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贝伐珠单抗会增加癌症患者的关节痛吗?前瞻性观察性 BEVARTHRALGIA 研究的结果。

Does bevacizumab increase joint pain in patients with cancer? Results of the prospective observational BEVARTHRALGIA study.

机构信息

Medical Oncology Department, CHU Lille, University of Lille, Lille, France.

ULR 2694, METRICS: Évaluation des Technologies de santé et des Pratiques Médicales, University Lille, CHU Lille, Lille, France.

出版信息

Cancer Chemother Pharmacol. 2021 Apr;87(4):533-541. doi: 10.1007/s00280-020-04226-6. Epub 2021 Jan 12.

Abstract

PURPOSE

The occurrence of arthralgia and myalgia during treatment with bevacizumab (Bev) has been described but not spontaneously reported. We aimed to evaluate the frequency of arthralgia in patients treated with Bev and identify the risk factors.

METHODS

In this observational prospective study, a self-administered questionnaire was distributed to patients at the initiation of Bev and at 3 and 6 months of treatment. Bev (5-15 mg/kg) was administered every 2 or 3 weeks, with or without chemotherapy.

RESULTS

A total of 71 patients (42 with colorectal cancer, 22 with ovarian cancer, and 7 with lung cancer) were enrolled from January to November 2018. All patients completed the questionnaire at initiation, while only 56 (78.9%) and 36 (50.7%) patients completed the questionnaire at 3 and 6 months, respectively. The frequency of joint pain was 29.6% before Bev treatment and increased to 41.8% and 50% at 3 and 6 months, respectively, without reaching significance. The evolution of pain was significant according to the Common Terminology Criteria for Adverse Events grades (P = 0.032). No significant increase in the impact of pain on instrumental or elementary activities was observed over time. The frequency of arthralgia significantly increased at 3 months in patients with ovarian cancer versus those with colorectal cancer (odds ratio: 19.50; 95% confidence interval 4.53-83.98; P < 0.001).

CONCLUSIONS

Bev‑including regimens tend to be associated with a significant increase in the frequency of arthralgia in women treated for ovarian cancer. Physicians should be aware of this side effect.

CLINICAL TRIAL NUMBER

NCT03455907, date of registration: March 7, 2018.

摘要

目的

贝伐珠单抗(Bev)治疗期间出现关节痛和肌痛已有描述,但并非自发报告。我们旨在评估接受 Bev 治疗的患者关节痛的频率,并确定相关风险因素。

方法

在这项观察性前瞻性研究中,在开始使用 Bev 治疗时以及治疗 3 个月和 6 个月时,向患者发放了一份自我管理问卷。Bev(5-15mg/kg)每 2 或 3 周给药一次,联合或不联合化疗。

结果

2018 年 1 月至 11 月期间共纳入 71 例患者(42 例结直肠癌、22 例卵巢癌和 7 例肺癌)。所有患者均在起始时完成了问卷,而仅有 56(78.9%)和 36(50.7%)例患者分别在 3 个月和 6 个月时完成了问卷。在 Bev 治疗前,关节痛的发生率为 29.6%,分别增加至 3 个月时的 41.8%和 6 个月时的 50%,但无显著差异。根据通用不良事件术语标准(Common Terminology Criteria for Adverse Events,CTCAE)等级,疼痛的演变具有显著意义(P = 0.032)。随着时间的推移,疼痛对基本或辅助活动的影响无显著增加。与结直肠癌患者相比,卵巢癌患者在 3 个月时关节痛的发生率显著增加(优势比:19.50;95%置信区间:4.53-83.98;P < 0.001)。

结论

含 Bev 的方案可能与接受卵巢癌治疗的女性关节痛频率显著增加相关。医生应注意这一副作用。

临床试验注册号

NCT03455907,注册日期:2018 年 3 月 7 日。

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