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依托泊苷/顺铂联合或不联合异环磷酰胺治疗小细胞肺癌的III期比较研究。

A phase III comparison of etoposide/cisplatin with or without added ifosfamide in small-cell lung cancer.

作者信息

Miyamoto H, Nakabayashi T, Isobe H, Akita H, Kawakami Y, Arimoto T, Asakawa M, Suzuki A, Fujikane T, Shimizu T

机构信息

First Department of Medicine, Hokkaido University, Sapporo, Japan.

出版信息

Oncology. 1992;49(6):431-5. doi: 10.1159/000227087.

DOI:10.1159/000227087
PMID:1334539
Abstract

A total of 92 patients with small-cell lung cancer (SCLC) were randomized to receive cisplatin (80 mg/m2, day 1)/etoposide (100 mg/m2, days 1, 3, 5) (PE) or cisplatin (80 mg/m2, day 1)/etoposide (100 mg/m2, days 1, 3, 5)/ifosfamide (2 g/m2, days 1, 2, 3) (PEI) combination chemotherapy. After 2 courses of chemotherapy, patients with limited disease (LD) received chest irradiation of 40-50 Gy. Of the 89 patients who could be wholly evaluated, the overall response rate was 78% for PE and 74% for PEI therapy (NS). For all patients the complete response (CR) rates were 14 versus 21%, respectively, and 22 versus 30% for LD. However, the median survival times for all patients were 55 weeks for PE therapy versus 56 weeks for PEI therapy (NS). The 2-year survival rates were 15 and 17%, respectively, for all patients (NS). There was no difference in the duration of response between PE and PEI therapy in cases with CR or partial response. However, severe leukopenia (< 2,000/mm3) occurred more often after PEI (73%) than after PE (44%) therapy (p < 0.05). These results suggest that PEI is not superior to PE chemotherapy in SCLC. The use of ifosfamide in multimodality treatment regimens needs to be studied further.

摘要

总共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 - 50Gy的胸部放疗。在89例可进行全面评估的患者中,PE方案治疗的总缓解率为78%,PEI方案治疗的为74%(无统计学差异)。所有患者的完全缓解(CR)率分别为14%和21%,LD患者分别为22%和30%。然而,所有患者中,PE方案治疗的中位生存时间为55周,PEI方案治疗的为56周(无统计学差异)。所有患者的2年生存率分别为15%和17%(无统计学差异)。CR或部分缓解的病例中,PE和PEI方案治疗的缓解持续时间无差异。然而,PEI治疗后严重白细胞减少(<2000/mm³)的发生率(73%)高于PE治疗(44%)(p<0.05)。这些结果表明,在SCLC中PEI并不优于PE化疗。异环磷酰胺在多模式治疗方案中的应用需要进一步研究。

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