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异环磷酰胺与美司钠治疗无法切除的弥漫性恶性间皮瘤的II期评估。西南肿瘤学组研究。

A phase II evaluation of ifosfamide and mesna in unresectable diffuse malignant mesothelioma. A Southwest Oncology Group study.

作者信息

Zidar B L, Metch B, Balcerzak S P, Pierce H I, Militello L, Keppen M D, Berenberg J L

机构信息

Allegheny Health, Education & Research Foundation, Pittsburgh, Pennsylvania.

出版信息

Cancer. 1992 Nov 15;70(10):2547-51. doi: 10.1002/1097-0142(19921115)70:10<2547::aid-cncr2820701025>3.0.co;2-f.

Abstract

BACKGROUND

Malignant mesothelioma is a highly treatment-resistant neoplasm. This study represents an attempt to define an effective form of systemic therapy.

METHODS

Twenty-six patients with unresectable diffuse malignant mesothelioma were enrolled in Southwest Oncology Group (SWOG) study 8731 and treated with ifosfamide, 2 g/m2 intravenously for 4 days, and mesna 2 g/m2 intravenously for 5 days, every 3 weeks. Patients were either previously untreated with chemotherapy or had at most one prior systemic treatment.

RESULTS

Two patients, or 8% (95% confidence interval, 1-25%), achieved partial response, with response durations of 4 and 6 months. One additional patient met criteria for tumor size reduction but not duration criteria. Thirteen (50%) patients had stable disease of 4 months' median duration (range, 1-13 months). The median survival of the entire group was 6.5 months. The dose-limiting toxicity was granulocytopenia (11 patients, < or = 250/microliters).

CONCLUSIONS

Ifosfamide/mesna has modest activity in malignant mesothelioma. It could be tested using alternate dosage schedules and in combination with other agents in treating this highly resistant neoplasm.

摘要

背景

恶性间皮瘤是一种具有高度治疗抵抗性的肿瘤。本研究旨在确定一种有效的全身治疗形式。

方法

26例无法切除的弥漫性恶性间皮瘤患者参加了西南肿瘤协作组(SWOG)8731研究,接受异环磷酰胺治疗,静脉注射2 g/m²,共4天,美司钠静脉注射2 g/m²,共5天,每3周重复一次。患者此前未接受过化疗,或最多接受过一次全身治疗。

结果

2例患者(8%,95%置信区间为1%-25%)达到部分缓解,缓解持续时间分别为4个月和6个月。另有1例患者符合肿瘤大小缩小标准,但不符合持续时间标准。13例患者(50%)病情稳定,中位持续时间为4个月(范围1-13个月)。整个组的中位生存期为6.5个月。剂量限制性毒性为粒细胞减少(11例患者,≤250/微升)。

结论

异环磷酰胺/美司钠对恶性间皮瘤有一定活性。可采用不同的给药方案并与其他药物联合使用来治疗这种高度耐药的肿瘤,对此进行试验。

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