联合放化疗与单纯放疗治疗65例局部中晚期鼻咽癌比较研究

[目的]探讨诱导化疗联合放疗和辅助化疗治疗中晚期鼻咽癌的疗效。[方法]65例中晚期鼻咽癌分为治疗组45例,采用放疗前诱导化疗1次＋根治性放疗＋辅助化疗3～5次;对照组20例,行单纯行根治性放疗。化疗方案为氟尿嘧啶（5-Fu）0.5g/m^2,d1～3;表柔比星（EPI）60mg/m^2,d1;顺铂（DDP）30mg/m^2,d1～3;静脉滴注。两组放疗方法、时间和剂量分割均相同。[结果]治疗组与对照组3年无瘤生存率分别为71.0%、35.0%（P〈0.05）,远处转移率分别为46.7%、75.0%（P〈0.05）。无不可耐受的毒副反应发生。[结论]诱导化疗联合放疗和辅助化疗治疗局部中晚期鼻咽癌能提高生存率,降低远处转移率。     

诱导化疗和放疗综合治疗晚期鼻咽癌的前瞻性研究

目的：比较诱导化疗加放疗与单纯放疗治疗晚期鼻咽癌的疗效。方法：将78例Ⅲ、Ⅳa期鼻咽癌随机分为2组，每组39例。治疗组（A组）诱导化疗2个疗程后再行放疗（化疗方案：卡铂300mg/m^2,静脉滴注，第1天；5－Fu 500mg/m^2,静脉滴注，第1－3天；平阳霉素16mg/m^2,静脉滴注，第1天）；对照组（B组）单纯放疗。结果：诱导化疗后鼻咽癌病灶及颈淋巴结有效率（CR＋PR）分别为53．8％（21／39）、72．7％（24／33）。A、B组5年总生存率及无瘤生存率分别为43．6％、40．8％、38．4％、34．0％（P＞0．05）；远处转移率A、B组分别为38．5％；、41．0％；2组远期严重并发症发生率相近。结论：诱导化疗加放疗不能提高晚期鼻咽癌患者的生存率，也不能降低其远处转移率。     

放疗同步化疗治疗晚期鼻咽癌的临床疗效观察

目的：探讨放疗同步化疗治疗晚期鼻咽癌的疗效及毒副反应。方法：92例病理证实的晚期鼻咽癌病例随机分为单纯放疗组46例，放疗同步化疗组46例，单纯放射治疗，鼻咽原发灶DT70Gy，颈部预防照射DT50Gy，转移灶DT65-70Gy。同步化疗，DDP 30mg静脉滴注，第1－3天，5－FU0.5静脉滴注，第1－3天，21天为一周期，连用二周期。结果：5年生存率，单纯放疗组32．6％，放疗同步化疗组58．17，有显著差异P＜0．05。其毒副反应为胃肠道反应，口腔粘膜反应，白细胞减少等，均对症处理后，能完成放疗计划。结论：放疗同步化疗能提高晚期鼻咽癌的5年生存率和降低远处转移率，延长生存期。     

联合放化疗治疗晚期鼻咽癌的临床研究

目的 比较放、化疗与单纯放射治疗鼻咽癌的生存率、局部控制率、远处转移发生率和毒副反应。方法 从1991年4月至1993年10月。126例N2、N3期鼻咽癌患者随机分入放、化疗组和常规放疗组。放、化疗组放疗前、中及（或）放疗后各用PDD＋5－Fu化疗一个疗程,化疗方案为PDD20mg/m^2,1至5天;5－Fu500mg/m^21至5天;两组放疗方法相同,全部病例用8MV光子线及^60CO外照射,鼻咽部剂量65Gy-70Gy/6.5周－7周。颈淋巴结转移灶剂量65Gy-70Gy/6.5周－周,颈淋 地预防剂量50Gy/5周。结果 放、化疗组和单放组鼻咽肿瘤完全消退率分别为93.6％和85.7％（P＞0.05）,颈部转移淋巴结完全消退率分别为84.1％和57.1％（P＜0.05）;两组3年生存率分别为68.3％和52.4％（P＞0.05）;N2期鼻咽癌患者3年生存率分别为75.5％和58.7％（P＞0.05）,N3期鼻咽癌患者3年生存率分别为50.0％和35.3％（P＞0.05）;3年鼻咽部肿瘤控制率两组分别为71.4％和57.1％（P＜0.05),颈转移淋巴结控制率分别为69.8%和52.3％（P＜0.05）;化疗组远处转移发生率为20.6％,单放组为39.7％（P＜0.05）。放、化疗组急性毒副反应较单放组严重且出现早,经对症治疗后,绝大部分患者能按计划完成治疗。结论 对N2、N3期鼻咽癌行放、化疗联合有助于提高中控制率和减少远处转移。     

局部区域晚期鼻咽癌同期放化疗联合辅助化疗的前瞻性Ⅲ期临床研究

目的：探讨同期放、化疗联合辅助化疗对鼻咽癌高发区人群的疗效。方法：选取中山大学肿瘤防治中心2002年7月至2005年9月316例非角化型或未分化型鼻咽癌，第五版AJCC分期为Ⅲ～ⅣB的患者入组。将患者随机分为单纯放疗组（对照组）和同期放、化疗联合辅助化疗组（试验组）。两组均采用根治性常规分割放疗。试验组患者在放疗期间同时给予Cisplatin 40mg／m^2，d1，1次/周，连续7次，放疗结束后1个月开始辅助化疗，采用Cisplatin 80mg／m^2，d1，5-FU800mg/m^2，d1～5，1次／4周，共3个疗程。结果采用意向性分析，比较两组疗效、治疗毒性及顺应性。结果：两组病例的主要预后因素包括性别、年龄、活动状态、分期方法及临床分期等，均具有可比性。试验组68.4％的患者完成了7个疗程同期化疗，84．2％的患者完成了6个疗程以上同期化疗，91．1％的患者完成了5个疗程以上同期化疗，61．4％的患者完成了3个疗程辅助化疗。试验组和对照组3级以上急性毒副反应为62．6％ vs 32.3％（P=0．000）。试验组和对照组2年总生存率、无瘤生存率、无远处转移生存率及无局部区域复发生存率分别为89．8％ vs 79．7％（P=0．003），84．6％ vs 72．5％（P=0．001），86．5％vs78．7％（P=0．024）及98．0％ vs 91．9％（P=0．007）。结论：在鼻咽癌高发区，同期放、化疗联合辅助化疗可提高局部区域晚期鼻咽癌患者总生存率、无瘤生存率、无远处转移生存率及无局部区域复发生存率，长期疗效有待进一步随访证实。     

新辅助化疗联合放疗治疗中晚期鼻咽癌的疗效观察

目的研究新辅助化疗在治疗中晚期鼻咽癌(NPC)中的疗效。方法63例中晚期NPC病人随机分为单纯放疗组30例、新辅助化疗联合放疗组33例。化疗方案PFL方案(DDP80mg/m2~100mg/m2,d1;5-FU3.5/m248h;CF0.3,d1),共2~3疗程;化疗后2周常规放射治疗鼻咽癌原发灶DT68.0Gy/7周,颈转移灶DT65.0Gy/6周,颈预防剂量55.0Gy。结果新辅助化疗联合放疗组原发灶及颈转移灶完全缓解率优于单纯放疗组,毒性反应与单纯放疗组相比无明显差异。结论新辅助化疗联合放疗可提高中晚期NPC患者近期肿瘤缓解率,毒性反应可耐受,但远期生存率需进一步观察。     

诱导化疗联合放疗治疗晚期鼻咽癌的临床研究

目的观察诱导化疗联合放疗治疗晚期鼻咽癌的疗效.方法前瞻性临床试验采用诱导化疗,方案:DDP 100mg,第1天,采用水化,5-Fu 500mg/m2,1～5天,化疗2个疗程.放射治疗,鼻咽剂量:70-74Gy/35～37次,共7～8周,颈部淋巴结剂量60～70Gy/30～35次;颈部预防量46～50Gy.结果1995-1997年共有134例鼻咽癌进入研究,诱导化疗加放疗组(综合组)65例,单纯放疗组(单放组)69例.5年生存率分别为60%和31.9%(P＜0.01),鼻咽局部控制率和颈淋巴结转移控制率分别为69.2%和56.5%(P＜0.05).综合组急性毒性反应较单放组重,但可以耐受.结论PF方案诱导化疗能提高中晚期鼻咽癌的生存率,局部区域控制率.     

诱导加同期放化疗对局部晚期鼻咽癌的临床疗效

目的探讨诱导加同期放化疗对局部晚期（Ⅲ、Ⅳa期）鼻咽癌的临床疗效。方法对101例Ⅲ、Ⅳa期鼻咽癌患者行诱导加同期放化疗（IC组）,同时与同期行单纯放疗的102例（RT组）进行比较,两组放疗方法相同。诱导加同期放化疗组放疗前诱导化疗2个周期：DDP20mg／m^2,d1-5;5-Fu500mg／m^2,d1-5;21天为1个周期,同期化疗于放疗第1、4周进行;DDP20mg／m^2,d1-3;5-Fu500mg／m^2,d1-3。结果诱导加同期放化疗组及单纯放疗组鼻咽肿瘤全消率分别为95．0％和83．3％（P〈0．05）;颈部淋巴结全消率分别为94．1％和82．3％（P〈0．05）;5年总生存率为72．3％和51．0％（P〈0．05）;5年无进展生存率为68．3％和48．0％（P〈0．05）;局部复发率为17．8％和33．3％（P〈0．05）;远处转移率为17．8％和29．4％（P〈0．05）。结论诱导加同期放化疗可提高Ⅲ、Ⅳa期鼻咽癌肿瘤全消（CR）率、5年总生存率和无瘤生存率,降低局部复发率和远处转移率。DDP联合5-Fu的方案急性不良反应仍较重。     

放疗同步化疗治疗晚期鼻咽癌的临床疗效观察

目的：探讨放疗同步化疗治疗晚期鼻咽癌的疗效及毒副反应。方法：92例病理证实的晚期鼻咽癌病例随机分为单纯放疗组46例，放疗同步化疗组46例，单纯放射治疗，鼻咽原发灶DT70Gy，颈部预防照射DT50Gy，转移灶DT65～70Gy。同步化疗，DDP 30Ing静脉滴注，第1～3天，5-FU 0.5静脉滴注，第1～3天，21天为一周期，连用二周期。结果：5年生存率，单纯放疗组32.6％，放疗同步化疗组58.17，有显著差异P＜0.05。其毒副反应为胃肠道反应，口腔粘膜反应，白细胞减少等，均对症处理后，能完成放疗计划。结论：放疗同步化疗能提高晚期鼻咽癌的5年生存率和降低远处转移率，延长生存期。     

同期放化疗加辅助化疗治疗鼻咽癌的临床观察

目的:探讨放化疗同期治疗及辅助化疗对Ⅲ～ⅣA期鼻咽癌的临床疗效,评价鼻咽癌放化疗同期治疗及辅助治疗的毒副反应.方法:96例Ⅲ～ⅣA期鼻咽癌患者随机分为两组.A组为治疗组48例,采用常规放疗+同期化疗及辅助化疗;B组为对照组48例,单纯放疗.两组放疗方案相同,均采用6 MV X线外照射+6～12 MeV电子线,放疗技术为双面颈联合野DT 36 Gy后,改为双面颈联合小野避开脊髓加量放疗DT 34 Gy及下颈部切线野DT 50 Gy.鼻咽原发灶及阳性淋巴结区放疗DT 70～78 Gy,2 Gy/次,下颈部及锁骨上淋巴结预防区DT 50 Gy.A组同期及辅助化疗方案为DDP 30 mg/m2,静脉滴入,d1～d3,或CBP 60 mg/m2,静脉滴入,d1～d5;5-FU 600 mg/m2,静脉滴入,d1～d5.3～4周为1个周期,放疗同期化疗2个周期,放疗后辅助化疗1、2周期.结果:A组3年无瘤生存率(DFS)为79.2%,B组为52.1%,鳘2=7.804, P＝0.005;A组3年总生存率(OS)为83.3%,B组为64.6%,鳘2=4.381, P＝0.036.结论:同期放化疗加辅助化疗能提高中晚期鼻咽癌的无瘤生存率及总生存率,毒副反应可耐受.     

Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma.

PURPOSE: A prospective randomized trial was performed to evaluate the contribution of neoadjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma. PATIENTS AND METHODS: Patients with locoregionally advanced nasopharyngeal carcinoma were treated either with radiotherapy alone (RT group) or neoadjuvant chemotherapy plus radiotherapy (CT/RT group). Neoadjuvant chemotherapy consisting of two to three cycles of cisplatin (100 mg/m(2), day 1), bleomycin (10 mg/m(2), days 1 and 5), and fluorouracil (5-FU; 800 mg/m(2), days 1 through 5, continuous infusion) followed by radiotherapy was given to the CT/RT group. All patients were treated in a uniform fashion by definitive-intent radiation therapy in both groups. RESULTS: Between July 1993 and July 1994, 456 patients were entered onto the study, with 228 patients randomized to each treatment arm, and 449 patients (225 in the RT group and 224 in the CT/RT group) were assessable. All 456 patients were included in survival analysis according to the intent-to-treat principle. The 5-year overall survival (OS) rates were 63% for the CT/RT group and 56% for the RT group (P =.11). The median relapse-free survival (RFS) time was 50 months for the RT group and not reached for the CT/RT group. The 5-year RFS rate was 49% for the RT group versus 59% for the CT/RT group (P =.05). The 5-year freedom from local recurrence rate was 82% for the CT/RT group and 74% for the RT group (P =.04). There was no significant difference in freedom from distant metastasis between the two treatment groups (CT/RT group, 79%; RT group, 75%; P =.40). CONCLUSION: This randomized study failed to demonstrate any significant survival benefit with the addition of neoadjuvant chemotherapy for patients with locoregionally advanced nasopharyngeal carcinoma. Therefore, neoadjuvant chemotherapy for nasopharyngeal carcinoma should not be used outside of the context of a clinical trial.     

局部晚期鼻咽癌化疗和放射综合治疗--随机临床研究

目的：研究局部晚期鼻咽癌化疗和放射综合治疗的疗效及毒副反应。方法：1995年9月—1997年7月，86例病理确诊为鼻咽癌、根据福州九二新分期为N2-3的初治患者随机分组，综合治疗组41例，其中2例拒绝接受放疗后的辅助化疗，即综合治疗组可评估39例，单纯放疗组45例。综合治疗组接受2程诱导化疗[每天顺铂(DDP)20mg／m^2，第1～3天，每天氟尿嘧啶(5-FU)500mg／m^2，第1—3天，第二程化疗在第14天进行，放疗在第27天开始)及放疗后3程的辅助化疗。放疗为常规分割放疗。原发灶用^60Co治疗，每次1．85—1．9Gy，一周5次，7—7．5周总剂量65．1—70．3Gy／35—37次。颈部行双侧全颈根治性照射7—7．5周共56．6—65．5Gy／35—38次。如有残留，则局部缩野加量。两组鼻咽加量及颈淋巴结加量无显著差异。结果：中位随访期5．04年，综合治疗组和单纯放疗组五年生存率为72．3％，58．4％，(P=0．154)；无瘤生存率为59．9％，47．7％，(P=0．207)；鼻咽局控率为89．5％，81．4％，(P=0．151)；颈部局控率为88．3％，75．2％，(P=0．134)；无远处转移生存率为76．3％，60．3％，(P=0．181)，发生转移的中位时间分别为1．08年和0．88年。虽未达统计学意义，但综合治疗组有较单纯放疗组提高疗效的趋势。综合治疗组的主要毒性反应为白细胞降低、血小板降低及胃肠道反应。两组急性粘膜反应的严重程度差异无显著性。无与治疗有关的死亡发生。两组后期反应差异无显著性。结论：经5年观察，综合治疗有提高局控、降低远处转移、延迟远处转移的发生、提高无瘤生存率的可能，但均未达统计学意义，综合治疗未明显增加放疗反应。     

Neoadjuvant chemotherapy and radiation therapy compared with radiation therapy alone in advanced nasopharyngeal carcinoma

PURPOSE: To analyze the impact of neoadjuvant chemotherapy on the treatment of locoregionally advanced nasopharyngeal carcinoma and to assess the outcomes of patients receiving such treatment. METHODS AND MATERIALS: We analyzed 137 previously untreated and histologically confirmed advanced stage nasopharyngeal carcinoma patients treated with either radiation therapy only or combined radiation therapy and chemotherapy at the Seoul National University Hospital between 1984 and 1996. The stage distribution was as follows: AJCC Stage III-21, Stage IV-61 in the radiation therapy group (RT group); AJCC Stage III-1, Stage IV-54 in neoadjuvant chemotherapy and radiation therapy group (CT/RT group). The median follow-up for surviving patients was 48 months. RESULTS: The 5-year overall survival (OS) rates were 71% for the CT/RT group and 59% for the RT group (p = 0.04). The 5-year actuarial disease-free survival (DFS) rates were 63% for the CT/RT group and 52% for the RT group (p = 0.04). Distant metastasis (DM) incidence was significantly lower in the CT/RT group. The 5-year freedom from distant metastasis rates were 84% for the CT/RT group and 66% for the RT group (p = 0.01). The incidence of locoregional failures was also lower in the CT/RT group, although this difference did not reach statistical significance (69% vs. 56%, p = 0.09) CONCLUSION: While not providing conclusive evidence, historical evidence from this institution suggests that neoadjuvant chemotherapy significantly improves both overall and the disease-free survival of patients with advanced stage nasopharyngeal carcinoma.     

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.     

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。     

化疗加放疗治疗晚期鼻咽癌的临床研究

目的：观察放化综合治疗晚期鼻咽癌的疗效,方法：110例Ⅲ、Ⅳa期鼻咽癌患者随机分为放疗加化疗组（综合组）和单纯放疗组（单放组）,每组55例,两组放疗方法、时间／剂量分割均相同。综合组放疗前后采用顺铂（cisplatin,DDP) -氟尿嘧啶（5－Florouracil,FU)(PF方案）化疗4－6疗程,DDP20mg.(m^2.d)^-1。静脉滴注,第1－5天,5－FU500mg.(m^2.d)^-1,静脉滴注,第1－5天,每3－4周1疗程,第1程化疗在放疗前1周进行,第2－6程化疗在放疗结束后第1天开始进行。结果：综合组和对照组5年生存率分别为65．5％和34．5％（X^2=10.51,P=0.0012),鼻咽局部控制率分别为69．1％和43．6％（X^2=7.24,P=0.0071),颈淋巴结转移控制率分别为67．3％和45．4％（X^2=5.32,P=0.021),远处转移率分别为21．8％和41．8％(X^2=5.07,P=0.0243);两组比较均有显著差异（P＜0．05）。综合组急性毒性反应较单放组重,但未影响治疗进程,结论：PF方案化疗和尽早开始放疗的交替综合治疗能提高晚期鼻咽的生存率、局部区域控制以及减少远处转移。     

新辅助化疗加同步放化疗治疗局部晚期鼻咽癌的Ⅱ期临床研究

目的：比较新辅助化疗加同步放化疗与单纯同步放化疗治疗局部晚期鼻咽癌的近期疗效和毒副作用。方法：２００４年４月～２００６年５月,８３例Ⅲ ～ⅣＡ期鼻咽癌初治患者采用随机数字表法分为试验组４４例,对照组３９例。两组患者均行相同的常规分割根治性二维放疗;试验组在放射治疗前接受２个周期新辅助化疗,采用ＰＦ方案：顺铂（ＤＤＰ）８０ｍｇ／ｍ^２,ｄ_１,氟尿嘧啶（５-ＦＵ）８００ｍｇ／ｍ^２,ｄ_１～ｄ_５,２１天为１周期。新辅助化疗结束后２周,行同步放化疗,对照组仅行同步放化疗。同步化疗方案：ＤＤＰ４０ｍｇ／ｍ^２,１次／周,共６次。结果：中位随访期２６.７个月,平均随访期（２７.６±１０.９）个月,两组患者基本特征具有可比性。试验组的口腔黏膜炎发生率高于对照组（Ｐ＜０.０５）,其余各项急性毒副反应两组差异均无统计学意义（Ｐ＞０.０５）。试验组与对照组２年局部区域复发率分别为１３.２％和１９.４％（Ｐ＝０.９４６）,２年远处转移率分别为１５.８％和２２.２％（Ｐ＝０.０２１）,２年生存率分别为９２.１２％和８９.１６％（Ｐ＝０.２５１）。结论：初步结果表明,国人局部晚期鼻咽癌采用新辅助化疗加同步放化疗急性毒副反应可以耐受,２年远处转移率较单纯同步放化疗降低,２年局部复发率和生存率相似,推荐行大样本的Ⅲ期临床研究以明确新辅助化疗对局部晚期鼻咽癌是否受益。     

Randomized study of sinusoidal chronomodulated versus flat intermittent induction chemotherapy with cisplatin and 5-fluorouracil followed by traditional radiotherapy for locoregionally advanced nasopharyngeal carcinoma

Neoadjuvant chemotherapy plus radiotherapy is the most common treatment regimen for advanced nasopharyngeal carcinoma (NPC). Whether chronomodulated infusion of chemotherapy can reduce its toxicity is unclear. This study aimed to evaluate the toxic and therapeutic effects of sinusoidal chronomodulated infusion versus flat intermittent infusion of cisplatin (DDP) and 5-fluorouracil (5-FU) followed by radiotherapy in patients with locoregionally advanced NPC. Patients with biopsy-diagnosed untreated stages III and IV NPC (according to the 2002 UICC staging system) were randomized to undergo 2 cycles of sinusoidal chronomodulated infusion (Arm A) or flat intermittent constant rate infusion (Arm B) of DDP and 5-FU fol owed by radical radiotherapy. Using a“MELODIE”multi-channel programmed pump, the patients were given 12-hour continuous infusions of DDP (20 mg/m2) and 5-FU (750 mg/m2) for 5 days, repeated every 3 weeks for 2 cycles. DDP was administered from 10:00 am to 10:00 pm, and 5-FU was administered from 10:00 pm to 10:00 am each day. Chronomodulated infusion was performed in Arm A, with the peak deliveries of 5-FU at 4:00 am and DDP at 4:00 pm. The patients in Arm B underwent a constant rate of infusion. Radiotherapy was initiated in the fifth week, and both arms were treated with the same radiotherapy techniques and dose fractions. Between June 2004 and June 2006, 125 patients were registered, and 124 were eligible for analysis of response and toxicity. The major toxicity observed during neoadjuvant chemotherapy was neutropenia. The incidence of acute toxicity was similar in both arms. During radiotherapy, the incidence of stomatitis was significantly lower in Arm A than in Arm B (38.1%vs. 59.0%, P = 0.020). No significant differences were observed for other toxicities. The 1-, 3-, and 5-year overal survival rates were 88.9%, 82.4%, and 74.8%for Arm A and 91.8%, 90.2%, and 82.1%for Arm B. The 1-, 3-, and 5-year progression-free survival rates were 91.7%, 88.1%, and 85.2%for Arm A and 100%, 94.5%, and 86.9% for Arm B. The 1-, 3-, and 5-year distant metastasis-free survival rates were 82.5%, 79.1%, and 79.1%for Arm A and 90.2%, 85.2%, and 81.7%for Arm B. Chronochemotherapy significantly reduced stomatitis but was not superior to standard chemotherapy in terms of hematologic toxicities and therapeutic response.     

A randomized trial of induction chemotherapy plus concurrent chemoradiotherapy versus induction chemotherapy plus radiotherapy for locoregionally advanced nasopharyngeal carcinoma

The aim of this randomized study was to compare the efficacy of induction chemotherapy plus concurrent chemoradiotherapy (IC+CCRT) versus induction chemotherapy plus radiotherapy (IC+RT) for patients with locoregionally advanced nasopharyngeal carcinoma. From August 2002 to April 2005, 408 patients were randomly divided into two groups: an IC+CCRT group and an IC+RT group. Patients in both groups received the same induction chemotherapy: two cycles of floxuridine (FuDR)+carboplatin (FuDR, 750mg/m(2), d1-5; carboplatin, area under the curve [AUC]=6). The patients received radiotherapy 1week after they finished the induction chemotherapy. The patients in the IC+CCRT group also received carboplatin (AUC=6) on days 7, 28, and 49 of radiotherapy. Eight patients did not meet the inclusion criteria, and the remaining 400 cases were analyzed. Grade III or IV toxicity was found in 28.4% of the patients in the IC+CCRT group and 13.1% of those in the IC+RT group (P<.001). Five-year overall survival rates were 70.3% and 71.7% (P=0.734) in the IC+CCRT and IC+RT groups, respectively. No significant differences in failure-free survival, locoregional control, and distant control were found between the two groups. Compared with the IC+RT program, the IC+CCRT program used in the present study did not improve the overall survival and failure-free survival in patients with locoregionally advanced nasopharyngeal carcinoma. Using carboplatin in the concurrent chemoradiotherapy was not suitable for nasopharyngeal carcinoma.     

精确放疗同步含顺铂方案化疗治疗局部晚期食管鳞癌的临床分析

目的 分析局部晚期食管鳞癌进行精确放疗同步顺铂或顺铂联合紫杉醇脂质体化疗的临床疗效及不良反应。方法 收集精确放疗同步含顺铂方案化疗的局部晚期食管鳞癌46例,其中单药顺铂化疗（RT+P组）26例,顺铂联合紫杉醇脂质体化疗（RT+TP组）20例。回顾性分析两种同步放化疗方法的近期疗效,1、2及3年生存率以及放射性食管炎、放射性肺炎、胃肠道反应、骨髓抑制等不良反应发生率,并与同期17例单纯放疗（RT组）病例进行比较。结果 三组患者观察期内均未出现Ⅳ~Ⅴ级不良反应。三组仅12%~15%的患者出现Ⅰ~Ⅱ级放射性肺炎,发生率低、程度轻,三组相互间差异无统计学意义（P=0.939）。RT组的Ⅰ~Ⅱ级胃肠道反应发生率及Ⅲ级骨髓抑制发生率均明显低于其他组。同步放化疗组的治疗有效率高于单纯放疗组,但差异无统计学意义（P=0.161）。同步放化疗组总的1、2、3年生存率及中位生存期均高于单纯放疗组。RT+TP组的生存率明显优于RT组（P=0.019）。结论 精确放疗同步顺铂联合紫杉醇脂质体化疗治疗局部晚期食管鳞癌,具有较好的近期疗效及生存获益,明显优于单纯放疗。