紫杉醇或草酸铂联合氟脲嘧啶/亚叶酸治疗晚期胃癌的对比研究

目的：观察并比较紫杉醇联合氟脲嘧啶／亚叶酸（5-FU／CF）与草酸铂联合5-FU／CF治疗晚期胃癌的疗效及毒副反应：方法：随机将晚期胃癌患者分为两组：紫杉醇联合5-FU／CF组（A组）27倒．草酸铂联合5-FU／CF（B组）29例．每例患者至少完成2周期以上的化疗。结果：A组有效率（CR＋PR）为59．26％，中位缓解期5．8个月，中位生存期11．6个月、B组有效率（CR＋PR）为55．17％，中位缓解期6．2个月，中位生存期10．8个月。两组的主要毒副反应为骨髓抑制、神经毒性和消化道反应。两者相比A组的骨髓抑制、脱发较重．B组轻度腹泻的发生率稍高。结论：紫杉醇联合5-FU／CF与草酸铂联合5-FU／CF两方案治疗晚期胃癌疗效相当，毒副反应均可耐受。     

周剂量多西紫杉醇、奥沙利铂联合低剂量氟尿嘧啶方案治疗晚期胃癌的临床观察

目的：研究周剂量多西紫杉醇、奥沙利铂联合低剂量氟尿嘧啶（5-FU）持续滴注治疗晚期胃癌的近期疗效和毒副作用。方法：晚期胃癌31例，应用多西紫杉醇40mg／m^2，静滴1小时，每周1次，连用2周；奥沙利铂70mg／m^2，静滴2小时，每周1次，连用2周；5-FU200mg／m^2，连用14天。以上化疗方案每4周重复，2周期后评定疗效。结果：31例晚期胃癌总有效率67．7％，其中CR2例，PR19例。主要毒性反应为骨髓抑制、消化道反应、脱发等。结论：多西紫杉醇、奥沙利铂作为新的抗胃癌药物，联合低剂量5-FU持续滴注对晚期胃癌近期效果显著，毒副反应较小，可以作为晚期胃癌的一种选择方案。     

奥沙利铂加5-FU/CF联合顺铂腹腔温热灌注治疗晚期大肠癌的临床观察

目的 观察奥沙利铂(L—OHP) 氟尿嘧啶 亚叶酸钙(甲酰四氢叶酸)联合顺铂腹腔温热灌注治疗晚期大肠癌的近期疗效及毒副反应。方法 28例晚期大肠癌采用腹腔DDP灌注，全身予奥沙利铂 5-FU／CF化疗。结果 28例中CR1例，PR14例，CR PR为53．5％，腹水有效率为44．4％。毒副反应主要为周围神经毒性，但为可逆性。结论 L—OHP 5-FU／CF联合DDP腹腔温热灌注治疗晚期大肠癌疗效确切，值得进一步研究。     

长春瑞滨联合铂类治疗中晚期子宫内膜癌

目的：比较长春瑞滨和紫杉醇分别与铂类联合治疗中晚期子宫内膜癌的近期疗效及毒副反应。方法：33例晚期子宫内膜癌，治疗组（NP方案组）21例，长春瑞滨＋顺铂或卡铂化疗，长春瑞滨25mg／m^2，静注d1、8；顺铂25mg／m^2，静注d1～3，或卡铂（300mg／m^2或者AUC4～5）静脉滴注d1。对照组（TP方案组）12例：紫杉醇135～150mg／m^2，静注d1；顺铂或卡铂用法同前。结果：全组均完成2周期以上化疗，其中CR4例．PR14例，NC10例，PD5例。有效率（CR＋PR）54．54％。NP方案组，CR2例，PR9例，有效率（CR＋PR）52．38％；TP方案组，CR2例，PR5例，有效率（CR＋PR）58．33％，两组间无统计学差异（P〉0．05）。副反应主要为骨髓抑制、白细胞、血小板减少，Ⅲ～Ⅳ度发生率，NP组为71．43％，TP组为75．0％（P〉0．05）。结论：长春瑞滨＋铂类联合与紫杉醇＋铂类联合化疗治疗中晚期子宫内膜癌有相同的疗效且毒副反应可以耐受。     

周剂量多西紫杉醇、奥沙利铂联合5-氟尿嘧啶／亚叶酸钙治疗晚期胃癌疗效观察

目的：观察周剂量多西紫杉醇、奥沙利铂联合5-氟尿嘧啶／亚叶酸钙治疗晚期胃癌的近期疗效，毒副作用及生活质量改善情况。方法：18例晚期胃癌患者以多西紫杉醇25mg／m^2d1、d8、d15静脉滴注1小时，奥沙利铂65mg／m2d1、d8静脉滴注3小时，亚叶酸钙100mgd～d5静脉滴注2小时，5-氟尿嘧啶500mg／m^2 d1—d5静脉滴注4小时。4周为1个周期，2周期为1个疗程。所有病人至少接受2周期以上。客观疗效（CR＋PR）和毒副作用按WHO进行评价，生活质量按临床受益反应（cBR）进行评价。结果：18例均可评价疗效，完全缓解（CR）0例，部分缓解（PR）10例，总有效率55．6％，临床受益反应有效率72％，中位唧5．6月。主要毒副反应为骨髓抑制，消化道反应和神经毒性，大部分为Ⅰ～Ⅱ级，可以耐受。结论：每周低剂量多西紫杉醇、奥沙利铂联合5-氟尿嘧啶／亚叶酸钙治疗晚期胃癌近期疗效好，毒副反应轻，耐受性好，病人生活质量明显改善。     

奥沙利铂联合卡培他滨治疗胃癌术后淋巴转移的近期疗效

[目的]探讨奥沙利铂联合卡培他滨治疗胃癌手术后淋巴转移的近期疗效。[方法]48例胃癌手术后淋巴转移患者采用奥沙利铂联合卡培他滨方案治疗共176个周期。[结果]CR4例，PR28例，NC12例和PD4例，总有效率（CR＋PR）为66．7％f32／48）。中位缓解期6．2个月，中位生存期12.3个月，1年生存率为60．5％，临床受益者共44例（90．5％）。毒副反应可耐受，无患者因为毒副反应终止治疗，无相关死亡出现。[结论]奥沙利铂加卡培他滨方案治疗胃癌手术后淋巴转移疗效较好。毒副反应能够耐受。可作为一线方案在胃癌手术后淋巴转移的病人中应用。     

改进的多西紫杉醇联合顺铂方案治疗晚期非小细胞肺癌的临床观察

目的目前临床上广泛应用多西紫杉醇联合顺铂作为晚期非小细胞肺癌（NSCLC）的一线化疗方案，但传统3wk方案毒副反应较大。因此本研究为比较多西紫杉醇联合顺铂改进的3wk方案与传统3wk方案治疗晚期NSCLC的疗效、毒副反应及1a生存率。方法68例经组织学或细胞学确诊的Ⅲb或Ⅳ期NSCLC病人，随机分为两组，分别接受改进方案（A组）和传统3wk方案（B组）化疗。A组：多西紫杉醇总剂量按75mg／m^2，分2次分别于d1、d8，静脉滴注；每天顺铂25mg／m^2，静脉滴注，dl-d3，每3wk重复；B组：多西紫杉醇75mg／m^2，静脉滴注，d1，顺铂用法同A组，每3wk重复。2周期后评价疗效与毒副反应，并随访la生存率。结果两组均无CR，A组PR10例，SD20例，PD4例，总有效率为29.4％；B组PR11例，SD20例，PD3例，总有效率为32.4％；A组1a生存率为38．2％，B组1a生存率为35.3％，两组疗效（P=0．793）及1a生存率（P=0．801）差异无显著性。中性粒细胞Ⅲ／Ⅳ度减少A组17．6％；B组47．1％，两组差异有显著性（P=0．010）。结论多西紫杉醇联合顺铂改进的3wk方案治疗NSCLC与传统3wk方案相比，疗效相似，但血液学毒性明显下降，耐受性好。     

不同方法输注氟脲嘧啶、亚叶酸钙联合奥沙利铂治疗晚期消化道肿瘤的临床研究

目的:比较氟脲嘧啶(5-FU)不同输注法联合亚叶酸钙、奥沙利铂对晚期消化道肿瘤疗效及不良反应。方法:76例晚期消化道肿瘤患者随机分成A、B2组,A组36例,5-FU采用双周疗法;B组40例,5-FU采用持续5天滴注疗法。结果:A组CR 6例(胃癌4例、大肠癌2例),PR 18例(胃癌8例、大肠癌10例),总有效率66.67％(胃癌75％、大肠癌60％)。B组CR 4例(胃癌3例、大肠癌1例),PR 12例(胃癌5例、大肠癌7例),总有效率40％(胃癌44.44％、大肠癌36.36％),二组比较有显著性差异(P<0.01)。主要副作用有:白细胞数下降、感觉神经毒性、口腔粘膜炎、腹痛及腹泻等,A、B 2组相比无显著性差异(P>0.05)。结论:5-FU双周疗法联合亚叶酸钙、奥沙利铂较持续5天滴注疗法有效率明显提高,且未增加不良反应。     

拓扑替康、依托泊甙联合顺铂治疗小细胞肺癌的临床观察

目的：比较拓扑替康、依托泊甙联合顺铂与EP方案治疗小细胞肺癌的临床疗效和毒副反应。方法：患随机分为两组，A组使用TEP方案：TPT0．75～1．25mg／m^2／d，静滴30分钟，d1～5，VP-16 100mg口服或静滴，d2～6，DDP 40mg／d，静滴d1～3；B组使用EP方案：VP-16 100mg静滴或口服d1～5，DDP 40mg／d静滴d1～3。结果：A组14例病例，CR21．43％，PR56．14％，有效率为78．57％；B组13例病例，CR23．08％，PR38．46％，有效率为61．54％。主要毒副反应为血液学毒性及消化道反应。结论：拓扑替康、依托泊甙联合顺铂治疗小细胞肺癌临床效果好，虽然毒副反应较大，但值得进一步研究。     

氟尿嘧啶和亚叶酸钙联合紫杉醇和奥沙利铂双周方案治疗晚期胃癌

目的：评价氟尿嘧啶和亚叶酸钙联合紫杉醇和奥沙利铂双周方案治疗晚期胃癌的有效性和安全性。方法：选择晚期胃癌患者先静脉滴注紫杉醇135mg／m^2（3h），再静脉滴注奥沙利铂85mg／m^2和亚叶酸钙400mg／m^2（2h），接着持续静脉滴注氟尿嘧啶2400mg／m^2（46h），每14d为1周期。研究的主要终点是有效率。结果：32例患者入组，总有效率是62．5％，其中4例完全缓解（CR），16例部分缓解（PR）。1年生存率为56．3％。在既往没有接受过化疗的25例患者中，有效率为68．0％。常见的Ⅲ、Ⅳ级毒副反应是中性粒细胞下降（25．0％）、疲乏（18．8％）、周围神经病变（12．5％）、口腔炎（9．4％）、恶心（6．3％）、呕吐（6．3％）。没有出现治疗相关性死亡。结论：此联合方案治疗晚期胃癌具有良好的疗效和耐受性。     

Phase II study of oxaliplatin, 5-fluorouracil and leucovorin in previously platinum-treated patients with advanced gastric cancer.

BACKGROUND: Oxaliplatin shows preclinical activity in many cancer cell lines that are resistant to cisplatin, and also has synergism with 5-fluorouracil (5-FU). We undertook this study to evaluate the efficacy and toxicities of a combined oxaliplatin, 5-FU and leucovorin (LV) continuous infusion regimen in patients with advanced gastric cancer who progressed during or after treatment with 5-FU and platinum compounds. PATIENTS AND METHODS: Twenty-six patients with advanced gastric cancer, whose disease progressed while receiving, or after discontinuing, chemotherapy with a 5-FU and platinum regimen, were enrolled in this study. Treatment comprised oxaliplatin (85 mg/m2 on day 1) as a 2-h infusion followed by bolus 5-FU (400 mg/m2 on day 1), and 48-h infusion of 5-FU 2.4-3.0 g/m2 concurrently with LV 150 mg/m2. Cycles were repeated at 2-week intervals. RESULTS: Of the 23 evaluable patients, there were six partial responses (response rate 26%). All responding patients were among those who entered into this trial immediately after failure of previous chemotherapy with 5-FU and cisplatin. The median time to progression was 4.3 months and the median overall survival was 7.3 months. The most common hematologic toxicity was grade 1-2 anemia in 39 cycles (39%). No grade 4 leukopenia or thrombocytopenia were observed. The most common non-hematologic toxicity was nausea/vomiting (33%). Peripheral neuropathy of grade 1 or 2 was noted (27%), but there was no grade 3 or 4 neurotoxicity. CONCLUSIONS: This phase II study of oxaliplatin, 5-FU and LV continuous infusion showed activity in previously platinum-treated patients with advanced gastric cancer, with acceptable toxicities.     

FOLFOX４与FLP方案用于食管胃结合部癌和远端胃癌辅助化疗的比较

目的　回顾分析ＦＯＬＦＯＸ４方案与ＦＬＰ方案在食管胃结合部癌和远端胃癌根治术后辅助化疗中的疗效和不良反应。方法　２００７年３月至２００９年１０月,我科收治食管胃结合部癌及远端胃癌根治术后应用ＦＯＬＦＯＸ４方案及ＦＬＰ方案治疗的患者２６７例,其中食管胃结合部癌１２３例,远端胃癌１４４例,均经病理诊断证实。ＦＯＬＦＯＸ４方案：奥沙利铂８５ｍｇ／ｍ２静滴,ｄ１;氟尿嘧啶４００ｍｇ／ｍ２静推,６００ｍｇ／ｍ２持续静滴２２ｈ,ｄ１、ｄ２;亚叶酸钙２００ｍｇ静滴,ｄ１、ｄ２;２周为１周期。ＦＬＰ方案：顺铂３０ｍｇ／ｍ２静滴,ｄ１～ｄ３;氟尿嘧啶５００ｍｇ／ｍ２静滴４ｈ,ｄ１～ｄ５;亚叶酸钙２００ｍｇ静滴,ｄ１～ｄ５;３周为１周期。主要观察指标为无病生存期（ＤＦＳ）、总生存期（ＯＳ）及不良反应,并对两组疗效和不良反应进行比较。结果　食管胃结合部癌中,ＦＯＬＦＯＸ４方案组及ＦＬＰ方案组的中位ＤＦＳ分别为３５.９个月和１６.８个月（Ｐ＝０.００８）,中位ＯＳ分别为４１.３个月和２５.６个月（Ｐ＝０.０１３）。远端胃癌中,ＦＯＬＦＯＸ４方案组及ＦＬＰ方案组的中位ＤＦＳ分别为３５.８个月和３１.８个月（Ｐ＝０.９２５）,中位ＯＳ分别为４６.６个月和４３.５个月（Ｐ＝０.７２０）。ＦＯＬＦＯＸ４及ＦＬＰ方案耐受性均良好,血液学不良反应无显著性差异,ＦＯＬＦＯＸ４方案非血液学不良反应主要表现为外周神经毒性,ＦＬＰ方案为消化道反应。结论　在食管胃结合部癌辅助化疗中,与ＦＬＰ方案比较,ＦＯＬＦＯＸ４方案可延长患者的ＤＦＳ和ＯＳ,且不良反应能够耐受,可开展进一步前瞻性研究;在远端胃癌辅助化疗中,未发现上述两方案的ＤＦＳ或ＯＳ差异,不良反应能够耐受,均可作为根治术后辅助化疗方案。     

Two consecutive phase II trials of biweekly oxaliplatin plus weekly 48-hour continuous infusion of nonmodulated high-dose 5-fluorouracil as first-line treatment for advanced colorectal cancer

The combination of 5-fluorouracil (5-FU) plus leucovorin (LV) with oxaliplatin has become one of the standard treatments for advanced colorectal cancer (CRC). Two consecutive phase II trials assessed the efficacy and safety of combined therapy with oxaliplatin and high-dose 5-FU without LV for patients with advanced CRC. A total of 89 patients were enrolled in both trials. Fifty-nine patients in trial A underwent a scheduled regimen of biweekly oxaliplatin 85 mg/m(2) and weekly nonmodulated 5-FU 3.0 g/m(2). Increased incidence of toxicity led to a 25% reduction in the starting dose of 5-FU (2.25 g/m(2)) for trial B. Patients treated in trial B showed a higher cumulative dose and relative dose intensity for oxaliplatin and 5-FU than those treated in trial A. Response to treatment, time to progression (TTP), overall survival (OS), and duration of response were evaluated as efficacy variables. Overall response rate was preserved despite the reduction in 5-FU dose (55.9% and 63.0%, respectively). Median durations of responses were 10.6 and 10.4 months, median TTPs were 7.7 and 7.3 months, and OS times were 21.7 and 13.1 months, respectively. Reduction in the starting 5-FU dose from 3.0 to 2.25 g/m(2) resulted in a decrease in the main grade 3/4 hematologic toxicities (neutropenia, 22.0% to 10.0%) and nonhematologic toxicities (diarrhea, 52.5% to 23.3%; nausea/vomiting, 18.6% to 3.3%). Neurosensory toxicity was similar in both trials (16.9% and 16.7%). Biweekly oxaliplatin in combination with nonmodulated high-dose 5-FU is an active, well-tolerated treatment that offers a lower cost than a modulated schedule for patients with advanced, metastatic CRC.     

氟尿嘧啶/亚叶酸钙+紫杉醇联合化疗双周方案治疗晚期胃癌

背景与目的：近来有临床研究显示紫杉醇(paclitaxel,PTX)可用于治疗胃癌,与5．氟尿嘧啶(5-fluorouracil,5-FU)联合治疗晚期胃癌疗效显著,不良反应轻。本研究观察5-Fu／亚叶酸钙(1eueovorin,CF) PTX联合化疗双周方案治疗晚期胃癌的临床疗效和不良反应。方法：采用高剂量5-FU／CF PTX深静脉输注方案(CF 200mg／m^2,静滴2小时,第1天;5-FU 500mg／m^2,静脉推注,第1天;5-FU 1500mg／m^2,静滴46小时;PTX90mg／m^2,静脉输注3小时,第1天),化疗方案以每两周为1周期,重复4周期后评定疗效。结果：全组20例均可评价疗效,总有效率为65．0％(13／20),其中完全缓解(CR)率为10.0％(2／20),部分缓解率为55．0％(11／20)。无治疗相关死亡,主要不良反应为口腔炎、手足综合征和脱发。结论：5-FU／CF PTX联合化疗双周方案治疗晚期胃癌缓解率较高、不良反应可耐受,是治疗晚期胃癌安全有效的化疗方案。     

Treatment outcomes of oxaliplatin, 5-FU, and leucovorin as salvage therapy for patients with advanced or metastatic gastric cancer: a retrospective analysis

Purpose  We performed a single-institution retrospective study to evaluate the efficacy and toxicities of oxaliplatin, 5-fluorouracil (5-FU), leucovorin (LV) combination chemotherapy as salvage treatment in patients with metastatic or advanced gastric cancer. Methods  Sixty-two patients with advanced gastric cancer previously treated were eligible for the study. Patients received oxaliplatin 100 mg/m² and LV 100 mg/m² (2-h intravenous infusion) followed by 5-FU 2,400 mg/m² (46-h continuous infusion) every 2 weeks, and responses were assessed after every three cycles. Results  Fifty-nine out of 62 patients were assessable for response. Among them, 46 patients had previously been treated with cisplatin based chemotherapy. Patients had a median age of 57 years (range 32–76 years), 72.6% had an Eastern Cooperative Oncology Group performance status of 0 or 1. Total 296 courses of chemotherapy were administered as second-line (67.7%) or third-line (27.4%), and the median courses per patient was three cycles. Out of 59 evaluable patients, 14 partial responses were observed (overall response rate, 22.6%). Stable disease was observed in 22 patients (35.5%), and progressive disease in 23 patients (37.1%). The median response duration, time to progression, and overall survival were 2.3, 3.0, and 8.0 months, respectively. The major toxicities were neutropenia, mucositis, and peripheral neuropathy. Grade 3 or 4 hematologic toxicities included neutropenia in nine patients (14.5%) and thrombocytopenia in one patient (1.6%). Other grade 3 or 4 toxicities included mucositis in one patient (1.6%) and vomiting in two patients (3.2%). Grade 1 or 2 peripheral neuropathy were observed in 18 patients (29.0%), however there were no cases of grade 3 or 4 peripheral neuropathy and no treatment-related deaths. Conclusion  The combination of oxaliplatin, 5-FU and LV was effective and safe salvage chemotherapy in advanced gastric cancer patients.     

Mortality associated with daily bolus 5-fluorouracil/leucovorin administered in combination with either irinotecan or oxaliplatin: results from Intergroup Trial N9741

BACKGROUND: Intergroup Trial N9741 evaluated 5-fluorouracil (5-FU)/leucovorin (LV) administered in conjunction with either irinotecan or oxaliplatin in the first-line treatment of advanced colorectal carcinoma (CRC). The current report describes two treatment arms that were withdrawn from the protocol due to unexpected treatment-related toxicities and a high mortality rate. The complications observed in these arms highlight the importance of aggressive and immediate supportive care in the management of digestive toxicity. METHODS: In Trial N9741, patients were randomly assigned to receive one of the following six regimens: 1) irinotecan plus bolus 5-FU/LV (Arm A); 2) sequential irinotecan plus bolus 5-FU/LV (Arm B); 3) bolus 5-FU/LV only (Mayo Clinic regimen; Arm D); 4) oxaliplatin plus bolus 5-FU/LV (Arm E); 5) oxaliplatin plus infusional 5-FU/LV (Arm F); or 6) oxaliplatin plus irinotecan (Arm G). In the current study, the authors investigated treatment-related toxicity in patients who received either of the two combination regimens containing daily bolus 5-FU (i.e., patients in Arm B or Arm E). RESULTS: Sixty-one and 47 patients were enrolled in Arm B and Arm E, respectively. Diarrhea and neutropenia were the most common toxicities in both groups. Five patients in Arm B (8.2%) and 4 patients in Arm E (8.5%) died within 60 days of study entry. All fatal toxicities occurred within 15 days of treatment administration, and all deaths were associated with the simultaneous occurrence of multiple symptoms, which were dominated by Grade > or = 3 diarrhea. CONCLUSIONS: Combination regimens containing daily bolus 5-FU/LV and oxaliplatin or irinotecan can be associated with severe gastrointestinal toxicity and high mortality rates. Therefore, the authors recommend the use of more tolerable infusional 5-FU-based regimens in the treatment of metastatic CRC.     

A phase II study of oxaliplatin with low dose leucovorin and bolus and continuous infusion 5-fluorouracil (modified FOLFOX-4) as first line therapy for patients with advanced gastric cancer

To determine the activity and toxicities of a low dose leucovorin (ldLV) plus fluorouracil (5-FU) regimen, combined with oxaliplatin administered fortnightly (modified FOLFOX-4), as a first-line therapy for patients with advanced gastric cancer. Patients were treated with cycles of oxaliplatin 85 mg/m² on day 1 plus LV 20 mg/m², followed by 5-FU a 400 mg/m² bolus and a 22 hour continuous infusion of 600 mg/m² 5-FU on days 1 - 2 every two week intervals. Forty-five patients were enrolled in this study. Forty-two patients were assessable for response. One of the 42 patients demonstrated complete response, and 20 partial responses, and overall response rate of 50%. The median time to progression and overall survival time were 7.7 months (95% CI: 3.6 - 11.9 months) and 11.2 months (95% CI: 9.1 - 13.3 months), respectively. Major hematologic toxicities included grade 1 - 2 anemia (39.7%), neutropenia (30.4%) and grade 3 - 4 neutropenia (10.9%). Twelve cycles were associated with neutropenic fever. The most common non-hematological toxicities were grade 2 nausea/vomiting (20%). There was no treatment related death. The modified FOLFOX-4 regimen was found to be a safe and effective first line therapy in advanced gastric cancer.     

Multicenter phase II study of gemcitabine and oxaliplatin (GEMOX) as second-line chemotherapy in colorectal cancer patients pretreated with 5-fluorouracil plus irinotecan

PURPOSE: To evaluate the efficacy and tolerance of the gemcitabine/oxaliplatin (GEMOX) combination as second-line chemotherapy for patients with advanced colorectal cancer (CRC) pretreated with an irinotecan (CPT-11)/5-fluorouracil (5-FU)/leucovorin (LV) regimen. PATIENTS AND METHODS: Patients with documented disease progression during or after first-line treatment with CPT-11 and 5-FU/LV were enrolled. Gemcitabine (1,000 mg/m(2) days 1 and 8) and oxaliplatin (100 mg/m(2) day 1) were administered every 3 weeks. RESULTS: Partial responses were observed in 6 of the 34 (17.7%) patients enrolled (intention-to-treat analysis; overall response rate: 17.7%; 95% confidence interval 4.8-30.5%). Eight (23.5%) patients experienced disease stabilization and 20 (59%) disease progression (tumor growth control rate = 41.2%). The median duration of response was 5.5 months, and the median time to tumor progression 2.7 months. The median overall survival was 9.1 months (1-year survival rate: 44.0%). Grade 3 neutropenia and thrombocytopenia occurred in 18 and 15% of the patients, respectively. Other severe non-hematologic toxicities were rare. CONCLUSION: The interesting tumor growth control rate and the favorable toxicity profile of the GEMOX regimen in pretreated patients with advanced CRC strongly suggest that this regimen may provide an alternative therapeutic option for this group of patients.     

Phase II study of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin

Purpose

To evaluate the efficacy and safety of FOLFIRI regimen in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.

Methods

The FOLFIRI regimen consisted of intravenous infusion of irinotecan 180?mg/m² on day 1 plus leucovorin (LV) 400?mg/m² on day 1 plus 5-fluorouracil (5-FU) 400?mg/m² bolus on day 1 plus 46-hour intravenous infusion of 5-FU 2,400?mg/m², every 2?weeks as one cycle. The main selection criterion for this study was the advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.

Results

Of the 57 evaluable patients for efficacy, 4 (7.5%) had a partial response, 36 (67.9%) had stable disease, and 13 (24.5%) had progressive disease. Median progression-free survival was 4.8?months (95% CI 3.9?C5.7?months), and median overall survival was 7.8?months (95% CI 13.1?C16.5?months). Safety analysis was based on the data of 57 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia 16 (27.8%), nausea/vomiting 7 (12.3%), and diarrhea 1 (1.8%).

Conclusion

FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin in Chinese population.