西妥昔单抗联合同期顺铂化疗加调强放疗局部晚期鼻咽癌的安全性研究

目的 通过开放性、多中心临床研究探讨西妥昔单抗联合同期顺铂化疗加调强放疗(IMRT)局部晚期鼻咽癌的安全性。方法 100例Ⅲ~Ⅳ_b期初治鼻咽癌患者入组,IMRT处方剂量鼻咽原发灶 66.0~75.9 Gy,颈部阳性淋巴结 60~70 Gy;同期顺铂化疗剂量80 mg/m²(每3周);西妥昔单抗首剂400 mg/m²(放疗前,第1周),其后250 mg/m²(每周)。按不良反应常见术语标准3.0版评价这一联合方案的不良反应。结果 全组患者治疗依从性良好。鼻咽原发灶大体肿瘤体积实际中位剂量为69.96 Gy,颈部阳性淋巴结大体肿瘤体积为68 Gy。同期顺铂中位剂量为133 mg/疗程;西妥昔单抗中位起始剂量为690 mg,中位维持剂量为410 mg/周。治疗期间主要不良反应为痤疮样皮疹、口腔黏膜炎以及放射性皮炎,其中1级放射性皮炎及>2级口腔黏膜炎分别占58%、90%,2%患者出现4级口腔黏膜炎。骨髓抑制较为轻微,仅分别有8%、4%和5%患者出现>2级中性粒细胞减少、血小板降低和贫血。结论 西妥昔单抗联合同期顺铂化疗加调强放疗局部晚期鼻咽癌的患者依从性好,不良反应可耐受。     

食管鳞癌西妥昔单抗联合同期放化疗疗效与Kras、EGFR关系研究

西妥昔单抗是人鼠嵌合型的IgG1 单克隆抗体,在大肠癌、头颈部鳞癌、NSCLC等应用中取得一定疗效[1]. 笔者观察了2008年12月至2010年5月本院应用西妥昔单抗联合同期放化疗治疗食管鳞癌19例患者疗效,并检测了 Kras、EGFR基因,为西妥昔单抗在食管癌个体化治疗提供依据.     

尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌初步临床研究

目的 初步观察尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌的治疗结果。方法 共23例Ⅱ-Ⅲ期食管鳞癌患者入组,尼妥珠单抗 200 mg,第1-5周应用,1 次/周。DDP 20 mg/m²,PTX 45 mg/m²,第2-5周应用,1 次/周。放疗第2-5周进行,2 Gy/次,5 次/周,共40 Gy。新辅助治疗结束后4周行手术切除。结果 全组23例患者均完成术前放化疗及尼妥珠单抗治疗,22例接受手术切除。术前治疗的临床有效率为96%,毒副反应主要为胃肠道反应、骨髓抑制及黏膜炎,大多为1-2级。手术R0切除率为100%,病理完全缓解率为41%。术后肺部感染、吻合口瘘、声嘶、心律失常的发生率分别为14%、9%、4%、4%,无围手术期死亡病例发生。全组1、3、5年生存率分别为86%、52%、52%,中位生存时间为28.9个月。术后淋巴结阴性(15例)和淋巴结阳性(7例)组1、3、5年生存率分别为100%、62%、62%和57%、29%、29%(P=0.033),中位生存时间分别为42.6个月和14.2个月。结论 尼妥珠单抗联合术前同期放化疗治疗局部进展期食管鳞癌安全有效,术后淋巴结阴性患者的长期生存率显著提高。     

西妥昔单抗联合放化疗治疗进展期鼻咽癌的临床研究

背景与目的:最新研究报道,西妥昔单克隆抗体(单抗)联合放疗较单纯放疗降低了局部晚期头颈部鳞癌患者的死亡率.为探讨西妥昔单抗在鼻咽癌中的作用,本研究初步观察西妥昔单抗联合放化疗治疗晚期鼻咽癌患者的不良反应及近期疗效.方法:取我院收治的晚期鼻咽癌患者12例.西妥昔单抗与放疗或化疗或同步放化疗同时使用,用法:西妥昔单抗第1周初始剂量为400 mg/m2,以后每周维持剂量为250 mg/m2,共8周.初诊或局部复发鼻咽癌患者均采用调强放疗技术,给予鼻咽部GTV处方剂量D6 975 cGy/31次,6.2周完成.对鼻咽癌转移灶姑息放疗,予转移灶外照射D3 000 cGy/10次,2周完成.结果:2例放疗后多脏器转移患者因病情进展而停用西妥昔单抗,2例初诊鼻咽癌因西妥昔单抗引起的Ⅲ级舌黏膜反应而停药,2例因Ⅲ级皮疹延迟用药1周,余6例顺利完成治疗计划.西妥昔单抗主要不良反应为皮疹、甲沟炎、黏膜反应、疲乏等.10例鼻咽部调强放疗同时使用西妥昔单抗的患者中,5例出现Ⅲ级口咽黏膜反应,其中4例同时出现Ⅲ级舌黏膜反应.全组完全缓解7例(58.3%),部分缓解3例(25.0%),疾病稳定2例(16.7%).中位随访14个月,2例死亡,10例存活且肿瘤无进展.结论:西妥昔单抗联合放化疗治疗晚期鼻咽癌的安全有效,但联合鼻咽部调强放疗时少部分患者出现较重的舌黏膜反应,影响治疗计划的顺利进行,需进行进一步临床试验研究.     

西妥昔单抗联合放化疗治疗中晚期恶性肿瘤

背景与目的：西妥昔单抗是一种特异性阻断EGFR的单克隆抗体.本研究观察西妥昔单抗联合放化疗治疗晚期头颈部和结直肠癌的有效性和安全性.方法：全组6例患者,均经病理证实,西妥昔单抗联合伊立替康、卡培他滨方案治疗晚期结直肠癌;联合多西他赛、放疗治疗晚期头颈鳞癌.西妥昔单抗首剂400 mg/m2,然后250 mg/m2每周1次维持.结果：6例患者治疗后取得PR 2例,SD 3例,PD 1例,中位TTP 18.5周.其中3例晚期头颈鳞癌患者,PR 1例,SD 2例;3例晚期中分化结直肠癌患者,PR 1例,SD 1例,PD 1例.主要的毒性反应是痤疮样皮疹和腹泻.结论：西妥昔单抗联合多西他赛＋放疗治疗晚期头颈鳞癌,西妥昔单抗联合伊立替康、卡培他滨治疗晚期结直肠癌患者有效.除皮疹之外,毒副反应较单用化疗、放疗无明显增加.     

食管鳞癌新辅助放化疗后复发风险分层分析

目的 探讨胸段食管鳞癌新辅助放化疗联合手术治疗后的复发风险模式,并分析术后病理分期与复发风险之间的关系。方法 回顾分析2002-2015年郑州大学附属肿瘤医院及中山大学肿瘤防治中心收治的174例局部晚期胸段食管鳞癌患者的病历资料。全组患者均采用术前同期放化疗联合手术治疗,化疗采用以铂类为基础的化疗方案,放疗剂量为40.0~50.4 Gy,常规分割。采用Kaplan-Meier法计算生存率,Logrank检验差异,Cox模型多因素分析。结果 中位随访时间为53.9个月,新辅助放化疗后病理完全缓解率为44.8%,其中59例(33.9%)患者复发。术后病理分期为0/Ⅰ、Ⅱ、Ⅲ期患者复发率分别为22.2%、38.7%、68.2%(P=0.000),疗后5年无复发生存率分别为74.7%、61.4%、20.9%(P=0.000)。20.5%的0/Ⅰ期或Ⅱ期患者的复发时间在术后3年以上,而Ⅲ期患者的复发时间均在2年以内。多因素分析结果显示年龄、临床分期、化疗方案、放化疗相关病理反应是影响无复发生存的因素(P=0.027、0.047、0.010、0.005)。结论 胸段食管鳞癌新辅助放化疗后的病理分期与复发风险密切相关,临床医生可根据不同的病理分期制定个体化的随访监测策略。     

局部进展期食管鳞癌术前同期放化疗的Ⅱ期临床研究

目的 评价术前同期放化疗联合手术治疗局部进展期食管鳞癌的长期OS率和术后并发症发生率。方法 2007—2013年间共46例食管鳞癌患者入组,化疗方案为顺铂75 mg/m²分3 d静脉滴注;氟尿嘧啶500 mg/m²第1~5天静脉滴注,共1个周期。同期3DCRT 常规分割40 Gy。放疗结束后4周行手术切除。结果 全组46例患者均完成术前放化疗,44例接受手术切除。术前放化疗的临床有效率为94%,不良反应轻微。R₀切除率为96%,pCR率为30%。术后肺部感染、吻合口瘘、声嘶、颈部切口感染、围手术期死亡率分别为14%、7%、5%、2%、2%。全组1、3、5年样本数分别为38、29、27例,OS率分别为84%、54%、45%。pCR组与非pCR组1、3、5年OS率分别为89%、49%、49%和82%、60%、44%(P=0.681)。37例放化疗后降期的1、3、5年OS率分别为94%、68%、57%,稳定+上升的7例分别为43%、0、0(P=0.000)。结论 术前同期放化疗能提高局部进展期食管鳞癌术后疗效,且不增加术后并发症,放化疗后降期患者的长期OS显著提高,但还需大样本观察证实。     

西妥昔单抗联合化疗治疗转移性结直肠癌的临床观察

目的:观察西妥昔单抗联合FOLFIRI或FOLFOX方案治疗转移性结直肠癌的近期疗效及毒副反应.方法: 2006年11月至2009年1月,我院收治的12例转移性结直肠癌患者,接受西妥昔单抗联合化疗治疗,西妥昔单抗首次给予负荷剂量400mg/m2 ,而后每周维持量为250mg/m2.有7例联合FOLFIRI方案, 4例联合FOLFOX方案,1例联合奥沙利铂+放疗.分别按照RECIST标准和NCI-CTC 3.0评价疗效和毒性.结果:全组12例均可评价疗效, PR 7例,SD 3例,PD 2例,总有效率58.3%,疾病控制率83.3%.疾病进展时间(TTP)1.5个月～15个月.主要毒副反应为痤疮样皮疹和腹泻.结论:西妥昔单抗联合FOLFIRI或FOLFOX方案治疗转移性结直肠癌安全有效,除痤疮样皮疹外,毒副作用无明显增加.     

西妥昔单抗联合mIFL治疗15例奥沙利铂耐药性转移性结直肠癌的疗效

目的：观察西妥昔单抗联合mIFL治疗15例奥沙利铂耐药性转移性结直肠癌的疗效及安全性。方法：15例经病理或细胞学诊断的奥沙利铂治疗无效或失败的晚期结直肠癌患者,西妥昔单抗首剂400mg/m^2,第1周,随后每周1次250mg/m^2,3周为一疗程,西妥昔单抗先于化疗药物使用,均联合mIFL方案治疗。结果：CR2例,PR3例,SD6例,PD4例,RR为33.33%,DCR为73.33%。TTP为3～48周,中位TTP17周。最常见的毒性反应为痤疮样皮疹、腹泻、恶心、呕吐。结论：西妥昔单抗联合mIFL治疗奥沙利铂耐药性转移性结直肠癌具有较高的总体疾病控制率,且耐受性好,不良反应多为轻中度,可作为一线奥沙利铂治疗失败转移性结直肠癌的推荐方案。     

西妥昔单抗联合化疗治疗晚期结直肠癌的近期疗效观察

目的:观察西妥昔单抗联合化疗治疗晚期结直肠癌的近期疗效和安全性。方法:全组29例患者均经病理组织学证实,治疗方案为西妥昔单抗联合FOLFOX4或FOLFIRI方案治疗,西妥昔单抗首剂400mg/m2,然后250mg/m2每周1次维持。3-4周期后评价疗效和不良反应。结果:29例患者治疗6-8周后取得CR 1例,PR 13例,SD 10例,PD 5例,有效率40.6%,疾病控制率69.6%。主要的不良反应是痤疮样皮疹,中性粒细胞降低和腹泻。结论:西妥昔单抗联合化疗对耐药性晚期结直肠癌患者有效。除皮疹外,不良反应较单用化疗无明显增加。     

Cetuximab with concurrent chemoradiation for esophagogastric cancer: assessment of toxicity

PURPOSE: To determine the feasibility and toxicity of the addition of cetuximab with paclitaxel, carboplatin, and radiation for patients with esophagogastric cancer on a Phase II study. METHODS AND MATERIALS: Patients with locoregional esophageal and proximal gastric cancer without distant organ metastases were eligible. All patients received cetuximab, paclitaxel, and carboplatin weekly for 6 weeks with 50.4 Gy radiation. RESULTS: Sixty patients were enrolled, 57 with esophageal cancer and 3 with gastric cancer. Forty-eight had adenocarcinoma and 12 had squamous cell cancer. Fourteen of 60 patients (23%) had Grade 3 dermatologic toxicity consisting of a painful, pruritic acneiform rash on the face outside of the radiation field. The rates of Grades 3 and 4 esophagitis were 12% and 3%, respectively. Three patients had Grade 3/4 cetuximab hypersensitivity reactions and were not assessable for response. Forty of 57 patients (70%) had a complete clinical response after chemoradiation. CONCLUSION: Cetuximab can be safely administered with chemoradiation for esophageal cancer. Dermatologic toxicity and hypersensitivity reactions were associated with the addition of cetuximab. There was no increase in esophagitis or other radiation-enhanced toxicity.     

周剂量紫杉醇联合顺铂同步调强放疗治疗局部晚期食管癌的疗效分析

目的 探讨周剂量紫杉醇联合顺铂同步调强放疗（IMRT）治疗局部晚期食管癌的疗效及安全性。方法 2010年1月至2015年4月36例初诊局部晚期食管癌患者接受周剂量紫杉醇联合顺铂同步IMRT治疗,具体方案：紫杉醇50 mg／m2静滴,顺铂25 mg／m2静滴,均为每周1次;IMRT：60 Gy／30次,每周5次。采用RECIST 1.1版标准评价客观疗效,采用国立癌症研究所毒性判定标准（NCI CTC）4.0评价化疗毒性反应,同时随访其生存情况。结果 29例（80.6％）患者完成了治疗计划,36例患者均可评价疗效,其中17例获CR,13例PR,4例SD,2例PD,有效率和疾病控制率分别为83.3％和94.4％;中位无进展生存期为13.0个月,中位总生存期为250个月,1、2、3年生存率分别为77.8％、639％和33.3％。3级以上毒性反应包括白细胞减少（25.0％）、粒缺性发热（11.1％）、厌食（27.8％）和食管炎（25.0％）。结论 周剂量紫杉醇联合顺铂同步IMRT治疗局部晚期食管癌的疗效确切,不良反应可以耐受,是一种有前景的治疗方案。     

Cetuximab in combination with chemoradiotherapy in Chinese patients with non-resectable,locally advanced esophageal squamous cell carcinoma: A prospective,multicenter phase II trail

Background and purpose

This multicenter phase II trial investigated cetuximab combined with chemoradiotherapy in patients with esophageal squamous cell carcinoma (ESCC).

Material and methods

Eligible patients with non-resectable, locally-advanced ESCC received cetuximab 400 mg/m² loading dose on day 1; and on day 1 of the 2nd–7th weeks: cetuximab 250 mg/m², paclitaxel 45 mg/m², and cisplatin 20 mg/m², concurrent with 59.4 Gy/33 fractions of radiation therapy. Primary endpoint was clinical response rate. Secondary endpoints included overall survival (OS), progression-free survival (PFS), safety, and KRAS status.

Results

Of 55 patients enrolled, 45 completed therapy. Forty-four patients had a clinical response: 29 complete response and 15 partial response. One-year PFS and OS of 45 evaluable patients were 84.23% and 93.33%, respectively, and 2-year PFS and OS were 74.87% and 80.00%, respectively. Non-hematologic adverse events were generally grade 1 or 2; primarily rash (92.7%), mucositis (45.5%), fatigue (41.8%), and nausea (38.2%). Grade 3 hematologic adverse events included neutropenia (32.7%) and anemia (1.8%). No KRAS mutations were identified in 50 evaluated samples.

Conclusions

Cetuximab can be safely administered with chemoradiotherapy to patients with locally-advanced ESCC and may improve clinical response rate.     

Promising outcomes of definitive chemoradiation and cetuximab for patients with esophageal squamous cell carcinoma

This study investigated cetuximab added to definitive concurrent chemoradiation for esophageal squamous cell carcinoma (ESCC). Previously untreated patients with stage II–IVa ESCC received cetuximab (400 mg/m² per week in week 1, then 250 mg/m² per week during weeks 2–8), paclitaxel (45 mg/m² per week) and cisplatin (20 mg/m² per week) in weeks 2–8 with 59.4 Gy radiotherapy. Epidermal growth factor receptor (EGFR) status in tumor specimens was assessed. Thirty‐one patients were enrolled and evaluated for toxicity. Of the 29 patients assessable for a response, 20 (69.0%) had a clinical complete response (CR). Over a median follow up of 23.6 months, disease progression was observed in seven patients. The 1‐ and 2‐year progression‐free survival (PFS) rates were 85.5% and 75.1%, respectively. The PFS was shorter for patients with lymphatic metastatic disease than for those with locally confined tumor; the 1‐year PFS rates were 78.7% and 92.3%, respectively (P = 0.038). Sixteen (55.2%) patients were immunohistochemically positive for EGFR. The patients with EGFR‐expressing tumor had a CR rate of 75.0% compared with 61.5% in those with negative EGFR expression (P = 0.024). The PFS for patients with EGFR‐expressing tumor was longer compared with the PFS of patients with negative EGFR (P = 0.133). The patients with prominent cetuximab‐induced rash (≥grade 2) had a better CR rate and PFS than those with no or grade 1 rash (P < 0.05). The rates of grades 3/4 esophagitis, hematological and dermatological toxicities were 9.7%, 29.0% and 16.1%, respectively. The regimen of definitive chemoradiation plus cetuximab achieved good clinical response and has an acceptable safety profile in Chinese ESCC patients.     

A phase II trial of modified weekly irinotecan and cisplatin for chemotherapy-naïve patients with metastatic or recurrent squamous cell carcinoma of the esophagus

Purpose

This phase II study assessed the efficacy and toxicity profile of a modified weekly irinotecan and cisplatin for chemotherapy-naïve patients with metastatic/recurrent esophageal squamous cell carcinoma (SQCC).

Methods

The eligibility criteria included histologically confirmed esophageal SQCC, no prior chemotherapy, adequate organ functions and written informed consent. Patients received irinotecan 65 mg/m² plus cisplatin 30 mg/m² on days 1 and 8, every 3 weeks.

Results

Thirty-two patients were assessed for response and toxicity. Ten patients achieved a partial response (31.3%; 95% CI, 16.0–50.0%). With a median follow-up of 19.0 months, median progression-free and overall survival was 4.4 and 9.6 months, respectively, with a 1-year survival rate of 27.4%. Grade (G) 3/4 neutropenia was observed in 50.0% of the patients, which was the most common cause of dose reduction or therapy delay. G3 non-hematologic toxicity included seven (21.9%) asthenias, four (12.5%) diarrheas, and one (3.1%) nausea/vomiting, but no G4 non-hematologic toxicity was observed.

Conclusions

This modified weekly irinotecan and cisplatin failed to ameliorate hematologic toxicity and to improve efficacy. However, easy administration and favorable non-hematologic toxicity as well as modest anti-tumor activity against metastatic or recurrent esophageal SQCC can make this regimen a potential treatment option, given the complexity of administration and toxicity of conventional infusional 5-FU and cisplatin.     

A phase II study of concurrent cetuximab-cisplatin and intensity-modulated radiotherapy in locoregionally advanced nasopharyngeal carcinoma

BackgroundBased on our previous work on the clinical activity of cetuximab in recurrent nasopharyngeal carcinoma (NPC), we evaluated the feasibility of adding cetuximab to concurrent cisplatin and intensity-modulated radiotherapy (IMRT) in locoregionally advanced NPC.Patients and methodsPatients with American Joint Committee on Cancer stage III–IVB NPC were given an initial dose of cetuximab (400 mg/m²) 7–10 days before receiving concurrent IMRT, weekly cisplatin (30 mg/m²/week) and cetuximab (250 mg/m²/week).ResultsThirty patients (median age of 45 years) with stage III (67%), IVA (30%) and IVB (3%) nonkeratinizing NPC were enrolled. Grade 3–4 oropharyngeal mucositis occurred in 26 (87%) patients and 10 (33%) patients required short-term nasogastric feeding. Grade 3 radiotherapy-related dermatitis occurred in six patients (20%) and three patients (10%) had grade 3 cetuximab-related acneiform rash. These grade 3–4 skin and mucosal toxic effects were manageable and reversible. At a median follow-up of 31.8 months [95% confidence interval (CI) 26.2–32.1 months], the 2-year progression-free survival was 86.5% (95% CI 74.3% to 98.8%).ConclusionsConcurrent administration of cetuximab, weekly cisplatin and IMRT is a feasible strategy against locoregionally advanced NPC. Preliminary survival data compare favorably with historic data and further follow-up is warranted.     

Weekly cisplatin paclitaxel and continuous infusion fluorouracil in patients with recurrent and/or metastatic head and neck squamous cell carcinoma: a phase II study

Background Cisplatin, paclitaxel and 5-fluorouracil (5-FU) have demonstrated significant activity in patients with advanced squamous head and neck cancer (HNSCC) despite relevant toxicity. A weekly administration of cisplatin and paclitaxel with continuous infusion of 5-FU could offer a better toxicity profile without affecting dose intensity or treatment outcome. We evaluated the toxicity and the activity of weekly cisplatin/paclitaxel with continuous infusion 5-FU in patients with recurrent and/or metastatic HNSCC.Methods A total of 44 patients were studied. Treatment consisted of two 6-week cycles with weekly cisplatin 20 mg/m² and paclitaxel 60 mg/m² and daily continuous infusion 5-FU 200 mg/m² from day 1 to 42. Patients were evaluated for toxicity and response.Results 40 out of 44 patients were evaluable for response. After two cycles we observed seven complete responses (16%) and 12 partial responses (27%), with a 43% (95% CI 28–58%) overall response rate. Stable disease was seen in 13 patients (29%) and progressive disease in 12 patients (27%). Toxicity was mild in treated patients: we observed less than 10% of grade 3/4 hematological and gastroenteric toxicity.Conclusions A weekly schedule of cisplatin and paclitaxel associated with continuous infusion 5-FU showed low toxicity in the treatment of advanced HNSCC while significant activity was conserved.     

紫杉醇联合氟尿嘧啶同期放疗治疗初治局部晚期食管鳞癌患者的Ⅱ期临床研究

背景与目的：同期放化疗是局部晚期食管癌非手术治疗的标准方案。该研究评价放疗同期紫杉醇联合氟尿嘧啶每周方案化疗对初治局部晚期食管鳞癌患者的疗效及安全性。方法：入组条件为初治局部晚期食管鳞癌患者(T2-4N0-1M0-1a),卡氏评分(KPS)大于等于70,无放化疗禁忌证。治疗方法：调强放疗,61.2 Gy/34次(每天1次1.8 Gy),放疗第1天开始：紫杉醇50 mg/m2,第1天,联合氟尿嘧啶300 mg/m2连续静脉输注96 h,每周1次,共5次。同期放化疗结束后予以2个疗程巩固化疗：紫杉醇175 mg/m2,第1天,联合氟尿嘧啶1800 mg/m2连续静脉输注72 h,每28 d 1次,共2次。研究患者的5年生存率及不良反应。结果：2008年11月—2010年9月共入组50例患者。其中男性38例,女性12例;中位年龄58岁(26~75岁);化疗完成率为72%、放疗完成率为98%;1、2、3和5年生存率分别为75%、56%、42%和28%;血液学毒性中,3度粒细胞缺乏发生率为16%,未出现1例4度粒细胞缺乏及2度以上血小板下降及血红蛋白下降。非血液学毒性中,2度手足麻木、肌肉酸痛、恶心、呕吐及乏力的发生率分别为8%、4%、4%、2%和6%,2度及以上急性放射性食管炎、放射性肺炎及放射性皮肤反应发生率为32%、44%和14%。无一例患者发生4度及以上不良反应。结论：紫杉醇联合氟尿嘧啶每周方案是一种有效的治疗局部晚期食管癌根治性放疗同期化疗方案,该方案的不良反应较轻,安全可靠。     

Trastuzumab, paclitaxel, cisplatin, and radiation for adenocarcinoma of the esophagus: a phase I study

Purpose: To conduct a phase I study incorporating trastuzumab with paclitaxel, cisplatin, and radiation for adenocarcinoma of the esophagus. Methods and Materials: Patients with adenocarcinoma of the esophagus without distant organ metastases were eligible. All patients received cisplatin 25 mg/m² and paclitaxel 50 mg/m² weekly for 6 weeks with radiation 50.4 Gy. HER-2/neu-positive patients (2 + /3 + by immunohistochemistry) received weekly trastuzumab at dose levels of 1, 1.5, or 2 mg/kg weekly for 5 weeks after an initial bolus of 2, 3, or 4 mg/kg, respectively. HER-2/neu-negative patients received the same chemoradiation without trastuzumab as a control for toxicity. Dose-limiting toxicities were defined as grade 3 esophageal, cardiac, or pulmonary toxicity. Results: Twelve of 36 screened patients (33%) overexpressed HER-2/neu by immunohistochemistry (seven 3 + and five 2 + ). Eight of 12 patients with HER-2/neu overexpression by IHC had an increase in the number of HER-2/neu genes, six from amplification of the HER-2/neu gene and two were hypderdiploid for chromosome 17. Thirty patients were enrolled (12 HER-2/neu-positive and 18 HER-2/neu-negative controls). No increase in toxicity was seen with the addition of trastuzumab. One of 12 patients in the trastuzumab arm and 8 of 17 in the control arm had grade 3 esophagitis (p ≤ .026). Mean left ventricular ejection fraction for the trastuzumab group was 57% before treatment and 56% after treatment. Conclusion: HER-2/neu is overexpressed in approximately one-third of esophageal adenocarcinomas. Trastuzumab can be added at full dose to cisplatin, paclitaxel, and radiation. Future studies of trastuzumab in esophageal adenocarcinoma are indicated.