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己酮可可碱对非小细胞肺癌放射反应的影响:一项III期随机多中心试验。

Effect of pentoxifylline on radiation response of non-small cell lung cancer: a phase III randomized multicenter trial.

作者信息

Kwon H C, Kim S K, Chung W K, Cho M J, Kim J S, Kim J S, Moon S R, Park W Y, Ahn S J, Oh Y K, Yun H G, Na B S

机构信息

Chon-buk National University Hospital and Institute for Medical Sciences, Chon-Ju, South Korea.

出版信息

Radiother Oncol. 2000 Aug;56(2):175-9. doi: 10.1016/s0167-8140(00)00221-8.

DOI:10.1016/s0167-8140(00)00221-8
PMID:10927136
Abstract

PURPOSES

The objectives of this prospective clinical trial were to determine whether pentoxifylline improves the radiation response and survival in patients with non-small cell lung cancer.

MATERIALS AND METHODS

From July 1993 through October 1994, 64 patients with histologically confirmed Stage I, II and III non-small cell lung cancer were randomly divided into pentoxifylline (Pento)+Radiotherapy (RT) group and RT alone group. Out of the 64 patients, only 47 patients who had measurable tumors on chest X-ray views were analyzed and divided into Pento+RT group (n=27) and RT alone group (n=20). Total tumor dose of 65-70 Gy was delivered as conventional fractionated radiation schedules. Pento was given to the patients 3 x 400 mg/day with a daily dose of 1200 mg during RT.

RESULTS

Complete response (CR), partial response (PR), and stable in Pento+RT group were three (11%), 13 (48%), and 11 (41%), respectively, as compared with corresponding values of three (15%), 13 (65%), and four (20%) in the RT alone group. The median time to relapse in the Pento+RT group was 11 months which was 2 months longer than for the RT alone group (P>0.05). All the patients in both groups showed lower than or equal to grade 2 dysphagia, odynophagia, pulmonary fibrosis, and pneumonitis. The median survival was 18 months in the Pento+RT group and 7 months in the RT alone group. The 1-year survival rate was 60% in the Pento+RT group and 35% in the RT alone group, the 2-year survival rate was 18% in the Pento+RT group and 12% in the RT alone group. But these differences were not statistically significant (P>0.05).

CONCLUSION

We concluded that Pento is a modestly effective radiation response modifier and provide benefit in the treatment of non-small cell lung cancer.

摘要

目的

这项前瞻性临床试验的目的是确定己酮可可碱是否能改善非小细胞肺癌患者的放射反应和生存率。

材料与方法

从1993年7月至1994年10月,64例经组织学确诊为I、II和III期非小细胞肺癌的患者被随机分为己酮可可碱(Pento)+放疗(RT)组和单纯放疗组。在这64例患者中,仅对47例胸部X线片上有可测量肿瘤的患者进行分析,并分为Pento+RT组(n=27)和单纯放疗组(n=20)。按照常规分割放疗方案给予总肿瘤剂量65-70 Gy。在放疗期间,给予患者己酮可可碱,每日3次,每次400 mg,日剂量为1200 mg。

结果

Pento+RT组的完全缓解(CR)、部分缓解(PR)和病情稳定率分别为3例(11%)、13例(48%)和11例(41%),而单纯放疗组相应的值分别为3例(15%)、13例(65%)和4例(20%)。Pento+RT组的中位复发时间为11个月,比单纯放疗组长2个月(P>0.05)。两组所有患者的吞咽困难、吞咽痛、肺纤维化和肺炎均为2级或以下。Pento+RT组的中位生存期为18个月,单纯放疗组为7个月。Pento+RT组的1年生存率为60%,单纯放疗组为35%;2年生存率在Pento+RT组为18%,单纯放疗组为12%。但这些差异无统计学意义(P>u003e0.05)。

结论

我们得出结论,己酮可可碱是一种中等有效的放射反应调节剂,对非小细胞肺癌的治疗有益。

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