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lung cancer

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...

breast cancer

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 ...

FDA Clinical Trial Guidances Share Biden Administration’s Goals for Advancing Development of Cancer Treatments

The U.S. Food and Drug Administration (FDA) has issued three final guidances to industry regarding cancer clinical trials that parallel the goals of President Biden’s recently announced effort to renew and build upon his 2016 Cancer Moonshot initiative. Both endeavors aim to facilitate continued...

hematologic malignancies

FDA Approves Pacritinib for Adult Patients With Myelofibrosis and Thrombocytopenia

On February 28, the U.S. Food and Drug Administration (FDA) approved pacritinib (Vonjo) for the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L. Pacritinib is a...

multiple myeloma
immunotherapy

FDA Approves Ciltacabtagene Autoleucel for Relapsed or Refractory Multiple Myeloma

On February 28, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel (Carvykti) for the treatment of adults with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 ...

head and neck cancer

Phillip Pifer, MD, PhD, on Head and Neck Squamous Cell Carcinoma: New Data on Focal Adhesion Kinase

Phillip Pifer, MD, PhD, of the UPMC Hillman Cancer Center, discusses findings that suggest focal adhesion kinase is a potentially important target for therapeutic sensitization in patients with mutant TP53 HPV-negative head and neck squamous cell carcinoma.

head and neck cancer

Biomarker Test May Predict Recurrence of HPV-Driven Oropharyngeal Cancer

A large, multi-institutional study demonstrated that a blood test to detect circulating tumor DNA may accurately predict recurrence of human papillomavirus (HPV)-driven oropharyngeal cancer following treatment. Results also indicated that the biomarker test may detect recurrent disease earlier than ...

lymphoma
immunotherapy

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...

multiple myeloma
immunotherapy

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...

lung cancer

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...

Expert Point of View: Amy Tiersten, MD, and Carlos L. Arteaga, MD

Amy Tiersten, MD, Professor of Medicine, Hematology, and Medical Oncology, Icahn School of Medicine at Mount Sinai, and Carlos L. Arteaga, MD, Director of the Simmons Comprehensive Cancer Center and Associate Dean of Oncology at The University of Texas Southwestern Medical Center, Dallas,...

breast cancer

PADA-1 Trial: With Early Identification of ESR1 Mutation, Switch to Fulvestrant in Metastatic Breast Cancer

Switching from an aromatase inhibitor to fulvestrant upon early identification of the ESR1 mutation in plasma—before disease progression—doubled progression-free survival in the phase III PADA-1 trial, presented at the 2021 San Antonio Breast Cancer Symposium.1 “PADA-1 is the first trial to...

breast cancer

EMERALD Trial: Oral Selective Estrogen Receptor Degrader as Second- or Third-Line Therapy for Advanced Breast Cancer

Use of the first investigational oral selective estrogen receptor degrader (SERD) elacestrant significantly reduced the risk of death or disease progression and lengthened progression-free survival compared with standard-of-care endocrine therapy with fulvestrant or an aromatase inhibitor in...

Expert Point of View: Charles Shapiro, MD

Charles Shapiro, MD, Professor of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, commented on the study findings. “MA.32 is a large, randomized placebo-controlled trial of metformin in over 3,600 women with invasive breast cancer. The rationale for...

breast cancer

Metformin Added to Standard Adjuvant Chemotherapy Fails to Improve Outcomes in Early Breast Cancer

The addition of metformin, a drug commonly used to treat type 2 diabetes, to standard adjuvant treatment failed to improve invasive disease–free survival or overall survival for hormone receptor–positive or –negative breast cancer, according to the results of a large landmark trial led by the...

Expert Point of View: Matthew J. Ellis, MB, BChir, PhD, FACP

The final results of the phase III PALLAS trial1 are “deeply disappointing,” said session moderator Matthew J. Ellis, MB, BChir, PhD, FACP, Professor of Medicine and Director of the Lester and Sue Smith Breast Center at Baylor College of Medicine. The results of the final primary analysis of...

breast cancer

Final Analysis of PALLAS Trial: No Benefit of Adjuvant Palbociclib Plus Endocrine Therapy in Early Breast Cancer

The final protocol-defined analysis of the phase III PALLAS trial confirmed the negative results of the second interim analysis, showing no benefit of palbociclib plus endocrine therapy in the adjuvant breast cancer setting. Michael Gnant, MD, of the Medical University of Vienna, reported these...

Expert Point of View: Anne Blaes, MD

Invited discussant Anne Blaes, MD, of the University of Minnesota, Minneapolis, emphasized the main takeaway finding of the combined updated analysis of the SOFT and TEXT trials. “In early-stage estrogen receptor–positive breast cancer, premenopausal women who don’t require chemotherapy do very...

Evidence Supports Ovarian Function Suppression Plus Aromatase Inhibitor in Premenopausal Women With Early Breast Cancer

The benefits of ovarian function suppression were sustained long term for premenopausal women with hormone receptor–positive breast cancer, according to updates from SOFT and TEXT, two randomized, controlled trials, presented at the 2021 San Antonio Breast Cancer Symposium.1 A separate large...

Expert Point of View: David Cescon, MD, PhD

David Cescon, MD, PhD, Clinician Scientist at the Princess Margaret Cancer Centre in Toronto, Canada, was the invited discussant of the two MONALEESA analyses.1,2 He noted that the most recent overall survival analysis, presented at the European Society for Medical Oncology (ESMO) Congress 2021,...

breast cancer

MONALEESA Analyses Show Widespread Benefit for Ribociclib in Hormone Receptor–Positive, HER2-Negative Breast Cancer

Further analyses of the MONALEESA metastatic breast cancer trials have shown that the benefit of ribociclib plus endocrine therapy in the first-line setting extends to most intrinsic molecular subtypes and is consistent across multiple subgroups. The studies were presented at the 2021 San Antonio...

Expert Point of View: Anne Blaes, MD, MS, and Virginia Kaklamani, MD

Commenting on the update of RxPONDER presented at the 2021 San Antonio Breast Cancer Symposium were Anne Blaes, MD, MS, Associate Professor of Hematology/Oncology at the University of Minnesota and Co-Director of the Screening, Prevention, Etiology and Cancer Survivorship Program at the Masonic...

breast cancer

RxPONDER Update Explores Benefit of Chemotherapy in Subgroups

Updated results of the SWOG S1007 RxPONDER trial confirmed the key takeaway from the previous analysis: adjuvant chemotherapy benefits premenopausal women but not postmenopausal women with hormone receptor–positive, HER2-negative disease, one to three positive lymph nodes, and a 21-gene Oncotype DX ...

Expert Point of View: Angela DeMichele, MD, MSCE

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 in Philadelphia, commented on NIMBUS1 for The ASCO Post. She said obtaining information on tumor mutational burden is simple, as it is...

breast cancer

Dual Checkpoint Inhibitor Therapy Elicits Responses in Highly Mutated Breast Cancer

Patients with advanced HER2-negative metastatic breast cancer and high tumor mutational burden achieved responses—often durable—from treatment with the immunotherapy doublet of nivolumab and ipilimumab, according to the results of the phase II NIMBUS trial reported at the 2021 San Antonio Breast...

Expert Point of View: Hope S. Rugo, MD, FASCO

Invited discussant of the KEYNOTE-355 trial, Hope S. Rugo, MD, FASCO, one of the coauthors of the study, had presented the survival data at the European Society for Medical Oncology (ESMO) Congress 2021.1 The San Antonio presentation was a more in-depth evaluation of survival by different PD-L1...

breast cancer

Identifying Women With Triple-Negative Breast Cancer Who May Benefit From Pembrolizumab Plus Chemotherapy

Results of the phase III randomized KEYNOTE-355 trial showed that the addition of the PD-1 inhibitor pembrolizumab to investigator’s choice of first-line chemotherapy improved progression-free and overall survival in women with metastatic triple-negative breast cancer compared with placebo and...

Expert Point of View: Hope S. Rugo, MD, FASCO

The discussant of KEYNOTE-522 at the 2021 San Antonio Breast Cancer Symposium, Hope S. Rugo, MD, FASCO, Professor of Medicine and Director of Breast Oncology and Clinical Trials Education at the University of California San Francisco Comprehensive Cancer Center, commented: “We are clearly making...

breast cancer

KEYNOTE-522: Sensitivity Analyses Confirm Value of Neoadjuvant Pembrolizumab in Triple-Negative Breast Cancer

Updated results from the pivotal KEYNOTE-522 trial have confirmed the benefit of neoadjuvant therapy with pembrolizumab plus chemotherapy in patients with early triple-negative breast cancer.1 The results were presented at the 2021 San Antonio Breast Cancer Symposium by Peter Schmid, MD, PhD,...

Expert Point of View: Debu Tripathy, MD, and Hope S. Rugo, MD, FASCO

The ASCO Post asked Debu Tripathy, MD, Professor and Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, and Hope S. Rugo, MD, FASCO, Professor of Medicine, Director of Breast Oncology and Clinical Trials Education at the University of California San...

breast cancer

Datopotamab Deruxtecan Shows Activity in Advanced Triple-Negative Breast Cancer

Datopotamab deruxtecan, an antibody-drug conjugate directed against trophoblast cell surface antigen-2 (Trop-2), is showing activity as a treatment for relapsed or refractory advanced triple-negative breast cancer, according to early findings from the phase I TROPION-PanTumor01 trial presented...

breast cancer

Clinical Trials Underway for T-DXd in Breast Cancer

The current standard of care for the neoadjuvant treatment of HER2-positive early-stage breast cancer consists of trastuzumab plus pertuzumab and polychemotherapy. But some patients, particularly those with locally advanced or inflammatory disease, still relapse and die. Furthermore, multiagent...

Expert Point of View: Priyanka Sharma, MD

Priyanka Sharma, MD, of the University of Kansas Medical Center in Westwood, the invited discussant of the poster, noted that the DAISY study asked whether HER2-targeted antibody-drug conjugates—in this case, fam-trastuzumab deruxtecan-nxki (T-DXd)—have activity beyond the conventional...

breast cancer

T-DXd Shows Activity in HER2-Low, HER2-Undetectable Breast Cancer

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) has led to practice changes in previously treated HER2-positive metastatic breast cancer. Most notably, in the DESTINY-Breast03 trial, treatment with T-DXd produced a doubling in 12-month progression-free survival vs...

Expert Point of View: Ciara O’Sullivan, MB, BCh, BAO

Invited discussant Ciara O’Sullivan, MB, BCh, BAO, of Mayo Clinic, Rochester, Minnesota, commented on the DESTINY-Breast03 trial at the 2021 San Antonio Breast Cancer Symposium. “The treatment of HER2-positive disease is an evolving landscape, with eight approved agents. Despite this rapid...

breast cancer

Second-Line T-DXd Improves Progression-Free Survival Across HER2-Positive Metastatic Breast Cancer Subgroups

The antibody-drug conjugate fam-trastuzumab deruxtecan-nxki (T-DXd) lengthened progression-free survival and improved the objective response rate compared with the antibody-drug conjugate ado-trastuzumab emtansine (T-DM1) after trastuzumab and taxane therapy in women with HER2-positive metastatic...

breast cancer

Highlights From the 2021 San Antonio Breast Cancer Symposium

In its first return to a hybrid model since the COVID-19 pandemic began, the 2021 San Antonio Breast Cancer Symposium (SABCS) brought together researchers, clinicians, industry experts, patients, and advocates from across the globe to present and grapple with new data and important topics in breast ...

breast cancer

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...

leukemia

Study Identifies New Mutation That May Define Novel Pediatric AML Subtype

A new mutation was identified in 9% of relapsed cases of pediatric acute myeloid leukemia (AML) that may define a new subtype of the disease, according to a study published by Umeda et al in Blood Cancer Discovery. The mutation is a tandem duplication (a series of adjacent repeats of a DNA...

covid-19

Older Patients With Cancer and High-Risk Geriatric Profiles at Greater Risk for Death and Other Adverse Sequelae of COVID-19

In a large study of 5,671 older adults with COVID-19 and cancer, performed by the COVID-19 and Cancer Consortium (CCC19), the CCC19 geriatric risk index was associated with poorer outcomes, including clinical complications, hospitalization, and mortality. A higher CCC19 geriatric risk index was...

gastrointestinal cancer

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 ...

supportive care

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...

prostate cancer

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...

skin cancer

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...

covid-19

T-Cell Responses May Help Predict Protection Against SARS–CoV-2 Infection in Individuals With and Without Cancer

T-cell responses directed against the receptor-binding domain of the SARS–CoV-2 spike protein were associated with protection from SARS–CoV-2 infection in vaccinated individuals with or without cancer, with lower T-cell responses observed in patients with blood cancers, according to results from a...

lung cancer

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....

leukemia

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...

Jeffrey Peppercorn, MD, MPH, Named Editor-in-Chief of JCO Oncology Practice

Jeffrey Peppercorn, MD, MPH, has been appointed as the next Editor-in-Chief of the ASCO journal JCO Oncology Practice (JCO OP). The journal publishes impactful information and insights to keep oncology practice current on changes and challenges inherent in delivering equitable, high-quality...

solid tumors

Alfredo Berruti, MD, on Adrenocortical Carcinoma: Preliminary Study Results With Adjuvant Mitotane

Alfredo Berruti, MD, of Italy’s University of Brescia, discusses the first study to give adjuvant mitotane to patients with adrenocortical carcinoma, a rare disease with a high risk of relapse after radical surgery. Although theoretically this treatment may be clinically worthwhile, the findings...

solid tumors
immunotherapy

Hielke-Martijn de Vries, MD, on Penile Cancer: New Data on Atezolizumab and Radiotherapy

Hielke-Martijn de Vries, MD, of the Netherlands Cancer Institute, discusses phase II findings on the use of atezolizumab with or without radiotherapy for patients with advanced squamous cell carcinoma of the penis. The study was designed to address the poor prognosis for this disease by exploring...

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