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妇科肿瘤学 Arbeitsgemeinschaft 卵巢癌研究组的随机研究:比较顺铂/紫杉醇与卡铂/紫杉醇治疗的卵巢癌患者的生活质量。

Randomized study of the Arbeitsgemeinschaft Gynaekologische Onkologie Ovarian Cancer Study Group comparing quality of life in patients with ovarian cancer treated with cisplatin/paclitaxel versus carboplatin/paclitaxel.

作者信息

Greimel Elfriede R, Bjelic-Radisic Vesna, Pfisterer Jacobus, Hilpert Felix, Daghofer Fedor, du Bois Andreas

机构信息

Department of Obstetrics and Gynecology, University Graz, Graz, Austria.

出版信息

J Clin Oncol. 2006 Feb 1;24(4):579-86. doi: 10.1200/JCO.2005.02.4067.

Abstract

PURPOSE

The objective of this study was to compare the quality of life (QoL) of ovarian cancer patients treated with paclitaxel/carboplatin (TC) versus paclitaxel/cisplatin (PT) and to determine the impact of treatment toxicity on the various QoL domains.

PATIENTS AND METHODS

In this phase III trial, 798 patients with ovarian cancer stages IIB-IV were randomly assigned to receive TC or PT. The primary end point was progression-free survival; secondary end points included toxicity, QoL, and response to treatment. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 before treatment, within 3 days before the second and the fourth chemotherapy cycle, and 3 weeks after completion of chemotherapy.

RESULTS

Previously reported data showed that patients undergoing TC or PT did not differ in progression-free survival and overall survival. However, the TC arm was superior, indicating a better overall QoL compared with the PT arm. Controlling for toxicity and age, a significant treatment by assessment time interaction was found for four QoL functioning scales and three symptoms scales. Patients in the TC arm showed better means scores after treatment on overall QoL (P = .012), physical functioning (P = .012), role functioning (P = .005), and cognitive functioning (P = .024), compared with the PT arm. Concerning symptom experience, patients undergoing TC showed less nausea and vomiting (P < .001), less appetite loss (P < .001), and less fatigue (P = .033) after completion of treatment compared with patients undergoing PT.

CONCLUSION

The TC regimen achieved better QoL outcomes compared with the PT regimen. Thus, clinicians may consider replacing cisplatin with carboplatin when treating ovarian cancer patients with chemotherapy.

摘要

目的

本研究的目的是比较接受紫杉醇/卡铂(TC)与紫杉醇/顺铂(PT)治疗的卵巢癌患者的生活质量(QoL),并确定治疗毒性对各个QoL领域的影响。

患者与方法

在这项III期试验中,798例IIB-IV期卵巢癌患者被随机分配接受TC或PT治疗。主要终点是无进展生存期;次要终点包括毒性、QoL和治疗反应。患者在治疗前、第二个和第四个化疗周期前3天以及化疗完成后3周完成欧洲癌症研究与治疗组织的QLQ-C30问卷。

结果

先前报道的数据显示,接受TC或PT治疗的患者在无进展生存期和总生存期方面没有差异。然而,TC组更具优势,表明与PT组相比总体QoL更好。在控制毒性和年龄后,发现四个QoL功能量表和三个症状量表在评估时间与治疗之间存在显著交互作用。与PT组相比,TC组患者在治疗后总体QoL(P = .012)、身体功能(P = .012)、角色功能(P = .005)和认知功能(P = .024)方面的平均得分更高。关于症状体验,与接受PT治疗的患者相比,接受TC治疗的患者在治疗完成后恶心和呕吐更少(P < .001)、食欲减退更少(P < .001)、疲劳更少(P = .033)。

结论

与PT方案相比,TC方案取得了更好的QoL结果。因此,临床医生在用化疗治疗卵巢癌患者时可考虑用卡铂替代顺铂。

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