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III期非小细胞肺癌超分割放疗联合或不联合每日低剂量卡铂/依托泊苷的随机研究

Hyperfractionated radiation therapy with or without concurrent low-dose daily carboplatin/etoposide for stage III non-small-cell lung cancer: a randomized study.

作者信息

Jeremic B, Shibamoto Y, Acimovic L, Milisavljevic S

机构信息

Department of Oncology, University Hospital, Kragujevac, Yugoslavia.

出版信息

J Clin Oncol. 1996 Apr;14(4):1065-70. doi: 10.1200/JCO.1996.14.4.1065.

Abstract

PURPOSE

To investigate the efficacy of concurrent hyperfractionated radiation therapy (HFX RT) and low-dose daily chemotherapy (CHT) in stage III non-small-cell lung cancer (NSCLC).

PATIENTS AND METHODS

Between January 1990 and December 1991, 131 patients with histologically or cytologically confirmed stage III NSCLC, Karnofsky performance status (KPS) > or = 50, and no previous therapy were randomly treated as follows: group I, HFX RT with 1.2 Gy twice daily to a total dose of 69.6 Gy (n = 66); and group II, same HFX RT with CHT consisting of 50 mg of carboplatin (CBDCA) and 50 mg of etoposide (VP-16) given on each RT day (n = 65).

RESULTS

Group II patients had a significantly longer survival time than group I patients, with a median survival of 22 versus 14 months and 4-year survival rates of 23% versus 9% (P = .021). The median time to local recurrence and 4-year local recurrence-free survival rate were also significantly higher in group II than in group I (25 v 20 months and 42% v 19% respectively, P = .015). In contrast, the distant metastasis-free survival rate did not significantly differ in the two groups (P = .33). The two groups showed similar incidence of acute and late high-grade toxicity (P = .44 and .75, respectively). No treatment-related toxicity was observed.

CONCLUSION

The combination of HFX RT and low-dose daily CBDCA plus VP-16 was tolerable and improved the survival of patients with stage III NSCLC as a result of improved local control.

摘要

目的

探讨同步超分割放射治疗(HFX RT)与低剂量每日化疗(CHT)治疗Ⅲ期非小细胞肺癌(NSCLC)的疗效。

患者与方法

1990年1月至1991年12月,131例经组织学或细胞学确诊为Ⅲ期NSCLC、卡诺夫斯基功能状态(KPS)≥50且未接受过先前治疗的患者被随机分为以下两组治疗:第一组,HFX RT,每日两次,每次1.2 Gy,总剂量69.6 Gy(n = 66);第二组,相同的HFX RT联合CHT,每次放疗日给予50 mg卡铂(CBDCA)和50 mg依托泊苷(VP - 16)(n = 65)。

结果

第二组患者的生存时间明显长于第一组患者,中位生存期分别为22个月和14个月,4年生存率分别为23%和9%(P = 0.021)。第二组的局部复发中位时间和4年无局部复发生存率也显著高于第一组(分别为25个月对20个月,42%对19%,P = 0.015)。相比之下,两组的无远处转移生存率无显著差异(P = 0.33)。两组急性和晚期重度毒性的发生率相似(分别为P = 0.44和0.75)。未观察到与治疗相关的毒性反应。

结论

HFX RT与低剂量每日CBDCA加VP - 16联合使用耐受性良好,由于改善了局部控制,提高了Ⅲ期NSCLC患者的生存率。

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