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Showing 2551 - 2600FDA Approves Dalteparin Sodium for VTE in Pediatric Patients
On May 16, 2019, the U.S. Food and Drug Administration (FDA) approved dalteparin sodium (Fragmin) to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients 1 month of age and older. This is the first FDA-approved therapy to treat VTE in pediatric patients....
2019 ASCO: Nearly One-Quarter of Participants in the Pediatric MATCH Trial Have an Actionable Molecular Alteration
A study investigating the frequency of targetable molecular alterations in pediatric cancer among patients enrolled in the National Cancer Institute–Children’s Oncology Group Pediatric Molecular Analysis for Therapy Choice (MATCH) trial has found that about one-quarter of patients with...
2019 ASCO: Lenalidomide May Reduce the Risk of Smoldering Multiple Myeloma Progressing to Active Disease
A phase III randomized trial (E3A06) by Lonial et al testing the effect of single-agent lenalidomide vs observation in patients with intermediate- or high-risk smoldering multiple myeloma has found that lenalidomide significantly reduces the risk of smoldering multiple myeloma progressing to active ...
Dual-Immunotherapy Approach Shows Efficacy in High-Grade Neuroendocrine Tumors
COMBINING TWO established immunotherapy agents achieved tumor shrinkage in rare, aggressive, extrapancreatic high-grade neuroendocrine tumors, according to the results of SWOG S1609, a phase II clinical basket trial also known as DART (Dual Anti– CLTA-4 and Anti–PD-1 Blockade in Rare Tumors). The...
Osimertinib Plus Savolitinib in Advanced NSCLC Driven by MET Resistance
THE ADDITION of the MET inhibitor savolitinib to the EGFR inhibitor osimertinib led to activity in patients with MET-amplified, EGFR-mutated non–small lung cancer (NSCLC) with acquired resistance to previous therapies, according to interim results from two expansion cohorts of a phase Ib clinical...
Front-Line Therapy in Advanced Renal Cell Carcinoma: Developing a New Standard
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...
GOG-252: Intravenous vs Intraperitoneal Chemotherapy in Advanced Ovarian Carcinoma
In the phase III NRG Oncology/Gynecologic Oncology Group (GOG)-252 study reported in the Journal of Clinical Oncology, Walker et al found no progression-free survival benefit of postsurgical intraperitoneal (IP) chemotherapy vs intravenous (IV) chemotherapy, each combined with bevacizumab, in...
AUA 2019: OLYMPUS Trial Assesses Mitomycin Gel in Low-Grade Upper Tract Urothelial Carcinoma
Findings from a secondary analysis of the phase III OLYMPUS trial were presented by Kleinmann et al during the Plenary Session at the 2019 American Urological Association (AUA) Annual Meeting (Abstract LBA-16). Results showed that instillation of UGN-101, an investigational formulation of mitomycin ...
ASBrS 2019: Bioimpedance Spectroscopy for Surveillance of Breast Cancer–Related Lymphedema
Surveillance of women at risk for breast cancer–related lymphedema using bioimpedance spectroscopy was more effective in preventing lymphedema progression than traditional arm circumference measurement when each was combined with immediate compression therapy. These were the results of an...
FDA Approves First-Line Ivosidenib for IDH1-Mutated AML
On May 2, the U.S. Food and Drug Administration (FDA) expanded its approval of ivosidenib (Tibsovo) to include newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, in patients who are at least 75 years old or who have comorbidities that ...
ESTRO 38: Radiotherapy After ABVD May Improve Survival in Advanced Hodgkin Lymphoma
Patients with advanced Hodgkin lymphoma with bulky lesions at the time of diagnosis may benefit from radiotherapy after chemotherapy, according to late-breaking results presented by Ricardi et al at ESTRO 38, the annual congress of the European Society for Radiotherapy & Oncology...
ESTRO 38: Long-Term Results of Adjuvant Radiotherapy Plus Antihormonal Treatment in Hormone Receptor–Positive Breast Cancer
Women with early-stage, low-risk, hormone receptor–positive breast cancer may be less likely to experience disease recurrence if they have radiotherapy after surgery as well as antihormonal treatment, according to results from a trial that has followed 869 women for 10 years. These findings...
ESMO Breast Cancer 2019: Does Continuous Chemotherapy Benefit Patients With Advanced Breast Cancer?
Continuous chemotherapy showed greater benefit in patients with advanced breast cancer by both improving survival and maintaining quality of life compared to intermittent scheduling, according to analyses of the Stop&Go study presented by Erdkamp et al and Claessens et al at the European...
FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
On April 15, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing...
Ramucirumab After Sorafenib in Advanced Hepatocellular Carcinoma: An Efficacious Therapy With Applicability Challenges
In the 2 years since the U.S. Food and Drug Administration’s (FDA) approval of regorafenib in the treatment of patients with sorafenib-refractory advanced hepatocellular carcinoma, we oncologists have witnessed a veritable avalanche of newly approved medicines for the treatment of advanced...
Expert Point of View: High-Risk Smoldering Multiple Myeloma
IN SPITE of the high response rates and lack of progression to active disease with the regimens described at the 2018 American Society of Hematology Meeting & Exposition, several myeloma experts interviewed by The ASCO Post said the data do not yet move them to routinely intervene in high-risk...
Expert Point of View: Aaron S. Mansfield, MD
The discussant of the STELLAR trial abstract, Aaron S. Mansfield, MD, a translational scientist at the Mayo Clinic in Rochester, called the survival outcomes “very promising” for a trial that included a relatively large population of patients with the more aggressive sarcomatoid variant of...
Tumor-Treating Fields Plus Chemotherapy Improved Survival in Unresectable Malignant Pleural Mesothelioma
The addition of tumor-treating fields to standard-of-care chemotherapy has been found to be safe and effective in the treatment of unresectable malignant pleural mesothelioma. Data presented at the 2019 Multidisciplinary Thoracic Cancers Symposium showed that patients receiving the combination of...
The Microbiome: The Next Target in Cancer Therapy
With the recent breakthroughs in immunotherapy, treatments that modulate the immune system are now being used across numerous cancer types and across the spectrum of disease with significant success, but not all patients achieve objective responses. There is still a critical need to better...
Phase III Data Support Use of Gilteritinib in Relapsed or Refractory FLT3-Mutated AML
Treatment with gilteritinib, an oral type 1, FLT inhibitor, significantly improved overall survival compared with chemotherapy in patients with FLT3-positive relapsed or refractory acute myeloid leukemia (AML), according to the final results of the phase III ADMIRAL trial.1 The longest survival for ...
FDA Approves Pembrolizumab Plus Axitinib for First-Line Treatment of Advanced Renal Cell Carcinoma
On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...
FDA Grants Accelerated Approval to Erdafitinib for Metastatic Urothelial Carcinoma
Today, the U.S. Food and Drug Administration (FDA) granted accelerated approval to erdafitinib (Balversa) for patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 or FGFR2 genetic alterations that has progressed during or following platinum-containing...
FDA Expands Pembrolizumab Indication for NSCLC in First-Line Setting
Today, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) for the first-line treatment of patients with stage III non–small cell lung cancer (NSCLC) who are not candidates for surgical resection or definitive chemoradiation, or those with metastatic NSCLC....
Vaccine Plus Trastuzumab in Preventing Recurrence of HER2–Low-Expressing Breast Cancer
IN HIGH-RISK patients with breast cancer and low expression of HER2 (HER2 low), a peptide vaccine targeting HER2, combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), and given concurrently with trastuzumab, may help to prevent recurrence. Final analysis of a randomized phase...
Maitake Mushroom
GUEST EDITOR Integrative Oncology is guest edited by Jun J. Mao, MD, MSCE, Laurance S. Rockefeller Chair in Integrative Medicine and Chief of Integrative Medicine Service at Memorial Sloan Kettering Cancer Center, New York. The ASCO Post’s Integrative Oncology series is intended to...
Advanced HER2-Positive Breast Cancer: All Eyes on These Novel Agents
NEW AGENTS for the treatment of advanced HER2-positive breast cancer should be coming soon to your clinic, according to Sara A. Hurvitz, MD, Director of the Breast Cancer Clinical Research Program and Associate Professor of Medicine at the David Geffen School of Medicine at the University of...
Study Finds Shorter Treatment Course for Rectal Cancer May Actually Improve Outcomes
In patients with locally advanced rectal cancer, the delivery of all radiotherapy and chemotherapy neoadjuvantly—with a shorter course of radiation—may improve the chance of complete response and downstaging over conventional treatment, according to investigators from Washington University, St....
Study Finds Pembrolizumab Active in Advanced Non–Clear Cell Kidney Cancer
IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Response rates were...
Enzalutamide Plus ADT Extends Progression-Free Survival in Metastatic Hormone-Sensitive Prostate Cancer
Adding enzalutamide to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of disease progression or death by 61% compared with ADT plus placebo, according to the results of the ...
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),...
Antibody-Drug Conjugate Shows Activity in Heavily Pretreated Bladder Cancer
PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...
SBRT vs Conventionally Fractionated, or Moderately Hypofractionated External-Beam Radiotherapy, for Localized Prostate Cancer
TREATMENT WITH stereotactic body radiation therapy (SBRT) results in a similar safety profile to conventionally fractionated, or moderately hypofractionated external-beam radiotherapy, in men with low- or intermediate- risk prostate cancer, according to preliminary results of the Prostate Advances ...
Interim Analysis of the ARCHES Trial: Enzalutamide Plus Androgen-Deprivation Therapy for Metastatic Hormone-Sensitive Prostate Cancer
ADDING ENZALUTAMIDE to androgen-deprivation therapy (ADT) significantly prolonged radiographic progression-free survival in men with metastatic hormone-sensitive prostate cancer, reducing the risk of progression or death by 61% compared with ADT plus placebo, according to results of the phase III...
Nivolumab/Ipilimumab in Intermediate- and Poor-Risk Advanced Renal Cell Carcinoma
NIVOLUMAB PLUS low-dose ipilimumab continued to demonstrate strong responses as well as a survival benefit with a median of 32.4 months of follow-up as front-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, according to an update of the phase II CheckMate...
AACR 2019: Maintenance Rucaparib Treatment in BRCA- or PALB2-Mutated Pancreatic Cancer
Maintenance treatment with the PARP inhibitor rucaparib was well tolerated and showed activity among patients with advanced BRCA- or PALB2-mutated pancreatic cancer sensitive to platinum-based chemotherapy, according to results from an interim analysis of an ongoing phase II clinical...
AACR 2019: Entinostat Plus Pembrolizumab in Patients With Melanoma Previously Treated With Anti–PD-1 Therapy
A combination of the experimental histone deacetylase (HDAC) inhibitor entinostat with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab showed clinical responses in patients with melanoma that had progressed on prior anti–PD-1 treatment, according to results from the phase...
AACR 2019: Gilteritinib in Patients With FLT3-Mutated Acute Myeloid Leukemia
Treatment with the FLT3-targeted therapeutic gilteritinib improved survival for patients with relapsed or refractory acute myeloid leukemia (AML) harboring an FLT3 mutation compared with standard chemotherapy regimens, according to results from the phase III ADMIRAL trial presented by Perl et al at ...
FDA Pipeline: Mammography Policies, Designations for Leukemias and Myelodysplastic Syndrome
This week, the U.S. Food and Drug Administration (FDA) announced policy changes to modernize mammography policies and issued a Breakthrough Therapy designation, an Orphan Drug designation, and an investigational new drug application. FDA Advances Policy Changes to Modernize Mammography Services...
Prostatectomy vs Watchful Waiting: Clinical Dilemma Centers on Aggressive vs Indolent Disease
THE MANAGEMENT of localized prostate cancer remains controversial. Although the widespread use of prostate-specific antigen (PSA) testing has resulted in a dramatic increase in the diagnosis and treatment of prostate cancer, many men do not benefit from intervention because the disease is either...
Maintenance Ixazomib Delays Disease Progression in Newly Diagnosed Myeloma
IN PATIENTS with newly diagnosed multiple myeloma who responded well to induction therapy and underwent transplant, 2 years of maintenance therapy with ixazomib led to a 38% improvement in progression-free survival compared with placebo, according to the results of the phase III TOURMALINE-MM3...
Expert Point of View: Ajay K. Nooka, MD, MPH
THE ASCO POST asked Ajay K. Nooka, MD, MPH, Associate Professor, Division of Bone Marrow Transplant at Winship Cancer Institute, Emory University, to comment on studies involving daratumumab. “After the phase III SWOG S0777 trial demonstrated a survival benefit with a 3-drug induction regimen...
Antibody-Drug Conjugate Shows Activity in Heavily Pretreated Bladder Cancer
PRELIMINARY EVIDENCE suggests that the antibody-drug conjugate sacituzumab govitecan is active in patients previously treated with chemotherapy or checkpoint inhibitor therapy for metastatic urothelial cancer. These results from a phase I/II basket study of this agent were presented at the 2019...
New Data in Colorectal, Neuroendocrine, Gastric, and Hepatocellular Cancers
THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...
CheckMate 384 Supports More Convenient Dosing of Nivolumab in Advanced NSCLC
PATIENTS WITH advanced non–small cell lung cancer (NSCLC) may no longer have to come to the clinic every 2 weeks for treatment. According to a descriptive analysis of the phase IIIb/IV CheckMate 384 study, a more convenient dosing option of nivolumab has demonstrated convincing short-term safety...
SGO 2019: Post Hoc Exploratory Analyses From the ARIEL3 Trial in Recurrent Ovarian Cancer
Data from post hoc exploratory analyses from the phase III ARIEL3 clinical study of rucaparib in recurrent ovarian cancer was presented during oral plenary and poster sessions at the Society of Gynecologic Oncology’s (SGO) 50th Annual Meeting on Women’s Cancer. These analyses...
SGO 2019: Dendritic Cell–Based Immunotherapy in Combination With Chemotherapy in Recurrent Ovarian Cancer
Results from a clinical trial presented by Cibula et al at the Society of Gynecologic Oncology’s (SGO) 50th Annual Meeting on Women’s Cancer showed that a new immunotherapy treatment significantly prolongs survival in women with recurrent ovarian cancer when added to standard...
The Risks of Drug Approval Based on Shaky Evidence
Two recent publications in The New England Journal of Medicine (NEJM), and the resulting drug approval applications that have already been filed, lead to concern that the basis of medical practice on valid evidence may be corrupted. Each involves statistically shaky analysis leading to a striking...
Assessing the Clinical Utility of ASCO’s and ESMO’s Value Frameworks
In 2015, ASCO and the European Society for Medical Oncology (ESMO) introduced value frameworks that utilize algorithmic scales to evaluate the clinical benefit of cancer therapies and provide an objective assessment of outcomes and treatment toxicities experienced by patients.1,2 Although the two...
Viral Vector–Based Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
In a phase III trial reported in the Journal of Clinical Oncology, Gulley et al found that PROSTVAC, a viral vector-based immunotherapy, did not improve overall survival or 6-month event-free survival vs placebo in patients with asymptomatic or minimally symptomatic metastatic castration-resistant...
Addition of Pegylated Recombinant Human Hyaluronidase to FOLFIRINOX in Metastatic Pancreatic Adenocarcinoma
In the phase I/II SWOG S1313 trial, which was reported in the Journal of Clinical Oncology by Ramanathan et al, researchers found that the addition of pegylated recombinant human hyaluronidase (PEGPH20) to modified (m) FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) worsened...
