Front-line weekly chemotherapy with gemcitabine for unfit patients with non-small cell lung cancer (NSCLC)
Front-line weekly chemotherapy with gemcitabine for unfit patients with non-small cell lung cancer (NSCLC)
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DOI：
10.1016/j.lungcan.2004.01.023
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发表时间：
2004-09-01
期刊：
影响因子：
5.3
通讯作者：
Buccheri, G
中科院分区：
文献类型：
--
作者：
Ferrigno, D;Buccheri, G
自Gridelli及其同事首次证明化疗（在他们的情况下，长春瑞滨（VNB），单药）能够产生显着的生存益处以来，老年患者的化疗（CT）正在成为一种标准。关于CT用于不适合患者的情况知之甚少。这项II期试验的目的是对单药吉西他滨（GEM）（健择（R））作为不能手术或复发的非小细胞肺癌患者的一线化疗的活性、毒性和耐受性进行综合评价。如果患者有病理诊断且既往未接受过化疗，则符合资格;他们应小于76岁，体能状态（ECOG-PS）等于3;还需要知情同意。吉西他滨静脉输注，剂量为1250 mg/m2，每周1次，每月3周，每28天1次。给予治疗直至进展、持续毒性或拒绝。45名患者（39名配偶）入组研究;中位年龄为73岁（范围45-75岁）;细胞类型为：腺癌（21）、鳞状细胞（18）、大细胞（6）。以前的手术治疗包括三个肺叶切除术和一个肺切除术。由于快速临床恶化或撤回同意书，6名登记参加研究的患者从未开始治疗;其他6名患者提前暂停化疗。这些患者在“意向治疗”的基础上被纳入分析。中位化疗周期数为9（范围0-15）;中位剂量强度为预计的75%。毒性为轻度，主要为血液学毒性，从未危及生命（325次化疗前评价中仅1次出现4级毒性）。4例患者获得部分缓解（9%，C.I. 1-17%），其他6例患者有一定的肿瘤消退（13%，C.I. 3-23%）。估计的中位进展时间为17周（四分位数范围：9-24），中位生存期为35周（四分位数范围：20-51）。我们发现，吉西他滨单药治疗对于不能手术的非小细胞癌（NSCLC）患者是一种足够安全的治疗选择。(C)2004年由Elsevier爱尔兰有限公司出版
Chemotherapy (CT) for elderly patients is becoming a standard, since the first demonstration by Gridelli and co-workers that chemotherapy (in their case Vinorelbine (VNB), single agent) is capable to produce significant survival benefits. Much less is known concerning the use of CT for unfit patients. The purpose of this phase II trial was to perform a comprehensive evaluation of activity, toxicity, and tolerabitity of single-agent Gemcitabine (GEM) (Gemzar(R)) as a first-tine chemotherapy for unfit patients with inoperable or recurrent non-small cell lung cancer. Patients were eligible if they had a pathological diagnosis and no previous chemotherapy; they should be younger than 76, with a performance status (ECOG-PS) equal to three; informed consent was also required. Gemcitabine was given by intravenous infusion at a weekly dose of 1250 mg/m(2), 3 weeks per month, every 28 days. Treatment was given until progression, persistent toxicity, or refusal. Forty-five patients (39 mates) entered the study; median age was 73 years (range 45-75); cell types were: adenocarcinoma (21), squamous (18), large cell (6). Previous surgical treatments included three lobectomies and one pneumectomy. Because of rapid clinical deterioration or consent withdrawal, six patients, registered for study, never started their treatment; other six had early chemotherapy suspension. These patients were included in the analysis, on an "intent-to-treatment" basis. The median number of chemotherapy cycles was nine (range 0-15); median dose-intensity was 75% of projected. Toxicity was mild, mainly hematological and never life threatening (only 1 grade 4 toxicity out of 325 pre-chemotherapy evaluations). Four patients obtained a partial response (9%, C.I. 1-17%) and other six patients had some tumor regression (13%, C.I. 3-23%). The estimated median time to progression was 17 weeks (quartile range: 9-24), with a median survival of 35 weeks (quartile rage: 20-51).We have found that single-agent gemcitabine represent a sufficiently safe therapeutic option in unfit patients with inoperable non-small cell carcinoma (NSCLC). (C) 2004 Published by Elsevier Ireland Ltd.