Bevacizumab plus infusional 5-fluorouracil, leucovorin and irinotecan for advanced colorectal cancer that progressed after oxaliplatin and irinotecan chemotherapy： A pilot study

AIM： To evaluate the combination of bevacizumab with infusional 5-fluorouracil （5-FU）, leucovorin （LV） and irinotecan （FOLFIRI） in patients with advanced colorectal cancer （CRC） pretreated with combination regimens including irinotecan and oxaliplatin. METHODS： Fourteen patients （median age 56 years） with advanced CRC, all having progressed after oxaliplatin- and irinotecan-based combination chemotherapy, were enrolled in this study. Patients were treated with 2 h infusion of irinotecan 150 mg/m2 on d 1, plus bevacizumab 5 mg/kg iv infusion for 90 min on d 2, and iv injection of LV 20 mg/m2 followed by a bolus of 5-FU 400 mg/m2 and then 22 h continuous infusion of 600 mg/m2 given on two consecutive days every 14 d. RESULTS： The median number of cycles of chemotherapy was six （range 3-12）. The response rate was 28.5%, one patient had a complete response, and three patients had a partial response. Eight patients had stable disease. The median time to progression was 3.9 mo （95% CI 2.0-8.7）, and the median overall survival was 10.9 mo （95% CI 9.6-12.1）. Grade 3/4 neutropenia occurred in five patients, and two of these developed neutropenic fever. Grade 3 hematuria and hematochezia occurred in one. Grade 2 proteinuria occurred in two patients. However, hypertension, bowel perforation or thromboembolic events did not occur in a total of 90 cycles. CONCLUSION： Bevacizumab with FOLFIRI is well tolerated and a feasible treatment in patients with heavily treated advanced CRC.     

FOLFOX4方案治疗晚期胃癌的临床观察

目的 观察FOLFOX4方案治疗晚期胃癌的近期疗效和毒副反应.方法 30例晚期胃癌患者,先给予FOLFOX4方案,即:奥沙利铂(L-OHP)85 mg/m2静脉点滴2 h,d1;亚叶酸钙(CF)200 mg/m2静脉点滴2 h,d1、d2,随后5-氟尿嘧啶(5-FU)400 mg/m2静脉推注,d1、d2,5-FU 600 mg/m2微泵持续滴注22 h,d1、d2.2周重复.4个周期后以WHO评价标准评价疗效和毒性.结果 全组30例均可评价,其中完全缓解(CR)2例,部分缓解(PR)16例,稳定(SD)7例,进展(PD)5例,总有效率(CR+PR)60%.中位肿瘤进展时间(TTP)5.5月,中位生存时间(MST)为9个月.毒副反应主要是骨髓抑制,白细胞降低发生率达83.3%,其次为胃肠道反应,恶心呕吐发生率为80.0%,口腔粘膜炎为21.3%,腹泻36.7%,无Ⅳ度胃肠道反应,周围神经毒性发生率为50.0%.结论 FOLFOX4方案治疗晚期胃癌的近期疗效较好,毒副反应可以耐受,值得进一步研究应用.     

Non-platinum-based chemotherapy for treatment of advanced gastric cancer:5-fluorouracil,taxanes,and irinotecan

Despite numerous advances in treatment options,advanced gastric cancer(AGC)remains a major public health issue and the leading cause of cancer-related deaths.Cisplatin is one of the most effective broadspectrum anticancer drugs for AGC and a doublet combination regimen of either cisplatin-based or 5-fluorouracil(5FU)-based chemotherapy is generally used for treatment of patients with AGC.However,there is still no consensus on the best regimen for treating AGC.Recently,various new chemotherapeutic agents,including oral 5FU,taxanes,and irinotecan,have been identified as improving the outcomes for AGC when used as a single agent or in combination with nonplatinum chemotherapy.Nonetheless,it is still unclear whether non-platinum-based chemotherapy is a viable treatment option for patients with AGC.Accordingly,this review focuses on the efficacy and tolerability of non-platinum-based chemotherapy for patients with AGC.     

First-line panitumumab plus irinotecan/5-fluorouracil/leucovorin treatment in patients with metastatic colorectal cancer

Purpose  

Panitumumab monotherapy is approved for KRAS wild-type (WT) metastatic colorectal cancer (mCRC) progressing after standard chemotherapy. This study evaluated first-line panitumumab plus FOLFIRI in patients with mCRC.     

Randomized trial of 5-fluorouracil, leucovorin and cisplatin in advanced pancreatic cancer.

BACKGROUND/AIMS: Phase II trials of combined 5 fluorouracil, leucovorin and cisplatin have demonstrated an 18-28% response rate in advanced pancreatic carcinomas. We investigated the effect of this chemotherapy regime on patients' survival. METHODOLOGY: Patients included gave informed consent. They had an advanced and proven pancreatic adenocarcinoma. The trial was multicentric, prospective and randomized. It compared a 5-day course of leucovorin (200 mg/m2/day), 5-fluorouracil (375 mg/m2/day) and cisplatin (15 mg/m2/day) repeated every 21 days (23 patients) with a control group (22 patients). The main end points were survival time (Kaplan-Meier and log-rank methods) a[not readable: see text]side effects of chemotherapy. RESULTS: Association of leucovorin, 5-fluorouracil and cisplatin failed to demonstrate any advantage of this regimen compared with supported care alone. Median survival times were 8.6 months (SD +/- 1.8) and 7.0 months (SD +/- 0.6), respectively. The modulation of 5-fluorouracil by leucovorin and cisplatin was well tolerated with moderate toxic effects. CONCLUSIONS: This multicentric trial failed to demonstrate any advantage of the evaluated chemotherapy regime in the palliative treatment of cancer of the exocrine pancreas. Other trials including gemcitabine and/or radiotherapy are needed in advanced pancreatic adenocarcinoma.     

Regional administration of irinotecan in combination with 5-fluorouracil and leucovorin in patients with colorectal cancer liver metastases--a pilot experience

BACKGROUND/AIMS: Regional chemotherapy represents an effective approach for the control of isolated liver metastases of colorectal cancer. Fluoropyrimidines have been the basis of systemic and regional chemotherapy of this disease for several decades, but recent studies have demonstrated that the addition of irinotecan (CPT-11) ameliorates the results of systemic treatment. METHODOLOGY: Fifteen patients with isolated liver metastases of colorectal carcinoma were treated with regional administration of CPT-11 in combination with 5-fluorouracil/folinic acid (5-FU/FA). CPT-11 (100-200 mg, mean: 93 +/- 25, range: 51-125 mg/m2) was administered weekly in combination with 5-FU (1000-2000 mg, 857 +/- 182, range: 538-1301 mg/m2) and FA (100-350 mg). Peripheral blood leukocyte phenotype was examined during the treatment in selected patients. RESULTS: One patient achieved complete response, 4 patients had partial response, 7 patients had stable disease, 1 patient progressed and 2 patients were not evaluable. The response rate was 38% in evaluable patients, and a more than 50% decrease in serum carcinoembryonic antigen levels was observed in 12 out of 14 patients. The treatment was generally well tolerated. All patients, except one, are currently alive at mean follow-up of 11 +/- 6 (median: 10, range: 5-24) months. The therapy is still being continued in 8 patients. CONCLUSIONS: Weekly CPT-11/5-FU/FA is highly effective in the treatment of patients with metastatic colorectal cancer limited to the liver, even after failure of previous 5-FU/FA. The present regimen should be tested as a first line treatment in phase III trial.     

Combination chemotherapy comprising 5-fluorouracil,leucovorin, etoposide,and cis-diamminedichloroplatinum for the treatment of advanced gastric cancer

PURPOSE: The FLEP regimen (5-FU, LV, ETP, and CDDP) has been recommended as a combination chemotherapy to control advanced and recurrent gastric cancer. We performed a phase II study of this regimen in 49 patients with advanced gastric cancer. METHODS: The treatment regimen consisted of: 5-FU at 370 mg/m(2) (days 1-5, i.v. 24 h); LV at a dose of 30 mg (days 1-5, i.v. bolus); and ETP and CDDP each at 70 mg/m(2) (days 7 and 21, i.a. 2 h), which was repeated every five weeks. RESULTS: The overall response rate was 40.8% (20/49 patients) and the median survival time was 12.6 months (range 1.1-41.8). The adverse events were Grade 3/4 leukocytopenia (16.3%), Grade 3/4 thrombocytopenia (8.2%), Grade 3 nausea and/or vomiting (4.1%), and Grade 3 stomatitis (2.0%). CONCLUSIONS: Based on the encouraging response rate and prognosis, we recommend applying the FLEP regimen to patients with primary advanced gastric cancer.     

Clinical pharmacokinetics of oxaliplatin and 5-fluorouracil administered in combination with leucovorin in Korean patients with advanced colorectal cancer

Purpose: Oxaliplatin and 5-fluorouracil (5-FU) act synergistically in colorectal cancer. Here, we evaluated the pharmacokinetics of oxaliplatin and 5-FU administered in combination with leucovorin in Korean advanced colorectal cancer patients. Methods: Nine patients with advanced colorectal cancer were included in this study. The 3-week regimen consisted of oxaliplatin (2-h infusion, 130 mg/m² on day 1) followed by 5-FU and leucovorin (2-h infusion, 425 and 20 mg/m², respectively, from day 1 to day 5). Blood samples were taken and platinum concentrations in total plasma, plasma ultrafiltrate, and RBCs were determined. Plasma concentrations of 5-FU were also determined. Results: The C _max of oxaliplatin was observed at the end of infusion, with mean values of 4.66, 0.84, and 2.69 μg/ml for total plasma, plasma ultrafiltrate, and RBC samples, respectively. C _max ratios of total/free were significantly higher than those reported in other ethnic groups. An accumulation of platinum was observed in RBCs, but not in total plasma and plasma ultrafiltrate samples. A significant correlation was found between the total body clearance of ultrafiltrable platinum and creatinine clearance. The C _max of plasma 5-FU ranged from 23.9 to 533.8 ng/ml, indicating large inter-patient pharmacokinetic variations. Conclusions: This study shows that pharmacokinetics of oxaliplatin in Korean patients is comparable with that of other ethic groups, except for the higher C _max ratios of total/free. The C _max of 5-FU in plasma showed large variations among patients. Antitumor efficacy in Korean advanced colorectal cancer patients given oxaliplatin and 5-FU should be further evaluated with respect to pharmacokinetic variabilities.     

Phase II clinical trial of 5-fluorouracil, trimetrexate, and leucovorin (NFL) in patients with advanced pancreatic cancer

Background. Advanced pancreatic cancer has limited treatment options. 5-fluorouracil (5-FU) is frequently used in the treatment of pancreatic cancer. Preclinical studies suggest synergism between trimetrexate (TMTX), 5-FU, and leucovorin (NFL). Aim. We conducted a phase II trial to evaluate the activity and safety of NFL in pancreatic cancer. Method. Eligible patients (n=21) with untreated advanced pancreatic cancer were treated with 110 mg/m² intravenous (IV) THTX on day 1 and 200 mg/m² IV leucovorin prior to 500 mg/m² IV 5-FU on day 2. Oral leucovorin (15 mg every 6 h for seven doses) started intravenous 24 h later. Results. Treatment was administered for 6 wk followed by a 2-wk rest period. Response was evaluated every 8 wk. All patients were evaluable for response and toxicity. Most patients (80%) had distant metastases. Forty-five cycles of chemotherapy were administered. The most common serious toxicities were Grade 3 diarrhea (23.8%) and nausea and vomiting (14.2%). The response rate was 4.1% (95% CI, 0–23%), median survival was 6.8 mo, and 1-yr survival was 19%. Conclusion. Treatment with NFL is well-tolerated in patients with advanced pancreatic cancer. The median survival and 1-yr survival in these patients with poor prognosis compares favorably with other treatment options.     

草酸铂及羟基喜树碱联合亚叶酸钙和氟尿嘧啶治疗进展期结直肠癌的比较

目的：比较草酸铂及羟基喜树碱联合亚叶酸钙、氟尿嘧啶治疗进展期结直肠癌的近期疗效、不良反应和生存期．方法：经病理证实的进展期结直肠癌病例60例,40例(OLF组)采用草酸铂联合亚叶酸钙和氟尿嘧啶方案化疗92个周期,20例(HLF组)采用羟基喜树碱联合亚叶酸钙和氟尿嘧啶方案化疗40个周期,观察化疗不良反应,2-3周期后评价疗效,随访观察无疾病进展生存期、总生存期,统计1a生存率．结果：OLF和HLF组近期有效率分别为30．0%(12/40)和25．0%(5/20),无统计学差异(χ~2 =0．531,P=0．811)；中位无疾病进展生存期分别为6．4和7．3 mo,无统计学差异(u=1．5088,P＞0．05)；中位总生存期分别为10．2和10．8 mo,无统计学差异(u=0．3487,P＞0．05)；1 a生存率分别为34．09%和38．55%,无统计学差异(u= 0．3275,P＞0．05)．两组间Ⅲ,Ⅳ度不良反应均以骨髓抑制和消化道反应为主,其中腹泻发生率HLF组高于OLF组,有统计学差异(χ~2=7．876,P=0．044)．结论：OLF和HLF两方案治疗进展期结直肠癌疗效相似,前者外周神经毒性较常见,后者腹泻更常见．     

5-氟尿嘧啶节律性化疗对晚期胃癌患者的临床疗效观察

目的观察5-氟尿嘧啶节律性化疗对晚期胃癌患者的临床疗效。方法选择我院24例晚期胃癌患者,使用5-氟尿嘧啶500 mg静脉持续泵入12 h d1-21,4周1个疗程,3～9个疗程后,对接受至少3个疗程的患者进行疗效评价。结果 24例患者随访8～24个月,3例部分缓解(12.5%),9例病情稳定(37.5%),无1例患者完全缓解,12例患者病情进展(50.0%),疾病控制率为50.0%。治疗有效患者的中位疾病进展时间(TTP)为3.2个月。结论 5-氟尿嘧啶节律性化疗可以有效控制老年晚期胃癌患者的病情进展,不良反应少且轻。     

Phase II trial of 5-fluorouracil,high-dose leucovorin calcium,and dipyridamole in advanced prostate cancer

Summary To examine the effect of altering intracellular folate pools on the efficacy of 5-fluorouracil (FUra) in the treatment of advanced prostate cancer, we performed a phase II trial of FUra (300–370 mg m^–2 day^–1×5 as an i.v. bolus) combined with high-dose folinic acid (500 mg m^–2 day^–1×5.5 days by continuous i.v. infusion) and dipyridamole (75 mg p.o. every 6h×5.5 days) administered on a 28-day schedule in patients with stage D₂ disease. A group of 13 patients have been treated. The median age was 68 years (range 48–78 years); the performance status ranged from 50% to 90%. Among 12 evaluable patients, there were no objective responders; the median time to progression was 1.9 months. Median survival after entry on this trial was 8.6 months. Treatment with FUra, high-dose folinic acid and dipyridamole was well tolerated. Only one episode each of grade 3 leukopenia, granulocytopenia, and thrombocytopenia was observed. These results suggest that, despite previous trials demonstrating activity for FUra in stage D₂ prostate cancer, this disease may be relatively resistant to fluoropyrimidines and, thus, less amenable to biochemical modulation with high-dose folinic acid and dipyridamole.This study was supported, in part, by NCI Cancer Center support grant CA 33572     

Double modulation of 5-fluorouracil by leucovorin and low-dose methotrexate in advanced colorectal cancer

A phase II study was carried out to evaluate the efficacy and toxicity of a double biochemical modulation of 5-fluorouracil (5-FU) by methotrexate (MTX) and leucovorin (LV) in patients with advanced unresectable colorectal cancer. Forty-two patients with measurable metastases of colorectal cancer were treated with 5-FU in daily doses of 600 mg/m2 given in a 6-hour intravenous (i.v.) infusion on days 1-5, LV 50 mg/m2 i.v. on days 2,3 and 5, and MTX 40 mg/m2 i.v. on days 1 and 4, every 4 weeks. Twenty-eight patients had a single metastatic site, eleven double, whereas three had more than two metastatic sites. Objective response (one complete response) was observed in 12 of 40 patients (30%) (95% confidence interval 16-48), stable disease in 19 patients (47%) and progression in 9 patients (23%). Overall median survival was 12 months. Median time to progression was 6 months. Treatment was generally well tolerated. The most frequent adverse reactions were stomatitis (38%), nausea and vomiting (35%), diarrhea (31%), leukopenia (18%), and plantar-palmar erythroderma (15%). The combination of 5-FU, LV and MTX seems to be an active regimen in advanced colorectal cancer.     

Effect of chemotherapy with 5-fluorouracil on intestinal permeability and absorption in patients with advanced colorectal cancer

5-Fluorouracil (5-FU), in association with leucovorin (LV), is the most used chemotherapy agent in the treatment of colorectal cancer. Response rate, as well as side-effect incidence, increases with the dose intensity of regimens that are used. The most common dose-limiting toxicity for 5-FU/LV modulation is diarrhea. To assess the modification of small intestinal function, we investigated the changes in intestinal permeability (IP) and intestinal absorption (IA) in 41 chemo-naive patients (21 men and 22 women; mean age, 61 +/- 9 years) with advanced colorectal cancer after treatment with the association of folinic acid and 5-FU. After chemotherapy administration, we found a marked increase in IP and a reduction in IA, measured as cellobiose-mannitol (CE-MA) ratio (p < 0.0001) and D-xylose absorption (p = 0.0001), respectively. Patients who experienced diarrhea have an increase in CE-MA ratio and a reduction in D-xylose absorption values, both statistically significant. Cellobiose-mannitol ratio and D-xylose absorption tests can be used for the assessment of toxic effect of 5-FU on mature intestinal epithelium and also for evaluating the role of cytoprotective agents.     

Adjuvant chemotherapy with folinic acid and 5-fluorouracil in patients with locally advanced rectal cancer previously treated by preoperative radiochemotherapy and curative tumor resection

BACKGROUND AND AIMS: The role of postoperative adjuvant chemotherapy in patients with rectal cancer pretreated by preoperative radiochemotherapy (RCT) and curative surgery is still poorly investigated. PATIENTS AND METHODS: We pooled data from both arms of a phase III trial in which patients with locally advanced (T3/4) rectal cancer were randomized to preoperative RCT alone or combined with pelvic radio-frequency hyperthermia. After surgery, R0-resected patients were scheduled to adjuvant chemotherapy with four monthly courses of 50 mg folinic acid (FA) and gradually escalated 5-fluorouracil (5-FU, 350-500 mg/m2, days 1-5). Reasons preventing initiation of chemotherapy and treatment-related toxicities were evaluated. Patients' characteristics and survival parameters were compared between the treated and untreated patient groups. RESULTS: Out of 93 patients, 73 (79%) started adjuvant chemotherapy, whereas 19 (21%) did not, mostly due to perioperative complications and refusal. Chemotherapy-related toxicities were mild to moderate in most cases, but--together with protracted postoperative complications--prevented the intended dose escalation of 5-FU in 71% of patients. Distant-failure-free (p=0.03) and overall survival (p=0.03) were improved in the chemotherapy group, although there was a negative selection of patients with unfavourable characteristics into the untreated patient group. INTERPRETATION/CONCLUSION: Adjuvant chemotherapy using FA and 5-FU can be safely applied to the majority of patients with rectal cancer pretreated by RCT and surgery. Survival data are not suitable to allow far-reaching conclusions, but are in line with suggestions of a favourable effect of adjuvant chemotherapy in these patients.     

奥沙利铂、顺铂联合5-FU/LV治疗晚期胃癌的系统评价

目的:收集中英文相关随机对照试验的研究结果进行Meta分析,对奥沙利铂联合5-FU/LV(FOLFOX)方案的疗效进行评价.方法:采用Cochrane系统评价方法.检索Cochrane Library、PubMed、EMBase、中国生物医学文献数据库(CBM)、中文期刊全文数据库,中文科技期刊全文数据库(CSJD)等数据库,并辅以手工检索和其他检索.结果:共8个随机对照试验662例患者纳入研究,其中1个随机对照研究来自美国,另7个均来自中国:且8篇RCT存在偏倚的可能性均为中等程度.FOLFOX与顺铂联合5-FU/LV(PLF)方案治疗胃癌在1年生存率方面差异无统计学意义,但在总的生存率方面有显著差异.其OR值和95%CI分别为1.37(0.93,2.01)、1.93(1.41,2.66).3/4级的不良反应中白细胞减少和恶心呕吐等治疗组轻于对照组;在外周神经毒性反应方面,治疗组重于对照组,差异有统计学意义;而血小板减少方面差异无统计学意义.其OR值和95%CI分别为0.48(0.28,0.83)、0.26(0.16,0.42)、7.38(2.16,25.23)及1.20(0.44,3.30).结论:FOLFOX方案总有效率优于PLF方案,但是1年生存率并不优于对照组.白细胞减少和恶心呕吐治疗组轻于对照组,外周神经毒性重于对照组.     

Gastrointestinal perforation during neoadjuvant chemotherapy with cisplatin and 5-fluorouracil in patients with esophageal cancer: a report of two cases

Neoadjuvant chemotherapy (NAC) followed by surgery is the standard treatment for esophageal squamous cell carcinoma diagnosed as clinical stage II/III in Japan, and the indications for chemotherapy for esophageal cancer are increasing. Here, we report two patients who suffered from upper gastrointestinal perforation during NAC for esophageal cancer. NAC with cisplatin and 5-fluorouracil (CF regimen) was performed for both patients. Emergency operations were performed in all the patients prior to curative surgery for esophageal cancer. Endoscopic examination should be performed to confirm peptic ulcers or scars before NAC with CF regimen, and premedication with a proton pump inhibitor and the avoidance of steroid use are recommended for patients with a history of peptic ulcer to prevent perforation during NAC. Whether the occurrence of perforations during NAC is a risk factor for recurrence or a poor prognosis should be investigated in patients with esophageal cancer.     

Neoadjuvant chemotherapy in locally advanced cervical cancer: two randomised studies

Between August 1990 and January 1992, 184 patients with squamous cell carcinoma of the cervix, FIGO stage IIBIV A were randomised (study 1) to receive either two cycles of bleomycin, ifosfamide-mesna and cisplatin (BIP) chemotherapy (CT) followed by radiotherapy (RT) ‘CT-RT Group’ a=94 or RT alone, RT Group n=90. In the ‘CT-RT Group’, of evaluable 89 patients, 64 responded: complete response (CR) four (4.5%) and partial response (PR) 60 (67.5%). Of the remaining 25 patients 23 had stable disease and two progressed. Eighty of 89 patients completed RT as planned. Following RT 56 (70%) achieved CR, 19 (23.7%) had residual disease and five (6.3%) had progressed. Patients aged>45 and those with Hb >10 gm/dL had significantly better response to CT. Further, CT responders had a better response to RT; 83% (49/59) vs 33.3% (seven/21), p<0.01. In the ‘RT Group’ 88 patients were evaluable; 61 (69.3%) patients achieved CR, 25 had residual disease and two progressed. The estimated overall survival at 48 months in the ‘CT-RT Group’ and the ‘RT Group’ is 38%+2.01 (SE) and 36%+1.85 (SE), p=0.59 respectively. In a subsequent randomised study (study 2) 36 patients with stage III B cervical cancer received three cycles of BIP (as above) followed by RT vs 36 patients who received RT alone. In the ‘CT RT Group’ 29 patients responded; CR-8 (22.2%>), PR-21 (58.3%). Six patients had no response to CT and one patient died of CT toxicity. Following RT - 24 of 35 (68.6%) patients achieved CR, eight had residual disease and three patients progressed while on RT. In the ‘RT Group’ - 21 of 36 (58.4%) achieved CR, 12 had residual disease and three progressed. Estimated survival was 71%> in the ‘CT-RT Group’ and 69% in the ‘RT Group’, p=ns. Nausea/vomiting, alopecia, grade I-II myelosuppression, diarrhoea and mucositis were the major side effects of CT. Three patients died of CT toxicity - two in study 1 and one in study 2. Cystitis, proctitis and local skin reaction after RT occurred equally in the two groups in both the studies. BIP CT prior to RT in patients with locally advanced cervical cancer results in a high response rate. Response to CT predicts response to RT. There is no increase in the toxicity to subsequent RT. Our studies have failed to demonstrate any significant difference in overall and disease-free survival when neoadjuvant CT is added prior to the standard RT regimen.     

FOLFOX4方案治疗晚期胃癌40例临床观察

目的观察FOLFOX4方案治疗晚期胃癌的临床疗效及毒副反应。方法40例晚期胃癌患者，给予FOLFOX4方案化疗。即：奥沙利铂（L-OHP）85mg／m^2。静脉点滴，2h，dl；亚叶酸钙（LV）200mg／m^2，静脉点滴，2h，d1，d2；氟尿嘧啶（5-FU）400mg／m^2静脉推注，后600mg／m^2微泵持续静脉滴注22h，d1，d2；每2周重复，4周为1周期。均治疗2周期以上，按WHO标准评价客观疗效和毒副反应。结果全组40例均可评价疗效，其中完全缓解（CR）3例，部分缓解（PR）17例，稳定（SD）13例，进展（PD）7例，总有效率（CR＋PR）50．0％。中位肿瘤进展时间（m）5．7个月，中位生存时间（MST）为9．8个月。毒副反应主要是骨髓抑制，胃肠道反应及外周神经毒性。白细胞下降发生率为75．0％。主要为Ⅰ／Ⅱ度反应，恶心呕吐发生率62．5％，腹泻30．0％。口腔粘膜炎22．5％。L—OHP引起的可逆性周围神经毒性发生率为45．0％，表现为肢端感觉异常，遇冷加重，但患者一般都能耐受。结论FOLFOX4方案治疗国人晚期胃癌的近期疗效较好，毒副反应可以耐受，值得进一步研究应用。