Intravenous chemotherapy for resected gastric cancer:meta-analysis of randomized controlled trials

来源 :World Journal of Gastroenterology | 被引量 : 0次 | 上传用户:minister635298
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AIM:To assess the safety and efficacy of different intravenouschemotherapeutic regimens in patients with gastric carcinomaswho had undergone gastrectomy.METHODS:A meta-analysis of all the relevant randomizedcontrolled trials(RCTs)was performed.Language wasrestricted to Chinese and English.RCTs were identified fromMedline and Embase(1980-2001/4),and Chinese Bio-medicine Database(1990-2001/1).Literature referenceswere checked at the same time.We included randomizedand quasi-randomized trials comparing the efficacy ofintravenous chemotherapy after gastrectomy with that ofsurgery alone in patients with confirmed gastric carcinomaswho had undergone gastrectomy.Selection criteria were:randomized or quasi-randomized trials with following-upresults;Trials could be double-blind,single-blind or not blind;Chemotherapy groups were given intravenous chemotherapyafter gastrectomy without neo-adjuvant chemotherapy,intraperitoneal hyperthermic perfusion,radiotherapy orchemoimmunotherapy;Controlled group included thosereceiving gastrectomy alone.The following data wereextracted:the number of survival and death by the end ofthe follow-up;the different agents and doses of theintravenous chemotherapy;the baseline of the chemotherapygroup and the controlled arm;the serious adverse events;the statistical consideration;cost-effectiveness analysis.Thestatistical analysis was performed by RevMan4.1 softwarewhich was provided by the Cochrane Collaboration.A Pvalueof<0.05 was considered statistically significant.Meta-analysis was done with random effects model.Heterogeneitywas checked by chi-square test.Sensitivity analysis wasperformed by excluding the trials in which Jadad-scale wasonly i score.The result was expressed with odds ratio(OR)for the categorical variable.RESULTS:Fourteen trials involving 4543 patients wereincluded.Meta-analysis was done with random effects model. Heterogeneity and sensitivity analysis were performed also.The effect of intravenous chemotherapy after gastrectomywas better than surgery alone(odds ratio 0.56,95 %CI0.40-0.79).There was a significant difference between thetwo groups by u-test(P=0.0008).Sensitivity analysis revealedthe same difference(odds ratio 0.81,95 % CI 0.70-0.94).Offourteen trials,only three studies were of high qualityaccording to the Jadad-scale(with three score).There wasone meta-analysis trial and the others,about ten trials,wereof low quality.There was no trial which mentioned sample-size calculation,allocation concealment,intention-to-treatanalysis.Most of the trials didn’t describe the blind-procedure.There were five trials which detailed the side-effectsaccording to the toxicity grade by WHO standard.The side-effects halting treatment were haematologic and biochemicaltoxicity,debilitating nausea and vomiting.There were twopatients died of chemotherapy toxicity.CONCLUSION:Based on the review,intravenouschemotherapy after gastrectomy may have positive treatmenteffect on gastric cancer.However,the evidence is not strongbecause of the general low methodologic quality of the RCTs.Therefore,we can’t make the conclusion that intravenouschemotherapy after gastrectomy may have better treatmenteffect on gastric cancer than that of surgery alone.Rigorouslydesigned,randomised,double-blind,placebo-controlled trialsare required. AIM: To assess the safety and efficacy of different intravenous chemotherapeutic regimens in patients with gastric carcinomas who had undergone gastrectomy. METHODS: A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. Language wasrestricted to Chinese and English. RCTs were identified from Medline and Embase (1980-2001 / 4), and Chinese Bio-medicine Database (1990-2001 / 1) .Literature referenceswere checked at the same time. We included randomized and quasi-randomized trials comparing the efficacy ofintravenous chemotherapy after gastrectomy with that ofsurgery alone in patients with confirmed gastric carcinomaswho had undergone gastrectomy. Selection criteria were: randomized or quasi-randomized trials with following-upresults; Trials could be double-blind, single-blind or not blind; Chemotherapy groups were given intravenous chemotherapyafter gastrectomy without neo-adjuvant chemotherapy, intraperitoneal hyperthermic perfusion, radiotherapy or chemoimmunotherapy; Controlled gro the included ofreceiving gastrectomy alone.The following data wereextracted: the number of survival and death by the end of the follow-up; the different agents and doses of the intravenous chemotherapy; the baseline of the chemotherapygroup and the controlled arm; the serious adverse events; the statistical consideration; cost-effectiveness analysis. Statistical analysis was performed by RevMan 4.1 softwarewhich was provided by the Cochrane Collaboration. A Pvalue of <0.05 was taken seriously significant. Meta-analysis was done with random effects model. Heterogeneity was checked by chi-square test . Sensitivity analysis wasperformed by excluding the trials in which Jadad-scale was not only i score. The result was expressed with odds ratio (OR) for the categorical variable .RESULTS: Fourteen trials involving 4543 patients wereincluded. Meta-analysis was done with random effects model Heterogeneity and sensitivity analysis were performed also. The effect of intravenous chemotherapy after gastrectomywas better than surgery alone (odds ratio 0.56, 95% CI 0.40-0.79). There was a significant difference between thetwo groups by u-test (P = 0.0008) .Sensitivity analysis revealed the same difference (odds ratio 0.81, 95% CI Offourteen trials, only three studies were of high qualityaccording to the Jadad-scale (with three score). There was a meta-analysis trial and the others, about ten trials, were of low quality. There was no trial which mentioned sample-size calculation, allocation concealment, intention-to-treatanalysis. Most of the trials did not describe the blind-procedure. There were five trials which detailed the side-effectsaccording to the toxicity grade by WHO standard. side-effects halting treatment were haematologic and biochemical toxicity, debilitating nausea and vomiting.There were twopatients died of chemotherapy toxicity. CONCLUSION: Based on the review, intravenouschemotherapy after gastrectomy may have positive treatmenteffect on gastric cancer .However, the evidence is not strongb ecause of the general low methodologic quality of the RCTs.Therefore, we can not make the conclusion that intravenouschemotherapy after gastrectomy may have better treatmenteffect on gastric cancer than that of surgery alone .Rororouslydesigned, randomized, double-blind, placebo-controlled trialsare required .
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