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Showing 4651 - 4700FDA Grants Accelerated Approval to Pembrolizumab Combination for HER2-Positive Gastric Cancer
On May 5, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic...
Expanding Role of Liquid Biopsies in Cancer Detection and Therapeutics: Now and in the Near Future
“It is possible that within the next several years, perhaps 75% of cancers can be detected by screening,” Bert Vogelstein, MD, PhD, projected at the Society of Surgical Oncology (SSO) 2021 International Conference on Surgical Cancer Care.1 “I anticipate that perhaps 50% of cancers can be detected...
One vs Two Doses of the BNT162b2 COVID-19 Vaccine in Patients With Cancer: Immunogenicity and Efficacy
In an interim analysis of a prospective observational study reported in The Lancet Oncology, Monin et al found that a single dose of the BNT162b2 Pfizer–BioNTech COVID-19 vaccine was poorly immunogenic in patients with cancer, with immunogenicity markedly improving at 2 weeks after a second dose...
Variations in Testing and Treatment Across Medical Specialties for Men Initiating Active Surveillance for Prostate Cancer
In a study reported in JCO Oncology Practice, Lai et al found that although the majority of men who have initiated active surveillance for prostate cancer are followed by urologists, some are managed by physicians in other specialties, and that testing and subsequent treatment patterns vary across...
FDA Pipeline: Priority Reviews of Treatments for Bladder and Lung Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review designation to treatments for surgically resected, high-risk, muscle-invasive urothelial carcinoma and epidermal growth factor receptor exon 20 insertion mutation–positive metastatic non–small cell lung cancer (NSCLC)....
Brentuximab Vedotin Plus Chemotherapy in Newly Diagnosed Early-Stage Unfavorable-Risk Hodgkin Lymphoma
In a pilot study reported in the Journal of Clinical Oncology, Kumar et al found that the combination of brentuximab vedotin with AVD (doxorubicin, vinblastine, and dacarbazine) was highly active in patients with newly diagnosed, early-stage, unfavorable-risk Hodgkin lymphoma and may permit the...
Antiviral T Cells for BK Virus–Associated Hemorrhagic Cystitis
A phase II trial has found found that BK virus (BKV)-specific T cells from healthy donors were safe and effective as an off-the-shelf therapy for BKV-associated hemorrhagic cystitis, a painful complication that is common after allogeneic stem cell transplants for patients with leukemia or lymphoma. ...
First-Line Single-Agent Carboplatin vs Carboplatin/Paclitaxel in Older Women With Ovarian Cancer
In a phase II trial reported in JAMA Oncology, Falandry et al found that single-agent carboplatin was associated with poorer survival vs a standard carboplatin/paclitaxel regimen as first-line treatment for stage III/IV ovarian cancer in women aged 70 or older with high geriatric vulnerability...
More From the FDA ODAC: Votes on Agents for Pretreated Hepatocellular Carcinoma and Gastric Cancer
More news has emerged from this week’s meeting of the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC). The group voted 8 to 0 in favor of continuing the accelerated approval for pembrolizumab in sorafenib-pretreated patients with hepatocellular carcinoma; 6 to 2...
Five-Year Efficacy Outcomes With Pembrolizumab vs Chemotherapy in Metastatic NSCLC With PD-L1 Tumor Proportion Score of at Least 50%
As reported by Martin Reck, MD, PhD, and colleagues in the Journal of Clinical Oncology, the 5-year follow-up of the pivotal phase III KEYNOTE-024 trial shows maintained overall survival benefit in patients treated with pembrolizumab vs chemotherapy—despite substantial crossover to the...
Fertility Concerns May Influence Decisions About Endocrine Therapy in Young Women With Breast Cancer
Concerns about fertility often influence how young women with breast cancer approach treatment decisions and are a reason for forgoing or delaying hormone-blocking therapy, according to findings from a recent study published by Sella et al in the journal Cancer. The findings reinforce the need for...
Contralateral Esophagus-Sparing Radiotherapy Technique Reduces Rates of Esophagitis in Patients With Lung Cancer Receiving High-Dose Chemoradiation
In a small, single-institution phase I trial reported in JAMA Oncology, Kamran et al found that the use of a contralateral esophagus-sparing radiotherapy technique in patients receiving high-dose chemoradiation for locally advanced lung cancer was associated with no cases of grade ≥ 3 esophagitis,...
FDA ODAC Votes in Favor of Retaining Accelerated Approval for Bladder Cancer Treatments
Roche has announced the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining the accelerated approval of atezolizumab for the treatment of adults with locally advanced or metastatic urothelial carcinoma who are not eligible for...
Cryoablation Emerging as Effective Treatment for Low-Risk Breast Cancers
Nonsurgical breast cancer cryoablation, which destroys tumor cells by exposing them to subfreezing temperatures, is proving to be an effective alternative to surgery for small breast tumors with low-risk features in women older than age 60. These were the early findings from 3-year results of the...
Daratumumab in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Newly Diagnosed Multiple Myeloma
Results from the single-institution phase II MANHATTAN study were reported in JAMA Oncology recently by Ola Landgren, MD, PhD, and colleagues. The investigators found that daratumumab in combination with weekly carfilzomib, lenalidomide, and dexamethasone resulted in high rates of minimal residual...
Sacituzumab Govitecan-hziy Improves Survival vs Single-Agent Chemotherapy in Metastatic Triple-Negative Breast Cancer
As reported in The New England Journal of Medicine by Aditya Bardia, MD, of the Division of Medical Oncology, Massachusetts General Hospital Cancer Center, and colleagues, the phase III ASCENT trial has shown prolonged progression-free and overall survival with the Trop-2–directed antibody-drug...
Health-Related Quality of Life With Adjuvant Pembrolizumab vs Placebo in Resected Stage III Melanoma
As reported in The Lancet Oncology by Andrew Bottomley, PhD, and colleagues, an analysis of the phase III EORTC 1325-MG/KEYNOTE-054 trial showed no clinically significant decline in health-related quality of life (HRQoL) with adjuvant pembrolizumab vs placebo in resected high-risk stage III...
Sentinel Lymph Node Biopsy–Navigated vs Elective Neck Dissection for Early Oral Cancer
In a Japanese noninferiority phase III trial reported in the Journal of Clinical Oncology, Hasegawa et al found noninferior survival and improved neck functionality with sentinel lymph node biopsy (SLNB)-navigated neck dissection vs elective neck dissection in patients with previously untreated...
Hormonal Intrauterine Device Under Study for Managing Early Endometrial Cancer
Disease regression was observed in 82% of women with endometrial hyperplasia with atypia and 43% of women with endometrial cancer after treatment for 6 months with a hormonal intrauterine device in a phase II study reported during the virtual edition of the Society of Gynecologic Oncology (SGO)...
Chernobyl at 35 Years: An Oncologist’s Perspective
Editor’s note: Dr. Gale is an authority on medical response to nuclear and radiation accidents and participated in rescue efforts at the Chernobyl disaster, as well as at Goiania, Tokaimura, and Fukushima, among other radiation and nuclear accidents. Anyone reading the popular press or even...
Safety of Stereotactic Body Radiotherapy for Patients With Multiple Metastases
In the phase I NRG-BR001 trial reported in JAMA Oncology, Chmura et al found that stereotactic body radiotherapy (SBRT) could be used safely to treat multiple metastases in patients with breast, lung, and prostate cancers. Study Details The trial was conducted within a consortium of North...
Lobaplatin- vs Cisplatin-Based Induction and Chemoradiotherapy in Previously Untreated Locoregionally Advanced Nasopharyngeal Carcinoma
In a Chinese phase III trial reported in The Lancet Oncology, Lv et al found noninferior progression-free survival with induction therapy with the third-generation platinum lobaplatin/fluorouracil vs cisplatin/fluorouracil, followed by lobaplatin- vs cisplatin-based chemoradiotherapy, in patients...
ROCK2 Inhibitor Belumosudil for Chronic Graft-vs-Host Disease
In a phase IIa study reported in the Journal of Clinical Oncology, Jagasia et al found that the oral ROCK2 inhibitor belumosudil produced high response rates and reduced corticosteroid use among patients with chronic graft-vs-host disease after allogeneic bone marrow or hematopoietic cell...
FDA Grants Accelerated Approval to Loncastuximab Tesirine-lpyl for Large B-Cell Lymphoma
On April 23, the U.S. Food and Drug Administration (FDA) granted accelerated approval to loncastuximab tesirine-lpyl (Zynlonta), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, ...
AACR and The Mark Foundation for Cancer Research Announce New Grants
The American Association for Cancer Research (AACR) and The Mark Foundation for Cancer Research recently announced five grants to support innovative research focused on understanding the influence of a patient’s biology on the genesis, development, treatment, and survivorship of cancer. Each...
How Interested Are Patients in Integrative Therapies, and How Much Are They Willing to Pay for Them?
The top two barriers to accessing complementary and integrative therapies, according to a survey of 576 patients with cancer and caregivers, were cost, cited by 56%, and a lack of knowledge about the therapies, cited by 52.1%. “Other barriers included a lack of time (29.2%), location of the...
Incidence and Cancer-Related Mortality in Belize
Located on the northeast coast of Central America, Belize is a small, upper middle–income country bordered by Mexico, Guatemala, and the Caribbean Sea. Belize has a population of about 405,000 people (Table 1), of which about 15% are immigrants. Belize is considered to be one of the most...
Umbralisib for Previously Treated Relapsed or Refractory Marginal Zone Lymphoma and Follicular Lymphoma
On February 5, 2021, umbralisib was granted accelerated approval for the following indications: adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti–CD20-based regimen and adult patients with relapsed or refractory follicular lymphoma who have...
Anti-BCMA–Directed CAR T-Cell Gene Therapy in Relapsed or Refractory Myeloma
"The noblest pleasure is the joy of understanding.” —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 novel...
A Physician-Scientist’s Mother, Who Nursed Those With Chronic Diseases, Fueled His Passion for Biomedical Research
For this installment of the Living a Full Life series, guest editor Jame Abraham, MD, spoke with Griffin P. Rodgers, MD, MACP, Director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health (NIH). Dr. Rodgers, a physician-scientist,...
Sitagliptin Added to Tacrolimus/Sirolimus Prophylaxis Regimen for Acute Graft-vs-Host Disease After HSCT
In a phase II trial reported in The New England Journal of Medicine, Sherif S. Farag, MD, PhD, of Indiana University School of Medicine, and colleagues found that the addition of the dipeptidyl peptidase 4 (DPP-4; CD26) inhibitor sitagliptin to tacrolimus and sirolimus prophylaxis resulted in a low ...
Transmission of Cancer to Infants From Mothers With Cervical Cancer During Vaginal Delivery
In a brief report in The New England Journal of Medicine, Ayumu Arakawa, MD, of the Department of Pediatric Oncology, National Cancer Center Hospital, Tokyo, and colleagues described identification of lung cancer in two boys that likely resulted from transmission of maternal cervical cancer tumor...
Cemiplimab-rwlc for Locally Advanced and Metastatic Basal Cell Carcinoma
On February 9, 2021, cemiplimab-rwlc was granted regular approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who were previously treated with a Hedgehog pathway inhibitor or for whom this type of therapy is not appropriate and granted accelerated approval for...
‘Dangling’ Accelerated Approvals of Anti–PD-1/PD-L1 Antibodies to Be Discussed at FDA Oncologic Drugs Advisory Committee Meeting
In a Perspective article in The New England Journal of Medicine, Julia A. Beaver, MD, and Richard Pazdur, MD, of the U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCD), discussed issues surrounding “dangling” accelerated approvals of anti–PD-1/PD-L1 antibodies—ie,...
Improvement Programs to Optimize Patient Care for Black Americans With Breast Cancer
Eight oncology practices in eight different U.S. metropolitan areas with high rates of breast cancer disparities between Black and White Americans have been selected to participate in ASCO’s quality programs, including the Quality Oncology Practice Initiative (QOPI®)and Quality Training Program...
Addressing Oncologist Burnout, Emotional Well-Being, and Moral Distress in the Pandemic
JCO Oncology Practice recently published an editorial that examines the intensified burnout oncology practitioners are experiencing due the COVID-19 pandemic and outlines critical interventions to support oncologists now and throughout a long-term recovery.1 The article was written by past,...
Can Brachytherapy for Cervical Cancer Continue After Uterine Perforation?
A study published by Small et al in the journal Brachytherapy found that the common procedure of interstitial or intracavitary radiotherapy may continue safely—potentially without delay or antibiotics—in patients with cervical cancer following uterine perforation. According to the World Health...
Addition of Neoadjuvant FOLFIRINOX to Preoperative Chemoradiotherapy in Locally Advanced Rectal Cancer
As reported in The Lancet Oncology by Thierry Conroy, MD, and colleagues, the French phase III UNICANCER-PRODIGE 23 trial has shown that intensification of preoperative therapy with FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, fluorouracil [5-FU]) prior to chemoradiotherapy resulted in improved ...
Glofitamab for Relapsed or Refractory B-Cell Lymphoma
In a phase I trial reported in the Journal of Clinical Oncology, Hutchings et al found that the bivalent CD20-targeting T-cell–engaging bispecific antibody glofitamab produced high response rates and was associated with manageable toxicity in patients with predominantly refractory aggressive B-cell ...
Nivolumab/Ipilimumab Plus Two Cycles of Histology-Based Chemotherapy: Another Option in First-Line Metastatic NSCLC
Introduction of immunotherapy has revealed a paradigm shift in the management of patients with metastatic non–small cell lung cancer (NSCLC) that does not harbor a therapeutically targetable driver mutation. Over the past 5 years, several trials have informed treatment decisions, based on disease...
First-Line Nivolumab/Ipilimumab Plus Chemotherapy Improves Overall Survival vs Chemotherapy in Stage IV or Recurrent NSCLC
As reported in The Lancet Oncology by Luis Paz-Ares, MD, of the Universidad Complutense & CiberOnc, Madrid, and colleagues, the phase III CheckMate 9LA trial has shown improved overall survival with first-line nivolumab/ipilimumab plus two cycles of chemotherapy vs four cycles of chemotherapy...
FDA Grants Accelerated Approval to Dostarlimab-gxly for dMMR Endometrial Cancer
On April 22, the U.S. Food and Drug Administration (FDA) granted accelerated approval to dostarlimab-gxly (Jemperli) for adult patients with mismatch repair–deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior...
Study Finds Tranexamic Acid Unable to Prevent Bleeding in Patients With Hematologic Malignancies
In the first randomized trial to evaluate prophylactic antifibrinolytic therapy in patients with hematologic malignancies, tranexamic acid failed to reduce bleeding or the need for transfusion vs placebo. The study was featured as a Plenary Session during the 2020 American Society of Hematology...
Expert Point of View: Aaron T. Gerds, MD, MS
Aaron T. Gerds, MD, MS, Associate Professor of Medicine, Deputy Director for Clinical Research at the Cleveland Clinic Taussig Cancer Institute and Medical Director of the Case Comprehensive Cancer Center Clinical Research Office, found the MANIFEST-2 findings to be highly noteworthy. He cited a...
Improvement in Survival With Adjuvant Pembrolizumab for Resected Stage III Melanoma
As reported in The Lancet Oncology by Alexander M.M. Eggermont, MD, and colleagues, the pivotal phase III EORTC 1325/KEYNOTE-054 trial has shown significant improvement in the secondary endpoint of distant metastasis–free survival—as well as continued benefit in the primary endpoint of...
MANIFEST-2: CPI-0610 Shows Benefit in Myelofibrosis
The novel targeted agent CPI-0610 enhanced responses to ruxolitinib in patients with myelofibrosis enrolled in the global phase II MANIFEST-2 trial, investigators reported at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1,2 “Preliminary data demonstrate the...
Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer
In a phase II study (innovaTV 204/GOG-3023/ENGOT-cx6) reported in The Lancet Oncology, Robert L. Coleman, MD, and colleagues found that the tissue factor–directed antibody-drug conjugate tisotumab vedotin produced durable responses in previously treated patients with recurrent or metastatic...
Pembrolizumab Monotherapy for Heavily Pretreated Patients With Metastatic Breast Cancer and High Tumor Mutational Burden
Findings from the ASCO-designed phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket trial, reported in the Journal of Clinical Oncology by Alva et al, indicated that pembrolizumab showed activity in heavily pretreated patients with metastatic breast cancer and high mutational...
Genitourinary Oncology Highlights 2020–2021 Almanac
Landmark changes in the treatment of genitourinary cancers have occurred over the past year, as summarized in this year’s Genitourinary Oncology Almanac from The ASCO Post. Starting with our area of focus, metastatic renal cell carcinoma, the saga continues with two more positive phase III trials...
Two Lenvatinib Combinations Improve Progression-Free Survival vs Sunitinib Alone in First-Line Treatment of Advanced Renal Cell Carcinoma
As reported in The New England Journal of Medicine by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center (MSK), and colleagues, the phase III CLEAR trial has shown prolonged progression-free survival with lenvatinib/pembrolizumab and with lenvatinib/everolimus vs sunitinib and...
