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老年卵巢癌患者:卡铂和聚乙二醇脂质体阿霉素与卡铂和紫杉醇治疗晚期复发:妇科癌症国际组织(GCIG)CALYPSO 子研究。

Ovarian cancer in elderly patients: carboplatin and pegylated liposomal doxorubicin versus carboplatin and paclitaxel in late relapse: a Gynecologic Cancer Intergroup (GCIG) CALYPSO sub-study.

机构信息

Department of Hematology and Oncology, Hôpitaux Universitaires de Strasbourg, Strasbourg.

Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre les Nancy.

出版信息

Ann Oncol. 2011 Nov;22(11):2417-2423. doi: 10.1093/annonc/mdr001. Epub 2011 Mar 14.

Abstract

BACKGROUND

CALYPSO (CAeLYx in Platinum Sensitive Ovarian) patients compared carboplatin-pegylated liposomal doxorubicin (C-PLD) with carboplatin-paclitaxel (C-P) in patients with late-relapsing recurrent ovarian cancer (ROC). We analyzed outcomes in patients ≥70 years.

PATIENTS AND METHODS

Nine hundred and seventy-six patients with taxane-pretreated ROC relapsing >6 months after first- or second-line platinum-based therapy were randomly assigned to 4-weekly C area under the curve (AUC) 5 plus PLD 30 mg/m(2) or 3-weekly C AUC 5 plus P 175 mg/m(2) for six or more cycles.

RESULTS

One hundred and fifty-seven (16%) patients ≥70 years (median: 74 years, C-PLD; 73 years, C-P; range 70-82 years) were included (n = 71, C-PLD; n = 86, C-P). In comparing elderly and younger, elderly patients experienced fewer grade ≥2 allergic reactions (P = 0.005) but more grade ≥2 sensory neuropathy (P = 0.007). Myelosuppression did not differ with age. Elderly patients completed planned treatment as frequently as younger (79%, C-PLD; 82%, C-P). In comparing arms within elderly patients, C-P was associated with more grade ≥2 alopecia, sensory neuropathy, arthralgia/myalgia (P < 0.001 for all), severe leukopenia plus febrile neutropenia; C-PLD was associated with more grade ≥2 hand-foot syndrome (P = 0.005). Median progression-free survival was 11.6 months (C-PLD) and 10.3 months (C-P; P = 0.44).

CONCLUSIONS

Patients ≥70 years experienced more neuropathy, with a higher incidence in the C-P arm. Similar to all study patients, C-PLD provided a better therapeutic index with less toxicity than C-P in elderly women with platinum-sensitive ROC.

摘要

背景

CALYPSO(CAeLYx 在铂类敏感卵巢癌中的应用)研究中比较了卡铂聚乙二醇脂质体多柔比星(C-PLD)与卡铂紫杉醇(C-P)在铂类敏感复发性卵巢癌(ROC)患者中的疗效,该研究中纳入了末次复发时间超过 6 个月且接受过紫杉烷类药物治疗的患者。本研究分析了≥70 岁患者的结局。

患者和方法

976 例接受过紫杉烷类药物预处理且末次复发时间超过 6 个月的铂类敏感 ROC 患者,随机接受 4 周 1 次卡铂 AUC5 联合 PLD 30mg/m2(C-PLD 组)或 3 周 1 次卡铂 AUC5 联合 P 175mg/m2(C-P 组)治疗,6 个周期以上。

结果

157 例(16%)患者年龄≥70 岁(中位年龄 74 岁,C-PLD 组;73 岁,C-P 组;年龄范围 70-82 岁)(n=71,C-PLD 组;n=86,C-P 组)。与年轻患者相比,老年患者发生≥2 级过敏反应的比例较低(P=0.005),但发生≥2 级感觉神经病变的比例较高(P=0.007)。两组骨髓抑制程度无差异。老年患者与年轻患者一样,能够按时完成计划的治疗(79%,C-PLD 组;82%,C-P 组)。在比较老年患者中不同治疗组间的差异时发现,C-P 组患者发生≥2 级脱发、感觉神经病变、关节痛/肌痛(所有 P 值均<0.001)、严重白细胞减少伴发热性中性粒细胞减少的比例较高,而 C-PLD 组患者发生≥2 级手足综合征的比例较高(P=0.005)。中位无进展生存期分别为 11.6 个月(C-PLD 组)和 10.3 个月(C-P 组;P=0.44)。

结论

≥70 岁患者发生神经病变的比例较高,C-P 组的发生率更高。与所有研究患者一样,在接受过紫杉烷类药物治疗且末次复发时间超过 6 个月的铂类敏感 ROC 老年女性中,与 C-P 相比,C-PLD 具有更好的治疗指数和更低的毒性。

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