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Gastroesophageal Cancer
Immunotherapy

EGFR Inhibition in EGFR-Amplified Advanced Gastroesophageal Cancer

As reported in the Journal of Clinical Oncology by Maron et al, a retrospective study found that use of EGFR inhibitor therapy was associated with benefit in patients with unresectable or metastatic EGFR-amplified gastroesophageal adenocarcinoma. As stated by the investigators, “Subset analyses...

Gastroesophageal Cancer

Adjuvant Nivolumab Improves Disease-Free Survival vs Placebo in Resected Esophageal or Gastroesophageal Junction Cancer After Neoadjuvant Chemoradiotherapy

As reported in The New England Journal of Medicine by Ronan J. Kelly, MB BCh, MBA, of The Charles A. Sammons Cancer Center at Baylor University Medical Center, and colleagues, an interim analysis of the phase III CheckMate 577 trial has shown a significant improvement in disease-free survival with ...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

KEYNOTE-811: Pembrolizumab Plus Trastuzumab and Chemotherapy in Previously Untreated Advanced HER2-Positive Gastric Adenocarcinoma

As reported in Nature by Yelena Y. Janjigian, MD, of the Gastrointestinal Oncology Service at Memorial Sloan Kettering Cancer Center, and colleagues, the first interim analysis of the phase III KEYNOTE-811 trial has shown a significantly higher objective response rate with the addition of...

Colorectal Cancer
Hepatobiliary Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Recent FDA Approvals in Gastrointestinal Cancer

Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology. Cetuximab Plus Encorafenib On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib...

Gastroesophageal Cancer
Immunotherapy

Expert Point of View: Samuel J. Klempner, MD

Samuel J. Klempner, MD, Associate Professor at Massachusetts General Hospital and Harvard Medical School, commented on the NEONIPIGA study for The ASCO Post. “This study was the first prospective data set to show what many have suspected—that neoadjuvant immune checkpoint blockade would lead to a...

Gastroesophageal Cancer
Immunotherapy

Neoadjuvant Checkpoint Inhibitor Doublet Yields Complete Responses in Gastroesophageal Cancers

In patients with resectable microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) gastric and gastroesophageal junction adenocarcinoma, dual checkpoint inhibition with ipilimumab and nivolumab given as neoadjuvant therapy led to a pathologic complete response rate of 58.6%,...

Gastroesophageal Cancer
Immunotherapy

Adding Pembrolizumab to Chemotherapy Improves Overall and Progression-Free Survival in First-Line Treatment of Advanced Esophageal Cancer

As reported in The Lancet by Jong-Mu Sun, MD, of Samsung Medical Center, Sungkyunkwan University, Seoul, and colleagues, an interim analysis in the phase III KEYNOTE-590 trial has shown that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Adding First-Line Nivolumab to Chemotherapy Improves Survival in Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas

As reported in The Lancet by Yelena Y. Janjigian, MD, of the Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, and colleagues, the phase III CheckMate 649 trial has shown that the addition of first-line nivolumab to chemotherapy resulted in improved overall and...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Stefano Cascinu, MD

Stefano Cascinu, MD, of the Comprehensive Cancer Center, Università Vita-Salute, IRCCS-Ospedale San Raffaele, Milan, Italy, was the invited discussant of KEYNOTE-5901 and CheckMate 649.2 “These landmark studies could change the treatment paradigm of advanced esophageal and gastric cancers. They...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Checkpoint Inhibitors in Esophagogastric Cancer: Updates of Landmark Trials

Updates of landmark trials of immune checkpoint inhibitors as first-line therapy for advanced HER2-negative esophagogastric cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium. The studies upheld previous findings of an overall survival benefit when these agents are paired...

Gastroesophageal Cancer
Immunotherapy

Expert Point of View: Samuel J. Klempner, MD

Samuel J. Klempner, MD, Associate Professor at Massachusetts General Hospital and Harvard Medical School, commented on the NEONIPIGA study for The ASCO Post. “This study was the first prospective data set to show what many have suspected—that neoadjuvant immune checkpoint blockade would lead to a...

Gastroesophageal Cancer
Immunotherapy

Neoadjuvant Checkpoint Inhibitor Doublet Yields Complete Responses in Gastroesophageal Cancers

In patients with resectable microsatellite instability–high (MSI-H)/mismatch repair–deficient (dMMR) gastric and gastroesophageal junction adenocarcinoma, dual checkpoint inhibition with ipilimumab and nivolumab given as neoadjuvant therapy led to a pathologic complete response rate of 58.6%,...

Gastroesophageal Cancer
Colorectal Cancer
Gastrointestinal Cancer
Immunotherapy

Updated Findings on T-DXd in Gastrointestinal Malignancies

Updates of phase II studies evaluating fam-trastuzumab deruxtecan-nxki (T-DXd) in gastrointestinal cancers were presented at the 2022 ASCO Gastrointestinal Cancers Symposium, continuing to offer support for the antibody-drug conjugate in these malignancies. In HER2-expressing gastric cancer, T-DXd...

Gastroesophageal Cancer

Pretreatment Cardiovascular Disease and Events in Patients Receiving Curative-Intent Chemoradiation for Esophageal Cancer

In a Danish single-institution study reported in JACC: CardioOncology, Mette Marie A. Søndergaard, MD, of the Department of Cardiology, Aarhus University Hospital, Denmark, and colleagues found a high rate of undetected or inadequately treated preexisting cardiovascular disease (CVD) prior to...

Gastroesophageal Cancer
Immunotherapy

CheckMate 648: Nivolumab Plus Chemotherapy or Ipilimumab vs Chemotherapy in Previously Untreated Advanced Esophageal Squamous Cell Carcinoma

As reported in The New England Journal of Medicine by Doki et al, the phase III CheckMate 648 trial has shown improved overall survival with nivolumab combined with chemotherapy or ipilimumab vs chemotherapy alone in patients with previously untreated advanced esophageal squamous cell carcinoma, in ...

gastroesophageal cancer
immunotherapy

Thierry André, MD, on Esophagogastric Adenocarcinoma: New Findings on Nivolumab and Ipilimumab

Thierry André, MD, of Sorbonne University and Saint-Antoine Hospital, discusses phase II results from the GERCOR NEONIPIGA study, which suggests neoadjuvant therapy with nivolumab and ipilimumab may be associated with a high pathologic complete response rate in patients with localized microsatellite instability–high or mismatch repair–deficient esophagogastric adenocarcinoma. This study raises the question of whether surgery could be delayed or avoided for some patients (Abstract 244).

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Zev A. Wainberg, MD, on Gastric or Gastroesophageal Junction Adenocarcinoma: Follow-up Data on Pembrolizumab and Chemotherapy

Zev A. Wainberg, MD, of the University of California, Los Angeles, discusses an update, of 25 additional months, on phase III safety and efficacy results from the KEYNOTE-062 trial. This study compared pembrolizumab with or without chemotherapy vs chemotherapy alone for patients with PD-L1–positive advanced gastric or gastroesophageal junction adenocarcinoma (Abstract 243).

Gastroesophageal Cancer
Immunotherapy

Addition of Perioperative Trastuzumab to Neoadjuvant Chemoradiation for Patients With HER2-Overexpressing Esophageal Adenocarcinoma

As reported in The Lancet Oncology by Howard P. Safran, MD, and colleagues, the phase III NRG Oncology/RTOG-101 trial has shown no significant disease-free survival benefit with the addition of perioperative trastuzumab to neoadjuvant chemoradiation in previously untreated patients with...

Gastroesophageal Cancer
Immunotherapy

Pembrolizumab Plus Chemotherapy in Advanced Esophageal Cancer: Good News for Some, but More Work to Be Done

Multiple comparisons of traditional cytotoxic chemotherapy combinations that began decades ago led to the adoption of the platinum plus fluorouracil doublet as the standard of care for treatment of recurrent or metastatic esophageal cancer.1 Other combinations created by the addition and/or...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Kohei Shitara, MD, on Gastric and Esophageal Cancers: Long-Term Follow-up on Nivolumab Plus Chemotherapy

Kohei Shitara, MD, of Japan’s National Cancer Center Hospital East, discusses a long-term data follow-up from CheckMate 649, which support the continued use of nivolumab plus chemotherapy as first-line treatment in patients with advanced gastric, gastroesophageal junction, and esophageal adenocarcinomas (Abstract 240).

Gastroesophageal Cancer

Pretreatment Cardiovascular Disease and Events During Follow-up in Patients Receiving Curative-Intent Chemoradiation for Esophageal Cancer

In a Danish single-institution study reported in JACC: CardioOncology, Søndergaard et al found a high rate of undetected or inadequately treated preexisting cardiovascular disease prior to the receipt of chemoradiation and a high rate of cardiovascular events during follow-up in patients undergoing ...

Gastroesophageal Cancer

Long-Term Swallowing Quality-of-Life Results With Radiotherapy vs Transoral Robotic Surgery for Oropharyngeal Cancer

In a long-term longitudinal analysis of the phase II ORATOR trial reported in the Journal of Clinical Oncology, Anthony Nichols, MD, and colleagues found that a statistically significant improvement in swallowing quality of life persisted through 3 years after treatment with radiotherapy vs...

Gastroesophageal Cancer

Selecting Patients With Barrett's Esophagus for Endoscopic Surveillance: Role of Nonendoscopic Device Biomarkers

In a study reported in The Lancet Oncology, Pilonis et al found that nonendoscopic cell collection device (marked as the Cytosponge)–detected atypia and p53 overexpression could be used in combination with clinical risk factors to triage patients with Barrett’s esophagus for endoscopic...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Addition of Nivolumab to Oxaliplatin-Based Chemotherapy for HER2-Negative, Unresectable, Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer

In an Asian phase II/III trial (ATTRACTION-4) reported in The Lancet Oncology, Yoon-Koo Kang, MD, and colleagues found that the addition of nivolumab to oxaliplatin-based chemotherapy improved progression-free survival—but not overall survival—as first-line treatment of HER2-negative, unresectable, ...

Gastroesophageal Cancer

New Research Aims to Uncover Cellular Source of Barrett’s Esophagus

Two recent studies correct a long-standing misconception about the origins of Barrett’s esophagus and, in doing so, may point to new avenues of treatment or prevention to lower the risk of esophageal cancer. The first study, published by Singh et al in the journal Gastroenterology, demonstrated...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Study Suggests Lack of Benefit With the Addition of Immune Checkpoint Inhibition to Chemotherapy in Low PD-L1–Expressing Gastric or Esophageal Adenocarcinoma

In an analysis reported in the Journal of Clinical Oncology, Zhao et al found that the addition of an immune checkpoint inhibitor to chemotherapy in trials of first-line treatment of advanced gastric or esophageal adenocarcinoma was not associated with benefit in low PD-L1–expressing subgroups not...

Gastroesophageal Cancer
Immunotherapy

Health-Related Quality of Life With Pembrolizumab vs Chemotherapy for Advanced Esophageal Cancer

In a study reported in the Journal of Clinical Oncology, Adenis et al found that health-related quality of life was maintained with both pembrolizumab and chemotherapy in the pivotal phase III KEYNOTE-181 trial, which included patients with advanced esophageal cancer who had received previous...

Skin Cancer
Gynecologic Cancers
Prostate Cancer
Breast Cancer
Solid Tumors
Hepatobiliary Cancer
Gastroesophageal Cancer
Immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...

Gastroesophageal Cancer

Nivolumab Plus Chemotherapy Improves Survival in Advanced Gastric and Esophageal Adenocarcinomas: Now to Figure Out the Details in These Heterogeneous Diseases

There is no doubt that subsets of patients with esophageal and gastric cancers benefit from immune checkpoint inhibitor therapy. The complexity lies in identifying the appropriate histology, tumor location, expression of programmed cell death receptors and ligands, mechanism of checkpoint...

Gastroesophageal Cancer

Adding First-Line Nivolumab to Chemotherapy Improves Survival in Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinomas

As reported in The Lancet by Yelena Y. Janjigian, MD, of the Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center, and colleagues, the phase III CheckMate 649 trial has shown that the addition of first-line nivolumab to chemotherapy resulted in improved overall and...

Gastrointestinal Cancer
Immunotherapy
Gastroesophageal Cancer

DESTINY-Gastric02: Fam-Trastuzumab Deruxtecan-nxki Produces Responses in Patients With HER2-Positive Gastric Cancers

In the primary analysis of the phase II DESTINY-Gastric02 trial, fam-trastuzumab deruxtecan-nxki (T-DXd) produced clinically meaningful and durable responses in Western patients with advanced HER2-positive gastric or gastroesophageal junction cancers whose disease had progressed after a...

Gastroesophageal Cancer

Reduced-Intensity Chemotherapy for Older, Frail Patients With Advanced Gastroesophageal Cancer

Patients who had advanced gastroesophageal cancer but were considered unsuitable for full-dose chemotherapy because of their advanced age and/or frailty “had an improved patient experience with no significant detriment in cancer control” when treated with reduced-intensity chemotherapy in the phase ...

Immunotherapy
Gastroesophageal Cancer

Pembrolizumab Combined With Trastuzumab and Chemotherapy for HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma

On May 5, 2021, pembrolizumab was granted accelerated approval for use in combination with trastuzumab and fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal...

Gastroesophageal Cancer
Immunotherapy

Addition of Pembrolizumab to Chemotherapy for the First-Line Treatment of Advanced Esophageal Cancer: KEYNOTE-590

As reported in The Lancet by Sun et al, the phase III KEYNOTE-590 trial showed that the addition of first-line pembrolizumab to chemotherapy resulted in improved overall and progression-free survival in patients with advanced esophageal and Siewert type 1 gastroesophageal junction (GEJ) cancers....

Gastroesophageal Cancer
Immunotherapy

Expert Point of View: Kei Muro, MD, PhD

The RATIONALE 302 trial1 was discussed by Kei Muro, MD, PhD, of Aichi Cancer Center Hospital in Nagoya, Japan, who found the results promising. However, Dr. Muro questioned the role of PD-1/L1 inhibitors as second-line therapy for advanced esophageal squamous cell carcinoma. RATIONALE 302 is the...

Gastroesophageal Cancer
Immunotherapy

RATIONALE 302: Tislelizumab Improves Overall Survival as Second-Line Treatment of Esophageal Cancer

In the phase III RATIONALE 302 trial, the novel anti–PD-1 antibody tislelizumab, being developed in China, improved overall survival vs chemotherapy as second-line therapy for esophageal squamous cell carcinoma, according to Jaffer Ajani, MD, of The University of Houston MD Anderson Cancer Center,...

Gastroesophageal Cancer

S-1 Chemoradiation vs Radiotherapy Alone in Patients Aged 70 to 85 With Esophageal Cancer

In a Chinese phase III trial reported in JAMA Oncology, Ji et al found that concurrent chemoradiation with S-1 was associated with improved overall survival and acceptable toxicity vs radiotherapy alone in older patients with esophageal cancer.   As stated by the investigators, “Most older patients ...

Gastrointestinal Cancer
Gastroesophageal Cancer

Perioperative or Postoperative Oxaliplatin/S-1 vs Postoperative Oxaliplatin/Capecitabine for Locally Advanced Gastric Cancer

In the Chinese phase III RESOLVE trial reported in The Lancet Oncology, Zhang et al found that perioperative S-1/oxaliplatin was superior to—and adjuvant S-1/oxaliplatin was noninferior to—adjuvant capecitabine/oxaliplatin in terms of disease-free survival in patients undergoing D2 gastrectomy for...

Solid Tumors
Gastroesophageal Cancer

Pembrolizumab Combined With Chemotherapy for Advanced Esophageal or Gastroesophageal Junction Carcinoma

On March 22, 2021, pembrolizumab was approved for use in combination with platinum- and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal junction (tumors with epicenter 1 to 5 cm above the gastroesophageal junction) carcinoma who...

Gastroesophageal Cancer
Gastrointestinal Cancer

International Esodata Study Group Model for Predicting 90-Day Mortality After Esophagectomy

In a retrospective analysis reported by researchers from the International Esodata Study Group (IESG) in JAMA Surgery, D’Journo et al developed a model for predicting risk of 90-day mortality following esophagectomy for patients with esophageal or gastroesophageal junction cancer. As stated by the...

Gastroesophageal Cancer

Effect of Radiotherapy Dose Escalation in Definitive Chemoradiation for Locally Advanced Esophageal Cancer

In a Dutch phase III trial (ARTDECO) reported in the Journal of Clinical Oncology, Hulshof et al found that increasing the dose of radiation therapy in a definitive chemoradiation regimen did not improve local progression-free survival in patients with inoperable, locally advanced esophageal...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Addition of First-Line Nivolumab to Chemotherapy in Advanced Gastric Cancers: CheckMate 649

As reported in The Lancet by Yelena Y. Janjigian, MD, and colleagues, the phase III CheckMate 649 trial has shown that the addition of first-line nivolumab to chemotherapy resulted in improved overall and progression-free survival among patients with advanced HER2-negative gastric, gastroesophageal ...

Gastroesophageal Cancer

PET Response–Adapted Chemoradiotherapy for Esophageal and Esophagogastric Junction Adenocarcinoma

As reported in the Journal of Clinical Oncology by Karyn A. Goodman, MD, and colleagues, mature results of the phase II CALGB 80803/Alliance trial indicated that treatment guided by early positron-emission tomography (PET) assessment of response to induction neoadjuvant chemotherapy improved...

Gastroesophageal Cancer

Disease-Free Survival Benefit With Adjuvant Immunotherapy in Resectable Esophageal Cancer: Practice-Changing for All Patients?

The CheckMate 577 trial—reported in The New England Journal of Medicine by Kelly et al1 and reviewed in this issue of The ASCO Post—is the first global randomized controlled trial for patients with resectable esophageal cancer that showed a significant disease-free survival benefit for adjuvant...

Gastroesophageal Cancer

Adjuvant Nivolumab Improves Disease-Free Survival vs Placebo in Resected Esophageal or Gastroesophageal Junction Cancer After Neoadjuvant Chemoradiotherapy

As reported in The New England Journal of Medicine by Ronan J. Kelly, MB BCh, MBA, of The Charles A. -Sammons Cancer Center at Baylor University Medical Center, and colleagues, an interim analysis of the phase III CheckMate 577 trial has shown a significant improvement in disease-free survival...

Gastroesophageal Cancer
Immunotherapy

Nivolumab Plus Chemotherapy and Nivolumab Plus Ipilimumab as First-Line Treatment for Patients With Advanced Esophageal Cancer

The first results from the phase III CheckMate 648 study represent significant progress in the treatment of patients with advanced esophageal squamous cell carcinoma. The trial evaluated first-line treatment with nivolumab plus chemotherapy or nivolumab plus ipilimumab in patients with advanced...

gastroesophageal cancer
immunotherapy

Ian Chau, MD, on Esophageal Squamous Cell Carcinoma: Nivolumab, Ipilimumab, and Chemotherapy for Advanced Disease

Ian Chau, MD, of Royal Marsden NHS Foundation Trust, discusses first results of the CheckMate 648 study, which showed that nivolumab plus chemotherapy and nivolumab plus ipilimumab both demonstrated superior overall survival vs chemotherapy alone in patients with advanced esophageal squamous cell carcinoma. These regimens may represent potential new first-line treatment options (Abstract 4001).

Gastroesophageal Cancer
Geriatric Oncology

Reduced-Intensity Oxaliplatin/Capecitabine for Older and Frail Patients With Advanced Gastroesophageal Cancer

In the phase III GO2 trial reported in JAMA Oncology, Hall et al found that reduced-intensity oxaliplatin/capecitabine was associated with improved patient experience, reduced toxicity, and noninferior progression-free survival compared with higher-intensity treatment among older and frail patients ...

Gastroesophageal Cancer
Immunotherapy

FDA Approves Nivolumab for Resected Esophageal or Gastroesophageal Junction Cancer

On May 20, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) for patients with completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy. CheckMate 577 Efficacy was evaluated in CheckMate ...

Gastroesophageal Cancer

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

On April 16, 2021, 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...

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