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口服节拍式环磷酰胺给药在老年和经大量预处理的上皮性卵巢癌患者中的真实临床获益。

Real-life clinical benefit of oral metronomic cyclophosphamide administration in elderly and heavily pretreated epithelial ovarian cancer patients.

机构信息

Academic Division of Gynecology and Obstetrics, University of Torino, Mauriziano Umberto I Hospital, Torino, Italy.

Division of Gynecology and Obstetrics, Cardinal Massaia Hospital, Asti, Italy.

出版信息

Arch Gynecol Obstet. 2024 Oct;310(4):2183-2190. doi: 10.1007/s00404-024-07670-4. Epub 2024 Aug 2.

Abstract

PURPOSE

Oral metronomic cyclophosphamide (OMC) implicates the daily administration of low doses of chemotherapy. Its antitumor activity combined with an oral administration route and a good toxicity profile makes OMC an attractive option for heavily pretreated patients. We retrospectively evaluated OMC's clinical benefit and objective response in recurrent ovarian cancer patients.

METHODS

This is a retrospective observational study involving patients treated with OMC (50 mg daily) from 2017 to 2022 at the Academic Division Gynaecology, Mauriziano Hospital, Torino, Italy. Clinical benefit assessment included CA125 response, radiological response, and reported symptomatic improvement. Toxicities were reported using Common Terminology Criteria for Adverse Events version 5.0.

RESULTS

Thirty-eight patients (average age 72, range 49-88) were included. 90% had FIGO stage III/IV at diagnosis and 64% underwent ≥ 3 previous lines of chemotherapy. Before OMC, 79% had ECOG 1 or 2. 8.6% of patients had a partial response (PR), and 40% a stable disease (SD). Median duration of response was 7.4 months. After 3 months on OMC, 51% experienced symptom improvement, and 53.3% experienced Ca125 reduction or stabilization. 66.7% of patients older than 75 responded to treatment; in 40% of cases, responses lasted ≥ 6 months (p = 0.08). No G3-4 hematological toxicities occurred. Nausea and fatigue G1-G2 were reported in 5 (13%) and 13 (34%) cases, respectively.

CONCLUSION

OMC is a feasible therapeutic option for recurrent ovarian cancer, providing satisfying clinical responses with a good toxicity profile, even in elderly and heavily pretreated patients with a suboptimal performance status.

摘要

目的

口服节拍式环磷酰胺(OMC)涉及每日给予低剂量化疗。其抗肿瘤活性、口服给药途径和良好的毒性特征使其成为治疗预处理较多的患者的一种有吸引力的选择。我们回顾性评估了 OMC 在复发性卵巢癌患者中的临床获益和客观缓解情况。

方法

这是一项回顾性观察性研究,纳入了 2017 年至 2022 年在意大利都灵的 Mauriziano 医院妇科接受 OMC(50mg 每日)治疗的患者。临床获益评估包括 CA125 反应、影像学反应和报告的症状改善。毒性反应采用 5.0 版常见不良事件术语标准进行报告。

结果

共纳入 38 例患者(平均年龄 72 岁,范围 49-88 岁)。90%的患者在诊断时为 FIGO 分期 III/IV 期,64%的患者接受了≥3 线化疗。在 OMC 治疗前,79%的患者 ECOG 评分为 1 或 2。8.6%的患者有部分缓解(PR),40%的患者有疾病稳定(SD)。中位缓解持续时间为 7.4 个月。接受 OMC 治疗 3 个月后,51%的患者症状改善,53.3%的患者 CA125 降低或稳定。75 岁以上的患者中有 66.7%对治疗有反应;在 40%的情况下,反应持续时间≥6 个月(p=0.08)。无 3-4 级血液学毒性。5 例(13%)和 13 例(34%)患者分别出现 1-2 级恶心和疲劳。

结论

OMC 是复发性卵巢癌的一种可行的治疗选择,具有良好的毒性特征,可提供令人满意的临床反应,甚至在年龄较大、预处理较多、体能状态较差的患者中也如此。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/19d9/11393194/884464712d8a/404_2024_7670_Fig1_HTML.jpg

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