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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...
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...
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...
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...
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...
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 ...
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...
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...
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...
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...
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...
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...
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 ...
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...
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...
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).
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...
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 ...
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 ...
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...
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...
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....
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...
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...
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...
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...
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...
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...
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 ...
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...
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).
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).
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).
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...
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...
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...
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...
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 ...
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...
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 ...
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...
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...
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...
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,...
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...
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...
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...
In a study reported in JAMA Oncology, Li et al found that MUC16 mutation was associated with increased tumor mutation load and improved prognosis in gastric cancer. The study involved analysis of genomic data from 437 gastric cancer samples from The Cancer Genome Atlas (TCGA; discovery set) and...
The European Commission (EC) has approved Trazimera, a biosimilar to trastuzumab (Herceptin), for the treatment of human epidermal growth factor (HER2)–overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. This approval...
Researchers from Samsung Medical Center and Guardant Health, Inc have demonstrated the feasibility of determining a measure analogous to tumor mutation burden, a promising biomarker that may predict patient response to certain immunotherapies, utilizing the Guardant360 assay, a...