1367P - Predictive clinical characteristics for body weight gain in patients treated with alectinib: Analyses of J-ALEX, ALUR, and ML29453

Background

Alectinib has emerged as one of the anaplastic lymphoma kinase (ALK) directed therapy of choice in patients with advanced ALK+ non-small cell lung cancer (NSCLC). Body weight gain is a side effect reported in 12% of patients, caused by an increased amount of body fat. Baseline waist circumference has been found to be a positive predictor of the increase in visceral adipose tissue. We hypothesize that baseline body mass index (BMI) is positively associated with body weight gain.

Methods

Individual data from patients treated with alectinib were obtained via Vivli data-sharing platform. Studies with body weight data were selected. All body weight measurements during the first year of treatment were included. A mixed-effects model with random intercept was conducted to assess the trend of % change in body weight over time and to explore the effect of baseline characteristics on % change in body weight from baseline.

Results

Three prospective trials with body weight data were eligible (J-ALEX, ALUR, ML29453). All 309 patients were included in the analysis. During the first year of treatment, 2632 measurements of body weight were documented. Data from J-ALEX (n=103) was analyzed separately, as reference values for BMI differ between Japanese and Western populations. Percent change in body weight increased significantly over time in the mixed-model analyses in both J-ALEX (β = 0.48, p < 0.001) and ALUR/ML29453 (β = 0.31, p = 0.001). In the ALUR/ML29453 dataset there was an association between baseline albumin level and % change in body weight (β = 0.08, p = 0.003). A maximum body weight gain of ≥ 10% during the first year was observed in 23 patients (22.3%) in J-ALEX and 31 patients (15.0%) in ALUR/ML29453. Table: 1367P

Baseline characteristics

Conclusions

A significant and clinically relevant increase in body weight was observed in the first year of treatment with alectinib. Baseline BMI was not predictive for body weight gain. Informing patients before start of alectinib is strongly recommended.

Clinical trial identification

Trials included in analysis: J-ALEX trial, JO28928, JapicCTI-132316 ML29453, NCT02271139 ALUR trial, MO29759, CT02604342.

Editorial acknowledgement

This abstract is based on research using data that has been made available through Vivli, Inc. Vivli has not contributed to or approved, and is not in any way responsible for, the contents of this publication.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

R.H. Mathijssen: Financial Interests, Institutional, Research Grant, Investigator-initiated research: Astellas, Bayer, Cristal Therapeutics, Pfizer, Roche, Sanofi, Servier, Boehringer Ingelheim, Novartis; Financial Interests, Institutional, Coordinating PI: Pamgene. E.F. van Rossum: Financial Interests, Personal, Research Grant: ElisabethFoundation, ZonMW/NWO. A-M.C. Dingemans: Financial Interests, Institutional, Advisory Board: Roche, Sanofi, Amgen, Bayer, Boehringer Ingelheim; Financial Interests, Institutional, Invited Speaker: Takeda, Lilly, Jansen, Pfizer, AstraZeneca; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Local PI: Lilly, Amgen, Daiichi Sankyo, JNJ, Mirati; Financial Interests, Institutional, Coordinating PI: Roche; Financial Interests, Institutional, Steering Committee Member: Roche; Non-Financial Interests, Other, Chair EORTC lung cancer group: EORTC; Non-Financial Interests, Member: IASCL, ASCO, AACR. All other authors have declared no conflicts of interest.