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Gastrointestinal Cancer
Lung Cancer
Leukemia
Hepatobiliary Cancer
Kidney Cancer
Immunotherapy

FDA Pipeline: Two Breakthrough Therapy Designations for Fam-Trastuzumab Deruxtecan-nxki, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...

Gastrointestinal Cancer

FDA Approves Ripretinib for Previously Treated Patients With Advanced Gastrointestinal Stromal Tumor

On May 15, the U.S. Food and Drug Administration (FDA) approved ripretinib (Qinlock) for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with three or more kinase inhibitors, including imatinib. INVICTUS Trial Efficacy was...

Colorectal Cancer
Gastrointestinal Cancer
Immunotherapy

Regorafenib Plus Nivolumab in Advanced Gastric and Colorectal Cancers

In a Japanese phase Ib/dose-expansion trial reported in the Journal of Clinical Oncology, Fukuoka et al found that the combination of regorafenib and nivolumab showed activity in patients with previously treated gastric cancer and colorectal cancer with microsatellite stable/mismatch...

Colorectal Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Aspirin Use and Risk of Cancers of the Digestive Tract

Aspirin may be associated with a reduction in the risk of developing several cancers of the digestive tract. The largest and most comprehensive analysis to date of the link between aspirin and digestive tract cancers, published by Bosetti et al in Annals of Oncology, found reductions in the risk of ...

Gastrointestinal Cancer

Surgical Margins and Survival in Trial of Adjuvant Imatinib for Localized GIST

A post hoc observational study from the phase III EORTC 62024 trial of adjuvant imatinib in patients with localized gastrointestinal stromal tumors (GIST) showed that improvement in survival with R0 vs R1 resection was no longer evident when tumor rupture was excluded from the R1 category. The...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

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...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

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...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

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,...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer

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...

Gastrointestinal Cancer
Genomics/Genetics

Avapritinib for Gastrointestinal Stromal Tumor With PDGFRA Exon 18 Mutation

On January 9, 2020, avapritinib was approved for treatment of adults with unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including D842V mutations.1,2 It is the first therapy approved for...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

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...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

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...

Gastrointestinal Cancer

Expert Point of View: George A. Fisher, Jr, MD, PhD

George A. Fisher, Jr, MD, PhD, the Colleen Haas Chair in Medicine-Oncology at Stanford University School of Medicine, commented on the cell-free DNA methylation blood-based test from the Circulating Cell-Free Genome Atlas (CCGA) study. The findings presented by Dr. Wolpin, he said, “lead us to the ...

Gastrointestinal Cancer

Use of Cell-Free DNA Methylation–Based Blood Test in Detecting Gastrointestinal Cancers

A noninvasive, blood-based, cell-free DNA test focused on the presence of DNA methylation appears to be highly sensitive in detecting gastrointestinal cancers and may pinpoint the tissue of origin in the vast majority of these cancers.1 The assay was developed based on findings from the...

Lung Cancer
Lymphoma
Bladder Cancer
Head and Neck Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lung Cancers, Lymphoma

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for non–small cell and small cell lung cancers, as well as for diffuse large-B cell lymphoma (DLBCL); Breakthrough Therapy designation to an antibody-drug conjugate for bladder cancer; and a double Fast...

Lymphoma
Lung Cancer
Gastrointestinal Cancer
Breast Cancer
Head and Neck Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Lymphoma, Lung Cancer, GIST, and Breast Cancer

This week, the U.S. Food and Drug Administration (FDA) granted Priority Review to agents in lymphoma, lung cancer, gastrointestinal stromal tumors, and breast cancer, and granted Fast Track designation to a first-in-class radioenhancer hafnium oxide nanoparticle in head and neck cancer. Priority...

Gastrointestinal Cancer

Does Treating Individuals for H pylori Infection Reduce Gastric Cancer Risk in Those With a Family History of the Disease?

In a large Korean single-center study reported in The New England Journal of Medicine, Choi et al found that eradication of Helicobacter pylori infection was associated with a reduced risk of gastric cancer in individuals with a family history of gastric cancer in first-degree relatives. As stated ...

gastrointestinal cancer

Brian M. Wolpin, MD, on Performance of a Blood-Based Test for the Detection of Multiple Cancers

Brian M. Wolpin, MD, of Dana-Farber Cancer Institute, discusses a noninvasive blood test evaluating methylation of circulating free DNA. In his study, the blood test detected multiple gastrointestinal cancers at a sensitivity of approximately 81% and a prespecified specificity of > 99%. It also accurately localized the tissue of origin across more than 20 cancer types (Abstract 283).

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Zev A. Wainberg, MD, on PD-L1­–Positive Advanced Gastric Cancer: MSI and Combined Positive Score and Pembrolizumab vs Chemotherapy

Zev A. Wainberg, MD, of the UCLA Medical Center, discusses the first subset analysis of how a combined positive score in gastric and gastroesophageal junction cancers related to the efficacy of pembrolizumab in PD-L1–positive disease (Abstract 427).

Gastrointestinal Cancer
Palliative Care

2020 GI Cancers Symposium: Does Receipt of Palliative Care Increase Survival in Patients With Metastatic Esophageal Cancer Declining Chemotherapy?

Patients with metastatic esophageal cancer who declined chemotherapy but received palliative care had a numerically higher, but not statistically significant, difference in overall survival. These findings will be presented by Manguso et al at the 2020 Gastrointestinal Cancers Symposium (Abstract...

Gastrointestinal Cancer

Cancer No Longer Scares Me

Cancer was a disease I feared until 3 years ago, when I was diagnosed with gastric cancer. After receiving the diagnosis, I knew I didn’t have any time to indulge in fear; I had to take action if I was going to survive. In hindsight, symptoms of the cancer, including some fatigue and indigestion,...

Gastrointestinal Cancer

2020 GI Cancers Symposium: Detecting GI Tumors Using a Cell-Free DNA Test

A blood-based screening test using cell-free DNA to identify methylation signals of hard-to-detect gastrointestinal (GI) cancers could potentially help detect disease at earlier stages. This research will be presented by Brian M. Wolpin, MD, MPH, and colleagues at the 2020 Gastrointestinal Cancers...

Gastrointestinal Cancer

FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor

On January 9, the U.S. Food and Drug Administration (FDA) approved avapritinib (Ayvakit) for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) that harbors platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation. This approval includes...

Gastrointestinal Cancer

Working to Improve Survival Rates in Pancreatic Cancer

Although pancreatic cancer survival rates have slowly improved over the past few decades for all stages of pancreatic cancer combined, the 1-year rate is 20%, and the 5-year rate is about 9%. There is no single diagnostic test to detect pancreatic cancer, and less than 20% of tumors are confined to ...

Gastrointestinal Cancer

Combination of Atezolizumab and Bevacizumab for Unresectable Hepatocellular Carcinoma

Combination therapy with the programmed cell death ligand 1 inhibitor atezolizumab and the vascular endothelial growth factor inhibitor bevacizumab significantly improved overall and progression-free survival in patients with unresectable hepatocellular carcinoma compared with sorafenib, according...

Hepatobiliary Cancer
Lymphoma
Neuroendocrine Tumors
Gastrointestinal Cancer
Genomics/Genetics

FDA Pipeline: Recent Designations in Hepatocellular Carcinoma, Cholangiocarcioma, Lymphoma, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) granted reviews or designations to treatments for gastrointestinal cancers and lymphoma, and also provided authorizations for products designed to screen for malignancies and tumor mutational burden. Priority Review for Nivolumab...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil in Recurrent, Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

Early in 2019, trifluridine/tipiracil tablets were approved for the treatment of adult patients with metastatic gastric or gastroesophageal junction adenocarcinoma previously treated with at least two prior lines of chemotherapy that included a fluoropyrimidine; a platinum; either a taxane or...

Gastrointestinal Cancer

Pivotal Study Reports Positive Findings in Fourth-Line Setting for Advanced GIST

In a late-breaking, oral presentation at the European Society for Medical Oncology (ESMO) 2019 Congress, Margaret von Mehren, MD, presented results from INVICTUS, a pivotal phase III clinical study of ripretinib in patients with advanced gastrointestinal stromal tumor (GIST).1 Ripretinib is an...

Gastrointestinal Cancer

Circulating Tumor DNA: A Prognostic Marker in Stage III Colon Cancer?

Circulating tumor DNA in the blood could serve as a marker of prognosis in patients with colon cancer receiving adjuvant oxaliplatin, according to a subanalysis of the IDEA trial, presented at the European Society for Medical Oncology (ESMO) Congress 2019.1 After 2 years of adjuvant...

Gastrointestinal Cancer

Maximizing Benefit in the Treatment of Immune-Mediated Colitis

Immune-related colitis is the second most common toxicity associated with checkpoint inhibitors, affecting up to 40% of patients. The ASCO Post interviewed Yinghong Wang, MD, PhD, Director of Medication-Induced Colitis and Enteritis, Director of Fecal Microbiota Transplantation, and Associate...

Gastrointestinal Cancer

Pivotal Phase III Study Evaluates Investigational TKI in Fourth-Line Setting for Advanced GIST

In a late-breaking, oral presentation at the ESMO Congress 2019, Margaret von Mehren, MD, presented results from ­INVICTUS, a pivotal phase III clinical trial of ripretinib in patients with advanced gastrointestinal stromal tumor (GIST).1 Ripretinib is an investigational tyrosine kinase inhibitor...

Gastrointestinal Cancer

Machine-Learning Model May Predict Unplanned Hospitalizations After Radiation Therapy for Gastrointestinal Cancer

Unplanned hospitalizations may be common among patients with cancer, but they diminish quality of care while racking up high costs for patients and the health-care system alike. According to data presented at the 2019 ASCO Quality Care Symposium, however, a new predictive model may help providers...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil Survival Benefit for Patients With Metastatic Gastric Cancer Who Had or Had Not Undergone Prior Gastrectomy

In a subgroup analysis of the phase III TAGS trial (TAS-102 Gastric Study) reported in JAMA Oncology, David H. Ilson, MD, PhD, and colleagues found positive trends in survival benefit with trifluridine/tipiracil treatment vs placebo for patients with pretreated metastatic gastric cancer or...

Gastrointestinal Cancer

Individual Patient Meta-analysis of Microsatellite Instability as a Prognostic Marker in Resectable Gastric Cancer

In an individual patient data meta-analysis reported in the Journal of Clinical Oncology, Pietrantonio et al found that microsatellite instability (MSI) status was a strong prognostic marker in patients with resectable gastric cancer. The study involved data from 1,556 patients with resectable...

Gastrointestinal Cancer

New NCCN Guidelines®: First to Address Small Intestine Cancers

THE NATIONAL COMPREHENSIVE Cancer Network® (NCCN®) recently announced the publication of a new set of recommendations focused on cancers in the small intestine. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Small Bowel Adenocarcinoma are the first treatment guidelines in...

leukemia
prostate cancer
gastrointestinal cancer

FDA Pipeline: Designation in CLL, New Drug Application in GIST, New Prostate Ablation System Receives 510(k) Clearance

Recently, the U.S. Food and Drug Administration granted Breakthrough Therapy designation to acalabrutinib in chronic lymphocytic leukemia (CLL), accepted a new drug application for avapritinib in some types of gastrointestinal stromal tumors (GIST), and granted 501(k) clearance to market the...

Gastrointestinal Cancer
Immunotherapy

Brief Update on Clinical Trials of New Treatments in Gastrointestinal Cancers

The 2019 ASCO Annual Meeting provided attendees with an abundance of clinically relevant abstracts in gastrointestinal cancers. Briefly featured here are clinical trial updates on pembrolizumab in the second-line treatment of hepatocellular carcinoma (KEYNOTE-240 trial), laparoscopic vs open...

lung cancer
gastroesophageal cancer
bladder cancer
gastrointestinal cancer
immunotherapy

Ramucirumab Plus Pembrolizumab in Previously Treated Advanced Gastroesophageal Cancer, NSCLC, and Urothelial Carcinoma

Results from a phase IB trial expansion stage reported in The Lancet Oncology by Herbst et al showed the combination of ramucirumab plus pembrolizumab had manageable toxicity and antitumor activity in previously treated advanced gastroesophageal cancer, non–small cell lung cancer (NSCLC), and ...

Breast Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Approves New Trastuzumab Biosimilar

On June 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction...

Gastroesophageal Cancer
Gastrointestinal Cancer

Trifluridine/Tipiracil in Recurrent, Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma

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. On February 22, trifluridine/tipiracil...

issues in oncology
gastrointestinal cancer

ESMO World GI 2019: Incidence of Gastric Cancer in Younger Individuals

The incidence of gastric cancer has been increasing in younger individuals, and those under 40 with chronic digestive symptoms should be more actively investigated. These findings follow new data from a retrospective, observational study in Mexico, which showed that 1 in 7 of over 2,000...

Gastrointestinal Cancer

Study Shows Benefit With Pazopanib in Treatment of Carcinoid Tumors

Pazopanib significantly improved progression-free survival by 47% in patients with progressive carcinoid tumors, in a prospective randomized phase II trial presented at the 2019 ASCO Annual Meeting.1 “With these results, Alliance A021202 becomes the first randomized study to show that the vascular...

Gastrointestinal Cancer

Study Supports Neoadjuvant Chemotherapy in Operable Colon Cancer

For patients with operable colon cancer, neoadjuvant chemotherapy resulted in numerous benefits in the FOxTROT trial but did not reach target significance for the primary endpoint. The study was presented at the 2019 ASCO Annual Meeting by Matthew T. Seymour, MD, of the University of Leeds School...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Expert Point of View: Ian Chau, MD

IAN CHAU, MD, a consultant medical oncologist at the Gastrointestinal and Lymphoma Units of The Royal Marsden NHS Foundation Trust in London and Surrey, United Kingdom, was the invited discussant of KEYNOTE-062. In an interview with The ASCO Post, he first commented that although single-agent...

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

KEYNOTE-062: Pembrolizumab Is a New First-Line Option in Gastric/Gastroesophageal Junction Cancer

KEYNOTE-062, a study of first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma, found pembrolizumab to be noninferior to chemotherapy and perhaps better than chemotherapy in a subgroup of patients. The results were reported at the 2019 ASCO Annual Meeting ...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves New Trastuzumab Biosimilar

Today, the U.S. Food and Drug Administration (FDA) approved trastuzumab-anns (Kanjinti) for all approved indications of the reference product trastuzumab (Herceptin): for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...

gastrointestinal cancer

Does Adding HIPEC to Cytoreductive Surgery Improve Outcomes in Patients With Gastric Cancer and Peritoneal Metastases?

In a propensity score analysis reported in the Journal of Clinical Oncology, Bonnot et al found that the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to cytoreductive surgery improved outcomes among patients with gastric cancer with peritoneal metastases. The study included 277...

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