Teysuno launched for advanced gastric cancer

Teysuno (tegafur/gimeracil/oteracil) is indicated for use in combination with cisplatin for advanced gastric cancer.

Effective contraception is required during and for 6 months after treatment with Teysuno
Effective contraception is required during and for 6 months after treatment with Teysuno

PHARMACOLOGY

Teysuno is an oral fluoropyrimidine antineoplastic agent. It is a fixed dose combination of three active substances: tegafur, which after absorption is converted into 5-fluorouracil (5-FU); gimeracil, a dihydropyrimidine dehydrogenase (DPD) inhibitor that prevents degradation of 5-FU by the body; and oteracil, an orotate phosphoribosyltransferase (OPRT) inhibitor that decreases the activity of 5-FU in normal gastrointestinal mucosa. This combination maintains 5-FU exposure to sustain anti-tumour activity while reducing toxicity associated with 5-FU alone.1

CLINICAL STUDIES

The FLAGS Trial conducted in 24 countries randomised 1,053 patients to receive intravenous cisplatin plus either 5-FU by intravenous infusion or the fixed-dose combination of tegafur, gimeracil and oteracil (molar ratio 1.0:0.4:1.0) by mouth. Patients received 5-FU at 1g/m2/24 hours for 120 hours and cisplatin 100mg/m2 on day 1, repeated every 28 days (n=526) or the fixed-dose combination at 50mg/m2 daily (expressed as tegafur dose) in 2 divided doses for 21 days and cisplatin at 75mg/m2 on day 1, repeated every 28 days (n=527).2

The primary endpoint was superiority in overall survival from cisplatin plus combination therapy and cisplatin plus 5-FU in patients with advanced, untreated gastric or gastroesophageal adenocarcinoma. The secondary endpoints were response rate, progression-free survival, time to treatment failure and safety.2

Median overall survival was 8.6 months in the cisplatin/fixed-dose combination group and 7.9 months in the cisplatin/5-FU group (HR 0.92; 95% CI 0.80 to 1.05; p=0.20).2

Whilst the cisplatin/fixed-dose combination did not prolong the overall survival of patients with advanced gastric or gastroesophageal adenocarcinoma compared with cisplatin/5-FU, it did have a significantly improved safety profile.

The incidence of grade 3/4 neutropenia was reduced in the cisplatin/fixed-dose combination group compared with the cisplatin/5-FU group (32.3% versus 63.6%; p<0.01), as was the incidence of complicated neutropenia (5.0% versus 14.4%; p≤0.01).2

References:

  1. Teysuno Summary of Product Characteristics, March 2011.
  2. Ajani JA et al. J Clin Oncol 2010; 28: 1547-53.

View Teysuno drug record

Further information: Nordic Pharma Ltd

Want news like this straight to your inbox?
Sign up for our bulletins

Have you registered with us yet?

Register now to enjoy more articles and free email bulletins

Register
Already registered?
Sign in

More from MIMS

Drug shortages - live tracker

Drug shortages - live tracker

Added: co-fluampicil.
Use our constantly updated...

Further drug shortages prompt advice to consider unlicensed alternatives

Further drug shortages prompt advice to consider unlicensed alternatives

Prescribers are being advised to prioritise supplies...

Vaping still safer than smoking, say health bosses after report of severe lung injury
Free online vestibular rehabilitation tool 'highly effective' for vertigo symptoms

Free online vestibular rehabilitation tool 'highly effective' for vertigo symptoms

GPs should consider online vestibular rehabilitation...