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Showing 2151 - 2200FDA Approves Ripretinib for Previously Treated Patients With Advanced Gastrointestinal Stromal Tumor
On May 15, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. INVICTUS Trial Efficacy was...
FDA Approves Nivolumab/Ipilimumab for First-Line Treatment of Patients With Metastatic NSCLC and PD-L1 Tumor Expression ≥ 1%
On May 15, 2020, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) plus ipilimumab (Yervoy) as first-line treatment for patients with metastatic non–small cell lung cancer (NSCLC) whose tumors express programmed cell death ligand 1 (PD-L1) at ≥ 1%, as...
FDA Approves Pomalidomide for Kaposi Sarcoma
On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with acquired immunodeficiency syndrome (AIDS)-related Kaposi sarcoma after failure of highly active antiretroviral therapy and those with Kaposi...
Videoconference Intervention Can Reduce Levels of Anxiety and Distress Among Distance Caregivers
According to the National Alliance for Caregiving, the number of adult individuals in the United States providing care for patients with cancer ranges between 2.8 million and 6.1 million. Caregivers for patients with cancer who live more than 1 hour away report having higher levels of anxiety and...
Geriatrician Assessment and Integrated Care May Help Older Patients as Well as the Health-Care System
A full geriatric assessment and geriatrician-led multidisciplinary care improved the quality of life of patients aged 70 and older undergoing chemotherapy, targeted therapy, or immunotherapy, according to results of a prospective, randomized, controlled, open-label trial, reported in a press...
Expert Point of View: Don S. Dizon, MD, FACP, FASCO
Commenting on the SOLO2 trial for The ASCO Post was Don S. Dizon, MD, FACP, FASCO, Director of Women’s Cancers at Lifespan Cancer Institute and Professor of Medicine at Brown University, Providence, Rhode Island. “It’s great to get an overall survival advantage from a PARP inhibitor study. Coming...
Overall Survival Benefit Shown for Maintenance Olaparib in Ovarian Cancer
For the first time, overall survival has been improved with maintenance therapy involving a poly (ADP-ribose) polymerase (PARP) inhibitor in patients with platinum-sensitive recurrent ovarian cancer associated with BRCA1/2 mutations. In the final, preplanned, overall survival analysis in the...
Cancer vs COVID-19: Clinical Trial Research During the Pandemic
The COVID-19 pandemic transformed cancer care, seemingly overnight, as practices scrambled to ensure a safe environment for caregivers and patients. Although regulatory burdens have been relaxed to allow patients to continue on trial treatment and telemedicine has expanded its competency and reach, ...
AACR 2020: Continuous Dosing of Dabrafenib Plus Trametinib Improves Progression-Free Survival vs Intermittent Dosing in Advanced Melanoma
Continuous dosing with dabrafenib and trametinib improved progression-free survival in patients with BRAF-mutated advanced melanoma compared with an intermittent-dosing strategy, according to results of the phase II SWOG S1320 randomized trial reported at the opening Plenary Session of the 2020...
Understanding 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...
Pooled Analysis Supports Benefit of Dual HER2-Targeted Therapy, but Questions Remain
In the treatment of HER2-positive early breast cancer, patients who receive dual HER2-targeted therapy in both the neoadjuvant and adjuvant settings are less likely to experience recurrence than those who received dual therapy only as neoadjuvant treatment, according to a pooled analysis of...
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...
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...
Early Signs of Activity With Immunotherapies in Low-Incidence Cancers
Immunotherapy is showing promise for patients with rare cancers, offering new treatment opportunities and clinical trials to those with previously limited options. At the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium, presenters discussed the use of immunotherapy in three low-incidence cancers: ...
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...
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,...
FDA Approves Olaparib Plus Bevacizumab as Maintenance Treatment for Ovarian, Fallopian Tube, or Primary Peritoneal Cancers
On May 8, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of olaparib (Lynparza) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in...
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...
Dexrazoxane, Cardiac Function, and Treatment Outcomes in Pediatric AML
In a study reported in the Journal of Clinical Oncology, Getz et al found that use of dexrazoxane was associated with preservation of cardiac function in pediatric patients receiving front-line treatment for acute myeloid leukemia (AML) and resulted in no adverse effects on treatment outcomes. As...
Expert Point of View: Charles Sawyers, MD
“The hypothesis of combining kinase inhibitors with checkpoint inhibitors could be a fantastic idea,” said formal study discussant Charles Sawyers, MD, of Memorial Sloan Kettering Cancer Center, New York. “This trial [IMspire150] is positive, and that is great news. Triple therapy is superior to...
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 ...
AACR 2020: Atezolizumab Alone or in Combination With Cobimetinib for Biliary Tract Cancer
A randomized multicenter study of a combination of immunotherapy with a targeted therapy improved cancer control for some patients with biliary tract cancer, according to research presented by Yarchoan et al at the American Association for Cancer Research (AACR) Virtual Annual Meeting (Abstract...
FDA Issues Emergency Use Authorization for Remdesivir for Treatment of Severe COVID-19
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. Severe disease is defined as low...
Outcomes With Autologous-Allogeneic vs Tandem Autologous Hematopoietic Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma
In a pooled analysis reported in the journal Bone Marrow Transplantation, Costa et al found that autologous followed by reduced-intensity conditioning allogeneic hematopoietic cell transplantation (auto-allo) was associated with longer overall survival compared with tandem autologous...
Negotiating the Obstacles to Conducting Clinical Trials of Immunotherapy During the Coronavirus Pandemic
Coronavirus disease 2019 (COVID-19) is perhaps the biggest challenge health-care systems have ever had to face. As part of a series of interviews The ASCO Post is conducting with oncologists, we talked with Charles G. Drake, MD, PhD, about the impact of COVID-19 on his practice and on the conduct...
FDA Approves Daratumumab and Hyaluronidase-fihj in Multiple Myeloma
On May 1, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for adult patients with newly diagnosed, relapsed, or refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj...
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;...
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...
FDA Approves New Pembrolizumab Dosing Regimen
On April 28, the U.S. Food and Drug Administration (FDA) granted accelerated approval to a new dosing regimen for pembrolizumab (Keytruda)—400 mg every 6 weeks—across all currently approved adult indications, in addition to the current 200 mg every 3 weeks dosing regimen. The approval was based on...
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...
PD-1 Inhibition in Mismatch Repair–Deficient/Microsatellite Instability–High Cancers Other Than Colorectal Cancer
Mismatch repair (MMR)-deficiency and consequently high DNA microsatellite instability (MSI-H) are associated with high tumor mutational burden. A high mutational load increases the potential number of neoantigens that can be presented by the tumor cell and recognized by host lymphocytes. Detection...
NCI-MATCH Subprotocol Finds Nivolumab Active in Mismatch Repair–Deficient Cancers Other Than Colorectal Cancer
In a study (NCI-MATCH trial subprotocol, arm Z1D) reported in the Journal of Clinical Oncology, Nilofer S. Azad, MD, of Johns Hopkins Medicine Sidney Kimmel Comprehensive Cancer, and colleagues found that nivolumab was active in mismatch repair (MMR)-deficient noncolorectal cancers.1 As stated by...
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...
Expert Point of View: Dana E. Rathkopf, MD
Study discussant Dana E. Rathkopf, MD, Director of Clinical Research, Prostate Cancer, at Memorial Sloan Kettering Cancer Center, New York, began her presentation by noting that the “complicated” landscape of metastatic prostate cancer can be approached like a chess game. She used a chess analogy...
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...
Pembrolizumab Plus Cetuximab Shows Antitumor Activity in Squamous Cell Head and Neck Cancer
The first trial to evaluate anti–programmed cell death protein 1 (PD-1) blockade combined with epidermal growth factor receptor (EGFR) inhibition in head and neck squamous cell carcinoma demonstrates promising activity of the drug combination in patients with platinum-refractory or -ineligible...
Chemotherapy and the Sweat Lodge
The ASCO Post is pleased to reproduce installments of Art of Oncology as published previously in the Journal of Clinical Oncology. These articles focus on the experience of suffering from cancer or of caring for people diagnosed with cancer, and they include narratives, topical essays, historical...
FDA Approves Ibrutinib/Rituximab for CLL/SLL
On April 21, the U.S. Food and Drug Administration (FDA) expanded the indication of ibrutinib (Imbruvica) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This review was conducted...
FDA Approves Pemigatinib for Patients With Cholangiocarcinoma and an FGFR2 Rearrangement or Fusion
On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or...
FDA Approves Mitomycin Gel for Low-Grade Upper Tract Urothelial Cancer
On April 15, the U.S. Food and Drug Administration (FDA) approved mitomycin (Jelmyto) for adult patients with low-grade upper tract urothelial cancer. OLYMPUS Trial Efficacy determination was based on OLYMPUS, an ongoing, single-arm, multicenter trial enrolling 71 patients with treatment-naive or...
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...
FDA Approves Selumetinib for Pediatric Patients With NF1 and Symptomatic Inoperable Plexiform Neurofibromas
On April 10, the U.S. Food and Drug Administration (FDA) approved selumetinib (Koselugo) for pediatric patients aged 2 years and older with neurofibromatosis type 1 (NF1) who have symptomatic inoperable plexiform neurofibromas. Selumetinib, a kinase inhibitor, is the first therapy approved for...
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...
Should Restrictions on Genetic Testing Be Loosened?
The loosening of restrictions on genetic testing would mean that all health-care providers could help move this needle to where it should be, according to Kevin S. Hughes, MD, a surgeon at Massachusetts General Hospital, Professor of Surgery at Harvard Medical School, and Medical Director of the...
Pembrolizumab Plus Radiotherapy Worthy of Further Study in Locally Advanced Squamous Cell Head and Neck Cancer
The combination of the checkpoint inhibitor pembrolizumab and definitive radiation therapy appears to be a safe and feasible option for patients with locally advanced head and neck cancer who are not eligible for cisplatin, according to data presented at the 2020 Multidisciplinary Head and Neck...
FDA Approves Encorafenib/Cetuximab for BRAF V600E–Mutated Metastatic Colorectal Cancer
On April 8, the U.S. Food and Drug Administration (FDA) approved encorafenib (Braftovi) in combination with cetuximab (Erbitux) for the treatment of pretreated adult patients with metastatic colorectal cancer with a BRAF V600E mutation detected by an FDA-approved test. BEACON CRC Efficacy was...
Brief Highlights on Novel Therapies for Prostate, Bladder, and Kidney Cancers
Attendees gathered at the 2020 Genitourinary Cancers Symposium in San Francisco to hear the latest news about treating patients with cancers of the prostate, bladder, kidneys, and testicles. In addition to the comprehensive coverage of the meeting in The ASCO Post, here are some brief highlights...
Apixaban for Cancer-Associated Venous Thromboembolism
For patients with cancer, the oral blood thinner apixaban is at least as effective as dalteparin, a low–molecular-weight heparin given by injection, in preventing a repeat venous thromboembolism (VTE), with no excess in major bleeding events. These findings from the phase III Caravaggio study were...
Quality of Life After Adjuvant Radiotherapy With vs Without Tumor Bed Boost for Patients With Non–Low-Risk DCIS
In a health-related quality-of-life study reported in The Lancet Oncology, King et al found that adjuvant radiotherapy with a tumor bed boost was associated with poorer cosmetic status and arm and shoulder functional status than radiotherapy with no boost among women with non–low-risk ductal...
