Study On Precise Comprehensive Treatment Of Nasopharyngeal Carcinoma Based On Clinical Stage

Background:Intensity-modulated radiotherapy(IMRT)enhances the treatment ratio of nasopharyngeal carcinoma(NPC),narrowing the treatment gap between radiation alone and chemoradiotherapy.Whether chemotherapy is unnecessary for patients with T1-2N1M0 NPC remains controversial.This study aims to explore the role of chemotherapy in T1-2N1M0 NPC in the IMRT era.Methods:We collected data of patients diagnosed with T1-2N1M0 NPC between January 2008 and December 2016 in two cancer centers(n=343).Comparisons of locoregional failure-free survival(LRFFS),distant metastasis-free survival(DMFS),progression-free survival(PFS),cancer-specific survival(CSS),and overall survival(OS)were performed between the IMRT group and chemo-radiotherapy(CRT)group.We measured the 5-and 10-year post-treatment outcomes of the patients.Results:The median follow-up time for surviving patients was 91(range:49-138)months.The number of patients who received IMRT,Concurrent Chemoradiotherapy(CCRT),Induction chemotherapy+concurrent chemoradiotherapy(IC+CCRT),and concurrent chemoradiotherapy+adjuvant chemotherapy(CCRT+AC)was 114,101,89,and 39,respectively.The 5-year OS,CSS,PFS,LRFFS,and DMFS of the CRT group were not superior to those of the IMRT group(P=0.679;P=0.832;P=0.732;P=0.456;and P=0.537).Multivariable analyses revealed age as an independent adverse prognostic factor for OS,PFS,CSS,and DMFS.Conclusions:This retrospective study showed that the prognosis of IMRT alone was comparable to that of chemoradiotherapy in patients with T1-2N1M0 NPC,supporting the omission of chemotherapy in this group of patients.However,the safety of exemption from chemotherapy needs to be further confirmed by well-designed,prospective,randomized clinical trials.Background:The aims of the current study were to compare the PFS and side effect between locoregionally advanced NPC patients who received induction chemotherapy with cisplatin and fluorouracil(PF)or docetaxel plus cisplatin and fluorouracil(TPF),followed by chemoradiotherapy.Methods:We randomly assigned 506 patients(all of whom had stage Ⅲ or Ⅳdisease with no distant metastases)treated at six centers in China between April 1st,2012 and November 3rd,2016 to receive either PF or TPF induction chemotherapy,followed by chemoradiotherapy with every 3 weeks cisplatin therapy and radiotherapy for 5 days per week.The primary end point was 3-year PFS in the intention-to-treat(ITT)population.The non-inferiority was met if the upper limit of 95%CI for the differences did not exceed 14%.Adverse events were analyzed in the patients received at least one cycle of IC.Results:After a median follow-up of 64 months,the 3-year PFS in the ITT population was 78.2%(95%CI 72.2-82.8)in the PF group and 84.0%(95%CI 79.5-88.5)in the TPF group with a difference of 5.8%(95%CI-1.0%to 12.6%;p non-inferiority=0.008)with a Hazard ratio(HR)of 1.23(95%CI 0.86-1.76,log-rank p=0.262).No differences were observed in the locoregional(90.9%vs.93.0%,HR:1.33[95%CI 0.82-2.17],log-rank p=0.241),distant disease control(89.0%vs.92.7%,HR:1.37[95%CI 0.81-2.33],log-rank p=0.243),and overall survival rates(92.0%vs.94.8%,HR:1.47[95%CI 0.92-2.33],log-rank p=0.109).During the IC phase,higher frequency of grade 3-4 Leucopenia(27%vs.5%,p<0.001),neutropenia(39%vs.27%,p=0.004),febrile neutropenia(8%vs.2%,p=0.003),and lymphopenia(23%vs.4%,p<0.001)were recorded in the TPF group while in the PF group,more common grade 3-4 mucositis was noted(7.5%vs.2.4%,p=0.008).No differences were observed in other grade-3 or 4 adverse events.Also,no difference was recorded in grade-3 or 4 adverse events during the concurrent chemoradiotherapy(CCRT).Conclusions:Our study showed that the tolerance and compliance of PF induction chemotherapy are substantially better than TPF induction chemotherapy.Moreover,PF achieved non-inferior survival and disease control compared to TPF for locoregional advanced stage NPC.Background:A previous phase-2 trial to assess the addition of Endostar to gemcitabine and cisplatin(GP)chemotherapy showed that it improves prognosis in metastatic nasopharyngeal carcinoma(M-NPC)but the study cohort was small.We wished to update that phase-2 trial by enrolling an additional 44 patients and to assess the benefit of Endostar+GP chemotherapy.Methods:An analysis of 72 M-NPC patients treated between July 2010 and November 2016 was done.The treatment regimen was a combination of gemcitabine(1,000 mg/m2)on days 1 and 8,cisplatin(80 mg/m2)on day 1,and Endostar(15 mg/day)from day 1 to day 14 of a 21-day cycle for≥2 cycles.The acute toxic effects and therapeutic efficacy were analyzed.Results:A total of 329 cycles of GP and 288 cycles of Endostar were delivered to 72 patients,with the median number of four(range,2-10)cycles administered per patient.The response rate was 77.8%.The median PFS and OS were 12 and 19.5 months,respectively.For the entire group,the 1-,2-,and 3-year PFS was 45.4%,26.7%,and 23.3%while the 1-,2-,and 3-year OS was 87.4%,54.2%,and 31.9%,respectively.The main grade-3/4 hematologic toxicities were leukopenia(54.1%)and neutropenia(59.8%).The number of non-hematologic adverse events was minimal.The regimen was well-tolerated.Conclusions:Endostar+GP chemotherapy is an effective,well-tolerated regimen for M-NPC.