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脂质体阿霉素治疗HIV相关卡波西肉瘤的II期研究。

A phase II study of liposomal doxorubicin in the treatment of HIV-related Kaposi's sarcoma.

作者信息

Newell M, Milliken S, Goldstein D, Lewis C, Boyle M, Dolan G, Ryan S, Cooper D A

机构信息

National Centre in HIV Epidemiology and Clinical Research, Faculty of Medicine, University of New South Wales, Sydney.

出版信息

Aust N Z J Med. 1998 Dec;28(6):777-83. doi: 10.1111/j.1445-5994.1998.tb01553.x.

DOI:10.1111/j.1445-5994.1998.tb01553.x
PMID:9972406
Abstract

OBJECTIVES

To evaluate the toxicity and clinical efficacy of liposomal encapsulated doxorubicin (DOX-SL) in the treatment of HIV-related Kaposi's sarcoma (KS).

METHODS

DOX-SL 20-40mg/m2 was administered by intravenous infusion over 30-60 minutes every two weeks. Toxicity was assessed in all patients and response assessed in patients who completed two or more cycles of therapy.

RESULTS

Twenty-five patients with KS were enrolled. Nine had received previous KS chemotherapy but only one prior anthracycline therapy. Eighteen patients had CD4 counts < 50/mm3. Eight had pulmonary and/or visceral KS. A total of 191 cycles were given, median 6, range 1-33. Twenty patients completed two or more cycles and were considered evaluable for efficacy. A defined response occurred in 11 patients, nine achieving a partial response and two a complete response. The median duration of response was 120 days and the median time to disease progression was 187 days. Acute toxicity was minimal, except in one patient who had generalised erythema, hypotension and diaphoresis within ten minutes of starting DOX-SL infusion. Grade 3 or 4 neutropenia occurred in 13.6 and 3.7% of cycles respectively. Neutropenic sepsis secondary to drug therapy was not reported. Alopecia and gastrointestinal symptoms were mild and infrequent. No cardiac toxicity was seen. Nine/25 patients developed HIV-associated illnesses while on study (three Pneumocystis carinii pneumonia, two systemic Cytomegalovirus infection, three cryptosporidiosis, one Mycobacterium avium intracellulare--(MAC) infection). Median survival in the evaluable patients was 219 days.

CONCLUSIONS

DOX-SL is an effective and well tolerated palliative therapy in AIDS-related KS.

摘要

目的

评估脂质体包裹阿霉素(DOX-SL)治疗HIV相关卡波西肉瘤(KS)的毒性和临床疗效。

方法

每两周静脉输注DOX-SL 20 - 40mg/m²,持续30 - 60分钟。对所有患者评估毒性,对完成两个或更多周期治疗的患者评估反应。

结果

纳入25例KS患者。9例曾接受过KS化疗,但仅1例曾接受过蒽环类药物治疗。18例患者CD4计数<50/mm³。8例有肺部和/或内脏KS。共给予191个周期,中位数为6个周期,范围为1 - 33个周期。20例患者完成两个或更多周期,被认为可评估疗效。11例患者出现明确反应,9例部分缓解,2例完全缓解。反应的中位持续时间为120天,疾病进展的中位时间为187天。急性毒性极小,除1例患者在开始输注DOX-SL后10分钟内出现全身红斑、低血压和出汗。3级或4级中性粒细胞减少分别发生在13.6%和3.7%的周期中。未报告药物治疗继发的中性粒细胞减少性败血症。脱发和胃肠道症状轻微且不常见。未观察到心脏毒性。9/25例患者在研究期间发生HIV相关疾病(3例卡氏肺孢子虫肺炎、2例全身性巨细胞病毒感染、3例隐孢子虫病、1例鸟分枝杆菌胞内感染)。可评估患者的中位生存期为219天。

结论

DOX-SL是治疗艾滋病相关KS的一种有效且耐受性良好的姑息治疗方法。

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