Single agent activity of oxaliplatin in heavily pretreated advanced epithelial ovarian cancer.
Single agent activity of oxaliplatin in heavily pretreated advanced epithelial ovarian cancer.
复制标题
奥沙利铂在经过深度治疗的晚期上皮性卵巢癌中的单药活性。
DOI：
10.1093/oxfordjournals.annonc.a010500
复制
发表时间：
1996
期刊：
影响因子：
--
通讯作者：
E. Cvitkovic
中科院分区：
文献类型：
--
作者：
P. Chollet;M. A. Bensmaïne;S. Brienza;C. Deloche;H. Curé;H. Caillet;E. Cvitkovic
背景
含铂化疗组合在晚期卵巢癌女性患者中取得较高的缓解率。不幸的是，大多数患者需要进一步的治疗选择。奥沙利铂（L - OHP）是一种二氨基环己烷（DACH）铂类类似物，在体外和体内对人类和鼠类细胞（包括卵巢细胞系）有活性，与第一代（顺铂，CDDP）和第二代（卡铂，CBDCA）铂类化合物无交叉耐药性。在一个单中心的同情用药项目框架内，对34例连续接受过铂类预处理且不符合其他II期试验条件的卵巢癌患者，研究了奥沙利铂单药的活性。
材料与方法
35例患者（其中34例符合条件）接受L - OHP治疗，初始中位剂量为100 mg/㎡，每3周1次（5例患者：58 - 89 mg/㎡；24例患者：90 - 100 mg/㎡；6例患者：120 - 130 mg/㎡），通过短时间（30分钟 - 2小时）静脉输注；每3周重复治疗，直至出现限制治疗的毒性反应或疾病进展。
结果
31例患者（既往化疗疗程中位数：3）可进行抗肿瘤活性评估，客观缓解率为29%。根据马克曼标准，在13例可评估的潜在铂敏感患者中有6例出现客观部分缓解（46%），在18例可评估的铂耐药患者中有3例缓解（17%）。耐受性良好，尽管分别有6例和8例患者既往接受过自体骨髓移植（ABMT）和腹盆腔放疗，但无3 - 4级（世界卫生组织标准，WHO）的白细胞减少和中性粒细胞减少。无肾毒性或耳毒性，恶心/呕吐症状为中度。唯一记录的3级（WHO）周围神经病变涉及一名基线时神经毒性状态为2级的患者。
结论
在重度预处理的卵巢癌患者中，奥沙利铂在血液学亚毒性剂量下具有29%的客观缓解率（ORR）单药活性，在铂难治性患者中也有客观缓解，这支持了其与其他现有铂类化合物无交叉耐药以及临床毒性特征不同的实验数据。这一预后不良的患者队列（62%为铂难治性患者，既往化疗疗程中位数为3）的中位总生存期为12个月，为进一步探索奥沙利铂在验证性II期研究和联合化疗研究中的作用提供了有力的经验基础。
BACKGROUND
Platinum-containing chemotherapy combinations achieve high response rates in women with advanced ovarian cancer. Unfortunately, most patients need further therapeutic options. Oxaliplatin (L-OHP) is a diaminocyclohexane (DACH) platinum analog active against human and murine cells in vitro and in vivo, including ovarian cells lines, with non-cross resistance characteristics with first (CDDP) and second (CBDCA) generation platinum compounds. The single agent activity of oxaliplatin in 34 consecutive platinum-pretreated ovarian cancer patients, not eligible for other phase II trials, was explored in a compassionate use program framework in a single institution.
MATERIALS AND METHODS
Thirty-five patients (34 of them eligible) were treated by L-OHP at the median initial dose of 100 mg/sqm q 3 weeks (5 patients: 58-89 mg/m2; 24 patients: 90-100 mg/m2; 6 patients: 120-130 mg/m2) by short (30'-2 hours) i.v. infusion; the treatment was repeated every three weeks until treatment limiting toxicity or disease progression.
RESULTS
Thirty-one patients (median previous chemotherapy lines: 3) were evaluable for antitumoral activity, with a 29% objective response rate. According to Markman's criteria, objective partial responses were seen in six out of 13 evaluable potentially platinum-sensitive patients (46%) and three responses in the 18 evaluable platinum-resistant patients (17%). The tolerance was excellent, with no grade 3-4 (WHO) leukoneutropenia despite previous ABMT and abdominopelvic radiotherapy in six and eight cases, respectively. There was no renal or ototoxicity, and nausea/vomiting were moderate. The only grade 3 (WHO) peripheral neuropathy recorded concerned a patient with a neurotoxicity status grade 2 at baseline.
CONCLUSION
The 29% ORR single agent activity of oxaliplatin at hematological subtoxic doses in heavily pretreated ovarian cancer patients, with objective responses in platinum refractory patients, supports experimental data on non cross-resistance and a differential clinical toxicity profile to other available platinum compounds. The 12 month median overall survival of this poor prognosis patients cohort (62% platinum-refractory patients, median number of three previous chemotherapy lines) gives a strong empirical basis for the further exploration of oxaliplatin's role in confirmatory phase II and combination chemotherapy studies.
影响因子：
45.3
作者：
MARKMAN, M;ROTHMAN, R;LEWIS, JL
通讯作者：
LEWIS, JL
影响因子：
11.2
作者：
R. Schilder;F. LaCreta;R. Perez;S. Johnson;J. Brennan;A. Rogatko;S. Nash;C. McAleer;T. C. Hamilton;D. Roby
通讯作者：
R. Schilder;F. LaCreta;R. Perez;S. Johnson;J. Brennan;A. Rogatko;S. Nash;C. McAleer;T. C. Hamilton;D. Roby
使用异丙铂治疗晚期可测量卵巢癌的二线治疗：西南肿瘤学小组的一项研究。
DOI：
10.1016/0277-5379(91)90470-x
发表时间：
1991
期刊：
European journal of cancer (Oxford, England : 1990)
影响因子：
--
作者：
Weiss,G;Green,S;Alberts,DS;Thigpen,JT;Hines,HE;Hanson,K;Pierce,HI;Baker,LH;Goodwin,JW
通讯作者：
Goodwin,JW