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Showing 13051 - 13100FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy
Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...
Resuming Immune Checkpoint Inhibitor Therapy After Immune-Mediated Diarrhea and Colitis
In a retrospective multicenter study reported in the Journal of Clinical Oncology, Abu-Sbeih et al found that approximately one-third of patients resuming immune checkpoint inhibitor therapy after improvement in immune-mediated diarrhea and colitis experienced a recurrence of the adverse effect....
Patient Perceptions of Management of Cancer-Related Pain, Fatigue, and Emotional Distress in Community Oncology Centers
In a study reported in the Journal of Clinical Oncology, Smith et al found that a high proportion of patients in community cancer centers did not report discussing, getting advice, or receiving desired help for cancer-related pain, fatigue, or emotional distress. The study involved surveys of...
2019 ASCO: Paclitaxel/Carboplatin vs Paclitaxel/Ifosfamide in Carcinosarcoma of the Uterus or Ovary
Results from the phase III NRG Oncology clinical trial GOG 0261 comparing paclitaxel plus carboplatin to paclitaxel plus ifosfamide in women with stage I–IV recurrent carcinosarcoma of the uterus or ovary found that treatment with paclitaxel/carboplatin was not inferior to...
2019 ASCO: OPTiM Study on T-VEC for Unresectable Melanoma
New research on the immunotherapy talimogene laherparepvec (T-VEC)—an injectable oncolytic virus—for patients with unresectable melanoma was presented by Milhem et al at the 2019 ASCO Annual Meeting (Abstract 9524). Researchers reported the ad hoc analysis of progression-free survival...
Survival Improvements for AYA Survivors Undermined by Late-Stage Diagnosis, Racial and Socioeconomic Disparities
The 2006 publication of the National Cancer Institute’s report Closing the Gap: Research and Care Imperatives for Adolescents and Young Adults With Cancer highlighted the lack of improvement in cancer survival among people between the ages of 15 and 39 compared to children and older adults...
2019 ASCO: Long-Term Survival With Dabrafenib Plus Trametinib in Metastatic BRAF-Mutated Melanoma
In an extended analysis of the COMBI-d and COMBI-v trials reported at the 2019 ASCO Annual Meeting (Abstract 9507) and in The New England Journal of Medicine, Robert et al found a 5-year overall survival rate of 34% with the combination of dabrafenib and trametinib in previously untreated...
Clinical Outcomes of Incidental Pulmonary Embolism in Patients With Cancer
In an international prospective cohort study reported in the Journal of Clinical Oncology, Kraaijpoel et al found that incidental pulmonary embolism in patients with cancer is associated with substantial risk of recurrent venous thromboembolism, despite anticoagulant treatment. Study Details The...
2019 ASCO: New TAILORx Data Provide Treatment Guidance for Women Under 50 With Early Breast Cancer
New information about adjuvant therapy to prevent recurrence of breast cancer in women 50 years of age or younger has emerged from the Trial Assigning Individualized Options for Treatment (Rx), or TAILORx. An analysis of a prespecified secondary endpoint in this trial found that an assessment of a ...
2019 ASCO: No Benefit From Pazopanib in Advanced Renal Cell Carcinoma After Metastasectomy
The E2810 trial was conducted to determine whether treatment with the oral drug pazopanib following surgery to remove further metastases in patients with advanced renal cell carcinoma would improve their disease-free survival. Results from the study—which showed that primary endpoint of...
2019 ASCO: Addition of Veliparib to Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer
Results from an experimental arm of the phase II NRG-GI002 trial using veliparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, as part of total neoadjuvant therapy (induction chemotherapy followed by chemoradiotherapy and surgery) in patients with locally advanced rectal adenocarcinoma were...
2019 ASCO: TOPARP-B Finds Olaparib Shows Efficacy in Men With BRCA-Mutant Prostate Cancer
The poly (ADP-ribose) polymerase (PARP) inhibitor olaparib may benefit some men with prostate cancer, according to findings from the phase II TOPARP-B trial presented by Mateo et al at the 2019 ASCO Annual Meeting (Abstract 5005). Olaparib previously showed activity against metastatic...
2019 ASCO: Combination Therapy With SurVaxM in Newly Diagnosed Glioblastoma
Ahluwalia et al shared research results on SurVaxM at the 2019 ASCO Annual Meeting, reporting that combination therapy with the immunotherapy vaccine was more effective than standard therapy for nearly all patients with newly diagnosed glioblastoma in a phase II trial (Abstract 2016). SurVaxM...
Medicaid Expansion and Colorectal Cancer Screening
A new study examining Medicaid expansion and cancer screening found that the five states and District of Columbia that first adopted Medicaid expansion saw larger increases in colorectal cancer screening than states that did not expand Medicaid. The study—published by Fedewa et al in...
2019 ASCO: CLL14 Trial Evaluates First-Line Venetoclax/Obinutuzumab in Previously Untreated CLL
The phase III CLL14 trial—reported by Fischer et al at the 2019 ASCO Annual Meeting (Abstract 7502) and in The New England Journal of Medicine—found that the BCL2 inhibitor venetoclax plus the monoclonal antibody obinutuzumab prolonged progression-free survival vs obinutuzumab and...
CheckMate 205: Nivolumab in Newly Diagnosed, Advanced Classical Hodgkin Lymphoma
Findings in a cohort of the phase II CheckMate 205 study, reported in the Journal of Clinical Oncology by Ramchandren et al, indicate that nivolumab monotherapy followed by nivolumab plus doxorubicin, vinblastine, and dacarbazine (N-AVD) is highly active in newly diagnosed, advanced-stage classical ...
2019 ASCO: Subgroups of Patients With Low-Grade Glioma May Benefit From PCV Chemotherapy Plus Radiotherapy
A recent, updated predictive analysis of the three World Health Organization (WHO)-defined molecular subgroups based on IDH mutation status and 1p/19q codeletion status represented in the high-risk treatment arms of a phase III trial found that both IDH-mutant subgroups may derive benefit ...
2019 ASCO: Discrimination, Gender Bias in Oncology Training and Professional Meetings
Two studies that explored types of discrimination and gender bias in health-care organizations were presented at the 2019 ASCO Annual Meeting. Discrimination Experienced by Fellows An abstract that reviewed discrimination and inclusion among hematology and oncology trainees was presented by...
Cancer-Specific and Other-Cause Mortality Among Black Men With Prostate Cancer
In a study reported in JAMA Oncology, Dess et al found that after adjustment for nonbiologic differences, black men with nonmetastatic prostate cancer did not appear to have higher rates of prostate cancer–specific mortality vs white men. Black patients had higher rates of other-cause...
Prognostic Significance of PET Score in Early-Stage Hodgkin Lymphoma
In an analysis from the UK RAPID study reported in the Journal of Clinical Oncology, Barrington et al found that a postchemotherapy positron-emission tomography (PET) score of 5 was associated with poorer outcomes among patients with early-stage Hodgkin lymphoma. Study Details In the trial,...
FDA Approves Pembrolizumab for the First-Line Treatment of Head and Neck Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved the anti–programmed cell death protein 1 immunotherapy pembrolizumab (Keytruda) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma. Pembrolizumab was...
FDA Approves Polatuzumab Vedotin-piiq in Combination With Bendamustine and a Rituximab Product for DLBCL
On June 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to polatuzumab vedotin-piiq (Polivy), a CD79b-directed antibody-drug conjugate, in combination with bendamustine and a rituximab product for adult patients with relapsed or refractory diffuse large B-cell lymphoma...
NCI Annual Report to the Nation on the Status of Cancer
The latest Annual Report to the Nation on the Status of Cancer finds that, for all cancer sites combined, cancer death rates continued to decline in men, women, and children in the United States from 1999 to 2016. Overall cancer incidence rates, or rates of new cancers, decreased in men from 2008...
As My Outside World Became Smaller, My Family Focus Became Larger
As I write this, I think I’m making sense but am not 100% sure. My brain is a little scrambled after nearly 4 years of treatment for grade 4 glioblastoma multiforme, but I think the essence of my humor and humanity is still intact. When I experienced my first partial seizure while riding my...
Addition of a Tyrosine Kinase Inhibitor to Immunotherapy in Advanced Sarcomas
In a phase II trial reported in The Lancet Oncology, Breelyn Wilky, MD, and colleagues found evidence of activity of axitinib plus pembrolizumab in advanced sarcomas, including alveolar soft-part sarcoma. Study Details The study involved 33 patients with advanced or metastatic sarcomas, including...
Addition of Bevacizumab to Erlotinib Improves Progression-Free Survival in EGFR-Mutated, Nonsquamous NSCLC
In an interim analysis of the phase III NEJ026 trial reported in The Lancet Oncology, Makoto Maemondo, MD, and colleagues found that the addition of bevacizumab to erlotinib improved progression-free survival in patients with EGFR-positive, nonsquamous non–small cell lung cancer (NSCLC). In the...
George Laramore, MD, PhD, FACR, FASTRO, Awarded National Association for Proton Therapy Lifetime Achievement Award
The Board of Directors of the National Association for Proton Therapy (NAPT) has awarded George Laramore, MD, PhD, FACR, FASTRO, of the Seattle Cancer Care Alliance Proton Therapy Center and the University of Washington, the 2019 NAPT Lifetime Achievement Award, in recognition of his decades of...
Ronald Walters, MD, and Ruth O’Regan, MD, Elected to NCCN Board of Directors
The National Comprehensive Cancer Network® (NCCN®) recently announced the election of Ronald Walters, MD, to the role of Chair of the Board of Directors and Ruth O’Regan, MD, was named Vice Chair. Dr. Walters is Associate Head for the Institute for Cancer Care Innovation and a breast cancer...
From Leeches to Liquid Biopsy: Uncovering the Mysteries of Blood
BOOKMARK Title: Nine Pints: A Journey Through the Money, Medicine, and Mysteries of BloodAuthor: Rose GeorgePublisher: Metropolitan BooksPublication date: October 2018Price: $27.00, hardcover, 368 pages Blood has been mythologized and misunderstood since the earliest records of humankind and still ...
Scientist, Father of A Child With Autism Pushes Back on the Antivaccine Movement
BOOKMARK Title: Vaccines Did Not Cause Rachel’s Autism: My Journey as a Vaccine Scientist, Pediatrician, and Autism DadAuthor: Peter J. Hotez, MD, PhDPublisher: Johns Hopkins University PressPublication date: October 2018Price: $22.95, hardcover; 240 pages English physician Edward Jenner invented...
Major Settlement Raises Questions About Evidence-Based Value in Cancer Care
An Oklahoma jury recently awarded $25.5 million to the widower of a 53-year-old woman diagnosed with stage IV nasopharyngeal cancer who was denied coverage for proton therapy by her health insurer, Aetna. The patient’s family subsequently raised $92,000 to cover her proton therapy at The University ...
Cytogenetic Prognostic Index for Survival in Multiple Myeloma
In a study reported in the Journal of Clinical Oncology, Perrot et al identified a cytogenetic prognostic index predictive of survival in patients with newly diagnosed multiple myeloma. Study Details The study involved data from 1,635 patients in four trials conducted by the Intergroupe...
Adverse Events and Outcomes in Patients Receiving Anti–PD-1/PD-L1 Antibody Treatment for Advanced Urothelial Cancer
In an analysis reported in the Journal of Clinical Oncology, Maher et al found that treatment-related adverse events of special interest and immune-mediated adverse events were more common among patients with advanced urothelial cancer with vs without response to anti–programmed cell death...
Selected Abstracts From the 2019 ASCO Annual Meeting
To complement The ASCO Post’s comprehensive coverage of the 2019 ASCO Annual Meeting, here are several abstracts selected from the meeting proceedings focusing on novel therapeutic regimens for plasma cell dyscrasias, particularly multiple myeloma. For full details of these study abstracts, visit ...
FDA Pipeline: Reviews and Designations in Multiple Myeloma, Lymphoma, Prostate Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review for daratumumab in combination with a triplet therapy in multiple myeloma, Breakthrough Therapy designation to copanlisib for marginal zone lymphoma, and Fast Track designation for ARV-110 in metastatic...
Ibrutinib in Combination With Obinutuzumab in Treatment-Naive CLL/SLL
In the Clinic provides overviews of novel hematology and oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Early in 2019, ibrutinib was approved for...
2019 ASCO: NEOSTAR: Neoadjuvant Nivolumab Plus Ipilimumab in Early-Stage, Resectable NSCLC
Neoadjuvant treatment with nivolumab plus ipilimumab resulted in an overall major pathologic response rate of 33% of treated patients with early-stage, resectable non–small cell lung cancer (NSCLC). With these results, the combination immunotherapy met the prespecified trial...
Aspirin Use and Cancer Prevention: Long-Term Data Needed on Benefits and Risks
In addition to its well-known cardioprotective benefits, aspirin has a substantial body of observational, preclinical, and clinical evidence supporting its efficacy in preventing cancer, most strongly for colorectal cancer.1 The strength of this evidence led the U.S. Preventive Services Task...
Regular Aspirin Use and Risk of Hepatocellular Carcinoma and Epithelial Ovarian Cancer
Data from two large U.S. prospective cohort studies indicate the benefits of regular aspirin use in preventing hepatocellular carcinoma and epithelial ovarian cancer. As reported by Tracey G. Simon, MD, MPH, of Massachusetts General Hospital, Harvard Medical School, and colleagues, in JAMA...
2019 Integra Connect Golf Classic Raises More Than $1 Million for Conquer Cancer®, the ASCO Foundation
Conquer Cancer Board Member Raj Mantena, RPh, Founder and Chief Executive Officer of Integra Connect™, recently organized and sponsored the second Integra Connect Golf Classic and a dinner benefitting Conquer Cancer. More than $1 million was raised at the 2-day event, which took place March 31 and...
Expert Point of View: Kristin Higgins, MD
The discussant of the abstract on the use of prophylactic cranial irradiation in patients with extensive-stage small-cell lung cancer (SCLC), Kristin Higgins, MD, underscored the marked shift in practice patterns in the United States. However, she noted that many questions remain concerning...
Survey Finds Prophylactic Cranial Irradiation Use in Decline for Extensive-Stage Small Cell Lung Cancer
Delivery of prophylactic cranial irradiation to patients with extensive-stage small cell lung cancer (SCLC) has declined significantly since the publication of a study by Takahashi et al, according to a recent survey of academic radiation oncologists.1 Data presented at the 2019 Multidisciplinary...
Expert Point of View: Jeffrey S. Falk, MD
Jeffrey S. Falk, MD, a surgical oncologist at the Ascension Saint John Hospital in Grosse Pointe Woods, Michigan, commented on these studies of same-day mastectomy and home recovery programs: “The impetus behind these two significant quality-improvement studies was to allow patients to recover...
Studies Report Early Success With Same-Day Mastectomy and Home Recovery Programs
Patients can safely recover from mastectomy at home, according to two studies reported at the 2019 American Society of Breast Surgeons Annual Meeting.1,2 The studies examined outcomes after implementation of comprehensive postmastectomy surgical home recovery programs, showing that they...
Nipple-Sparing Mastectomy May Be Suitable for Growing Number of Well-Selected Patients
As nipple-sparing mastectomy gains favor, it is being performed on a broader spectrum of patients once considered off limits by surgeons. A Mayo Clinic study in a contemporary cohort found no increase in complication rates or decrease in reconstruction success with this surgical approach.1 “We...
Using Bioimpedance Spectroscopy to Prevent Progression of Lymphedema
Surveillance of women at risk for breast cancer–related lymphedema using bioimpedance spectroscopy was more effective in preventing lymphedema progression than traditional measurement of arm circumference, when each is combined with immediate compression therapy. These findings came from the...
Head and Neck Cancer Immunotherapy in Locally Advanced Disease: Clinical Trial Updates
Programmed cell death protein 1 (PD-1) inhibitors are approved for the second-line treatment of head and neck cancer and likely will be soon in the first-line treatment of locally advanced disease. According to Robert L. Ferris, MD, PhD, developments in immunotherapy for this population should be...
Pembrolizumab Improves Survival vs Chemotherapy in Previously Untreated Advanced NSCLC With PD-L1 Expression ≥ 1%
As reported in The Lancet by Tony S.K. Mok, MD, of Chinese University of Hong Kong, and colleagues, the KEYNOTE-042 trial has shown an improvement in overall survival with pembrolizumab vs standard chemotherapy in previously untreated patients with locally advanced or metastatic non–small cell lung ...
Ruxolitinib Approved for Acute Graft-vs-Host Disease
On May 24, the U.S. Food and Drug Administration (FDA) approved ruxolitinib (Jakafi) for steroid-refractory acute graft-vs-host disease (GVHD) in adult and pediatric patients 12 years and older. Approval was based on the REACH1 trial/Study INCB 18424-271, an open-label, single-arm, multicenter...
NovoTTF-100L System in Combination With Chemotherapy Approved for Malignant Pleural Mesothelioma
On May 23, the U.S. Food and Drug Administration (FDA) approved the NovoTTF-100L System in combination with pemetrexed plus platinum-based chemotherapy for the first-line treatment of unresectable locally advanced or metastatic malignant pleural mesothelioma. NovoTTF-100L is a noninvasive,...
