TRIFLUOX-DP: Safety of Trifluridine/tipiracil as replacement of fluoropyrimidines (5-fluorouracil and capecitabine) based chemotherapy as first line metastatic colorectal or gastroesophageal cancer regimens in patients with dihydropyrimidine dehydrogenase deficiency: a phase II trial

Patients with pMMR/MSS metastatic adenocarcinoma of the colon or rectum or gastroesophageal cancer (lower esophagus, gastroesophageal junction and gastric) and with known dihydropyrimidine dehydrogenase (DPD) deficiency defined as plasma uracil concentration ≥16 ng/ml, who undergo first-line treatment

The co-primary endpoint including: the rate of patients without specific toxicities defined as grade 3-4-5 digestive toxicities (diarrhoea and/or stomatitis) and grade 4-5 neutropenia or febrile neutropenia over the first 2 cycles (1 month of treatment) of first-line metastatic treatment (NCI CTCAE v5.0) AND the disease control rate after the 1st evaluation at 2 months of treatment.

Safety of combination treatment (NCI CTCAE v5.0) determined through the incidence of adverse events, treatment-related adverse events, serious adverse events (SAE), and death; for the whole population and depending on glomerular filtration rate ([50-60[ vs [60- 90[ vs ≥90 mL/min per 1.73 m2), Dose intensity of combination treatment per patient and per cycle for cycle 1 and cycle 2 before third cycle, Treatment efficacy : PFS, Overall survival, Objective response rate, Disease control rate, Health-related quality of life will be assessed using the EORTC QLQ-C30 and EORTC QLQ-OG25 questionnaires for patients with gastroesophageal adenocarcinomas or EORTC QLQ-CR29 for patients with colorectal adenocarcinomas at baseline and every 2 months until disease progression and/or at least 3 months after study treatment stop

No related papers found yet.

France