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.
