Lancet Gastroenterol Hepatol: Lonsurf in combination with Remo Reeds to treat the efficacy and safety of non-removable advanced stomach cancer

Lonsurf (trifluridine/tipiracil) is a new anti-metabolic compound drug consisting of the anti-tumor nucleoside analoga FTD (trifluoroside, trifluridine) and the thoracic glycoside phosphorylase inhibitor TPI (tipiracil), which was approved by the FDA in 2015 for treatment of refractory metastatic colorectal cancer (mCRC) that no longer responds to other therapies (chemotherapy and biotherapy).
preclinical and clinical trial results of colorectal cancer showed that Lonsurf combined VEGF inhibition had good anti-tumor effect.
study aims to assess the efficacy and safety of Lonsurf's combination ramucirumab, an antagonist for the growth factor 2 of vascular endotent cells, for the treatment of advanced stomach cancer.
this is an open-label, one-arm, two-queue Phase 2 trial, conducted in eight centers in Japan, recruiting advanced stomach cancer or gastroesophageal junction adenocarcinoma that cannot be surgically removed.
A cohort was included in patients who had previously received first-line chemotherapy without reed monotherapy, and B-queue was included in patients who had previously received 2-4 lines of chemotherapy, including remolu monotherapy.
patients were treated with Lonsurf (35 mg/m2, 2/day, oral, day 1-5 and day 8-12) and remolu monoantigen (8 mg/kg, static drops, day 1 and day 15 medication) every 28 days.
end point is disease control.
April 8 - October 11, 2019, 64 patients were recruited to include safety and efficacy analysis, 33 in Queue A and 31 in Queue B.
rate of 85 per cent (28/33) and 77 per cent (24/31), respectively, in queues A and B.
common level 3-4 treatment-related side reactions were a decrease in the number of neutral granulocyte counts (27 cases in the A and B queues (82 percent) and 23 cases (23 percent) and a decrease in plateboard counts (8 .24 percent) and 4 .14 percent, respectively).
three patients in the
A cohort had severe treatment-related side-reaction events (reduced fatigue and neutral granulocyte count; perforation of the large intestine; reduction of highly thermal neutral granulocytes, reduction of plate plate parts, and anemia).
B-queue patients had no severe adverse reactions.
no treatment-related deaths were observed.
In summary, Lonsurf combined with Remo reed monoantigen for patients with advanced gastric cancer treated in the past has certain clinical efficacy, safety is controllable, and is not affected by the past with or without Remo reed monoantigen exposure.