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顺铂联合依托泊苷与顺铂/依托泊苷/异环磷酰胺联合化疗治疗小细胞肺癌的多中心随机对照研究。北海道小细胞肺癌治疗研究组

[Cisplatin etoposide versus cisplatin/etoposide/ifosfamide combination chemotherapy in small-cell lung cancer: a multicenter randomized controlled study. Hokkaido Study Group of Treatment for Small-Cell Lung Cancer].

作者信息

Miyamoto H, Kawakami Y, Arimoto T, Asakawa M, Suzuki A, Fujikane T, Onodera S, Nakabayashi T, Yasuda S, Shimizu T

机构信息

First Dept. of Medicine, Hokkaido University.

出版信息

Gan To Kagaku Ryoho. 1991 Jun;18(7):1127-34.

PMID:1647149
Abstract

Ninety-two patients with small-cell lung cancer (SCLC) were randomized to receive cisplatin (80 mg/m2, day 1)/etoposide (100 mg/m2, day 1, 3, 5) (PE) or cisplatin (80 mg/m2, day 1)/etoposide (100 mg/m2 1, 3, 5)/ifosfamide (2 g/m2, day 1, 2, 3) (PEI) combination chemotherapy. After 2 courses of chemotherapy, patients with limited disease (LD) received chest irradiation with 40-50 Gr. Of the 89 patients evaluable, the overall response rate was 77.8% in PE therapy, and 73.7% in PEI therapy (NS). The complete response rate (CR) of PE v PEI was 13.9% v 21.2% for all patients (NS), 22.2% v 30.4% for LD. Median survival times of PE v PEI for all patients were 55 weeks v 56 weeks (NS). The 2-year survival rate of PE v PEI was 15.4% v 16.5% for all patients (NS). There was no difference of the duration of response in cases with CR or PR between PE and PEI therapy. Leucopenia occurred more often after PEI than after PE therapy (p less than 0.01). These results suggest that PEI is not superior to PE chemotherapy in SCLC.

摘要

92例小细胞肺癌(SCLC)患者被随机分为两组,分别接受顺铂(80mg/m²,第1天)/依托泊苷(100mg/m²,第1、3、5天)(PE)或顺铂(80mg/m²,第1天)/依托泊苷(100mg/m²,第1、3、5天)/异环磷酰胺(2g/m²,第1、2、3天)(PEI)联合化疗。化疗2个疗程后,局限期(LD)患者接受40 - 50格雷的胸部照射。在可评估的89例患者中,PE治疗组的总缓解率为77.8%,PEI治疗组为73.7%(无统计学差异)。所有患者中,PE组与PEI组的完全缓解率(CR)分别为13.9%和21.2%(无统计学差异),LD患者中分别为22.2%和30.4%。所有患者中,PE组与PEI组的中位生存时间分别为55周和56周(无统计学差异)。所有患者中,PE组与PEI组的2年生存率分别为15.4%和16.5%(无统计学差异)。PE治疗与PEI治疗的CR或PR患者的缓解持续时间无差异。PEI治疗后白细胞减少的发生率高于PE治疗(p<0.01)。这些结果表明,在小细胞肺癌中,PEI并不优于PE化疗。

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