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...
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...
Pembrolizumab in Microsatellite Instability–High Advanced Gastric or Gastroesophageal Junction Cancer
In an analysis reported in JAMA Oncology, Joseph Chao, MD, and colleagues found improved outcomes with pembrolizumab treatment in patients with microsatellite instability–high (MSI-H) advanced gastric or gastroesophageal junction cancer, irrespective of line of treatment. The findings suggest that...
Gene Sequencing, Esophageal Brushings May Identify Patients With Barrett’s Esophagus at Risk for Cancer Progression
A combination of esophageal brushing and extensive genetic sequencing of the sample collected may detect chromosome alterations in people with Barrett’s esophagus, identifying patients at risk for progressing to esophageal cancer. These findings were published by Douville et al in ...
Mary F. Mulcahy, MD, and Crystal S. Denlinger, MD, on NCCN Guidelines Updates: Gastric and Esophageal Cancers
Crystal S. Denlinger, MD, of Fox Chase Cancer Center, and Mary F. Mulcahy, MD, of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University, discuss biomarkers for determining treatment; immune checkpoint inhibitors; when to employ such treatments as platinum/fluoropyrimidine and fam-trastuzumab deruxtecan-nxki; and other second- or later-line therapies such as paclitaxel, ramucirumab, irinotecan-based regimens, and trifluridine/tipiracil.
Locally Advanced Esophageal Cancer: Neoadjuvant Chemoradiotherapy vs Chemotherapy Followed by Minimally Invasive Esophagectomy
In an early analysis from a Chinese phase III trial reported in JAMA Surgery, Wang et al found similar safety and improved histopathologic outcome among patients undergoing minimally invasive esophagectomy for locally advanced esophageal squamous cell carcinoma following neoadjuvant...
Adjuvant Nivolumab in Resected Esophageal or Gastroesophageal Junction Cancer Following Neoadjuvant Chemoradiation Therapy
Adjuvant nivolumab is the first therapy to provide a statistically significant and clinically meaningful improvement in disease-free survival in patients with resected esophageal and gastroesophageal junction cancer, according to research presented by Guillaume Piessen, MD, PhD, and colleagues at...
Expert Point of View: Rutika Mehta, MD, MPH
The FIGHT study’s invited discussant, Rutika Mehta, MD, MPH, a gastrointestinal oncologist at Moffitt Cancer Center, Tampa, Florida, noted the emergence of new biomarkers and their targeted agents in HER2-negative gastric or gastroesophageal junction cancer. Two important ones are FGFR2b—now...
Targeting FGFR2b With Bemarituzumab Plus Chemotherapy in Gastric or Gastroesophageal Junction Cancer
Gastric cancer appears to have a new druggable target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rate in...
FDA Approves Pembrolizumab Combination for Advanced Esophageal or Gastroesophageal Junction Carcinoma
On March 22, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1–5 cm above the...
Hybrid Minimally Invasive vs Open Esophagectomy for Esophageal Cancer: 5-Year Outcomes
In long-term follow-up of the French phase III MIRO trial reported in JAMA Surgery, Nuytens et al found no significant difference in 5-year overall or disease-free survival with hybrid minimally invasive esophagectomy vs open esophagectomy in patients with esophageal cancer. In the multicenter...
Circulating Hybrid Cells May Help to Monitor Treatment Response in Patients With Rectal and Esophageal Cancers
An analysis of 58 peripheral blood specimens from patients with rectal and esophageal cancers demonstrated that circulating hybrid cells may be a novel, noninvasive biomarker with potential for monitoring treatment response and disease progression to help guide decisions for further therapy,...
Addition of Andecaliximab to mFOLFOX6 in First-Line Treatment of HER2-Negative Advanced Gastric Cancer
As reported in the Journal of Clinical Oncology by Manish A. Shah, MD, and colleagues, the phase III GAMMA-1 trial showed no improvement in overall survival with the addition of andecaliximab to modified oxaliplatin, leucovorin, and fluorouracil (mFOLFOX6) in the first-line treatment of...
FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer
The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...
Early Integration of Nutritional and Psychological Interventions for Previously Untreated Patients With Metastatic Esophagogastric Cancer
In a Chinese single-institution phase III trial reported in the Journal of Clinical Oncology, Lu et al found that early interdisciplinary supportive care with a focus on nutrition and psychological status was associated with improved overall survival vs standard care in previously untreated...
Are Some Oral Pathogens More Common in Patients With Esophageal Cancer?
In a new study published by Kawasaki et al in the journal Cancer, researchers reported that certain oral pathogens are more prevalent in patients with esophageal cancer, and pointed out this information may be used as a novel diagnostic tool. The oral cavity is a rich source of microbial diversity, ...
Anti–PD-1 Therapy Dostarlimab for dMMR Gastrointestinal Cancers: Safety and Efficacy Examined
Dostarlimab, a monoclonal antibody targeting PD-1, showed strong and durable antitumor activity in patients with mismatch repair–deficient (dMMR) gastrointestinal tumors in the phase I GARNET study, reported Thierry André, MD, of Sorbonne Université and Hôpital Saint Antoine, Paris, and colleagues...
Bemarituzumab Plus Chemotherapy Improves Outcomes in Advanced Gastric/Gastroesophageal Junction Cancer
Gastric cancer has a new target: fibroblast growth factor receptor 2b (FGFR2b). Targeting FGFR2b with bemarituzumab plus chemotherapy led to clinically meaningful and statistically significant improvements in progression-free survival, overall survival, and response rates in the randomized phase II ...
Wasat Mansoor, MBChB, PhD, on Esophageal Cancer: Quality of Life With Pembrolizumab and Chemotherapy
Wasat Mansoor, MBChB, PhD, of The Christie NHS Foundation Trust, discusses phase III results from the KEYNOTE-590 trial, which showed no deterioration in health-related quality of life when pembrolizumab was added to chemotherapy in patients with metastatic and unresectable esophageal cancers (Abstract 168).
FDA Approves Fam-Trastuzumab Deruxtecan-nxki for Previously Treated Patients With HER2-Positive Gastric Cancers
On January 15, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki (Enhertu) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen....
Zev A. Wainberg, MD, on Gastric/Gastroesophageal Junction Adenocarcinoma: Bemarituzumab and FOLFOX
Zev A. Wainberg, MD, of UCLA Medical Center, discusses phase II results from the FIGHT study, which combined bemarituzumab with modified FOLFOX6 in first-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma. This is reportedly the first randomized trial of any FGFR inhibitor, validating this target in gastric cancer (Abstract 160).
Study Finds Incidence of Young-Onset Esophageal Adenocarcinoma Is Rapidly Increasing
A new study published by Codipilly et al in Cancer Epidemiology, Biomarkers & Prevention investigated the trends in incidence, stage at presentation, and survival outcomes of young-onset esophageal adenocarcinoma—defined as patients aged 50 and younger at diagnosis—over the past 4 decades....
Avelumab Maintenance vs Continued Chemotherapy After First-Line Induction for Advanced Gastric Cancer
As reported in the Journal of Clinical Oncology by Markus Moehler, MD, and colleagues, the phase III JAVELIN Gastric 100 trial showed no improvement in overall survival with avelumab maintenance vs continued chemotherapy after first-line induction in HER2-negative, unresectable, locally advanced or ...
FDA Pipeline: Priority Reviews in NSCLC, Gastric Cancer
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to a PD-1 inhibitor for the treatment of patients with locally advanced or metastatic non–small cell lung cancer (NSCLC), and also granted Priority Review to a HER2-directed antibody-drug conjugate for patients with...
FDA Pipeline: Priority Reviews in EGFR-Mutant Lung Cancer, Advanced Renal Cell Carcinoma; Fast Track Designations in CLL and Solid Tumors
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....
KEYNOTE-181 Trial: Second-Line Pembrolizumab vs Chemotherapy in Advanced Esophageal Cancer
As reported in the Journal of Clinical Oncology by Takashi Kojima, MD, and colleagues, the phase III KEYNOTE-181 trial has shown that second-line pembrolizumab improved overall survival vs investigator’s choice of chemotherapy in patients with advanced or metastatic esophageal cancer with a PD-L1...
FDA Pipeline: Designations for Treatments of Rare Blood Cancer, B-Cell Malignancies, and Gastric Cancers
Recently, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to an antibody-drug conjugate for the treatment of patients with relapsed or refractory blastic plasmacytoid dendritic cell neoplasm (BPDCN); gave Fast Track designation to a novel chimeric antigen...
FDA Pipeline: Priority Review for Agents in Multiple Myeloma, Anaplastic Large Cell Lymphoma
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to therapies for pretreated patients with multiple myeloma and pediatric patients with ALK-positive anaplastic large cell lymphoma; granted Fast Track designation to novel agents in gastric/gastroesophageal junction...
First-Line Checkpoint Inhibitors May Improve Survival in Gastroesophageal Cancers
Immune therapy for advanced gastroesophageal cancer has taken a leap forward by showing its value in the first-line setting, according to two studies in which nivolumab and pembrolizumab, both given with chemotherapy, significantly improved overall survival vs chemotherapy alone. The studies,...
First-Line PD-1 Inhibitor With or Without Chemotherapy vs Chemotherapy Alone in Advanced Gastric Cancer: KEYNOTE-062
As reported in JAMA Oncology by Kohei Shitara, MD, and colleagues, the phase III KEYNOTE-062 trial showed no significant improvement in overall or progression-free survival with first-line pembrolizumab with or without chemotherapy vs chemotherapy alone in patients with PD-L1–positive advanced...
Modeling Study Aims to Estimate the Effect of the COVID-19 Pandemic on Cancer Deaths in England
In a population-based modeling study reported in The Lancet Oncology, Maringe et al estimated that delays in diagnosis due to the COVID-19 pandemic could result in 3,291 to 3,621 additional deaths from breast, colorectal, esophageal, and lung cancers within 5 years. As stated by the investigators,...
Nivolumab in Previously Treated Esophageal Squamous Cell Carcinoma
On June 10, 2020, nivolumab was approved for treatment of patients with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy.1,2 Supporting Efficacy Data Approval was based on findings from the open-label,...
Margetuximab/Pembrolizumab for Previously Treated Patients With HER2-Positive Advanced Gastroesophageal Adenocarcinoma
In a phase Ib/II trial reported in The Lancet Oncology, Daniel V.T. Catenacci, MD, and colleagues found that the combination of margetuximab and the anti–PD-1 therapy pembrolizumab showed evidence of activity in patients with previously treated HER2-positive gastroesophageal adenocarcinoma. As...
Study Finds Racial Disparities in Esophageal Cancer Surgical Rates
A new study published by Savitch et al in the Journal of Gastrointestinal Surgery found that black patients are less likely to receive surgery for resectable esophageal cancer, which may contribute to higher rates of death. “National guidelines suggest that early-stage esophageal cancer should be...
FDA Pipeline: Fast Track Designations in Colorectal and Pancreatic Cancers, Lymphoplasmacytic Lymphoma/Waldenström’s Macroglobulinemia
Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...
FDA Approves Nivolumab for Pretreated Patients With Esophageal Squamous Cell Carcinoma
On June 10, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after prior fluoropyrimidine- and platinum-based chemotherapy. ATTRACTION-3 Efficacy was investigated in...
Outcomes With Minimally Invasive vs Open Esophagectomy in Routine Practice
In a Dutch study reported in the Journal of Clinical Oncology, Markar et al found that routine use of minimally invasive vs open esophagectomy for esophageal cancer was associated with increased risk of pulmonary complications and other adverse outcomes, contrary to the findings of the clinical...
Pembrolizumab, Trastuzumab, and Chemotherapy in HER2-Positive Metastatic Esophagogastric Cancer
In a single-center phase II trial reported in The Lancet Oncology, Janjigian et al found that the addition of pembrolizumab to trastuzumab and chemotherapy showed activity in the first-line treatment of HER2-positive metastatic esophagogastric cancer. Study Details The investigator-initiated trial...
Do Marital Status and Race Affect the Treatment of Esophageal Cancer?
A study using data from the Michigan state cancer registry, reported in JCO Oncology Practice by Paniagua Cruz et al, found that a higher proportion of white vs black patients with esophageal cancer were married; that single patients were less likely to receive esophagectomy and chemotherapy; and...
Trastuzumab Beyond Disease Progression in HER2‑Positive Advanced Gastric/Gastroesophageal Junction Cancer
In the Japanese phase II T-ACT study reported in the Journal of Clinical Oncology, Makiyama et al found no benefit of continued trastuzumab combined with paclitaxel after disease progression on first-line trastuzumab plus fluoropyrimidine/platinum chemotherapy in patients with HER2-positive...
Bemarituzumab for FGFR2b-Overexpressing Gastroesophageal Adenocarcinoma
In a phase I trial reported in the Journal of Clinical Oncology, Daniel V.T. Catenacci, MD, PhD, and colleagues found that the first-in-class anti–fibroblast growth factor receptor 2b (FGFR2b) antibody bemarituzumab showed activity in patients with high FGFR2b-overexpressing, advanced-stage...
Phase III JAVELIN Gastric 100 Trial Finds No Survival Benefit for Maintenance Avelumab
In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...
Expert Point of View: Daniel V.T. Catenacci, MD
The analysis by Chao et al “highlights how well patients with MSI-H tumors do, compared to microsatellite-stable patients, and how much better they do in a randomized setting, being exposed to immunotherapy as compared to standard-of-care chemotherapy…The data also show that this is a...
Pembrolizumab in MSI-H and CPS ≥ 10 Advanced Gastric or Gastroesophageal Junction Cancer: Subanalysis of KEYNOTE-059, -061, and -062
The survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a combined positive score (CPS) ≥ 10 was established in post hoc subanalysis of three KEYNOTE trials. Findings were presented at the 2020...
Conference Highlights From the 2020 Gastrointestinal Cancers Symposium
This past January, the 2020 Gastrointestinal Cancers Symposium was held in San Francisco. More than 3,600 individuals attended and more than 900 abstracts and posters were presented. Among the highlights presented at the meeting and reported in the pages of The ASCO Post, several studies in...
Proton Beam Therapy vs Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer
In a single-institution phase IIb trial reported in the Journal of Clinical Oncology, Steven H. Lin, MD, PhD, and colleagues found that proton beam therapy was associated with less toxicity and similar progression-free survival vs intensity-modulated radiation therapy in patients with locally...
Expert Point of View: Daniel V.T. Catenacci, MD
Daniel V.T. Catenacci, MD, of the University of Chicago Medical Center and Biological Sciences, emphasized the value of the patient having microsatellite instability–high (MSI-H) status as a biomarker for immunotherapy. The analysis by Chao et al “highlights how well patients with MSI-H tumors do,...
Survival Benefits Achieved With Pembrolizumab in MSI-H and CPS ≥ 10 Gastric/Gastroesophageal Junction Cancer
Post hoc subanalyses of three KEYNOTE trials established the survival benefit of pembrolizumab in advanced gastric/gastroesophageal junction cancer with microsatellite instability–high (MSI-H) tumors or a programmed cell death ligand 1 (PD-L1) combined positive score (CPS) ≥ 10 (ie, the number of...
Expert Point of View: Daniel V.T. Catenacci, MD
Daniel V.T. Catenacci, MD, Associate Professor of Medicine and Director of the Gastrointestinal Oncology Program at the University of Chicago, was the JAVELIN Gastric 100 study’s invited discussant. After offering an extensive background on the use of immunotherapy in gastric or gastroesophageal...
No Survival Benefit for Maintenance Avelumab in Advanced Gastric or Gastroesophageal Junction Cancer
In the phase III JAVELIN Gastric 100 trial, a strategy called “switch maintenance” with the immune checkpoint inhibitor avelumab after 12 weeks of first-line induction chemotherapy did not statistically improve overall survival for treatment-naive patients with HER2-negative advanced gastric or...
