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Lean Body Mass–Based Oxaliplatin Dosing and Risk of Neurotoxicity in Adjuvant Treatment of Stage III Colon Cancer


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In a French phase II trial (LEANOX) reported in the Journal of Clinical Oncology, Assenat et al examined survival outcomes and oxaliplatin-induced peripheral neurotoxicity (OIPN) risk associated with lean body mass (LBM)-based oxaliplatin dosing in the adjuvant treatment of stage III colon cancer.

Study Details

The multicenter open-label trial enrolled 160 patients eligible for adjuvant leucovorin, fluorouracil, and oxaliplatin treatment between December 2017 and December 2021. Patients without reduced LBM received body surface area (BSA)-based oxaliplatin doses of 85 mg/m2 (nonreduced LBM/BSA group, n = 33). Patients with reduced LBM were randomly assigned to receive BSA-based oxaliplatin doses (LBM/BSA group, n = 64) or LBM-based oxaliplatin doses of 3.09 mg/kg (LBM/LBM group, n = 63). The primary outcome measure was percentage of patients without grade ≥ 2 OIPN in the first six chemotherapy cycles in the reduced LBM groups receiving BSA-based dosing vs LBM-based dosing.

Key Findings

The proportions of patients without grade ≥ 2 OIPN after six cycles was 67.2% in the LBM/LBM group vs 42.1% in the LBM/BSA group (P = .01). Compared with the LBM/BSA group, the LBM/LBM group had improved grade ≥ 2 OIPN-free survival (hazard ratio [HR] = 0.53, 95% confidence interval [CI] = 0.34–0.84, P = .01), longer time to grade ≥ 2 OIPN onset (P = .006), higher cumulative oxaliplatin doses without grade ≥ 2 OIPN (P = .044), and fewer oxaliplatin dose reductions (P < .001).

The relapse-free survival rates at 36 months were 73% in the nonreduced LBM/BSA group, 70% in the LBM/BSA group, and 71% in the LBM/LBM group. No significant difference was observed for the LBM/BSA vs LBM/LBM group (HR = 1.05, 95% CI = 0.54–2.06, P = .88). The overall survival rates at 36 months were 93% in the nonreduced LBM/BSA group, 94% in the LBM/BSA group, and 88% in the LBM/LBM group (HR = 1.20, 95% CI = 0.36–3.92, P = .77).

Quality-of-Life Questionnaire Chemotherapy-Induced Peripheral Neuropathy 20 scores were better in the LBM/LBM group vs the LBM/BSA group.

The investigators concluded: “In adjuvant settings for stage III colon cancer, using an LBM-based oxaliplatin dose significantly reduces OIPN and improves quality of life without affecting relapse-free survival and [overall survival].”

Eric Assenat, MD, PhD, of the Department of Medical Oncology, Montpellier Cancer Institute, Montpellier University, Montpellier, France, is the corresponding author of the Journal of Clinical Oncology article.

Disclosure: The study was supported by the French Ministry of Health and French National Institute of Cancer. For full disclosures of all study authors, visit the Journal of Clinical Oncology.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
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