Safety and efficacy of single-day GemOx regimen in patients with pancreatobiliary cancer: a single institution experience

Background: GemOx (gemcitabine 1000 mg/m² >?100 min on day 1 and oxaliplatin 100 mg/m² on day 2 every 2 weeks) achieved a response rate of 26.8%, improved progression-free survival (PFS) but failed to demonstrate a benefit in overall survival (OS) compared with gemcitabine in pancreatic cancer. This regimen has regained attention after recent pooled- and meta-analysis suggested a survival benefit of gemcitabine–platinum doublets over gemcitabine. However, GemOx is associated with inconvenience to patients, early cumulative dose developing neuropathy and thrombocytopenia. In addition, fixed dose rate of gemcitabine showed no benefit >?30 min infusion schedule in the ECOG6201 study. Pharmacokinetic profiles of both drugs did not show statistically significant difference regardless of the order of administration.

Patients and methods: In order to create a more convenient and equally effective regimen, we conducted a retrospective study to evaluate the efficacy and safety of single-day modified GemOx (S-GemOx, gemcitabine 1000 mg/m² >?30 min and oxaliplatin 85 mg/m² >?2 h on day 1 every 2 weeks) in patients with pancreatic and biliary cancers.

Results: In all, 34 patients (median age 60 years, male/female: 17/17) received S-GemOx including locally advanced or metastatic pancreatic cancer (26) and biliary duct carcinoma (8). Median treatment was six cycles with duration of 12 weeks (range (r): 2 – 56). Median cumulative dose of oxaliplatin was 517.5 mg/m² (r: 85 – 2380). A total of 27 of 34 patients were evaluated for efficacy after initial staging: 1 (3.7%) complete response (CR), 4 (14.8%) partial response (PR), 18 (66.7%) stable disease and 4 (14.8%) progression of disease. Overall response rate (CR + PR) was 18.5%. Median PFS and OS were 7 and 11.6 months, respectively. All patients were assessed for toxicities. Grade 3/4 hematological toxicities include anemia (8%), neutropenia (11%), thrombocytopenia (5%), nausea/vomiting (3%), diarrhea (3%), hypersensitivity reaction (14%) and neuropathy (3%). No deaths occurred due to therapy.

Conclusions: S-GemOx regimen provides convenient schedule, toxicities appear to be comparable with GemOx. The incidence of neuropathy (3 vs 19.1%) and thrombocytopenia (5 vs 14%) are substantially lower compared with GemOx. Prospective studies of S-GemOx in a large patient population are warranted.     

卡培他滨联合奥沙利铂治疗晚期及复发性结肠癌的临床分析

目的观察卡培他滨联合奥沙利铂治疗晚期及复发性结肠癌的临床疗效及副作用。方法选择经病理证实的Ⅲ期和Ⅳ期晚期及复发性结肠癌患者36例,d1静脉滴注奥沙利铂130mg/m2;d1～14口服卡培他滨化疗2000mg/m2,分两次服用,早、晚饭后半小时各1次,1个治疗周期为3周,每位患者至少接受3个周期的化疗。结果经化疗达到CR的有7例,达到PR的有18例,达到SD的有9例,达到PD的有2例,总有效率为69.44%,中位缓解期为9.1个月,中位生存期为14.2个月,患者的毒副反应均较轻。结论卡培他滨联合奥沙利铂治疗晚期结肠癌疗效确切,不良反应小,值得推广应用。     

Comparative bioavailability study of capecitabine tablets of 500 mg in metastatic breast cancer and colorectal cancer patients under fed condition

Capecitabine (oral prodrug of 5-fluorouracil) is the first-line treatment for the metastatic breast and colorectal cancer. The objective of the study was to determine the bioequivalence between the test product (capecitabine tablets 500?mg) of Dr. Reddy’s Laboratories Limited relative to that of reference product XELODA^® (capecitabine) 500?mg tablets of Roche Registration Inc. in patients of metastatic breast or colorectal cancer stabilized with twice daily dosing of capecitabine monotherapy. This was an open-label, randomized, single dose, two-way cross-over bioequivalence study under fed conditions. The subjects received either of the treatments (test or reference) 30?min after consumption of a high fat, high calorie breakfast as a single morning dose of 2000?mg on two separate days (days 1 and 2) based on their body surface area. Blood samples were collected up to 10?h post-dose and analyzed for capecitabine using the validated liquid chromatographic mass spectrometric (LC-MS/MS) method. The least square mean ratio and 90% confidence intervals of C_max, AUC_0–t and AUC_0–∞ were within the regulatory acceptance criteria of 80.00–125.00% and considered as bioequivalent.     

希罗达联合奥沙利铂治疗晚期大肠癌17例临床观察

目的:观察希罗达联合奥沙利铂治疗晚期大肠癌的疗效与不良反应。方法:17例晚期大肠癌患者采用希罗达2500mg/(m2·d),分两次口服,第1～14天,休息7天。奥沙利铂130mg/m2 5%葡萄糖注射液500ml中静脉滴注2小时,第一天,21天为1周期,连用2周期以上评价疗效及不良反应。结果:15例中完全缓解(CR)1例,部分缓解(PR)7例,稳定(SD)5例,进展(PD)4例。有效率(RR)47.1%。不良反应主要为胃肠道反应,骨髓抑制,手足综合征,末梢神经炎,口腔黏膜炎。结论:希罗达联合奥沙利铂治疗晚期大肠癌的疗效确切,不良反应小,患者可以耐受。     

Small molecule dipeptidylpeptidase IV inhibitors under investigation for diabetes mellitus therapy

Importance of the field: Fluoropyrimidines with oxaliplatin or irinotecan, bevacizumab, cetuximab and panitumumab constitute the drugs currently approved by the FDA for the treatment of patients with metastatic colorectal cancer (mCRC). Patients who have progressed on the approved drugs pose a major challenge for medical oncologists, as the therapeutic choices outside the context of a clinical trial are limited.

Areas covered in this review: Mitomycin C is an old drug that acts synergistically with capecitabine and irinotecan. Relevant studies were identified in PubMed (years 1950 – 2009), Ovid, Cochrane database and the American Society of Clinical Oncology abstracts (years 1995 – 2009) using the following search terms: mitomycin C, fluorouracil, capecitabine, irinotecan, oxaliplatin, and colorectal cancer. Only studies using the combination of mitomycin C with one of the aforementioned agents were selected.

What the reader will gain: An overview of the clinical trials where mitomycin has been used in combination with modern compounds in the various settings of metastatic colorectal cancer.

Take home message: Mitomycin C combinations are less efficacious than modern drugs in the first-line treatment of colorectal cancer. However, they are acceptable alternatives for best supportive care in colorectal cancer that is refractory to standard regimens, as they show some modest efficacy at low cost.     

Phase I study of gefitinib, oxaliplatin, 5-fluorouracil, and leucovorin (IFOX) in patients with advanced solid malignancies

Summary Purpose: Aphase 1 study of gefitinib in combination with oxaliplatin, 5-fluorouracil and leucovorin (IFOX)was conducted to evaluate the safety and feasibility of this regimen. Patients and Methods: Patients with advanced solid malignancies were treated with escalating doses of gefitinib (250 mg or 500 mg once daily) in combination with FOLFOX (oxaliplatin, 5-fluorouracil, and leucovorin). The initial dose of oxaliplatin was 70 mg/m2 with sequential dose escalation to 85 mg/m2. Results: Sixteen patients received a total of 138 14-day courses of daily gefitinib in combination with FOLFOX. Escalation of gefitinib from 250 mg/d to 500 mg/d with FOLFOX was well-tolerated. In addition, no severe toxicities precluded subsequent dose escalation of oxaliplatin from 70 mg/m2 to 85 mg/m2 at which no dose-limiting toxicity was seen. No further dose escalation was performed as this represented the oxaliplatin dose administered in the standard FOLFOX-4 regimen. The most predominant toxicity was diarrhea, which was well controlled with oral antidiarrheal agents. Four partial remissions occurred in patients with metastatic colorectal cancer. Conclusions: Gefitinib as a 500 mg daily continuous dose was well tolerated in combination with full doses of FOLFOX-4.     

Economic analysis of a multicentre,randomised, phase III trial comparing FOLFOXIRI with FOLFIRI in patients with metastatic colorectal cancer in Greece

ABSTRACT

Introduction: An economic evaluation of the irinotecan, leucovorin, 5-fluorouracil (FOLFIRI) combination versus the irinotecan, oxaliplatin, leucovorin, 5-fluorouracil (FOLFOXIRI) regimen in patients with metastatic colorectal cancer was performed in the context of a randomised phase III study.

Methods: The trial did not find any differences in efficacy and, therefore, a cost-minimisation analysis was undertaken. Treatment cost accounts for the administration of first and second line chemotherapy, for concomitant medications, for laboratory and other examinations and hospitalisations due to treatment side effects. Unit prices used reflect 2006 and are common among NHS hospitals in Greece.

Results: The mean total cost of therapy in the FOLFOXIRI group (€18?344, 95% CI: €16?951–€19?776), was significantly higher than the FOLFIRI group (€12?201, 95% CI: €11?011–€13?427). Mean chemotherapy cost of the FOLFOXIRI group (€9016; 95% CI: €8338–€9669) was significantly higher than that of the FOLFIRI group (€4830; 95% CI: €4435–€5231). The next largest component of cost involves second line drugs, where the average cost per patient was €3306 (95% CI: €2479–€4237) in the FOLFIRI group and €3996 (95% CI: €3196–€4892) in the FOLFOXIRI group. The cost of hospitalisations was €1814 (95% CI: €1672–€1954) in the first group and €2663 (95% CI: €2469–€2859) in the second. The rest of the components represent a small part of the total cost and there are no differences in the two groups.

Conclusion: The combination of irinotecan, leucovorin, 5-fluorouracil has the same effectiveness as the combination of irinotecan, oxaliplatin, leucovorin, 5-fluorouracil in patients with metastatic colorectal cancer, nonetheless it is associated with a much lower overall treatment cost and it should be the preferred treatment regimen in this context.     

奥沙利铂联合卡培他滨治疗晚期胃癌临床观察

目的 观察奥沙利铂联合卡培他滨治疗晚期胃癌的疗效及毒副作用.方法 35例确诊为晚期胃癌患者采用奥沙利铂联合卡培他滨方案化疗,奥沙利铂130 mg/m2,静脉滴注2h,第1天;卡培他滨2500 mg/m2,分2次口服,第1 ～14 d,21 d为1个周期,2个周期后评价疗效.结果 全组完全缓解(CR)2例,部分缓解(PR) 17例,稳定(SD) 10例,进展(PD)6例,总有效率(CR+ PR)54.3％,肿瘤控制率(CR+PR+SD)82.9％,中位生存时间11.5个月,1年生存率40.0％.主要不良反应有骨髓抑制、外周神经毒性、胃肠道反应、手足综合征等.结论 奥沙利铂联合卡培他滨治疗晚期胃癌有一定疗效,患者耐受性良好,值得推广.     

奥沙利铂联合表阿霉素与卡培他滨一线治疗晚期胃癌的临床观察

目的：评价奥沙利铂联合表阿霉素与卡培他滨一线治疗晚期胃癌的有效性与安全性。方法晚期胃癌32例,奥沙利铂100 mg· m-2,静脉滴注2 h,第1天;表阿霉素50mg· m-2,静脉滴注10～15 min,第1天;卡培他滨1250 mg· m-2,分2次口服,连服14 d,21 d为1个周期。化疗每2周期后评价疗效和不良反应。结果2例因不能耐受化疗仅接受1个周期治疗未能评价疗效,30例可评价患者中完全缓解（CR）1例,部分缓解（PR）10例,疾病稳定（SD）13例,疾病进展（PD）6例。客观缓解率为（CR＋PR）36．66％,疾病控制率为（CR＋PR＋SD）80％。主要不良反应为中性粒细胞减少、末梢神经炎和恶心呕吐,无治疗相关性死亡。结论奥沙利铂联合表阿霉素与卡培他滨一线治疗晚期胃癌,近期疗效较好,不良反应可耐受,值得临床进一步探索。     

奥沙利铂联合亚叶酸钙及氟尿嘧啶治疗晚期大肠癌的临床分析

目的观察奥沙利铂联合亚叶酸钙及氟尿嘧啶方案治疗晚期大肠癌的临床疗效及毒副反应。方法 64例晚期大肠癌患者给予化疗方案为:L-OHP 130 mg/m2静脉点滴2 h,d1;CF 200 mg/m2,静脉点滴2 h,d1;5-FU 400 mg/m2静脉推注,后2 400 mg/m2微泵持续静脉滴注48 h。每2周重复,4周为1个周期,完成2个周期后判定疗效,按WHO标准评价客观疗效和毒副反应。结果全组64例均可评价疗效,其中完全缓解8例,部分缓解24例,稳定18例,进展14例,总有效率CR+PR=50.0%。中位肿瘤进展时间为5.6个月,中位生存时间为9.5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。结论奥沙利铂联合亚叶酸钙及氟尿嘧啶方案治疗晚期肠癌患者的近期疗效较好,毒副反应可以耐受,值得进一步研究应用。     

A Phase II,open-label,randomised study to assess the efficacy and safety of the MEK1/2 inhibitor AZD6244 (ARRY-142886) versus capecitabine monotherapy in patients with colorectal cancer who have failed one or two prior chemotherapeutic regimens

Objectives To assess the efficacy and safety of the MEK1/2 inhibitor AZD6244 (ARRY-142886) in patients with metastatic colorectal cancer who had failed one or two previous chemotherapeutic regimens that included oxaliplatin and/or irinotecan. Methods This was a Phase II, multicentre, open-label, randomised, two-arm, parallel-group study comparing AZD6244 with capecitabine monotherapy. Patients received either 100 mg twice daily oral AZD6244 free-base suspension every day or 1,250 mg/m² twice daily oral capecitabine, for 2 weeks, followed by a 1-week rest period, in 3-weekly cycles. The primary endpoint was the number of patients experiencing disease progression events. Results Sixty-nine patients were randomised in the study (34 and 35 patients in the AZD6244 and capecitabine groups, respectively). Disease progression events were experienced by 28 patients (∼80%) in both the AZD6244 and capecitabine treatment groups. Median progression-free survival was 81 days and 88 days in the AZD6244 and capecitabine groups, respectively. Ten patients in the AZD6244 treatment arm had a best response of stable disease. For capecitabine, best response was a partial response in one patient, with stable disease in a further 15 patients. The most frequently observed adverse events reported with AZD6244 were acneiform dermatitis, diarrhoea, asthenia and peripheral oedema, compared with hand-foot syndrome, diarrhoea, nausea and abdominal pain with capecitabine. Conclusions AZD6244 showed similar efficacy to capecitabine in terms of the number of patients with a disease progression event and of progression-free survival. AZD6244 is currently undergoing evaluation in Phase II trials in combination with other chemotherapeutic agents.     

卡培他滨联合表柔比星和奥沙利铂治疗晚期胃癌的临床观察

目的观察卡培他滨联合表柔比星和奥沙利铂治疗晚期胃癌的疗效及安全性。方法对19例晚期胃癌患者采用表柔比星75mg/m2静脉推注(d1),奥沙利铂130mg/m2静脉滴注2小时(d1),卡培他滨1250mg/m2口服,每天2次(d1-d14),每3周重复。2周期评价疗效及不良反应。结果全组19例患者均可评价疗效,其中完全有效2例(10.5%),部分有效8例(42.1%),稳定8例(42.1%),进展1例(5.3%),总有效率52.6%。主要不良反应为骨髓抑制及外周神经毒性,无化疗相关性死亡。结论卡培他滨联合表柔比星和奥沙利铂方案治疗晚期胃癌疗效较高,不良反应轻。     

奥沙利铂联合卡培他滨治疗晚期胃癌23例疗效观察

目的观察奥沙利铂联合卡培他滨治疗晚期胃癌的疗效及安全性。方法23例晚期胃癌患者给予奥沙利铂130mg／m^2静脉滴注2小时,第1天;卡培他滨1000mg／m^2口服,每日2次,第1—14天,3周为1个周期,连用3个周期。结果23例患者中CR1例,PR10例,SD9例,PD3例,RR为47．8％。中位缓解期5．6个月,中位生存时间10．8个月。不良反应主要为恶心、呕吐、腹泻、手足综合征、皮肤色素沉着、骨髓抑制等,毒副反应为Ⅰ-Ⅱ度。结论奥沙利铂联合卡培他滨治疗晚期胃癌疗效显著,耐受性良好。     

Tirofiban: an investigational plateletglycoprotein IIb/IIIa receptor antagonist

Introduction: Fluoropyrimidines with oxaliplatin or irinotecan plus bevacizumab is the standard chemotherapy combination in patients with advanced colorectal cancer (CRC). Gemcitabine acts synergistically with fluoropyrimidines to enhance the binding of thymidylate synthase and increase inhibition of DNA synthesis. The objective of this review is to evaluate the literature for evidence of efficacy and safety of fluoropyrimidine plus gemcitabine (FG) in patients with advanced CRC. Methods: Relevant studies were identified in PubMed, Ovid, Cochrane database and the American Society of Clinical Oncology abstracts using the following search terms: gemcitabine, fluorouracil, capecitabine and colorectal cancer. Only studies using the FG combination were selected. Results: Forty-two advanced CRC patients were evaluated in two Phase I studies and the maximum tolerated dose of gemcitabine was 900 – 1,000 mg/m² weekly with either bolus 5-fluorouracil (5-FU) or capecitabine. A total of 216 advanced CRC patients were evaluated in six Phase II studies. Gemcitabine (750 – 1,250 mg/m²) with either 5-FU (continuous infusion or bolus) or capecitabine was administered as first-line therapy in two studies and as third-line therapy in three studies. The range reported for overall response rate was 30 – 38.3%, median time to progression was 4 – 8.3+ months and median survival was 9.8 – 18+ months. The most commonly reported grade 3 – 4 toxicities were neutropenia, thrombocytopenia and mucositis. Conclusions: Fluoropyrimidine plus gemcitabine is clinically active in patients with refractory CRC demonstrating prolonged median time to progression and acceptable toxicity only when bolus 5-FU was not used. Studies are underway to evaluate the combinations of FG with other chemotherapy or targeted agents. Meanwhile, FG may be considered for patients with advanced CRC who are refractory to primary treatment without other options or who are not eligible for clinical studies.     

奥沙利铂联合卡培他滨方案治疗晚期胃癌的临床观察

目的观察奥沙利铂联合卡培他滨方案治疗晚期胃癌的近期疗效及安全性。方法对29例晚期胃癌患者采用奥沙利铂85 mg/m^2,静脉滴注,第1天;卡培他滨2500 mg/m^2/d分早晚2次餐后口服,第1-14天,每3周重复,连用2个周期以上。按照WHO实体肿瘤近期客观疗效评定标准进行评价。结果全组29例病例均可评价疗效。其中CR 2例（6.89%）,PR 9例（31.03%）,SD 11例（37.93%）,PD 7例（24.14%）,总有效率为37.92%。主要不良反应为中性粒细胞减少、手足综合征、恶心呕吐、腹泻等,均可逆,无治疗相关死亡。结论奥沙利铂联合卡培他滨方案二线治疗晚期胃癌,疗效肯定,耐受性良好,值得进一步研究。     

XELOX与FOLFOX4方案治疗晚期结直肠癌的近期疗效及毒副反应比较

目的比较草酸铂联合希罗达方案（XELOX）与草酸铂联合FU／LV（FOLFOX4）方案治疗的晚期结直肠癌的近期疗效和毒副反应。方法62例转移或复发晚期结直肠癌患者随机分为两组,草酸铂联合希罗达（XELOX）A组31例,草酸铂联合FU／LV（FOLFOX4组）B组31例。转移部位包括：肝脏32例,肺脏19例,淋巴结、软组织、肠道、附件、骨、脑、前列腺等。结果两组患者各有31例可评价疗效。A组,CR3例,PR12例,有效率（CR＋PR）48．4％,疾病进展时间（TTP）为6．21个月。B组CR4例PR13例,有效率（CR＋PR）54．8％,TTP为5．71个月。A组中性粒细胞减少发生率12．9％,显著低于B组45．2％（P=0．005〈0．01）;A组神经毒性发生率16．13％显著低于B组58．1％（P=0．001〈0．01）;A组的手足综合症发生率（48．4％）明显高于B组12．9％（P=0．002〈0．01）,但程度较轻,主要为Ⅰ-Ⅱ度。结论XELOX方案与FOLFOX4方案的疗效相近,但XELOX方案用药更为方便,安全性更好等优点。     

Characterization of nano oxaliplatin prepared by novel Fat Employing Supercritical Nano System,the FESNS®

Background: Oxaliplatin has long been used for the treatment of colorectal cancer via intra-venous infusion. In order to improve patient compliance, a solid dosage form for oral administration of oxaliplatin was prepared as nano-sized particles.

Method: Nano oxaliplatin was prepared employing Fat Employing Supercritical Nano System (FESNS^®) with Supercritical Fluid (SCF) apparatus by using myristyl alcohol as solvent. Morphology of nano oxaliplatin was examined by Scanning Electron Microscopy (SEM), and the particle size and zeta potential were confirmed with Dynamic Light Scattering (DLS). To characterize the nano oxaliplatin particles, solubility rate and in vitro efficacy study (MTS growth inhibition assay) were investigated compared to crude oxaliplatin as reference.

Result: FESNS^® provided reproducible nano oxaliplatin with high manufacturing yield (> 95%). SEM images showed that the particle size distribution of nano oxaliplatin ranged between 20 and 400?nm with the medium particle sizes (d₅₀) of about 164?nm determined by DLS. Pertaining to the long-term stability, no recrystallization of the nano oxaliplatin was observed with negative zeta potential in the state of solution. Nano oxaliplatin was completely dissolved within a couple of minutes in pH 4.0 and pH 6.8 buffer solutions while crude oxaliplatin took a couple of hours to go into solution. In case of MTS growth inhibition assay, the average concentration required to inhibit 50% of cell growth (GI₅₀) of nano oxaliplatin was decreased by about 45% in comparison to the crude oxaliplatin.

Conclusion: These results lead us to conclude that nano oxaliplatin would have a great potential for the improvement of efficacy and toxicity in human colorectal cancer treatment compared to the crude oxaliplatin.     

XELOX方案与FOLFOX方案治疗101例晚期大肠癌的临床观察

目的:比较奥沙利铂联合卡培他滨(XELOX方案)与奥沙利铂联合氟尿嘧啶+亚叶酸钙(FOLFOX方案)治疗晚期大肠癌近期疗效和不良反应。方法:101例晚期大肠癌患者随机分成XELOX组54例和FOLFOX组47例进行化疗。XELOX方案:奥沙利铂130 mg.m-2,静脉滴注,d1;卡培他滨2 500 mg.m-2.d-1,分早晚2次口服,d1～14。FOLFOX:奥沙利铂130 mg.m-2,静脉滴注,d1;氟尿嘧啶400 mg.m-2,静脉注射,d1;氟尿嘧啶2.4～3 g.m-2,静脉持续输注46 h,d1,2;亚叶酸钙200 mg.m-2,静脉滴注,d1。每3周重复。结果:XELOX方案总有效率(CR+PR)为46.30%,中位疾病进展时间7.8个月,中位生存期13.5个月。FOLFOX方案总有效率(CR+PR)为42.6%,中位疾病进展时间6.5个月,中位生存期11.8个月。2组疗效比较,差异无统计学意义(P>0.05)。结论:2种方案治疗晚期大肠癌有效率近似,不良反应均可耐受,但XELOX方案的耐受性、患者依从性更好。     

Xelox方案联合沙利度胺治疗胃癌术后淋巴结转移的近期疗效

目的探讨奥沙利铂、卡培他滨联合沙利度胺治疗胃癌手术后淋巴结转移的近期疗效。方法50例胃癌手术后淋巴结转移患者采用奥沙利铂,卡培他滨联合沙利度胺方案治疗共189个周期。结果完全缓解（CR）4例,部分缓解（PR）28例,无变化（NC）13例和进展（PD）5例,总有效率（CR＋PR）为64%（32/50）。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45例（90%）。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,卡培他滨联合沙利度胺方案治疗胃癌手术后淋巴结转移疗效较好,毒副反应能够耐受,可作为一线方案在胃癌手术后淋巴结转移的患者中应用。     

FOLFOX与XELOX方案治疗晚期结直肠癌毒性表现的系统评价

目的 系统评价氟尿嘧啶/亚叶酸钙联合奥沙利铂（FOLFOX方案）与卡培他滨联合奥沙利铂（XELOX方案）治疗晚期结直肠癌毒性差异,为晚期结直肠癌＂个体化＂药物治疗方案选择提供依据。方法 检索PubMed、Embase、Cochrane、CNKI等数据库和ASCO会议文献,采用系统评价的方法进行系统评价。结果共10个研究4084例患者纳入毒性的系统评价,结果 表明XELOX方案在手足综合症（RR=3.60,95%CI：2.27~5.72,P〈0.0001）、血小板减少（RR=1.83,95%CI：1.36~2.48,P〈0.0001）发生率高于FOLFOX方案,在中性粒细胞减少（RR=0.24,95%CI：0.14~0.41,P〈0.0001）发生率低于FOLFOX方案;恶心、呕吐、腹泻以及神经毒性发生率两方案无统计学差异。结论 在晚期结直肠癌治疗中,FOLFOX方案与XELOX方案在毒性反应方面各有特点,应结合患者具体情况,选择最宜治疗方案。