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Showing 2601 - 2650Outcomes With Dose-Intense Adjuvant Chemotherapy in Early Breast Cancer
In a patient-level meta-analysis reported in The Lancet, the Early Breast Cancer Trialists’ Collaborative Group found that an increased dose intensity of adjuvant taxane and anthracycline chemotherapy in early breast cancer was associated with a decreased risk of recurrence and death from breast...
Update on Newer Treatments in Non-Hodgkin Lymphomas
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on several different studies on new therapeutics in non-Hodgkin lymphomas (NHLs), including follicular lymphoma, diffuse large B-cell lymphoma (DLBCL), ...
FDA Grants Accelerated Approval to Atezolizumab/Nab-Paclitaxel; Regular Approval Contingent on Confirmatory Trials
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq) plus nanoparticle albumin-bound (nab)-paclitaxel (Abraxane) for the treatment of adults with unresectable, locally advanced or metastatic, programmed cell death ligand 1 (PD-L1)-positive ...
Reshaping the Treatment Landscape in Refractory Multiple Myeloma
THE TREATMENT approaches for multiple myeloma, both newly diagnosed and relapsed disease, continue to undergo major transformation as new agents and combinations are being introduced.1 This change has been driven by the introduction of novel drug classes such as monoclonal antibodies, as well as...
FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
Long-Term Study Finds Axillary Radiotherapy Safe and Effective After Positive Sentinel Node Biopsy
Following identification of a positive sentinel lymph node, surgical axillary lymph node dissection and axillary radiation therapy provide comparable locoregional control and survival, according to a 10-year follow-up of the large European Organisation for Research and Treatment of Cancer AMAROS...
More Data Show Small Benefit From Extended Endocrine Therapy
Two studies presented at the 2018 San Antonio Breast Cancer Symposium validated a small benefit of extending adjuvant aromatase inhibitor therapy beyond thestandard 5 years for postmenopausal women with hormone receptor–positive breast cancer. In a meta-analysis of 24,912 patients from 12...
Radioligand Therapy Achieves Responses in Metastatic Prostate Cancer
In a prospective, single-center, single-arm phase II trial reported at the 2019 Genitourinary Cancers Symposium, a novel approach using a tumor-specific radioligand therapy that binds to prostate-specific membrane antigen (PSMA) (lutetium-177 PSMA-617 -[LuPSMA]) achieved responses in a majority of...
Pembrolizumab/Axitinib Combination Improves Outcomes vs Sunitinib in Kidney Cancer
The checkpoint inhibitor pembrolizumab plus the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor axitinib significantly improved overall survival, progression-free survival, and objective response rates vs sunitinib as first-line therapy for clear cell metastatic renal cell...
2019 ASCO-SITC: Combined Targeting of TIM-3 and PD-L1 Immune Checkpoint Pathways in Advanced Relapsed or Refractory Solid Tumors
A phase Ia/Ib trial was launched in order to evaluate the safety of LY3321367, an anti–T-cell immunoglobulin domain and mucin domain–containing molecule-3 (TIM-3) antibody, administered alone or in combination with LY3300054, an anti-programmed death ligand 1 (PD-L1) antibody, in...
First-Line Ibrutinib/Rituximab Combination Shows Benefit for Younger Patients With CLL
FIRST-LINE therapy with the combination of ibrutinib and rituximab reduced disease progression by two-thirds compared with standard chemotherapy using fludarabine, cyclophosphamide, and rituximab (FCR) in younger patients with chronic lymphocytic leukemia (CLL), according to the late-breaking...
Large Single-Arm Trial of Hydroxyurea for Sickle Cell Anemia in Sub-Saharan Africa
THE LARGEST PROSPECTIVE trial of hydroxyurea for sickle cell anemia has shown that this treatment is feasible, accepted, well tolerated, and safe for children living in sub-Saharan Africa. Hydroxyurea has long been the standard of care for treating children with sickle cell anemia in developed...
Expert Point of View: Mrinal Patnaik, MBBS, and David P. Steensma, MD
Mrinal S. Patnaik, MBBS, Associate Professor of Internal Medicine and Oncology and a consultant in hematology at the Mayo Clinic, Rochester, commented on the MEDALIST trial for The ASCO Post. “Given its unique mode of action, relative ease of administration, and excellent tolerability,...
Luspatercept May Reduce the Need for Transfusion in Lower-Risk Myelodysplastic Syndromes
IN THE RANDOMIZED, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.8% of patients remained...
Update on FDA-Approved CAR T-Cell Products
AXICABTAGENE CILOLEUCEL (also known as CAR19) is an anti-CD19 chimeric antigen receptor (CAR) T-cell product approved by U.S. Food and Drug Administration to treat selected hematologic malignancies.1 To appreciate the clinical trial findings summarized here, from selected abstracts presented at the ...
Highlights From the 2018 ASH Annual Meeting & Exposition
TO ADD to our ongoing coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, we bring readers of The ASCO Post these summaries of an assortment of interesting studies. They focus on novel therapies under investigation in the treatment of acute lymphoblastic...
Expert Point of View: Michael J. Overman, MD
INVITED STUDY discussant Michael J. Overman, MD, Professor of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center, Houston, is a co-investigator on CheckMate 142, which led to the approval of another immunotherapy doublet—nivolumab plus ipilimumab—in patients...
Durvalumab and Tremelimumab Combination Active in Refractory Microsatellite-Stable Colorectal Cancer
THE COMBINATION of durvalumab and tremelimumab prolonged median overall survival by 2.5 months compared with best supportive care alone in patients with advanced treatment-refractory colorectal cancer. These findings, which are from the randomized phase II Canadian Cancer Trials Group (CCTG) CO.26...
Crizanlizumab Improves Prevention of Vaso-occlusive Crises in Patients With Sickle Cell Disease
For the first time in more than 20 years, patients with sickle cell disease may have another treatment option to reduce painful vaso-occlusive crises, according to data presented at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition.1 Results of the phase II, randomized,...
Direct Oral Anticoagulants Show Reduced Risk of Venous Thromboembolism in Patients With Cancer
Results of a recent study suggest that direct oral anticoagulants can reduce the risk of thromboembolism in patients with cancer who are starting a new systemic therapy regimen, without significantly increasing the risk of major bleeding. Data presented at the 2018 ASH Annual Meeting &...
Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma: Outcomes From the MAIA Trial
In patients with newly diagnosed multiple myeloma who are not eligible for stem cell transplantation, the addition of daratumumab to lenalidomide and dexamethasone significantly reduced the risk of death or disease progression by 44%, according to a late-breaking abstract presentation by Thierry...
FDA Pipeline: Priority Reviews in Solid Tumors and Lymphoma; Plus an sNDA in Acute Myeloid Leukemia
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews and accepted a supplemental new drug application: Priority Review for Entrectinib in NTRK Fusion–Positive Solid Tumors and Metastatic, ROS1-Positive NSCLC This week, the FDA accepted new drug...
Meta-analysis of Outcomes With Dose-Intense Adjuvant Chemotherapy in Early Breast Cancer
In a patient-level meta-analysis reported in The Lancet, the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) found that an increased dose intensity of adjuvant taxane and anthracycline chemotherapy in early breast cancer was associated with a decreased risk of recurrence and death ...
2019 GU Cancers Symposium: Adjuvant Sequential Chemotherapy Plus Radiotherapy vs Radiotherapy Alone for Locally Advanced Bladder Cancer
A phase III Egyptian trial presented by Zaghloul et al (Abstract 351) at the 2019 Genitourinary Cancers Symposium focused on the benefit of adjuvant chemotherapy in patients with locally advanced bladder cancer treated with postoperative radiotherapy. Researchers compared postoperative radiotherapy ...
FDA Approves Adjuvant Pembrolizumab for Melanoma
On February 15, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the adjuvant treatment of patients with melanoma with lymph node involvement following complete resection. Approval was based on the phase III EORTC1325/KEYNOTE-054 trial, a randomized, double-blind,...
Alisertib vs Investigator’s Choice in Relapsed or Refractory Peripheral T-Cell Lymphoma
In the phase III Lumiere trial reported in the Journal of Clinical Oncology, O’Connor et al found that the Aurora A kinase inhibitor alisertib did not improve outcomes vs investigator’s choice of single-agent treatment in relapsed or refractory peripheral T-cell lymphoma (PTCL). Study...
2019 GU Cancers Symposium: Small Trial of LuPSMA in PSMA-Positive, Metastatic, Castration-Resistant Prostate Cancer
A single-arm, phase II trial in men with prostate-specific membrane antigen (PSMA)-positive, metastatic, castration-resistant prostate cancer that progressed despite standard therapies found that a majority of men treated with a novel, targeted radiation therapy called lutetium-177 PSMA-617...
FDA Approves Daratumumab Split-Dosing Regimen
The U.S. Food and Drug Administration (FDA) has approved a split-dosing regimen for daratumumab (Darzalex), a CD38-directed antibody, providing health-care professionals and patients with multiple myeloma an option to split the first infusion over 2 consecutive days. The approval is based on...
Neoadjuvant Combination Checkpoint Blockade in Advanced Melanoma
Neoadjuvant combination checkpoint blockade showed activity among patients with high-risk stage III melanoma in a small study. However, a high incidence of side effects caused the trial to be closed early. These results were published by Rodabe N. Amaria, MD, Assistant Professor of Melanoma...
Novel Treatments of Myelodysplastic Syndromes
AS PART of The ASCO Post’s continued coverage of the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition, here is an update on seven different studies on new therapeutics in myelodysplastic syndromes (MDS). Among the treatments highlighted here are the erythroid maturation...
Data Mount for Venetoclax as Add-on Therapy in Acute Myeloid Leukemia
The benefit of adding venetoclax to a hypomethylating agent or low-dose cytarabine in the front-line treatment of acute myeloid leukemia (AML) was evident from a number of studies reported at the 2018 American Society of Hematology (ASH) Annual Meeting & Exposition (see Table 1). For elderly...
Expert Point of View: Mrinal S. Patnaik, MBBS and David P. Steensma, MD
Mrinal S. Patnaik, MBBS, Associate Professor of Internal Medicine and Oncology and a consultant in hematology at the Mayo Clinic, Rochester, commented on the MEDALIST trial for The ASCO Post. “Given its unique mode of action, relative ease of administration, and excellent tolerability,...
Luspatercept May Reduce the Need for Transfusion in Lower-Risk Myelodysplastic Syndromes
In the randomized, double-blind, phase III MEDALIST trial, the experimental drug luspatercept significantly reduced the need for frequent red blood cell transfusions in patients with lower-risk myelodysplastic syndromes (MDS) and ring sideroblasts. With luspatercept, 37.9% remained transfusion-free ...
Small Differences Found in Breast Cancer Recurrence With Partial-Breast vs Whole-Breast Irradiation
Partial-breast irradiation delivered over 5 to 10 days did not meet noninferiority criteria compared with whole-breast irradiation given over 5 to 7 weeks, according to 10-year results of the large NRG (NSABP B-39/RTOG 0413) trial presented at the 2018 San Antonio Breast Cancer Symposium.1 However, ...
Selected Abstracts From the San Antonio Breast Cancer Symposium
Each year, The ASCO Post asks Jame Abraham, MD, FACP, Director of the Breast Oncology Program 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 the 2018 San Antonio Breast Cancer ...
Andecaliximab in Untreated Gastric or Gastroesophageal Junction Cancer
The large phase III GAMMA-1 trial failed to replicate the encouraging findings from a previous smaller study of andecaliximab plus chemotherapy in untreated HER2-negative gastric or gastroesophageal junction adenocarcinoma, according to Manish A. Shah, MD, of Weill Cornell Medicine/New York...
Expert Point of View: Harry H. Yoon, MD
KEYNOTE-181’s invited discussant, Harry H. Yoon, MD, Associate Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, said the findings have a “potentially immediate clinical impact” for second-line treatment of esophageal cancer, including esophageal squamous cell carcinoma and Siewert...
KEYNOTE-181: Pembrolizumab vs Chemotherapy in Second-Line Treatment of Advanced Esophageal Cancer
In the global phase III KEYNOTE-181 trial, pembrolizumab as second-line therapy for advanced esophageal cancer did not improve overall survival in the whole population, vs chemotherapy, but did improve survival for patients with strong expression of programmed cell death ligand 1 (PD-L1),...
FDA Expands Pemetrexed Label With Combination of Pembrolizumab and Platinum Chemotherapy for the First-Line Treatment of Metastatic Nonsquamous NSCLC
Today, the U.S. Food and Drug Administration (FDA) granted approval for a new indication for pemetrexed (Alimta) for injection in combination with pembrolizumab (Keytruda) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non–small cell...
FDA Approves Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
Today, the U.S. Food and Drug Administration (FDA) approved ibrutinib (Imbruvica), a Bruton's tyrosine kinase inhibitor, in combination with obinutuzumab in treatment-naive patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). This is the first approval of a...
IMpassion130 Trial: Changing the Treatment Landscape in Metastatic Triple-Negative Breast Cancer
THE IMPASSION130 trial—reported in The New England Journal of Medicine by Schmid et al1 and reviewed in this issue of The ASCO Post—was an eagerly awaited study in newly diagnosed metastatic triple-negative breast cancer. To briefly review, 902 patients were randomly assigned in a 1:1 fashion to...
Expert Point of View: Elihu H. Estey, MD; Steven Gore, MD; and Mark J. Levis, MD, PhD
ELIHU H. ESTEY, MD, Professor of Medicine at the University of Washington and Director of Acute Myeloid Leukemia (AML) Clinical Research at the Fred Hutchinson Cancer Research Center, Seattle, added that with these “robust” outcomes, future trial patients may “not be eager to wind up in the...
Use of Isocitrate Dehydrogenase Inhibitors in Induction Therapy for Newly Diagnosed AML
IN AN OPEN-LABEL phase I study of 153 patients newly diagnosed with acute myeloid leukemia (AML) and mutations in isocitrate dehydrogenase-1 (IDH1) or IDH2, treatment with standard chemotherapy plus the oral IDH inhibitors ivosidenib and enasidenib led to high response rates and possibly impressive ...
Primary Prophylaxis With a Direct Oral Anticoagulation Agent Reduces Venous Thromboembolism Rate in Ambulatory Patients With Cancer
LATE-BREAKING results from the large, randomized, placebo-controlled CASSINI trial showed that primary prophylaxis with the direct oral anticoagulation agent rivaroxaban reduced the incidence of venous thromboembolism (VTE) as well as VTE-related deaths in high-risk patients with cancer who were...
Oxybutynin: A Novel Option for Managing Hot Flashes?
OXYBUTYNIN, AN ANTICHOLINERGIC drug approved for the treatment of overactive bladder, reduced the frequency and intensity of hot flashes in women who were suffering frequent hot flashes, including breast cancer survivors who were receiving tamoxifen or aromatase inhibitors. These results of the...
Role of Adjuvant Capecitabine in Triple-Negative Breast Cancer
ADJUVANT CAPECITABINE added to standard neoadjuvant chemotherapy failed to significantly improve disease-free or overall survival in patients with early triple-negative breast cancer in the large phase III CIBOMA/2004-01_GEICAM/2003-11 (CIBOMA/GEICAM) trial.1 However, extended treatment with...
PACIFIC Trial of Durvalumab Sets Standard in Stage III Unresectable NSCLC
IMMUNOTHERAPY HAS revolutionized the treatment of lung cancer over the past several years. Although lung cancer is associated with immunosuppression at baseline for most patients, the addition of immune checkpoint inhibitors can overcome that suppression and lead to antitumor immune responses....
Low-Dose Tamoxifen Halves Breast Cancer Risk in Women With Preinvasive Breast Lesions
A VERY LOW DOSE of tamoxifen—5 mg/d, given for 3 years rather than 5 years—halved the risk of breast cancer recurrence or new lesions over placebo in women with breast intraepithelial neoplasia, without producing the usual toxicities seen with the standard dose, Italian researchers reported at the...
2019 GI Cancers Symposium: Is Adjuvant HIPEC Effective in Reducing the Risk of Peritoneal Metastases in Patients With Colon Cancer?
Patients with advanced or perforated colon cancer may be at elevated risk of peritoneal metastases. Since many patients with peritoneal metastases are diagnosed at a late stage, researchers sought to study the effectiveness of hyperthermic intraperitoneal chemotherapy (HIPEC) in the adjuvant...
2019 GI Cancers Symposium: Durvalumab, Tremelimumab, and Best Supportive Care vs Best Supportive Care Alone in Advanced, Refractory Colorectal Cancer
The phase II CCTG CO.26 trial evaluated whether the combination of durvalumab, a programmed cell death ligand 1 (PD-L1) inhibitor, and tremelimumab, an anti–cytotoxic T-lymphocyte–associated protein 4 (CTLA-4) antibody, plus best supportive care improved survival vs best supportive care ...
