GEMOX方案一线治疗晚期转移性胆道系统肿瘤的临床观察

目的 探讨吉西他滨联合奥沙利铂（GEMOX）方案一线治疗晚期转移性胆道系统肿瘤的疗效及安全性。方法 收集2005年7月至2012年4月共49例接受GEMOX方案一线治疗的晚期胆道系统肿瘤患者,具体方案为：吉西他滨 1000mg／m2 静滴,d1、d8;奥沙利铂 100mg／m2 静滴,d2,21天为1周期,2个周期后评价疗效。结果 49例患者共接受了239个周期化疗,平均4.88个周期（2～10个周期）。49例患者均可评价疗效和毒副反应,获CR 2例（4.1％）,PR 8例（16.3％）,SD 26例（53.1％）,PD 13例（26.5％）,总有效率（RR）为20.4％,疾病控制率（DCR）为73.5％。中位疾病进展时间（mTTP）为6.0个月,中位生存时间（mOS）为11.0个月。主要毒副反应为白细胞减少、血小板减少、恶心呕吐和肝功能损害,均以1～2级为主。结论 GEMOX方案治疗晚期转移性胆道系统肿瘤疗效较好,毒副反应可耐受,值得临床进一步应用。     

XELOX方案联合恩度一线治疗晚期胆系肿瘤的临床观察

目的 观察卡培他滨和奥沙利铂（XELOX方案）联合重组人血管内皮抑制素（恩度）一线治疗晚期胆系肿瘤的临床疗效及毒副反应。方法 收集2008年1月至2013年12月我院肿瘤科收治的胆系肿瘤Ⅳ期患者42例,随机分为联合组（n=18）和单纯化疗组（n=24）。单纯化疗组应用XELOX方案化疗：卡培他滨1.25 g/m2 口服,d1~d14;奥沙利铂85 mg/m2 静脉滴注,d1。联合组在应用以上药物的同时给予恩度15 mg静滴3~4 h,d1~d14。21 d为1个周期,每2个周期评价疗效、生活质量（QOL）及毒副反应,比较两组有效率（RR）、疾病控制率（DCR）、中位无疾病进展生存期（mPFS）和中位生存时间（mOS）。结果 单纯化疗组患者获CR 0例,PR 6例,SD 8例,PD 10例,RR为25.0%,DCR为58.3%;mPFS为 5个月,mOS 为9.5个月,QOL改善稳定率为66.7%。联合组患者获CR 0例,PR 5例,SD 6例,PD 7例,RR为27.8%,DCR为61.1%;mPFS为7.5个月,mOS为14个月,QOL改善稳定率为77.8%。两组mPFS、mOS和QOL改善稳定率比较,差异均有统计学意义（P均<0.05）。两组毒副反应主要为消化道反应、手足综合征、骨髓抑制、神经毒性及口腔黏膜炎,多为Ⅰ级/Ⅱ级,Ⅲ级/Ⅳ级少见,差异均无统计学意义（P均＞0.05）。结论 XELOX方案联合恩度一线治疗晚期胆系肿瘤的疗效较好,毒副反应可耐受,安全性良好,值得进一步观察及临床推广应用。     

GEMOX方案联合重组人血管内皮抑素一线治疗晚期胆系肿瘤的初步观察

目的 观察吉西他滨（GEM）、奥沙利铂（OXA）联合重组人血管内皮抑素（恩度）一线治疗晚期胆系肿瘤（BTCs）的疗效及安全性。方法 回顾性分析2009年1月至2013年8月ⅣB期BTCs患者 48例,分为联合组（n=20）和单纯化疗组（n=28）。联合组：吉西他滨1000mg／m2静滴,d1、d8;奥沙利铂 100mg／m2 静滴 d2,3周为1周期;恩度 15mg 静滴 d1～d14,3周为1周期。单纯化疗组仅给予GEMOX方案化疗,剂量与使用方法同联合组。2个周期后按照RECIST11标准评价近期疗效,参考KPS变化评价生活质量（QoL）,根据NCI CTC30标准评价不良反应,并观察疾病进展时间（TTP）和总生存时间（OS）。结果 联合组获CR 1例、PR 3例、SD 12例、PD 4例,有效率（RR）为200％,疾病控制率（DCR）为80.0％;中位TTP为8.6个月,中位OS为14.0个月;QoL改善稳定率为80.0％。单纯化疗组获CR 1例、PR 5例、SD 15例、PD 7例,RR 为21.5％,DCR 为75.0％;中位TTP为 6.0个月,中位OS 为10.0个月; QoL改善稳定率为71.4％。两组中位TTP和OS的差异有统计学意义（P＜0.05）。两组最常见的不良反应为骨髓抑制,其他不良反应包括恶心呕吐、肝功能损害、外周神经炎、皮肤过敏反应等,以1～2级为主,两组比较差异无统计学意义（P＞0.05）。化疗联合恩度组仅2例出现心电图T波改变,1例出现房性早搏,1例出现轻度血压升高。结论 GEMOX联合恩度方案一线治疗转移性BTCs疗效较好,可以改善或稳定QoL,延长生存时间,且耐受性较好,值得临床推广使用和进一步深入观察。     

卡培他滨单药改良方案治疗老年晚期胃癌临床研究

目的:观察卡培他滨作为一线药物改良方案治疗老年晚期胃癌的疗效及安全性.方法: 对92例老年晚期胃癌患者采用卡培他滨2 500 mg/(m2·d),分早晚2次服用, 每3周重复共用4个周期.治疗1～2个周期出现Ⅲ～Ⅳ血液学毒性或消化道毒性者38例作为观察组,调整卡培他滨用药间歇2 500 mg/(m2·d),分早晚2次服用,连服7 d, 休7 d,再服7 d,28 d为1个周期,共用＞4个周期.休息1个月评定疗效.结果: 观察组38例患者中CR 2例、PR 9例、SD 15例和PD 12例,缓解率(CR+PR)为28.94%,肿瘤控制率(CR+PR+SD)为68.42%.与对照组疗效比较,差异无统计学意义,P>0.05.主要毒副反应为厌食、恶心、呕吐、腹泻、手足综合征、皮肤色素沉着、白细胞减少、转氨酶升高等.毒副反应轻微,多为Ⅰ/Ⅱ级.结论: 卡培他滨作为一线药物治疗老年或体质差的晚期胃癌患者即使改良方案也有较好的疗效,毒副反应轻.     

Capecitabine plus oxaliplatin as first-line treatment in patients with advanced biliary system adenocarcinoma: a prospective multicentre phase II trial

This prospective multicentre phase II study characterises the toxicity and activity of first-line capecitabine and oxaliplatin combination therapy (CAPOX) in advanced biliary system adenocarcinomas. Patients received oxaliplatin (130 mg m(-2), day 1) plus capecitabine (1000 mg m(-2) b.i.d., days 1-14) every 3 weeks. Patients were stratified prospectively into two groups based on location of the primary (gallbladder carcinoma (GBC) or extrahepatic cholangiocarcinoma (ECC) versus intrahepatic mass-forming type cholangiocarcinoma (ICC)). Sixty-five patients were evaluable. The response rate in 47 patients with GBC/ECC was 27% (4% complete responses), and in 23 patients (49%) stable disease (SD) was encountered. In 18 patients with ICC, we observed no objective responses, but 6 patients (33%) had SD. Median survival was 12.8 months (95% CI, 10.0-15.6) for patients with GBC or ECC (GBC: 8.2 months; 95% CI, 4.3-11.7; ECC: 16.8 months; 95% CI, 12.7-20.5), and 5.2 months (95% CI, 0.6-9.8) for ICC patients. In both cohorts, therapy was well tolerated. The most common grade 3-4 toxicity was peripheral sensory neuropathy (11 patients). Our data suggest that the CAPOX regimen is a well-tolerated and active treatment option for advanced ECC and GBC but might produce poorer results for ICC.     

GLX方案一线治疗晚期转移性胆系肿瘤的临床观察

目的 观察吉西他滨联合亚叶酸钙、希罗达组成的GLX方案一线治疗晚期转移性胆系肿瘤（BTCs）的有效性和安全性。方法 2008年4月至2014年10月间48例经病理组织学和影像学检查确诊的晚期BTCs患者接受GLX方案一线治疗,具体方案如下：吉西他滨1000 mg/m2静滴,d1、d8;亚叶酸钙40~60 mg/m2口服 2/日,d1~d14;希罗达1250 mg/m2 口服 2/日,d1~d14;21天为1周期。2个周期后按照RECIST 1.1版标准评价近期疗效,参考Karnofsky体力状况评分（KPS）评价患者生活质量（QoL）,根据NCI-CTC 4.0版标准评价毒副反应,并随访疾病进展时间（TTP）和总生存期（OS）。结果 全组共接受238个周期化疗,每例2~10个周期,平均4.9个周期。48例均可评价疗效和毒副反应。获CR 1例,PR 8例,SD 26例,有效率为18.7%,疾病控制率为72.9%;中位TTP为 7个月,中位OS为13个月,治疗后23例QoL改善,15例QoL稳定,10例QoL降低,有效率为79.2%;常见毒副反应为血液学毒性,以白细胞减少为主,发生率为52.1%,其中3级减少发生率分别为6.3%;手足综合征发生率为20.8%,3级发生率为6.3%。结论 GLX方案一线治疗晚期转移性BTCs疗效较好,可以改善或稳定QoL,延长生存;耐受性较好,值得临床推广使用和进一步深入观察。     

吉西他滨联合长春瑞滨二线治疗转移性鼻咽癌的临床疗效

目的 观察吉西他滨联合长春瑞滨(GV)二线治疗含铂类药物方案化疗失败转移性鼻咽癌(nasopharyngeal carcinoma,NPC)患者的疗效,并分析影响预后的因素。方法 回顾性分析2010年1月至2016年3月于广西医科大学附属肿瘤医院经含铂类药物方案一线化疗失败后予GV方案治疗的41例转移性NPC患者的临床病理资料,采用Cox比例风险回归分析影响其预后的因素。结果 41例转移性NPC患者共完成146个周期化疗,中位周期数为4个周期,总有效率为42.9%,疾病控制率为85.8%。中位无进展生存期为6.0个月(95%CI:4.4~7.6),中位生存期为16.4个月(95%CI:8.8~24.0)。骨髓抑制是主要的不良反应,患者可耐受。多因素分析结果显示,二线化疗周期数是影响患者预后的独立因素(HR=2.660, 95%CI:1.044~6.781,P=0.040)。结论 GV方案二线治疗含铂类药物方案一线化疗失败的转移性NPC患者安全有效,且化疗周期数≥4的患者预后可能更佳。     

吉西他滨联合卡培他滨治疗41例复发或转移性胆管细胞癌的临床疗效和安全性观察

目的 观察吉西他滨联合卡培他滨治疗复发或转移性胆管细胞癌的临床疗效和安全性.方法 收集2000年3月至2004年12月间在南京军区福州总医院经病理确诊并符合入组条件的41例复发或转移性胆管细胞癌患者,给予吉西他滨联合卡培他滨方案化疗,观察近期疗效、远期疗效和安全性.结果 36例患者可评价疗效,其中完全缓解(CR)0例,部分缓解(PR)11例,病情稳定(SD)11例、病情进展(PD)14例;临床有效率为30.1%,临床受益率为61.1%.患者的中位生存时间和中位疾病进展时间分别为10个月和6个月.化疗后常见的毒副反应为胃肠道反应、乏力和手足综合征等,且以Ⅰ、Ⅱ级毒副反应居多.结论 卡培他滨联合吉西他滨治疗复发或转移性胆管细胞癌是安全和有效的,值得开展多中心临床协作研究来进一步探讨.     

Phase II study of gemcitabine and cisplatin as first-line chemotherapy in inoperable biliary tract carcinoma.

OBJECTIVES: The prognosis for patients with unresectable biliary tract cancer is poor and existing chemotherapy is relatively ineffective. Therefore, a need exists for new, effective chemotherapeutic regimens. The aim of this study was to determine the efficacy and safety profile of gemcitabine plus cisplatin in patients with unresectable biliary tract cancer (cholangiocarcinoma) and gall bladder cancer. METHODS: From December 2000 to July 2002, 43 patients received gemcitabine 1250 mg/m(2) in a 30-min i.v. infusion on d1, 8 and cisplatin 75 mg/m(2) in a 2-h i.v. infusion on d1 (with appropriate hydration), every 3 weeks. ELIGIBILITY: Normal hematologic parameters and creatinine levels; serum bilirubin < 5 mg/dl. RESULTS: Forty-three patients enrolled; 40 were assessable (three patients were not assessable due to incomplete treatment; they chose to discontinue chemotherapy after the first cycle). There were 23 males and 17 females, median age 50 years (range 31-69), median Karnofsky PS 80%. Tumor types: cholangiocarcinoma (39), gall bladder cancer (1). Median number of chemotherapy courses was four (range 1-8). Overall response rate was 27.5% (PR in 11 pts), with 32.5% SD and/or minor response. Median survival time was 36 weeks. Grade 3 hematologic toxicity: anemia (4.33%), leukopenia (1.73%). Non-hematologic toxicity (i.e. rash, nausea, vomiting, neuropathy and myalgia) ranged from mild to moderate. CONCLUSIONS: Gemcitabine plus cisplatin is active in biliary tract carcinoma. These data warrant further investigation of single-agent gemcitabine versus gemcitabine plus cisplatin or its derivative, i.e. oxaliplatin.     

Biweekly cisplatin and gemcitabine in patients with advanced biliary tract cancer

Treatment with cisplatin and gemcitabine demonstrates a survival benefit in patients with advanced biliary tract cancer (ABTC). However, the weekly administration can add significant toxicities that may prohibit prolonged treatment. Based on previous studies, we implemented a modified biweekly regimen of GC in an attempt to optimize the prescribed regimen with an improved toxicity profile, added convenience to patients while maintaining efficacy. Patients with ABTC were treated with fixed dose rate (FDR) gemcitabine (1,000 mg/m²/min) and cisplatin 20 mg/m² on days 1 and 15 of every 28‐day cycle. Patients received treatment until time of progression, death, or discontinuation due to intolerance. Collected data included demographics, clinico‐pathologic features, toxicities, and survival. Kaplan‐Meier curves were used to calculate the median overall survival (OS) and progression free survival (PFS). The study included 107 evaluable pts with unresectable ABTC who received the biweekly regimen. Sites of tumor included gallbladder (21.5%), ampullary (3.7%), and bile duct (74.8%). Median number of cycles was 6 (1–27). Median PFS was 8.34 (6.74, 9.23) months and median OS was 10.32 (9.10, 11.43) months. Most common grade ≥3 adverse events included neutropenia (11%), fatigue (10%), and thrombocytopenia (6.4%). Biweekly FDR GC in ABTC is associated with a more favorable toxicity profile while maintaining efficacy similar to that observed in prior clinical trials. Minimal toxicities were observed despite a prolonged course for many patients. Further prospective trials should consider evaluating the role of biweekly GC regimen in ABTC, including a potentially more favorable platform in novel experimental strategies.     

A multicenter phase III trial comparing irinotecan-gemcitabine (IG) with gemcitabine (G) monotherapy as first-line treatment in patients with locally advanced or metastatic pancreatic cancer

Our purpose was to determine the response rate and median and overall survival of gemcitabine as monotherapy versus gemcitabine plus irinotecan in advanced or metastatic pancreatic cancer. Patients with histologically or cytologically confirmed adenocarcinoma who were chemotherapy and radiotherapy naive were enrolled. Patients were centrally randomised at a one-to-one ratio to receive either gemcitabine monotherapy (900 mg m(-2) on days 1, 8 and 15 every 4 weeks (arm G), or gemcitabine (days 1 and 8) plus irinotecan (300 mg m(-2) on day 8) (arm IG), repeated every 3 weeks. The total number of cycles administered was 255 in the IG arm and 245 in the G arm; the median number of cycles was 3. In all, 145 patients (71 in arm IG and 74 in arm G) were enrolled; 60 and 70 patients from arms IG and G, respectively, were evaluable. A complete clinical response was achieved in three (4.3%) arm G patients; nine (15%) patients in arm IG and four (5.7%) in arm G achieved a partial response. The overall response rate was: arm IG 15% and arm G 10% (95% CI 5.96-24.04 and 95% CI 2.97-17.03, respectively; P=0.387). The median time to tumour progression was 2.8 months and 2.9 months and median survival time was 6.4 and 6.5 months for the IG and G arms, respectively. One-year survival was 24.3% for the IG arm and 21.8% for the G arm. No statistically significant difference was observed comparing gemcitabine monotherapy versus gemcitabine plus irinotecan in the treatment of advanced pancreatic cancer, with respect to overall and 1-year survival.     

奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤的临床观察

目的 观察奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤的疗效及不良反应。方法 收集2008年1月至2011年3月均经影像和病理组织学确诊的晚期胆道系统肿瘤38例,具体用药方案：奥沙利铂85mg/m²静滴2h,d₁;吉西他滨835 mg/m2静滴30min,d_¹、d₈,21天为1周期。化疗2个周期评价疗效,并记录不良反应。结果 38例均可评价疗效,获CR 1例,PR 7例,有效率（RR）为21.1%(8/38)。主要不良反应包括骨髓抑制、外周神经毒性及恶心呕吐,均未出现重度不良反应。结论 奥沙利铂联合吉西他滨治疗晚期胆道系统肿瘤患者的近期疗效较好,不良反应可以耐受,值得深入研究。     

Fixed-dose-rate gemcitabine combined with cisplatin in patients with inoperable biliary tract carcinomas

Background

Biliary tract cancers (BTC) have a poor prognosis, and there is no consensus on the best chemotherapy regimen. This study determined the response rate for fixed-dose-rate (FDR) gemcitabine combined with cisplatin.

Methods

This multicentre phase II trial enrolled 50 patients with inoperable locally advanced or metastatic BTC. Treatment consisted of FDR gemcitabine 1,000?mg/m² (10?mg/m²/min) and cisplatin 20?mg/m² on days 1 and 8 of a 21-day cycle. The primary endpoint was response rate. Secondary endpoints included safety, response duration (RD), progression-free (PFS) and overall survival (OS), and cancer antigen 19-9 response.

Results

Thirteen patients (26%, 95% CI 14.6?C40.4) had a partial response, and 12 (24%) had stable disease. The median RD was 8.3?months (95% CI 6.91?C9.99); median PFS 4?months (95% CI 2.5?C6.77); and median OS 6.8?months (95% CI 5.0?C8.7). Treatment was well tolerated. Grade 3 and grade 4 nausea, vomiting, and fatigue were uncommon. Thirty-eight per cent of patients discontinued treatment because of toxicity, patient or clinician preference.

Conclusions

This treatment combination had moderate activity with acceptable toxicity, supporting previous results that this combination has a role to play. The study does not suggest that FDR gemcitabine is superior to bolus infusion.     

卡培他滨联合顺铂一线治疗晚期胃癌的Ⅱ期临床研究

目的 评价卡培他滨联合顺铂一线治疗晚期胃癌的有效性和安全性.方法 对符合入组标准的141例晚期胃癌患者进行卡培他滨联合顺铂方案化疗,卡培他滨1000 mg/m2,2次/d,早、晚饭后30 min内口服,第1～14 d;顺铂20 mg/m2静脉滴注,第1～5天.21 d为1个疗程,共完成了705个周期的化疗.根据实体瘤反应评估标准(RECIST)评价疗效,根据美国国立癌症研究所抗癌药物常见不良反应评价标准(3.0版)评估不良反应.化疗结束后第1年每3个月随访1次,以后每6个月随访1次.结果 完全缓解13例,部分缓解38例,稳定54例,进展36例,总有效率为36.2%.患者中位疾病进展时间为9.0个月,中位生存时间为12.0个月.最常见的血液学毒副反应是中性粒细胞减少,有24例患者(17.0%)出现3～4级中性粒细胞减少.最常见的非血液学毒性反应是手足综合征,有35例(24.8%)出现手足综合征.本组患者无治疗相关性死亡发生.结论 卡培他滨联合顺铂一线治疗晚期胃癌具有较好的疗效,患者对此方案具有较好的耐受性,并且比5-Fu联合顺铂方案更方便,适合患者门诊应用.     

吉西他滨/多西他赛联合铂类一线治疗转移性鼻咽癌的临床对照研究

目的:观察吉西他滨联合铂类与多西他赛联合铂类方案在转移性鼻咽癌一线治疗中的疗效及耐受性。方法:2011年1 月至 2015年12月广西医科大学第四附属医院诊疗的转移性鼻咽癌120例。随机分两组接受一线化疗:吉西他滨联合铂类组60例,多西他赛联合铂类组60例。观察疾病缓解率（RR）、疾病控制率(DCR)及不良反应;采用 Kaplan-Meier法、Log-rank检验分析中位无进展生存（mPFS）、中位总生存（mOS）。结果:113例可评价病例,吉西他滨联合组56例,多西他赛联合组57例。吉西他滨联合组RR显著高于多西他赛联合组,差异有统计学意义(71.4% vs 52.6%,P=0.04)。中位随访15.8个月,与多西他赛联合组比较,吉西他滨联合组mPFS、mOS显著延长,差异有统计学意义（mPFS:9.7个月 vs 7.8个月,P=0.014; mOS:20.6个月 vs 16.8个月,P=0.005)。两组主要不良反应为均为骨髓抑制、胃肠道反应,但差异无统计学意义（P＞0.05）。多西他赛联合组1级末梢神经损害发生率显著高于吉西他滨联合组,差异有统计学意义(12.3% vs 1.8%,P=0.030),但两组均无2～4级末梢神经损害发生。结论:与多西他赛联合铂类方案比较,吉西他滨联合铂类一线治疗转移性鼻咽癌患者有更高的RR,可显著延长患者的PFS及OS时间,耐受性良好,末梢神经毒性更轻,可作为转移性鼻咽癌一线治疗的良好选择。     

S-1 monotherapy as first-line treatment in patients with advanced biliary tract cancer: a multicenter phase II study

A pilot phase II study showed S-1 monotherapy to be safe and active against biliary tract cancer (BTC). We, therefore, conducted a multicenter phase II study to evaluate the antitumor effect and safety of S-1 in previously untreated patients with advanced BTC. Eligible patients had pathologically proven, unresectable adenocarcinoma with no prior chemotherapy or radiotherapy. Patients received S-1 orally at 80 mg/m2 total daily dose divided b.i.d. for 28 days followed by 14 days of rest. Of the 41 enrolled patients, 40 were assessable. The primary tumor sites were as follows: gallbladder (n = 20), extrahepatic bile duct (n = 15), and the ampulla of Vater (n = 5). One patient (2.5%) achieved a complete response, 13 patients (32.5%) had partial responses, 17 patients (42.5%) had no change, 7 patients (17.5%) had progressive disease, and 2 patients (5.0%) were not evaluable. The overall objective response rate was 35.0%. The median overall survival (median OS) was 9.4 months, and the median time to progression was 3.7 months. Grade 3 or 4 toxicities included fatigue (7.5%), anorexia (7.5%) and T-Bil elevation (7.5%). Significant antitumor activity combined with a mild toxicity profile was observed. This monotherapy warrants further evaluation in a randomized study.     

聚乙二醇化脂质体多柔比星联合异环磷酰胺治疗晚期转移性软组织肉瘤

背景与目的：软组织肉瘤一旦出现远处转移,预后极差,中位生存时间不到1年。多柔比星联合异环磷酰胺(ifosfamide,IFO)(AI方案)是晚期软组织肉瘤常用的一线联合治疗方案。聚乙二醇脂质体多柔比星(pegylated liposomal doxorubicin,PLD)活性成分为盐酸多柔比星,药物包裹在脂质体中,可减少多柔比星的临床毒性反应。该研究探讨PLD联合IFO治疗晚期转移性软组织肉瘤的临床疗效和安全性。方法：选取晚期转移性软组织肉瘤患者25例,使用PLD联合IFO方案,PLD剂量30 mg/m²,静脉滴注,第1天;IFO剂量1.8 g/m²,静脉滴注,第1~5天;美司钠360 mg/m²,用IFO时0、4和8 h,21 d为1个周期。结果：所有患者化疗1~8个周期,中位周期数4。25例患者中部分缓解9例(36%),疾病稳定12例(48%),疾病进展4例(16%),疾病控制率(完全缓解+部分缓解+疾病稳定)为84%(21/25)。中位无进展生存时间为7.3个月(95%CI：4.6~10.0个月)。由于失访病例较多,中位总生存时间未随访到。化疗后3/4级不良反应包括白细胞下降(20%)、粒细胞下降(28%)、贫血(4%)和呕吐(4%)。只有1例患者治疗过程中予以减量。结论：临床应用PLD联合IFO方案治疗晚期转移性软组织肉瘤疗效确切,且毒性反应较轻,值得进一步深入研究。     

Efficacy of nimotuzumab plus gemcitabine usage as first-line treatment in patients with advanced pancreatic cancer

Advanced pancreatic cancer patients have poor prognosis and scarcely respond to conventional therapies. Clinical trials support the use of molecular-targeted therapy against epidermal growth factor receptor (EGFR) signaling. The objective of the current study was to evaluate the contribution of a monoclonal antibody against EGFR, nimotuzumab, to standard gemcitabine therapy. Patients with unresectable locally advanced or metastatic pancreatic adenocarcinoma were assigned to receive gemcitabine plus nimotuzumab. The primary end point was overall survival, whereas the secondary end points included progression-free survival, objective response, and adverse side effects. A total of 18 eligible patients were accrued between December 2007 and July 2010. The disease control rate, calculated as the sum of complete response, partial response, and stable disease, was 55.6 %. The median overall survival time was 9.29 months (95 % CI, 5.499 to 13.072). The median progression-free survival was 3.71 months (95 % CI, 2.526 to 4.902), and the 1-year survival rate was 38.9 %. Of all the patients, 88.8 % had at least one adverse side effect; however, no grade 4 adverse side effect was reported. Nimotuzumab as a high-purity humanized monoclonal antibody with favorable safety profile, its value in the treatment of pancreatic cancer along with gemcitabine, particularly in the comprehensive treatment of advanced pancreatic cancer, is appealing for further prospective randomized large-scale clinical trials.