替吉奥治疗老年晚期胃癌临床观察

目的:观察替吉奥治疗老年晚期胃癌的近期疗效及毒副反应.方法:对44例老年晚期胃癌患者进行随机分组,每组22例.替吉奥胶囊组:替吉奥80 mg/m2 d－1,分早、晚2次口服,连续服用4周,休息2周,6周为1个周期,2个周期后评价疗效及安全性.FOLFOX组:奥沙利铂100mg/m2,静脉滴注d1;四氢叶酸200mg/m2,静脉滴注,dl-5,5-氟尿嘧啶500mg/m2持续静脉泵入12小时,dl-5,3周为一个周期,2个周期后评价疗效及安全性.结果:替吉奥胶囊组:CR 1例,PR 9例,SD 8例,PD 4例,总有效率45.5％;FOLFOX组:CR 0例,PR 7例,SD 8例,PD 7例,总有效率31.8％;两组有效率比较差异无统计学意义(x2=0.863,P=0.353).两组患者疾病控制率分别为81.82％、68.18％,差异无统计学意义(x2=1.091,P=0.296).替吉奥组消化道反应、外周神经毒性发生率均低于FOLFOX组(P＜0.05),替吉奥组与FOLFOX组Ⅲ度～Ⅳ度不良反应发生率分别为4.3％和27.3％,两组差异有统计学意义(x2=4.247,P=0.039).结论:替吉奥治疗老年晚期胃癌疗效肯定,较目前常规化疗方便、安全、患者耐受性好.     

替吉奥为基础的化疗方案一线治疗晚期胃癌的Meta分析

目的:评价以替吉奥(S-1)为基础的化疗方案在晚期胃癌一线治疗中的疗效和不良反应.方法:通过中国知网、万方、EmBase及Pubmed数据库检索晚期胃癌一线接受以S-1为基础的化疗对比非S-1化疗方案的多中心随机对照研究(multicenter randomized clinical trial,mRCT),采用Rev...     

局部晚期鼻咽癌替吉奥化疗同步放疗临床观察

目的:观察局部晚期鼻咽癌替吉奥化疗同步放疗临床应用效果以及安全性.方法:选取2011年1月-2012年1月于我院进行治疗的局部晚期鼻咽癌患者60例,随机分为两组,研究组和对照组,每组各30例.对照组采取单纯放疗方式进行治疗,研究组采用替吉奥化疗同步放疗进行治疗.观察并比较两组患者的疗效、不良反应、复发以及生存情况.结果:研究组患者治疗后总有效率为80.00％(24/30)显著高于对照组的53.33％ (16/30) (P ＜0.05).对照组患者治疗后骨髓抑制10例(33.33％)、胃肠反应14例(46.67％)、口腔黏膜反应10例(33.33％)、放射性皮炎12例(40.00％)均显著低于研究组的20例(66.67％)、24例(80.oo％)、20例(66.67％)、22例(73.33％)(均P＜0.05).研究组患者治疗后1年生存率为100％,与对照组的93.33％没有差异(P＞0.05).研究组患者治疗后2年生存率为96.67％,1年复发率为3.33％,2年复发率为6.67％均显著优于对照组的83.33％,16.67％,23.33％(均P＜0.05).结论:替吉奥化疗同步放疗对于局部晚期鼻咽癌患者近、远期疗效好,值得推广应用,但应注意毒副反应.     

常规化疗联合替吉奥对乳腺肿瘤患者淋巴结转移的影响

目的:研究常规化疗联合替吉奥对乳腺肿瘤患者淋巴结转移的影响。方法:临床纳入2016年5月至2017年5月期间我院收治的84例乳腺肿瘤患者进行研究,按随机数字表法分为两组各42例。其中42例患者采用常规化疗治疗作为对照组;另42例患者在常规化疗的基础上给予替吉奥治疗作为观察组。观察患者淋巴转移、肿瘤标志物水平和不良反应情况。结果:观察组淋巴结转移率为7.14%,明显低于对照组的28.57%,P＜0.05。治疗前两组患者CEA、CA15-3以及CA125水平对比无差异,P＞0.05;治疗后观察组CEA、CA15-3以及CA125水平明显低于对照组,P＜0.05。观察组不良反应发生率为21.43%,对照组为16.67%,两组不良反应发生率对比无差异,P＞0.05。结论:替吉奥可有效抑制乳腺肿瘤的淋巴结转移,促进化疗效果,且安全性较高,值得临床应用及推广。     

替吉奥联合静脉和腹腔化疗方案治疗胃癌腹水的临床观察

目的：观察口服国产替吉奥联合静脉（多西他赛）和腹腔（顺铂）化疗治疗晚期胃癌腹水的近期疗效及不良反应。方法：将56例晚期胃癌合并癌性腹水患者随机分为2组：治疗组28例采用口服替吉奥,联合静脉滴注多西他赛全身化疗和腹腔内灌注顺铂局部化疗方案;对照组28例采用持续静脉滴注氟尿嘧啶,联合与治疗组相同的静脉用多西他赛和腹腔灌注顺铂化疗方案;均3个周期后评价近期疗效、临床受益及不良反应。结果：56例均可评价;治疗组和对照组的腹水近期有效率（RR）、中位疾病进展时间（TTP）分别为78.6%（22/28）和6.4个月、67.9%（19/28）和5.9个月,差异均无统计学意义（P〉0.05）,但从数值上看治疗组似乎更有优势,且治疗组的临床受益反应（CBR）为92.9%（26/28）,优于对照组的71.4%（20/28）,差异有统计学意义（P〈0.05）;治疗组的不良反应及严重反应发生率均明显低于对照组（P〈0.05）。结论：含口服国产替吉奥联合静脉和腹腔化疗是治疗晚期胃癌腹水的有效手段,不良反应可以耐受,值得临床进一步推广应用。     

替吉奥联合静脉和腹腔化疗方案治疗胃癌腹水的临床观察

目的 观察口服国产替吉奥联合静脉(多西他赛)和腹腔(顺铂)化疗治疗晚期胃癌腹水的近期疗效及不良反应.方法 将56例晚期胃癌合并癌性腹水患者随机分为2组:治疗组28例采用口服替吉奥,联合静脉滴注多西他赛全身化疗和腹腔内灌注顺铂局部化疗方案;对照组28例采用持续静脉滴注氟尿嘧啶,联合与治疗组相同的静脉用多西他赛和腹腔灌注顺铂化疗方案;均3个周期后评价近期疗效、临床受益及不良反应.结果 56例均可评价;治疗组和对照组的腹水近期有效率(RR)、中位疾病进展时间(TTP)分别为78.6%(22/28)和6.4个月、67.9%(19/28)和5.9个月,差异均无统计学意义(P>0.05),但从数值上看治疗组似乎更有优势,且治疗组的临床受益反应(CBR)为92.9%(26/28),优于对照组的71.4%(20/28),差异有统计学意义(P<0.05);治疗组的不良反应及严重反应发生率均明显低于对照组(P<0.05).结论 含口服国产替吉奥联合静脉和腹腔化疗是治疗晚期胃癌腹水的有效手段,不良反应可以耐受,值得临床进一步推广应用.     

替吉奥胶囊单药联合放疗治疗晚期胃癌的临床观察

目的 观察替吉奥胶囊（S-1）单药化疗联合同步放疗治疗晚期胃癌的疗效及毒副反应。方法83例晚期胃癌患者均接受同步放化疗,依据化疗方案分为治疗组（n=43）和对照组（n=40）。两组放疗计划均为：6MV X线照射,DT 40～50Gy,4～5周完成。治疗组于放疗第1天开始口服S-1 40～60mg,每天2次,6周为1周期;对照组于放疗第1天开始行一线方案（如ECF、DCF、FOLFOX、FOLFIRI等）化疗2个周期以上。评价两组胃癌患者的疗效及毒副作用。结果82例患者可评价疗效,治疗组中1例因消化道不良反应退出。治疗组获CR 3例,PR 21例,SD 14例,PD 4例,RR为57.1％（24／42）;对照组获CR 2例,PR 15例,SD 15例,PD 8例,RR为42.5％（17／40）;两组RR的差异无统计学意义（P＞0.05）。治疗组的进食梗阻、疼痛等主观症状改善率为81.0％（34／42）,高于对照组的50.0％（20／40）,差异有统计学意义（P=0.008）。治疗组和对照组治疗后1年生存率分别为23.8％（10／42）和20.0％（8／40）,差异无统计学意义（P＞0.05）。全组患者的主要毒副反应为血液学毒性、肝功能损害、放射性胰腺炎和胃肠道反应。治疗组3～4级白细胞减少、1～2级转氨酶升高和3～4级恶心呕吐的发生率均低于对照组（P＜0.05）。结论 S-1联合放疗可以提高晚期胃癌患者生活质量,不良反应能够耐受,值得临床进一步探讨。     

替吉奥单药治疗晚期胃癌的疗效观察

目的探讨替吉奥单药治疗晚期胃癌的临床疗效和安全性。方法 24例晚期胃癌患者,根据体表面积的不同口服替吉奥胶囊40～60 mg,每天2次,连续治疗4周,休息2周,6周为1疗程,2疗程后观察疗效及毒副反应。结果 24例患者中,PR 5例,SD 3例,PD 16例,临床受益率为33.3%。中位疾病进展时间4.2个月,中位生存期6.9个月。主要毒副反应为骨髓抑制及胃肠道反应,未发生治疗相关性死亡。结论替吉奥单药治疗晚期胃癌安全有效。     

替吉奥联合奥沙利铂一线治疗晚期胃癌的疗效和安全性

目的评价替吉奥胶囊联合奥沙利铂(SOX方案)一线治疗局部晚期不可切除或转移性胃癌患者的疗效和安全性。方法奥沙利铂(130 mg/m2)第1天静脉滴注,替吉奥胶囊(40 mg/m2,2次/天),连用14天休7天,每3周重复。治疗至疾病进展或出现不能耐受的不良反应。结果共61例患者,所有患者均可评价安全性和生存期,46例患者可评价客观缓解率。缓解率为56.5%,疾病控制率76.1%。中位无进展生存时间(PFS)7.5月(95%CI:5.1～9.7月),1年生存率62.9%,估计的中位生存时间(OS)16月(95%CI:13.2～18.8月)。主要的3/4级不良反应为中性粒细胞下降(13.1%)和血小板下降(18%)。结论中国晚期胃癌患者中应用SOX方案是安全、有效的。     

胰岛素联合化疗治疗消化道肿瘤的临床意义

 目的 研究胰岛素对恶性肿瘤化疗的增效减毒作用。方法 将50例消化道肿瘤病人随机分为实验组和对照组,应用DLF方案化疗两周期,实验组于化疗前给予胰岛素0.3U/kg;每周期评价化疗毒副反应,包括外周血、毛发、肝、肾功能和消化道反应。两周期后评价疗效。结果 两组化疗疗效差异无统计学意义（P〉0.05）,但是,实验组患者肿瘤缩小和增大的程度均优于和低于对照组;实验组中,外周血减少和恶心呕吐发生率较对照组低（P〈0.05）,两组脱发、和腹泻的发生率差异无统计学意义（P〉0.05）;两组在肝肾功能的毒性反应无明显差异。结论 化疗前适量使用胰岛素可以降低毒副反应发生率和发生程度,而且并不降低化疗疗效。     

Lentinan prolonged survival in patients with gastric cancer receiving S-1-based chemotherapy

AIM: To examine whether administration of lentinan, purified β-1, 3-glucan, can prolong survival in advanced gastric cancer patients receiving S-1-based chemotherapy.METHODS: Since 2004, 78 patients with metastatic or recurrent gastric cancer have received S-1-based chemotherapy as first-line treatment. Survival, side effects, and the ratio of granulocytes/lymphocytes (G/L ratio) were compared between 2 groups of patients who received chemo-immunotherapy using lentinan and chemotherapy alone.RESULTS: Median overall survival was significantly longer in the former group than in the latter group [689 d (95% CI: 431-2339 d) vs 565 d (95% CI: 323-662 d), P = 0.0406]. In addition, the G/L ratio in patients who received lentinan was maintained around or below 2, which was significantly lower than that in patients who received chemotherapy alone (P < 0.001).CONCLUSION: Chemo-immunotherapy with lentinan offers a significant advantage over S-1-based chemotherapy alone in terms of survival in patients with advanced gastric cancer.     

Retrospective analysis of 45 consecutive patients with advanced gastric cancer treated with neoadjuvant chemotherapy using an S-1/CDDP combination

Background Standard treatment for highly advanced gastric cancer (AGC) has not been established yet. Neoadjuvant chemotherapy (NAC) represents a promising approach, which may improve the prognosis of AGC. In this study, we analyzed the feasibility and efficacy of NAC with S-1 (TS-1)/cisplatin CDDP in order to design appropriate clinical trials for AGC. Methods Results for a series of 45 consecutive patients with AGC treated with S-1/CDDP induction chemotherapy since January 2002 were analyzed retrospectively. Results The primary tumor was resected in 36 of the 45 patients (resectability, 80.0%). Progression of the disease during chemotherapy was observed in 1 patient only (2.2%). No treatment-related deaths occurred, and serious adverse effects (grade 3–4) were noted in only 2.2% of the patients. The overall median survival time was 1.82 years. Especially noteworthy is that, in patients with highly advanced disease (pretreatment [c]-stage IV; n = 27), resectability was 66.7% and curative (R0) resection was possible in 10 patients. The median survival times for c-stage IV patients who had total, curative, and noncurative resections were 20.8, 22.3 and 12.6 months, respectively. R0 resection was possible for all c-stage III patients (n = 17), with a 2-year overall survival of 90.9%. The downstaging rate was 55.6% (20/36), resulting in a significantly improved prognosis for the downstaged patients (P = 0.012). Conclusion Induction chemotherapy using S-1/CDDP for AGC appears to be a safe and promising treatment. We have therefore started two independent multiinstitutional clinical trials to evaluate the efficacy of this treatment.     

Retrospective analysis of stage IV advanced gastric cancer treated with S-1 or other chemotherapy

Background We retrospectively analyzed the influence of various clinicopathologic factors on the survival of patients treated with chemotherapy. Methods A retrospective analysis was made of 110 patients with stage IV gastric cancer who were treated from January 1996 to June 2004. Results Median survival time was 429 days for patients treated with S-1 therapy and 236 days for patients without S-1 therapy. A better survival was demonstrated in patients who had good performance status, one metastatic site, or had been given a second-line chemotherapy (P < 0.01). But very few patients (17%; 5/29) with multiple metastatic sites were able to receive the second-line chemotherapy. Conclusion Patients treated with S-1 therapy had a better prognosis than patients without S-1. One metastatic site and being given second-line chemotherapy were other factors for better prognosis. For patients with only one metastatic site, a good prognosis can be obtained by second-line chemotherapy for those refractory to S-1. The prognosis of patients who had more than two metastatic sites remained poor; more effective chemotherapy might improve the survival of such patients if they retain good performance status.     

A patient with gastric cancer and liver metastases successfully treated with combination chemotherapy including S-1

We report the case of a 62-year-old man with advanced gastric cancer and multiple liver metastases who was successfully treated with combined chemotherapy including S-1. The patient was clinically diagnosed with stage IV (T3 N2 H1 P0) disease and was initially treated with 100 mg/body per day S-1 administered orally for 21 days and 10 mg/body per day cisplatin (CDDP) infused on days 1–5, 8–12, and 15–19. This chemotherapy resulted in significant reduction of the liver and gastric tumors. After receiving additional CDDP/S-1 administration as an outpatient, the patient's liver masses disappeared as shown on abdominal computed tomography (CT). With the patient's desire and informed consent, he underwent curative surgery with total gastrectomy, D1+α lymph node dissection, and partial resection of liver S4. After discharge without any surgical complication, CT revealed regrowth of the S4 liver mass, and combined docetaxel and CDDP was selected as second-line chemotherapy with local radiation therapy against the hepatic metastasis. Additionally, a third regimen with irinotecan and S-1 was given. At 2 years 7 months after the initial treatment, no sign of cancer (including liver metastasis and peritoneal dissemination) has been identified by radiological follow-up examinations.     

S-1抗肿瘤药物在胃癌病人中的临床应用进展

药物治疗在胃癌治疗中具有重要地位.S-1作为一种新型口服抗肿瘤药物具有高效低毒、病人依从性好的优势,合理开展含S-1及S-1单药方案治疗胃癌的临床试验具有重要意义.     

奥沙利铂+替吉奥化疗方案在高龄晚期胃癌患者治疗中的应用

目的:研究奥沙利铂+替吉奥化疗方案在高龄晚期胃癌患者治疗中的应用效果。方法:选择2011年8月至2013年8月在我院接受化疗的高龄晚期胃癌患者68例,分为实验组(34例)与对照组（34例）,实验组以奥沙利铂+替吉奥方案化疗,对照组以FOLFOX6方案化疗,观察两组患者近期疗效、临床受益反应、免疫功能及不良反应。结果:经2个周期的化疗,实验组RR（61.76%）高于对照组RR（35.29%）,存在显著统计学差异（P＜0.05）;实验组受益率（61.76%）显著高于对照组受益率（35.29%）,存在显著统计学差异（P＜0.05）。两组患者化疗后CD3+、CD8+以及CD19+等免疫功能指标与化疗前比较（P＞0.05）;两组患者化疗后CD4+与CD4+/CD8+与化疗前组内比较（P＜0.05）;两组患者化疗后CD4+组间比较（P＜0.05）,均存在显著统计学差异。实验组Ⅰ-Ⅱ度不良反应发生率均低于对照组,两组间除恶心呕吐发生率存在统计学差异（P＜0.05）外,其他不良反应均无统计学差异（P＞0.05）。结论:奥沙利铂+替吉奥化疗方案疗效显著,不良反应发生率低,适合耐受程度较差的高龄晚期胃癌患者的治疗。     

Randomised phase II trial of S-1 plus oxaliplatin vs S-1 in patients with gemcitabine-refractory pancreatic cancer

Background:

This randomised, open-label, multicenter phase II study compared progression-free survival (PFS) of S-1 plus oxaliplatin (SOX) with that of S-1 alone in patients with gemcitabine-refractory pancreatic cancer.

Methods:

Patients with confirmed progressive disease following the first-line treatment with a gemcitabine-based regimen were randomised to receive either S-1 (80/100/120 mg day⁻¹ based on body surface area (BSA), orally, days 1–28, every 6 weeks) or SOX (S-1 80/100/120 mg day⁻¹ based on BSA, orally, days 1–14, plus oxaliplatin 100 mg m⁻², intravenously, day 1, every 3 weeks). The primary end point was PFS.

Results:

Between January 2009 and July 2010, 271 patients were randomly allocated to either S-1 (n=135) or SOX (n=136). Median PFS for S-1 and SOX were 2.8 and 3.0 months, respectively (hazard ratio (HR)=0.84; 95% confidence interval (CI), 0.65–1.08; stratified log-rank test P=0.18). Median overall survival (OS) was 6.9 vs 7.4 months (HR=1.03; 95% CI, 0.79–1.34; stratified log-rank test P=0.82). The response rate (RR) was 11.5% vs 20.9% (P=0.04). The major grade 3/4 toxicities (S-1 and SOX) were neutropenia (11.4% and 8.1%), thrombocytopenia (4.5% and 10.3%) and anorexia (12.9% and 14.7%).

Conclusions:

Although SOX showed an advantage in RR, it provided no significant improvement in PFS or OS compared with S-1 alone.