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头颈部局部晚期鳞状细胞癌超分割放疗联合或不联合每日低剂量顺铂的前瞻性随机试验。

Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial.

作者信息

Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, Vaskovic Z, Tadic L

机构信息

Departments of Oncology and Otorhynolaryngology, University Hospital, Kragujevac, Yugoslavia.

出版信息

J Clin Oncol. 2000 Apr;18(7):1458-64. doi: 10.1200/JCO.2000.18.7.1458.

DOI:10.1200/JCO.2000.18.7.1458
PMID:10735893
Abstract

PURPOSE

To investigate whether the addition of cisplatin (CDDP) to hyperfractionation (Hfx) radiation therapy (RT) offers an advantage over the same Hfx RT given alone in locally advanced (stages III and IV) squamous cell carcinoma of the head and neck.

PATIENTS AND METHODS

One hundred thirty patients were randomized to receive either Hfx RT alone to a tumor dose of 77 Gy in 70 fractions in 35 treatment days over 7 weeks (group I, n = 65) or the same Hfx RT and concurrent low-dose (6 mg/m(2)) daily CDDP (group II, n = 65).

RESULTS

Hfx RT/chemotherapy offered significantly higher survival rates than Hfx RT alone (68% v 49% at 2 years and 46% v 25% at 5 years; P =.0075). It also offered higher progression-free survival (46% v 25% at 5 years; P =.0068), higher locoregional progression-free survival (LRPFS) (50% v 36% at 5 years; P =.041), and higher distant metastasis-free survival (DMFS) (86% v 57% at 5 years; P =.0013). However, there was no difference between the two treatment groups in the incidence of either acute or late high-grade RT-induced toxicity. Hematologic high-grade toxicity was more frequent in group II patients.

CONCLUSION

As compared with Hfx RT alone, Hfx RT and concurrent low-dose daily CDDP offered a survival advantage, as well as improved LRPFS and DMFS.

摘要

目的

探讨在局部晚期(III期和IV期)头颈部鳞状细胞癌中,顺铂(CDDP)联合超分割(Hfx)放射治疗(RT)是否比单纯相同的Hfx RT更具优势。

患者与方法

130例患者被随机分为两组,一组(I组,n = 65)接受单纯Hfx RT,肿瘤剂量为77 Gy,分70次给予,在7周内的35个治疗日完成;另一组(II组,n = 65)接受相同的Hfx RT并同时每日给予低剂量(6 mg/m²)CDDP。

结果

Hfx RT联合化疗的生存率显著高于单纯Hfx RT(2年时分别为68%对49%,5年时分别为46%对25%;P = 0.0075)。它还具有更高的无进展生存率(5年时分别为46%对25%;P = 0.0068)、更高的局部区域无进展生存率(LRPFS)(5年时分别为50%对36%;P = 0.041)以及更高的远处转移无进展生存率(DMFS)(5年时分别为86%对57%;P = 0.0013)。然而,两组在急性或晚期重度放疗所致毒性的发生率上无差异。血液学重度毒性在II组患者中更常见。

结论

与单纯Hfx RT相比,Hfx RT联合每日低剂量CDDP可提高生存率,并改善LRPFS和DMFS。

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