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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...
As reported in The Lancet by Shitara et al, the phase III KEYNOTE-061 trial showed no significant overall survival benefit with pembrolizumab vs paclitaxel in patients with advanced gastric or gastroesophageal junction cancer progressing on platinum-fluoropyrimidine treatment with programmed cell...
Biologics are credited with increasing median overall survival in colorectal cancer to approximately 30 months. Their optimal use was discussed by Axel Grothey, MD, Professor of Oncology at the Mayo Clinic, Rochester, Minnesota, in an article he coauthored for the Journal of Oncology Practice 1...
It is widely acknowledged that the costs of cancer care are much higher in the United States than in Canada, with outcomes that are thought to be similar. A new study presented at the 2018 ASCO Annual Meeting supports that view, by documenting and quantifying the differences in health-care costs...
With a growing emphasis on value in cancer care, some types of resource-intensive therapies may need to be reconsidered. One such treatment may be hyperthermic intraperitoneal chemotherapy, which showed no benefit during surgery for colorectal cancer confined to the peritoneum in the PRODIGE 7...
In a meta-analysis reported in The Lancet Oncology, Yamada et al found that patients with cystic fibrosis are at increased risk of gastrointestinal (GI) cancers vs the general population. Improved management of cystic fibrosis has led to increased life expectancy and increased incidence of...
In the Scandinavian phase III CRITICS trial reported in The Lancet Oncology, Cats et al found no benefit of postoperative chemoradiotherapy vs chemotherapy among patients with gastric cancer who had received neoadjuvant chemotherapy. Compliance with postoperative regimens was poor in both groups....
As reported in JAMA Oncology by Fuchs et al, pembrolizumab (Keytruda) showed activity in patients with previously treated advanced gastric and gastroesophageal junction cancer in the phase II KEYNOTE-059 trial. Study Details In the study, 259 patients from sites in 16 countries who had disease...
In a Korean study reported in The New England Journal of Medicine, Choi et al found that antibiotic treatment for Helicobacter pylori was associated with a significant reduction in metachronous gastric cancer in patients who had undergone endoscopic resection of early gastric cancer or high-grade...
A team of researchers led by Naruihiko Ikoma, MD, MS, of The University of Texas MD Anderson Cancer Center in Houston, analyzed outcomes in 316 patients with gastric cancer to determine whether patients who had clinically positive nodal disease before preoperative therapy have...
Triplet therapy that inhibits the BRAF, MEK, and epidermal growth factor receptor (EGFR) pathways appears promising in BRAF-mutated colorectal cancer, a malignancy that typically does not respond to BRAF inhibition alone. Early results from the BEACON CRC study showed a 48% response rate and an...
Along with full coverage of key presentations from the 2018 Gastrointestinal Cancers Symposium, The ASCO Post brings our readers this additional news roundup. Side Matters in Colon Cancer One of the studies included in the global IDEA trial, which compared 3 vs 6 months of adjuvant chemotherapy in ...
On January 26, 2018, the radiolabeled somatostatin analog lutetium Lu-177 dotatate (Lutathera) was approved for the treatment of somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors, in adults.1,2 Supporting...
In a study reported in the Journal of Oncology Practice, Manzano et al found that unplanned rehospitalization within 30 days after gastrointestinal (GI) cancer hospitalization was more likely after medical vs surgical index hospitalizations among older patients. Some risk factors for...
STEPHEN LEONG, MD, of the University of Colorado Comprehensive Cancer Center, Aurora, discussed the RAINFALL findings at the symposium, commenting, “The study did meet its primary endpoint of progression-free survival; however, it was disappointing not to see a benefit in overall survival or...
BASED ON EFFICACY seen in the second-line setting for the treatment of metastatic gastric or gastroesophageal junction adenocarcinoma, ramucirumab (Cyramza) was evaluated as first-line therapy in the international phase III RAINFALL trial. Although the study met its primary endpoint, with a 25%...
On January 26, 2018, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The drug is indicated for adult patients with somatostatin receptor–positive GEP-NETs. GEP-NETs can be...
A type of cancer that occurs in the lower stomach has been increasing among some Americans under the age of 50, even though in the general population, the incidence of all stomach cancers has been declining for decades. These findings were published by Anderson et al in the Journal of the National...
On January 26, the U.S. Food and Drug Administration (FDA) approved lutetium Lu-177 dotatate (Lutathera) for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This is the first time a radiopharmaceutical has been approved for the treatment of GEP-NETs. Lu-177 dotatate is...
In a study reported in The Lancet Oncology, Sekhar and colleagues found that the increasing proportion of lymph node–positive disease associated with enhanced detection techniques has led to nodal stage migration in anal cancer, which may reduce prognostic discrimination on the basis of lymph...
Maria Svensson, MD, PhD Candidate, of Lund University, discusses high expression of PD-1 and PD-L1 in chemotherapy-naive esophageal and gastric adenocarcinomas, the implications for survival, and the link to a deficiency in mismatched repair genes (Abstract 9).
Manish A. Shah, MD, of Weill Cornell Medicine, discusses phase III study findings on cisplatin plus capecitabine or fluorouracil with or without ramucirumab as first-line therapy in patients with metastatic gastric or gastroesophageal junction adenocarcinoma (Abstract 5).
Florian Lordick, MD, of the University Medicine Leipzig, discusses study findings on intraperitoneal immunotherapy with the antibody catumaxomab for patients with peritoneal carcinomatosis from gastric cancer (Abstract 4).