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issues in oncology

Patients With Cancer Face Greater Risks From Abdominal Aneurysm Repair

Elective abdominal aortic aneurysm repair in patients with a cancer diagnosis is associated with several poor postoperative outcomes, according to a newly published study from researchers at the University of Missouri School of Medicine. Roush et al reported their findings in the Journal of...

issues in oncology
immunotherapy

Gut Microbiome May Alter Response to Cancer Therapy

Recent findings with the use of sequencing technology have suggested that the gut microbiome may play a role in the treatment of cancer. A review paper published in JAMA Oncology by Liu and Shah captured the current understanding of the connection between the gut microbiome and therapeutic response ...

breast cancer

Improved Long-Term Quality-of-Life Measures in Women Undergoing Breast Conservation vs Mastectomy and Reconstruction for Early Breast Cancer

In a study reported in JAMA Surgery, Hanson et al found no difference in long-term satisfaction with breasts among women with early breast cancer who underwent breast-conserving surgery with radiation therapy vs mastectomy and breast reconstruction without radiation therapy. Women who underwent...

issues in oncology

How to Get the Dose Right

OCE Insights is an occasional column developed for The ASCO Post by members of the Oncology Center of Excellence (OCE) at the U.S. Food and Drug Administration (FDA). In this installment, Mirat Shah, MD, of the Office of Oncologic Diseases, Center for Drug Evaluation and Research, FDA; Atiqur...

gynecologic cancers

SORAYA Trial: Mirvetuximab Soravtansine Improves Response Rate in Drug-Resistant Ovarian Cancer

The novel antibody-drug conjugate mirvetuximab soravtansine could become the new standard of care for patients with folate receptor alpha–positive, platinum-resistant ovarian cancer, according to data presented at the Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer.1...

breast cancer

Preoperative Radiotherapy and DIEP Flap Reconstruction in Women Requiring Mastectomy for Breast Cancer

In the PRADA study—reported by Thiruchelvam et al in The Lancet Oncology—researchers found that a strategy of preoperative radiotherapy and deep inferior epigastric perforator (DIEP) flap reconstruction was feasible and safe in women requiring mastectomy for breast cancer. As stated by the...

prostate cancer

Overall Survival in the ARCHES Trial: Addition of Enzalutamide to ADT for Metastatic Hormone-Sensitive Prostate Cancer

As reported in the Journal of Clinical Oncology by Andrew J. Armstrong, MD, ScM, and colleagues, the final overall survival analysis of the phase III ARCHES trial showed a significant benefit with the addition of enzalutamide to androgen-deprivation therapy (ADT) in patients with metastatic...

issues in oncology

Timothy A. Yap, MBBS, PhD, on Developing Novel Therapeutic Strategies to Target DNA Damage Response in the Clinic

Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses how research is building on the success of first-generation PARP inhibitors in the clinic and the potential of novel potent PARP1-selective inhibitors, which may lead to improved patient outcomes. Given...

solid tumors

Timothy A. Yap, MBBS, PhD, on Advanced Solid Tumors With DNA Damage Response Defects: Early Data on Elimusertib

Timothy A. Yap, MBBS, PhD, of The University of Texas MD Anderson Cancer Center, discusses results from a phase Ib expansion trial of the safety and efficacy of the oral ataxia telangiectasia and Rad3-related (ATR) inhibitor elimusertib in advanced solid tumors with DNA damage response defects....

hepatobiliary cancer
gastroesophageal cancer
genomics/genetics

Assessment of Cancer Risk Profile for Germline BRCA1 and BRCA2 Pathogenic Variants in Patients With Common Cancers

In a Japanese case-control study reported in JAMA Oncology, Momozawa et al found that germline BRCA1/2 pathogenic variants were associated with an increased risk of biliary tract, esophageal, and gastric cancers, in addition to an increased risk of cancers that have well-established associations...

prostate cancer

High-Dose Radiotherapy With Short- vs Long-Term Androgen Deprivation in Localized Prostate Cancer

As reported in The Lancet Oncology by Zapatero et al, 10-year results of the Spanish phase III DART 01/05 trial did not support the 5-year findings of significantly improved biochemical disease–free, metastasis-free, and overall survival with long-term vs short-term androgen deprivation plus...

gynecologic cancers

Fuzuloparib Maintenance Therapy in Patients With Platinum-Sensitive Recurrent Ovarian Carcinoma

In an interim analysis of a Chinese phase III trial (FZOCUS-2) reported in the Journal of Clinical Oncology, Li et al found that maintenance treatment with the poly (ADP-ribose) polymerase (PARP) inhibitor fuzuloparib significantly prolonged progression-free survival vs placebo in patients with...

genomics/genetics

Maternal Malignancies May Be Identified Through Noninvasive Prenatal Test Results

In a Dutch study reported in the Journal of Clinical Oncology, Heesterbeek et al found that results of noninvasive prenatal testing for fetal aneuploidy screening using cell-free DNA derived from maternal plasma raised suspicion of maternal malignancy in a very small proportion of pregnant women....

Expert Point of View: Angela DeMichele, MD, MSCE

Abstract discussant, Angela DeMichele, MD, MSCE, the Alan and Jill Miller Professor in Breast Cancer Excellence at the Perelman School of Medicine of the University of Pennsylvania, Philadelphia, complimented the study design and conduct of the ABC trial while exploring several possible...

Expert Point of View: Amit M. Oza, MD, MBBS

The invited discussant of the phase III ­ENGOT-EN5/GOG-3055/SIENDO trial was Amit M. Oza, MD, MBBS, Head of the Division of Medical Oncology & Hematology at University Health Network/Mount Sinai, Director of Clinical Research and Clinical Cancer Research Unit at Princess Margaret Hospital, and ...

breast cancer

New Factors That Can Predict Breast Cancer Recurrence Identified

Genetics and other factors that can determine if a woman is at risk for a recurrence of breast cancer have been identified by investigators at Georgetown Lombardi Comprehensive Cancer Center, providing new research avenues for preventing a new tumor from developing. The discovery was made possible...

lung cancer

CHOICE-01: Toripalimab Plus Chemotherapy Improves Survival in Advanced NSCLC Without Actionable Mutations

Adding the PD-1 inhibitor toripalimab to chemotherapy significantly improved survival compared with chemotherapy alone in patients with advanced non–small cell lung cancer (NSCLC) without EGFR/ALK mutations, according to research presented during the 2022 ASCO Monthly Plenary Series.1 At the...

breast cancer

Internal Mammary Node Irradiation in Node-Positive Early Breast Cancer: 15-Year Outcomes

As reported in the Journal of Clinical Oncology by Thorsen et al, 15-year follow-up of the Danish Breast Cancer Group Internal Mammary Node study indicates continued survival benefit with internal mammary node irradiation in women with right breast tumors vs without such therapy in those with left...

Virtual Panel Explores Impact of Racism on the Cancer Burden Facing Asian Americans

On July 21, 2021, the Oncology Center of Excellence at the U.S. Food and Drug Administration (FDA) convened a panel discussion entitled “Conversations on Cancer” to address the significant cancer disparities facing Asian Americans. The virtual “conversation” focused on the unfair burden impacting...

breast cancer

Role of 21-Gene Recurrence Score and Preoperative Endocrine Therapy Response in Guiding Treatment in Early Hormone Receptor–Positive, HER2-Negative Breast Cancer

In a German trial (WSG-ADAPT-HR1/HER2–) reported in the Journal of Clinical Oncology, Nitz et al found no difference in invasive disease-free survival between women with early hormone receptor–positive, HER2-negative breast cancer with zero to three positive nodes who had a 21-gene recurrence score ...

breast cancer

Breast Cancer Screening With Digital Breast Tomosynthesis Plus Synthesized Mammography vs Digital Mammography

In the German TOSYMA trial reported in The Lancet Oncology, Heindel et al found that screening with digital breast tomosynthesis plus synthesized mammography was superior in detecting invasive breast cancer vs standard digital mammography. As stated by the investigators, “Two-dimensional (2D)...

thyroid cancer

Association of Preexisting Thyroid Autoimmunity With Risk of Papillary Thyroid Cancer

In a case-control study among U.S. active-duty personnel reported in the Journal of Clinical Oncology, McLeod et al found that preexisting thyroid autoimmunity was associated with an increased risk of developing papillary thyroid cancer.  The study included 451 randomly selected personnel serving...

breast cancer
health-care policy

Race/Ethnicity Mortality Disparity in Patients With De Novo Stage IV Breast Cancer: Effect of Medicaid Expansion

In a study reported in JAMA Oncology, Malinowski et al found that Medicaid expansion resulted in a reduction in the racial and ethnic disparities in mortality among patients with de novo stage IV breast cancer. As stated by the investigators, “Patients who are uninsured and belong to racial and...

issues in oncology

Diagnosis of Cancer Within 30 Days After Emergency Hospital Admission

In an International Cancer Benchmarking Partnership study reported in The Lancet Oncology, McPhail et al identified the proportions of cancer diagnoses made within 30 days after emergency presentation and hospital admission. They also analyzed risk factors and outcomes for such diagnoses in a group ...

head and neck cancer
health-care policy

Effect of Changes to California Medicaid Dental Benefits on Earlier Diagnosis of Oral Cavity Cancer

In a study reported in a research letter in JAMA Oncology, Kana et al found that changes to Medicaid dental benefits in California from comprehensive to emergency services—and then back to comprehensive—were associated with reduced, then increased, percentages of cases of oral cavity cancer...

solid tumors

Factors Contributing to Mortality and Second Cancer Incidence After Treatment for Testicular Cancer

In a Norwegian study reported in the Journal of Clinical Oncology, Fosså et al identified factors associated with increased mortality and second cancer risk among testicular cancer survivors, including treatment factors and modifiable adverse health outcomes. Study Details The study included data...

Break Through Cancer Announces $50 Million in Grants to Researchers From Five Top Cancer Research Centers

Today, 1 year after its founding, Break Through Cancer announced $50 million in grants to support several cutting-edge research projects using a novel “TeamLab” structure—designed to maximize interdisciplinary collaboration among researchers at Dana-Farber Cancer Institute, Sidney Kimmel...

multiple myeloma

Association of MRD Status With Outcomes After Autologous Stem Cell Transplantation for Multiple Myeloma

In an analysis from the UK phase III MYELOMA XI trial reported in the Journal of Clinical Oncology, de Tute et al found that persistent measurable residual disease (MRD)-negative status after autologous stem cell transplantation (ASCT) and conversion from MRD-positive to -negative status were...

solid tumors

Therapies Targeting DNA Damage Response Show Antitumor Activity

Results from two early-stage clinical trials show two drugs that target the DNA damage response (DDR) pathway in cancers—the ATR inhibitor elimusertib and the PARP inhibitor AZD5305—are safe and clinically beneficial in treating patients with advanced solid tumors. Principal investigator Timothy...

breast cancer
colorectal cancer
immunotherapy

Researchers Seek to Expand Immunotherapy Options for Patients With Advanced Breast and Colorectal Cancers

Two presentations given at the American Association for Cancer Research (AACR) Annual Meeting 2022 focused on promising strategies for making breakthrough immunotherapies work for more patients. Both studies report findings from clinical trials that advance a novel immunotherapy platform in...

breast cancer
supportive care

Longitudinal Patterns of Fatigue After Breast Cancer Diagnosis and Treatment

In an analysis from the French prospective CANTO study reported in the Journal of Clinical Oncology, Vaz-Luis et al identified three trajectory groups for the risk of severe global fatigue over time among women treated for breast cancer, consisting of a high-risk group, deteriorating group, and...

solid tumors
genomics/genetics

Selumetinib in Children and Young Adults With Tumors That Have Activating MAPK Pathway Alterations

In a phase II trial (arm E of the NCI-COG Pediatric MATCH trial) reported in the Journal of Clinical Oncology, Eckstein et al found that the MEK inhibitor selumetinib showed little activity in pediatric and young adult patients with tumors harboring activating MAPK pathway mutations or fusions. As...

skin cancer
genomics/genetics

Turnaround Times in Melanoma BRAF Testing and Effect on Time to Treatment Initiation

In a single-center study reported in JCO Oncology Practice, Ceballos et al identified turnaround times for request and receipt of melanoma BRAF testing results. They also analyzed factors in differences in turnaround times and effects on time to initiation of treatment. The study included 66...

breast cancer

Risk of Cardiovascular Disease and Mortality in Women With Breast Cancer: The Pathways Heart Study

In an analysis from the prospective cohort Pathways Heart Study reported in the Journal of Clinical Oncology, Heather Greenlee, ND, PhD, and colleagues found that breast cancer survivors were at increased risk of cardiovascular disease and mortality compared with women without breast cancer, with...

kidney cancer
immunotherapy

Biomarker-Driven Assessment of Nivolumab, Nivolumab/Ipilimumab, and VEGFR Tyrosine Kinase Inhibitors in First-Line Treatment of Metastatic Clear Cell RCC

In the French phase II BIONIKK trial reported in The Lancet Oncology, Vano et al assessed outcomes of first-line treatment with nivolumab with or without ipilimumab and VEGFR tyrosine kinase inhibitors given according to characteristics of molecular subgroups in patients with metastatic clear cell...

head and neck cancer

Association of Pretreatment Lymphocyte Count With Overall Survival and Benefit of Addition of Cisplatin to Radiotherapy in Oropharyngeal Squamous Cell Carcinoma

In a UK observational cohort study reported in the Journal of Clinical Oncology, Price et al found that pretreatment absolute lymphocyte count (ALC) was associated with overall survival and predictive of benefit of the addition of cisplatin to radiotherapy in patients with oropharyngeal squamous...

issues in oncology

FDA Issues New Draft Guidance to Industry for Developing Plans to Enroll Participants From Underrepresented Racial and Ethnic Populations

Recently, the U.S. Food and Drug Administration (FDA) issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the United States into clinical trials—expanding on the agency’s previous guidances for industry to...

prostate cancer

Accounting for Genetic Factors That Cause Normal Variations in PSA Levels May Improve the Accuracy of Prostate Cancer Detection

The accuracy of prostate-specific antigen (PSA) screening for prostate cancer could be improved by accounting for genetic factors that cause changes in PSA levels not associated with cancer, according to data presented by Kachuri et al during the American Association for Cancer Research (AACR)...

leukemia

Study Examines Disparities in Relapse Among Pediatric Patients With ALL

According to a large multiethnic study presented by Sok et al at the American Association for Cancer Research (AACR) Annual Meeting 2022, Latinx children with acute lymphoblastic leukemia (ALL) and measurable residual disease (MRD)-negative status were more likely to relapse compared with...

colorectal cancer
covid-19

Maria Elena Martinez, PhD, MPH, on Colorectal Cancer Screening in Underserved Populations: COVID, Silver Linings, and Challenges Ahead

Maria Elena Martinez, PhD, MPH, of the University of California, San Diego Moores Cancer Center, provides an overview of the key components of the Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science program, challenges posed by the COVID-19 pandemic, and...

lung cancer

Sotorasib Achieves Durable Responses in KRAS G12C–Mutated Lung Cancer

Sotorasib, the first KRAS G12C inhibitor approved for the treatment of KRAS G12C–mutated non–small cell lung cancer (NSCLC), continues to demonstrate meaningful and durable efficacy at 2-year follow-up in the phase II CodeBreaK 100 trial. At a median follow-up of 15.3 months, 2-year overall...

global cancer care
covid-19

Pediatric Patients With Cancer in Lower- and Middle-Income Countries Faced a Significantly Higher Mortality Risk During the COVID-19 Pandemic

During the first 9 months of the COVID-19 pandemic, patients with pediatric cancer from lower- and middle-income countries faced a higher risk of all-cause mortality than those in high-income countries, according to data presented by Elhadi et al at the American Association for Cancer Research...

kidney cancer

Deciphering Clinical Outcomes Through Molecular Profiling: The IMmotion151 Trial

Over the past decade, an improved understanding of kidney cancer biology together with the development of novel systemic therapies have substantially improved the outcomes of patients with metastatic clear cell renal cell carcinoma (RCC).1 Following extensive clinical investigations, combinations...

issues in oncology

Reflections on the Evolution of Clinical Care Since the Passage of the National Cancer Act of 1971

Recently, I had the honor of coauthoring a chapter with Eric P. Winer, MD, President-Elect of ASCO, on the evolution of clinical cancer care since the enactment of the National Care Act of 1971 for the book A New Deal for Cancer: Lessons From a 50-Year War, by Abbe R. Gluck and Charles S. Fuchs,...

The Hamoui Foundation and LUNGevity Foundation Present Awards for RET-Positive Lung Cancer Research

The Hamoui Foundation and LUNGevity Foundation recently announced the 2022 recipients of the first The Hamoui Foundation/LUNGevity Clinical Research Award for RET-Positive Lung Cancer. RET is a driver mutation found in approximately 1% to 2% of people with non–small cell lung cancer. The goal of...

Improving Oral Anticancer Therapy Adherence, a Call to Action, and an Upcoming FDA-ASCO Workshop

In a recently published paper in the Journal of Clinical Oncology,1 R. Donald Harvey, PharmD, BCOP, FCCP, FHOPA, of Emory University, Atlanta, and coleagues reflected on the growth in availability of oral anticancer therapies over the past decade and noted that as these treatments are easy to take ...

bladder cancer
immunotherapy

Second-Line Combination Study in Urothelial Cancer

The combination of the antibody-drug conjugate sacituzumab govitecan-hziy and the immune checkpoint inhibitor pembrolizumab yielded antitumor activity as second-line therapy in patients with platinum-refractory, checkpoint inhibitor–naive, metastatic urothelial cancer, according to the results of...

covid-19
hematologic malignancies

Research Finds COVID-19 Vaccine Protects Most Patients With Cancer, but Risk Remains Higher for Patients With Blood Cancers

Using the nation’s largest COVID-19 data resource, a research team found that the COVID-19 vaccine offered protection for most patients with cancer. However, patients with certain types of cancer—especially those with hematologic malignancies—had a higher and widely varied risk of breakthrough...

breast cancer

Prognostic Value of sTILs in Young Women With Node-Negative Triple-Negative Breast Cancer Who Did Not Receive (Neo)Adjuvant Systemic Therapy

In a Dutch retrospective study reported in the Journal of Clinical Oncology, de Jong et al found that higher levels of stromal tumor-infiltrating lymphocytes (sTILs) were associated with “excellent prognosis” in young women with node-negative triple-negative breast cancer who did not receive...

gastroesophageal cancer
immunotherapy

EGFR Inhibition in EGFR-Amplified Advanced Gastroesophageal Cancer

As reported in the Journal of Clinical Oncology by Maron et al, a retrospective study found that use of EGFR inhibitor therapy was associated with benefit in patients with unresectable or metastatic EGFR-amplified gastroesophageal adenocarcinoma. As stated by the investigators, “Subset analyses...

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