A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.
A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.
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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。
DOI：
10.1038/bjc.1991.351
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发表时间：
1991-09
影响因子：
8.8
通讯作者：
Eraut, D
中科院分区：
文献类型：
--
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
在一项化疗作为姑息性治疗的研究中，300名未经治疗的有限期和广泛期小细胞肺癌（SCLC）患者，在第一个化疗周期后没有疾病进展，被随机分配接受常规“计划”化疗或“按需”化疗（AR）。所有患者接受相同的化疗：环磷酰胺1 gm m-2静脉滴注，长春新碱2 mg静脉滴注，依托泊苷120 mg m-2静脉滴注，依托泊苷100 mg每日口服，第2天和第3天。计划化疗每3周定期进行一次。针对肿瘤相关症状或疾病的放射学进展给予AR化疗。两组患者每3周评估一次，给予最多8个化疗周期。使用每日日记卡进行详细的生活质量评估。接受AR化疗的患者的中位生存期（MS）并不明显差于接受计划治疗的患者[MS: planned = 36周（95% ci . 32-40周），AR = 32周（95% ci . 28-37周）P = 0.960]。在AR患者中，治疗间隔的中位数为42天。平均而言，AR患者接受的化疗是计划患者的一半。第一和第二化疗周期之间无治疗间隔（TFI）超过8周的AR患者比间隔时间少于4周的患者存活时间更长；[MS: TFI > 8 = 47周（95% ci = 32-53周）；TFI小于4 = 24周（95% C.I. 17-34周）P = 0.013]。与预期相反，在生活质量评估中，AR患者认为自己的症状比接受计划治疗的患者更严重。AR化疗是一种尝试姑息性使用细胞毒性药物的新方法，其结果是较少的药物治疗可获得大致相同的生存期。然而，与计划化疗相比，按要求治疗的缓解效果不如计划化疗令人满意。
In a study of chemotherapy as palliative treatment, 300 patients with untreated limited and extensive stage small cell lung cancer (SCLC), who did not have progressive disease after the first cycle of chemotherapy, were randomised to receive either regular 'planned' chemotherapy or chemotherapy given 'as required' (AR). All patients received the same chemotherapy: cyclophosphamide 1 gm m-2 i.v., vincristine 2 mg i.v., and etoposide 120 mg m-2 i.v. on day 1, and etoposide 100 mg b.d. orally on days 2 and 3. Planned chemotherapy was given regularly every 3 weeks. AR chemotherapy was given for tumour-related symptoms, or for radiological progression of disease. Both groups of patients were assessed every 3 weeks and a maximum of eight cycles of chemotherapy was given. A detailed quality of life assessment was made using daily diary cards. The median survival (MS) of patients given AR chemotherapy was not significantly worse than those receiving planned treatment [MS: Planned = 36 weeks (95% C.I. 32-40 weeks), AR = 32 weeks (95% C.I. 28-37 weeks) P = 0.960]. In the AR patients the median interval between treatments was 42 days. On average AR patients received half as much chemotherapy as planned patients. AR patients with a treatment-free interval (TFI) of more than 8 weeks between the first and second cycles of chemotherapy survived longer than those in whom this interval was less than 4 weeks; [MS: TFI greater than 8 = 47 weeks (95% C.I. 32-53 weeks); TFI less than 4 = 24 weeks (95% C.I. 17-34 weeks) P = 0.013]. Contrary to expectation, in the quality of life assessment the AR patients scored themselves as having more severe symptoms than patients receiving planned treatment. AR chemotherapy is a novel method of attempting to use cytotoxic drugs palliatively, which resulted in less drug treatment for approximately equivalent survival. However the palliative effect seen with as required treatment was less satisfactory than with planned chemotherapy.