吉西他滨联合洛铂与联合顺铂方案治疗术后辅助化疗失败的卵巢癌患者的疗效对比

目的:观察吉西他滨联合洛铂与联合顺铂方案治疗术后辅助化疗失败的卵巢癌患者的疗效及安全性。方法:自2011年6月21日至2016年5月30日，我科收治的初治失败的卵巢癌患者共73例入组，随机分为吉西他滨联合洛铂组（GL组）与吉西他滨联合顺铂组（GP组），比较两方案在平均化疗周期数、总有效率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）、总生存期（OS）及不良反应发生率等方面的差异。结果:两组患者的平均化疗周期数GL组（4.73±1.305）周期，GP组(4.03±1.341)周期，P=0.027，差异有统计学意义。ORR、DCR间的比较差异均无统计学意义（P=0.345；P=0.127）。GL组中位PFS为6.0个月（95%可信区间5.722~6.278个月），GP组5.0个月（95%可信区间4.209~5.791个月），P=0.414，无统计学差异。GL组中位OS为10.0个月（95%可信区间8.675~11.325个月），GP组9.0个月（95%可信区间8.296~9.704个月），P=0.308，无统计学差异。不良反应中，GL组轻中度血小板降低较多（P=0.006），GP组有较多的轻中度肝功能异常（P=0.007）、中重度恶心（P=0.043）及中重度呕吐（P=0.019）。其余不良反应两组间无统计学差异。结论:GL方案对于初治失败的卵巢癌患者而言是安全有效的，可达到与GP方案类似的治疗效果，不良反应较GP方案轻，但需要注意血小板降低。

Clinical observation between gemcitabine plus lobaplatin regimen and gemcitabine plus cisplatin regimen in treating ovarian cancer patients after the failure of postoperative adjuvant chemotherapy

Objective:To evaluate the effectiveness and safety of gemcitabine plus lobaplatin or cisplatin regimen in treating ovarian cancer patients after the failure of postoperative adjuvant chemotherapy.Methods:From 2011-06-21 to 2016-05-30，73 cases of ovarian cancer who met the enrollment standards were collected and randomized divided into gemcitabine plus lobaplatin group(GL group) and gemcitabine plus cisplatin group(GP group).The mean chemotherapy cycle was recorded and compared using two-samples t-test.The overall response rate(ORR)，disease control rate(DCR) and the adverse events were observed and compared using Chi-square test while the progression-free survival (PFS) and overall survival(OS) were recorded and compared using Log-rank test.Results:The mean chemotherapy cycle of GL group was(4.73±1.305)cycles and (4.03±1.341)cycles of GP group，the difference was statistical significant(P=0.027).There were no statistically significant differences between ORR(P=0.345) and DCR(P=0.127).The median PFS of GL group was 6.0 months(95% confidence interval 5.722~6.278 months) and that of GP group was 5.0 months(95%CI 4.209~5.791 months) but there was no statistical difference between them(P=0.414).The same result was observed in OS，the median OS of GL group was 10.0 months(95%CI 8.675~11.325 months) and 9.0 months(95%CI 8.296~9.704 months) of GP group but there was still no statistical difference between them(P=0.308).GL group had more gradeⅠ/Ⅱ thrombocytopenia(P=0.006) and GP group had more gradeⅠ/Ⅱ abnormal liver function(P=0.007)，grade Ⅲ/Ⅳ nausea(P=0.043) and vomiting(P=0.019).Conclusion:In treating ovarian cancer patients after the failure of postoperative adjuvant chemotherapy，GL regimen had the same therapeutic effects with GP group and the adverse events was less，mild and well tolerated except for thrombocytopenia.