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奥拉帕利剂量升级治疗卵巢癌患者严重和/或不常见不良反应:病例系列研究。

Olaparib dose re-escalation in ovarian cancer patients who experienced severe and/or uncommon adverse events: A case series.

机构信息

Department of Obstetrics and Gynaecology, The University of Hong Kong, Queen Mary Hospital, Hong Kong.

出版信息

Asia Pac J Clin Oncol. 2021 Apr;17 Suppl 3:3-11. doi: 10.1111/ajco.13584.

DOI:10.1111/ajco.13584
PMID:33860646
Abstract

AIM

Few real-world studies have reported detailed management and dose adjustment strategies of adverse events (AEs) of ovarian cancer (OC) patients treated with the poly(adenosine diphosphate-ribose) polymerase inhibitor olaparib. This case series aimed to describe olaparib AEs in Chinese OC patients in real-life settings and to explore dose modification strategies.

METHODS

We conducted a detailed examination of the clinical records of OC patients who were treated with olaparib at the Gynecologic Oncology Unit in Hong Kong from September 2015 to December 2019, including baseline characteristics, treatment outcomes, AEs, and management strategies, particularly dose modifications.

RESULTS

Nineteen patients were included, with a median olaparib treatment duration of 12 (range: 3-30) months. For recurrent platinum-sensitive cases (n = 16), the median progression-free survival was 16.0 months (95% confidence interval: 9.5-22.5). Eighteen (95%) patients experienced AE(s) of any grade, including four (21%) who experienced grade ≥3 AE(s). The most common AEs were as follows: nonhematologic fatigue (68%), nausea (42%), vomiting (26%), decreased appetite (26%), dyspepsia (21%), dizziness (21%), anemia (37%), neutropenia (26%), and thrombocytopenia (21%). Four specific cases involving anemia, lower limb lymphedema, myeloid neoplasm, and erythema nodosum are discussed separately. Eight patients required dose interruption or reduction due to AEs, of which five patients attempted and tolerated dose re-escalation.

CONCLUSION

In this study, most AEs were mild, but rare AEs were observed. In OC patients, olaparib AE management with dose reductions followed by re-escalations was feasible, including for anemia.

摘要

目的

鲜有真实世界研究报告了接受聚(腺苷二磷酸核糖)聚合酶抑制剂奥拉帕利治疗的卵巢癌(OC)患者不良事件(AE)的详细管理和剂量调整策略。本病例系列旨在描述真实环境中中国 OC 患者的奥拉帕利 AE,并探讨剂量调整策略。

方法

我们详细检查了 2015 年 9 月至 2019 年 12 月在香港妇科肿瘤科接受奥拉帕利治疗的 OC 患者的临床记录,包括基线特征、治疗结果、AE 和管理策略,特别是剂量调整。

结果

19 名患者入组,中位奥拉帕利治疗持续时间为 12(范围:3-30)个月。对于复发性铂类敏感病例(n=16),中位无进展生存期为 16.0 个月(95%置信区间:9.5-22.5)。18 名(95%)患者出现任何等级的 AE,包括 4 名(21%)出现≥3 级 AE。最常见的 AE 如下:非血液学疲劳(68%)、恶心(42%)、呕吐(26%)、食欲下降(26%)、消化不良(21%)、头晕(21%)、贫血(37%)、中性粒细胞减少症(26%)和血小板减少症(21%)。单独讨论了 4 个具体病例,涉及贫血、下肢淋巴水肿、骨髓增生异常肿瘤和结节性红斑。由于 AE,8 名患者需要中断或减少剂量,其中 5 名患者尝试并耐受了剂量再递增。

结论

在这项研究中,大多数 AE 为轻度,但观察到罕见的 AE。在 OC 患者中,奥拉帕利 AE 管理采用剂量减少后再递增是可行的,包括贫血。

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