首页> 美国卫生研究院文献>British Journal of Cancer >A Medical Research Council phase II trial of alternating chemotherapy and radiotherapy in small-cell lung cancer. The Medical Research Council Lung Cancer Working Party.
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A Medical Research Council phase II trial of alternating chemotherapy and radiotherapy in small-cell lung cancer. The Medical Research Council Lung Cancer Working Party.

机译:医学研究理事会在小细胞肺癌中进行交替化疗和放疗的II期临床试验。医学研究委员会肺癌工作组。

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摘要

In a non-randomised study in six centres in the UK, 24 patients with previously untreated small-cell lung cancer of limited extent were treated with a regimen of alternating chemotherapy and radiotherapy to assess response, toxicity, and the feasibility of applying such a regimen on a multicentre basis in the UK. The intention was to give six courses of chemotherapy on five consecutive days at 4-week intervals: etoposide 75 mg m-2 on days 1, 2, and 3; doxorubicin 40 mg m-2 on day 1; cisplatin 100 mg m-2 on day 2; and cyclophosphamide 300 mg m-2 on days 2, 3, 4 and 5. A dose of 20 Gy thoracic radiotherapy was to be given following the 2nd and the 3rd courses, and one of 15 Gy following the 4th course. After 12 patients had been admitted, the cisplatin dosage was reduced to 80 mg m-2 because of unacceptable toxicity. Two patients were withdrawn during treatment on review of their histology because their diagnosis was found to be incorrect. Only one patient of the 12 treated with cisplatin 100 mg m-2 was able to complete treatment, compared with five of the eligible ten given the lower dosage. Among the 22 patients with confirmed small-cell disease, a complete response was reported in 14 (64%) and a partial response in a further three (total response rate 77%). Myelosuppression was the commonest serious adverse effect. It occurred in 19 of the 24 patients and gave rise to septicaemia in five, four of whom were receiving the higher cisplatin dose. Sixteen patients required blood transfusion and ten platelet transfusion. Vomiting, oesophagitis, and peripheral neuropathy occurred in 12, four and four patients, respectively, and radiation pneumonitis developed in two. Treatment was considered a contributory cause of death in four. The working party concluded that the alternating regimen was feasible in only a small proportion of centres in the UK, and decided not to embark on a multicentre randomised trial comparing alternating with conventional scheduling.
机译:在英国六个中心进行的一项非随机研究中,对24例先前未接受过治疗的有限程度小细胞肺癌患者进行了交替化疗和放疗方案的治疗,以评估疗效,毒性以及采用这种方案的可行性在英国以多中心为基础。目的是每4周间隔连续5天进行6个疗程的化疗:依托泊苷75 mg m-2在第1、2和3天服用;第1天阿霉素40 mg m-2;第2天顺铂100 mg m-2;在第2、3、4和5天服用环磷酰胺300 mg m-2,在第2和第3疗程后进行20 Gy胸腔放疗,在第4疗程后进行15 Gy胸腔放疗。入院12例患者后,由于毒性不可接受,将顺铂剂量降至80 mg m-2。两名患者在治疗期间因其组织学检查而退出治疗,因为发现他们的诊断不正确。在接受顺铂100 mg m-2治疗的12名患者中,只有1名患者能够完成治疗,而合格的10名患者中有5名给予了较低的剂量。在22例确诊的小细胞疾病患者中,有14例(64%)报告完全缓解,另有3例(部分缓解率为77%)。骨髓抑制是最常见的严重不良反应。它发生在24例患者中的19例中,并在5例中引起败血症,其中4例接受更高的顺铂剂量。 16名患者需要输血,10例血小板输注。呕吐,食道炎和周围神经病分别发生在12例,4例和4例,而放射性肺炎在2例中发展。治疗被认为是导致死亡的四分之一。工作组得出结论,在英国只有很少的中心可采用这种替代方案,因此决定不进行与传统方案相比的多中心随机试验。

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