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lymphoma

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...

multiple myeloma
immunotherapy

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,...

hematologic malignancies

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 ...

gynecologic cancers
lung cancer
issues in oncology

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...

skin cancer
immunotherapy

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...

issues in oncology
immunotherapy

‘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,...

breast cancer

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,...

gynecologic cancers

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...

colorectal cancer

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 ...

lymphoma
immunotherapy

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 ...

lung cancer

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...

lung cancer

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...

gynecologic cancers
immunotherapy

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...

hematologic malignancies
supportive care

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...

skin cancer
immunotherapy

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...

hematologic malignancies

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...

gynecologic cancers
immunotherapy

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...

breast cancer
immunotherapy

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...

kidney cancer
bladder cancer
prostate cancer
immunotherapy

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...

kidney cancer

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...

breast cancer

Alpelisib Plus Fulvestrant in PIK3CA-Mutant, Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer After Disease Progression

As reported in The Lancet Oncology by Hope S. Rugo, MD, and colleagues, findings in one cohort of the phase II BYLieve trial indicated activity of the PI3Kα-selective inhibitor and degrader alpelisib plus fulvestrant in patients with PIK3CA-mutated, hormone receptor–positive, HER2-negative advanced ...

issues in oncology

Effect of Antihypertensive Medications on Risk of Cancer

In an individual participant data meta-analysis of randomized clinical trials reported in The Lancet Oncology, Emma Copland, MSc, and colleagues found “no consistent evidence” of an association between antihypertensive treatment and risk for cancer. A potential increase in risk was observed for...

bladder cancer
gynecologic cancers
hepatobiliary cancer
solid tumors
colorectal cancer
immunotherapy

FDA Pipeline: Recent Designations in Urothelial Cancer, Cervical Cancer, Cholangiocarcinoma, and More

Recently, the U.S. Food and Drug Administration (FDA) issued regulatory decisions related to treatments for urothelial cancer, cervical cancer, cholangiocarcinoma, solid tumors, and colorectal cancer. Acceptance of Two Supplemental Biologics License Applications for Enfortumab Vedotin-ejfv in...

Expert Point of View: Deborah Armstrong, MD

The invited discussant of the SOLO-1 trial, Deborah Armstrong, MD, Professor of Oncology and Director of the Breast and Ovarian Surveillance Service at Johns Hopkins Medicine, said the update provides “important information for us,” showing that 2 years of maintenance olaparib conveys “a really...

breast cancer

PENELOPE-B: Palbociclib for Residual Invasive HR-Positive, HER2-Negative Early Breast Cancer After Neoadjuvant Chemotherapy

As reported in the Journal of Clinical Oncology by Sibylle Loibl, MD, PhD, and colleagues, the phase III PENELOPE-B trial has shown that palbociclib plus endocrine therapy did not improve invasive disease–free survival vs placebo plus endocrine therapy in patients with residual invasive hormone...

solid tumors

Pediatric Adrenocortical Carcinoma: Different Treatment Strategies by Disease Stage

As reported in the Journal of Clinical Oncology by Carlos Rodriguez-Galindo, MD, and colleagues, the Children’s Oncology Group ARAR0332 Protocol has identified outcomes associated with different treatment strategies according to disease stage in patients with pediatric adrenocortical carcinoma....

head and neck cancer
immunotherapy

Addition of Avelumab to Chemoradiotherapy in Previously Untreated Patients With Locally Advanced Head and Neck Cancer

As reported in The Lancet Oncology by Nancy Y. Lee, MD, and colleagues, the phase III JAVELIN Head and Neck 100 trial showed no improvement in progression-free survival with the addition of the PD-L1 inhibitor avelumab to chemoradiotherapy in patients with previously untreated locally advanced...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

FDA Approves Nivolumab in Combination With Chemotherapy for Metastatic Gastric Cancer and Esophageal Adenocarcinoma

Today, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. CheckMate 649 The efficacy of the...

colorectal cancer
immunotherapy

First-Line Pembrolizumab vs Chemotherapy for MSI-H or dMMR Metastatic Colorectal Cancer: Health-Related Quality of Life

In an analysis from the phase III KEYNOTE-177 trial reported in The Lancet Oncology, Thierry André, MD, and colleagues found that pembrolizumab was associated with clinically meaningful improvements in health-related quality of life (HRQOL) compared with chemotherapy in the first-line treatment of...

gynecologic cancers

Outcomes With MRI-Based Image-Guided Adaptive Brachytherapy for Locally Advanced Cervical Cancer

In an international prospective cohort study (EMBRACE-I) reported in The Lancet Oncology, Pötter et al found that magnetic resonance imaging (MRI)-based image-guided adaptive brachytherapy was associated with a high rate of long-term local disease control and relatively low cumulative severe...

solid tumors

Updated Outcomes for Patients With Metastatic Nonseminomatous Germ Cell Tumors and Development of New Prognostic Model

In a study reported in the Journal of Clinical Oncology, Silke Gillessen, MD, and colleagues in the International Germ Cell Cancer Collaborative Group (IGCCCG) Update Consortium analyzed outcomes in a more contemporary cohort of men with metastatic nonseminomatous germ cell tumors. They also...

breast cancer

Addition of Alpelisib to Fulvestrant for PIK3CA-Mutant, HR-Positive, HER2-Negative Advanced Breast Cancer: Patient-Reported Outcomes

In an analysis from the PIK3CA-mutant cohort of the phase III SOLAR-1 trial reported in the Journal of Clinical Oncology, Eva Ciruelos, MD, PhD, and colleagues found that the addition of alpelisib to fulvestrant was not associated with significant worsening of global health status/quality of life...

lymphoma
immunotherapy

Integration of Brentuximab Vedotin Into Front-Line Treatment for Pediatric Patients With High-Risk Hodgkin Lymphoma

In a study reported in the Journal of Clinical Oncology, Metzger et al found that the integration of brentuximab vedotin into front-line treatment of pediatric patients with high-risk classical Hodgkin lymphoma resulted in avoidance of radiotherapy in many patients, as well as high rates of...

gynecologic cancers
genomics/genetics

Genome-Wide Association Study of Variants Linked to Cervical Preinvasive and Invasive Disease

In a genome-wide association study reported in The Lancet Oncology, Bowden et al identified six independent variants among the PAX8, CLPTM1L, and HLA genes that were associated with risk for invasive cervical cancer or cervical intraepithelial neoplasia grade 3 (CIN3). As stated by the...

covid-19
immunotherapy

Short-Term Safety of the BNT162b2 mRNA COVID-19 Vaccine in Patients Receiving Immunotherapy

In an Israeli case-control study reported in a commentary in The Lancet Oncology, Waissengrin et al found that the short-term safety of the Pfizer BNT162b2 mRNA COVID-19 vaccine was similar in patients with cancer receiving immune checkpoint inhibitors compared with healthy controls. Study Details...

head and neck cancer

Squamous Cell Carcinoma of the Head and Neck: Current Status and Future Directions

Although head and neck cancers include multiple histologies and primary sites, squamous cell carcinomas (SCC) originating in the oropharynx, oral cavity, larynx, or hypopharynx are the most common. Today, we recognize different types of head and neck cancers, primarily those that are human...

lung cancer
immunotherapy

First-Line Tislelizumab Plus Chemotherapy vs Chemotherapy Alone in Advanced Squamous NSCLC

In the Chinese phase III RATIONALE 307 trial reported in JAMA Oncology, Wang et al found that tislelizumab plus chemotherapy significantly prolonged progression-free survival vs chemotherapy alone in the first-line treatment of patients with advanced squamous non–small cell lung cancer (NSCLC). As...

issues in oncology

Study Evaluates Method to Reduce Medication Errors and Side Effects of Newer Oral Anticancer Drugs

In the German AMBORA trial reported in the Journal of Clinical Oncology, Dürr et al found that an intensified clinical pharmacologic/pharmaceutical care initiative reduced medication errors and severe side effects, as well as improved treatment satisfaction, among patients receiving newer oral...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Adjuvant Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer After Neoadjuvant Chemoradiotherapy: CheckMate 577

As reported in The New England Journal of Medicine by Ronan J. Kelly, MBBCh, MBA, and colleagues, an interim analysis of the phase III CheckMate 577 trial has shown a significant improvement in disease-free survival with adjuvant nivolumab vs placebo in patients with resected esophageal or...

Expert Point of View: Jacqueline S. Garcia, MD

Jacqueline S. Garcia, MD, of Dana-Farber Cancer Institute, who was not involved in this study, agreed that “novel therapies for relapsed/refractory AML that are biomarker-directed are a dire unmet need and may help patients avoid ineffective therapies and unnecessary toxicity.” She noted that 36%...

leukemia

RARA Agonist Plus Azacitidine Shows Encouraging Activity in Relapsed/Refractory AML

The novel agentSY-1425 combined with azacitidine appears to be active in retinoic acid receptor alpha (RARA) superenhancer–positive newly diagnosed and relapsed or refractory acute myeloid leukemia (AML), according to the results of a phase II trial presented at the 2020 American Society of...

cns cancers
immunotherapy

Pediatric Patients With High-Grade Gliomas: Treatment With Oncolytic HSV-1 G207 Immunovirotherapy

In a phase I trial reported at the virtual American Association for Cancer Research (AACR) Annual Meeting 2021 (Abstract CT018) and simultaneously published in The New England Journal of Medicine, Friedman et al found that oncolytic virotherapy with genetically engineered herpes simplex virus-1...

gastrointestinal cancer

Anesthesiologist Volume and Adverse Short-Term Outcomes After Complex Surgery for Gastrointestinal Cancer

In a Canadian study reported in JAMA Surgery, Hallet et al found that higher anesthesiologist volume was associated with reduced risk of short-term adverse postoperative outcomes in patients undergoing complex surgery for gastrointestinal cancer. Study Details The population-based cohort study...

leukemia
immunotherapy

Long-Term Follow-up of Children and Young Adults With B-Cell ALL Treated With CD19 CAR T-Cell Therapy

In a long-term follow-up of a National Cancer Institute (NCI) phase I trial reported in the Journal of Clinical Oncology, Nirali N. Shah, MD, and colleagues found that autologous CD19 chimeric antigen receptor (CAR) T-cell therapy followed by allogeneic hematopoietic stem cell transplantation can...

lymphoma

Matthew J. Matasar, MD, on Indolent NHL: New Data on Copanlisib Plus Rituximab

Matthew J. Matasar, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III results of the CHRONOS-3 trial, which showed that copanlisib plus rituximab led to a 48% reduction in the risk of disease progression or death compared with placebo plus rituximab in patients with relapsed...

lung cancer
immunotherapy

Neoadjuvant Nivolumab Plus Chemotherapy Boosts Pathologic Complete Response Rate for Patients With Resectable NSCLC

Neoadjuvant nivolumab plus platinum-doublet chemotherapy significantly improved pathologic complete response (pCR) rates compared with chemotherapy alone in patients with resectable stage IB to IIIA non–small cell lung cancer (NSCLC), according to results of the randomized, phase III, open-label...

lymphoma

Copanlisib/Rituximab Extends Progression-Free Survival vs Rituximab/Placebo in Indolent Non-Hodgkin Lymphoma

The combination of copanlisib plus rituximab reduced the risk of disease progression or death by 48% compared with placebo plus rituximab in patients with indolent non-Hodgkin lymphoma, according to results of the phase III CHRONOS-3 trial presented by Matthew J. Matasar, MD, at the virtual...

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