局部晚期的早期子宫颈癌综合治疗模式探讨

目的:探讨局部晚期的早期宫颈癌(IB2和IIA期)综合治疗的模式。方法:2000年1月至2002年10月,我们以新辅化疗后 放疗后,行宫颈癌根治术,治疗宫颈肿瘤≥4cm的局部晚期的早期宫颈癌224例,术后根据盆腔淋巴结转移、宫颈间质深层浸润、脉管内癌栓、组织分化差等高危因素给予化疗和外照射治疗。回顾性分析同期收治的IB2~IIA期宫颈癌100例,作为对照组,均行术前腔内后装放疗 宫颈癌根治术。结果:治疗组与对照组癌细胞消失率差异有显著性(P=0.006);癌细胞浅肌层浸润率差异也有显著性(P=0.002);深肌层浸润率差异无显著性(P=0.316)。盆腔淋巴结转移率比较:髂血管区>闭孔区>骶前区同时合并髂血管区。结论:新辅助化疗 术前后装联合手术治疗是局部晚期的早期宫颈癌综合治疗的较佳模式。宫颈癌术中有必要做骶前区淋巴结清扫。     

局部晚期的早期子宫颈癌综合治疗模式探讨

目的：探讨局部晚期的早期宫颈癌（IB2和IIA期）综合治疗的模式。方法：2000年1月至2002年10月,我们以新辅化疗后＋放疗后,行宫颈癌根治术,治疗宫颈肿瘤≥4cm的局部晚期的早期宫颈癌224例,术后根据盆腔淋巴结转移、宫颈间质深层浸润、脉管内癌栓、组织分化差等高危因素给予化疗和外照射治疗。回顾性分析同期收治的IB2-IIA期宫颈癌100例,作为对照组,均行术前腔内后装放疗＋宫颈癌根治术。结果：治疗组与对照组癌细胞消失率差异有显著性（P=0.006）;癌细胞浅肌层浸润率差异也有显著性（P=0.002）;深肌层浸润率差异无显著性（P=0.316）。盆腔淋巴结转移率比较：髂血管区〉闭孔区〉骶前区同时合并髂血管区。结论：新辅助化疗＋术前后装联合手术治疗是局部晚期的早期宫颈癌综合治疗的较佳模式。宫颈癌术中有必要做骶前区淋巴结清扫。     

Phase II study of adjuvant chemotherapy with paclitaxel and nedaplatin for uterine cervical cancer with lymph node metastasis

The purpose of this phase II trial was to assess the efficacy and toxicity of paclitaxel and nedaplatin (TN) as the initial postoperative adjuvant chemotherapy for uterine cervical cancer with lymph node metastases (LNM). Patients with FIGO stage IB1‐IIA2 squamous cell carcinoma of the uterine cervix were enrolled. Histological confirmation of LNM was mandatory. Intravenous paclitaxel at 175 mg/m² and nedaplatin at 80 mg/m² were administered every 28‐day cycle, of which there were 5 cycles after radical hysterectomy. Sixty‐two patients were enrolled in the study from November 2011 to July 2015. Their median age was 48.5 years (range 28‐64). The median tumor diameter was 37 mm (5‐64). Overall, 30 patients (48.4%) had 1 metastatic lymph node, 11 (17.7%) had 2, 3 (4.8%) had 3, 5 (8.1%) had 4, and 13 (21.0%) had 5 or more. With a median follow‐up of 45.7 months (range 23.4‐69.5), the 2‐year relapse‐free survival and 2‐year overall survival rates were 79.0% (90% CI, 69.0%‐86.2%) and 93.5% (95% CI, 83.7%‐97.5%), respectively. Almost all adverse events were relatively mild. Grade 3‐4 adverse events (NCI‐CTC ver. 4.0) that occurred in 5% or more of patients were neutropenia (60.7%) and infection (6.6%). The proportion of patients who completed 5 cycles of treatment was 90.3%. Postoperative adjuvant chemotherapy with TN for cervical cancer with LNM was demonstrated to be an effective and feasible treatment. A phase III trial is warranted to compare this with concurrent chemoradiotherapy.     

调强放疗同期联合每周奈达铂治疗局部晚期鼻咽癌的临床研究

目的：观察调强放疗同期联合每周奈达铂治疗局部晚期鼻咽癌的疗效以及不良反应。方法：38例局部晚期鼻咽癌患者进入分析。所有患者均接受调强放疗。鼻咽肿瘤体积（ GTV）处方剂70Gy,颈部转移淋巴结（GTVnd）70Gy,临床靶体积1（CTV1）66Gy,临床靶体积2（CTV2）54Gy。于放疗第1周起静脉滴注奈达铂30mg/m2,每周1次,连用7周。结果：38例患者均可评价毒副反应及客观疗效。所有患者均完成了同期放化疗,少见严重不良反应。中位随访38个月,全组1、2、3年总生存率分别为94.7％、84.2％、78.9％,1、2、3年局部/区域控制率分别为100％、94.7％、92.1％,1、2、3年无远处转移生存率分别为97.3％、94.7％、73.6％。结论：调强放疗同期联合每周奈达铂治疗局部晚期鼻咽癌病人可达到较高的局部控制率和生存率,不良反应可耐受。     

紫杉醇联合奈达铂同期放化疗及巩固化疗治疗局部晚期宫颈癌

背景与目的：以顺铂（cisplatin，DDP）为基础的同期放化疗（concurrent chemoradiotherapv，CCRT）已成为局部晚期宫颈癌的标准治疗方案，但DDP毒性大，而且Ⅲ／Ⅳ。期宫颈癌的疗效并未提高，所以仍需寻找高效低毒的治疗方案。本研究旨为探宄紫杉醇（paclitaxel，TXL）联合奈达铂（nedaplatin，NDP）同期放化疗及巩固化疗治疗晚期宫颈癌的疗效以及不良反应。方法：2007年2月5日--2007年12月10曰共收治ⅡB-ⅢB期宫颈鳞癌初治患者29例，中位年龄48岁（35-64岁）。放疗采用盆腔外照射＋高剂量率腔内后装，B点剂量ⅡB期45Gy，Ⅲ期50Gy；A点剂量ⅡB期50Gy，Ⅲ期35Gy。同期化疗方案为TXL35mg／m^2＋NDP20mg／m^2，与放疗同时开始，每周1次，共6次；巩固化疗方案为：TXL135mg／m^2＋NDP60mg／m^2，CCRT完成后1个月开始，间隔3周，共4个疗程。结果：所有患者完成TCCRT，25例完成4个疗程巩固化疗，2例完成3个疗程，2例完成2个疗程。临床完全缓解（complete response，CR）为89．7％（95％CI，78．6％～100％），部分缓解（partial response，PR）10．3％（95％CI,0～21．4％）。在中位随访14个月后，无瘤生存率和总生存率分别为86．2％（95％CI,73．7％-98．7％），96．7％（95％CI，90．2％～100％）。1例ⅡB期PR者在治疗后8个月死于疾病进展。CCRT期间，3．6％个疗程发生3级WBC降低，0．6％个疗程发生3级腹泻；巩固化疗期间，8．7％个疗程发生3级WBC以及中性粒细胞降低。2例患者发生晚期3级直肠反应。结论：TXL＋NDP同期放化疗及巩固化疗治疗局部晚期宫颈鳞癌疗效高，耐受性好，值得进入Ⅲ期前瞻性随机研究。     

Capecitabine in combination with preoperative radiation therapy in locally advanced, resectable, rectal cancer: a multicentric phase II study.

BACKGROUND: The aim of the study was to evaluate tolerance and efficacy of preoperative treatment with capecitabine in combination with radiation therapy (RT) in patients with locally advanced, resectable, rectal cancer. PATIENTS AND METHODS: Fifty-three patients with potentially resectable T3, N0-2 (87%) and T4, N0-2 (13%) rectal cancer were treated with capecitabine (825 mg/m2, twice daily for 7 days/week) and concomitant RT (50.4 Gy/28 fractions). Patients underwent surgery after 6-8 weeks followed, upon physician's indications, by 4-months adjuvant capecitabine. The primary end point was to determine the rate of pathologic complete response. Secondary end points were to assess the rate of clinical response and the safety profile. RESULTS: All patients but two completed the RT programme and 47 (89%) received 81%-100% of the capecitabine dose (100% of dose in 72% patients, 81%-95% in 17% patients and 48%-74% in 11% of patients). No patient had grade 4 toxicity. Grade 3 toxicity occurred in six patients (11%) and consisted mainly of leucopenia (4%) and hand-foot syndrome (4%). Mild or moderate toxicity was common and included leucopenia (72%), diarrhea (40%), proctitis (34%) and skin toxicity (20%). The overall clinical response rate was 58% and the downstaging rate was 57%, with a pathologic complete response rate of 24%. Among 34 patients with low-lying tumors (相似文献   

Phase I-II study of irinotecan (CPT-11) plus nedaplatin (254-S) with recombinant human granulocyte colony-stimulating factor support in patients with advanced or recurrent cervical cancer

Combination chemotherapy with irinotecan (CPT-11) and platinum compounds is effective for treating cervical cancer. Nedaplatin (254-S) is a new cisplatin analogue that achieves a high response rate (53%) in patients with primary cervical cancer. We performed a phase I-II study of combination chemotherapy with CPT-11 plus 254-S for advanced or recurrent cervical cancer. The inclusion criteria were stage IV disease or recurrence. CPT-11 and 254-S were administered intravenously on day 1, while rhG-CSF (50 microg) was given on days 3-12. This regimen was repeated after 4 weeks. Dose escalation was carried out in tandem (CPT-11/254-S: 50/70, 50/80, and 60/80 mg m(-2)). A total of 27 patients (stage IV=seven, recurrence=20) were enrolled. The phase I study enrolled eight patients. At dose levels 1 and 2, no dose-limiting toxicities were observed. At dose level 3, the first two patients developed DLTs. The maximum tolerated dose of CPT-11 and 254-S was 60 and 80 mg m(-2), respectively, and the recommended doses were 50 and 80 mg m(-2). Grade 3/4 haematologic toxicity occurred in 67% in phase II study, but there were no grade 3 non-haematologic toxicities except for nausea or lethargy. In all 27 patients, there were two complete responses (7%) and 14 Partial responses (52%), for an overall response rate of 59% (95% confidence interval: 39-78%). Among the 12 responders with recurrent disease, the median time to progression and median survival were 161 days (range: 61-711 days) and 415 days (range: 74-801 days). This new regimen is promising for cervical cancer.     

A phase II study of weekly neoadjuvant chemotherapy followed by radical chemoradiation for locally advanced cervical cancer

Background:

We investigated the feasibility of dose-dense neoadjuvant chemotherapy (NACT) with paclitaxel and carboplatin before radical chemoradiation (CRT) and assessed the response rate to such a regimen.

Methods:

CxII is a single-arm phase II trial of 46 patients, with locally advanced cervical cancer (stage Ib2-IVa). Patients received dose-dense carboplatin (AUC2) and paclitaxel (80 mg m⁻²) weekly for six cycles followed by CRT (40 mg m⁻² of weekly cisplatin, 50.4 Gy, 28 fractions plus brachytherapy). The primary end point was response rate 12 weeks post-CRT.

Results:

Baseline characteristics were: median age at diagnosis 43 years; 72% squamous, 22% adenocarcinoma and 7% adenosquamous histologies; FIGO stage IB2 (11%), II (50%), III (33%), IV (7%). Complete or partial response rate was 70% (95% CI: 54–82) post-NACT and 85% (95% CI: 71–94) post-CRT. The median follow-up was 39.1 months. Overall and progression-free survivals at 3 years were 67% (95% CI: 51–79) and 68% (95% CI: 51–79), respectively. Grade 3/4 toxicities were 20% during NACT (11% haematological, 9% non-haematological) and 52% during CRT (haematological: 41%, non-haematological: 22%).

Conclusion:

A good response rate is achieved by dose-dense weekly NACT with carboplatin and paclitaxel followed by radical CRT. This treatment regimen is feasible as evidenced by the acceptable toxicity of NACT and by the high compliance to radiotherapy (98%).     

Phase II study of cisplatin and 5-fluorouracil with concurrent radiotherapy in advanced squamous cell carcinoma of the esophagus: a Japan Esophageal Oncology Group (JEOG)/Japan Clinical Oncology Group trial (JCOG9516)

BACKGROUND: In Japan, concurrent chemoradiotherapy is the standard treatment for unresectable esophageal cancer. The optimal combination of chemotherapeutic agents and radiotherapy dose remains controversial. The present study consists of a phase II trial of a cisplatin (CDDP)/5-fluorouracil (5-FU) infusion with concurrent radiotherapy in patients with unresectable, advanced esophageal cancer. METHODS: Between March 13, 1996, and April 28, 1998, 60 patients with advanced squamous cell carcinoma of the thoracic esophagus having either T4 tumor or distant lymph node metastasis (M1 Lym) were enrolled in this study. CDDP 70 mg/m(2) was administered on days 1 and 29, and 5-FU 700 mg/m(2)/day was administered on days 1-4 and 29-32. Fractionated radiotherapy was performed on days 1-21 and 29-49; a total dose of 60 Gy was delivered at the rate of 2 Gy per fraction. RESULTS: The overall response rate of all the 60 registered patients was 68.3% (41/60), and the complete response rate was 15% (9/60). The median survival time was 305.5 days, and the 2-year survival rate was 31.5%. One toxicity-related death occurred. The major form of toxicity exceeding grade 2 was found to be myelosuppression; grade 4 toxicity was observed in five patients. CONCLUSION: Based on the overall response rate, the results obtained from the present trial do not appear to be promising. However, it is currently suitable for the treatment of patients with unresectable, advanced esophageal cancer because of certain clinical advantages, a higher CR rate and a lower incidence of fistula formation. A phase II/III trial will be started in order to compare low-dose continual CDDP/5-FU infusion and concurrent radiotherapy with the results obtained in this study.     

奈达铂联合放疗治疗局部晚期鼻咽癌的临床观察

目的探讨奈达铂联合放疗治疗局部晚期鼻咽癌的临床疗效及毒副作用。方法入组2010年1月至2012年1月在我院诊治的60例局部晚期鼻咽癌患者,给予同期放化疗治疗,随机分为对照组（顺铂）和观察组（奈达铂）,每组各30例,对两组近期疗效、远期疗效、毒副作用进行观察和比较。结果观察组与对照组的鼻咽部肿瘤、颈部淋巴结完全缓解率（20.0%vs 16.7%;66.7%vs 60.0%）和部分缓解率（76.7%vs 76.7%;33.3%vs 40.0%）差异无统计学意义（P〉0.05）;与对照组相比,观察组骨髓抑制（23.3%vs 50.0%）、恶心呕吐（36.7%vs 76.7%）发生率显著降低,差异有统计学意义（P〈0.05）。结论奈达铂联合放疗治疗局部晚期鼻咽癌的毒副作用少,安全性相对较高,值得临床推广。     

奈达铂联合紫杉醇和顺铂联合紫杉醇同步放化疗局部晚期鼻咽癌的临床随机对照实验

目的 通过临床随机对照实验观察奈达铂是否能够替代顺铂与紫杉醇联合同步放化疗局部晚期鼻咽癌,是否能够提高治疗的耐受性.方法 实验组(TN组)30例,采用紫杉醇135 mg/m2ivgtt d1+奈达铂10 mg/m2 ivgttd1诱导化疗,每3周为1个化疗周期,共2个疗程,以后行同样方案同期放化疗,仍然每3周为1个化疗...     

放射治疗配合全身化疗治疗局部晚期鼻咽癌

 目的　评价放化结合和单独放疗治疗局部晚期鼻咽癌的疗效和毒副反应。方法　将 4 3例鼻咽癌随机分为放化组和单放组。结果　全组 1、3年生存率分别为 88.4 %和 5 1.2 % ,放化组和单放组的 1年生存率分别为 90 .5 %和 86 .4 % (P >0 .0 5 ) ,3年生存率分别为 5 7.1%和 4 5 .5 % (P >0 .0 5 )。放化组的主要毒副反应为恶心、呕吐和白细胞下降 ,发生率分别为 90 .5 %和 10 0 % ,均为Ⅰ～Ⅲ度。结论　研究结果显示POB联合化疗合并放射治疗晚期鼻咽癌是可以耐受的 ,对改进鼻咽癌的治疗效果仍有待进一步研究     

PF方案联合放疗治疗中晚期宫颈癌的疗效观察

目的：探讨PF方案联合放疗治疗中晚期宫颈癌的疗效及不良反应。方法：回顾分析52例中晚期宫颈癌的随访资料,根据PF方案联合放射治疗组和单纯放疗组进行比较,观察有效率及不良反应。结果：PF方案联合放疗组在肿瘤的缩小、消失方面优于单纯放疗组,两者差异有显著意义（P〈0.05）。PF方案联合放疗组有效率85%,单纯放疗组有效率68%,但化疗联合放疗组较单纯放疗组消化道Ⅰ-Ⅱ度不良反应发生率明显增加,骨髓抑制Ⅰ-Ⅱ度不良反应有增加。结论：PF方案联合放射治疗中晚期宫颈癌效果显著。     

不同病理类型局部晚期(ⅠB2及ⅡA2期)宫颈癌的预后情况分析

目的探讨不同病理类型局部晚期(ⅠB2、ⅡA2期)宫颈癌的预后情况。方法选取169例ⅠB2、ⅡA2期宫颈癌(鳞状细胞癌149例,腺癌或腺鳞癌20例)患者,根据治疗模式的不同将其分为同期放化疗组、根治性手术组、新辅助化疗+根治性手术组。比较不同病理类型及不同治疗模式局部晚期宫颈癌患者的2年无复发生存率,分析120例接受过根治性手术的局部晚期宫颈癌患者的病理类型与其他临床特征的关系,并比较新辅助化疗+根治性手术组中不同病理类型局部晚期患者对新辅助化疗的反应。结果截至随访结束,随访超过2年者137例,2年无复发生存率为83.9%(115/137),其中,鳞状细胞癌患者的2年无复发生存率高于腺癌或腺鳞癌患者(P﹤0.05)。同期放化疗组、根治性手术组、新辅助化疗+根治性手术组患者的2年无复发生存率分别为77.3%、87.0%、87.2%。接受根治性手术或新辅助化疗后行根治性手术+术后辅助放疗和(或)化疗的120例宫颈癌患者中,肌层浸润情况与局部晚期宫颈癌患者的病理类型可能有关(P﹤0.05)。接受新辅助化疗+根治性手术+术后辅助放疗和(或)化疗的62例患者中,鳞状细胞癌患者58例,包括CR患者14例,PR患者40例,SD患者4例;腺癌/腺鳞癌患者4例,包括CR患者1例,PR患者3例。鳞状细胞癌患者与腺癌/腺鳞癌患者对新辅助化疗的反应比较,差异无统计学意义(P﹥0.05)。结论局部晚期宫颈癌患者的近期预后较好,腺癌或腺鳞癌患者的预后较鳞状细胞癌患者差。对于病理类型为腺癌/腺鳞癌的局部晚期宫颈癌,建议在治疗方式上较鳞状细胞癌更激进,不建议保留卵巢功能,更倾向于以根治性手术为主的综合治疗,可望改善患者预后。     

PF方案联合放疗治疗中晚期宫颈癌的疗效观察

目的:探讨PF方案联合放疗治疗中晚期宫颈癌的疗效及不良反应.方法:回顾分析52例中晚期宫颈癌的随访资料,根据PF方案联合放射治疗组和单纯放疗组进行比较,观察有效率及不良反应.结果:PF方案联合放疗组在肿瘤的缩小、消失方面优于单纯放疗组,两者差异有显著意义(P＜0.05).PF方案联合放疗组有效率85%,单纯放疗组有效率68%,但化疗联合放疗组较单纯放疗组消化道Ⅰ-Ⅱ度不良反应发生率明显增加,骨髓抑制Ⅰ-Ⅱ度不良反应有增加.结论:PF方案联合放射治疗中晚期宫颈癌效果显著.     

A phase I-II study of weekly cisplatin and gemcitabine with concurrent radiotherapy in locally advanced cervical carcinoma.

BACKGROUND: The purpose of this study was to determine the maximum-tolerated dose (MTD) and the antitumor activity of gemcitabine when administered in combination with concurrent cisplatin and radiotherapy in locally advanced cervical carcinoma (LACC). PATIENTS AND METHODS: Patients with histologically confirmed LACC (International Federation of Gynecology and Obstetrics IIB-IVA), previously untreated, were eligible for entry in the study to receive radiotherapy and concomitant weekly chemotherapy with cisplatin 40 mg/m(2) and gemcitabine at increasing doses levels until the MTD was found. RESULTS: Thirty-six patients were included. Sixteen patients were entered at four dose levels. The MTD was 150 mg/m(2) and the recommended dose of gemcitabine for phase II was 125 mg/m(2). Twenty additional patients were entered at this level. Toxicity at the recommended dose was acceptable with grade 3/4 toxicity in <20% of patients. Thirty-five of thirty-six patients (97.3%) achieved an objective response, 32 (88.8%) a complete response (CR) three a (8.3%) partial response and one (2.7%) stable disease. At a median follow-up of 26 months, 28 of 36 patients (77.7%) are in sustained complete remission and seven of 36 (19.4%) have relapsed. The 3-year disease-free and overall survival rates are 67% and 72%, respectively. CONCLUSION: The association of cisplatin and gemcitabine with concurrent radiotherapy is active and well-tolerated in untreated LACC.     

Phase I/II study of S-1 combined with weekly docetaxel in patients with metastatic gastric carcinoma

We designed a phase I/II trial of S-1 combined with weekly docetaxel to determine the maximum tolerated dose (MTD) and recommended dose (RD) and to evaluate the efficacy and toxicity in metastatic gastric carcinoma (MGC). Patients with measurable disease received S-1 orally b.i.d. on days 1-14 and docetaxel intravenously on days 1 and 8 every 3 weeks. In phase I (n=30), each cohort received escalating doses of S-1 (30-45 mg m(-2) b.i.d.) and docetaxel (25-40 mg m(-2)); MTD was 45 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel and RD was 40 mg m(-2) b.i.d. S-1/35 mg m(-2) docetaxel. Dose-limiting toxicities included grade 3 elevated liver enzymes, gastric perforation, grade 3 diarrhoea/fatigue, febrile neutropenia with grade 3 anorexia/fatigue, and neutropenic infection with grade 3 stomatitis/anorexia. In phase II (n=52), the overall response rate was 66.7% (95% confidence interval (CI): 53.8-79.6%) and the median time to progression and overall survival were 6.5 months (95% CI: 4.9-8.1) and 13.7 months (95% CI: 9.9-17.5), respectively. The most common grade 3/4 toxicity was neutropenia (29.4%), and febrile neutropenia/neutropenic infection occurred in 19.6% of patients. Non-haematological toxicities were generally mild. There was one treatment-related death due to pneumonitis. S-1 combined with weekly docetaxel is active in MGC with moderate toxicities.     

Phase II trial of neoadjuvant chemotherapy with docetaxel,nedaplatin, and S1 for advanced esophageal squamous cell carcinoma

Although standard chemotherapy for esophageal cancer patients is fluorouracil and cisplatin, the prognosis is still unsatisfactory. A new therapeutic regimen combining docetaxel, cisplatin, and 5‐fluorouracil was recently developed to improve both local and distant tumor control. We developed a new regimen of docetaxel, nedaplatin, and S1 (DGS) and previously reported the recommended dose in a phase I dose‐escalation study. We then undertook a phase II study of DGS for advanced esophageal squamous cell carcinoma. Patients with clinical stage IB/II/III disease were eligible. Patients received two courses of chemotherapy: docetaxel 35 mg/m² with nedaplatin 40 mg/m² on day 8, 80 mg/m² S1 on days 1–14, and 2 weeks off. After completion of chemotherapy, patients underwent esophagectomy. The primary endpoint was the completion rate of protocol treatment (completion of two courses of preoperative chemotherapy and R0 surgery [no residual tumor]). We enrolled 32 patients. The completion rate of protocol treatment was 96.9%. During chemotherapy, the most common grade 3 or 4 toxicity was neutropenia (25.0%). No treatment‐related deaths were observed, and the incidence of operative morbidity was tolerable. The overall response rate after chemotherapy was 83.3%. This DGS regimen was well tolerated and highly active. This trial is registered with the University Hospital Medical Information Network (UMIN ID: 000014626).     

Phase II trial of combined regional hyperthermia and gemcitabine for locally advanced or metastatic pancreatic cancer

Purpose: Despite advances in cancer therapy, treating pancreatic cancer remains one of the major challenges in the field of medical oncology. We conducted this phase II study to evaluate the efficacy and safety of regional hyperthermia combined with gemcitabine for the treatment of unresectable advanced pancreatic cancer.

Methods: Eligibility criteria included histologically proven, locally advanced or metastatic pancreatic cancer. Gemcitabine was administered intravenously at a dose of 1000?mg/m² on days 1, 8, and 15 every 4 weeks. Regional hyperthermia was performed once weekly, 1 day preceding or following gemcitabine administration. The primary end point was the 1-year survival rate. Secondary objectives were determination of tumour response and safety.

Results: We enrolled 18 patients with advanced pancreatic cancer between November 2008 and May 2010. The major grade 3–4 adverse events were neutropenia and anaemia; however, there were no episodes of infection. The objective response rate (ORR) and disease control rate (ORR + stable disease) were 11.1% and 61.1%, respectively. Median overall survival (OS) was 8 months, and the 1-year survival rate was 33.3%. Median OS of patients with locally advanced pancreatic cancer was 17.7 months.

Conclusions: Regional hyperthermia combined with gemcitabine is well tolerated and active in patients with locally advanced pancreatic cancer.