摘要
目的比较多西他赛联合泼尼松和米托蒽醌联合泼尼松一线治疗转移性激素抵抗性前列腺癌的远期疗效和安全性。方法2007年1月至2010年8月共入组转移性激素抵抗性前列腺癌患者62例，按照1：1随机平行分配人米托蒽醌联合泼尼松组（A组）和多西他赛联合泼尼松组（B组）。A组化疗方案：米托蒽醌12mg／m2，静脉滴注30min，第1天；泼尼松5mg，第1天开始每天2次口服。B组化疗方案：多西他赛75mg／m2，静脉滴注60min，第1天；泼尼松5mg，第1天开始每天2次口服。两组均以21d为1个周期，最多10个周期。使用t检验、X2检验Fisher检验及Log—rank比较A、B两组患者的总生存期差异，前列腺特异性抗原（PSA）反应率和反应维持时间，肿瘤病灶缓解率（ORR）以及所有用药患者的安全性。结果除1例入组后未用药外，实际治疗61例，其中A组31例，中位接受化疗4个疗程（1—10个疗程）；B组30例，中位接受化疗7个疗程（2—10个疗程）。2组患者PSA反应率分别为45．2％、70．0％，差异有统计学意义（）（x2=3．85，P〈0．05）；PSA反应维持时间分别为121d（20～323d）和168d（42～447d），差异无统计学意义；A、B组患者ORR分别为15．0％（3／20）和10．3（3／29），差异亦无统计学意义。A组死亡24例，中位生存时间为511d（95％CI：357～665d），B组死亡15例，中位生存时间为833d（95％CI：634～1032d），2组患者总生存时间差异有统计学意义（X2=4．20，P=0．040）。A组患者血小板降低发生率高于B组（x2=5．60，P=0．018），B组患者恶心呕吐（X2=4．32，P=0．038）、腹泻（Fisher精确检验，P=0．024）、乏力（x2=5．90，P=0．015）和脱发（x2=5．42，P=0．020）发生率均高于A组。结论多西他赛联合泼尼松较米托蒽醌联合泼尼松能显著延长中国人群转移性激素抵抗性前列腺癌的总生存时间，提高PSA的反应率。
Objective To compare docetaxel plus prednisone with mitoxantrone plus prednisone as first-line chemotherapy for metastatic hormone-refractory prostate cancer （mHRPC）. Methods From January 2007 through August 2010, 62 patients with mHRPC received 5 mg of prednisone twice daily were randomly assigned to receive mitoxantrone 12 mg/m2 every three weeks （group A） or 75 mg,/m2 every three weeks （group B）. The cycles of each regimen were less than 10 times. The primary end point was overall survival. The secondary end points were the prostate-specific antigen （PSA） response rate, the duration of PSA response and the objective tumor response rate （ORR）. All the t test, X2 test and Fisher＇s exact test were performed between 2 groups. Results Thirty-one patients enrolled in group A received a median 4 cycles of regimen （range 1-10）, whereas 30 patients enrolled in group B received a median of 7 cycles of regimen （range 2-10）. There were 45.2% patients in group A and 70. 0% in group B had PSA response （X2 =3.85, P 〈0. 05）. The duration time of PSA response was 121 days （range 20-323 days） in group A and 168 days （range 42-447 days） in group B, respectively. The ORR was 15.0（3/20） in group A and 10. 3% （3/29） in group B, respectively. The median survival was 511 days （95% CI： 357-665 days） in group A and 833 days （95% CI： 634-1032 days） in group B, respectively （X2 = 4. 20, P = 0. 040）. The incidence of thrombocytopenia in group A was higher than group B （ X2 = 5.60, P = 0. 018 ） ; the incidences of nausea and vomiting （X2 =4. 32, P =0. 038） , diarrhea （P =0. 024） , fatigue （X2 =5.90, P =0. 015） , and alopecia （ X2 = 5.42, P = 0. 020） in group B were higher than group A. Conclusion Docetaxel plus prednisone can lead to superior overall survival and PSA response rate in patients with mHRPC.
出处
《中华外科杂志》
CAS
CSCD
北大核心
2012年第6期539-542,共4页
Chinese Journal of Surgery
关键词
前列腺肿瘤
抗肿瘤联合化疗方案
紫杉烷类
泼尼松
米托蒽醌
幸存
Prostatic neoplasms
Antineoplastie combined chemotherapy protocols
Taxoids
Prednisone
Mitoxantrone
Survival
作者简介
通信作者：叶定伟，Email：dwye@shca．org．cn
