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kidney cancer

Tivozanib for Relapsed or Refractory Advanced Renal Cell Carcinoma

On March 10, 2021, the VEGF tyrosine kinase inhibitor tivozanib was approved for treatment of adults with relapsed or refractory advanced renal cell carcinoma following at least two prior systemic therapies.1,2 Supporting Efficacy Data Approval was based on findings in the open-label, phase III...

Expert Point of View: Amit M. Oza, MD, MBBS

Invited discussant of the FORWARD II trial,1Amit M. Oza, MD, MBBS, concluded that bevacizumab and mirvetuximab soravtansine was a “very well tolerated and effective” combination with “encouraging activity,” even in patients previously treated with bevacizumab and weekly paclitaxel. Dr. Oza is Head ...

leukemia

B-Cell Acute Lymphoblastic Leukemia: Update on Clinical Trials

“Learning never exhausts the mind.” —Leonardo da Vinci To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition, here are several abstracts selected from the meeting proceedings focusing on treatments under study ...

gynecologic cancers

Early-Phase Trial Finds Mirvetuximab Soravtansine Plus Bevacizumab Active in Recurrent Ovarian Cancer

In patients with recurrent ovarian cancer, the antibody-drug conjugate mirvetuximab soravtansine, given with bevacizumab, showed antitumor activity leading to durable responses in platinum-agnostic patients with strong expression of folate receptor alpha (FRα), researchers reported at the 2021 ASCO ...

Expert Point of View: Kostas Stamatopoulos, MD, PhD

In the phase III GLOW trial, the all-oral regimen of fixed-duration ibrutinib plus venetoclax as first-line treatment for older or unfit patients with chronic lymphocytic leukemia (CLL) showed superior efficacy compared with chlorambucil and obinutuzumab.1Kostas Stamatopoulos, MD, PhD, of the...

leukemia

Phase III GLOW Trial: Improved Outcomes With First-Line Ibrutinib Plus Venetoclax in Elderly Patients With CLL

Fixed-duration ibrutinib and venetoclax as a first-line treatment yielded superior outcomes compared with chlorambucil plus obinutuzumab in patients with chronic lymphocytic leukemia (CLL), based on the primary analysis of the phase III GLOW trial presented during the European Hematology...

Oncology Community Mourns the Loss of Investigator Angelo Di Leo, MD, PhD

Oncologist Angelo Di Leo, MD, PhD, recently died after a long struggle with neurodegenerative disease. He was 58 years old. Dr. Di Leo was devoted to breast cancer research for more than 25 years. He first trained with Gianni Bonadonna, MD, in Milan, followed by postdoctoral research at Jules...

hematologic malignancies

MAIA Update: Overall Survival Benefit Reported With Daratumumab Plus Lenalidomide in Myeloma

In an updated analysis of the phase III MAIA trial, the addition of the monoclonal antibody daratumumab to the immunomodulatory agent lenalidomide and the corticosteroid dexamethasone (D-Rd) significantly improved overall survival over lenalidomide/dexamethasone alone in patients newly diagnosed...

lymphoma

Dual PI3Kδ/CK1ε Inhibitor Umbralisib in Relapsed or Refractory Indolent Non-Hodgkin Lymphoma

As reported in the Journal of Clinical Oncology by Nathan H. Fowler, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, a phase IIb trial (UNITY-NHL) has shown that the dual PI3Kδ/casein kinase (CK)1ε inhibitor umbralisib produced durable responses in patients with relapsed...

breast cancer
myelodysplastic syndromes

FDA Pipeline: Designations for Therapies in Myelodysplastic Syndromes and Triple-Negative Breast Cancer

Recently, the U.S. Food and Drug Administration (FDA) granted special designation status to treatments for myelodysplastic syndromes and advanced triple-negative breast cancer. Breakthrough Therapy Designation for Venetoclax in Combination With Azacitidine for  Myelodysplastic Syndromes Venetoclax...

lung cancer
immunotherapy

Addition of Ipilimumab to Nivolumab in Previously Treated, Immunotherapy-Naive Patients With Stage IV Squamous NSCLC

As reported in JAMA Oncology by Scott N. Gettinger, MD, and colleagues, the phase III Lung Cancer Master Protocol S1400I trial showed no improvement in overall survival with the addition of ipilimumab to nivolumab in previously treated, immune checkpoint inhibitor–naive patients with stage IV...

gynecologic cancers
immunotherapy

Expert Point of View: Carol Aghajanian, MD

“The phase III ENGOT/GCIG study1 proved to be negative, with no advantage seen with the extension of bevacizumab treatment,” said the abstract’s invited discussant, Carol Aghajanian, MD, Chief of the Medical Gynecologic Oncology Service at Memorial Sloan Kettering Cancer Center, New York. Dr....

gynecologic cancers
immunotherapy

Bevacizumab in Advanced Ovarian Cancer: Phase III Trial Finds More Is Not Better

In advanced ovarian cancer, the duration of maintenance bevacizumab should remain 15 months, according to the European multicenter phase III ENGOT/GCIG trial. These results were presented during the 2021 ASCO Annual Meeting by Jacobus Pfisterer, MD, PhD, of the AGO Study Group and Gynecologic...

hematologic malignancies
symptom management

Ruxolitinib for Glucocorticoid-Refractory or -Dependent Chronic Graft-vs-Host Disease After Allogeneic Stem Cell Transplantation

In the phase III REACH3 trial, reported in The New England Journal of Medicine, Robert Zeiser, MD, and colleagues found that ruxolitinib produced a significantly higher overall response rate vs investigator-selected control treatments in patients with glucocorticoid-refractory or -dependent chronic ...

breast cancer

Is There a Disease-Free Survival Benefit With Adjuvant Celecoxib in HER2-Negative Breast Cancer?

In the phase III REACT trial reported in JAMA Oncology, R. Charles Coombes, MD, PhD, and colleagues found no disease-free survival benefit with the addition of 2 years of adjuvant celecoxib vs placebo to conventional adjuvant treatment in patients with HER2-negative breast cancer. Study Details...

prostate cancer

Addition of AKT Inhibitor Ipatasertib to Abiraterone/Prednisolone in Metastatic Castration-Resistant Prostate Cancer With PTEN Loss

In the phase III IPATential150 trial reported in The Lancet, Christopher Sweeney, MD, and colleagues found that the addition of the AKT inhibitor ipatasertib to abiraterone and prednisolone produced a significant improvement in progression-free survival among patients with metastatic...

prostate cancer

PSMA PET-Positive Metastatic Castration-Resistant Prostate Cancer

In this video, Drs. Matthew R. Smith, Xin Gao, and Alicia K. Morgans discuss the emerging role of PSMA (prostate-specific membrane antigen)-targeted therapy in metastatic castration-resistant prostate cancer. Dr. Smith presents a case of a 67-year-old man with metastatic castration-resistant...

prostate cancer

High-Volume De Novo Metastatic Castration-Sensitive Prostate Cancer

In this video, Drs. Matthew R. Smith, Xin Gao, and Alicia K. Morgans discuss the management of metastatic castration-sensitive prostate cancer, focusing on data from the phase III PEACE-1 trial. The faculty present the case of a 61-year-old man with de novo metastatic high-volume...

prostate cancer

Low-Volume Recurrent Metastatic Castration-Sensitive Prostate Cancer

In this video, Drs. Matthew R. Smith, Xin Gao, and Alicia K. Morgans discuss the management of metastatic castration-sensitive prostate cancer, focusing on data from the phase III TITAN trial. The faculty present the case of a 73-year-old man with recurrent, low-volume/low-risk metastatic...

breast cancer
immunotherapy

Long-Term Analysis of Short-HER Trial of Adjuvant Trastuzumab

Long-term analysis of the Short-HER trial showed that 9 weeks of adjuvant trastuzumab conveyed benefits comparable to a 1-year course in patients with early HER2-positive breast cancer deemed to be at low or intermediate risk for recurrence. High-risk patients, however, derived considerably more...

prostate cancer

Addition of Docetaxel to Radiotherapy and ADT in Nonmetastatic Unfavorable-Risk Prostate Cancer

In a phase III trial reported in the Journal of Clinical Oncology, Anthony V. D’Amico, MD, PhD, and colleagues found that the addition of docetaxel to radiotherapy and androgen-deprivation therapy (ADT) did not improve overall survival in nonmetastatic, unfavorable-risk prostate cancer. However,...

pancreatic cancer

SBRT Plus Pembrolizumab/Trametinib vs Gemcitabine in Locally Recurrent Resected Pancreatic Cancer

In a Chinese phase II trial reported in The Lancet Oncology, Zhu et al found that stereotactic body radiotherapy (SBRT) plus pembrolizumab and trametinib produced a modest—but statistically significant—overall survival benefit vs SBRT plus gemcitabine in patients with locally recurrent resected...

kidney cancer

Oral Anticancer Agent Use in Patients With Metastatic Renal Cell Carcinoma

In a population-based cohort study reported in JCO Oncology Practice, Stephanie B. Wheeler, PhD, and colleagues found a low rate of oral anticancer agent use within 12 months after detection of metastatic disease in patients with renal cell carcinoma. Study Details The study used a novel, North...

skin cancer

LEAP-004 Trial Update on Lenvatinib Plus Pembrolizumab After Disease Progression in Metastatic Melanoma

Longer follow-up of the LEAP-004 trial in metastatic melanoma upheld the benefit seen with the VEGF kinase inhibitor lenvatinib plus the PD-1 inhibitor pembrolizumab for patients experiencing disease progression on prior checkpoint blockade, investigators reported at the 2021 ASCO Annual Meeting.1 ...

pancreatic cancer

Expert Point of View: Thomas Seufferlein, MD, PhD

The invited discussant of APACT,1 Thomas Seufferlein, MD, PhD, Professor of Medicine at the University of Ulm in Germany, said the updated overall survival data “suggest an improved outcome with nab-paclitaxel plus gemcitabine vs gemcitabine alone…. The combination improves long-term survival and...

pancreatic cancer

APACT: 5-Year Overall Survival Data Suggest Improved Outcomes in Pancreatic Cancer With Nab-Paclitaxel Plus Gemcitabine

Five-year outcomes in the APACT trial uphold the overall survival benefit with nab-paclitaxel plus gemcitabine in the adjuvant treatment of patients with resected pancreatic cancer, according to Margaret A. Tempero, MD, Director of the University of California San Francisco Pancreas Center, who...

leukemia

Calaspargase Pegol vs Pegaspargase in Pediatric ALL

In a phase III trial (DFCI 11-001) reported in the Journal of Clinical Oncology, Vrooman et al found that the novel pegylated asparaginase formulation calaspargase pegol (calaspargase) given every 3 weeks was associated with similar serum asparaginase activity nadir values, survival outcomes, and...

colorectal cancer
survivorship

Quality of Life With General Practitioner– vs Surgeon-Led Colon Cancer Survivorship Care

In a 1-year interim analysis of a Dutch study (I CARE) reported in The Lancet Oncology, Vos et al found no clinically meaningful difference in changes in quality of life from baseline among patients with colon cancer with general practitioner– vs surgeon-led survivorship care. In addition,...

thyroid cancer

Cabozantinib in Previously Treated, Radioiodine-Refractory Differentiated Thyroid Cancer: COSMIC-311

As reported in The Lancet Oncology by Marcia S. Brose, MD, and colleagues, the phase III COSMIC-311 trial has shown that cabozantinib produced a numerically higher objective response rate and significantly prolonged progression-free survival vs placebo in patients with previously treated,...

prostate cancer

VISION Trial: Novel PSMA-Targeted Radiotherapy Improves Outcomes in Metastatic Prostate Cancer

Lutetium-177–PSMA-617 (LuPSMA)—an investigational radiolabeled small molecule—significantly improved radiographic progression-free survival and overall survival when added to the standard of care compared with the standard of care alone for men with metastatic castration-resistant prostate cancer...

hematologic malignancies

Evaluation of Two Doses of Imetelstat in Patients With Relapsed or Refractory Myelofibrosis After JAK Inhibitor Treatment

In a phase II trial reported in the Journal of Clinical Oncology, John Mascarenhas, MD, and colleagues found that treatment with the telomerase inhibitor imetelstat at a dose of 9.4 mg/kg produced clinical benefit in patients with relapsed or refractory myelofibrosis after Janus-associated kinase...

breast cancer
global cancer care

Reflections on Evolution of Breast Cancer Care in India Over the Past 4 Decades

India has witnessed a major paradigm shift in the field of breast cancer and its management over the past 4 decades. The discipline of medical oncology has evolved exponentially over this period—a growth that few other scientific disciplines have experienced. Interventions at the individual,...

Conquer Cancer, the ASCO Foundation, Awards More Than $10 Million to Support Cancer Research

Conquer Cancer, the ASCO Foundation, is pleased to announce the recipients of its awards supporting researchers with projects spanning across many areas in cancer care, including immunotherapy, precision medicine, breast cancer, and palliative care. This year, Conquer Cancer is funding the largest...

breast cancer

Expert Point of View: Melinda Telli, MD

EA1131 study discussant, Melinda Telli, MD, Associate Professor of Medicine at Stanford University, Director of the Breast Cancer Program at the Stanford Cancer Institute, and Associate Director of the Stanford Women’s Cancer Center, commented: “At this point,1 capecitabine remains preferred as...

breast cancer

EA1131 Trial: Platinum Not Equal to Capecitabine for Residual Disease in Triple-Negative Breast Cancer

In patients with triple-negative breast cancer who have residual disease after neoadjuvant chemotherapy, adjuvant capecitabine remains the standard of care. In the multicenter randomized noninferiority EA1131 trial, which included primarily basal tumors, noninferiority of adjuvant platinum over...

hematologic malignancies

Novel Targeted Agents for the Treatment of Myelofibrosis

“Progress lies not in enhancing what is, but in advancing toward what will be.”                                                              –Kahlil Gibran To complement The ASCO Post’s continued comprehensive coverage of the 2020 American Society of Hematology (ASH) Annual Meeting &...

leukemia

Novel BCL2 Inhibitor Shows Activity in CLL in Phase I Trial

The novel, selective BCL2 inhibitor lisaftoclax (APG-2575) has shown activity in the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) in a phase I study reported at the 2021 ASCO Annual Meeting.1 Preliminary data suggest that lisaftoclax stands out for its favorable safety...

lymphoma
leukemia

Fixed-Dose, First-Line Ibrutinib/Venetoclax Combination Achieves Durable Remissions in CLL

The combination of fixed-duration, first-line treatment with ibrutinib plus venetoclax achieved complete responses in more than half of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL), based on the primary analysis of the fixed-dose cohort of the phase II CAPTIVATE ...

bladder cancer

Sacituzumab Govitecan-hziy: Welcome Addition to Advanced Urothelial Cancer Treatments, but Time to Figure Out Sequencing and Combinations

The results of Cohort 1 of the phase II trial TROPHY-U-01 (IMMU-132-06; ClinicalTrials.gov identifier NCT03547973), published in the Journal of Clinical Oncology by Tagawa et al and reviewed in this issue of The ASCO Post, led to the recent accelerated U.S. Food and Drug Administration (FDA)...

solid tumors

Enfortumab Vedotin Represents a Community of Work in Antibody-Drug Conjugates Targeting Cancer

The first known clinical trial report of an antibody-drug conjugate was a phase 0/I pharmacodynamic and safety study of a conjugate that targeted carcinoembryonic antigen and delivered a payload of vinca alkaloid in eight patients with ovarian or colorectal cancer.1 This work built on the work of...

bladder cancer

EV-301 Trial: Enfortumab Vedotin-ejfv Improves Overall Survival vs Chemotherapy in Previously Treated Advanced Urothelial Carcinoma

As reported in The New England Journal of Medicine by Thomas Powles, MD, of Barts Cancer Centre, Queen Mary University of London, and colleagues, a prespecified interim analysis of the phase III EV-301 trial has shown improved overall survival with the antibody-drug conjugate enfortumab...

global cancer care

Postoperative Mortality and Complications After Cancer Surgery in High- vs Low- or Middle-Income Countries

In a prospective cohort study reported in The Lancet, the GlobalSurg Collaborative found that 30-day mortality after surgery for colorectal and gastric cancers, but not breast cancer, was higher in low- or middle-income countries vs high-income countries.1 Among all patients, mortality rates...

head and neck cancer
immunotherapy

Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer

On May 20, 2021, nivolumab was approved for adjuvant treatment of patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease after neoadjuvant chemoradiotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the...

colorectal cancer

Using ctDNA to Measure Molecular Residual Disease in Patients With Colorectal Cancer

A team of investigators in Japan used a personalized assay for circulating tumor DNA (ctDNA) levels in plasma to monitor molecular residual disease following surgery in patients with resectable colorectal cancer. Their subgroup analysis found statistically significant associations between ctDNA...

hepatobiliary cancer

Donafenib May Improve Survival vs Sorafenib in First-Line Treatment of Unresectable or Metastatic Hepatocellular Carcinoma

In a Chinese phase II/III trial reported in the Journal of Clinical Oncology, Qin et al found that donafenib, a multikinase inhibitor and deuterated sorafenib derivative, improved overall survival vs sorafenib in the first-line treatment of unresectable or metastatic hepatocellular carcinoma. As...

colorectal cancer
immunotherapy

Addition of Pembrolizumab to Chemoradiotherapy in Total Neoadjuvant Therapy for Locally Advanced Rectal Cancer

As reported in JAMA Oncology by Osama E. Rahma, MD, and colleagues, initial results of the phase II NRG-GI002 trial showed no improvement in mean neoadjuvant rectal score with the addition of pembrolizumab to chemoradiotherapy in total neoadjuvant therapy for patients with locally advanced rectal...

cns cancers

Oncolytic Adenovirus for Malignant Glioma: Feasibility and Safety

In a first-in-human phase I trial reported in The Lancet Oncology, Fares et al found that neural stem cell delivery of an oncolytic adenovirus (NSC-CRAd-S-pk7) was safe and feasible in patients with newly diagnosed malignant glioma, with immunologic and histopathologic findings supporting continued ...

lymphoma

Recovery of Gonadal Function With PET-Adapted Regimen for Advanced Hodgkin Lymphoma

In a prospective analysis from the phase III Lymphoma Study Association AHL2011 trial reported in the Journal of Clinical Oncology, Demeestere et al found that patients with advanced Hodgkin lymphoma receiving a positron-emission tomography (PET)-adapted regimen had a reduced risk of gonadal...

skin cancer
immunotherapy

A Shift in the Treatment of Advanced Melanoma

Answers to questions about first-line treatment of metastatic melanoma are “going to be shifting,” Jason J. Luke, MD, told The ASCO Post, with the change coming on the heels of the phase III RELATIVITY-047 trial reported at the 2021 ASCO Annual Meeting.1 That abstract reported that using two...

Assessment of Targeted Methylation-Based Multicancer Early Detection Test in Independent Validation Cohort

In a validation study reported in Annals of Oncology, Klein et al found that a targeted methylation-based multicancer early detection (MCED) assay using cell-free DNA (cfDNA) sequencing had high specificity for cancer signal detection and high accuracy in predicting cancer signal origin across a...

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