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Showing 2251 - 2300Phase III Trials and Tribulations
Imagine this. You are a large pharmaceutical company that launches an international randomized phase III trial to assess whether one of your drugs improves the outcome of patients with a common type of cancer. The trial was solidly backed by preclinical evidence that the drug target was essential ...
CheckMate 816: Neoadjuvant Nivolumab Plus Chemotherapy in Resectable NSCLC
As reported in The New England Journal of Medicine by Forde et al, the phase III CheckMate 816 trial has shown improved pathologic complete response rate and event-free survival with the addition of nivolumab to platinum-based chemotherapy in the neoadjuvant treatment of resectable non–small cell...
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...
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 ...
Zev Wainberg, MD, on Gastroesophageal Junction Adenocarcinoma: Early Results With Anti-CD39 Antibody Plus Chemoimmunotherapy
Zev Wainberg, MD, of the University of California, Los Angeles Medical Center, discusses preliminary data on the safety and efficacy of TTX-030, an anti-CD39 antibody, in combination with budigalimab and FOLFOX for the first-line treatment of locally advanced or metastatic gastric or...
Study Shows Pemigatinib Activity in Treatment of Myeloid or Lymphoid Neoplasms With FGFR1 Rearrangement
In patients with myeloid or lymphoid neoplasms with FGFR1 rearrangements, pemigatinib produced high and durable response rates, despite patients’ extensive use of prior treatments or hematopoietic stem cell transplantation (HSCT), according to the early results of the multicenter phase II FIGHT-203 ...
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...
Ann S. LaCasce, MD, MMSc, on Relapsed/Refractory Indolent Follicular Lymphoma: Management Updates
Ann S. LaCasce, MD, MMSc, of Dana-Farber Cancer Institute, discusses the various agents available to treat patients with indolent B-cell lymphomas: lenalidomide plus rituximab, which has a superior progression-free survival profile compared with rituximab monotherapy; the PI3K inhibitors copanlisib ...
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...
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...
Association Between Venous Thromboembolism Risk and Blood Type
A new study published by Englisch et al in the journal Blood Advances suggests that people with cancer and non-O blood types—such as types A, B, and AB—may face an increased risk of developing venous thromboembolism (VTE) 3 months after their initial diagnosis. Scientists have long strived to...
In the Neoadjuvant Setting, Combination Immunotherapy With Durvalumab Is More Effective Than Durvalumab Alone for Early-Stage NSCLC
Combination immunotherapy with the anti–PD-L1 monoclonal antibody durvalumab and other novel agents outperforms durvalumab alone in the neoadjuvant setting for early-stage non–small cell lung cancer (NSCLC), according to research presented by Cascone et al at the American Association for Cancer...
New CAR T-Cell Therapy for Solid Tumors Was Safe and Showed Early Efficacy
A new chimeric antigen receptor (CAR) T-cell product had an acceptable safety profile and showed early signs of efficacy as a monotherapy and in combination with an mRNA vaccine in patients with solid tumors, according to preliminary data from a phase I/II clinical trial presented by Haanen et al...
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...
Meenakshi Anurag, PhD, on Breast Cancer: New Data on Combining Anastrozole and Fulvestrant
Meenakshi Anurag, PhD, of Baylor College of Medicine, discusses results from the ALTERNATE trial, which showed the combination of anastrozole plus fulvestrant was superior to either drug alone in inhibiting tumor proliferation in postmenopausal women with early-stage luminal B breast cancer...
Tina Cascone, MD, PhD, on NSCLC: New Findings From the NeoCOAST Trial on Durvalumab-Based Therapy
Tina Cascone, MD, PhD, of The University of Texas MD Anderson Cancer Center, discusses the findings of the phase II NeoCOAST study, which showed that combination immunotherapy with the anti–PD-L1 monoclonal antibody durvalumab and other novel agents resulted in numerically higher major pathologic...
Klaus Pantel, MD, on Liquid Biopsy Research: Opportunities and Challenges
Klaus Pantel, MD, of the University Medical Center Hamburg-Eppendorf, discusses liquid biopsy technologies and biomarkers, with a focus on circulating tumor cells and circulating tumor DNA; clinical applications such as early detection of cancer, improved staging, and surveillance of measurable...
An AI Model May Predict Elevated Pancreatic Cancer Risk Using Electronic Health Records
An artificial intelligence (AI) model trained using sequential health information derived from electronic health records identified a subset of individuals with a 25-fold risk of developing pancreatic cancer within 3 to 36 months, according to results presented by Placido et al at the American...
John B.A.G. Haanen, MD, PhD, on Solid Tumors: Early Study Results on CAR T Cells and the CARVac Vaccine Strategy
John B.A.G. Haanen, MD, PhD, of the Netherlands Cancer Institute, discusses findings from a phase I study designed to test the safety and efficacy of the CARVac (CAR-T cell-amplifying RNA vaccine) strategy to overcome poor CAR T-cell stimulation and responses in patients with CLDN6-positive...
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,...
Expert Point of View: Mark E. Robson, MD
“OlympiA is clearly a practice-changing trial, and olaparib should be offered to patients meeting the entry criteria for the study,” said Mark E. Robson, MD, Chief of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center, New York. Dr. Robson was invited to discuss the findings of...
OlympiA Trial: Adjuvant Olaparib Significantly Improves Overall Survival in Germline BRCA-Mutated Breast Cancer
The OlympiA trial of adjuvant olaparib in patients with HER2-negative, high-risk early-stage breast cancer and BRCA1 and BRCA2 mutations has now demonstrated a significant overall survival benefit, reducing the risk of death over placebo by 32% and yielding an absolute improvement of 3.8% at 3...
Congress Increases Federal Funding for Cancer Research
President Biden is soon expected to sign into law the Fiscal Year (FY) 2022 omnibus funding bill, which provides funding for all federal agencies through September 30, 2022. The bill was passed by the U.S. House of Representatives and the U.S. Senate during the week of March 7, 2022. The bill...
Rapid Guideline Revises Recommendations for Adjuvant Therapy in Patients With Early-Stage Lung Cancer
A rapid recommendation update to an ASCO guideline offers revised parameters for adjuvant therapy in patients with resected non–small cell lung cancer (NSCLC) who have stage IB to IIIA disease.1,2 The new guidance reflects the findings from two randomized clinical trials that assessed the use of...
ASCO Provisional Clinical Opinion Offers Guidance for Using and Interpreting Genomic Testing in Patients With Advanced Cancer
Somatic genomic testing should be a routine part of clinical care for many patients with metastatic or advanced solid tumors, according to a new ASCO provisional clinical opinion.1 As reported in the Journal of Clinical Oncology, the expert panel found that genomic testing in oncology practice has...
Leader in the Field of Integrative Oncology, Barrie Cassileth, PhD, Dies at 83
In 1999, Memorial Sloan Kettering Cancer Center (MSK) President Paul Marks, MD, recruited Barrie Cassileth, PhD, to establish an Integrative Medicine Service that “provided evidence-based complementary therapies that improve patients’ quality of life by alleviating physical and emotional symptoms...
AACR and MPM Oncology Charitable Foundation Announce Three Grants to Support Transformative Cancer Research
Three grants for research that could transform cancer therapies have been awarded by the AACR-MPM Oncology Charitable Foundation Transformative Cancer Research Grants Program, an innovative partnership between the American Association for Cancer Research (AACR) and the UBS Oncology Impact Fund...
Childhood Leukemia Pioneer, Donald P. Pinkel, MD, Dies at 95
When St. Jude Children’s Research Hospital was opened in 1962, childhood blood cancer, especially acute lymphoblastic leukemia (ALL), had an exceptionally grim prognosis. However, years of unflagging clinical research led by Donald P. Pinkel, MD, the pediatrician who developed an aggressive...
Conundrums of SARS–CoV-2 Infection in Cancer Care
The ASCO Post is pleased to present the Hematology Expert Review, an occasional feature that quizzes readers on issues in hematology. In this installment, Drs. Abutalib, Kröger, and Mikulska focus on the challenges of providing cancer care amid the COVID-19 pandemic. Here they present two...
Seven New Research Grants Awarded by The Prevent Cancer Foundation
The Prevent Cancer Foundation recently announced funding for seven scientists who are researching cancer prevention and early detection. Each scientist has been awarded $100,000 for 2 years. The following individuals are the 2022 research grantees: Sarah Bernhardt, PhD, Postdoctoral Fellow Oregon...
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 ...
Screening Platform May Contribute to Detection of Early-Stage Pancreatic Cancers, Other Malignancies
A novel screening platform flagged more than 95% of stage I pancreatic cancers, in addition to other early-stage malignancies, according to a pilot study published by Hinestrosa et al in Nature Communications Medicine. If validated by future studies, the approach may offer a new way to detect the...
Are Disadvantaged Patients Less Likely to Receive Advanced Radiotherapy Techniques for Head and Neck Cancer?
Advanced radiotherapy techniques may reduce the risk of severe and debilitating toxicity associated with radiation, but not all patients have equal access to these modalities, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.1 Retrospective analysis of the...
Protecting the Immunocompromised From COVID-19: Practical Information for Physicians
COVID-19 may have caught the world off guard in 2020, but in the 2 years since the pandemic began, several effective monoclonal antibodies and antiviral drugs have emerged to protect the most vulnerable patients. The ASCO Post spoke with Gunjan L. Shah, MD, a hematologic oncologist at Memorial...
Study Finds AI Ultrasound Platform Can Predict Thyroid Malignancy, Pathologic Stage, and BRAF Mutation Status
An artificial intelligence (AI) ultrasound platform that incorporates multiple methods of machine learning can accurately predict thyroid malignancy as well as pathologic and genomic outcomes, according to data presented at the 2022 Multidisciplinary Head and Neck Cancers Symposium.1 Findings from...
Advances in Managing Cardiac Side Effects Associated With Breast Cancer Treatment
Guideline-directed medical therapy for the prevention and treatment of cardiotoxicity is improving quality of life and oncologic outcomes associated with breast cancer treatment, according to Jean-Bernard Durand, MD, FACP, FCCP, FACC, FHFSA, Professor of Medicine at The University of Texas MD...
Collaboration Finds International Disparities in Screening, Treatment, and Outcomes for Patients With Lung Cancer
A consensus reached by a lung cancer clinical community within the International Cancer Benchmarking Partnership (ICBP) presented by Lynch et al at the European Lung Cancer Congress (Abstract 196P) has highlighted international disparities in the management and outcomes of patients with lung cancer ...
Transportation Barriers to Health Care Among Cancer Survivors in the United States
In a study reported in a research letter in JAMA Oncology, Changchuan Jiang, MD, MPH, and colleagues found that U.S. cancer survivors were more likely to report delays in health care due to transportation barriers than persons without a history of cancer, with the difference driven by barriers...
Emerging Endocrine Therapies for the Management of Breast Cancer
Novel hormonal therapies for breast cancer could provide additional therapeutic options for patients with hormone receptor–positive breast cancer. The emerging landscape for these new agents was described at the 2022 Miami Breast Cancer Conference, sponsored by PER, by Aditya Bardia, MD, MPH,...
Guideline-Concordant Surgery and Adjuvant Chemotherapy for Early-Stage NSCLC
In a retrospective cohort study reported in JAMA Oncology, Kenneth L. Kehl, MD, MPH, and colleagues found that only a slight majority of patients with early-stage non–small cell lung cancer (NSCLC) who were enrolled in a U.S. screening study (ALCHEMIST) received guideline-recommended adequate lymph ...
KRYSTAL-1: Adagrasib Controls Disease in Gastrointestinal Malignancies Beyond Colorectal Cancer
A disease control rate of 100% was achieved in gastrointestinal cancers treated with the KRAS G12C inhibitor adagrasib in the phase II KRYSTAL-1 trial, presented at the 2022 ASCO Gastrointestinal Cancers Symposium.1 The population included primarily those with pancreatic cancer; other noncolorectal ...
Expert Point of View: Anthony El-Khoueiry, MD
Anthony El-Khoueiry, MD, Member of the Section of Gastrointestinal Cancers, Director of the phase I program, and Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and USC Norris Comprehensive Cancer Center, said the findings of the...
HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma
Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....
COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma
The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...
Expert Point of View: Gabriel A. Brooks, MPH, MD
Gabriel A. Brooks, MPH, MD, Associate Professor of Medicine, Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, was invited to discuss the results of the ACCENT/IDEA database analysis of early treatment discontinuation in stage III colon cancer. Although the results confirm the...
Adjuvant Therapy for Colon Cancer: Impact of Stopping Treatment Early
For patients with stage III colon cancer, early discontinuation of adjuvant chemotherapy leads to worse outcomes—but early discontinuation of oxaliplatin did not. These findings, which came from an analysis of the large ACCENT and IDEA clinical trials databases, were presented at the 2022 ASCO...
Expert Point of View: Rona Yaeger, MD
Rona Yaeger, MD, Assistant Attending Physician at Memorial Sloan Kettering Cancer Center, New York, offered her thoughts on the findings of Morris et al for the combination regimen of encorafenib, cetuximab, and nivolumab in microsatellite-stable BRAF V600E–mutated metastatic colorectal cancer...
Gastrointestinal Oncology 2021–2022 Almanac
The past year has seen unprecedented progress across the spectrum of gastrointestinal malignances, including the advancement of immunotherapy and targeted molecular agents and the refinement of adjuvant therapy using novel as well as existing therapies. Three themes emerging from these reports are: ...
ASCO Provisional Clinical Opinion Offers Guidance for Using and Interpreting Genomic Testing in Patients With Advanced Cancer
Somatic genomic testing should be a routine part of clinical care for many patients with metastatic or advanced solid tumors, according to a new ASCO provisional clinical opinion.1 As reported in the Journal of Clinical Oncology, the expert panel found that genomic testing in oncology practice has...
Should Patients Aged 80 and Older Receive Single-Agent Immune Checkpoint Inhibitor Treatment?
The checkpoint inhibitors are among the most important advances in oncology in recent times. They have changed the natural history of many tumors, particularly melanoma. They have a favorable toxicity profile, which for most patients is manageable and tolerable. However, there are several...
