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Showing 4401 - 4450Understanding Patient-Reported Outcomes in Cancer Trials: A Beginner’s Guide
Patient-reported outcomes are measures used in clinical trials to capture aspects of a patient’s health condition, reported directly by the patient, without introduction of bias from third parties. They are distinct from the physical toxicities reported by clinicians1 and are collected using a...
Highlights From ASH 2019 Included New Data in Leukemia, Lymphoma, Myeloma, and Myelodysplastic Syndromes
The 2019 American Society of Hematology (ASH) Annual Meeting & Exposition featured a cornucopia of sessions. It was impossible to attend all the lectures, symposia, oral presentations, poster presentations, and special events because many were concurrent. Below, we have selected some...
KEYNOTE-522: A Biomarker Resource for PD-1 Inhibition in Early Triple-Negative Breast Cancer
In the phase III KEYNOTE-522 trial reported in The New England Journal of Medicine and reviewed in this issue of The ASCO Post, Schmid et al1 found that the addition of pembrolizumab to neoadjuvant chemotherapy in stage II or III triple-negative breast cancer significantly improved the pathologic...
Neoadjuvant and Adjuvant Pembrolizumab Improves Outcomes in Early Triple-Negative Breast Cancer
As reported in The New England Journal of Medicine by Peter Schmid, MD, PhD, of Barts Cancer Institute, Queen Mary University of London, and colleagues, analyses in the phase III KEYNOTE-522 trial have shown that the addition of pembrolizumab to neoadjuvant chemotherapy and the use of adjuvant...
Addition of Olaparib to Bevacizumab Maintenance in Advanced Ovarian Cancer: PAOLA-1 Trial
As reported in The New England Journal of Medicine by Isabelle Ray‑Coquard, MD, PhD, of the Centre Leon Berard, University Claude Bernard Lyon 1 and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens (GINECO), Paris, and colleagues, the phase III PAOLA-1 trial has shown a...
Novel Treatment Strategies Under Study in Advanced Melanoma
Several novel strategies for the treatment of patients with stage III or IV melanoma showed promise in studies presented at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium.1,2 Vaccine for High-Risk Patients After Resection A tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine was...
New Guideline on Systemic Therapy for Melanoma Tackles Rapid Developments in Treatment Options
Systemic treatment of melanoma has changed rapidly since the introduction of ipilimumab in 2011. Newer therapies approved for melanoma since that time include immunotherapy, targeted therapy for mutation-bearing tumors, and injectional therapy for cutaneous or palpable lesions. ASCO has released...
PARP Inhibitors in Maintenance Treatment for Advanced Ovarian Cancer
Based on multiple phase III prospective trials, there is evidence that both PARP inhibitors and antiangiogenic therapies such as bevacizumab provide benefit when utilized in a maintenance strategy in the first-line treatment of advanced epithelial ovarian cancer (GOG 218, ICON7, SOLO-1, PRIMA,...
Grant A. McArthur, MBBS, PhD, on Melanoma: IMspire150 Trial of Atezolizumab, Cobimetinib, and Vemurafenib
Grant A. McArthur, MBBS, PhD, of the Peter MacCallum Cancer Centre, discusses phase III results from a study of previously untreated patients with BRAF V600 mutation–positive advanced melanoma. His team evaluated whether combining vemurafenib and cobimetinib with atezolizumab improved the...
Expert Point of View: Alexandra Leary, MD, PhD
Alexandra Leary, MD, PhD, of the Gustave Roussy Institute of Oncology, Paris, underscored the controversy surrounding the use of neoadjuvant chemotherapy in advanced ovarian cancer, suggesting the discord may be “more cultural and emotional than scientific” to some degree. “Some countries, such as ...
Chemoablation of Low-Grade Upper Tract Urothelial Cancer With Mitomycin-Containing Reverse Thermal Gel
In the single-arm phase III OLYMPUS trial reported in The Lancet Oncology, Kleinmann et al found that primary chemoablation of low-grade upper tract urothelial carcinoma using a mitomycin-containing reverse thermal gel (UGN-101) resulted in disease eradication in more than half of patients. As...
FAST-Forward Trial: Long-Term Outcomes With Adjuvant Hypofractionated Radiotherapy for 1 vs 3 Weeks in Early Breast Cancer
As reported in The Lancet by Brunt et al, 5-year findings from the phase III FAST-Forward trial indicated that adjuvant radiotherapy with 26 Gy in 5 fractions over 1 week was noninferior to 40 Gy in 15 fractions over 3 weeks in preventing local tumor relapse in women with early-stage breast ...
AACR 2020: Triplet Regimen Improves Progression-Free Survival in Advanced Melanoma in IMspire150 Trial
The addition of the checkpoint inhibitor atezolizumab to two targeted therapies (the BRAF inhibitor vemurafenib and the MEK inhibitor cobimetinib) as initial therapy improved outcomes compared with the two targeted therapies plus placebo in patients with newly diagnosed BRAF V600E/K–mutant advanced ...
Treating Colorectal Cancer in the Time of COVID-19
The treatment of colorectal cancer has always been something of an art—but never more so than during the COVID-19 pandemic. The ASCO Post asked three experts in this malignancy to share their concerns and their approaches to achieving good patient outcomes while minimizing the risk of COVID-19...
PROfound Trial: Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer and Homologous Recombination Repair Gene Alterations
In a phase III trial reported in The New England Journal of Medicine, Johann de Bono, MB, ChB, PhD, and colleagues found that olaparib significantly improved progression-free survival vs hormonal therapy in patients with metastatic castration-resistant prostate cancer who had alterations in the...
Lajos Pusztai, MD, PhD, on Breast Cancer: I-SPY2 Trial on Durvalumab, Olaparib, and Paclitaxel
Lajos Pusztai, MD, PhD, of Yale Cancer Center, discusses study results on durvalumab in combination with olaparib and paclitaxel as neoadjuvant treatment in patients with high-risk HER2-negative stage II/III breast cancer. Compared with patients who received chemotherapy alone, the combination...
FDA Pipeline: Priority Review in AML, Fast Track Designations for Pancreatic Cancer and Neuroendocrine Tumors
Over the past 2 weeks, the U.S. Food and Drug Administration (FDA) granted Priority Review to a treatment for acute myeloid leukemia (AML); Fast Track designations for agents in pancreatic cancer and pancreatic/nonpancreatic neuroendocrine tumors; approvals for companion diagnostic tests;...
Are There Racial Differences in Time to Treatment for Melanoma?
Black patients with stage I to III melanoma are likely to experience a longer delay from diagnosis to surgery than non-Hispanic white patients, according to a study published by Tripathi et al in the Journal of the American Academy of Dermatology. “We already knew that black patients with melanoma...
Avoiding Use of Prophylactic Peg-filgrastim During Paclitaxel Treatment in Dose-Dense Chemotherapy for Breast Cancer
In a phase II study reported in the Journal of Clinical Oncology, Vaz-Luis et al found that the use of a prespecified algorithm enabled the avoidance of routine peg-filgrastim prophylaxis during the paclitaxel portion of neoadjuvant or adjuvant treatment with dose-dense...
AACR 2020: I-SPY2 Trial: Durvalumab/Olaparib/Paclitaxel ‘Graduates’ in HER2-Negative Breast Cancer
The I-SPY2 trial found that the combination of the checkpoint inhibitor durvalumab, the PARP inhibitor olaparib, and the taxane paclitaxel followed by doxorubicin/cyclophosphamide as neoadjuvant therapy improved pathologic complete responses vs paclitaxel followed by doxorubicin/cyclophosphamide...
Radiation and Chemoradiation Interruption and Noncompletion in Squamous Cell Anal Carcinoma
In a Canadian study reported in JAMA Oncology, Raphael et al found that interruption and noncompletion of definitive radiation and chemoradiation for patients with squamous cell anal carcinoma were common, and that failure to complete radiation and chemoradiation was associated with poorer...
AACR 2020: Cell-Free DNA Liquid Biopsy May Provide an Early Detection Test for Patients With Suspected Cancer
The Circulating Cell-free Genome Atlas Study is a large multicenter, case-controlled, observational study of 15,254 participants, 56% with cancer and 44% without cancer, with longitudinal follow-up to support the development of a cell-free DNA (cfDNA) multicancer early detection test. In this phase ...
ASCO Shares New Clinical Trial Data, Initiatives, and Path Forward for Post–COVID-19 Cancer Care Delivery System
ASCO (the Society) and its affiliate organization the Association for Clinical Oncology (the Association) recently announced the results of a survey that tracked the initial impact of the COVID-19 pandemic on cancer clinical trials, highlighted a new research initiative to address the data gap on...
AACR 2020: ctDNA May Be a Prognostic Biomarker of Disease Recurrence in Patients With Lung Cancer
The TRACERx study investigated phylogenetic tracking and minimal residual disease (MRD) detection using circulating tumor DNA (ctDNA) profiling following resection in patients with stage I to III non–small cell lung cancer (NSCLC). Investigators found that ctDNA is an adjuvant biomarker capable of...
AACR 2020: Final Overall Survival Results From the Phase III EMBRACA Trial
New data from the phase III EMBRACA trial showed the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib did not produce a statistically significant overall survival benefit for patients with locally advanced or metastatic HER2-negative germline BRCA-mutated breast cancer. Most patients...
Factors Potentially Associated With Progression of Advanced Small-Bowel Neuroendocrine Tumors After Multimodal Surgical Therapy
In a single-institution analysis reported in the journal Pancreas, Khetan et al found that age at diagnosis, perineural invasion, and elevated preoperative chromogranin levels may be associated with an increased risk of disease progression in patients with advanced grade 1 or 2 small-bowel...
Isatuximab-irfc for Previously Treated Multiple Myeloma
On March 2, 2020, the CD-38-directed cytolytic antibody isatuximab-irfc (Sarclisa) was approved for use in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor.1,2...
Actively Recruiting Clinical Trials Studying Multiple Myeloma
This Clinical Trials Resource Guide lists six actively recruiting clinical trials that focus on treating multiple myeloma. These studies, ranging from phase I to phase III, are evaluating the safety and efficacy of vaccines, cytotoxic T lymphocytes, and drug treatment regimens. Some studies center ...
Addition of Isatuximab to Pomalidomide and Dexamethasone in Relapsed and Refractory Multiple Myeloma
As reported in The Lancet by Michel Attal, MD, of the Institut Universitaire du Cancer Toulouse Oncopole, France, and colleagues, the phase III ICARIA-MM trial has shown that the addition of the CD38-targeted antibody isatuximab to pomalidomide and low-dose dexamethasone significantly improved...
ASCENT Study Halted: Efficacy Shown Across Multiple Study Endpoints in Triple-Negative Breast Cancer
The phase III confirmatory ASCENT study of the antibody drug-conjugate sacituzumab govitecan will be stopped based on efficacy across multiple study endpoints following unanimous recommendation from the independent data safety monitoring committee, according to a news release issued earlier this...
Beyond CDK4/6 Inhibitors: What Subsequent Treatment Is Best?
Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6) have changed the natural history of hormone receptor–positive metastatic breast cancer. While median progression-free survival on these drugs is approximately 27 months, the disease eventually progresses and clinicians must choose a subsequent ...
More Antibody-Drug Conjugates on the Horizon for Breast Cancer
Novel antibody-drug conjugates that target actionable cell-surface markers in metastatic breast cancer will soon expand the utility of the class that already includes ado-trastuzumab emtansine (T-DM1), according to two speakers at the 2020 Miami Breast Cancer Conference. These new agents were...
What’s the Current Status of Neoadjuvant Immunotherapy?
For several tumor types, can the successes achieved with immunotherapy in the metastatic and adjuvant settings be replicated in the neoadjuvant setting? An explosion in clinical trials—with more than 300 listed on ClinicalTrials.gov—point to “yes.” “The neoadjuvant use of immunotherapy is of great ...
Upfront Apalutamide Delays Time to Second Progression in Metastatic Castration-Sensitive Prostate Cancer
The addition of apalutamide to androgen-deprivation therapy (ADT) reduced the risk of second disease progression or death (PFS2) by 34% vs ADT alone in patients with metastatic castration-sensitive prostate cancer, in a post hoc analysis of the phase III TITAN trial presented at the 2020...
Study Finds Chemoradiation Plus Bevacizumab Safe and Feasible in Locally or Regionally Advanced Nasopharyngeal Cancer
The addition of bevacizumab to the current standard of care of chemoradiation therapy is safe and feasible for the treatment of locally or regionally advanced nasopharyngeal cancer, according to data presented at the 2020 Multidisciplinary Head and Neck Cancers Symposium.1 “I’m pleased to report...
FDA’s Draft Guidance Will Improve Evidence Base for Older Adults With Cancer
ASCO commends the U.S. Food and Drug Administration (FDA) for releasing draft guidance that encourages inclusion of older adults in clinical trials of drugs for the treatment of cancer. The guidance emphasizes the importance of including adults aged 75 or older in clinical trials to better enable...
ELEVATE-TN: Acalabrutinib With or Without Obinutuzumab vs Chlorambucil/Obinutuzumab in Patients With Previously Untreated CLL
As reported in The Lancet by Jeff P. Sharman, MD, and colleagues, the phase III ELEVATE-TN trial showed significantly improved progression-free survival with both acalabrutinib/obinutuzumab and acalabrutinib monotherapy vs chlorambucil/obinutuzumab in patients with treatment-naive chronic...
FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer
On April 22, the U.S. Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease. Sacituzumab govitecan-hziy is the first...
Hope S. Rugo, MD, on Talazoparib for Advanced Solid Tumors: Reduced Hospitalization and Supportive Care
Hope S. Rugo, MD, of the University of California, San Francisco, discusses an integrated analysis of five clinical trials, in phases I through III, for a variety of advanced cancers. Findings show that patients treated with talazoparib monotherapy had lower hospitalization rates (compared to those ...
Addition of Capecitabine to Taxane/Anthracycline Adjuvant Chemotherapy for Triple-Negative Breast Cancer
In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that the addition of capecitabine to taxane/anthracycline adjuvant therapy for triple-negative breast cancer was associated with improved disease-free survival. Study Details In the open-label multicenter...
First-Line Durvalumab With or Without Tremelimumab vs Chemotherapy for Metastatic NSCLC: MYSTIC Study
As reported in JAMA Oncology by Naiyer A. Rizvi, MD, and colleagues, the phase III MYSTIC trial showed no overall survival benefit with durvalumab vs chemotherapy, or overall or progression-free survival benefit with durvalumab/tremelimumab vs chemotherapy, as first-line treatment in patients with...
Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy in Early Breast Cancer
As reported in JAMA Oncology by Jayant S. Vaidya, MBBS, PhD, and colleagues, the phase III TARGIT-A trial showed that delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT) was not noninferior to whole-breast external-beam radiotherapy (EBRT) in preventing local recurrence of...
ASCO Releases New Guidance on Allocation of Limited Resources in the Oncology Community During COVID-19 Pandemic
ASCO has released a set of recommendations to support the oncology community as health-care institutions across the United States face potentially difficult decisions around the allocation of scarce health-care resources during the COVID-19 pandemic. In some geographic areas, the ongoing crisis is...
FDA Pipeline: Priority Reviews for Immunotherapy Based on Biomarker Status, Combination First-Line Therapy in Lung Cancer
Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to an immunotherapeutic agent for solid tumors with a high tumor mutational burden and to a combination treatment for the first-line treatment of metastatic or recurrent non–small cell lung cancer. The agency...
ASCO’s New COVID-19 Cancer Registry Aims to Understand Impact on Patients During Pandemic, Inform Future Care
On April 10, ASCO launched the ASCO Survey on COVID-19 in Oncology Registry (ASCO Registry) to help the entire cancer community learn about the pattern of symptoms and severity of COVID-19 among patients with cancer, as well as how COVID-19 infections impact the delivery of cancer care and patient...
‘Textbook Outcome’ in Patients Undergoing Resection of Pancreatic Neuroendocrine Tumors
In a study reported in the Journal of Surgical Oncology, Timothy M. Pawlik, MD, MPH, PhD, and colleagues found that approximately half of patients undergoing resection of pancreatic neuroendocrine tumors (PNETs) had a “textbook outcome”—a result associated with significantly improved disease-free...
R. Kate Kelley, MD: Breakthroughs for Hepatocellular Carcinoma
At the University of California, San Francisco School of Medicine, R. Kate Kelley, MD, contributes to research focused on improving outcomes for patients with hepatocellular carcinoma. The trial: This was a phase III study that included 707 patients who received sorafenib and had disease...
Living A Full Life After Pancreatic Cancer
I have been a radiologic technologist for 47 years, so after going to the bathroom one Sunday morning in October 2018 and finding my urine had suddenly turned dark, I knew something was wrong. I wasn’t in any pain and did not have a urinary tract infection, which would explain the discoloration of...
Highlights From Transplantation and Cellular Therapy Meetings of ASTCT and CIBMTR
The Combined Annual Meetings of the American Society for Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) were held in Orlando, Florida, from February 19–23, 2020. The scientific program addressed the most timely issues in ...
Updates From Selected Clinical Trials in Breast Cancer
Each year, The ASCO Post asks Jame Abraham, MD, FACP, Chairman of the Department of Hematology and Medical Oncology at Taussig Cancer Institute and Professor of Medicine at the Cleveland Clinic Lerner College of Medicine, to offer his picks for the most important research presented at 2019 San...
