IRESSA在非小细胞肺癌脑转移患者的试药结果
肿瘤学年鉴15:1042-1047
,
2004
© 2004,肿瘤内科欧洲协会
G. L. Ceresoli1,*, F. Cappuzzo2, V.
Gregorc1, S. Bartolini2,
L. Crinò2 and E. Villa1
1) 圣raffaele科学研究所,肿瘤学系,米兰,
2)博洛尼亚医院肿瘤内科,博洛尼亚,意大利
摘要
背
景:脑转移瘤是一种常见的发生在治疗非小细胞肺癌(非小细胞肺癌)
。全脑放射治疗(放疗)是标准疗法。更积极的做法,如外科手术或放射治疗都只适用于在这类病人的一个子集。这种治疗仍充满着争议。IRESSA是一种口服,高度容忍的,具有抑制剂表皮生长因子受体相关酪氨酸激酶,,在以前接受过化疗的治疗非小细胞肺癌中,它已表现出活性。本研究的目的是评价IRESSA在非小细胞肺癌患者的脑转移瘤有效性和安全性。
病人与方法:从2001年1月至2003年5月,连续的有41个具有可衡量的脑转移瘤的非小细胞肺癌患者,被给予口头上每天服用250毫克的IRESSA。
37例以前接受过化疗,18例以前经全脑放射治疗,并至少完成后3个月才进入试验。
结
果:有局部反应(PR)的4例( 10 %
)
,疾病稳定的(SD)7例。
作为一个整体,疾病控制(DC)率(疾病控制(DC)= 有局部反应(PR)+疾病稳定的(SD))的为27
%
(
95 %置信区间的13 %至40 %
)
。中位有局部反应(PR)时间为13.5个月。整体病人中位无进展生存率(PFS)为3个月。患者以前经全脑放射治疗( p =
0.05 )
,以及腺癌( p = 0.08 )疾病控制率(DC)较高,
;腺癌患者也较长中位无进展生存率( p
= 0.04 )
。
IRESSA毒性轻微,其中一级1 / 2皮肤毒性及腹泻发生,分别为,24 %和10 %
的患者,。
结论:IRESSA能用于在非小细胞肺癌患者脑部疾病。由于标准治疗脑转移瘤方法的结果是令人失望,
IRESSA似乎是一个可行的新的治疗选择。
Annals of Oncology 15:1042-1047, 2004 © 2004 European Society for Medical Oncology Gefitinib in patients with brain metastases from non-small-cell lung cancer: a prospective trial G. L. Ceresoli1,*, F. Cappuzzo2, V. Gregorc1, S. Bartolini2, L. Crinò2 and E. Villa1
1 Department of Oncology, Scientific Institute San Raffaele, Milan; 2 Division of Medical Oncology, Bellaria Hospital, Bologna, Italy
*Correspondence to: Dr G. L. Ceresoli, Department of Oncology, Scientific Institute San Raffaele, Via Olgettina, 60, 20123 Milano, Italy. Tel: +39-02-26432514; Fax: +39-02-26437625; Email: ceresoli.giovanni@hsr.it
Abstract Background: Brain metastases are a common occurrence in patients with non-small-cell lung cancer (NSCLC). Whole-brain radiotherapy (WBRT) is the standard therapy; more aggressive approaches such as surgery or radiosurgery are indicated in a subset of patients only. The role of systemic treatments remains controversial. Gefitinib is an oral, highly tolerable, specific inhibitor of epidermal growth factor receptor-associated tyrosine kinase, which has shown activity in chemotherapy pre-treated NSCLC. The aim of this study was to evaluate the activity and safety of gefitinib in NSCLC patients with brain metastases.
Patients and methods: From January 2001 to May 2003, 41 consecutive NSCLC patients with measurable brain metastases were treated with gefitinib, given orally at daily dose of 250 mg. Thirty-seven patients had received previous chemotherapy and 18 patients had been treated previously with WBRT, completed at least 3 months before entering the trial.
Results: A partial response (PR) was observed in four patients (10%), with stable disease (SD) in seven cases, for an overall disease control (DC) rate (DC=PR+SD) of 27% (95% confidence interval 13% to 40%). Median duration of PR was 13.5 months. Median progression-free survival (PFS) of the whole population was 3 months. DC rate was higher in patients pre-treated with WBRT (P=0.05) and with adenocarcinoma histological type (P=0.08); adenocarcinoma patients had also a longer PFS (P=0.04). Toxicity was mild and consisted of grade 1/2 skin toxicity and diarrhoea, occurring in 24% and 10% of patients, respectively.
Conclusions: Gefitinib can be active on brain disease in NSCLC patients. Since the results of standard therapy for brain metastases in this clinical setting are particularly disappointing, gefitinib appears to be a possible new treatment option.
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