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issues in oncology

Inclusion of Women in Oncology Clinical Trials From 2000 to 2020

In a study reported in a research letter in JAMA Oncology, Jenei et al found that women with cancer have been underrepresented in global oncology drug trials over the past 20 years, with underrepresentation persisting through the present in multiple cancer types.    Study Details The study involved ...

covid-19

Rates of Adverse Reactions to the Moderna mRNA-1273 COVID-19 Vaccine in Patients With Cancer and Recent Radiotherapy

In an Italian single-center study reported in a letter in The Lancet Oncology, Scoccianti et al found that patients who underwent radiotherapy for cancer within the 6 months prior to receipt of the Moderna mRNA-1273 COVID-19 vaccine did not experience a difference in adverse reactions to the...

leukemia
immunotherapy

AUTO1: CAR T-Cell Product for Adult Patients With Relapsed or Refractory B-Cell ALL

In a phase I trial (ALLCAR19) reported in the Journal of Clinical Oncology, Roddie et al found that the fast off-rate autologous CD19 chimeric antigen receptor (CAR) T-cell therapy CAT19-41BB-Z—also known as AUTO1—was well tolerated and produced high remission rates in adults with relapsed or...

issues in oncology

Cancer-Specific Urgent Care Center: Effect on Emergency Department Use and Hospitalization Rate

In a single-institution study reported in JCO Oncology Practice, Gould Rothberg et al found that establishment of a dedicated cancer urgent care center within a large tertiary academic center resulted in a significant but modest decrease in emergency department use—but no significant reduction in...

breast cancer
survivorship

Effect of Mindfulness Meditation and Survivorship Education on Depressive Symptoms in Younger Breast Cancer Survivors

In a phase III trial (Pathways to Wellness) reported in the Journal of Clinical Oncology, Julienne E. Bower, PhD, and colleagues found that both mindfulness meditation and survivorship education interventions significantly reduced depressive symptoms in younger breast cancer survivors. Study...

immunotherapy
symptom management

Technology-Enabled Monitoring of Adverse Reactions to Immune Checkpoint Inhibitors

In an interim analysis of a single-institution study reported in JAMA Network Open, Pavlos Msaouel, MD, PhD, and colleagues found that the use of a mobile device application for patient reporting of adverse reactions to immune checkpoint inhibition was feasible. It permitted identification of...

multiple myeloma
immunotherapy

Subcutaneous Daratumumab Added to Pomalidomide Plus Dexamethasone Improves Progression-Free Survival in Multiple Myeloma

As reported in The Lancet Oncology by Meletios A. Dimopoulos, MD, of the National and Kapodistrian University of Athens, and colleagues, the phase III APOLLO trial has shown significantly improved progression-free survival with the addition of subcutaneous (SC) daratumumab to oral...

gynecologic cancers
genomics/genetics

High Prevalence of Germline BRCA Mutations in Indian Women With Ovarian Cancer

In a prospective cross-sectional study reported in JCO Global Oncology, Sudeep Gupta, MBBS, MD, DM, of Tata Memorial Centre, and colleagues found that Indian women with ovarian cancer not selected for study based on clinical factors had a high prevalence of germline pathogenic or likely pathogenic...

prostate cancer

Adding LuPSMA to Standard Care Improves Outcomes in Castration-Resistant Prostate Cancer

As reported in The New England Journal of Medicine by Oliver Sartor, MD, of the School of Medicine, Tulane University, and colleagues, the phase III VISION trial has shown prolonged progression-free and overall survival with lutetium-177–PSMA-617 (LuPSMA) radioligand therapy plus standard care vs...

multiple myeloma

Daratumumab and Hyaluronidase-fihj With Pomalidomide Plus Dexamethasone in Multiple Myeloma

On July 9, 2021, daratumumab and hyaluronidase-fihj was approved for use in combination with pomalidomide and dexamethasone (Pd) for treatment of adults with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.1 Supporting...

prostate cancer

Maintained Benefit of Apalutamide Plus Androgen-Deprivation Therapy Shown in Metastatic Castration-Sensitive Prostate Cancer

As reported in the Journal of Clinical Oncology by Kim N. Chi, MD, of BC Cancer and Vancouver Prostate Centre, and colleagues, the final overall survival analysis of the phase III TITAN trial showed significant benefit of apalutamide plus androgen-deprivation therapy vs placebo plus...

lung cancer

Amivantamab-vmjw for Previously Treated Advanced NSCLC With EGFR Mutation

On May 21, 2021, amivantamab-vmjw, a bispecific antibody directed against EGFR and MET receptors, was granted accelerated approval for treatment of adults with locally advanced or metastatic non–small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by a U.S. Food and...

immunotherapy
gastroesophageal cancer

Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...

bladder cancer

Enfortumab Vedotin-ejfv in Urothelial Cancer

On July 9, 2021, enfortumab vedotin-ejfv, an antibody-drug conjugate targeting nectin-4, was granted regular approval. The agent is indicated for the treatment of adults with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and platinum chemotherapy or...

breast cancer
immunotherapy

Pembrolizumab for High-Risk, Early-Stage Triple-Negative Breast Cancer

On July 26, 2021, pembrolizumab was approved for high-risk, early-stage, triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and continued as adjuvant treatment.1 Pembrolizumab was also granted regular approval in combination with chemotherapy for locally...

covid-19

Resurgence of COVID-19 Infection in a Large, Vaccinated Health System Workforce

In a letter to the editor in The New England Journal of Medicine, Keehner et al describe a marked resurgence of COVID-19 infections among fully vaccinated members of the University of California San Diego Health (UCSDH) workforce in July 2021. The resurgence appears to be driven by the confluence...

prostate cancer

Effect of High-Intensity Interval Training on Biochemical Progression in Patients With Localized Prostate Cancer Under Active Surveillance

In a Canadian single-institution phase II study (ERASE) reported in JAMA Oncology, Kang et al found that increased exercise in the form of high-intensity interval training was associated with increased cardiorespiratory fitness and reductions in prostate-specific antigen (PSA) level, PSA velocity,...

cost of care

Pharmacy Strategy to Decrease Patient Copayments for High-Cost Cancer Drugs Through Financial Assistance Applications

In an observational retrospective study reported in JCO Oncology Practice, Seymour et al describe a strategy used by Karmanos Specialty Pharmacy (KSP) to successfully decrease patient copayments for high-cost cancer drugs. Study Details The study involved data from the KSP claims data set, accessed ...

head and neck cancer
issues in oncology

HPV Vaccination and Projected Oropharyngeal Cancer Incidence Through the Year 2045

In a population-based age-period-cohort study reported in JAMA Oncology, Zhang et al estimated that current human papillomavirus (HPV) vaccination rates will have a limited impact on overall oropharyngeal cancer incidence through 2045, due to a high risk of oropharyngeal cancer in unvaccinated...

covid-19

Rates of Newly Diagnosed Cancer Among U.S. Patients During the First Full Year of the COVID-19 Pandemic

In a study of Quest Diagnostics data reported as a research letter in JAMA Network Open, Kaufman et al found significant decreases in monthly new cancer diagnoses during the first full year of the COVID-19 pandemic compared with the prepandemic period. As stated by the investigators, “We previously ...

lung cancer

Ensartinib Shows Superior Efficacy to Crizotinib in Advanced ALK-Positive NSCLC: eXalt3 Trial

As reported in JAMA Oncology by Leora Horn, MD, MSc, FRCPC, and colleagues, the phase III eXalt3 trial has shown significantly prolonged progression-free survival with ensartinib vs crizotinib in patients with advanced, recurrent, or metastatic anaplastic lymphoma kinase (ALK)-positive non–small...

covid-19

Teleoncology for Veterans With Cancer During the COVID-19 Pandemic

In a single-center study reported in JCO Oncology Practice, Jiang et al found an overall high level of satisfaction with teleoncology care during the COVID-19 pandemic among veterans with cancer in the United States, although a preference for in-person visits was commonly expressed. Teleoncology...

skin cancer
immunotherapy

Phase II Trial Evaluates Oncolytic Coxsackievirus A21 for Unresectable Advanced Melanoma

In a phase II trial reported in the Journal of Clinical Oncology, Robert H.I. Andtbacka, MD, and colleagues found that intratumoral injection of the oncolytic RNA virus Coxsackievirus A21 (V937) was well tolerated and produced responses in some patients with unresectable stage III or stage IV...

leukemia
issues in oncology

Ibrutinib and Cardiovascular Risk in Patients With Chronic Lymphocytic Leukemia

In a Canadian population-based cohort study reported in the Journal of Clinical Oncology, Abdel-Qadir et al found that ibrutinib treatment for chronic lymphocytic leukemia (CLL) is associated with increased risks of atrial fibrillation, bleeding, and heart failure, but not ischemic stroke or acute...

bladder cancer
immunotherapy

Neoadjuvant Gemcitabine and Split-Dose Cisplatin Plus Pembrolizumab for Muscle-Invasive Bladder Cancer

In a phase II study reported in the Journal of Clinical Oncology, Tracy L. Rose, MD, MPH, and colleagues found that neoadjuvant therapy with pembrolizumab, gemcitabine, and primarily split-dose cisplatin resulted in pathologic downstaging (< pT2N0) in more than half of patients undergoing...

leukemia
genomics/genetics

Effect of Concurrent Focal 22q11.22 Deletions and IKZF1 Alterations on Outcomes in Pediatric Patients With B-Cell ALL

In a study reported in JAMA Oncology, Mangum et al found that focal deletions in chromosome 22q11.22 were associated with poor outcomes in pediatric patients with B-cell acute lymphoblastic leukemia (ALL) with IKZF1 alterations. As stated by the investigators, “Alterations in the IKZF1 gene drive...

breast cancer

Addition of Everolimus to Letrozole in Premenopausal Women With Advanced HR-Positive, HER2-Negative Breast Cancer

In the Chinese phase II MIRACLE trial reported in JAMA Oncology, Fan et al found that the addition of everolimus to letrozole significantly improved progression-free survival among premenopausal women with advanced hormone receptor (HR)-positive, HER2-negative breast cancer whose disease had...

covid-19
global cancer care

Effects of COVID-19 Infection in Children and Adolescents With Cancer: Global Analysis

In a Global Registry of COVID-19 in Childhood Cancer cohort study reported in The Lancet Oncology, Mukkada et al found that approximately one-fifth of children with cancer infected with COVID-19 worldwide had severe illness, with an associated mortality rate exceeding that reported in the general...

multiple myeloma

Addition of Venetoclax to Daratumumab/Dexamethasone With or Without Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma

In a phase I study reported in the Journal of Clinical Oncology, Bahlis et al found that venetoclax plus daratumumab/dexamethasone (VenDd) and VenDd with bortezomib (VenDVd) produced high rates of durable responses in patients with relapsed or refractory multiple myeloma with t(11;14) translocation ...

bladder cancer

Addition of ATR Inhibitor Berzosertib to Cisplatin/Gemcitabine in Metastatic Urothelial Carcinoma

In a phase II trial reported in JAMA Oncology, Sumanta K. Pal, MD, FASCO, and colleagues found that the addition of the ATR inhibitor berzosertib to cisplatin/gemcitabine provided no benefit in patients with metastatic urothelial carcinoma. The triplet did not prolong progression-free survival, and ...

gynecologic cancers

Inguinofemoral Radiotherapy vs Inguinofemoral Lymphadenectomy for Patients With Vulvar Cancer and Sentinel Node Metastasis

In the phase II GROINSS-V II study reported in the Journal of Clinical Oncology, Oonk et al found that inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy in women with early-stage vulvar cancer and sentinel node micrometastasis but was associated with a higher...

breast cancer
global cancer care

Global Breast Cancer Survival: Estimated Impact of Scaling Up Access to Treatment/Imaging Modalities and Quality of Care

In a study reported in The Lancet Oncology, Ward et al estimated the improvements in global overall survival for female breast cancer that could be achieved via increased availability of treatment and imaging modalities, as well as improvements in quality of care. Study Details The study used a...

gastroesophageal cancer
immunotherapy

Addition of Pembrolizumab to Chemotherapy for the First-Line Treatment of Advanced Esophageal Cancer: KEYNOTE-590

As reported in The Lancet by Sun et al, the phase III KEYNOTE-590 trial showed that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free survival in patients with advanced esophageal and Siewert type 1 gastroesophageal junction (GEJ) cancers....

lung cancer

First-Line Veliparib Plus Platinum-Based Chemotherapy in Current Smokers With Advanced Squamous Cell NSCLC

In a phase III trial reported in the Journal of Clinical Oncology, Suresh S. Ramalingam, MD, and colleagues found that the addition of the poly (ADP-ribose) polymerase inhibitor veliparib to platinum-based chemotherapy did not improve overall survival in current smokers with previously untreated...

breast cancer
symptom management

Pharmacologic Cardioprotection in Women With Nonmetastatic Breast Cancer Receiving Anthracycline-Based Chemotherapy

In an interim analysis of the Italian phase III SAFE trial reported in JAMA Oncology, Livi et al found that a cardioprotective strategy using ramipril and/or bisoprolol reduced the risk of myocardial dysfunction in women with nonmetastatic breast cancer receiving anthracycline-based chemotherapy....

cns cancers
genomics/genetics

ALK Fusion–Positive High-Grade Glioma: Response to Lorlatinib in a Single Pediatric Case

In a letter to the editor published in The New England Journal of Medicine, Bagchi et al describe the course of treatment in a 3-year-old child with an intracranial tumor and his response to therapy with the kinase inhibitor lorlatinib. Key Points Magnetic resonance imaging (MRI) of the head in a...

issues in oncology

Effects of Removing Race in the CKD-EPI Equation for Estimated Glomerular Filtration Rate

In a study reported in The Lancet Oncology, Casal et al showed that removing race as a factor in the Chronic Kidney Disease–Epidemiology Collaboration (CKD-EPI) equation for estimated glomerular filtration rate (eGFR) would result in calculation of a lower eGFR in Black patients. This might result...

myelodysplastic syndromes

Personalized Risk Prediction Model for Patients With Myelodysplastic Syndromes

As reported in the Journal of Clinical Oncology, Aziz Nazha, MD, and colleagues have developed a model for predicting the risk of disease progression for individual patients with myelodysplastic syndromes (MDS). To develop the prediction model for overall survival and leukemic transformation,...

prostate cancer

Prostate Cancer Screening Using the Stockholm3 Screening Test With MRI-Guided Biopsy

In a Swedish prostate cancer screening trial (STHLM3-MRI) reported in The Lancet Oncology, Nordström et al found that use of the Stockholm3 screening test together with magnetic resonance imaging (MRI)-guided biopsy reduced overdetection of disease while preserving the ability to detect clinically...

hematologic malignancies
lymphoma

Ixazomib/Rituximab/Dexamethasone for Relapsed or Refractory Waldenström’s Macroglobulinemia

In a phase I/II trial (HOVON124/ECWM-R2) reported in the Journal of Clinical Oncology, Kersten et al found that the combination of oral ixazomib with subcutaneous rituximab and dexamethasone showed efficacy in patients with relapsed or refractory Waldenström’s macroglobulinemia, with a manageable...

genomics/genetics

Cancer Predisposition Screening Tool for Predicting Subsequent Malignancies in Childhood Cancer Survivors

In a Canadian study reported in the Journal of Clinical Oncology, Cullinan et al found that the McGill Interactive Pediatric OncoGenetic Guidelines (MIPOGG) tool provided predictive value for risk of subsequent malignant neoplasms in childhood cancer survivors beyond risk associated with treatment...

breast cancer

Does Radiotherapy Reduce the Long-Term Risk of Ipsilateral Breast Recurrence in Women With DCIS Who Underwent Lumpectomy?

In an analysis of long-term outcomes from the phase III NRG/RTOG 9804 trial reported in the Journal of Clinical Oncology, Beryl McCormick, MD, and colleagues found that whole-breast irradiation vs observation was associated with reduced risk of all and invasive ipsilateral breast recurrence at 15...

immunotherapy

Profile of Adverse Events Related to PD-1 and PD-L1 Inhibitor–Based Therapy

In a systematic review and meta-analysis reported in The Lancet Oncology, Zhou et al provided a profile of treatment-related adverse events observed in clinical trials combining PD-1 or PD-L1 inhibitors with chemotherapy, targeted therapy, immunotherapy, and radiotherapy. Study Details The...

breast cancer
immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Triple-Negative Breast Cancer

On April 7, 2021, sacituzumab govitecan-hziy was granted regular approval for treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.1 Sacituzumab...

bladder cancer
immunotherapy

Sacituzumab Govitecan-hziy for Locally Advanced or Metastatic Urothelial Cancer

On April 13, 2021, sacituzumab govitecan-hziy was granted accelerated approval to treat patients with locally advanced or metastatic urothelial cancer who had received platinum-containing chemotherapy and either a PD-1 or a PD-L1 inhibitor.1 Supporting Efficacy Data Approval was based on findings...

hematologic malignancies
symptom management

Belumosudil for Chronic Graft-vs-Host Disease

On July 16, 2021, belumosudil, an inhibitor of Rho-associated coiled-coil kinase 2, was approved for the treatment of adult and pediatric patients 12 years and older with chronic graft-vs-host disease after the failure of at least two prior lines of systemic therapy.1 Supporting Efficacy Data...

lung cancer

High Prevalence of Previously Undiagnosed Emphysema Among Individuals Undergoing Low-Dose CT Screening for Lung Cancer

In a prospective cohort study reported in Clinical Imaging, David Steiger, MD, of the Division of Pulmonary, Critical Care and Sleep Medicine, Icahn School of Medicine at Mount Sinai, in New York, and colleagues in the International Early Lung Cancer Action Program (I-ELCAP) identified emphysema in ...

multiple myeloma

Isatuximab-irfc in Relapsed or Refractory Multiple Myeloma

On March 31, 2021, the anti-CD38 monoclonal antibody isatuximab-irfc was approved for use in combination with carfilzomib and dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.1 Supporting Efficacy Data...

kidney cancer
immunotherapy

Adjuvant Pembrolizumab May Improve Disease-Free Survival in Patients With High-Risk Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, and colleagues, an interim analysis of the phase III KEYNOTE-564 trial showed improved disease-free survival with adjuvant pembrolizumab vs placebo after nephrectomy in high-risk patients with clear cell renal cell...

solid tumors

Non–Testicular Cancer Mortality Rates in Men With Testicular Cancer in the Cisplatin Era

In a Norwegian population-based study reported in the Journal of Clinical Oncology, Hellesnes et al found that treatment of testicular cancer with platinum-based chemotherapy or radiotherapy was associated with a significant excess of non–testicular cancer mortality compared with the general...

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