泰素周疗和三周疗法作为卵巢癌一线化疗的多中心对照研究

A multicenter randomized clinical trial of weekly paclitaxel and carboplatin vs three weeks paclitaxel and carboplatin as first line chemotherapy in epithelial ovarian cancer

目的比较泰素周疗和铂尔定联合化疗与泰素3周疗法和铂尔定联合化疗作为卵巢癌一线化疗的效果,观察两种联合方案的毒性作用及两种联合方案对卵巢癌患者两年生存期的影响。方法采用多中心对照研究的方法,将手术后病理学诊断为晚期卵巢上皮癌的125例患者分为两组。(1)周疗组:51例患者,泰素60～80mg/m2,每周给药1次,共6次。铂尔定(药释曲线=5.0)仅在第1周,第4周用完泰素后给药。8周为1个疗程,化疗6周,休息2周。2个疗程(16周)后评价疗效。(2)3周疗法组:74例,泰素175mg/m2,3h静脉滴注。铂尔定:(药释曲线面积为5.0),每疗程的第一天联合应用泰素+铂尔定,3周为1个疗程,用药6个疗程(18周)后评价疗效。结果(1)CA125下降情况:经手术和化疗后102例(81.6%)患者CA125呈现满意的下降,其中3周疗法组为58例(78.4%),周疗组为44例(86.3%),两组比较差异无统计学意义(P>0.05)。(2)病情复发和未控情况:①总的复发和/或未控病例有32例,占26.4%。3周疗法组复发和/或未控病例有22例(29.7%),其中停化疗>6个月的复发有8例,停化疗<6月的复发有9例,肿瘤持续进展为5例。周疗组复发和/或未控病例有10例(19.6%),其中停化疗>6个月的复发有2例,停化疗<6个月的复发有6例,肿瘤持续进展为2例,两组在病情复发和未控发生率上差异无显著意义(P>0.05)。②肿瘤复发平均时间:3周疗法组平均复发时间为15.7个月,周疗组平均复发时间为13.6个月(P>0.05)。③无瘤生存时间(progressfreesurvival,PFS)3周疗法组平均复发时间为16.5个月,周疗组平均复发时间为15.6个月(P>0.05)。④生存情况:3周疗法组1年生存率为95.2%,2年生存率为78.7%;周疗组1年生存率为93.9%,2年生存率为85.3%,两组在1年和2年生存率上差异无统计学意义意义(P>0.05)。(3)毒副反应的情况:在血液毒性方面:3周疗法组,有34例发生3～4度骨髓抑制,发生率为45.9%,周疗组有14例发生3～4度骨髓抑制,发生率为27.5%,两组差异有统计学意义(P<0.05)。在神经毒性方面3周疗法的发生率略低于周疗组,但差异无统计学意义(P>0.05)。其他的毒性反应,两组比较差异无统计学意义(P>0.05)。结论(1)泰素的临床疗效周疗与3周疗法相同。(2)泰素周疗的骨髓抑制发生率明显低于3周疗法,其他的毒性作用与3周疗法比较差异无统计学意义。(3)泰素周疗的毒副反应较轻,更适用于年迈体弱的患者和门诊化疗。

Objective To compare the efficacy of combination regiments of taxol given weekly plus carboplatin and taxol given every three weeks plus carboplatin. To observe the toxicity of the two regiments.To observe the two-year survival rate in the two groups. Methods Total 125 eligible patients in 13 centers of CGOG were entered into the two arms of this randomized clinical trial, of whom 51 were entered into weekly taxol group and 74 entered into 3 weeks taxol group. Results 81.6% （ 102/125 ） of patients had satisfactory decreasing of CA125 level after optimal cytoreductive surgery and chemotherapy. 86. 3% （44/51 ） of patients is in weekly group and 78.4% （ 58/74 ） of patients in three weeks group（ P 〉 0. 05 ） Relapse frequency is 29.7% in every three weeks group and 19. 6% in weekly group （P 〉0. 05）. Median interval to relapse is 15. 7 months in every three weeks group and 13.6 months in weekly group （P 〉0. 05）. One-year survival rate is 95.2% in every three weeks and 93.9% in weekly group （ P 〉 0. 05 ）. Two- year survival rate is 78.7% in every three weeks and 85.3% in weekly group （P 〉 0.05）. Grade Ⅲ and Ⅳ myelosuooression is 45.9% in three weeks group and, 27. 5% in weekly group （P 〈 0.05 ） .Conclusion （1）The two regiments had equal efficacy . （2）Myelosuppression was less frequency in the weekly group than in every three weeks group. （3） Weekly taxol therapy has mild toxicity and is more suitable for the old and feeble patients. Weekly taxol therapy can be conveniently administered in outpatients department.