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聚乙二醇脂质体阿霉素治疗复发性铂耐药卵巢癌——特别关注心脏毒性的治疗指数评估。

Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity.

机构信息

Department of Obstetrics and Gynecology, Innsbruck Medical University, Innsbruck, Austria.

出版信息

Chemotherapy. 2009;55(6):391-8. doi: 10.1159/000262452. Epub 2009 Nov 30.

DOI:10.1159/000262452
PMID:19955744
Abstract

BACKGROUND

To study the efficacy of pegylated liposomal doxorubicin (PLD) at a modified dose of 45 mg/m(2) every 4 weeks in platinum-resistant ovarian cancer and to evaluate toxicities and effects on quality of life (QoL) of this single-agent regimen.

METHODS

Treatment response was evaluated by CT scan or CA 125 levels. Toxicity and QoL was recorded according to the common toxicity criteria of the National Cancer Institute and the EORTC QLQ-C30 questionnaire, respectively.

RESULTS

Eighty-five patients entered this nationwide observational study (384 cycles administered) and 4 (4.7%) achieved complete and 22 (25.8%) partial remission, giving an objective response rate of 30.5%. Eight patients experienced therapy-limiting side effects prompting discontinuation of treatment. Palmoplantar erythrodysesthesia (PPE) and/or stomatitis were the main reasons for discontinuation. Grade 3-4 PPE and stomatitis occurred in 4.2 and 2.2% of the 384 cycles, respectively. Grade 3-4 cardiotoxicity was absent and overall QoL was not significantly decreased following PLD treatment.

CONCLUSION

Single-agent PLD at a dose of 45 mg/m(2) is an efficient treatment in recurrent platinum-resistant ovarian cancer and exhibits an exceptionally favorable therapeutic index.

摘要

背景

研究每周 4 次、每次 45 毫克/平方米的改良剂量聚乙二醇脂质体阿霉素(PLD)在铂类耐药性卵巢癌中的疗效,并评估该单药方案的毒性和对生活质量(QoL)的影响。

方法

通过 CT 扫描或 CA 125 水平评估治疗反应。毒性和 QoL 分别根据国家癌症研究所的常见毒性标准和 EORTC QLQ-C30 问卷进行记录。

结果

85 例患者进入了这项全国性观察性研究(共给予 384 个周期的治疗),4 例(4.7%)完全缓解,22 例(25.8%)部分缓解,客观缓解率为 30.5%。8 例患者因治疗相关的不良反应而停止治疗。掌跖红斑感觉迟钝(PPE)和/或口腔炎是停止治疗的主要原因。384 个周期中,分别有 4.2%和 2.2%的患者出现 3-4 级 PPE 和口腔炎。无 3-4 级心脏毒性,且 PLD 治疗后总体 QoL 无显著下降。

结论

每周 4 次、每次 45 毫克/平方米的剂量的单药 PLD 是复发性铂类耐药性卵巢癌的有效治疗方法,具有极好的治疗指数。

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