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卡铂与全身热疗(WBH)用于复发性和转移性宫颈癌的II期研究。

Phase II study of carboplatin and whole body hyperthermia (WBH) in recurrent and metastatic cervical cancer.

作者信息

Richel O, Zum Vörde Sive Vörding P J, Rietbroek R, Van der Velden J, Van Dijk J D P, Schilthuis M S, Westermann A M

机构信息

Department of Medical Oncology, AMC Academic Medical Center, Meibergdreef 9, PO Box 22660, 1100 DD Amsterdam, The Netherlands.

出版信息

Gynecol Oncol. 2004 Dec;95(3):680-5. doi: 10.1016/j.ygyno.2004.08.023.

DOI:10.1016/j.ygyno.2004.08.023
PMID:15581981
Abstract

OBJECTIVE

Hyperthermia enhances carboplatin cytotoxicity preclinically, and clinical studies have shown radiant heat Whole Body Hyperthermia (WBH) to be safe. In this study, the efficacy and toxicity of the combination of 41.8 degrees C WBH and carboplatin in recurrent and/or metastatic cervical cancer were explored.

METHODS

Recurrent and/or metastatic cervical cancer patients were treated with 41.8 degrees C WBH and concurrent carboplatin, cycled every 28 days (max. 6 cycles).

RESULTS

Twenty-one of 25 participants were evaluable for response: one complete remission, six partial responses, stable disease in nine patients and progression in five, leading to a response rate of 33%. Three of four evaluable chemotherapy pre-treated patients progressed, while this was seen in only 2 of 17 chemotherapy-naive patients. The median survival is 7.8 months (range 1.3 to 43+) and no patients were lost to follow up. Grades 3/4 toxicities were common: leukopenia in 35%, thrombopenia in 61% and anemia in 22% of all treatments. Excessive, partly reversible renal toxicity was seen in two patients (grades 3 and 4).

CONCLUSION

The efficacy of WBH and carboplatin in recurrent and/or metastatic cervical cancer seems comparable to that of other palliative chemotherapy regimens in this disease. The considerable toxicity, though largely manageable, includes unexpected and severe unacceptable renal toxicity. This regimen seems less suitable for palliative care.

摘要

目的

临床前研究表明,热疗可增强卡铂的细胞毒性,且临床研究已证实辐射热全身热疗(WBH)是安全的。在本研究中,探讨了41.8摄氏度WBH联合卡铂治疗复发和/或转移性宫颈癌的疗效及毒性。

方法

复发和/或转移性宫颈癌患者接受41.8摄氏度WBH并同时使用卡铂治疗,每28天为一个周期(最多6个周期)。

结果

25名参与者中有21名可评估疗效:1例完全缓解,6例部分缓解,9例病情稳定,5例病情进展,有效率为33%。4例接受过化疗预处理的可评估患者中有3例病情进展,而17例未接受过化疗的患者中只有2例出现这种情况。中位生存期为7.8个月(范围1.3至43 +),无患者失访。3/4级毒性常见:所有治疗中白细胞减少占35%,血小板减少占61%,贫血占22%。两名患者出现了过度的、部分可逆的肾毒性(3级和4级)。

结论

WBH联合卡铂治疗复发和/或转移性宫颈癌的疗效似乎与该疾病的其他姑息化疗方案相当。尽管毒性在很大程度上可控,但毒性相当大,包括意外且严重的不可接受的肾毒性。该方案似乎不太适合姑息治疗。

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