一项评估沙铂联合吉西他滨治疗晚期实体瘤的开放性、剂量递增研究。

An open-label, dose-finding study of the combination of satraplatin and gemcitabine in patients with advanced solid tumors.

机构信息

Department of Medical Oncology, San Camillo and Forlanini Hospitals Rome, Italy ; Department of Science of Health, School of Medicine, University "Magna Graecia" Catanzaro, Italy.

出版信息

Front Oncol. 2012 Nov 22;2:175. doi: 10.3389/fonc.2012.00175. eCollection 2012.

DOI:10.3389/fonc.2012.00175

PMID:23189269

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3504330/

Abstract

PURPOSE

Satraplatin is a third generation oral platinum, which has demonstrated antitumor activity. The aim of this phase I study was to determine the maximum tolerated dose (MTD) of the combination of satraplatin and gemcitabine in patients previously treated with chemotherapy and in patients without prior chemotherapy.

PATIENTS AND METHODS

Two separate MTDs were planned in two different patient groups (those with and without prior chemotherapy treatment). Dose escalations were planned in cohorts of three patients. Tumor measurements were obtained every two cycles. Assessment of response was performed according to Response Evaluation Criteria in Solid Tumors (RECIST criteria v.1.0).

RESULTS

Thirty subjects were enrolled. A MTD of gemcitabine 1000 mg/m(2) days 1 and 8 plus satraplatin 60 mg/m(2) days 1-3, every 21 days was determined in the prior chemotherapy group. No MTD could be determined for the no prior chemotherapy group treated with this schedule. Five patients completed 12 treatment cycles; 22 serious adverse events (SAE) were observed. Although not an entry criteria, overall confirmed response was observed in 17 (24%) evaluable patients (complete response, CR = 1 and partial response, PR = 3) and in 3/7 (43%) patients with measure prostate cancer lesions.

CONCLUSIONS

In this phase Ib study, the combination of satraplatin and gemcitabine demonstrated to be safe and efficacious in particular in patients with prostate cancer.

摘要

目的

沙他铂金是第三代口服铂类药物，具有抗肿瘤活性。本 I 期研究的目的是确定先前接受过化疗的患者和未接受过化疗的患者中沙他铂金联合吉西他滨的最大耐受剂量（MTD）。

患者和方法

在两个不同的患者组（有和无先前化疗治疗的患者）中计划了两个单独的 MTD。剂量递增在每三例患者的队列中进行。每两个周期进行肿瘤测量。根据实体瘤反应评价标准（RECIST 标准 v.1.0）评估反应。

结果

共纳入 30 名受试者。在先前接受化疗的患者组中，确定了吉西他滨 1000mg/m²天 1 和 8 加沙他铂金 60mg/m²天 1-3，每 21 天的 MTD。未确定无先前化疗史患者按此方案治疗的 MTD。五名患者完成了 12 个治疗周期；观察到 22 例严重不良事件（SAE）。尽管不是入组标准，但在可评估的 17 名患者（完全缓解，CR=1 和部分缓解，PR=3）中观察到了 17 名患者（24%）的确认总缓解，并且在 7 名有前列腺癌病变的患者中观察到了 3 名（43%）患者的确认总缓解。