clinical Oncology by Zinzani et al, findings in a phase II expansion cohort of the CheckMate 436 study indicated high levels of activity with the combination of nivolumab and brentuximab vedotin in relapsed or refractory primary mediastinal large B-cell lymphoma. As...
T-Cell Receptor Gene Therapy in HPV-Associated Epithelial Cancers
In a first-in-human phase I/II study reported in the Journal of Clinical Oncology, Doran et al found that autologous genetically engineered T cells expressing a T-cell receptor directed against the human papillomavirus (HPV)16 E6 oncoprotein were capable of inducing tumor regression in metastatic,...
Neoadjuvant Letrozole Plus Taselisib or Placebo in Postmenopausal Women With ER-Positive, HER2-Negative Early Breast Cancer
In the phase II LORELEI trial reported in The Lancet Oncology, Saura et al found that the addition of the phosphatidylinositol-3 kinase (PI3K) inhibitor taselisib to neoadjuvant letrozole improved objective response rates but not pathologic complete response rates in women with estrogen receptor...
Pooled Analysis of 4-Year Survival With Nivolumab Therapy in Patients With Previously Treated Advanced NSCLC
In an analysis reported in The Lancet Oncology, Antonia et al identified long-term survival rates with nivolumab therapy in patients with previously treated advanced non–small cell lung cancer (NSCLC). The pooled analysis included data from the CheckMate 017, 057, 063, and 003 trials, each...
Surgical Resection Among Patients Receiving Primary Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Cancer
In an Italian prospective cohort study reported in JAMA Surgery, Maggino et al found that among patients receiving primary chemotherapy for newly diagnosed pancreatic ductal adenocarcinoma, conversion to surgical resection was achieved in 24% of those with borderline resectable disease and 9% of...
