A prospective,randomized trial comparing neoadjuvant chemotherapy with radiotherapy alone in patients with advanced nasopharyngeal carcinoma

BACKGROUND: A prospective, randomized study was performed to determine the efficacy of neoadjuvant chemotherapy over radiotherapy alone in patients with locally advanced nasopharyngeal carcinoma. METHODS: From January 1991 to December 1998, 80 patients were enrolled in this study. Patients with locoregional carcinoma of the nasopharynx were randomized to receive two courses of chemotherapy, consisting of cisplatin and 5-fluorouracil (CDDP-5FU), that were administered before radiation therapy (CT arm) or radiotherapy alone. The patients who received neoadjuvant chemotherapy were treated with radiation therapy, which was scheduled to commence 2 weeks after the second course chemotherapy. RESULTS: With a median follow-up of 49 months, a trend toward improved overall survival or disease free survival favoring the CT arm was observed (5-year overall survival rate, 60% vs. 48%; 5-year disease free survival rate, 55% vs. 43%), although this difference was not significant. There were no differences in locoregional failure free survival between the two arms. However, metastasis free survival favored the CT arm, although this difference was not significant. The results also demonstrated that most patients in the CT arm who experienced recurrent disease developed locoregional recurrences before distant metastases, suggesting that improvements in locoregional control may lead to improved disease free survival. CONCLUSIONS: The use of CDDP-5FU chemotherapy prior to radiotherapy in patients with nasopharyngeal carcinoma did not result in a significant improvement in disease free survival or overall survival. However, there was a positive tendency in favor of the CT arm for distant metastasis free survival, although there was no improvement in the locoregional recurrence free survival rate.     

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.     

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.     

中晚期鼻咽癌新辅助化疗联合放疗前瞻性临床试验

目的：评价大剂量Ｃｉｓｐｌａｔｉｎ，５－Ｆｕ及ＢＬＭ新辅助化疗在中晚期鼻咽癌治疗中的价值。材料及方法：１９９２￣１９９３年，４４０例治疗前行ＣＴ或ＭＲ检查确诊为Ⅲ、Ⅳａ期鼻咽癌（’９２分期），随机分为化疗＋放疗组（２１９例），及单纯放效组（２２１例）。化疗方案：Ｃｉｓｐｌａｔｉｎ：２０ｍｇ／ｍ＾２ １￣５天，５－Ｆｕ５００ｍｇ／ｍ＾２ １￣５天，ＢＬＭ：７ｍｇ／ｍ＾２ １、５天，化疗两个疗程。放射     

Preliminary results of a phase III randomized study comparing chemotherapy neoadjuvantly or concurrently with radiotherapy for locoregionally advanced nasopharyngeal carcinoma

The current study was conducted to compare neoadjuvant chemotherapy (NACT) with concurrent chemotherapy for efficacy, toxicities and compliance of locoregionally advanced nasopharyngeal carcinoma (NPC). Eligible patients were randomized to NACT + radiotherapy (RT) + adjuvant chemotherapy (AC) arm or concurrent chemoradiotherapy(CCRT) + AC arm. Two arms received same conventional RT at a planned dose of 70 Gy. Neoadjuvant chemotherapy comprised cisplatin 90 mg/m² (30 mg/m²/day) and 5-fluorouracil 1,500 mg/m² (500 mg/m²/day) over 3 days for two 21-day cycles. The same regimen at equal dosage was administered on the 1st and 22nd days of the radiotherapy as concurrent chemotherapy. Four cycles of the same chemotherapy regimen were given to both two arms as AC. A total of 338 NPC patients were recruited. 170 patients were randomized to NACT arm and 168 patients to CCRT arm. The median duration of follow-up was 38 months. The 3-year OS and DFS rates were 95.9 versus 94.5% (P = 0.54) and 78.5 versus 82.5% (P = 0.16), respectively, in NACT and CCRT arms. An unplanned subgroup analysis according to the N-classification suggested that CCRT improves MFS in patients with N0-1 disease (80.1 vs. 94.9%, P = 0.034). Among the acute toxicities observed, the rates of grade 3/4 mucositis (52.4 vs. 35.9% P = 0.023) and vomiting (13.7 vs. 4.7% P = 0.000) were significantly higher in CCRT arm. Our preliminary results only showed an advantage of CCRT over NACT in NPC patients with limited N disease in MFS. More acute toxicities were observed in CCRT arm and a trend of better tolerance was observed in NACT arm.     

Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial.

PURPOSE: Nasopharyngeal carcinoma (NPC) is highly sensitive to both radiotherapy (RT) and chemotherapy. This randomized phase III trial compared concurrent cisplatin-RT (CRT) with RT alone in patients with locoregionally advanced NPC. PATIENTS AND METHODS: Patients with Ho's N2 or N3 stage or N1 stage with nodal size > or = 4 cm were randomized to receive cisplatin 40 mg/m(2) weekly up to 8 weeks concurrently with radical RT (CRT) or RT alone. The primary end point was progression-free survival (PFS). RESULTS: Three hundred fifty eligible patients were randomized. Baseline patient characteristics were comparable in both arms. There were significantly more toxicities, including mucositis, myelosuppression, and weight loss in the CRT arm. There were no treatment-related deaths in the CRT arm, and one patient died during treatment in the RT-alone arm. At a median follow-up of 2.71 years, the 2-year PFS was 76% in the CRT arm and 69% in the RT-alone arm (P =.10) with a hazards ratio of 1.367 (95% confidence interval [CI], 0.93 to 2.00). The treatment effect had a significant covariate interaction with tumor stage, and a subgroup analysis demonstrated a highly significant difference in favor of the CRT arm in Ho's stage T3 (P =.0075) with a hazards ratio of 2.328 (95% CI, 1.26 to 4.28). For T3 stage, the time to first distant failure was statistically significantly different in favor of the CRT arm (P =.016). CONCLUSION: Concurrent CRT is well tolerated in patients with advanced NPC in endemic areas. Although PFS was not significantly different between the concurrent CRT arm and the RT-alone arm in the overall comparison, PFS was significantly prolonged in patients with advanced tumor and node stages.     

A Bayesian network meta-analysis comparing concurrent chemoradiotherapy followed by adjuvant chemotherapy,concurrent chemoradiotherapy alone and radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma

BackgroundGiven the lack of studies, whether the addition of adjuvant chemotherapy (AC) to concurrent chemoradiotherapy (CCRT) is superior to CCRT alone for locoregionally advanced nasopharyngeal carcinoma (NPC) remains unclear. The main objective of this Bayesian network meta-analysis was to determine the efficacy of CCRT + AC when compared with CCRT alone.Patients and methodsWe systematically searched databases and extracted data from randomized, controlled trials involving NPC patients randomly assigned to receive CCRT + AC, CCRT, or radiotherapy (RT). Overall survival (OS), locoregional recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) with hazard ratios (HRs) were investigated. A Bayesian network for different outcomes was established to incorporate all evidence. Multiple treatment comparisons based on the network integrated the efficacy of CCRT + AC, CCRT, and RT.ResultsEight studies involving 2144 patients were analyzed. In the network meta-analysis, CCRT + AC and CCRT were both significantly better than RT alone for all outcomes, except that no significant difference was found between CCRT and RT for LRFS. Though ranking probabilities showed that CCRT + AC was ranked superior to CCRT for OS, LRFS, and DMFS, no significant differences were found between CCRT+AC and CCRT for all outcomes [OS: HR = 0.86, 95% credible interval (CrI) 0.60–1.16; LRFS: HR = 0.72, 95% CrI 0.43–1.15; DMFS: HR = 0.86, 95% CrI 0.62–1.16].ConclusionsNo significant improvement was found following CCRT + AC compared with CCRT alone. Whether the omission of additional AC can reduce toxic effects without adversely affecting survival in patients with locoregionally advanced NPC should be further explored, in addition to the precise patient status that would benefit from AC following CCRT.     

Long-term results in patients with low-grade nodular non-Hodgkin's lymphoma. A randomized trial comparing chemotherapy plus radiotherapy with chemotherapy alone

One hundred and eighteen patients with nodular non-Hodgkin's lymphoma were randomized to receive either chemotherapy alone or chemotherapy plus radiotherapy (total nodal or involved field irradiation). Although the complete remission rate was similar in the three programs (about 90%) the relapse-free survival rate (RFS) among patients with complete remission was significantly higher in the groups treated with chemotherapy plus radiotherapy than among those treated with chemotherapy alone. The 7-year RFS in the groups treated with total node irradiation and involved field irradiation was 71% and 66% respectively, compared to only 33% in the group treated by chemotherapy alone (p less than 0.01). The results suggest that combined chemoradiotherapy may achieve complete long-term remission and potential cure in more than 60% of patients with nodular low-grade non-Hodgkin's lymphoma. Toxicity was moderate in all three arms. Bulky disease and a high level of lactic dehydrogenase were associated with a poor prognosis.     

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     

晚期鼻咽癌的诱导化疗联合放射治疗

目的：研究诱导化疗联合放射治疗Ⅲ、Ⅳ期鼻咽癌的疗效。方法：对50例Ⅲ、Ⅳ期鼻咽癌诱导化疗加放射治疗（CT／RT组）。并选取同期在本院行单纯放射治疗的50例Ⅲ、Ⅳ期鼻咽癌作为对照（RT组）。结果：五年局控率CR／RT组与RT组分别为61．2％及68．75;五年远处转移发生率CT／RT组与RT组分别为15．2％及27．4％;N2、N3期病人CT／RT组与RT组五年远处转移发生率分别为27．4％和43．85;CT／RT组与RT组五年生存率分别为57．8％和51．6％（P＝0．61）;N2、N3期病人CT／RT组与RT组5年生存率分别为60．6％和26．3％（P＝0．033）;T3、T4期病人CT／RT组与RT组五年生存率分别为36．8％和41．2％（P＝0．80）;两组放射治疗期间急性口腔粘膜发生率相似,Ⅰ、Ⅱ级骨髓抑制及胃肠道反应等副作用诱导化疗组较单纯放疗组稍重,但经对症处理后患者均能耐受,两组均无严重后期并发症。论：诱导化疗未能提高、Ⅲ、Ⅳ期鼻另癌病人五年生存率及局控率,但降低了N2、N3期病人的远处转移发生率,提高了N2、N3现人的五年生存率。     

Phase I clinical trial of nasopharyngeal radiotherapy and concurrent celecoxib for patients with locoregionally advanced nasopharyngeal carcinoma

We evaluated the incidence of acute toxicity of concurrent cyclooxygenase-2 inhibitor (celecoxib) plus radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC). Thirty-four patients received an accumulated radiation dose of 72-76Gy in 36-38 fractions to the primary lesion and 60Gy in 30 fractions to cervical lymph-node lesions. Palpable residual nodes were boosted to 70Gy at the 90% isodose level with an electron field. Celecoxib was administered at escalating doses of 400, 600, and 800mg/day, starting 3days before the first fraction of radiotherapy and continuing throughout the course of radiotherapy. The majority of toxicities were grade 1, with mucositis and weight loss most frequently observed (28 of 34, 82.4%), followed by dermatitis (27 of 34, 79.4%) and otitis (14 of 34, 41.2%). The toxicities were not related to celecoxib dose (all P>0.05). Stomach pain was considered related to celecoxib, which developed in 2 patients at doses of 400mg and 800mg/day. No grade-3 or -4 toxicities or episodes of toxic death occurred. The tumors in 31 patients (31/34, 91.2%) showed a complete response, and 3 patients (3/34, 8.8%) had partial responses. The actuarial local progression-free survival was 96.6% at 1year, and the 2year overall survival rate was 84.6%. Celecoxib can be safely administered concurrently with nasopharyngeal radiotherapy at doses up to 800mg/day. The tumors responded well to treatment warranting further assessment in a phase II trial.     

Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma

This phase III randomized study compared concurrent cisplatin-radiotherapy (CRT) versus radiotherapy (RT) alone in patients with locoregionally advanced nasopharyngeal carcinoma. A total of 350 patients were randomly assigned to receive external RT alone or concurrently with cisplatin at a dosage of 40 mg/m(2) weekly. The primary endpoint was overall survival, and the median follow-up was 5.5 years. The 5-year overall survival was 58.6% (95% confidence interval [CI] = 50.9% to 66.2%) for the RT arm and 70.3% (95% CI = 63.4% to 77.3%) for the CRT arm. In Cox regression analysis adjusted for T stage, age, and overall stage, the difference in overall survival was statistically significantly in favor of concurrent CRT (P = .049, hazard ratio [HR] = 0.71 [95% CI = 0.5 to 1.0]). Subgroup analysis demonstrated that there was no difference between overall survival in the arms for T1/T2 stage (P = .74, HR = 0.93 [95% CI = 0.59 to 1.4]), whereas there was a difference between the arms for T3/T4 stage (P = .013, HR = 0.51 [95% CI = 0.3 to 0.88]), favoring the CRT arm. The regimen of weekly concurrent CRT is a promising standard treatment strategy for locoregionally advanced nasopharyngeal carcinoma patients.     

大剂量诱导化疗联合放疗治疗局部晚期鼻咽癌的临床观察

背景与目的:鼻咽癌是中国南方地区常见的恶性肿瘤,大多数鼻咽癌的病理类型是低分化鳞癌,对放疗和化疗均敏感.鼻咽癌主要的治疗手段是放疗.对早期鼻咽癌患者有效.然而,局部晚期鼻咽癌单纯放疗常有局部复发和远处转移,5年生存率只有40%左右.为了减少局部复发和远处转移的发生,联合放、化疗十分必要.为此,本研究探讨大剂量诱导化疗 放疗治疗局部晚期鼻咽癌的疗效.方法:对1992年5月-1998年8月确诊为局部晚期的鼻咽癌患者113例作为诱导化疗 放疗组(CT/RT组),放疗前接受化疗.化疗方案:卡铂(Carboplantin)300 mg/m2,d1静脉点滴,5-氟尿嘧啶(5-Fluorinracil ,5-FU)1 000 mg/m2,d1～d5静脉点滴,化疗后休息2周,共3个疗程.在同期的鼻咽癌患者中,按照92福州分期标准,选择113例性别、年龄、病理类型和TNM分期与CT/RT患者相同或近似患者进行配对,作为单纯放疗组(RT组).结果:化疗的近期疗效:鼻咽部原发灶和颈部转移淋巴结的总缓解率分别为53.9%(61/113)和72.7%(56/77).远期疗效CT/RT组与RT组比较, Ⅲ期患者5年总的生存率分别为76.3%和47.3%(χ2=9.88507,P<0.01),Ⅳ期患者分别为32.4%和16.2%(χ2=5.10345,P<0.05),5年无瘤生存率Ⅲ期患者分别为57%和30.4%(χ2＝8.648,P<0.01).Ⅳ期患者分别为29%和16.2%(χ2=8.6218,P<0.01).5年无远处转移生存率,Ⅲ期患者分别为64.4%和37.8%(χ2＝9.50165,P<0.01),Ⅳ期患者分别为37.8%和16.2%,差异有显著性(χ2＝4.3831,P<0.05).结论:诱导化疗应用于局部晚期鼻咽癌,能够提高患者的生存率,值得推广应用.     

Results of a prospective randomised trial comparing conventional radiotherapy to split course bifractionated radiation therapy in patients with nasopharyngeal carcinoma.

BACKGROUND AND PURPOSE: Nasopharyngeal carcinoma (NPC) is generally responsive to radiation therapy. However therapeutic results after conventional radiotherapy remain relatively poor especially for patients with locoregional advanced NPC. The aim of this study was to evaluate the impact of a split course bifractionated radiotherapy regimen in a phase III randomised trial. PATIENTS AND METHODS: From January 1997 to September 2003, 154 patients with M0 histologically proven NPC were treated in our institution. They were staged according to the American Joint Committee on Cancer - International Union Against Cancer (AJCC-UICC) 1986 TNM classification. Patients with locally advanced nodal disease (N2-N3) received induction chemotherapy. All patients were randomised to receive either conventional radiotherapy at 2 Gy/fraction/day, 5 days/week to 70 Gy/7 weeks or split course bifractionated radiotherapy at 1.6 Gy/fraction, twice daily, 5 days/week to 70.4 Gy/6 weeks. Response and toxicity were evaluated according to the WHO and RTOG criteria. RESULTS: Patients were well balanced between the two arms. The complete remission rate was 91% in conventional radiotherapy arm and 93% in bifractionated radiotherapy arm (p=0.3). There was more grade II-III skin fibrosis in experimental arm with a 5 year actuarial probability of 66% vs 52% (p=0.04). Locoregional and distant relapses occurred in 34% of cases in conventional arm and 38% in experimental arm (p=0.28). With a median follow-up of 56 months, the 5 year overall survival and the disease free survival rates were, respectively (71% and 61%), in conventional arm and (62% and 60%) in bifractionated arm, the difference being statistically non significant. COMMENTS: The present trial comparing conventional radiotherapy to a split course bifractionated radiation therapy failed to demonstrate significant improvement in locoregional control and survival in experimental arm which was associated with more grade II-III skin fibrosis.     

Non-randomized clinical study comparing chemotherapy plus radiotherapy with radiotherapy alone in neoadjuvant therapy for oral cancer

Neoadjuvant therapy plays an important role for organ preservation and survival rate in the treatment of oral cancer. We clinically compared the effect of neoadjuvant radiotherapy and chemoradiotherapy in patients with oral cancer. We retrospectively examined 47 patients diagnosed with oral squamous cell carcinoma who underwent neoadjuvant therapy followed by curative surgery in the oral and maxillofacial surgery department of Ehime University Hospital. We divided them into two groups: radiotherapy alone (24 cases) and chemoradiotherapy (23 cases). The patients in the radiotherapy group underwent irradiation of 32.6 +/- 5.0 Gy (mean +/- SD). The patients in the chemoradiotherapy group received a low-dose fraction of cisplatin (8 mg/mm2/day, 5 days a week; total dose: 139.4 +/- 67.1 mg) and 5-fluorouracil (300 mg/mm2/day, 5 days a week; total dose: 5,900 +/- 1,839.8 mg) combined with simultaneous irradiation of 31.0 +/- 3.2 Gy. None of the 24 patients had a complete response to radiotherapy alone and 12 (50%) had a partial response. Six (26%) of the 23 patients had a complete response to chemoradiotherapy and 12 (52%) had a partial response. The primary control rate (82.6%) to chemoradiotherapy was higher than that (67.5%) to radiotherapy alone although no significant difference was found. The 5-year survival rate was 64.3% in the radiotherapy group and 62.8% in the chemoradiotherapy group. The findings of the present study suggest that while the combination of radiation and cisplatin/5-fluorouracil in neoadjuvant therapy for oral cancer may not bring a significant benefit to improve survival rate, the primary local control rate is improved in comparison with radiotherapy alone.     

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。     

Treatment outcomes after reduction of the target volume of intensity-modulated radiotherapy following induction chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: A prospective,multi-center,randomized clinical trial

Purpose

To investigate whether reducing the target volume of intensity-modulated radiotherapy (IMRT) after induction chemotherapy (IC) improves the quality of life (QOL) in locoregionally advanced nasopharyngeal carcinoma (NPC) without decreasing the local control and survival rate.

中晚期鼻咽癌新辅助化疗联合放疗的临床研究

目的　观察不同新辅助化疗方案联合放疗在局部晚期鼻咽癌的疗效及毒副反应。评价含HD DDP方案的临床可行性。方法　 10 0例局部晚期鼻咽癌患者随机分为单纯放射治疗组 46例 (A组 ) ,低剂量新辅助化疗组 2 8例 (B组 ) ,含HD DDP新辅助化疗组 2 6例 (C组 )。化疗方案 :B组DDP总量 10 0～ 12 0mg/ 3～ 5天 ,5 FU 5 0 0～ 75 0mg/天 ,共 5天 ;C组DDP 10 0～ 13 0mg/天 ,第一天用 ,同时水化利尿 2天 ,5 FU剂量同B组 ,B、C组还分别加用ADM、PYM、VCR、MTX、Me CCNU其中之一 ,2 1天为一周期 ,共用 2～ 3周期 ,化疗后 10～ 14天放疗。常规放射治疗 :鼻咽原发灶DT66～80Gy/ 6.5～ 8周 ,颈部转移灶DT60～ 70Gy/ 6～ 7周 ,颈部预防量DT5 0Gy。 结果　所有病例如期完成治疗。放疗 40Gy时 ,颈部转移灶消退率综合组高于单纯放疗组 (C、B、A组分别为 73 .0 7%、64 .2 8%、5 4.3 5 % )。结束时、结束 1～ 2个月后 ,综合组尤其HD DDP组颈部转移灶完全缓解率明显高于单纯放疗组 (C、B、A组分别为 10 0 %、92 .86%、82 .61% )。鼻咽原发灶缓解率亦有提高 (C、B、A组分别为 88.46%、78.5 7%、68.5 7% )。毒性反应主要表现是综合组较单纯放疗组更高的胃肠道反应及 1～ 3级骨髓抑制和脱发 ,B、C组无明显差别 ,无一例肾功能不