Body Weight Gain Associated With Alectinib in Patients With ALK+ Non-Small Cell Lung Cancer: Pooled Analysis of Individual Patient Data From Four Prospective Clinical Trials.

IF 42.1 1区 医学 Q1 ONCOLOGY Journal of Clinical Oncology Pub Date : 2025-02-20 Epub Date: 2024-12-11 DOI:10.1200/JCO-24-01579
Barend J Sikkema, Sara J Baart, Marthe S Paats, Egbert F Smit, Annemie M W J Schols, Ron H J Mathijssen, Elisabeth F C van Rossum, Anne-Marie C Dingemans
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Abstract

Purpose: Weight gain is a known adverse event (AE) of alectinib. This study evaluates the progression of actual weight gain over time and explores its association with baseline characteristics.

Methods: A pooled analysis of individual patient data from four clinical trials (ALEX, J-ALEX, ALUR, and ML29453) was conducted. Actual weight gain was calculated as the percent change from baseline. A linear mixed model estimated weight change over time and associations between clinical characteristics and weight change.

Results: Follow-up weights were available for three trials (J-ALEX, ALUR, and ML29453) and missing for ALEX. In total, 2,622 weights were recorded in the first year (N = 302). At baseline, 13.6% of the Japanese population were underweight and 5.0% in the Western population. Actual weight gain of any grade was substantially higher than reported AE rates (49% v 5%), with 18% experiencing ≥10% weight gain (from median 55.6 kg to 64.1 kg). Time on alectinib was positively associated with weight change (β = .37; 95% CI, 0.24 to 0.51; P < .001), corresponding to an average increase of 4.4% over 1 year. Baseline BMI was not associated with weight change in J-ALEX (β = -.090 [95% CI, -0.19 to 0.012]; P = .092) and ALUR/ML29453 (β = -.016 [95% CI, -0.077 to 0.044]; P = .59). Baseline albumin was positively associated with weight change in ALUR/ML29453 (β = .084 [95% CI, 0.027 to 0.14]; P = .0045), although not considered a clinically meaningful predictor.

Conclusion: Weight gain is under-reported as AE in trials. Actual weights showed ≥10% weight gain in 18% of patients. Clinicians should be aware of this AE, emphasizing the importance of timely identification and monitoring weight. Identifying predictors for weight gain remains challenging.

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ALK+非小细胞肺癌患者与Alectinib相关的体重增加:来自四项前瞻性临床试验的个体患者数据汇总分析
目的:体重增加是阿勒替尼已知的不良事件(AE)。本研究评估了实际体重增加随时间的进展,并探讨了其与基线特征的关系。方法:对四项临床试验(ALEX、J-ALEX、ALUR和ML29453)的个体患者数据进行汇总分析。实际体重增加是根据基线变化的百分比计算的。线性混合模型估计体重随时间的变化以及临床特征与体重变化之间的关系。结果:三个试验(J-ALEX、ALUR和ML29453)的随访权均可获得,ALEX的随访权缺失。第一年总共记录了2622个体重(N = 302)。在基线时,13.6%的日本人口体重过轻,西方人口为5.0%。任何级别的实际体重增加都大大高于报告的AE发生率(49% vs 5%),其中18%的体重增加≥10%(从中位55.6 kg增加到64.1 kg)。服用alectinib的时间与体重变化呈正相关(β = 0.37;95% CI, 0.24 ~ 0.51;P < .001),相当于1年内平均增加4.4%。基线BMI与J-ALEX患者的体重变化无关(β = -)。090 [95% CI, -0.19 ~ 0.012];P = 0.092)和ALUR/ML29453 (β = -。016 [95% CI, -0.077 ~ 0.044];P = .59)。ALUR/ML29453患者的基线白蛋白与体重变化呈正相关(β = 0.084 [95% CI, 0.027 ~ 0.14];P = .0045),尽管不被认为是有临床意义的预测因子。结论:试验中体重增加被低估为AE。18%的患者实际体重增加≥10%。临床医生应该意识到这种AE,强调及时识别和监测体重的重要性。确定体重增加的预测因素仍然具有挑战性。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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