Oral Dis: Improved efficacy and safety in Patients with Dosithalaplus cisplatin and 5-fluorourea (TPF) in SCCHN patients in China.

The purpose of this study was to assess the efficacy and safety of dose-improved Doxixace platinum and 5-fluorourea (TPF) in patients with head and neck squamous cell carcinoma (SCCHN) in China.
this Phase III, Open Label, Multicenter study included previously untreated TNM III or Iv SCCHN Chinese adults (NCT00995293).
patients were randomly (1:1) received TPF (Dorsey60 mg/m2 and cisplatin 60 mg/m2, 5-FU 750 mg/m2 continuous intravenous infusion stakes per day on the 1st-5th day) or PF (Cisplatin 75 mg/m2, 1-5 days per day 5-FU 750 mg/m2) to induce chemotherapy every 3 weeks, 3-4 cycles. the primary endpoint of
is Progressless Survival (PFS).
results show that the median PFS in the TPF (n - 108) and PF (n s 111) groups are 400 days and 342 days, respectively (HR s 0.75; 95% CI, 0.53 to 1.06; p . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
the overall response rate of TPF and PF was higher (76.3% vs. 52.9% ;p .001), although the post-treatment response rate tended to be balanced (75.0% vs. 73.9%).
in the TPF and PF groups, 104 (94.5%) and 110 (93.2%) patients had a treatment emergency.
in general, adding dose-improved dositacytosinininininied in PF did not significantly improve PFS, but may increase antitumor activity in patients with local late-stage SCCHN in China.
.