TP与PF方案同期放疗治疗食管癌的疗效对比

目的观察紫杉醇加顺铂化疗同步放疗与顺铂加氟尿嘧啶化疗同步放疗治疗中晚期食管癌的疗效和不良反应。方法将72例食管癌患者随机分成紫杉醇加顺铂化疗(TP组)同步放疗组和顺铂加氟尿嘧啶化疗(PF组)同步放疗组各36例。TP组采用紫杉醇:135～165 mg/m²,d1,顺铂：20～30 mg/m²,d1～3,21天一个周期,共3～4周期。PF组采用顺铂：20～30 mg/m²,d1～3,氟尿嘧啶：500 mg/m²,d1～5,21天一个周期,共3～4周期。两组放疗方法相同,总剂量GTV：(60～66)Gy/(30～33)F。结果两组近期疗效比较差异无统计学意义(P=0.691)。TP组和PF组的1年和3年生存率：TP组分别为86%和53%;PF组分别为83%和50%。两组比较差异无统计学意义(χ²=0.148,P=0.701)。不良反应的比较差异无统计学意义。结论紫杉醇加顺铂化疗同步放疗与顺铂加氟尿嘧啶化疗同步放疗食管癌相比疗效相当且不增加不良反应。     

诱导化疗＋IMRT同期化疗与IMRT同期化疗治疗局部中晚期鼻咽癌的远期疗效比较

目的 比较局部中晚期鼻咽癌诱导化疗+IMRT同期化疗与IMRT同期化疗的远期疗效。方法 诱导化疗+同期放化疗组（诱导组）118例,同期放化疗组（同期组）106例。诱导化疗方案为TP（多西他赛+顺铂）或PF（氟尿嘧啶+顺铂）,同期化疗全部采用单药顺铂方案,全组病例均接受调强放疗。Kaplan-Meier法计算生存率,Log rank检验比较组间生存曲线。结果 诱导组与同期组5年OS、DFS、DMFS、RFS分别为83.9%和82.1%（P=0.768）,86.1%和79.8%（P=0.216）,89.5%和84.5%（P=0.264）, 96.4%和90.8%（P=0.114）。亚组分析显示对于T晚期（T3-4N0-1）或N晚期（T1-4N2-3）的病例,诱导化疗均未明显提高OS、DFS、DMFS、RFS。两种诱导化疗方案TP与PF比较差异也无统计学意义。诱导组的血液系统不良反应及消化道不良反应较同期组明显增加。结论 诱导化疗的使用未明显提高局部中晚期鼻咽癌的远期生存率,且血液系统、消化道等不良反应明显增加。     

晚期口腔鳞状细胞癌术前TOF与TPF方案诱导化疗的临床疗效比较

目的 比较晚期口腔鳞状细胞癌术前多西他赛、奥沙利铂联合氟尿嘧啶方案（TOF方案）与 多西他赛、顺铂联合氟尿嘧啶方案（TPF方案)诱导化疗的疗效及不良反应。方法 将67例晚期口腔鳞状细胞癌患者随机分为TOF组35例和TPF组32例。TOF组：多西他赛75 mg/m²,d1;奥沙利铂 130 mg/m²,d1;氟尿嘧啶750 mg/m²,d1～d5。TPF组：多西他赛75 mg/m²,d1;顺铂75 mg/m²,d1;氟尿嘧啶750 mg/m²,d1～d5。两组均静脉滴注,19 d为一个周期,2个周期化疗后评价疗效及不良反应,随访中位生存时间。结果 TOF组和TPF组总有效率分别为65.71%（23/35）和62.50%（20/32）,中位生存期分别为31个月（95%CI：21.7~40.3）和33个月（95% CI：25.8~40.1）,两组总有效率和中位生存期比较差异均无统计学意义（P＞0.05）。TOF组骨髓抑制、胃肠道反应、肾毒性反应等发生率明显低于TPF组（P＜0.05）,周围神经毒性发生率明显高于TPF组（P＜0.05）,脱发发生率两组差异无统计学意义（P＞0.05）。结论 晚期口腔鳞状细胞癌患者术前采用TOF 和TPF 方案诱导化疗的疗效相当,患者均可耐受,但TOF方案不良反应较轻,可作为晚期口腔鳞状细胞癌较理想的术前诱导化疗方案。     

淋巴结阳性食管癌术后预防性IMRT同期化疗的临床Ⅰ期研究

目的 探讨淋巴结阳性食管癌术后预防性IMRT同期化疗的MTD和缩小靶区的影响。方法 对2007—2011年在我院行根治性手术的33例胸中、下段食管鳞癌伴淋巴结转移患者行术后预防性IMRT同期化疗临床Ⅰ期研究。中位年龄52岁,76%为T₃+T₄期。放疗随机分为60 Gy分30次(2.0 Gy/次)18例、54 Gy分30次(1.8 Gy/次)15例。化疗每周顺铂20 mg/m²+紫杉醇20、30、40、50 mg/m²递增(每阶梯3例),连用5~6周。依据CTCAE3.0标准,DLT为4级白细胞下降或≥3级血红蛋白、血小板下降及≥3级非血液学不良反应。结果 60 Gy分30次(2.0 Gy/次)组,紫杉醇20 mg/m²时1例3级体重下降,增加3例后1例4级白细胞降低,递增实验失败。54 Gy分30次(1.8 Gy/次)组1例紫杉醇过敏中止化疗,其余20~40 mg/m²无DLT,50 mg/m²时2例4级白细胞和3级血小板下降而终止实验;MTD为每周顺铂20 mg/m²+紫杉醇40 mg/m²连用5~6周。缩小靶区后60 Gy分30次(2.0 Gy/次)组12例无DLT,顺利完成递增实验;MTD为每周顺铂20 mg/m²+紫杉醇50 mg/m²连用5~6周。靶区修改前、后平均PTV和残胃D_mean差异有统计学意义(P=0.006、0.013)。结论 淋巴结阳性的胸中、下段食管癌术后预防性IMRT同期紫杉醇+顺铂周方案在合理缩小靶区下是安全、有效的。     

局部晚期鼻咽癌不同化疗方案配合IMRT多中心前瞻性随机对照研究

目的 评价局部晚期鼻咽癌奈达铂联合多西他赛诱导化疗+奈达铂同期IMRT与顺铂的疗效及不良反应。方法 2011—2012年间5个治疗中心共 223例经病理确诊的初治局部晚期鼻咽癌患者被随机分为两组,试验组 113例采用多西他赛(65 mg/m²第1天)+奈达铂(80 mg/m²第1天)诱导化疗2周期,奈达铂(40 mg/m²第1天)每周方案同期IMRT;对照组 110例采用相同方案诱导化疗2周期,IMRT顺铂(40 mg/m²第1天)每周方案同期IMRT。Kaplan-Meier计算生存率并Logrank检验两组差异,不良反应行z检验。结果 随访率为99.1%。治疗结束后3个月两组有效率均为100%,试验和对照组 2年LRFS、RRFS、DMFS、OS分别为94.0%和93.4%、94.2%和94.1%、88.2%和86.7%、90.3%和87.3%(P=0.757、0.478、0.509、0.413);试验组白细胞、中性粒细胞、血小板减少发生率及严重程度较对照组高(P=0.027、0.028、0.035),血红蛋白减少发生率及严重程度低于对照组(P=0.000);试验组恶心、呕吐发生率及程度低于对照组(P=0.023),两组口腔黏膜炎、口干发生率相近(P=0.483、0.781)。结论 局部晚期鼻咽癌奈达铂联合多西他赛诱导化疗+奈达铂同期IMRT的近期疗效与顺铂的相似,胃肠道反应轻患者可耐受,但其骨髓抑制较重使用时应密切监测。     

阿瑞匹坦对黑色素瘤患者顺铂治疗引起恶心呕吐的止吐作用

目的 旨在探讨阿瑞匹坦对黑色素瘤患者顺铂治疗引起的恶心呕吐的作用。方法 170例接受含顺铂方案治疗的黑色素瘤患者,随机分入阿瑞匹坦组和对照组进行预防性止吐治疗。记录患者顺铂治疗后的恶心、呕吐反应,解救治疗,功能性生活指数（呕吐）及其他不良反应。结果 两组中各84例患者可评价疗效。阿瑞匹坦组患者的完全缓解率（无呕吐,无解救治疗）为69%,显著高于对照组的44%（χ²=10.683,P=0.001）。阿瑞匹坦组和对照组的呕吐发生率分别为27%和51%,阿瑞匹坦组显著优于对照组（χ²=9.982,P=0.002）。阿瑞匹坦组未观察到相关的不良反应。结论 阿瑞匹坦可显著降低黑色素瘤患者中顺铂引起的呕吐反应。尽管阿瑞匹坦的安全性良好,在给药前仍需注意药物间的相互作用。     

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。     

重组人血管内皮抑制素联合顺铂胸腔灌注治疗非小细胞肺癌恶性胸腔积液的疗效观察

目的 观察重组人血管内皮抑制素联合顺铂胸腔灌注治疗非小细胞肺癌（non-small cell lung cance,NSCLC）恶性胸腔积液的疗效和不良反应。方法 将60例NSCLC合并恶性胸腔积液患者,按随机数字表法分为治疗组（重组人血管内皮抑制素45 mg +顺铂40 mg/m2）30例和对照组（顺铂40 mg/m2）30例,胸腔灌注治疗,每周1次,共3次。观察疗效、生活质量改善状况及药物不良反应。结果 治疗组胸腔积液治疗有效率（73.3%）明显高于对照组（43.3%）,差异有统计学意义（P＜0.05）;治疗组生活质量改善状况（76.7%）明显优于对照组（50.0%）,差异有统计学意义（P<0.05）;两组均未出现Ⅲ级以上不良反应,差异无统计学意义（P>0.05）。结论 重组人血管内皮抑制素联合顺铂治疗NSCLC合并恶性胸腔积液安全、有效。     

鼻咽癌患者调强放疗过程中体重变化及影响因素分析

目的 研究鼻咽癌(nasopharyngeal carcinoma,NPC)患者调强放疗(intensity-modulated radiotherapy, IMRT)过程中的体重变化规律及影响因素。方法 回顾性分析57例鼻咽癌患者调强放疗过程中体重及身体质量指数(body mass index, BMI)变化,探讨鼻咽癌调强放疗患者体重和BMI变化规律及影响因素。结果 57例患者放疗前后平均体重分别为（60.4±9.4）kg和（55.1±8.7）kg（P=0.0025）,变化范围为17 kg~-0.5 kg;放疗前后BMI分别为（22.8±3.5）kg/m²和（20.8±3.1）kg/m²（P=0.0017）,变化范围为6.0 kg/m²~-0.2 kg/m²。约93.0%患者调强放疗中出现不同程度体重和BMI减轻,平均体重减轻8.4%,35.1%患者体重减轻超过10.0%,68.4%体重减轻超过5.0%,体重减轻百分比范围23.4%~-0.7%。单变量多因素方差分析显示,患者性别、WHO病理分级、AJCC6th分期、身体状况评分（performance status,PS）、是否同期化疗及后程加速超分割放疗(late course accelerated hyperfractionated radiotherapy, LCAFR)）对体重和BMI无明显影响（P＞0.05）, 而年龄≥50岁或BMI＞25 kg/m²或体重＞60 kg者体重减轻更明显（P＜0.05）。线性回归分析每周平均放疗剂量和每周平均体重呈明显负相关（R2=-0.996,P＜0.001）。结论 鼻咽癌患者调强放疗过程中体重减轻现象非常普遍,性别、WHO病理分级、AJCC6th分期、身体状况评分、是否同期化疗及后程加速超分割放疗对患者体重和BMI变化影响可能较小,而年龄、放疗前体重和BMI、放疗剂量对患者体重和BMI影响更明显。     

GP、PF及TPF方案化疗联合调强适形放疗治疗鼻咽癌的临床疗效

背景与目的：诱导化疗联合放疗及辅助化疗治疗鼻咽癌的疗效目前尚未明确,本研究旨在比较GP（吉西他滨+顺铂）方案、PF（顺铂+氟尿嘧啶）方案及TPF（多西他赛+顺铂+氟尿嘧啶）方案化疗联合调强适形放疗（intensity-modulated radiotherapy,IMRT）在无远处转移鼻咽癌患者中的临床疗效。方法：本研究回顾性分析了2009年1月—2010年12月期间在复旦大学附属肿瘤医院放疗科接受诱导化疗联合IMRT及辅助化疗的134例无远处转移鼻咽癌患者。GP组（吉西他滨1 000 mg/m2,第1、8天+顺铂25 mg/m²,第1~3天）、PF组（顺铂25 mg/m²,第1~3天+氟尿嘧啶500 mg/m²,第1~5天,持续静脉滴注）及TPF组（多西他赛75 mg/m²,第1天+顺铂25 mg/m²,第1~3天+氟尿嘧啶500 mg/m²,第1~5天,持续静脉滴注）分别纳入55、20和59例患者。诱导化疗每21 d重复,2~3个疗程后行IMRT。原发灶及阳性淋巴结的大体肿瘤靶区（gross tumor volume,GTV）的处方剂量分别为（66.0~70.4）Gy/（30~32）次和66.0 Gy/（30~32）次。放疗结束28 d后行辅助化疗2~3个疗程,方案与之前接受的诱导化疗方案相同。随访并比较3组不同的诱导化疗联合放疗及辅助化疗方案的患者5年总生存期（overall survival,OS）、无病生存期（disease-free survival,DFS）及局部无复发生存期（local recurrence-free survival, LRFS）情况。结果：GP组、PF组和TPF组的5年OS率分别为91.9%、75.1%和90.8%,5年LRFS率分别为95.8%、82.3%和96%。GP组的5年OS率（P=0.041）高于PF组,TPF组的5年LRFS率高于PF组（P=0.043）。TPF组和GP组间生存曲线差异无统计学意义。结论：GP方案诱导化疗联合IMRT及辅助化疗治疗无远处转移鼻咽癌的临床疗效可能优于PF方案,尚待大样本数据验证。三药联合的TPF方案并未优于GP方案。可考虑展开Ⅲ期临床试验评价GP方案诱导化疗在无远处转移初治鼻咽癌人群中的疗效。     

局部晚期鼻咽癌吉西他滨和顺铂联合调强放疗Ⅱ期临床试验

目的 评价吉西他滨和顺铂与调强放疗序贯治疗局部晚期鼻咽癌的疗效和不良反应。方法 71例局部晚期鼻咽癌(Ⅲ期 41例、Ⅳ_A期 30例)患者接受新辅助化疗、调强放疗、辅助化疗,新辅助化疗、辅助化疗各2个疗程\[吉西他滨1000 mg/m²,第1、8天静脉滴注(>30 min);顺铂 25 mg/m²,第 1~3天,静脉滴注;21 d为1个疗程\]。调强放疗鼻咽大体肿瘤体积 66.0~70.4 Gy,颈部淋巴结大体肿瘤体积66 Gy, 临床高危靶体积60 Gy,临床低危靶体积54 Gy。结果 新辅助化疗后的有效率为91.2%,主要急性不良反应为 1~2级骨髓抑制。所有患者随访满 3年,3年鼻咽局部控制率、区域控制率、无远处转移率、总生存率分别为93%、99%、91%、90%。3级晚期不良反应中张口困难 1例、听力下降 2例、颅神经损伤 2例。结论 吉西他滨和顺铂联合调强放疗局部晚期鼻咽癌有效、方便、耐受性良好,值得进一步探索药物最适当的治疗周期。     

局部晚期鼻咽癌调强放疗同期化疗前TPF诱导化疗Ⅰ和Ⅱ期临床研究

目的 探讨局部晚期鼻咽癌调强放疗同期化疗前多西泰索加顺铂加氟尿嘧啶方案诱导化疗中顺铂最大耐受剂量(MTD)及方案安全性、有效性。方法 选取 33例局部晚期鼻咽癌患者,通过剂量递增试验确立顺铂MTD并评价临床疗效及不良反应。结果 多西泰索60 mg/m²第1天、氟尿嘧啶550 mg/m²第 1~5天剂量下顺铂MTD为65 mg/m²第1天,每3周重复下3、4级不良反应发生率分别为中性粒细胞降低 67%,粒细胞缺乏性发热9%,腹泻21%,口腔黏膜炎6%。除剂量限制性毒性患者外,其余均完成了治疗。诱导化疗后有效率为97%,其中完全缓解率为21%。结论 鼻咽癌流行地区每3周重复用多西泰索60 mg/m²第1天、顺铂65 mg/m²第1天、氟尿嘧啶550 mg/m²第 1~5天治疗局部晚期鼻咽癌患者是安全有效的。     

Cisplatin Weekly Versus Every 3 Weeks Concurrently with Radiotherapy in the Treatment of Locally Advanced Head and Neck Squamous Cell Carcinomas: What Is the Best Dosing and Schedule?

Purpose: The aim of this prospective randomized study is to compare cisplatin at 2 dose levels given concurrently with intensity modulated radiation therapy (IMRT) in the treatment of locally advanced HNSCC. The main objectives were to evaluate treatment toxicities, loco-regional control, tumor response and patients compliance. Methods: Patients were randomized into two groups that either received 30 mg/m2 cisplatin weekly (arm A) or 100 mg/m2 once every 3 weeks (arm B). Radiotherapy prescribed dose was 70Gy in 33 fractions. Treatment adverse events were documented. Results: Sixty patients with locally advanced HNSCC were included in this study. Recruitment started at the beginning of July 2016 and ended in July 2019. The Median follow-up was 24 months. Acute non-hematological toxicities of grade 3 or higher during the treatment course were significantly more observed in Arm B patients (76.6%) compared to Arm A patients (56.6%) with a P-value of 0.007. Hematological toxicities in the form of anemia, leucopenia and neutropenia were also significantly higher in Arm B patients with a p-value of 0.435, 0.002 & 0,002, respectively. The median 2 year loco-regional control rate in Arm B was 72.8% versus 57.6% in Arm A with a p-value of 0.015. Complete responses were similar between both groups (77%). Compliance to treatment was better in Arm A with 70% of the patients received at least 6 weekly doses where as 60% of the patients in Arm B completed the three cycles of treatment and 40 % received only 2 cycles. Conclusion: Once weekly low dose cisplatin treatment showed lower acute toxicity and a better compliance compared to once every 3 weeks high dose cisplatin treatment at the expense of a lower loco-regional control.     

A phase II study of weekly alternating chemotherapy in extensive-stage small cell lung cancer

Despite the recent development of new chemotherapeutic agents with activity in small cell lung cancer (SCLC), the long-term prognosis of patients with extensive-stage disease remains poor and has not improved in the past 20 years. The present study was designed to evaluate the activity and toxicity of weekly, alternating-regimen chemotherapy in patients with extensive-stage SCLC. Patients with previously untreated extensive-stage SCLC and performance status 0-2 were treated with cyclophosphamide 250 mg/m², etoposide 100 mg/m², and cisplatin 50 mg/m² on day 1; vincristine 1 mg/m² on day 8; and ifosfamide 1.2 gm/m² on days 8 and 9 with the entire treatment repeated every 14 days. Eighteen patients received chemotherapy for a median of 14 weeks (range, 1-35 weeks). Seventeen patients (94%) required dose delays and 16 patients (89%) required at least one dose reduction due to toxicity. Twelve patients (67%) exhibited an objective response (1 complete response, 11 partial response) with a median duration of response of 18 weeks (range, 8-32 weeks). Median survival was 33 weeks (range, 1-57 weeks) with a 1-year survival rate of 22%. Toxicity was primarily hematologic, including grade 3-4 leukopenia (82% of patients) and anemia (53% of patients). Only 2 patients developed grade 3 peripheral neuropathy and none exhibited grade 3-4 renal insufficiency. This regimen of weekly alternating combination chemotherapy resulted in tolerable toxicity as well as response and survival rates comparable to those achieved with standard chemotherapy in patients with extensive-stage SCLC. However, weekly chemotherapy regimens for the treatment of SCLC remain investigational.     

Partially hyperfractionated accelerated radiotherapy and concurrent chemotherapy for advanced nasopharyngeal carcinoma

A newly designed concomitant chemoradiotherapy was undertaken to assess the feasibility and efficacy for advanced nasopharyngeal carcinoma (NPC).

Sixty-three patients with biopsy-proven NPC were entered in this Phase II trial from March 1992 to November 1993. Most patients present with Stage IV disease (93.4%) and poorly differentiated epidermoid carcinoma or undifferentiated carcinoma were the major pathologic type. Radiotherapy was delivered using a telecobalt unit and 10 MV x-rays and by altered fractionation (72–74 Gy/45 fractions/6 weeks). Chemotherapy with cisplatin 75 mg/mm², 2 h infusion at day 1, followed by 5-FU 400 mg/m²/day, continuosly infused for 4 days was given concurrently during the first and fifth weeks of radiotheraphy.

The major toxicity was mucositis (61% belong to Grade 3, 31% to Grade 2). Weight loss, leucopenia, and skin reaction were frequently encountered. Three patients withdrew from treatment at 15, 25, and 55.5 Gy, three patients interrupted the radiotherapy for 1–4.5 weeks, and two patients refused the second cycle of concomitant chemotherapy due to toxicities. The initial tumor response showed 100% overall response rate, with 90.5% complete response. After a median follow-up tiem of 38 months, five patients failed at the primary and/or neck (four recurrent and one persistent), and 14 patients developed distant metastases alone. The 3-year primary disease-free, regional disease-free, distant disease-free, and overall survival rates are 89.1, 92.8, 74.3, and 73.6%, respectively. The late complication rate is acceptable so far.

Our data indicates that concurrent chemoradiotherapy for advanced NPC is both feasible and effective, with acceptable toxicities. Distant metastases are the major site of treatment failure. Postradition adjuvant chemotherapy to eradicate subclinical distant metastasis should be further studied.     

Alternating doublets: establishing the optimal multifractionated dosing schedule to administer docetaxel, cisplatin, gemcitabine, and vinorelbine in combination

The purpose was to determine the optimal multifractionated (MF) dosing schedule to permit the delivery of four active agents in nonsmall cell lung cancer simultaneously in alternating doublets (docetaxel-cisplatin alternating with gemcitabine-vinorelbine). Three MF schedules were used: schedule A weekly; schedule B twice weekly for 2 weeks repeated every 21 days; and schedule C twice weekly every other week. Dose fractions were fixed for each component drug: docetaxel 50 mg/m² plus cisplatin 20 mg/m² and gemcitabine 500 mg/m² plus vinorelbine 25 mg/m². GCSF 480 µg was administered as a single dose concomitant with chemotheray if the WBC was between 1500 and 3500 cells/mm³. Hematological toxicity, particularly leukopenia and anemia, was the predominant adverse effect observed and was demonstrated on all three schedules. Schedule B was not feasible in that none of the seven cycles were completed and six of seven required hospitalization for febrile neutropenia. The delivery of a four-drug combination chemotherapy regimen consisting of docetaxel, cisplatin, gemcitabine, and vinorelbine is feasible with an alternating doublet multifractionated dosing scheme with either a weekly or twice weekly every other week schedule.     

Gemcitabine and cisplatin in advanced nasopharyngeal carcinoma: a pilot study

A pilot study was performed to evaluate the efficacy and safety of gemcitabine and cisplatin combination in the treatment of patients with metastatic nasopharyngeal carcinoma (NPC). Eligible patients were those with metastatic NPC who had been treated with radiotherapy and cisplatin plus 5-fluorouracil chemotherapy. Cisplatin was given intravenously at the fixed dose of 30 mg/m² on days 1-3. Gemcitabine was intravenously administered over 30 min infusion with the dose escalated from 800 to 1200 mg/m² on days 1 and 8. The 3-week schedule defined a cycle of treatment. Fifteen patients were enrolled and assessed for the worst toxicities. For a total of 83 cycles, Grade 3-4 toxicity was 46.7% for neutropenia, 40.0% for thrombocytopenia, and 20.0% for anemia. Grade 3 nonhematologic toxicity was 13.3%. Fourteen patients were assessable for response. The overall response rate was 92.9%, with complete response in three patients (21.4%). Median survival was 10.2 months. Seven patients had lived more than one year, and two patients had lived more than 2 years. The recommended dose of gemcitabine was 1000 mg/m² on days 1 and 8 in each cycle. In conclusion, the present combination is well tolerated and highly active in the treatment of advanced NPC patients.