吉西他滨联合铂类治疗铂类耐药复发性卵巢癌的疗效和安全性

Evaluation on efficacy and safety of gemcitabine combined with platinum-based chemotherapy for platinum-resistant recurrent ovarian carcinoma

目的探讨对铂类耐药复发性卵巢癌采取吉西他滨(GEM)联合奥沙利铂(OX),即GEMOX方案治疗的疗效和安全性。方法选择2013年1月至2017年1月,于四川大学华西第二医院接受治疗的32例铂类耐药复发性卵巢癌患者为研究对象。本次入院后,对其采取GEMOX化疗方案为GEM 1 000 mg/(m^2·d),第1天和第8天静脉滴注,同时联合采用OX的剂量为100mg/(m^2·d),第1天静脉滴注;3周为1个治疗周期,共计治疗2～6个周期。统计学分析32例患者的治疗效果、患者生存、病情进展及不良反应发生情况。本研究遵循的程序符合2013年修订的《世界医学协会赫尔辛基宣言》要求。结果 (1)根据实体瘤疗效评价标准(RECIST),对本组卵巢癌患者采用GEMOX方案治疗后,无一例达到完全缓解(CR),而部分缓解(PR)、疾病稳定(SD)和疾病进展(PD)率分别为21.9%(7/32)、28.1%(9/32)和50.0%(16/32)。本组铂类耐药复发性卵巢癌对GEMOX方案的总反应率为21.9%(7/32),临床客观反应率为50.0%(16/32)。(2)本组卵巢癌患者的中位总体生存(OS)期为10.5个月(95%CI:8.4～12.6个月),中位无进展生存(PFS)期为6.3个月(95%CI:4.6～7.9个月);一年OS率为34.4%,一年PFS率为12.5%。(3)本组卵巢癌患者血液性不良反应中,12.5%(4/32)患者出现3级中性粒细胞减少,6.3%(2/32)患者出现3级白细胞减少,3.1%(1/32)患者出现4级贫血;在非血液性不良反应中,3级恶心、呕吐和肝脏毒性发生率均为3.1%(1/32),1～2级疲乏为最常见不良反应,发生率为65.6%(21/32)。结论 GEMOX方案治疗铂类耐药复发性卵巢癌,具有一定治疗效果,并且患者能耐受其不良反应。

Objective To investigate the efficacy and safety of gemcitabine （GEM） combined with oxaliplatin （OX） （GEMOX） in treatment of patients with platinum-resistant recurrent ovarian carcinoma. Methods A total of 32 cases of platinum-resistant recurrent ovarian carcinoma patients who were hospitalized in West China Second University Hospital, Sichuan University from January 2013 to January 2017, were chosen as research subjects. The GEMOX regimen of GEM at the dose of 1 000 mg/（m 2·d） was given on day 1 and day 8 by intravenously guttae every 21 days a treatment cycle, and combined OX at the dose of 100 mg/（m 2·d） was delivered after GEM infusion on day 1 in the cycle, and the total treatment cycles were 2-6. The therapeutic effect, survival, progression and adverse reactions of 32 patients were analyzed statistically. This study was in line with World Medical Association Declaration of Helsinki revised in 2013. Results ①According to response evaluation criteria in solid tumors （RECIST）, after GEMOX chemotherapy, none of the ovarian carcinoma patients in this study had achieved complete remission （CR）, while rates of partial remission （PR）, stable disease （SD） and progressive disease （PD） were 21.9%（7/32）, 28.1%（9/32） and 50.0% （16/32）, respectively. The total response rate of platinum-resistant recurrent ovarian carcinoma to GEMOX was 21.9%（7/32）, and the clinical objective response rate was 50%（16/32）. ②Among the ovarian carcinoma patients in this study, the median overall survival （OS） time was 10.5 months （95% CI ： 8.4-12.6 months）, median progression free survival （PFS） time was 6.3 months （95% CI ： 4.6-7.9 months）, one-year OS rate was 34.4%, and one-year PFS rate was 12.5%. ③The hematological adverse reactions of 32 ovarian carcinoma patients showed that 12.5%（4/32） patients had grade 3 neutropenia, 6.3%（2/32） patients had grade 3 leukopenia, and 3.1%（1/32） patients had grade 4 anemia. The non-hematological adverse reactions showed that 3.1%（1/32） patients had grade 3 nausea and （or） vomiting, and hepatotoxicity. Grade 1-2 fatigue was the most common non-hematological adverse reaction among 32 ovarian carcinama patients in this Study, with a total incidence of 65.6%（21/32）. Conclusions The GEMOX is a regimen with a beneficial therapeutic efficacy and tolerable adverse reactions in platinum-resistant recurrent ovarian carcinoma patients.