首页> 中文期刊> 《徐州医学院学报》 >吉西他滨固定剂量率或标准输注联合奥沙利铂方案治疗进展期胰腺癌随机对照研究

吉西他滨固定剂量率或标准输注联合奥沙利铂方案治疗进展期胰腺癌随机对照研究

         

摘要

目的:探讨奥沙利铂分别与吉西他滨固定剂量率输注、常规输注联合应用对进展胰腺癌的治疗效果。方法67例初治、无法手术切除的进展期胰腺癌患者,随机分成研究组和对照组。研究组采用吉西他滨固定剂量率(10 mg· m-2· min-1)输注联合奥沙利铂方案,对照组采用吉西他滨标准输注(30 min)联合奥沙利铂方案化疗,每21天为一个周期,每例患者完成4周期(至少2周期)化疗。治疗期间随访评价2组疗效、不良反应。结果研究组、对照组的客观缓解率分别为32.35%(11/34)、12.12%(4/33),差异有统计学意义(P<0.05);临床获益率及临床受益反应研究组亦优于对照组,分别为67.65% vs.36.36%、61.76% vs.42.42%,二者比较差异有统计学意义(P<0.05);研究组、对照组的总生存时间分别为(335.36±19.45)天、(243.59±21.87)天,至肿瘤进展时间分别为(163.52±17.08)天、(147.39±16.44)天,组间比较差异有统计学意义(P<0.05)。不良反应方面,主要为血液学毒性,尤其Ⅲ-Ⅳ度白细胞、血小板减少发生率研究组明显高于对照组( P<0.05);而非血液学不良反应发生率2组相似( P>0.05)。结论吉西他滨固定剂量率输注联合奥沙利铂方案治疗进展期胰腺癌具有较高的客观缓解率及临床受益反应,延长了总生存时间及至肿瘤进展时间;非血液学不良反应发生率较低,患者耐受性较好;但其血液学毒性较为显著,需引起足够重视。%Objective To compare the efficacy of oxaliplatin combined with gemcitabine through fixed-dose or rou-tine infusion to treat advanced pancreatic cancer.Methods A total of 67 advanced pancreatic cancer patients who were recently diagnosed and unable to perform surgery were enrolled into the current study.They were randomly divided into the following groups:a research group in which patients received oxaliplatin in combination with gemcitabine through infu-sion at a fixed dose rate of 10 mg/m2 per minute, and a control group in which patients were administrated with oxalipla-tin combined with gemcitabine through routine infusion within 30 min.Each patient underwent at least two courses of treatment, 21 days in each course.Then, both groups were compared for efficacy and adverse reactions during follow-up visits.Results The objective response rate (ORR) was 32.35 % (11/34) for the research group and 12.12% (4/33) for the control.The clinical benefit rate and clinical benefit response( CBR) were 67.65%and 36.36%for the re-search group, and 61.76%and 42.42% for the control.These data were significantly different from each other ( P<0.05).The overall survival (OS) was (335.36 ±19.45) days for the research group and (243.59 ±21.87) days for the control.The time to progression (TTP) was (163.52 ±17.08) days for the research group and (147.39 ±16.44) days for the control.These data were significantly different from each other (P<0.05).The major adverse events in-cluded hematological toxicity, especially significantly increased incidence of Grade III/IV leucocytopenia and thrombocy-topenia (P<0.05).The incidence of non-hematological toxicity was similar between both groups (P>0.05).Con-clusion Oxaliplatin in combination with gemcitabine through fixed dose infusion is effective for treatment of advanced pancreatic cancer, with a higher ORR and CBR as well as longer OS and TTP.Its non-hematological toxicity is less fre-quent and well-tolerated, despite of its remarkable hematological toxicity which needs special attention.

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