Randomised trial of four-drug vs less intensive two-drug chemotherapy in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis. Medical Research Council Lung Cancer Working Party.
Randomised trial of four-drug vs less intensive two-drug chemotherapy in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis. Medical Research Council Lung Cancer Working Party.
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DOI：
10.1038/bjc.1996.71
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发表时间：
1996-02
影响因子：
8.8
通讯作者：
Bailey, AJ
中科院分区：
文献类型：
--
作者：
Bleehen, NM;Girling, DJ;Hopwood, P;Lallemand, G;Machin, D;Stephens, RJ;Bailey, AJ
关键词：
这项随机试验的目的是比较作为对照的四种药物化疗方案与强度较低的两种药物方案在小细胞肺癌（SCLC）姑息治疗患者的生活质量（QL）、肿瘤反应和生存率方面的差异。和预后不良。共310例广泛性SCLC或局限性疾病但体能状态差的患者被随机分配至两种化疗方案，每种方案连续3天，间隔3周，共3个周期：依托泊苷、环磷酰胺、甲氨蝶呤和长春新碱（ECMV，154例患者）或依托泊苷和长春新碱（EV，156例患者）。患者使用鹿特丹症状自评量表、医院焦虑抑郁量表和每日日记卡评估生活质量。具体的疾病和治疗相关症状由临床医生记录。两组的缓解程度相似，但总的来说ECMV方案在缓解躯体症状和减少心理困扰方面具有上级优势。EV方案引起的毒性较低，特别是粘膜炎，使用Kaplan-Meier曲线，估计发生在34%的患者中，而ECMV组为54%。WHO 2级或更严重血液学毒性的估计发生率在EV组为21%，而在ECMV组为38%。在反应或生存方面没有总体差异; ECMV组的中位生存期为141天，EV组为137天，6个月时的生存率分别为37%和38%，1年时的生存率分别为12%和10%。然而，37例ECMV患者在开始第一个化疗周期后3周内死亡（其中24例在第2周），而EV患者为18（9）例。EV方案对于预后不良的SCLC患者是一种有用的姑息治疗方案。
This randomised trial was conducted to compare a four-drug chemotherapy regimen as a control vs a less intensive two-drug regimen in terms of quality of life (QL), tumour response and survival in the palliative treatment of patients with small-cell lung cancer (SCLC) and poor prognosis. A total of 310 patients with extensive SCLC or limited disease but poor performance status were allocated at random to two chemotherapy regimens, each given on 3 consecutive days at 3 week intervals for three cycles: etoposide, cyclophosphamide, methotrexate and vincristine (ECMV, 154 patients) or etoposide and vincristine (EV, 156 patients). QL was assessed by patients using the Rotterdam Symptom Checklist, the Hospital Anxiety and Depression Scale and a daily diary card. Specific disease- and treatment-related symptoms were recorded by clinicians. The levels of palliation were high and similar in the two groups, although the ECMV regimen was on balance superior in palliating physical symptoms and reducing psychological distress. The EV regimen caused less toxicity, particularly mucositis, which, using Kaplan-Meier curves, occurred in an estimated 34% of patients compared with 54% in the ECMV group. The estimated rates of WHO grade 2 or worse haematological toxicity were 21% in the EV compared with 38% in the ECMV patients. There was no overall difference in response or survival; the median survival periods were 141 days in the ECMV group and 137 in the EV group and the survival rates 37% and 38% at 6 months and 12% and 10% at 1 year respectively. Nevertheless, 37 ECMV patients died within 3 weeks of starting the first cycle of chemotherapy (24 of them during the 2nd week) compared with 18 (9) EV patients. The EV regimen is a useful palliative regimen for patients with SCLC and poor prognosis.
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影响因子：
8.8
作者：
Morittu, L;Earl, H M;Souhami, R L;Ash, C M;Tobias, J S;Geddes, D M;Harper, P G;Spiro, S G
通讯作者：
Spiro, S G
在小细胞肺癌中，计划的与计划进行的随机试验：一项癌症研究运动试验。
影响因子：
8.8
作者：
Earl, H M;Rudd, R M;Spiro, S G;Ash, C M;James, L E;Law, C S;Tobias, J S;Harper, P G;Geddes, D M;Eraut, D
通讯作者：
Eraut, D
影响因子：
8.8
作者：
de Haes JC;van Knippenberg FC;Neijt JP
通讯作者：
Neijt JP
影响因子：
168.9
作者：
HANSEN, HH
通讯作者：
HANSEN, HH
影响因子：
8.8
作者：
HOPWOOD, P;STEPHENS, RJ
通讯作者：
STEPHENS, RJ