| Objective:The objective of this study was to evaluate the efficacy and safety of gemcitabine plus cisplatin concurrent chemoradiotherapy(CCRT)in patients with locally advanced nasopharyngeal carcinoma.Methods:Radiotherapy was administered via define(2DRT),define(3DCRT)or intensity-modulated radiotherapy(IMRT)using 6MV linear accelerators.All radiotherapy plans were formulated by an experienced expert team.CT/MRI scans were used to define target volumes.For 2DRT or 3DCRT,66-70Gy was delivered to the primary tumor and metastatic cervical lymph nodes.Conventional fractionated radiotherapy was delivered in 2Gy fractions,once daily,five times per week over 7 weeks.For IMRT,the primary tumor and metastatic cervical lymph nodes received a total of 66-70Gy.The clinical target volume(CTV)was divided into the high-risk area(CTV1)and low-risk area(CTV2),which received at least 60-66Gy and 50-54Gy,respectively.IMRT was delivered as one fraction daily,5 days per week.Patients with locally advanced NPC were randomly assigned to the gemcitabine plus cisplatin(GP)group or fluorouracil plus cisplatin(PF)group.GP was two cycles of gemcitabine(1000mg/m~2,i.v.on days 1 and 8)/cisplatin(25mg/m~2,i.v.on days 1 to 3)every3 weeks.PF was two cycles of fluorouracil(750mg/m~2,i.v.over 120h infusion)/cisplatin(25mg/m~2,i.v.on days 1-3)every 3 weeks.Primary end-point was disease-free survival(DFS);secondary endpoints,overall survival(OS),locoregional relapse-free survival(LRRFS),distant metastasis-free survival(DMFS)and treatment-related adverse events.Results:We recruited 76 patients(55 males,21 female)with an average age of 46 years(range,24-60 years)to this study between October 1,2010 and October 1,2014,at the Affiliated Hospital of Guilin Medical University,the Affiliated Hospital of Youjiang Medical University for Nationalities and the Second People's Hospital of Yulin and the People's Hospital of Laibin.38 were assigned to GP and 38,to PF.All 76 patients received concurrent radiotherapy and chemotherapy.The complete response(CR)rate was 100%for both treatment groups.The GP group achieved significantly better DMFS than the PF group(89.5%vs.71.1%;HR 0.33,95%CI 0.11-1.03;P=0.045).Three-year overall survival(OS),disease-free survival(DFS),and locoregional relapse-free survival(LRRFS)were similar between the GP and PF groups(81.6%vs.74%,HR 0.69,95%CI 0.26-1.82;P=0.45;73.7%vs.60.5%,HR 0.66,95%CI0.30-1.44;P=0.30;81.6%vs.78.9%,HR 0.84,95%CI 0.30-2.32;P=0.74,respectively).Although the PFS data favored GP,no clear differences in OS and LRRFS were observed.As anticipated,the incidences of grade III-IV neutropenia and thrombocytopenia were higher in the GP group than the PF group(50%vs.26.3%,P=0.024,and 0.053%vs.0,P=0.000,respectively).With respect to non-hematologic adverse events,grade III gastrointestinal toxicities such as vomiting were less frequent in the GP group than the PF group(13%vs.29%,P=0.042),and diarrhea was more frequent in the PF group(7.9%vs.28.9%,P=0.000).Grade III mucositis was less frequent in the GP group than the PF group(34%vs.61%,P=0.046).Conclusions:GP during CCRT was feasible,tolerable and provided promising survival outcomes in locally advanced NPC.Gemcitabine plus cisplatin could be used as an alternative two drugs regimen in CCRT for nasopharyngeal carcinoma. |
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