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Showing 501 - 550Updated Results From the ADAURA Trial: Continued Disease-Free Survival Benefit With Adjuvant Osimertinib vs Placebo in EGFR-Mutated Stage IB–IIIA NSCLC
As reported in the Journal of Clinical Oncology by Roy S. Herbst, MD, PhD, of Yale Cancer Center and Yale School of Medicine, and colleagues, updated findings in the phase III ADAURA trial showed continued disease-free survival benefit with adjuvant osimertinib vs placebo after complete resection...
Adding Talazoparib to Enzalutamide Extends Progression-Free Survival in Metastatic Castration-Resistant Prostate Cancer
The addition of the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib to the androgen receptor signaling inhibitor enzalutamide resulted in a statistically significant and clinically meaningful improvement in radiographic progression–free survival compared with placebo plus enzalutamide as...
Recent FDA Approvals for Patients With Breast Cancer
On this episode, we’re reviewing two recent U.S. Food and Drug Administration (FDA) approvals for patients with breast cancer: the February 3 approval of sacituzumab govitecan-hziy, and the January 27 approval of elacestrant.
Quick Takes on Important Cancer Research From ASH 2022
The high-energy vibe at the 2022 American Society of Hematology (ASH) Annual Meeting and Exposition reflected the welcomed presence of enthusiastic on-site attendees and the high quality of the research presented. The ASCO Post has already reported in detail on many of these presentations, and now...
New Study Highlights Impact of COVID-19 Pandemic on Cancer Screening Delays
Investigators have found further evidence to quantify the vast, lingering impact of the global COVID-19 pandemic on timely cancer screening—highlighting the urgent need for health-care providers to address significant delays to cancer screenings in populations most likely to delay testing,...
COVID-19 Outcomes Across Pandemic Phases in European Patients With Breast Cancer
In a study using data from the European OnCovid registry reported in the Journal of Clinical Oncology, Tagliamento et al found that the severity of COVID-19 infection in patients with breast cancer decreased during the Omicron variant phase of the pandemic. In addition, a full vaccine course...
ctDNA as a Prognostic Marker in Intermediate-Risk Rhabdomyosarcoma
In a study from the Children’s Oncology Group reported in the Journal of Clinical Oncology, Abbou et al found that measuring circulating tumor DNA (ctDNA) in intermediate-risk rhabdomyosarcoma was feasible and that the presence of ctDNA prior to treatment was associated with poorer prognosis. As...
Adjuvant Osimertinib Significantly Improves Disease-Free Survival for Patients With Resected EGFR-Mutant NSCLC
The EGFR tyrosine kinase inhibitor osimertinib may improve rates of disease-free survival and reduce the risk of recurrence in patients with resected, EGFR-mutant non–small cell lung cancer (NSCLC), according to a new exploratory analysis of the ADAURA trial published by Roy S. Herbst, MD, PhD,...
FDA Grants Accelerated Approval to Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma
On January 27, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib (Jaypirca) for patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. BRUIN Efficacy was...
FDA Approves Elacestrant for ER-Positive, HER2-Negative, ESR1-Mutated Advanced or Metastatic Breast Cancer
On January 27, the U.S. Food and Drug Administration (FDA) approved elacestrant (Orserdu) for postmenopausal women or adult men with estrogen receptor (ER)-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine...
Being on the Other Side: An Oncologist’s Perspective on Grieving
As an oncologist, I had cared for patients facing grave illness and death. I imagined the loss of loved ones and expected grief to be an unbearable sadness, most poignant in the earliest days and lessening with time. I somehow expected that counseling people who grieved would make me more prepared. ...
Study Explores the Addition of First-Line Atezolizumab in BRAF V600–Mutant Advanced Melanoma
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, of the Istituto Nazionale Tumori Istituto di Ricovero e Cura a Carattere Scientifico Fondazione Pascale, Naples, and colleagues, the second interim overall survival analysis of the phase III IMspire150 trial has shown a numeric but...
FDA Oncology Center of Excellence Seeks Applications for New Research Funding Opportunities
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, Julie A. Schneider, PhD, Associate Director for Research Strategy and Partnerships, OCE; Jennifer J. Gao, MD,...
Addition of Veliparib to Cisplatin in Advanced Triple-Negative Breast Cancer With BRCA-Like and Non–BRCA-Like Phenotype
In a phase II trial (S1416) reported in The Lancet Oncology, Rodler et al found that the addition of the poly (ADP-ribose) polymerase (PARP) inhibitor veliparib to cisplatin significantly improved progression-free survival in patients with germline BRCA1/2 wild-type advanced triple-negative breast...
Ibrutinib in the First-Line Treatment of Chronic GVHD
As reported in the Journal of Clinical Oncology by Miklos et al, the phase III iNTEGRATE trial showed no benefit of the addition of ibrutinib to prednisone in the first-line treatment of moderate or severe chronic graft-vs-host disease (GVHD) after allogeneic hematopoietic cell transplantation....
Anti-TIGIT Antibody May Boost the Benefit of Immunotherapy in Stage IV Lung Cancer
In a phase II study of stage IV non–small cell lung cancer (NSCLC), domvanalimab, a novel antibody that blocks T-cell immunoglobulin and ITIM domain (TIGIT), when added to anti–PD-1 zimberelimab immunotherapy resulted in improved response rates and progression-free survival compared with...
Olutasidenib for Relapsed or Refractory Acute Myeloid Leukemia With a Susceptible IDH1 Mutation
On December 1, 2022, the IDH1 inhibitor olutasidenib was approved for the treatment of adults with relapsed or refractory acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Abbott...
Futibatinib in Previously Treated Patients With Advanced FGFR2-Rearranged Intrahepatic Cholangiocarcinoma
In a phase II study (FOENIX-CCA2) published in The New England Journal of Medicine, Lipika Goyal, MD, and colleagues found that the next-generation, covalently binding FGFR1-4 inhibitor futibatinib showed activity in previously treated patients with unresectable or metastatic FGFR2-altered...
Tremelimumab-actl in Combination With Durvalumab for Unresectable Hepatocellular Carcinoma
On October 21, 2022, tremelimu-mab-actl was approved by the U.S. Food and Drug Administration (FDA) for use in combination with durvalumab in the treatment of unresectable hepatocellular carcinoma.1 Supporting Efficacy Data Approval was based on a comparison of overall survival in the...
ASH 2022: Multiple Myeloma Highlights
The 2022 American Society of Hematology (ASH) Annual Meeting and Exposition was full of interesting abstracts in multiple myeloma. In addition to full coverage of several important presentations, The ASCO Post offers readers quick takes on some studies that could be practice-changing and others...
Risk of Contralateral Breast Cancer Among Patients With Invasive Breast Cancer and Various Germline Pathogenic Variants
In a study reported in the Journal of Clinical Oncology, Yadav et al estimated the risk of contralateral breast cancer among patients with invasive breast cancer and germline pathogenic variants in ATM, BRCA1, BRCA2, CHEK2, and PALB2. Study Details The study population consisted of 15,104...
Neoadjuvant Gemcitabine/Cisplatin in High-Risk Upper Tract Urothelial Carcinoma
In a phase II trial reported in the Journal of Clinical Oncology, Coleman et al found that neoadjuvant split-dose gemcitabine and cisplatin produced a high rate of pathologic response in patients with high-risk localized upper tract urothelial carcinoma. The investigators also showed that...
Neoadjuvant Pembrolizumab in Localized MSI-H/dMMR Solid Tumors
In a single-center phase II trial reported in the Journal of Clinical Oncology, Ludford et al found that neoadjuvant pembrolizumab produced a high pathologic complete response rate and radiographic objective response rate in patients with localized microsatellite instability–high/mismatch...
Genomic Profile to Identify Candidates for Omission of Local Adjuvant Radiation Among Patients With Breast Cancer
In a study reported in the Journal of Clinical Oncology, Sjöström et al identified a 16-gene signature—Profile for the Omission of Local Adjuvant Radiation, or POLAR—that predicted low likelihood of benefit from adjuvant radiotherapy in preventing locoregional recurrence in patients with...
Addition of Adjuvant Nab-paclitaxel to Gemcitabine in Pancreatic Ductal Adenocarcinoma
As reported in the Journal of Clinical Oncology by Margaret A. Tempero, MD, and colleagues, the phase III APACT trial has shown no improvement in independently assessed disease-free survival (the study’s primary endpoint) with the addition of adjuvant nab-paclitaxel to gemcitabine in...
Mitomycin Gel for Upper Tract Urothelial Cancers: Postmarket Analysis
Researchers have performed the first postmarkert analysis of a novel delivery system of mitomycin—a gel formation, also known as UGN-101—to treat upper tract urothelial cancers, according to a novel study published by Woldu et al in Urologic Oncology. Their findings showcase how the treatment is...
Updated Data From a Phase II Trial of Triplet Therapy in HPV-Positive Cancers
Expanded interim data from a phase II clinical trial investigating PDS0101-based triple combination therapy in advanced human papillomavirus (HPV)-positive cancers were recently announced. The triple combination of PDS0101—a novel T-cell HPV-specific immunotherapy—with the tumor-targeting IL-12...
Updated Position Statement on Drug Repository Programs Aims to Increase Access to Treatment
ASCO recently released an updated position statement on drug repository programs. The update shifts ASCO’s position to allow donation of oral cancer drug treatments in an open distribution system—which are drugs that have left the supply chain and have been dispensed to patients. ASCO’s previous...
Nearly All Oncology Providers Report Prior Authorization Causing Delayed Care, Other Patient Harms
Prior authorization is harming individuals with cancer, according to new survey results from ASCO. The survey found that prior authorization delays necessary care, worsens cancer care outcomes, and diverts clinicians from caring for their patients. Nearly all survey participants reported a patient...
Mirvetuximab Soravtansine for FRɑ-Positive, Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Peritoneal Cancer
On November 14, 2022, the U.S. Food and Drug Administration (FDA) granted mirvetuximab soravtansine-gynx accelerated approval for patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three...
Chronic Myelomonocytic Leukemia: Treatment and Prognosis, Part 2
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In the concluding half of this two-part installment, which began in our November 25 issue, Drs. Syed Ali Abutalib and Mrinal M. Patnaik continue to explore the current...
Managing Severe Diarrhea in Patients With Cancer
Diarrhea in patients with cancer is a well-known phenomenon with clear guidelines for prevention and management. However, it remains a condition with poorly explored consequences and a lack of sufficient and fast-acting treatments. In a webinar presented by members of the Multinational Association...
Changing Landscape in the Management of High-Risk Lesions for Breast Cancer
As the population of women at increased risk for breast cancer grows, with an estimated 140,000 high-risk lesions diagnosed each year, “the landscape for surgical excision of high-risk lesions continues to evolve,” Melissa Pilewskie, MD, reported at the 2022 Lynn Sage Breast Cancer Symposium in...
How the American Cancer Society Aims to Improve Outcomes in Breast and Cervical Cancers and Reduce Health Disparities
Just days before the publication of the 2022 Annual Report to the Nation on the Status of Cancer on October 27, 2022,1 which showed a continued downward trend in cancer deaths, Karen Knudsen, MBA, PhD, Chief Executive Officer of the American Cancer Society (ACS), joined the First Lady Dr. Jill...
In Stage IV NSCLC, Anti-TIGIT Antibody Boosts Immunotherapy Benefit
In the phase II ARC-7 study, when domvanalimab, a novel antibody that blocks T-cell immunoglobulin and ITIM domain (TIGIT), was added to immunotherapy for patients with stage IV non–small cell lung cancer (NSCLC), the combination resulted in improved response rates and progression-free survival...
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...
Ivosidenib/Azacitidine for Newly Diagnosed IDH1-Mutant Acute Myeloid Leukemia in Patients Aged 75 or Older or With Comorbidities
On May 25, 2022, ivosidenib was approved for use in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by a U.S. Food and Drug Administration–approved test, in patients aged 75 or older or in those who have comorbidities precluding...
Tremelimumab Combined With Durvalumab and Platinum-Based Chemotherapy in Metastatic NSCLC
On November 10, 2022, tremelimu-mab in combination with durvalumab and platinum-based chemotherapy was approved for patients with metastatic non–small cell lung cancer (NSCLC) with no sensitizing EGFR mutation or ALK genomic tumor aberrations.1 Supporting Efficacy Data Approval was supported by...
Brentuximab Vedotin Combined With Chemotherapy in Pediatric Classical Hodgkin Lymphoma
On November 10, 2022, brentuximab vedotin was approved for use in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged ≥ 2 years with previously untreated high-risk classical Hodgkin lymphoma.1 Supporting Efficacy Data Approval was...
Adavosertib in Refractory Solid Tumors With CCNE1 Amplification
In a phase II trial reported in the Journal of Clinical Oncology, Fu et al found that the WEE1 kinase inhibitor adavosertib was active in patients with refractory solid tumors with CCNE1 amplification, with evidence of increased activity in epithelial ovarian cancer. Study Details In the trial, 30...
TIL Therapy vs Ipilimumab in Advanced Melanoma
In a Dutch-Danish phase III trial reported in The New England Journal of Medicine, Rohaan et al found that tumor-infiltrating lymphocyte (TIL) therapy prolonged progression-free survival vs ipilimumab in patients with advanced melanoma. Study Details The open-label trial included 168 patients...
Older or High-Risk Patients With Newly Diagnosed AML May Respond to Triplet Therapy
Researchers observed encouraging response rates in older or high-risk patients with newly diagnosed acute myeloid leukemia (AML) when treated with the triplet combination therapy of azacitidine, venetoclax, and magrolimab in a phase I/II trial, according to new findings presented by Daver et al at...
FDA Grants Approval to Atezolizumab in Treatment of Alveolar Soft-Part Sarcoma
On December 9, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft-part sarcoma (ASPS). Study ML39345 Efficacy was evaluated in Study ML39345...
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 (NCT03875235), in which...
Addition of First-Line Atezolizumab to Vemurafenib/Cobimetinib in BRAF V600–Mutant Advanced Melanoma
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, and colleagues, the second interim overall survival analysis of the phase III IMspire150 trial has shown a numeric but statistically nonsignificant improvement with the addition of first-line atezolizumab to vemurafenib and cobimetinib in ...
FDA Approves Olutasidenib for Relapsed or Refractory AML With a Susceptible IDH1 Mutation
On December 1, the U.S. Food and Drug Administration (FDA) approved olutasidenib (Rezlidhia) capsules for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. The FDA also approved the Abbott RealTime IDH1...
Study Finds Americans Have a Low Awareness of the Link Between Alcohol Use and Increased Cancer Risk
Research shows that all beverage types containing ethanol, including wine, beer, and hard liquor, increase cancer risk, and that the risk increases with higher alcohol consumption. Even light drinking—no more than one drink per day—increases the risk for some cancers, including esophageal and...
Novel Bispecific Antibody Zanidatamab in Advanced HER2-Expressing or HER2-Amplified Cancers
In a phase I dose-escalation and expansion study reported in The Lancet Oncology, Funda Meric-Bernstam, MD, and colleagues found that zanidatamab, a novel bispecific monoclonal antibody directed against two nonoverlapping domains of HER2, showed activity in locally advanced or metastatic...
Longer-Term Follow-up From ADAURA Supports Adjuvant Osimertinib as Standard of Care for EGFR-Mutated Stage IB to IIIA NSCLC
With longer-term follow-up, adjuvant treatment with osimertinib led to a 77% reduction in the risk of disease recurrence or death following complete resection vs placebo-treated patients with EGFR-mutated, stage II to IIIA non–small cell lung cancer (NSCLC). Disease-free survival was improved...
Chronic Myelomonocytic Leukemia: Treatment and Prognosis, Part 1
The ASCO Post is pleased to present Hematology Expert Review, an ongoing feature that quizzes readers on issues in hematology. In this installment, Drs. Syed Ali Abutalib and Mrinal M. Patnaik explore the current treatment and prognosis of chronic myelomonocytic leukemia. For each quiz question...
