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Overall survival in metastatic gas­tric or gastroesophageal junction cancer improved significantly in patients who received the oral combination chemo­therapy Lonsurf regardless of whether they’d had a gastrectomy.
Overall survival in metastatic gas­tric or gastroesophageal junction cancer improved significantly in patients who received the oral combination chemo­therapy Lonsurf (trifluridine/tipiracil; TAS-102), regardless of whether they’d had a gastrectomy (surgical removal of all or part of the stomach).
These results from the phase 3, ran­domized, placebo-controlled TAGS trial were reported by David H. Ilson, M.D., of Memorial Sloan Kettering Cancer Center in New York City. Researchers in 17 countries enrolled patients with inoperable meta­static gastric or gastroesophageal junction cancer that had progressed despite two or more prior chemotherapy regimens. Data analysis included 507 patients, including 221 who’d had prior gastrectomy.
Lonsurf was approved to treat advanced colorectal cancer in 2015. On Feb. 25, 2019, the Food and Drug Admin­istration approved its use in previously treated patients with advanced or meta­static gastric adenocarcinoma, including cancer of the gastroesophageal junction.
Patients treated with Lonsurf lived a median of 5.7 months from the time they started the trial compared with 3.6 months for placebo-treated patients. Median progression-free survival — the time from the start of treatment until the disease progressed — also improved slightly with Lonsurf, from 1.8 to 2.0 months.
Surgery remains the only treatment with curative potential for early-stage gastric cancer. However, as many as half of patients have recurrent disease, and about 40 percent of those patients have undergone gastrectomy. The research­ers considered many factors that might predict outcomes for patients who took Lonsurf and found that prior gastrectomy was not one of them, Ilson said.
In the overall population and the gas­trectomy subgroup, side effects, particu­larly hematologic ones such as decreased blood counts, occurred more often with Lonsurf. Other reported serious or severe symptoms included decreased appetite (9 percent in the Lonsurf group versus 7 percent in the placebo group), fatigue (7 percent versus 6 percent), lack of energy (5 percent versus 7 percent) and back pain (1 percent versus 2 percent).
Gastrointestinal symptoms of those who took Lonsurf were very infrequent and similar in incidence to those expe­rienced by patients who took placebo. Types and rates of symptoms in patients with prior gastrectomy were similar to those in the study population overall.
“Hematologic side effects, such as neutropenia and leukopenia, may have been somewhat more frequent among TAS-102-treated patients with gastrectomy than in the overall population, but this did not result in more treatment discontinuations,” Ilson said.