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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...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Josep Tabernero, MD, PhD, on Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: Pembrolizumab With or Without Chemotherapy vs Chemotherapy

Josep Tabernero, MD, PhD, of the Vall d’Hebron Institute of Oncology, discusses phase III findings of the KEYNOTE-062 study showing that, for some patients with advanced gastric or gastroesophageal junction cancer, pembrolizumab may improve survival and may be an effective alternative to chemotherapy, with fewer side effects (Abstract LBA4007).

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

2019 ASCO: KEYNOTE-062: Pembrolizumab With or Without Chemotherapy vs Chemotherapy in Advanced Gastric or GEJ Adenocarcinoma

The randomized, phase III KEYNOTE-062 trial achieved its primary endpoint, showing that for patients with programmed cell death ligand 1 (PD-L1)-positive, HER2-negative, advanced gastric or gastroesophageal junction (GEJ) cancer, initial therapy with pembrolizumab resulted in noninferior overall...

Gastrointestinal Cancer

Study Finds Less Chemotherapy Noninferior to More in Frail and Elderly Patients With Advanced Gastroesophageal Cancer

A large randomized trial has found that frail and elderly patients with advanced gastroesophageal cancer may be safely and successfully treated with dose-reduced chemotherapy. In the GO2 phase III trial, low doses of oxaliplatin/capecitabine performed similarly to intermediate and high doses of the ...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

Trastuzumab Deruxtecan in Advanced HER2-Positive Gastric and Breast Cancers

Two phase I studies reported in The Lancet Oncology indicate activity of the antibody-drug conjugate trastuzumab deruxtecan in advanced HER2-positive gastric cancer and advanced HER2-positive breast cancer previously treated with trastuzumab emtansine (T-DM1). Trastuzumab deruxtecan (DS-8201a) is a ...

Gastrointestinal Cancer
Colorectal Cancer

New ASCO Guidelines on Early Detection and Treatment of Colorectal Cancer in Resource-Stratified Settings

ASCO has approved two new resource-stratified guidelines aimed at improving the early detection and treatment of colorectal cancer in all resource settings. The guidelines are a continuation of ASCO’s efforts to provide evidence-based recommendations for the management of malignancies applicable...

gastroesophageal cancer
gastrointestinal cancer

Perioperative Therapy With FLOT vs ECF/ECX in Locally Advanced Gastric Adenocarcinoma

In the German phase II/III FLOT4 trial reported in The Lancet, Al-Batran et al found that perioperative therapy with the docetaxel-based triplet FLOT (fluorouracil [5-FU]/leucovorin, oxaliplatin, and docetaxel) was associated with improved overall survival vs ECF/ECX (epirubicin and cisplatin plus...

Colorectal Cancer
Gastrointestinal Cancer

Study Finds Shorter Treatment Course for Rectal Cancer May Actually Improve Outcomes

In patients with locally advanced rectal cancer, the delivery of all radiotherapy and chemotherapy neoadjuvantly—with a shorter course of radiation—may improve the chance of complete response and downstaging over conventional treatment, according to investigators from Washington University, St....

Colorectal Cancer
Neuroendocrine Tumors
Gastrointestinal Cancer
Hepatobiliary Cancer

New Data in Colorectal, Neuroendocrine, Gastric, and Hepatocellular Cancers

THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves Trastuzumab-qyyp in HER2-Overexpressing Breast and Gastric Cancers

The U.S. Food and Drug Administration (FDA) has approved trastuzumab-qyyp (Trazimera), a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor receptor-2 (HER2)-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal...

Gastroesophageal Cancer
Gastrointestinal Cancer

FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma

ON FEBRUARY 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or gastroesophageal junction...

Immunotherapy
Gastrointestinal Cancer

Study Shows Limited Antitumor Activity of Pembrolizumab in Neuroendocrine Tumors

Neuroendocrine tumors appear resistant to single-agent immunotherapy, according to the results of the KEYNOTE-028 trial of pembrolizumab. “Pembrolizumab monotherapy showed limited antitumor activity but a manageable safety profile in patients with previously treated, advanced neuroendocrine...

gastroesophageal cancer
gastrointestinal cancer

FDA Approves Trifluridine/Tipiracil for Recurrent, Metastatic Gastric and GEJ Adenocarcinoma

On February 22, the U.S. Food and Drug Administration approved trifluridine/tipiracil tablets (Lonsurf)—a fixed combination of trifluridine, a nucleoside metabolic inhibitor, and tipiracil, a thymidine phosphorylase inhibitor—for adult patients with metastatic gastric or...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Addition of First-Line Ramucirumab to Cisplatin and Fluoropyrimidine in Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma

In the phase III RAINFALL trial reported in The Lancet Oncology, Fuchs et al found no apparent benefit of the addition of the VEGFR-2 inhibitor ramucirumab to first-line cisplatin and fluoropyrimidine treatment in metastatic gastric or gastroesophageal junction adenocarcinoma. Study Details The...

Immunotherapy
Gastrointestinal Cancer

First-Line Trastuzumab Plus Pembrolizumab Shows Efficacy in Patients With Metastatic Esophagogastric Cancer

When added to first-line chemotherapy in patients with untreated metastatic HER2-positive esophageal, gastroesophageal junction, and gastric adenocarcinoma, the combination of pembrolizumab and trastuzumab produced responses in 87% of patients, with 100% of patients experiencing disease control and ...

Gastrointestinal Cancer
Head and Neck Cancer

Andecaliximab in Untreated Gastric or Gastroesophageal Junction Cancer

The large phase III GAMMA-1 trial failed to replicate the encouraging findings from a previous smaller study of andecaliximab plus chemotherapy in untreated HER2-negative gastric or gastroesophageal junction adenocarcinoma, according to Manish A. Shah, MD, of Weill Cornell Medicine/New York...

gastrointestinal cancer

Rongbo Lin, MD, on Gastric Cancer: Results From the FNF-004 Trial

Rongbo Lin, MD, of Fujian Cancer Hospital, discusses phase II study findings on FOLFOX alone vs paclitaxel plus FOLFOX vs intraperitoneal paclitaxel plus FOLFOX as a first-line treatment in advanced gastric cancer (Abstract 6).

gastroesophageal cancer
gastrointestinal cancer

Manish A. Shah, MD, on Gastric Cancer: Results From the GAMMA-1 Study on First-Line Combination Therapy

Manish A. Shah, MD, of NewYork–Presbyterian/Weill Cornell Medical Center, discusses phase III data on the efficacy and safety of andecaliximab combined with mFOLFOX6 as first-line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma (Abstract 4).

gastrointestinal cancer

David H. Ilson, MD, PhD, on Gastric Cancer: Results From the TAGS Study on Third-Line Trifluridine/Tipiracil

David H. Ilson, MD, PhD, of Memorial Sloan Kettering Cancer Center, discusses findings on the efficacy and safety of third-line trifluridine/tipiracil in patients with metastatic gastric cancer with or without prior gastrectomy (Abstract 3).

breast cancer
gastroesophageal cancer
gastrointestinal cancer

FDA Approves Biosimilar Trastuzumab-dttb

On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or...

head and neck cancer
gastrointestinal cancer
immunotherapy

2019 GI Cancers Symposium: Pembrolizumab in Second-Line Therapy for Advanced Esophageal Cancer

Pembrolizumab significantly improved overall survival in the second-line setting of advanced esophageal cancer in patients whose tumors tested positive for programmed cell death ligand 1 (PD-L1) with a combined positive score (CPS) of 10 or greater. This was compared to investigator’s choice...

gastrointestinal cancer

2019 GI Cancers Symposium: Safety, Efficacy of Trifluridine/Tipiracil in Metastatic Gastric Cancer With or Without Gastrectomy

In a poster session earlier today David Ilson, MD, of Memorial Sloan Kettering Cancer Center, and colleagues reported on a preplanned subgroup analysis of the double-blind phase III TAGS study looking at the safety and efficacy of the oral agent trifluridine/tipiracil (FTP/TPI) in heavily...

gastroesophageal cancer
gastrointestinal cancer

2019 GI Cancers Symposium: Addition of Andecaliximab to mFOLFOX6 in Treatment-Naive Advanced Gastric or GEJ Adenocarcinoma

A phase I/Ib study found that the addition of andecaliximab, a monoclonal antibody that inhibits matrix metalloproteinase 9, to modified fluorouracil (5-FU), leucovorin, and oxaliplatin (mFOLFOX6) showed activity in gastric and or gastroesophageal junction (GEJ) carcinoma. Based on these...

hepatobiliary cancer
gastrointestinal cancer

EORTC-NCI-AACR: Dabrafenib Plus Trametinib Active in Some BRAF V600E–Mutated Gastrointestinal Cancers

In a late-breaking presentation at the 30th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Zev Wainberg, MD, reported on results from a phase II international clinical trial of dabrafenib (Tafinlar) plus trametinib (Mekinist), which showed some activity in 36 patients ...

Gastrointestinal Cancer
Colorectal Cancer
Immunotherapy

First-Line Immunotherapy Shows Benefit in Metastatic Colorectal Cancer Subset

In previously untreated patients with metastatic colorectal cancer and tumors demonstrating microsatellite instability–high (MSI-high) or mismatch repair deficiency (dMMR), immunotherapy with nivolumab (Opdivo) and low-dose ipilimumab (Yervoy) produced a durable clinical benefit in the...

Gastrointestinal Cancer

Neoadjuvant Immunotherapy Yields Major Response in Colon Cancer Subset

In a small study of patients with early-stage colon cancer, neoadjuvant ipilimumab (Yervoy) plus nivolumab (Opdivo) produced major pathologic responses in 100% of patients with mismatch repair (MMR)-deficient tumors but in none of the patients with MMR-proficient tumors, researchers reported at the ...

breast cancer
gynecologic cancer
lymphoma
pancreatic cancer
gastroesophageal cancer
bladder cancer
symptom management
gastrointestinal cancer

FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More

The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...

gastrointestinal cancer

PERSIST-5: 5-Year Adjuvant Imatinib in Resected Intermediate- or High-Risk Primary Gastrointestinal Stromal Tumor

In the phase II PERSIST-5 study reported in JAMA Oncology, Raut et al found that 5 years of adjuvant imatinib therapy was associated with little risk of recurrence in patients with resected intermediate- or high-risk primary gastrointestinal stromal tumor (GIST). As noted by the investigators, 3...

gastrointestinal cancer

Trifluridine/Tipiracil in Heavily Pretreated Metastatic Gastric Cancer

In the phase III TAGS trial reported in The Lancet Oncology, Shitara et al found that trifluridine/tipiracil (Lonsurf) significantly improved overall survival vs placebo in patients with heavily pretreated metastatic gastric cancer. In the double-blind trial, 507 patients with nonresectable...

Gastrointestinal Cancer

Neuroendocrine Tumors: New Data, New Options

Because neuroendocrine tumors are not one disease but a continuum of diseases, ranging from well-differentiated tumors to poorly differentiated and small cell tumors, treatment approaches can vary greatly. At the 2018 Debates and Didactics in Hematology and Oncology conference, held on Sea Island,...

Gastrointestinal Cancer
Colorectal Cancer

Maintenance Therapy for Metastatic Colorectal Cancer: Benefit Seen With Panitumumab Combination

Although the optimal approach to maintenance is not definitive in patients with metastatic colorectal cancer who have undergone chemotherapy-based induction with anti–endothelial growth factor receptor (EGFR) agents, the phase II VALENTINO trial showed that anti-EGFR maintenance therapy with...

gastroesophageal cancer
gastrointestinal cancer
immunotherapy

Pertuzumab and Trastuzumab Plus Chemotherapy in HER2-Positive, Metastatic Gastric or Gastroesophageal Junction Cancer

As reported in The Lancet Oncology by Tabernero et al, the phase III JACOB trial showed no significant overall survival benefit of adding pertuzumab (Perjeta) to trastuzumab (Herceptin) plus chemotherapy in first-line treatment of HER2-positive metastatic gastric or gastroesophageal junction...

Gastrointestinal Cancer
Colorectal Cancer

Ipilimumab in Combination With Nivolumab for MSI-H or dMMR Metastatic Colorectal Cancer

On July 10, 2018, ipilimumab (Yervoy) was granted accelerated approval for use in combination with nivolumab (Opdivo) for the treatment of patients at least 12 years of age with microsatellite instability–high (MSI-H) or mismatch repair–deficient (dMMR) metastatic colorectal cancer progressing...

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