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小细胞肺癌计划性化疗与按需化疗的随机试验:一项癌症研究运动试验

A randomised trial of planned versus as required chemotherapy in small cell lung cancer: a Cancer Research Campaign trial.

作者信息

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

机构信息

Department of Oncology, University College and Middlesex School of Medicine, London, UK.

出版信息

Br J Cancer. 1991 Sep;64(3):566-72. doi: 10.1038/bjc.1991.351.

Abstract

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.

摘要

在一项关于化疗作为姑息治疗的研究中,300例未经治疗的局限期和广泛期小细胞肺癌(SCLC)患者在接受第一个化疗周期后病情未进展,被随机分为接受常规“计划性”化疗或“按需”(AR)化疗。所有患者接受相同的化疗方案:第1天静脉注射环磷酰胺1 g/m²、长春新碱2 mg、依托泊苷120 mg/m²,第2天和第3天口服依托泊苷100 mg,每日2次。计划性化疗每3周定期进行。AR化疗用于治疗与肿瘤相关的症状或疾病的影像学进展。两组患者每3周评估一次,最多给予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化疗患者的中位生存期(MS)并不显著差于接受计划性治疗的患者[MS:计划性 = 36周(95%置信区间32 - 40周),AR = 32周(95%置信区间28 - 37周),P = 0.960]。AR组患者治疗间隔的中位数为42天。AR组患者平均接受的化疗量是计划性治疗患者的一半。在第一个和第二个化疗周期之间无治疗间隔(TFI)超过8周的AR组患者比间隔少于4周的患者生存期更长;[MS:TFI大于8周 = 47周(95%置信区间32 - 53周);TFI少于4周 = 24周(95%置信区间17 - 34周),P = 0.013]。与预期相反,在生活质量评估中,AR组患者自我评分显示其症状比接受计划性治疗的患者更严重。AR化疗是一种尝试将细胞毒性药物用于姑息治疗的新方法,其在生存期大致相同的情况下减少了药物治疗。然而,按需治疗的姑息效果不如计划性化疗。

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