紫杉醇治疗卵巢癌周疗与月疗的临床对比研究

China-made paclitaxel in the treatment of ovarian cancer :a clinical study of weekly therapy compared with monthly therapy of ovarian cancer

目的 近年来国内外已将紫杉醇与铂类联合应用作为治疗卵巢癌的一线化疗方案 ,但其最适用药方法未定 ,本文旨在比较紫杉醇联合铂类治疗上皮性卵巢癌时 ,周疗法和月疗法的两种不同给药方式的近期疗效和毒性反应。方法 将 116例上皮性卵巢癌患者随机分为两组 ,周疗组 5 9例 ,紫杉醇 60mg/m2 iv( 1h)d1,8,15 ,卡铂 (或顺铂 ) 3 0 0mg/m2 ( 70mg/m2 )ivd2 ,以上为一个周期 ,第 2 9天开始重复上述方案为第二个周期 ,至少两周期。月疗组 5 7例 ,紫杉醇 13 5mg/m2 iv( 3h)d1,卡铂 (或顺铂 ) 3 0 0mg/m2 ( 70mg/m2 )ivd2 ,3～ 4周为一周期 ,至少两周期 (用药顺序及注意事项同研究组 )。结果 紫杉醇治疗上皮性卵巢癌的总有效率为 5 8.6% ,初次化疗患者治疗的有效率为 76.4% ,其中周疗和月疗的有效率分别为 84.3 %和 68.4% ,两组间比较无显著性差异 (P >0 .0 5 ) ,周疗组和月疗组的中位生存期分别为 2 1个月和 17个月 ,两组间比较有显著性差异 (P <0 .0 5 ) ;对复发癌患者治疗的有效率为40 .7% ,其中周疗和月疗的有效率分别为 12 .5 %和 5 2 .6%。两组间比较有显著性差异 (P <0 .0 5 ) ;紫杉醇的毒副反应程度较轻 ,主要为白细胞减少 ,肌肉关节痛 ,脱发及胃肠道反应 ,且两组间无显著性差别。

Objective Theaimofthisstudywastomakeanassessmentoftheeffectandtoxicitiesofweeklytherapycomparedwithmonthly therapyofovariancancerbyChina -madepaclitaxel.Methods 116patientsweredividedintotwogroups .Weeklytherapygroup :paclitaxelwas administeredbyivinfusionatadoseof 60mg/m2 in 1-hour(days 1,8,15 )incombinationwithcarboplatin 3 0 0mg/m2 orcisplatin 70mg/m2 ivon day 2every 4weekswasconductedin 5 9patientswithovariancancer ;monthlytherapygroup :paclitaxelwasadministeredbyivinfusionatadoseof 13 5mg/m2 in 3 -hours(day 1)incombinationwithcarboplatin 3 0 0mg/m2 orcisplatin 70mg/m2 ivonday 2every 4weekswasconductedin 5 7pa tientswithovariancancer ,atleast 2coursesweregiven .Results theoverallresponseratewas 5 8.6% ,itwas 76.4%forthena ve -chemothera pypatients ,and 84.3 %intheweeklygroupand 68.4%inthemonthlygrouprespectively ,therewasnodifferenceinthetwogroups(P >0 .0 5 ) ; Medianprogression -freesurvival(PFS)intheweeklygroupandmonthlygroupwas 2 1monthsand 17monthsrespectively(P <0 .0 5 ) .theresponse rateinthepatientswithrecurrentdiseasewas 40 .7% ,itwas 12 .5 %and 5 2 .6%intheweeklygroupandmonthlygrouprespectively ,therewas greatsignificantdifferenceinthetwogroups(P <0 .0 5 ) .onthemajortoxicityassociatedwithpaclitaxelincludedmildneutropenia ,arthralgia ,myal giavomittingandseverealopecia .noseverehypersensitivityreactionswereobservedinthetwogroups .Conclusion inna ve -chemotherapypa tients ,china -madepaclitaxeltreatingovariancancerismuchmoreeffectiveinweeklytherapyregimenthanmonthlytherapyregimen ;inthepa tientswithrecurrentdisease ,whichregimen(weeklyormonthly)wouldbebetterdeservesfurtherevaluation .thetoxiceffectsaretolerabletothepa tientsinbothregimens .