安罗替尼联合替吉奥治疗三线及以上晚期非小细胞肺癌的安全性和有效性

目的:前瞻性应用安罗替尼联合替吉奥治疗三线及以上晚期非小细胞肺癌,观察临床疗效和药物的安全性。方法:均经组织病理或细胞学明确诊断晚期非小细胞肺癌,且二线化疗治疗后疾病进展。口服安罗替尼胶囊8 mg/d,d1~14联合替吉奥胶囊60 mg/m2 bid d1~14,21天为一个周期。治疗终止时间为疾病进展或出现不可接受的毒副反应。结果:本研究结果显示,总体客观缓解率（ORR）可达到26.8%,总体疾病控制率（DCR）可达到80.5%,中位无进展生存期（mPFS）达到5.2个月（95%CI:3.9~6.6个月）。单因素分析,脑转移组患者mPFS（4.8个月）对比无脑转移组患者mPFS（5.9个月）,两组差异具有统计学意义（P=0.039）。多变量回归分析显示,ECOG评分(P=0.002)、治疗线数（P=0.015）和疗效(P=0.014)是PFS的独立影响因素。最常见毒副反应为高血压、蛋白尿、骨髓抑制、胃肠道反应、疲乏和口腔黏膜炎。结论:安罗替尼联合替吉奥胶囊在晚期非小细胞肺癌三线及以上治疗中,其总体的疗效确切且药物毒副反应可控。     

替吉奥单药治疗老年或体弱转移性结直肠癌患者疗效分析

目的 观察分析替吉奥单药作为老年或体弱转移性结直肠癌(mCRC)患者治疗方案的疗效和毒副反应.方法 24例老年或体弱mCRC患者接受口服替吉奥治疗,即替吉奥35 mg·m-2,每天2次,连用2周,停药1周.观察其近期疗效、疾病无进展生存期、总生存期、毒副反应等.结果 全组24例患者的总有效率为16.7％,疾病控制率为75.0％;中位无进展生存期为4.1(95％CI为2.8 ～5.4)个月,中位总生存期:12.3(95％CI为9.9 ～14.7)个月;主要毒副反应为胃肠道反应、骨髓抑制,多为轻度,无患者因毒副反应终止治疗.结论 替吉奥单药治疗老年或体弱mCRC患者安全性高、疗效好.     

奥沙利铂联合紫杉醇脂质体治疗晚期胃癌的疗效分析

目的 探讨奥沙利铂联合紫杉醇脂质体或替吉奥治疗晚期胃癌的临床疗效及不良反应.方法 选取46例晚期胃癌患者作为研究对象.按照随机数字表法将46例晚期胃癌患者随机分为A组和B组,每组23例.其中,A组患者接受奥沙利铂联合紫杉醇脂质体方案化疗,B组患者接受奥沙利铂联合替吉奥方案化疗.比较两组患者的客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良反应发生情况.结果 A组患者的ORR为47.8%,DCR为78.3%;B组患者的ORR为43.5%,DCR为69.6%;两组患者的ORR和DCR比较,差异均无统计学意义(P=0.767、0.502).A组和B组患者的中位OS分别为9.4个月和9.5个月,两组比较,差异无统计学意义(P=0.911).A组患者的中位PFS为6.9个月(95%CI:6.2~7.8个月),长于B组患者的5.4个月(95%CI:4.0~5.9个月),差异有统计学意义(P=0.048).两组患者的中性粒细胞减少、血小板减少、贫血、疲劳乏力、腹泻、关节肌肉疼痛、恶心呕吐以及神经毒性的发生率比较,差异均无统计学意义(P﹥0.05).结论 奥沙利铂联合紫杉醇脂质体方案和奥沙利铂联合替吉奥方案治疗晚期胃癌的临床疗效接近,但在晚期胃癌患者的无进展生存期方面,奥沙利铂联合紫杉醇脂质体方案可能优于奥沙利铂联合替吉奥方案.     

替吉奥联合草酸铂治疗晚期胃癌的临床观察

目的 评价替吉奥联合草酸铂治疗晚期胃癌的临床疗效和安全性.方法 31例晚期胃癌患者接受替吉奥联合草酸铂一线化疗,至少完成2周期后评价化疗有效率和毒副反应.结果 31例患者均可评价疗效,其中PR 14例,SD 9例,PD 8例,有效率为45.2%,疾病控制率为74.2%.中位疾病进展时间为7.3个月.主要毒副反应为血液学毒性、胃肠道反应和外周神经毒性,以Ⅰ、Ⅱ度为主.结论 替吉奥联合草酸铂化疗方案一线治疗晚期胃癌近期疗效较好,毒副反应可耐受.     

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。     

替吉奥在一线化疗后晚期鼻咽癌患者维持治疗中的疗效观察

目的:探讨替吉奥在晚期鼻咽癌患者一线治疗后的维持治疗中的疗效。方法:选取2012年1月至2014年12月我院收治的58例晚期鼻咽癌患者,以上患者在一线姑息化疗4~6个疗程中获得完全缓解（CR）、部分缓解（PR）、疾病稳定（SD）。观察组30例患者给予替吉奥维持治疗;对照组28例患者以临床观察为主。观察和比较两组患者的客观有效率、不良反应、无进展生存时间及中位生存时间。结果:观察组的客观有效率为80.0％,显著高于对照组（35.7％）,差异具有统计学意义（P＜0.05）。对照组无疾病进展生存期为4.8个月（95％置信区间为3.8~5.8个月）,中位生存期为12.3个月（95％置信区间为8.7~15.9个月）;观察组无疾病进展生存期为9.6个月（95％置信区间为8.5~10.7个月）,中位生存期为18.8个月（95％置信区间为15.7~21.9个月）,均显著长于对照组（P均＜0.05）。观察组患者白细胞减少、胃肠道反应、口腔黏膜反应的发生率均显著高于对照组,差异有统计学意义（P均＜0.05）,但患者能耐受。结论:晚期鼻咽癌患者在一线治疗结束后给予替吉奥维持治疗,能够有效地延长患者的生存时间,提高疗效,不良反应可耐受,值得临床进一步研究。     

替吉奥联合奥沙利铂对比替吉奥联合顺铂方案一线治疗老年晚期胃癌的临床研究

目的 探讨替吉奥联合奥沙利铂方案（SOX）与替吉奥联合顺铂方案（SP）一线治疗老年晚期胃癌的疗效和毒副反应。方法 将56例老年晚期胃癌患者随机分为SOX组（n=30）和SP组（n=26）。SOX组：奥沙利铂130mg／m2 静滴,d1;替吉奥40～60mg／次口服,每天2次,d1～d14,21天为1周期。SP组：顺铂25mg／m2静滴,d1～d3;替吉奥用法同SOX组,21天为1周期。至少2个周期进行疗效评价。结果 SOX组和SP组的有效率分别为46.7％和38.5％（P=0.596）,疾病控制率分别为80.0％和76.9％（P=1.000）;中位无进展生存时间分别为6.0个月和5.6个月（P=0.831）,中位总生存时间分别为12.3个月和11.5个月（P=0.401）。SOX组和SP组的毒副反应均以血液学毒性为主,3～4级发生率的差异无统计学意义;非血液学毒性两组均为1～2级,SOX组以周围神经炎为主,SP组主要为恶心呕吐和肾功能异常。SOX组和SP组的KPS评分提高率分别为83.3％和46.2％（P=0.027）,FACT-G评分提高率分别为76.7％和38.5％（P=0.006）。结论 老年晚期胃癌患者可从替吉奥联合奥沙利铂方案或替吉奥联合顺铂方案一线治疗中获益,但替吉奥联合奥沙利铂方案的毒副反应更小,安全性更好。     

多西他赛联合替吉奥对比多西他赛单药二线冶疗晚期非小细胞肺癌临床观察

目的 探讨多西他赛联合替吉奥对比多西他赛单药二线冶疗晚期非小细胞肺癌的临床疗效.方法 收集经一线治疗后进展的晚期非小细胞肺癌患者100例,参照抽签法将患者随机分为试验组和对照组,每组各50例.试验组患者行多西他赛(60 mg/m2,静滴1 h,第1天)联合替吉奥(40 mg/m2,早晚饭后各服1次,连服14 d,每3周重复)治疗;对照组患者行多西他赛单药治疗(75 mg/m2,静滴1 h,第1天,每3周重复),所有患者随访至疾病进展或死亡.对比两组患者的临床疗效、生存情况及不良反应发生情况.结果 试验组患者的疾病控制率(72.00%)高于对照组患者(56.00%)(P﹤0.05);两组患者的客观缓解率比较,差异无统计学意义(P﹥0.05);试验组患者的中位无进展生存期为4.6个月(95%CI:3.994~5.206)长于对照组患者的3.1个月(95%CI:2.494~3.706)(P﹤0.05);试验组患者的中位生存期为9.2个月(95%CI:8.871~10.529)长于对照组患者的7.9个月(95%CI:5.575~10.225)(P﹤0.05);两组患者各种不良反应发生率及总不良反应发生率比较,差异均无统计学意义(P﹥0.05).结论 多西他赛联合替吉奥二线治疗晚期非小细胞肺癌的临床疗效优于多西他赛单药治疗.     

阿帕替尼联合替吉奥治疗晚期胃癌的疗效及安全性的Meta分析

目的:总结阿帕替尼联合替吉奥治疗晚期胃癌的疗效及安全性,以期为临床提供更多的循证医学证据。方法:通过计算机文献检索中英文数据库,收集国内外公开发表的阿帕替尼联合替吉奥（试验组）对比替吉奥（对照组）治疗晚期胃癌的随机对照试验,检索时间截止于2019年8月21日,由两名研究者独立地筛选文献、提取资料并使用Cochrane风险偏倚评估工具评价文献质量后,主要采用Review Manager 5.3软件进行Meta分析。结果:共纳入20篇文献,合计1 150名患者。Meta分析结果显示,阿帕替尼联合替吉奥组患者客观缓解率［OR=2.02,95%CI（1.56,2.63）,P<0.000 01］、疾病控制率［OR=3.10,95%CI（2.30,4.17）,P<0.000 01］、中位总生存期［MD=3.99,95%CI（3.56,4.43）,P<0.000 01］均高于替吉奥组,两者中位无进展生存期无显著性差异［MD=1.24,95%CI（-1.19,3.67）,P=0.32］,不良反应中仅阿帕替尼联合替吉奥组的高血压发生率［OR=6.19,95%CI（1.89,20.23）,P=0.003］及蛋白尿发生率［OR=4.02,95%CI（1.11,14.62）,P=0.03］高于替吉奥组,其余不良反应间亦无显著性差异,另外阿帕替尼联合替吉奥组的IFN-γ、TNF-α水平高于替吉奥组,IL-10、IL-4、TSGF、CA199、CEA水平则低于替吉奥组。结论:当前证据显示,阿帕替尼联合替吉奥较单药替吉奥可获得更高的客观缓解率、疾病控制率、中位总生存期,不良反应较少,免疫功能有所提高,能有效降低肿瘤标志物水平。但受纳入研究数量及质量的限制,上述结论尚需开展更多高质量研究予以验证。     

替吉奥联合顺铂一线治疗晚期胃癌的疗效观察

[目的]观察替吉奥胶囊联合顺铂一线治疗晚期胃癌的临床疗效和毒副反应。[方法]共57例晚期胃癌患者入组。29例患者接受替吉奥联合顺铂治疗(S-1组),28例患者接受氟尿嘧啶联合顺铂治疗(5-Fu组),每2个周期行影像学检查评价疗效。[结果]S-1组和5-Fu组的有效率(RR)分别为20.7%和14.3%(P=0.774),疾病控制率(DCR)分别为82.8%和75.0%(P=0.473),中位无疾病进展生存期(PFS)分别为6.0个月和3.9个月(P=0.049),生活质量改善率分别为27.6%和10.7%(P=0.201),1年生存率分别为52.7%和41.2%(P=0.203),两组主要毒性反应为骨髓抑制及胃肠道反应,但差异均无统计学意义。[结论]替吉奥联合顺铂一线治疗晚期胃癌能提高患者PFS,且毒副反应可以耐受,值得临床进一步研究应用。     

替吉奥联合复方苦参注射液治疗老年晚期胃癌的疗效和安全性分析

目的 探讨替吉奥（S-1）联合复方苦参注射液治疗老年晚期胃癌的疗效和安全性。方法选取沈阳军区总医院肿瘤科收治的70岁以上老年胃癌患者63例,剔除中途因疾病进展而中止治疗及脱落的4例患者,共59例入组,按随机数字表法分为对照组（n=28）和联合组（n=31）,对照组口服单药S-1（40 mg/m2,2次/日）,联合组在其基础上联合复方苦参注射液（20 ml,d1～d14）,两组均28天为1个周期。评价两组的疗效、不良反应并随访生存情况。结果联合组总有效率（RR）和疾病控制率（DCR）分别为54.9%和90.3%,对照组的RR和DCR分别为393%和857%,差异无统计学意义（P>0.05）;两组的不良反应多为1～2级,其中联合组乏力、肝功损伤发生率分别为83.9%、74.2%,低于对照组的100.0%、96.4%,差异有统计学意义（P<0.05）;联合组的中位无进展生存期为9.0个月,长于对照组的 7.9个月,差异有统计学意义（P<0.05）;两组中位总生存期分别为14.6个月和13.1个月,差异无统计学意义（P>0.05）。结论S-1联合复方苦参注射液可延长老年晚期胃癌患者的无进展生存期,且不良反应轻微,安全性较高,值得临床推广。     

A phase II study of docetaxel and oxaliplatin combination in recurrent gastric cancer patients after fluoropyrimidine and/or cisplatin adjuvant treatment: a Korean Cancer Study Group Protocol ST06-02

Background

Surgery alone is no longer an adequate standard of care for patients with resectable gastric cancer. Thus, research efforts should focus on which regimens are the most effective for patients with recurrent gastric cancer after combined treatment with surgery and perioperative or adjuvant chemotherapy.

Methods

Patients with histologically confirmed and measurable advanced gastric cancer who showed a relapse even after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy received docetaxel (35?mg/m²) intravenously on day 1 and 8 plus oxaliplatin (100?mg/m²) intravenously on day 1 every 3?weeks until disease progression or unacceptable toxicity.

Results

A total of 34 patients with relapsed advanced gastric cancer who had received adjuvant chemotherapy with fluoropyrimidine and/or cisplatin for a median of 6?months (range, 1–48?months) were enrolled in this trial; 22 (64.7?%) patients had been exposed to both agents. Their median age was 58?years (range, 50–68?years). The overall response rate was 55.9?% (95?% confidence interval (CI), 38.3–73.5?%), including 1 complete response and 18 partial responses. At a median follow-up duration of 28.5?months (range, 9.2–50.7?months), the median progression-free survival for all patients was 5.3?months (95?% CI, 4.4–6.1?months) and the median overall survival was 13.8?months (95?% CI, 11.1–16.4?months). The most common grade 3 or 4 hematologic and nonhematologic toxicities were neutropenia (47.1?%) and diarrhea (17.6?%), respectively. Five patients (14.7?%) experienced febrile neutropenia.

Conclusions

Docetaxel and oxaliplatin combination chemotherapy was active and tolerable in patients with recurrent gastric cancer after fluoropyrimidine and/or cisplatin-based adjuvant chemotherapy.     

Phase I/II study of S-1 plus carboplatin in patients with advanced non-small cell lung cancer

The objective of this phase I/II study was to determine the recommended dose (RD) of S-1 and carboplatin (CBDCA), and to evaluate the efficacy and safety of this combination in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Chemotherapy-naïve patients were treated with S-1 given orally on days 1–14, and CBDCA infused intravenously on day 1, repeated every 3 weeks. RD was AUC5 of CBDCA and 80 mg/m² of S-1. Nineteen patients were treated at the RD. The overall response was 30.8% (95% confidence interval: 17.1–58.3%). The response rate in the RD was 36.8% (95% CI: 16.3–61.6%). The median overall survival time was 11.1 months (95% CI: 8.1–15.3 months) and the median progression-free survival time was 5.0 months (95% CI: 3.6–6.0 months). Major grades 3–4 toxicities were thrombocytopaenia (47%), anaemia (26%) and infection (16%). This is the first report to show promising activity of this combination in phase II, including survival data and manageable toxicity, especially in outpatients receiving treatment for advanced NSCLC.     

卡培他滨联合奥沙利铂治疗进展期胃癌68例

目的：观察卡培他滨联合奥沙利铂治疗进展期胃癌的疗效及安全性。方法：经病理证实的进展期胃癌患者，应用卡培他滨2000mg／m^2，分早晚2次口服，d1-d14，服用2周后休息1周；奥沙利铂130mg／m^2，静脉滴注，持续4h以上，d1，21天为1个周期。结果：全组68例患者，获CR2例，PR34例，总有效率为52．9％，中位疾病进展时间（TTP）为7．3个月。中位生存期（OS）11．9个月。1年生存率为42．9％。毒副反应以Ⅰ～Ⅱ度为主，出现Ⅲ度白细胞减少3例、血小板减少5例、恶心呕吐1例以及腹泻4例，无Ⅳ度毒副反应。结论：卡培他滨联合奥沙利铂治疗进展期胃癌有效率较高，毒副反应较低，患者耐受性好。     

Phase II study of S-1 as first-line treatment for elderly patients over 75 years of age with advanced gastric cancer: the Tokyo Cooperative Oncology Group study

Purpose

This prospective multicenter phase II study was carried out to investigate the efficacy, safety and pharmacokinetics of S-1 monotherapy in elderly patients over 75 years of age, with unresectable advanced or recurrent gastric cancer.

Methods

Patients had measurable or evaluable lesions according to the Japanese Classification of Gastric Carcinoma. S-1 (25–60 mg determined by the body surface area and creatinine clearance) was given orally, twice daily. A course of treatment consisted of 4-week administration followed by a 2-week rest period, and the patients received repeated courses.

Results

Thirty-three patients were enrolled. Pharmacokinetics of S-1 was studied in six patients, and the maximum plasma concentrations of respective metabolites after S-1 administration were found to be similar to those reported for younger cancer patients. The overall response rate in 33 patients was 21.2% (95% CI, 10.7–37.8%), and median progression-free survival was 3.9 months, with a median overall survival of 15.7 months. Frequently noted adverse events include leukopenia, neutropenia, anemia, anorexia, and fatigue. As for serious adverse events, relatively higher frequencies of anemia (9%) and anorexia (12%) of grade 3 severity were found, but there were no grade 4 episodes.

Conclusions

The results suggest that S-1 monotherapy is safe and useful for elderly patients with unresectable advanced or recurrent gastric cancer when the dose is selected with caution, taking into account renal function.     

SOX方案联合阿帕替尼一线治疗晚期胃癌的临床研究

目的 观察替吉奥、奥沙利铂联合阿帕替尼在晚期胃癌一线治疗中的临床疗效。方法 选择2015年2月至2016年10月于新疆维吾尔自治区人民医院就诊的晚期胃癌患者88例，随机分为试验组和对照组，每组44例。对照组给予替吉奥联合奥沙利铂（SOX方案）化疗，试验组在对照组的基础上应用阿帕替尼，比较两组患者的近期疗效、不良反应及生存情况。结果 试验组患者的客观缓解率明显高于对照组（40.91% vs 20.45%，χ²=4.238，P=0.037），疾病控制率与对照组比较差异无统计学意义（86.36% vs 70.45%，χ²=3.289，P=0.070）。试验组中位总生存期较对照组长（12个月 vs 9.5个月，χ²=4.254，P=0.039），中位无疾病进展生存期亦较对照组长（9个月 vs 6个月，χ²=8.815，P=0.003）；试验组高血压和手足综合征总发生率高于对照组（P＜0.05），其余不良反应发生率差异无统计学意义（P＞0.05）。结论 替吉奥和奥沙利铂联合阿帕替尼一线治疗晚期胃癌患者可取得较好的临床疗效，能有效延长患者的生存期和疾病进展时间，且安全性良好。     

吉西他滨单药或联合白蛋白结合型紫杉醇治疗东亚人群晚期胰腺癌临床疗效的荟萃分析

目的 系统评价吉西他滨单药和吉西他滨联合白蛋白结合型紫杉醇一线治疗东亚人群晚期转移性胰腺癌的疗效，以期为中国转移性胰腺癌临床一线治疗的合理用药提供依据。方法 按照预设的纳入和排除标准，在万方、Cochran Library、MEDLINE、PubMed和CNKI等数据库中系统性检索2010年1月至2018年6月发表的文献。主要观察终点为客观缓解率（ORR）， 次要终点为无进展生存期（PFS） 和总生存期（OS）。提取纳入文献的相关资料，采用Rav Man 3.5.0版软件进行Meta分析。结果 共纳入38项研究，合计1945例患者。吉西他滨单药治疗晚期胰腺癌的ORR为0.15（95％CI：0.11～0.18）、中位PFS为3.39（95％CI：2.74～4.05）个月、中位OS为7.39（95％CI：6.54～8.23）个月；吉西他滨联合白蛋白结合型紫杉醇治疗晚期胰腺癌的ORR为0.40（95％CI：0.29～0.52）、中位PFS为5.68（95％CI：4.30～7.06）个月、中位OS为9.80（95％CI：7.89～11.71）个月。结论 吉西他滨联合白蛋白结合型紫杉醇与吉西他滨单药比较， 具有明显的优效性，适合东亚人群，特别是中国晚期胰腺癌患者。     

A phase II study of S-1 monotherapy administered for 2 weeks of a 3-week cycle in advanced gastric cancer patients with poor performance status

Systemic chemotherapy for gastric cancer is often associated with treatment-related toxicity, which is particularly severe in patients with a poor performance status. In this paper, we describe the first study to evaluate S-1 monotherapy as an option for advanced gastric cancer patients who are not candidates for combination chemotherapy due to poor clinical condition. Fifty-two patients with Eastern Cooperative Oncology Group (ECOG) performance scale 2-3, whose general condition had made use of combination chemotherapy impossible, were enrolled. S-1 was administered to 30 patients as second- or third-line therapy. The initial dose of S-1 was 35 mg m(-2), administered b.i.d for 14 days every 3 weeks. With a median follow-up period of 33 weeks, the median progression-free survival, and overall survival were 11 weeks (95% CI, 8-14) and 33 weeks (95% CI, 19-47), respectively. The overall 1-year survival rate was 29% by intent-to-treat analysis. The overall response rate was 12% (95% CI, 3-21), and the percentage of stable disease was 35%, resulting in the disease control rate of 47% (95% CI, 32-60). Significant drug-related toxicity included grade 3 diarrhoea (14%), anorexia (14%), fatigue (10%), neutropenia (10%), and leucopenia (6%). In conclusion, this study indicated the modest activity of S-1 in gastric cancer patients with poor performance status.     

A phase II study of doxifluridine and docetaxel combination chemotherapy for advanced or recurrent gastric cancer

Background

The aim of this study was to establish the efficacy and safety of doxifluridine and docetaxel for patients with advanced or recurrent gastric cancer.

Methods

The regimen consisted of oral administration of doxifluridine 533 mg/m² per day on days 1–14 and an intravenous infusion of docetaxel 50 mg/m² on day 8. The primary endpoint was the overall response rate. The secondary endpoints were overall survival, progression-free survival, and toxicities.

Results

Between June 2004 and December 2006, a total of 40 eligible patients were enrolled in this study. Seven of them showed a partial response, with an overall response rate of 17.5%. The response rate was 18.8% in 32 patients with refractory tumors. The median progression-free survival time and the median overall survival time were 2.6 months and 12.7 months, respectively, in all 40 patients; and 2.6 months and 14.0 months, respectively, in the 32 patients with refractory tumors. Grade 3/4 hematological toxicity included neutropenia in 52.5%, leukocytopenia in 17.5%, and febrile neutropenia in 7.5%. Grade 3 or more nonhematological toxicities were infrequent.

Conclusion

The combination chemotherapy of doxifluridine and docetaxel was well tolerated and relatively effective when used as a second-line chemotherapy for advanced or recurrent gastric cancer.     

Phase II study of capecitabine and cisplatin as first-line combination therapy in patients with gastric cancer recurrent after fluoropyrimidine-based adjuvant chemotherapy

To evaluate the efficacy and safety of capecitabine and cisplatin in patients with recurrent gastric cancer after fluoropyrimidine-based adjuvant therapy. Patients with histologically confirmed and measurable advanced gastric cancer that had relapsed after fluoropyrimidine-based adjuvant chemotherapy received oral capecitabine (1250 mg m(-2) twice daily, days 1-14) and intravenous cisplatin (60 mg m(-2) over 1 h, day 1) every 3 weeks. In total, 32 patients were enrolled, of whom 30 were evaluable for efficacy and 32 for safety. A median of 5 cycles (range 1-10) was administered. One patient achieved a complete response and eight had partial responses, giving an overall response rate of 28% (95% CI, 13-44%). The median time to progression and median overall survival were 5.8 months (95% CI, 4.1-7.5 months) and 11.2 months (95% CI, 5.5-16.9 months), respectively. Grade 3 neutropenia and thrombocytopenia were observed in 38 and 6% of patients, respectively. Grade 2/3 nonhaematological toxicities included diarrhoea (19%), stomatitis (19%) and hand-foot syndrome (31%). No grade 4 toxicity, neutropenic fever or treatment-related deaths occurred. Capecitabine in combination with cisplatin was effective and well tolerated as first-line treatment in patients with recurrent gastric cancer after fluoropyrimidine-based adjuvant chemotherapy.