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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 effect of first-line chemotherapy with paclitaxel and combination of paclitaxel and paclitaxel in the first-line chemotherapy for ovarian cancer and to observe the toxic effects of the two combination regimens and the two combination regimens on patients with ovarian cancer The impact of annual survival. Methods A multicenter controlled study was performed to divide 125 patients with postoperative pathologic diagnosis of advanced ovarian cancer into two groups. (1) Weekly treatment group: 51 patients, Taxol 60 ~ 80mg / m2, administered once a week, a total of 6 times. Pullin (drug release curve = 5.0) was administered only after the first week and the fourth week after the administration of taxol. 8 weeks for a course of treatment, chemotherapy for 6 weeks, rest for 2 weeks. After 2 courses (16 weeks), the curative effect was evaluated. (2) 3-week treatment group: 74 cases, 175mg / m2 paclitaxel, 3h intravenous infusion. Platinum: (drug release curve area of 5.0), the first day of each course combined with taxol + platinum, 3 weeks for a course of treatment, medication 6 courses (18 weeks) after the evaluation of the effect. RESULTS: (1) Decreased CA125: CA125 decreased satisfactorily in 102 patients (81.6%) after operation and chemotherapy, including 58 cases (78.4%) in the three-week treatment group and 44 cases (86.3% There was no significant difference between the two groups (P> 0.05). (2) Recurrence and uncontrolled condition: ① There were 32 cases (26.4%) of total recurrent and / or uncontrolled cases. Twenty-two patients (29.7%) experienced recurrence and / or uncontrolled disease in the 3-week therapy group, 8 of whom relapsed after> 6 months of discontinuation of chemotherapy, 9 of 6 patients who relapsed after stopping chemotherapy, and 5 patients who sustained tumor progression. There were 10 cases (19.6%) of recurrent and / or uncontrolled cases in the treatment group, including 2 cases of recurrent chemotherapy> 6 months, 6 cases of recurrent chemotherapy <6 months, 2 cases of continuous tumor progression, There was no significant difference between the two groups in recurrence and uncontrolled incidence (P> 0.05). ② The average time of tumor recurrence: The average recurrence time was 15.7 months in the three-week treatment group and 13.6 months in the peripheral treatment group (P> 0.05). The mean recurrence time was 16.5 months in the three-week treatment group and 15.6 months in the peripheral treatment group (P> 0.05). Survival: The 1-year survival rate was 95.2% in the 3-week treatment group and 78.7% in 2-year survival rate. The 1-year survival rate was 93.9% in the peripheral treatment group and 85.3% in the 2-year treatment group, There was no significant difference in annual survival rate (P> 0.05). (3) Toxicity and side effects: In the aspect of hematologic toxicity, bone marrow suppression was observed in 34 cases in 3 to 4 degrees of myelosuppression for 45.9% of the patients in the 3-week treatment group, and 3 to 4 degrees of myelosuppression in 14 cases in the peripheral treatment group. The incidence was 27.5%, the difference between the two groups was statistically significant (P <0.05). The incidence of neurotoxicity in 3-week therapy was slightly lower than in the treatment group, but the difference was not statistically significant (P> 0.05). Other toxic reactions, no significant difference between the two groups (P> 0.05). Conclusions (1) The clinical efficacy of taxol is the same as that of 3 weeks. (2) The incidence of myelosuppression in Taxol treatment group was significantly lower than that in 3-week treatment group. The other toxic effects were not statistically different from those in 3-week treatment group. (3) TAXU weekly treatment of toxic side effects lighter, more suitable for infirm and elderly patients and outpatient chemotherapy.