Phase II trial of pemetrexed as second-line therapy in patients with metastatic urothelial carcinoma

Summary Purpose: The purpose of this single-center phase II study was to determine the activity of pemetrexed administered as second-line therapy in patients with advanced urothelial carcinoma. Methods: Patients with advanced urothelial carcinoma that had relapsed after receiving perioperative chemotherapy, or progressed on first-line chemotherapy for metastatic disease, were eligible for enrollment. Patients received pemetrexed 500 mg/m² every 21 days along with folic acid and vitamin B12 supplementation. Results: A total of 13 patients were enrolled. An objective response was achieved in 1/12 evaluable patients for an overall response rate of 8% (90% upper limit 29%). This level of activity did not meet criteria for expansion based on the pre-defined optimal 2-stage Simon design and the trial was concluded. Treatment was generally well tolerated, however, 2/13 patients developed febrile neutropenia. Non-hematologic grade ≥ 3 toxicity was rare. Conclusions: Pemetrexed as second-line therapy in advanced urothelial carcinoma is associated with modest activity. The role of this novel antifolate in chemotherapy-na?ve patients warrants further investigation.     

Biweekly administration of gemcitabine and cisplatin chemotherapy in patients with anthracycline and taxane-pretreated metastatic breast cancer

Gemcitabine and cisplatin are the active agents in metastatic breast cancer pretreated with anthracycline and/or taxane as a second line treatment. The present study was designed to assess the efficacy and safety of this regimen given biweekly schedule in these patients. Twenty-seven women, median age 57, with metastatic breast cancer previously treated with anthracycline and taxane were eligible for enrollment. Gemcitabine was administered intravenously on days 1 and 15 at a dose of 2,000 mg/m(2) and Cisplatin was given intravenously on day 1 and 15 at a dose of 50 mg/m(2). Treatment cycles were repeated on an outpatient basis every 28 days. Of all 27 evaluable patients, the overall response rate was 26% (7 of 27; 95% CI: 11-46%) with seven all partial responses. The stable diseases were found in 9 (33%) patients. At the time of last follow-up, 11 (41%) of the patients died of their disease progression. The median overall survival duration was 7.4 +/- 2.8 months. The 1-year overall survival rate was 46.9% +/- 12.3. Hematological toxicity was not found as the principal dose-limiting toxicity. Severe (grade III/IV) neutropenia was observed only one (4%) patients. No patient was complicated by febrile neutropenia and G-CSF usage was not performed. Grade III and IV anemia were seen in only 4 (15%) and thrombocytopenia was noted only one (4%) patients. Severe hepatic (n = 2) and renal toxicity (n = 1) were observed and these all recovered completely without complication. Several other severe non-hematological side effects were managed easily. Permanent dose reductions were necessary in 9 (33%) patients and chemotherapy administration was also delayed in 7 (26%) patients because of delayed both hematological and non-hematological toxicity recovery. Treatment was discontinued in one (4%) patient due to severe fatigue and deteriorating performance status. In conclusion, gemcitabine and cisplatin combination therapy with this biweekly schedule and dosage is moderately active and extremely safe in patients with metastatic breast cancer previously treated with anthracycline and taxanes.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌的临床效果观察

目的：探讨吉西他滨联合顺铂治疗晚期非小细胞肺癌的临床效果。方法选取本院2011年10月~2013年10月诊治的晚期非小细胞肺癌患者42例,根据随机数字表法将患者随机分为两组,每组各21例。对照组采用多西紫杉醇联合顺铂治疗,观察组采用吉西他滨联合顺铂治疗,比较两组的治疗效果及不良反应情况。结果观察组的总有效率、疾病控制率均高于对照组,但差异均无统计学意义（P〉0.05）。观察组的肾功能受损、肝功能受损、脱发、肌肉关节疼痛、皮疹、腹泻的发生率均低于对照组,但差异均无统计学意义（P〉0.05）;观察组白细胞减少、血红蛋白减少、血小板减少、恶心呕吐的发生率均明显低于对照组（P〈0.05）。结论吉西他滨联合顺铂是治疗晚期非小细胞肺癌的有效方法,可明显改善患者的预后,临床效果显著,不良反应少,安全性高,值得临床推广应用。     

吉西他滨加顺铂治疗晚期鼻咽癌疗效观察

目的评价吉西他滨加顺铂治疗晚期鼻咽癌的疗效和毒副作用.方法分为治疗组：12例,给予吉西他滨1 000 mg/m2 d 1、8天;顺铂70 mg/m2 d 2天,静脉滴注.对照组：12例,给予氟尿嘧啶2 500 mg/m2静脉持续注射48小时,加亚叶酸钙200 mg/m2静脉注射d 1、2天,顺铂用法同前.21天一疗程.结果治疗组：完全缓解（CR）1例、部分缓解（PR）8例、稳定（SD）2例、进展（PD）1例,有效率75%;对照组：CR 2例、PR 4例、SD 4例、PD 2例,有效率50%;毒副反应：两组比较消化道反应、骨髓抑制以及肝肾功能的损伤方面均无明显差别,对照组出现严重的静脉炎.结论有效率高和耐受性良好是吉西他滨加顺铂方案化疗治疗晚期鼻咽癌的突出特点.     

吉西他滨联合顺铂治疗晚期非小细胞肺癌临床观察

目的评估青西他滨联合顺铂治疗晚期非小细胞肺癌（NSCLC）的近期疗效和安全性。方法对35例晚期NSC∽患者采用吉西他滨1000me,／m2,静滴,第1、8天;顺铂25mg／m2,静滴,第1—3天。28d为1个周期,2个周期后进行一次疗效评价。结果35例患者中完全缓解（CR）0例,部分缓解（PR）14例,稳定（sD）16例,进展（PD）5例,总有效率（cR＋PR）为40．0％。初治组有效率为52．2％,显著高于复治组的116．7％（P〈0．05）。中位疾病进展时间（个rP）6个月。主要毒副作用是骨髓抑制和胃肠道反应。结论GP方案对晚期NSCLC疗效较好,毒副反应轻,是晚期NSCLC特别是初治者的有效治疗方案。     

吉西他滨联合奥沙利铂或顺铂治疗非小细胞肺癌的临床疗效观察

目的：比较吉西他滨联合奥沙利铂与吉西他滨联合顺铂治疗非小细胞肺癌（ NSCLC）患者的临床效果。方法2013年6月＿2014年6月收治确诊的非小细胞肺癌患者68例,根据联合用药不同分为奥沙利铂组与顺铂组各34例。奥沙利铂组患者给予吉西他滨1000mg/ m2,d1、d8＋奥沙利铂130mg/ m2,d1,静脉滴注,3周为1个疗程;顺铂组给予吉西他滨1000mg/ m2,d1、d8＋顺铂25mg/ m2,d 1、2、3,静脉滴注,3周为1个疗程。2组均治疗2个疗程,随访6~24个月,比较2组临床疗效、近期不良反应、1年生存率。结果奥沙利铂组总有效率为41.2％（14/34）,顺铂组为35.3％（12/34）,2组比较差异无统计学意义（P ﹥0.05）。奥沙利铂组患者中位 PFS、OS 分别为24.5周、44.6周,顺铂组分别为18.2周、36.5周,2组中位 PFS 和中位 OS 比较差异无统计学意义（P ﹥0.05）。奥沙利铂组1年生存率为47.0％（16/34）,顺铂组为41.2％（14/34）,2组比较差异无统计学意义（P ﹥0.05）。2组患者不良反应主要表现为骨髓抑制、胃肠道反应和神经毒性等,以1~2级为主。奥沙利铂组1~2级神经毒性发生率为79.4％（27/34）,高于顺铂组35.3％（12/34）（P ＜0.01）,而3~4级不良反应发生率顺铂组为52.9％（18/34）,高于奥沙利铂组的20.6％（7/34）（P ＜0.01）,2组比较差异均有统计这意义（P ﹥0.05）。结论吉西他滨联合顺铂或奥沙利铂对非小细胞肺癌患者临床疗效相当,但联合奥沙利铂不良反应少,因而患者耐受性好,临床应用更安全。     

Phase II study of vinflunine in patients with metastatic renal cell carcinoma

Summary Purpose: An open-label, multicentre, non-comparative phase II trial to determine the response rate of intravenous vinflunine as first line chemotherapy in patients with metastatic renal cell carcinoma (RCC). Patients and methods: Patients with metastatic RCC were treated with vinflunine 350 mg/m² (n = 11) or 320 mg/m² (n = 22) administered intravenously every 21 days. Results: Out of 33 patients included in this study, one partial response was observed in the group treated at 350 mg/m² and none in the group receiving 320 mg/m² resulting in a response rate in this population of 9.1% (95% CI: 0.2–41.3). Median progression free survival was 5.6 months (95% CI: 2.8–14.4) for patients treated at 350 mg/m², and 3.3 months (95% CI: 1.6–6.4) for those treated at 320 mg/m².The median survival time was 10.4 months (95% CI: 6.8–12.4) for the whole study population. The principal toxicities were grade 3/4 neutropaenia —90.9% at 350 mg/m² and 68.1% at 320 mg/m², febrile neutropaenia was recorded in 3 patients (27.3%) at 350 mg/m² and in 5 patients (22.7%) at 320 mg/m². One episode of thromboembolic event was reported in 1 patient at each dose level. Conclusion: Vinflunine given intravenously once every 3 weeks has not shown any clinically relevant activity in the management of patients with metastatic renal cell carcinoma; tolerance of the treatment was better at a dose of 320 mg/m² than at 350 mg/m². Supported by Institute de Recherche Pierre Fabre Oncologie, Boulogne-Billancourt, France.     

吉西他滨与多西紫杉醇联合顺铂在治疗非小细胞肺癌中的价值

目的探讨吉西他滨与多西紫杉醇联合顺铂在治疗非小细胞肺癌中的临床价值。方法选择35例患者使用吉西他滨联合顺铂治疗,并与35例使用多西紫杉醇联合顺铂的患者比较,连续2个治疗周期后观察患者的不良反应,并对所有患者电话随访1年,比较两组的临床疗效。结果吉西他滨组有效率为31．4％,多西紫杉醇组有效率为34-3％,两组有效率差异无统计学意义（P〉0．05）。吉西他滨组恶心呕吐的发生率显著高于多西紫杉醇组（P〈0．05）：多西紫杉醇组发生白细胞减少的概率显著高于吉西他滨组（P〈0．05）;两组发生血小板减少的概率均较高．但发生率之间差异无统计学意义（P〉0．05）;两组发生血红蛋白减少和肝肾功能受损的概率差异亦无统计学意义（P〉0．05）。结论吉西他滨与多西紫杉醇联合顺铂治疗非小细胞肺癌均有一定的临床效果,在使用吉西他滨治疗时主要注意患者的血小板调控以及预防恶心呕吐,使用多西紫杉醇治疗时则要注意患者的白细胞和血小板的数目。     

吉西他滨和顺铂联合重组人血管内皮抑制素治疗晚期非小细胞肺癌临床观察

目的评价吉西他滨和顺铂联合重组人血管内皮抑制素（恩度）治疗晚期非小细胞肺癌的疗效和安全性。方法 38例病理确诊的晚期非小细胞肺癌患者给予吉西他滨和顺铂联合恩度治疗,吉西他滨1000mg/m2,第1,8天,顺铂75mg/m2,第2天,恩度注射液7.5mg/m2加入500ml生理盐水中,滴注时间3～4小时,第1～14日,每21天为一周期。结果 38例患者入组,部分缓解13例,疾病稳定17例,疾病进展8例,客观有效率为34.2%,疾病控制率为78.9%。本组中位无进展生存期为4.6个月,95%CI为2.600～6.600个月,中位生存期为13.5个月,95%CI为9.599～17.401个月,1年生存率42.1%。结论吉西他滨和顺铂联合恩度治疗晚期非小细胞肺癌,有较好的疗效和安全性,具有较好临床应用前景。     

培美曲塞联合顺铂治疗原发性晚期十二指肠腺癌的效果评价

目的探讨培美曲塞联合顺铂治疗原发性晚期十二指肠腺癌的临床疗效。方法 21例原发性晚期十二指肠腺癌患者,给予培美曲塞联合顺铂治疗,在化疗的第2、4、6周期分别进行疗效评价;在化疗前及化疗6个周期后进行生活质量评分及KPS评分。结果化疗2个周期后疾病控制率（DCR）为90.48%,4个周期后为76.19%,6个周期后为52.38%;治疗后患者的功能评分、症状评分、生活质量评分及KPS评分较治疗前均有明显改善（P〈0.01）。结论培美曲塞联合顺铂是治疗原发性晚期十二指肠腺癌的有效治疗方案。     

多西他赛和吉西他滨分别联合顺铂治疗晚期非小细胞肺癌效果比较

目的 比较多西他赛与吉西他滨联合顺铂方案治疗晚期非小细胞肺癌(NSCLC)的临床疗效及不良反应.方法 120例晚期非小细胞肺癌患者完全随机分为2组.多西他赛组60例给予多西他赛37.5 mg/m2,第1、8天;顺铂25 mg/m2,第1～3天.吉西他滨组60例给予吉西他滨1000 mg/m2,第1、8天;顾铂用量同前.化疗每3周重复,每周期评价不良反应,评价疗效并随访生存期.结果 20例患者均可评价疗效和不良反应,2组有效率分别为多西他赛组45.0%(27/60)和吉西他滨组43.3%(26/60),1年生存率分别为45%和43.3%,两组之间有效率和1年生存率均无统计学意义(P＞0.05).不良反应主要为骨髓抑制和肝功能损害[多西他赛组白细胞产减少率为85.0%(51/60),吉西他滨组为78.0%(47/60),2组差异无统计学意义(P＞0.05);2组肝功能损害率分别为33.3%(20/60)、26.7%(16/60),差异有统计学意义(P＜0.05)].结论 多西他赛与吉西他滨联合顺铂方案治疗晚期NSCLC均具有较好的疗效,且两者的疗效相似,不良反应可以耐受,可以作为临床一线治疗.

Abstract：

Objective To compare the efficacy and safety of docetaxel plus cisplatin and gemcitabine plus cisplatin in advanced non-small cell lung cancer (NSCLC). Methods A total of 120 patients with advanced NSCLC were divided into two groups. The patients received docetaxel in docetaxel group. In gemcitabine group the patients received gemcitabine and cisplatin. The treatment schedule was repeated every 3 weeks. The toxicity,quality response and survival rate of life were evaluated after every cycle. Results The response rates of the docetaxel group and the gemcitabine group were 45% and 43.3%,respectively. One-year survival rates in the two groups were 45% and 43.3%,respectively. The response rate,one-year survival time showed no significance (P ＞0.05). The main side effects were myelosupp ression,nausea and vomiting. Conclusion Regimens of DC and GC are both safe and effective in the treatment of advanced stage NSCLC. They can be used as the first regimen of chemotherapy in patients with advanced stage NSCLC.     

不同剂量顺铂联合吉西他滨治疗非小细胞肺癌的比较研究

目的 比较不同剂量顺铂联合吉西他滨治疗非小细胞肺癌的临床疗效。方法 选取2016年2月-2018年2月复旦大学附属中山医院青浦分院收治的150例非小细胞肺癌患者为研究对象,按照化疗药物剂量不同,将150例患者随机平均分为A、B、C三组,每组各50例。A组患者第1~5天每天连续静脉输入15 mg/m²顺铂注射液;B组患者第1~3天每天连续静脉输入25 mg/m²顺铂注射液;C组患者仅第1天静脉输入80 mg/m²顺铂注射液,3组患者均在第1天、第8天和第15天输入1 g/m²注射用盐酸吉西他滨,每4周为1个疗程,共治疗4个疗程。观察3组患者的临床疗效,比较3组治疗前后血清CYFRA21-1、SCC-Ag、生活质量评分的变化情况。结果 治疗后,3组总有效率分别是32.0%、34.0%、38.0%,3组患者的总有效率比较差异无统计学意义。治疗后,3组患者CYFRA21-1、SCC-Ag水平均显著下降（P<0.05）,但3组患者之间比较差异无统计学意义。化疗结束1周后,B组评分略有升高或降低,C组患者评分均有所下降,但A组患者的评分有所提升（P<0.05）;治疗后B、C两组生活质量评分和A组相比差异有统计学意义（P<0.05）。结论 低剂量顺铂联合吉西他滨治疗非小细胞肺癌有较好的临床疗效,可改善患者生活质量,小剂量顺铂连续给药可降低患者化疗的毒副反应,具有一定的临床推广应用价值。     

A phase II study of pemetrexed in patients with advanced hepatocellular carcinoma

Pemetrexed has demonstrated activity in hepatocellular carcinoma (HCC) cell lines, and has a manageable toxicity profile in clinical trials, suggesting its potential as a treatment for HCC patients. A multicenter, Phase II community-based study was conducted to assess the response rate and toxicity profile of single-agent pemetrexed in first-line patients with advanced or metastatic HCC. Patients premedicated with folic acid, vitamin B(12), and dexamethasone were administered pemetrexed 600 mg/m(2) IV on day 1 of each 21-day cycle until disease progression. This nonrandomized study employed Simon's 2-stage design, enrolling 21 eligible patients in the first stage, stopping accrual if < or =2 responders were observed. Responses were four stable disease, 14 progressive disease, and three not evaluable: two had early toxicities (renal/liver failure, sepsis) and one was noncompliant. The most common grade 3 hematological toxicities were neutropenia 6 of 21 (29%) and thrombocytopenia 3 of 21 (14%); with no grade 4 toxicities. Thirteen patients died on-study: 12 PD and one liver failure; none were drug-related. The median survival was 5.2 months (range, <1-12.2). The planned second stage was cancelled, and the trial was closed owing to lack of response. While pemetrexed was tolerated in this patient population, it was not active.     

培美曲塞联合奥沙利铂与吉西他滨联合奥沙利铂治疗老年晚期肺腺癌

目的探讨培美曲塞联合奥沙利铂与吉西他滨联合奥沙利铂治疗老年晚期肺腺癌的疗效及毒副反应。方法将经病理组织学或细胞学确诊为晚期肺腺癌的老年患者(年龄≥70岁)64例作为研究对象,按所接受的方案分为培美曲塞联合奥沙利铂组及吉西他滨联合奥沙利铂组,其中培美曲塞500mg/m2,第1天静脉滴注30min;培美曲塞用药前1周始,补充维生素B12l000μg,叶酸400μg/d,于输注培美曲塞的前日、当日、次日口服地塞米松4mg,每日2次;吉西他滨1000mg/m2,第1、8天静脉滴注30min;奥沙利铂65mg/m2,第1、8天静脉滴注2h;21d为1个周期,每例患者至少治疗2个周期以上,按照RECIST标准评价化疗疗效和毒性。结果 PO组32例,完全缓解0例,部分缓解16例,稳定13例,总有效率为50.0%;GO组32例,完全缓解0例,部分缓解14例,稳定13例,总有效率为43.8%,PO组与GO组比较差异无统计学意义(P>0.05)。PO组的骨髓抑制、消化道反应、肾功能损害、脱发的发生率明显低于GO组,差异有统计学意义(P<0.05)。结论 PO方案与GO方案治疗老年晚期肺腺癌的疗效相似,但PO方案较GO方案的不良反应轻,老年患者更容易耐受,是老年晚期肺腺癌较理想的化疗方法。     

顺铂联合吉西他滨或多西他赛对晚期非小细胞肺癌的近期疗效和不良反应的观察

目的 比较顺铂联合吉西他滨或多西他赛治疗晚期非小细胞肺癌的近期疗效和不良反应.方法 选取浙江省舟山医院2009年1月至2012年3月晚期非小细胞肺癌化疗初治患者120例,完全随机分为GP组（吉西他滨±顺铂）和DP组（多西他赛±顺铂）,每组60例.2组均给予顺铂30 mg/m^2,静脉滴注,第1～3天;GP组给予吉西他滨1 000 mg/m^2,静脉滴注30 min,第1、8天;DP组给予多西他赛75 mg/m^2,静脉滴注60 min,第1天.21 d为1个周期,共化疗2个周期.评价近期疗效和不良反应.结果 2组均无完全缓解病例.GP组和NP组的总缓解率分别为41.7％ （25/60）和43.3％（26/60）,差异无统计学意义（P＞0.05）.GP组白细胞下降、肌肉酸痛的发生率明显低于DP组,差异有统计学意义[白细胞下降：63.3％ （38/60）比81.7％（49/60）,肌肉酸痛：0比31.7％ （19/60）,P＜0.05];血小板减少、皮疹的发生率明显高于DP组,差异有统计学意义[血小板减少：73.3％ （44/60）比33.3％（20/60）,皮疹：36.7％（22/60）比0,P＜0.05].结论 以顺铂为基础联合吉西他滨或多西他赛的双药化疗方案的近期疗效相当,不良反应各有侧重点,化疗过程中对不良反应应针对性地观察、预防和治疗.     

培美曲塞与DP方案在非小细胞肺癌二线治疗中临床疗效观察

目的 比较DP 方案与培美曲塞在晚期非小细胞肺癌(NSCLC) 治疗中的近期疗效和毒副反应.方法 NSCLC 患者27例.分别接受DP方案和培美曲塞两种方案的治疗,其中培美曲塞组13例,DP组14例,治疗2个周期后分别评价疗效和毒副反应.结果 有效率培美曲塞组为23.1%,DP组为28.6%,差异无统计学意义(P>0....     

Phase I trial of thalidomide and Interleukin-2 in patients with metastatic renal cell carcinoma

Summary Background: The treatment of advanced renal cell cancer remains unsatisfactory, therefore new combination regimens such as thalidomide and IL-2 are of interest. A phase I trial of SC IL-2 and oral thalidomide was performed to identify the toxicity, maximum tolerated dose (MTD) and preliminary clinical activity of this regimen. Methods: 33 patients with advanced/metastatic RCC were enrolled. An established 8-week outpatient schedule of subcutaneously administered IL-2 in escalating doses, days 1–5, for 6 weeks with a 2 week rest was utilized with daily oral thalidomide. Cohorts of 4–6 patients were treated at 4 dose levels. Results: Toxicity was moderate to severe and related to dose level. All patients developed fever, chills and fatigue. 29/33 patients developed ≤ Grade 2 desquamation of hands and feet and/or rash. Dose limiting toxicity (DLT) included Grade 3 neutropenia and pulmonary embolus. The maximum tolerated dose (MTD) of IL-2 and thalidomide was 9.0 MIU/m² SC days 1–5, weeks 1 to 6 and 100 mg po daily, respectively. A median of 2 cycles of therapy was administered (range 1–9). 2/33 patients responded (1 CR—prior IL-2 therapy, 1 PR—no prior therapy) with an overall response of 6% (95% CI, 1–20%). One minimal response was converted to a surgical CR (remains disease free at 24 + months). Conclusion: Outpatient administration of IL-2 and thalidomide is possible with acceptable toxicity. Further evaluation of this regimen is underway.     

Phase I trial of pemetrexed plus oxaliplatin administered every other week in patients with metastatic cancer

PURPOSE: To identify the maximum tolerated dose (MTD) and describe dose-limiting toxicities (DLT) of pemetrexed and oxaliplatin given on a once-every-2-week schedule in patients with metastatic cancer. PATIENTS AND METHODS: Twenty-five patients were enrolled. Due to toxicities observed at the first dose level in unselected patients, a second MTD was determined in patients who had received zero to two prior chemotherapy regimens. RESULTS: DLT was observed at dose level 1-pemetrexed 400 mg/m(2) and oxaliplatin 85 mg/m(2)-in the form of grade 3 fatigue in two of six patients. Enrollment was then limited to lightly pretreated patients and DLT was observed at dose level 2-pemetrexed 500 mg/m(2) and oxaliplatin 85 mg/m(2)-in the form of neutropenic fever in one of five patients. Complete response was confirmed in one patient (squamous cell carcinoma of the head and neck) and partial response was confirmed in three patients. CONCLUSIONS: The combination of pemetrexed and oxaliplatin can be safely administered at doses of 400 to 500 mg/m(2) of pemetrexed and 85 mg/m(2) in patients without extensive prior therapy and 300 and 85 mg/m(2), respectively, every 2 weeks in patients with more extensive prior therapy. Based on promising results observed in this study, a phase II trial in patients with recurrent head and neck cancer has been initiated.     

培美曲塞联合顺铂治疗晚期肺腺癌的临床分析

目的评价培美曲塞联合顺铂治疗晚期肺腺癌的疗效和毒副反应。方法 35例经病理或细胞学确诊的晚期肺腺癌初治患者,采用培美曲塞500mg/m2,第1天给药,并口服地塞米松、叶酸和肌内注射维生素B12预处理;顺铂75mg/m2,静滴,分2～4d给药,均予以保肝、护胃、止吐药物。治疗21d为1个周期,2个周期后评价疗效、毒副反应。结果 35例患者中,客观有效率为29%,疾病控制率为69%,PFS8个月(2～12个月),中位总生存期9个月(3～19个月)。毒副反应主要是骨髓抑制、胃肠道反应,均未达到Ⅲ～Ⅳ度。结论培美曲塞联合顺铂一线治疗晚期肺腺癌疗效较好,毒性反应轻,值得临床推广应用。     

培美曲塞联合顺铂在局部晚期肺腺癌同步放化疗中的临床研究

目的 观察培美曲塞联合顺铂同步放化疗治疗局部晚期肺腺癌的近期疗效和急性毒副反应.方法 18例经病理确诊的局部晚期肺腺癌患者（ⅢA或ⅢB）接受同步放化疗,放疗均采用IMRT计划,照射剂量60～70 y,1.8～2 Gy/次,5次/周.同步化疗方案为培美曲塞（500 mg/m2 d1）,顺铂（75 mg/m2d1）.3周重复,共2个周期,与放疗同期进行.部分患者接受1～2周期的新辅助化疗,化疗方案同同步化疗方案.结果 完全缓解（CR）3例,部分缓解（PR） 12例,稳定（SD）2例,进展（PD）1例,客观有效率（CR＋PR）为83.4％,疾病控制率（CR＋PR＋SD）为94.5％.主要毒副反应是放射性食管炎、骨髓抑制和轻度胃肠道反应,经对症支持治疗患者均能耐受.结论 培美曲塞联合顺铂同步放化疗治疗局部晚期肺腺癌,近期疗效肯定,耐受性良好,远期疗效和晚期并发症有待进一步观察.