TPF诱导化疗或PF诱导化疗联合同期放化疗治疗局部晚期鼻咽癌的临床观察

背景与目的：TPF(多西他赛+顺铂+氟尿嘧啶)诱导化疗加同期放化疗治疗局部晚期鼻咽癌的疗效尚不清楚。该研究旨在比较TPF诱导化疗或PF(顺铂+氟尿嘧啶)诱导化疗联合同期放化疗治疗局部晚期鼻咽癌的疗效和耐受性。方法：将局部晚期鼻咽癌患者随机分为两组。TPF组116例接受TPF诱导化疗(多西他赛60 mg/m2,第1天+顺铂60 mg/m2,第1天+氟尿嘧啶750 mg/m2,持续静脉滴注120 h),每3周重复,共3个疗程。PF组116例接受PF诱导化疗(顺铂80 mg/m2,第1天+氟尿嘧啶750 mg/m2,持续静脉滴注120 h),每3周重复,共3个疗程。诱导化疗结束后行同期放化疗,放疗采用调强适形放疗(intensity modulated radiation therapy,IMRT)技术,大体肿瘤靶区(gross tumor volume,GTV)6810 cGy/30次,5次/周,共6周,同期化疗用顺铂80 mg/m2,第1、22天。评价完全缓解(complete response,CR)、部分缓解(partial response,PR)和有效缓解率(response rate,RR), RR=CR+PR。评价两组患者的近期疗效及不良反应,并随访比较5年无进展生存(progression-free survival,PFS)和5年总生存(overall survival,OS)。结果：诱导化疗结束后和治疗结束后13周TPF组的有效缓解率都高于PF组,两组差异有统计学意义(P=0.001,P=0.002);TPF组中位复发时间为2.98年,5年的PFS为84.48%,PF组中位复发时间为2.32年,5年的PFS为82.75%,差异无统计学意义(P=0.458);TPF组5年的OS为87.06%,PF组5年的OS为85.34%,差异无统计学意义(P=0.274)。TPF组在中性粒细胞下降、血小板下降、肝功能和肾功能损伤、腹泻以及黏膜坏死的发生上均明显高于PF组,差异有统计学意义(P<0.001),TPF组发生Ⅲ度和Ⅳ度不良反应较PF组明显增高,差异有统计学意义(P<0.001)。结论：TPF方案诱导化疗治疗局部晚期鼻咽癌的临床疗效并不优于PF方案诱导化疗治疗局部晚期鼻咽癌,且TPF方案诱导化疗的不良反应较PF方案明显,临床上不适合推广。     

Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: Long-term results of phase 3 randomized controlled trial

To report long-term results of a randomized controlled trial that compared cisplatin/fluorouracil/docetaxel (TPF) induction chemotherapy (IC) plus concurrent chemoradiotherapy (CCRT) with CCRT alone in locoregionally advanced nasopharyngeal carcinoma (NPC). Patients with stage III–IVB (except T3–4 N0) NPC were randomly assigned to receive IC plus CCRT (n = 241) or CCRT alone (n = 239). IC included three cycles of docetaxel (60 mg/m² d1), cisplatin (60 mg/m² d1), and fluorouracil (600 mg/m²/d civ d1–5) every 3 weeks. Patients from both groups received intensity-modulated radiotherapy concurrently with three cycles of 100 mg/m² cisplatin every 3 weeks. After a median follow-up of 71.5 months, the IC plus CCRT group showed significantly better 5-year failure-free survival (FFS, 77.4% vs. 66.4%, p = 0.019), overall survival (OS, 85.6% vs. 77.7%, p = 0.042), distant failure-free survival (88% vs. 79.8%, p = 0.030), and locoregional failure-free survival (90.7% vs. 83.8%, p = 0.044) compared to the CCRT alone group. Post hoc subgroup analyses revealed that beneficial effects on FFS were primarily observed in patients with N1, stage IVA, pretreatment lactate dehydrogenase ≥170 U/l, or pretreatment plasma Epstein–Barr virus DNA ≥6000 copies/mL. Two nomograms were further developed to predict the potential FFS and OS benefit of TPF IC. The incidence of grade 3 or 4 late toxicities was 8.8% (21/239) in the IC plus CCRT group and 9.2% (22/238) in the CCRT alone group. Long-term follow-up confirmed that TPF IC plus CCRT significantly improved survival in locoregionally advanced NPC with no marked increase in late toxicities and could be an option of treatment for these patients.     

Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial

Aim of the studyPrevious results from our trial showed that adjuvant cisplatin and fluorouracil chemotherapy did not significantly improve survival after concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) at 2 years. Here, we present the data of long-term survival and late toxicities to further assess the ultimate therapeutic index of adjuvant chemotherapy (AC).MethodsPatients with stage III–IVB (except T3-4N0) NPC were randomly assigned to receive CCRT plus AC or CCRT only at seven institutions in China. Patients in both groups received cisplatin 40 mg/m² weekly up to 7 weeks concurrently with radiotherapy. The CCRT plus AC group subsequently received adjuvant cisplatin 80 mg/m² and fluorouracil 800 mg/m²/d for 120 h every 4 weeks for three cycles. The primary end-point was failure-free survival.ResultsTwo hundred and fifty-one patients were randomised to the CCRT plus AC group and 257 to the CCRT only group. After a median follow-up of 68.4 months, estimated 5-year failure-free survival rate was 75% in the CCRT plus AC group and 71% in the CCRT only group (hazard ratio 0.88, 95% confidence interval 0.64–1.22; p = 0.45). 66 (27%) of 249 patients in the CCRT plus AC group and 53 (21%) of 254 patients in the CCRT only group developed one or more late grade 3–4 toxicities (p = 0.14).ConclusionAdjuvant cisplatin and fluorouracil chemotherapy still failed to demonstrate significant survival benefit after CCRT in locoregionally advanced NPC based on the long-term follow-up data, and addition of adjuvant cisplatin and fluorouracil did not significantly increase late toxicities.Registration numberNCT00677118.     

Concurrent chemoradiotherapy in locoregionally recurrent nasopharyngeal carcinoma

PURPOSE: To analyze the results of concurrent chemoradiotherapy in patients with locoregional recurrent nasopharyngeal carcinoma. METHODS AND MATERIALS: We performed a retrospective analysis of 35 patients with locoregional recurrent nasopharyngeal carcinoma referred to our department between March 1994 and November 2002. Most patients were male (77%), Chinese (97%), and had undifferentiated carcinoma (89%). Most had extensive locally recurrent Stage rT3-T4 disease (66%) with a median age at recurrence of 49 years (range, 35-69 years). A repeat course of radiotherapy was given concurrently with cisplatin, with cisplatin/5-fluorouracil as consolidation treatment. Significant morbidities were present, including cranial nerve palsies due to extensive recurrent local disease before treatment of the recurrence. RESULTS: The response rate to concurrent chemoradiotherapy was 58% (29% complete response and 29% partial response). The 5-year progression-free and overall survival rate, calculated using the Kaplan-Meier method, was 15% and 26%, respectively. Only 3 patients developed systemic metastases. Grade 3-4 acute toxicities included emesis (9%) and neutropenia (14%), and Grade 3-4 late toxicities consisted of temporal lobe necrosis (3%), cranial neuropathy (6%), and endocrine abnormalities (14%). CONCLUSION: Concurrent chemoradiotherapy is feasible in a selected group of patients with locoregional recurrent NPC, but the risk of major late toxicities is significant.     

Concurrent chemoradiotherapy followed by adjuvant chemotherapy compared with concurrent chemoradiotherapy alone for the treatment of locally advanced nasopharyngeal carcinoma: a retrospective controlled study

Objective

We evaluated the survival benefit of providing concurrent chemoradiotherapy (ccrt) plus adjuvant chemotherapy compared with ccrt alone to patients with locally advanced nasopharyngeal carcinoma.

Methods

This retrospective study included 130 patients with nasopharyngeal carcinoma treated with ccrt plus adjuvant chemotherapy from June 2005 to December 2010. Another 130 patients treated with ccrt alone during the same period were matched on age, sex, World Health Organization histology, T stage, N stage, and technology used for radiotherapy. The endpoints included overall survival, locoregional failure-free survival, distant metastasis failure-free survival, and failure-free survival.

Results

At a mean follow-up of 42.1 months (range: 8–85 months), the observed hazard ratios for the group receiving ccrt plus adjuvant chemotherapy compared with the group receiving ccrt alone were: for overall survival, 0.77 [95% confidence interval (ci): 0.37 to 1.57]; for locoregional failure-free survival, 1.00 (95% ci: 0.37 to 2.71); for distant metastasis failure-free survival, 1.15 (95% ci: 0.56 to 2.37); and for failure-free survival, 1.26 (95% ci: 0.69 to 2.28). There were no significant differences in survival between the groups. After stratification by disease stage, ccrt plus adjuvant chemotherapy provided a borderline significant benefit for patients with N2–3 disease (hazard ratio: 0.35; 95% ci: 0.11 to 1.06; p = 0.052). Multivariate analyses indicated that only tumour stage was a prognostic factor for overall survival.

Conclusions

Patients with locally advanced nasopharyngeal carcinoma received no significant survival benefit from the addition of adjuvant chemotherapy to ccrt. However, patients with N2–3 disease might benefit from the addition of adjuvant chemotherapy to ccrt.     

N晚期鼻咽癌诱导加同期化放疗与同期化放疗的疗效比较

目的:探讨诱导加同期化放疗及同期化放疗对N晚期鼻咽癌患者的远期临床疗效。方法:选取160例N晚期鼻咽癌患者,分为诱导加同期化放疗组80例(A组)和同期化放疗组80例(B组),两组放疗方法相同。A组在放疗前给予2个周期诱导化疗,DDP 20mg/m2,d1-5,5-FU 500mg/m2,d1-5,21天为1周期。两组均于放疗第1周及放疗第4周给予DDP 20mg/m2,d1-3,5-FU 500mg/m2,d1-3,同期化疗。结果:A组和B组5年总生存率(OS)分别为67.5%和51.3%(P<0.05);5年无进展生存率(PFS)分别为65.0%和48.8%(P<0.05);局部复发率分别为17.5%和22.5%(P>0.05);远处转移率分别为13.8%和27.5%(P<0.05)。结论:诱导加同期化放疗可提高N晚期鼻咽癌患者的5年OS、PFS。     

Preliminary results of a prospective randomized trial comparing concurrent chemoradiotherapy plus adjuvant chemotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma in endemic regions of china

PURPOSE: A prospective randomized trial was performed to evaluate the efficacy of concurrent chemotherapy and adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC) in endemic regions of China. METHODS AND MATERIALS: Between July 2002 and September 2005, 316 eligible patients were randomly assigned to receive either radiotherapy alone (RT) or chemoradiotherapy concurrent with adjuvant chemotherapy (CRT). All patients received 70 Gy in 7 weeks using standard RT portals and techniques. The CRT patients were given concurrent cisplatin (40 mg/m(2) on Day 1) weekly during RT, followed by cisplatin (80 mg/m(2) on Day 1) and fluorouracil (800 mg/m(2) on Days 1-5) every 4 weeks (Weeks 5, 9, and 13) for three cycles after completion of RT. All patients were analyzed by intent-to-treat analysis. RESULTS: The two groups were well-balanced in all prognostic factors and RT parameters. The CRT group experienced significantly more acute toxicity (62.6% vs. 32%, p = 0.000). A total of 107 patients (68%) and 97 patients (61%) completed all cycles of concurrent chemotherapy and adjuvant chemotherapy, with a median follow-up time of 29 months. The 2-year overall survival rate, failure-free survival rate, distant failure-free survival rate, and locoregional failure-free survival rate for the CRT and RT groups were 89.8% vs. 79.7% (p = 0.003), 84.6% vs. 72.5% (p = 0.001), 86.5% vs. 78.7% (p = 0.024), and 98.0% vs. 91.9% (p = 0.007), respectively. CONCLUSIONS: This trial demonstrated the significant survival benefits of concurrent chemotherapy plus adjuvant chemotherapy in patients with locoregionally advanced NPC in endemic regions of China.     

新辅助化疗后根治性手术与同步放化疗在局部晚期宫颈癌的远期疗效评价

目的本研究的目的是比较ⅠB2-ⅡB期局部晚期宫颈癌新辅助化疗后根治性手术与同步放化疗的远期生存情况。方法回顾性分析从2000年1月—2004年12月间ⅠB2-ⅡB期局部晚期宫颈癌共222例,将其分为二组：新辅助化疗＋根治性全子宫切除术＋盆腔淋巴结切除术共155例;同步放化疗组67例。所有患者最长随访时间为114个月,最短随访时间为54个月,中位随访时间为72．6个月。且对所有可能影响无瘤生存时间和总生存时间的高危因素进行评估。结果本研究中位随访时间为72．6个月,新辅助化疗后根治性手术组和同步放化疗组5年无瘤生存率分别是88．39％和70．94％,两组比较有统计学意义（P：0．006）;而5年总生存率分别为88．52％和72．91％,两组比较有统计学意义（P=0．0004）。在Cox风险回归模型中,调整宫颈癌患者的年龄、病理分型后,结果显示：接受新辅助化疗后根治性手术组和同步放化疗组治疗的宫颈癌患者5年无瘤生存时间有明显差异（HR：2．765,95％CI：1．446—5．288,P=0．0021）;在5年总生存时间上也有显著性差异（HR=3．516,95％CI：1．822—6．784,P=0．0002）。结论本研究ⅠB2-ⅡB期局部晚期宫颈癌新辅助化疗后根治性手术组在无瘤生存时间和总生存时间方面显著优于同步放化疗组。     

局部晚期鼻咽癌放疗同步ＰＦ方案或顺铂单药的临床对照研究

目的　对比观察顺铂（ＤＤＰ）单药用于局部晚期鼻咽癌同步放化疗与ＤＤＰ联合氟尿嘧啶（５-ＦＵ）方案（ＰＦ方案）同步放化疗的有效性和安全性。方法　７６例局部晚期鼻咽癌分为两组,４０例接受ＰＦ方案同步放化疗（５-ＦＵ５００ｍｇ／ｍ^２静滴,ｄ１～ｄ５;ＤＤＰ８０ｍｇ／ｍ^２静滴,ｄ１,２１天为１周期）,３６例接受ＤＤＰ单药同步放化疗（ＤＤＰ４０ｍｇ／ｍ２静滴,每周１次,共７次）。鼻咽部病灶及颈部阳性淋巴结给予放疗总量为７０Ｇｙ,颈部预防性照射给予放疗量５０Ｇｙ。结果　全部患者均可评价疗效和毒副反应,ＰＦ方案组及ＤＤＰ单药组有效率均为１００％。ＰＦ方案组的１、３年生存率分别为１００％、８５％,ＤＤＰ单药组分别为１００％、８９％（Ｐ＞０.０５）;ＰＦ方案组与ＤＤＰ单药组的３年无进展生存率分别为７７.５％和７５.０％ （Ｐ＞０.０５）;ＰＦ方案组的中位生存时间为５０.６个月,ＤＤＰ单药组为４８.０个月（Ｐ＞０.０５）。两组毒副反应以恶心呕吐、口腔黏膜炎及白细胞减少为主,差异均有统计学意义（Ｐ＜０.０５）。结论　ＤＤＰ单药与ＰＦ方案用于局部晚期鼻咽癌同步放化疗的疗效相近,患者均可耐受,但ＤＤＰ单药组反应较轻。     

局部晚期鼻咽癌诱导加同期化放疗与诱导化放疗的对照研究

背景与目的：诱导化放疗与同时期化放疗被认为是治疗局部晚期鼻咽癌最有效的两种策略。本随机研究目的在于比较诱导化疗加同时期化放疗与诱导化放疗治疗局部区域晚期鼻咽癌的疗效。方法：从2002年8月到2005年4月,408例患者随机分为诱导化放疗（induction chemoradiotherapy, IC/RT）和诱导加同时期化放疗（induction-concurrent chemoradiotherapy, IC/CCRT）两组。两组患者接受同样的诱导化疗方案：两程氟尿嘧啶脱氧核苷（floxuridine,FuDR）（750mg/m^2,d1-5）＋卡铂（carboplatin,CBP）（AUC=6）,化疗结束后1周行放疗。诱导加同时期化放疗组的患者在在放疗的第7、28、49d接受卡铂AUC=6的化疗。8例不符合人组标准的患者被排除。剩余的400例患者被纳入进行了分析。结果：诱导加同时期化放疗组和诱导化放疗组Ⅲ、Ⅳ度毒性率分别为28．4％和13．1％（P〈0．001）。中位随访3．9年。诱导加同时期化放疗组和诱导化放疗组的3年总生存分别为75．9％和83．4％（P=0．12）。两组的无病生存、局部区域控制和远处转移控制率无统计学差异。结论：本研究采用的诱导加同时期化放疗方案未能较诱导化放疗进一步提高局部区域晚期鼻咽癌患者的总生存率。     

Induction chemotherapy forlocoregionally advanced nasopharyngeal carcinoma

The value of adding induction chemotherapy (IC) to concurrent chemoradiotherapy (CCRT) for the treatment of locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear. In our recent article entitled “Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial” published in theLancet Oncology, we reported the results of a phase III, multicenter, randomized controlled trial comparing cisplatin, 5?lfuo?rouracil, and docetaxel (TPF) IC plus CCRT versus CCRT alone in patients with T3?4N1/TxN2?3M0 NPC (ClinicalTrials.gov registration number NCT01245959). The IC?plus?CCRT group showed signiifcantly higher 3?year failure?free survival, overall survival, and distant failure?free survival rates than the CCRT?alone group, with an acceptable toxicity proifle. Our study suggests that adding TPF IC to CCRT could increase survival rates and reduce distant failure in patients with locoregionally advanced NPC. However, long?term follow?up is required to assess the eventual effcacy and toxicity of this strategy, and a more accurate method to determine prognosis is needed to enable better tailoring of treatment strategy for individual patients.     

诱导化疗在局部晚期鼻咽癌放射治疗中的价值

目的 :评价诱导化疗对局部晚期鼻咽癌放射疗效的影响。方法 :12 7例病理确诊的Ⅲ、ⅣA期初诊鼻咽癌患者接受诱导化疗 (含顺铂为主的联合方案1～ 3个疗程 )加放射治疗 ,按TNM分期、性别、年龄、病理类型的匹配条件与同期12 7例单纯放疗患者配对进行比较 ,两组采用的放射治疗技术基本一致。结果 :化放组和单放组 3年远处转移率分别为10 2 %和 2 4 4% ,P =0 0 0 3 ,两组的 3年总生存率 (OS)、无瘤生存率 (DFS)、无远处转移生存率 (DMFS)、无复发生存率(RFS)分别为 78 1%和 67 4% ,P =0 0 85 ;72 1%和 63 1% ,P =0 0 47;88 1%和 72 1% ,P =0 0 0 1;84 9%和94 5 % ,P =0 10 5。对N2 ～N3 期患者 ,两组的OS、DFS、DMFS分别为 79 7%和64 9% ,P =0 0 2 7;74 6%和 60 2 % ,P=0 0 14 ;87 9%和 68 6% ,P =0 0 0 2。化放组化疗 2个疗程的 3年DFS要明显高于化疗 1个疗程 ( 83 1%对 65 7% ,P=0 0 49)或单纯放疗 ( 83 1%对 63 1% ,P =0 0 1)。结论 :诱导化疗综合放疗能明显降低局部晚期鼻咽癌患者的远处转移率 ,提高无瘤生存率 ,但不能提高局控率和总生存率 ;诱导化疗力度不足 ( <2个疗程 )将会影响疗效     

中晚期鼻咽癌调强放疗联合同期化疗疗效分析

目的:探讨调强放疗联合同期化疗治疗中晚期鼻咽癌的疗效及不良反应。方法:60例中晚期鼻咽癌患者随机分为两组。A组(研究组):调强放疗联合同期化疗,B组(对照组):调强放疗。两组放疗方法相同:调强放疗加或不加下颈普放。原发灶及上颈采用调强放疗(IMRT),下颈采用IMRT或普放。采用逆向TPS。各靶区处方剂量均以其PTV定义。鼻咽肿瘤(GTVnx)和颈部转移淋巴结(GTVnd)处方剂量为69-72Gy。鼻咽预防区域PTV1处方剂量为60-65Gy。颈部预防区域PTV2处方剂量为50-60Gy。常规剂量体积保护关键器官。化疗采用DDP 60mg/m2d1iv dvip,5-FU750mg/m2d2-4iv dvip。与放疗同时开始,间隔3周,重复2-3个疗程。结果:A组鼻咽病灶CR率及有效率为81%(24/30)、96.67%(29/30),B组鼻咽病灶CR率及有效率为50%(15/30)、83.33%(25/30);A组颈部病灶CR率及有效率为73.33%(22/30)、90%(27/30),B组颈部病灶CR率及有效率为43.33%(13/30)、83.33%(25/30)。两组鼻咽病灶及颈部病灶CR率有显著性差异。但有效率及1、3年生存率无显著性差异。A组患者白细胞下降及恶心呕吐较B组严重,但患者可耐受。结论:中晚期鼻咽癌(NPC)联合同期化疗短期疗效CR率较单纯放疗好。但长期疗效未显示优越性,不良反应稍增加。     

单药顺铂在局部晚期鼻咽癌同步放化疗中的临床应用分析

目的：评价局部晚期鼻咽癌PDD同步化疗的疗效及毒副反应。方法：52例局部晚期鼻咽癌接受顺铂同步放疗,PDD化疗的第1天就开始实施同步放疗,顺铂30 mg/m2静脉滴注,每周1次,共7次;鼻咽部病灶及阳性的淋巴结给予放疗总量为70Gy,颈部预防性照射给予放疗量50Gy,每周5次,每次2Gy。结果：全部患者均可评价,近期有效率为100%;1年、3年和5年OS分别为100%、88.5%、25%;3年、5年的无病生存率分别为80.8%和19.2%;平均生存时间和中位生存时间分别为48.7月和47月。无病平均生存时间和无病中位生存时间分别为45.7月和45月。结论：局部晚期鼻咽癌含PDD方案的CCRT有较好的疗效,毒性反应可耐受,长期生存需要进一步观察。     

Sequential chemoradiotherapy with gemcitabine and cisplatin for locoregionally advanced nasopharyngeal carcinoma

We investigated a new chemoradiotherapy (CRT) regimen for locoregionally advanced nasopharyngeal carcinoma (NPC). A total of 240 patients were randomly assigned to three different CRT regimens: sequential CRT [1 cycle chemotherapy + Phase I radiotherapy (RT) + 1 cycle chemotherapy + Phase II RT + 2 cycles chemotherapy] with a cisplatin–gemcitabine (GC) regimen (800 mg/m² gemcitabine on Days 1 and 8 and 20 mg/m² cisplatin on Days 1–5, every 4 weeks) (sGC‐RT); sequential chemoradiotherapy with a cisplatin–fluorouracil (PF) regimen (20 mg/m² DDP and 500 mg/m² 5‐FU on Days 1–5, every 4 weeks) (sPF‐RT) and cisplatin‐based concurrent chemoradiotherapy plus adjuvant PF chemotherapy (Con‐RT + PF). The complete response rate was higher in the sGC + RT group than in the other two groups (98.75% vs. 92.50%, p < 0.01). The 3‐year overall survival (OS), disease‐free survival (DFS) and distant metastasis‐free survival (DMFS) rates in the sGC‐RT group were significantly higher than those observed in the Con‐RT group (OS, 95.0% vs. 76.3%, p < 0.001; DFS, 89.9% vs. 67.5%, p < 0.001; DMFS, 92.5% vs. 76.0%, p = 0.004) and in the sPF + RT group (OS, 95.0% vs. 73.6%, p < 0.001; DFS, 89.9% vs. 63.3%, p < 0.001; DMFS, 92.5% vs. 74.7%, p = 0.002). There were no significant differences in 3‐year OS, DFS and MFS rates between the Con‐RT and the sPF‐RT groups. The GC‐RT group experienced more hematologic toxicity, constipation and rash; however, there were no differences in late RT toxicity between the groups. These results demonstrate that a sGC‐RT regimen is effective and well tolerated in patients with locoregionally advanced NPC.     

Ten-year outcomes of a randomised trial for locoregionally advanced nasopharyngeal carcinoma: A single-institution experience from an endemic area

ObjectiveWe previously reported the five-year results of a randomised trial that compared induction chemotherapy plus concurrent chemoradiotherapy (IC + CCRT) with induction chemotherapy plus radiotherapy (IC + RT) in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). The aim of this study was to report the ten-year results and to explore potential prognostic factors.MethodsFrom August 2002 to April 2005, 408 patients with locoregionally advanced NPC were randomly assigned to receive either IC (carboplatin and floxuridine) + CCRT (carboplatin) or IC + RT. The survival rates were analysed using the Kaplan–Meier method and compared using the log-rank test. Multivariable analysis was performed to identify valuable prognostic factors.ResultsThe ten-year overall survival, failure-free survival, locoregional failure-free survival and distant failure-free survival rates for the entire patient cohort were 49.5%, 48.0%, 80.8% and 66.9%, respectively. No significant survival differences were found between the IC + CCRT and IC + RT arms. By 3 years from the date of randomisation, 62.5% of the relapses had been detected; no recurrence occurred after 8 years. Within 3 years after randomisation, 77.0% of the metastases were detected; 0.8% was identified after 8 years. Age, Union for International Cancer Control (UICC) N-stage, serum lactate dehydrogenase (LDH) and body mass index (BMI) were independent prognostic factors that predicted death. Smoking status and total radiotherapy dose were independent prognostic factors that predicted locoregional recurrence. UICC N-stage, LDH and BMI were independent prognostic factors that predicted distant metastasis.ConclusionsConcurrent carboplatin chemotherapy did not significantly improve the long-term survival after inductive carboplatin and floxuridine chemotherapy in locoregionally advanced nasopharyngeal carcinoma. In addition to patient and tumour characteristics, LDH, BMI and smoking status were important baseline prognostic factors for tumour recurrence or distant metastasis; these are worthy of further prognostic investigation in future studies.