Combination chemotherapy with epirubicin, docetaxel and cisplatin (EDP) in metastatic or recurrent, unresectable gastric cancer

Based on single agent activities and the additive or synergistic effects of three individual drugs in gastric cancer, we performed a phase II study of a new regimen combining epirubicin, docetaxel and cisplatin (EDP) for unresectable gastric cancer. The patients with histologically confirmed metastatic or recurrent, unresectable gastric cancer and no history of palliative chemotherapy were eligible for this trial. In total, 40 mg m(-2) epirubicin (reduced to 30 mg m(-2) due to high incidence of febrile neutropaenia; 75%) intravenously (i.v.) over 30 min, followed by 60 mg m(-2) docetaxel i.v. over 1 h, then 75 mg m(-2) cisplatin i.v. over 1 h was administered every 3 weeks. Between January 2002 and February 2003, 30 patients (epirubicin 40 mg m(-2), eight; 30 mg m(-2), 22) were enrolled. The median age was 52 years (range, 33-68). The patients received a median of four cycles (range, 1-8). One patient (3%) achieved a complete response, 13 (43%) showed partial responses, 13 (43%) had stable diseases and three (10%) progressed. The overall response rate was 47% (95% CI, 28-66%), and the median duration of response was 5.0 months (95% CI, 3.0-7.0). The median time to progression was 4.1 months (95% CI, 2.4-5.9), and the median overall survival was 11.0 months (95% CI, 9.5-12.4). Grade 4 neutropaenia were observed in 41%, and febrile neutropaenia in 32%, out of the patients receiving 30 mg m(-2) of epirubicin. Grade 3 nonhaematological toxicities included nausea, vomiting, anorexia and peripheral neuropathy. In conclusion, EDP is active in gastric cancer, with a manageable and predictable toxicity profile.     

多西他赛联合顺铂治疗转移性乳腺癌的临床观察

目的:观察多西他赛联合顺铂治疗转移性乳腺癌的疗效及不良反应.方法:选择我科2005年6月-2008年6月收治的31例转移性乳腺癌患者,给予多西他赛联合顺铂(TP方案)化疗,21d为1个周期,2周期后评价疗效.有效者给予6周期的化疗.结果:31例患者有效率51.6%,其中CR2例,PR14例.中位疾病进展时间8.6个月,中位生存时间19.2个月.主要不良反应为骨髓抑制及消化道反应和脱发.其中Ⅲ度以上白细胞减少的发生率26.0%.结论:多西他赛联合顺铂治疗转移性乳腺癌的疗效确切,不良反应可以耐受.     

多西他赛联合顺铂治疗转移性乳腺癌的临床观察

目的：观察多西他赛联合顺铂治疗转移性乳腺癌的疗效及不良反应。方法：选择我科2005年6月-2008年6月收治的31例转移性乳腺癌患者,给予多西他赛联合顺铂（TP方案）化疗,21d为1个周期,2周期后评价疗效。有效者给予6周期的化疗。结果：31例患者有效率51．6％,其中012例,PR14例。中位疾病进展时间8．6个月,中位生存时间19．2个月。主要不良反应为骨髓抑制及消化道反应和脱发。其中Ⅲ度以上白细胞减少的发生率26．0％。结论：多西他赛联合顺铂治疗转移性乳腺癌的疗效确切,不良反应可以耐受。     

Phase I study of S-1, docetaxel and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer

The aim of this dose escalation study was to determine the maximum-tolerated dose (MTD), dose-limiting toxicities (DLTs) and preliminary efficacy of docetaxel, S-1 and cisplatin combination chemotherapy in patients with unresectable metastatic gastric cancer. Seventeen patients received oral S-1 (40 mg m(-2) bid) on days 1-14, intravenous cisplatin (60 mg m(-2)) and docetaxel (60, 70 or 80 mg m(-2) depending on DLT) on day 8 every 3 weeks. The MTD of this combination was presumed to be docetaxel 70 mg m(-2). At this dose level, 40% of the patients (two of five) developed grade 4 neutropenia and 20% (one of five) exhibited grade 3 nausea during the first course. Therefore, the recommended dose of docetaxel was defined as 60 mg m(-2). The DLT was neutropenia. The response rate (RR) was 88.2% (15 of 17), consisting of one complete response and 14 partial responses. There were two stable diseases but no progressive disease. Of these 15 responders, four (23.5%) with high VEGF expression showed rapid tumour regression and achieved downstaging, leading to subsequent curative gastrectomy. Three of these have been disease free for about 3 years, suggesting a complete cure. In conclusion, this regimen was tolerable and showed a quite high RR, with an appreciable downstaging rate in metastatic gastric cancer.     

Irinotecan, docetaxel and oxaliplatin combination in metastatic gastric or gastroesophageal junction adenocarcinoma

This phase II study was designed to evaluate the activity and safety of a combination of irinotecan, docetaxel and oxaliplatin in metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Forty patients with measurable distant metastasis received irinotecan 150 mg m(-2) and docetaxel 60 mg m(-2) on day 1, and oxaliplatin 85 mg m(-2) on day 2. Cycles were repeated every 3 weeks. The primary end point was to demonstrate a 50% improvement in time-to-progression (TTP) over historical controls. All patients were evaluable. Median TTP was 6.5 months (95% confidence interval (CI) 5.6-7.4), the overall response rate was 50% (95% CI 35-65%) and the median overall survival was 11.5 months (95% CI 8.7-14.3). Grade 3/4 neutropaenia occurred in 47.5% of patients. There were four episodes of febrile neutropaenia in three patients. Other non-haematological grade 3 toxicities included diarrhoea in four patients (10%), vomiting in three patients (7.5%) and mucositis in two patients (5%). The irinotecan, docetaxel and oxaliplatin combination chemotherapy is an active and well-tolerated novel regimen for treating metastatic gastric or GEJ adenocarcinoma and deserves further evaluation in randomised trials and in combination with molecular targeting agents.     

Combination chemotherapy of docetaxel, ifosfamide and cisplatin (DIP) in patients with metastatic urothelial cancer: a preliminary report

OBJECTIVE: The aim of this study was to evaluate the efficacy and toxicity of a new combination chemotherapy of docetaxel, ifosfamide and cisplatin (DIP) in the treatment of metastatic urothelial cancer. METHODS: Fourteen patients (nine male and five female; aged 59-82 years) with metastatic urothelial carcinoma, including five patients who have a history of methotrexate, vinblastine, doxorubicin and cisplatin (MVAC) chemotherapies, received the combination of docetaxel 60 mg/m(2) on day 1, and ifosfamide 1.0 g/m(2) and cisplatin 20 mg/m(2) on days 2-6 and repeated every 21 days, to a maximum of six cycles. Eligibility criteria included performance status (World Health Organization) 0-3; normal bone marrow and liver function; and no symptomatic peripheral neuropathy. RESULTS: Ten of the 14 patients (72%) demonstrated a partial response (PR), with durations of response ranging from 3 to 12 months [median 6.5 months; 95% confidence interval (CI), 4.1-8.7 months]. The response rate of the five patients with MVAC-refractory cancer was 80% with median duration of response 5.5 months, comparable with that of the cases without previous MVAC therapies. Grade 3-4 granulocytopenia occurred in 10 cases (71%), resulting in three episodes (21%) of febrile neutropenia. Grade 3 thrombocytopenia was observed in five cases (36%). No toxic death was observed. Grade 2 peripheral neuropathy was identified in one case. CONCLUSIONS: This pilot study demonstrated that DIP is an effective regimen for the treatment of metastatic urothelial cancer, and warrants further investigation.     

Irinotecan plus cisplatin combination against metastatic gastric cancer

In this phase II study, we aimed to detect efficacy and toxicity of the combination of CPT-11 and cisplatin administered to patients with metastatic gastric carcinoma. On d 1, CPT-11, 100 mg/m², was administered by intravenous infusion for 90 min, followed by a 2 h infusion of cisplatin, at 70 mg/m² every 3 wk. Forty-one patients were enrolled into the study. Twenty-eight patients were chemotherapy naive. The total number of chemotherapy cycles administered was 165, and the median number of cycles received was 4 (range, 1–8 cycles). The median follow-up time was 12 mo (range, 4–34 mo). There were 4 complete responses (9.7%) and 14 partial responses (34.2%), which result in a response rate of 43.9% (18 of 41 patients). The median time to progression was 8.0 ± 0.8 mo with 56% and 13% of patients progression free at 6 and 12 mo, respectively. The median overall survival was 9.0 ± 1.1 mo, with 68 % and 32% of patients alive at 6 and 12 mo, respectively. Grade 3–4 nausea and vomiting was observed in five patients (12%) and grade 3–4 neutropenia in five patients (12%). Grade 3 infection was observed in only one patient (2%). Grade 2 transient liver dysfunction related to chemotherapy was observed in one patient (2%). Chemotherapy was stopped due to nephrotoxicity in one patient (2%). There was no treatment-related death. In conclusion, administration of CPT-11 and cisplatin in this particular dose every 3 wk is effective and well-tolerated treatment regimen.     

改良DCF方案治疗27例晚期胃癌的疗效及毒副作用观察

Objective  

The aim of this study was to evaluate the efficacy and toxicity of modified docetaxel, cisplatin and calcium folinate (CF)/5-fluorouracil (mDCF) combination therapy for 27 patients with recurrent or metastatic gastric adenocarcinoma (R/MGC).     

DCF方案治疗晚期胃癌患者的临床分析

目的:观察DCF方案治疗局部进展期或转移性胃癌的疗效和不良反应。方法:自2007年10月至2009年8月,42例晚期胃癌患者采用DCF,DXT(多西紫杉醇)75mg/m2,静脉滴注,第1天;DDP(顺铂)25 mg/m2,第1-3天;CF(亚叶酸钙)200mg/d,静脉滴注2小时,第1-5天;5-FU(氟尿嘧啶)500mg/m2,第1-5天,静脉滴注5-6小时,3周为1周期,方案治疗,按WHO标准评价近期疗效和不良反应,随访疾病进展时间(TTP)和中位生存期(MST)。结果:全组42例均可评价疗效,其中CR 3例,PR 19例,SD 11例,PD 9例。有效率(RR)为54.7%,中位TTP为5.5个月,中位MST为10个月。不良反应主要是骨髓抑制及胃肠道反应,其次为口腔黏膜炎、腹泻及周围神经毒性。结论:DCF方案治疗晚期胃癌的疗效较好,不良反应可以耐受。     

DCF方案治疗晚期胃癌患者的临床分析

目的：观察DCF方案治疗局部进展期或转移性胃癌的疗效和不良反应。方法：自2007年10月至2009年8月,42例晚期胃癌患者采用DCF,DXT（多西紫杉醇）75mg/m2,静脉滴注,第1天;DDP（顺铂）25 mg/m2,第1-3天;CF（亚叶酸钙）200mg/d,静脉滴注2小时,第1-5天;5-FU（氟尿嘧啶）500mg/m2,第1-5天,静脉滴注5-6小时,3周为1周期,方案治疗,按WHO标准评价近期疗效和不良反应,随访疾病进展时间（TTP）和中位生存期（MST）。结果：全组42例均可评价疗效,其中CR 3例,PR 19例,SD 11例,PD 9例。有效率（RR）为54.7%,中位TTP为5.5个月,中位MST为10个月。不良反应主要是骨髓抑制及胃肠道反应,其次为口腔黏膜炎、腹泻及周围神经毒性。结论：DCF方案治疗晚期胃癌的疗效较好,不良反应可以耐受。     

DP与IP方案二线治疗进展期胃癌临床观察

目的 进展期胃癌(advanced gastric cancer,AGC)的一线化疗方案主要以氟尿嘧啶类及顺铂为基础,一旦出现肿瘤进展,二线治疗疗效欠佳.本研究主要观察多西他赛联合顺铂(DP)以及伊立替康联合顺铂(IP)二线治疗AGC的有效性和安全性.方法 回顾性分析2011-01-01-2014-01-31入住于皖南医学院弋矶山医院肿瘤内科的94例既往接受以氟尿嘧啶类药物为基础的一线化疗方案治疗失败的AGC患者,分为DP和IP组.DP组51例,多西他赛(docetaxel,TXT) 35 mg/m2,静脉滴入,d1、d8;顺铂(cisplatin,DDP) 20 mg/m2,静脉滴入,d1～d4;21 d为1个周期.IP组43例,伊立替康(irinotecan,CPT-11) 65 mg/m2,静脉滴入,d 1、d8;DDP 20 mg/m2,静脉滴入,d1～d4;21 d为1个周期.化疗过程中注意观察不良反应,根据不良反应的程度调整药物用量.每2个周期评价疗效.结果 94例患者均可评价疗效.DP组完全缓解(complete response,CR)1例(1.96％),部分缓解(partial response,PR) 13例(25.49％),稳定(stable disease,SD) 15例(29.41％),进展(progressive disease,PD) 22例(43.14％),客现有效率(objective response rate,ORR)为27.45％,疾病控制率(disease control rate,DCR)为56.86％,中位无进展生存时间(median progression-freesurvival,mPFS) 5.1个月,中位总生存时间(median overall survival,mOS)8.4个月.IP组PR 9例(20.93％),SD 13例(30.23％),PD 21例(48.84％),ORR为20.93％,DCR为51.16％,mPFS 4.5个月,mOS 7.6个月.2组间ORR(x2-0.063,P=0.467)、DCR(x2 =0.305,P=0.581)、mPFS(x2=0.320,P=0.571)和mOS(x2 =0.436,P=0.509)均差异无统计学意义;2组间临床分期较早者疗效明显优于临床分期较晚者,P=0.009;ECOG评分较好者疗效明显优于ECOG评分较差者,P=0.009.常见的不良反应主要为骨髓抑制、胃肠道反应、口腔黏膜炎和脱发等.DP组的脱发和口腔黏膜炎发病率高于IP组,差异有统计学意义,Z值分别为-7.854和-2.726,P值分别为＜0.001和0.006;IP组的腹泻及胆碱能综合征发病率远高于DP组,差异有显著统计学意义,Z值分别为=5.648和-2.741,P值分别为＜0.001和0.006;2组血液学毒性类似,多为Ⅰ～Ⅱ度,可耐受,IP组血小板下降发病率高于DP组,但差异无统计学意义,Z=-1.777,P=0.076.结论 DP和IP方案二线治疗以氟尿嘧啶类药物为基础的一线化疗失败的AGC疗效相当,不良反应轻,患者可耐受,不失为较好的挽救方案.     

Epirubicin/vinorelbine as first line therapy in metastatic breast cancer

This study was aimed at investigating the toxicity and activity of the combination epirubicin and vinorelbine in chemotherapy-naive patients with metastatic breast cancer. Fifty-one patients with measurable or evaluable metastatic breast cancer entered the study. The regimen consisted of epirubicin 90 mg/m² as a slow i.v. infusion on day 1, followed by vinorelbine 25 mg/m² by 30-minute intravenous infusion on days 1 and 8; the courses were repeated every 21 days for a maximum of 8 cycles. All the patients were assessable for toxicity and 47 were evaluable for response according to the World Health Organization (WHO) criteria.Objective responses were observed in 33 out of 47 evaluable patients (70.2%; 95% C.I. 55.1%–82.6%) with 4 complete (8.5%) and 29 partial responses (61.7%); 11 patients had stable disease (23.4%) and 3 patients progressed while on treatment. The median time to progression was 10 months (range 1 – 21) and the median overall survival was 23 months (range 2 – 32+). Neutropenia was the most frequent toxicity: a grade 4 neutropenia (WHO) was reported in 70% of 252 courses with a median duration of 3 days (range 1–6). Seventeen episodes of febrile neutropenia were observed but only 1 patient required hospital admission. Other hematologic toxicities were negligible. One patient experienced a paralytic ileus requiring hospitalization; no peripheral neuropathy such as muscle weakness or paresthesia was observed. No treatment-related cardiotoxicity was reported. The encouraging response rate achieved with epirubicin/vinorelbine, the easily manageable toxicities of the combination, and its feasibility in an outpatient setting make this combination worthy of further comparative trials with standard regimens.     

多西他赛联合氟尿嘧啶、顺铂方案与多西他赛联合氟尿嘧啶、洛铂方案治疗胃癌的疗效比较

目的:比较多西他赛联合氟尿嘧啶、顺铂方案与多西他赛联合氟尿嘧啶、洛铂方案治疗晚期不可手术胃癌患者的疗效和不良反应。方法:回顾性分析2015年2月至2018年6月126例晚期不可手术的胃癌患者。洛铂组55例:多西他赛+氟尿嘧啶+洛铂,顺铂组71例:多西他赛+氟尿嘧啶+顺铂。洛铂组和顺铂组均21天为一个疗程,连续治疗四个疗程。结果:洛铂组患者客观有效率为50.91%,顺铂组为35.21%,差异无统计学意义（P＞0.05）。洛铂组患者疾病控制率达到83.64%,顺铂组为67.61%,差异有统计学意义（P＜0.05）。洛铂组患者在恶心、呕吐、白细胞减少和四肢麻木方面发生率明显低于顺铂组,差异有统计学意义（P＜0.05）。洛铂组患者血小板减少发生率高于顺铂组,差异有统计学意义（P＜0.05）。洛铂组患者严重不良反应的发生率为21.82%,顺铂组为39.44%,差异具有统计学意义（P＜0.05）。结论:将多西他赛联合氟尿嘧啶、顺铂方案中的顺铂以洛铂替代,取得了更好的疾病控制率,而患者的不良反应更轻,严重不良反应的发生率也更低,值得临床进一步研究。     

Split-dose docetaxel, cisplatin and leucovorin/fluorouracil as first-line therapy in advanced gastric cancer and adenocarcinoma of the gastroesophageal junction: results of a phase II trial.

BACKGROUND: Phase II and III trials of docetaxel, cisplatin and fluorouracil (DCF) have shown superior efficacy versus cisplatin and fluorouracil alone but high rates of hematologic toxicity in advanced gastric cancer. To reduce toxicity while maintaining the efficacy of DCF, we investigated split doses of docetaxel (T), cisplatin (P), leucovorin (L) and fluorouracil (F). PATIENTS AND METHODS: Chemotherapy-naive patients with advanced gastric-/esophageal adenocarcinomas received T 50 mg/m(2) and P 50 mg/m(2) on days 1, 15 and 29 and L 500 mg/m(2) plus F 2000 mg/m(2) weekly, every 8 weeks. Because significant dose reductions to <80% became necessary in 80% of patients, the regimen was amended after the first 15 patients to T 40 mg/m(2), P 40 mg/m(2), L 200 mg/m(2) and F 2000 mg/m(2). The primary endpoint was response rate. RESULTS: Sixty patients were enrolled: 24 had locally advanced (LA) tumors and 36 had metastatic disease. Grade 3/4 toxicities included neutropenia (22%), febrile neutropenia (5%), diarrhea (20%) and lethargy (18%). The overall response rate was 47%. Twenty-three LA patients underwent secondary surgical resection (96%); complete resection was achieved in 87%. Overall, median time to progression and overall survival were 9.4 and 17.9 months, respectively (8.1 and 15.1 months, respectively, for patients with metastatic disease). CONCLUSION: T-PLF regimen is highly active and has a favorable toxicity profile.     

多西他赛联合顺铂、氟尿嘧啶和亚叶酸的新辅助化疗方案治疗不能切除进展期胃癌的疗效观察

背景与目的：手术治疗目前仍是无远处转移胃癌的标准治疗方法，但大多数胃癌患者就诊时已经是进展期而不宜手术。新辅助化疗足指在外科手术术前给予化疗，其目的之一是通过缩小原发肿瘤使之可以进行手术切除，最终延长生存期。本临床试验目的在于研究多西他赛（商品名：泰索帝）联合顺铂、氟尿嘧啶和亚叶酸给药方案术前进行诱导化疗对不能切除的进展期胃癌的临床疗效及毒副反应。方法：入组患者均为本院2003年6月-2005年6月收治的12例晚期胃癌而无法行根治手术者。术前的新辅助化疗方案为：泰索帝75mg／m^2、顺铂75mg/m^2。第1天；氟尿嘧啶500mg／m^2、亚叶酸200mg／m^2第1～5天，每三周为一个周期，共两个周期。观察新辅助化疗后原发病灶的变化情况并观察用药后的毒副反应。结果：新辅助化疗后9例患者获得肿瘤减期，疗程结束后4～6周8例进行根治性手术切除。临床完全缓解（CR）1例，部分缓解（PR）8例，无变化（NC）3例，进展（PD）0例，有效率75％（9／12），腹水消退率63.6％（7／11）。组织学效果：轻度有效3例，中度有效4例，显著有效1例。副反应主要为骨髓抑制、腹泻、恶心呕吐、脱发，经对症以及营养支持治疗后均能缓解。结论：多西他赛加顺铂、氟尿嘧啶及亚叶酸的新辅助化疗方案在高度进展期胃癌的治疗中，对提高手术切除率疗效显著，耐受性良好。     

多西他赛联合顺铂、5-Fu治疗晚期胃癌近期疗效分析

目的 观察多西他赛联合顺铂、5-Fu治疗晚期胃癌的疗效及耐受性。方法 TDF方案：Docetaxel 75mg/m^2静脉滴注，第1天，化疗前预处理；顺铂20mg，静脉滴注，第1～5天;5-Fu 2.5g/m^2持续静脉灌注120小时，21天为1周期。结果全组CR 1例、PR 12例、SD 9例、PD 1例，总有效率56.5%。初治组有效率70%，复治组有效率46%。中位生存期为13月，不良反应主要有消化道反应和白细胞下降。结论 TDF方案疗效肯定,不良反应能耐受。     

Phase II study of docetaxel and irinotecan combination chemotherapy in metastatic gastric carcinoma

The current treatment for metastatic gastric cancer (MGC) consists of cisplatin and/or fluorouracil (5-FU) based combination chemotherapy, but cisplatin-based regimens are associated with considerable toxicity. We evaluated the efficacy and safety of a noncisplatin-, non-5-FU-containing regimen, docetaxel/irinotecan in MGC. Chemo-naive patients with MGC received docetaxel (30 mg m(-2)) and irinotecan (70 mg m(-2)) on days 1 and 8 every 3 weeks. The 48 eligible patients (median age 56 years) received a median of four cycles of docetaxel/irinotecan (range 1-18). Of the 46 patients in whom efficacy could be evaluated, 21 showed a partial response (response rate=45.7%; 95% confidence interval (CI) 31.3-60.1%). At a median follow-up of 15.0 months, the median time to progression was 4.5 months (95% CI 3.8-5.2 months) and overall survival was 8.2 months (95% CI, 5.8-10.6 months). Grade 3/4 neutropenia developed in 57.4% of patients, and febrile neutropenia/neutropenic infection in 19.1%. Nonhaematological toxicities were moderate; grade 3/4 diarrhoea occurred in 19.1% of patients, however, was manageable by a dose reduction. There was one possible treatment-related death. In conclusion, weekly docetaxel/irinotecan is a promising outpatient regimen in MGC, with appropriate dose modification.     

DCX方案一线治疗晚期胃癌的临床观察

目的观察DCX方案一线治疗晚期胃癌的临床疗效和毒副作用。方法多西紫杉醇60mg/m2,静滴,第1天,顺铂20mg/m2,静滴,第1~3天,希罗达1000mg/m2,口服,2次/日,连续14天,休息7天。21天作为1个周期。至少连续治疗2个周期后进行评价。结果全组19例病人,可评价18例,总有效率为61.11%,其中CR2例(11.11%),PR9例(50%),SD4例(22.22%),PD4例(16.67%),平均TTP为6.9个月;血液学毒性主要表现为白细胞减少,III~IV度发生率为27.78%,手足综合征发生率为38.89%。结论DCX方案治疗晚期胃癌疗效确实,不良反应可耐受和控制,可以作为晚期胃癌的一线治疗方案。     

Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study)

Background:

The conventional treatment options for advanced gastric patients remain unsatisfactory in terms of response rate, response duration, toxicity, and overall survival benefit. The purpose of this phase II study was to evaluate the activity and safety of cetuximab combined with cisplatin and docetaxel as a first-line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma.

Methods:

Untreated patients with histologically confirmed advanced gastric or gastro-oesophageal adenocarcinoma received cetuximab at an initial dose of 400 mg m⁻² i.v. followed by weekly doses of 250 mg m⁻², cisplatin 75 mg m⁻² i.v. on day 1, docetaxel 75 mg m⁻² i.v. on day 1, every 3 weeks, for a maximum of 6 cycles, and then cetuximab maintenance treatment was allowed in patients with a complete response, partial response, or stable disease.

Results:

Seventy-two patients (stomach 81.9% and gastro-oesophageal junction 18.1%; locally advanced disease 4.2%; and metastatic disease 95.8%) were enrolled. The ORR was 41.2% (95% CI, 29.5–52.9). Median time to progression was 5 months (95% CI, 3.7–5.4). Median survival time was 9 months (95% CI, 7–11). The most frequent grades 3–4 toxicity was neutropenia (44.4%). No toxic death was observed.

Conclusions:

The addition of cetuximab to the cisplatin/docetaxel regimen improved the ORR of the cisplatin/docetaxel doublet in the first-line treatment of advanced gastric and gastro-oesophageal junction adenocarcinoma, but this combination did not improve the TTP and OS. The toxicity of cisplatin/docetaxel chemotherapy was not affected by the addition of cetuximab.     

低剂量5-氟尿嘧啶持续静注联合顺铂、周剂量多西紫杉醇治疗晚期胃癌

目的:观察低剂量5-氟尿嘧啶(5-Fu)持续静注联合顺铂(DDP),周剂量多西紫杉醇(DOC)即FPD方案治疗晚期胃癌的疗效和毒性。方法:60例晚期胃癌患者随机分成两组,A组30例用FPD方案:5-Fu 200mg.m-2.d-1,经静脉微量泵持续24h注射,DDP 6mg.m-2.d-1,静滴1h,每周5d,DOC 25 mg.m-2.w-1静滴,均连用3周。B组30例应用低剂量5-Fu持续静注联合DDP(FP)方案,具体用法同A组。两组均以21d为1个疗程,间隔1周重复,2个周期后评定疗效。结果:A、B两组近期有效率分别为73.3%(22/30)及63.3%(19/30);中位无进展时间分别为4.8个月及2.6个月;中位生存期分别为9个月及5个月。两组无与化疗药物毒性有关死亡,毒副作用较轻。A组主要剂量限制性不良反应为骨髓抑制,Ⅲ/Ⅳ度白细胞减少占13.3%(4/30),无Ⅲ/IV度血小板及血红蛋白下降。非血液毒性主要是消化道反应和脱发。而对照组B组有轻度骨髓抑制及消化道副反应,无Ⅲ/IV度血液毒性及其他严重副反应。结论:FPD方案治疗晚期胃癌近期疗效较好,毒副反应较小,是较为理想的方案。