Abstract
BackgroundFirst-line oxaliplatin-based therapy is the standard treatment of metastatic colorectal cancer (mCRC), but its dose-limiting toxicity is sensory neuropathy. The OPTIMisation of OXaliplatin (OPTIMOX) stop-and-go approach with oxaliplatin-free interval (OFI) offers a reasonable strategy. Influence of the first-line oxaliplatin-based treatment efficacy and the duration of OFI on tumour sensitivity to oxaliplatin reintroduction were investigated. MethodsThis was a pooled analysis of OPTIMOX1 and OPTIMOX2 studies, on 285 patients with previously untreated mCRC and FOLFOX reintroduction. An optimal OFI was estimated. Efficacy endpoints measured from reintroduction of FOLFOX included response rate (RR), progression-free survival (PFS) and overall survival (OS). FindingsTwo groups of OFI <6 and ⩾6months, were defined. The RR following FOLFOX reintroduction were 14% and 22% in patients with an OFI <6 and ⩾6months, respectively (overall RR 19%). The median PFS after FOLFOX reintroduction following OFI< 6 and ⩾6months were 3.0 [95% confidence intervals (CI): 2.7–3.7] and 5.5months [95% CI: 4.8–6.5], respectively. The median OS following OFI <6months was 8.8months [95% CI: 7.5–10.5] and OFI ⩾6 was months 16.8months [95% CI: 15.3–19.6]. In the case of partial response (PR), median PFS and OS were 4.6 [95% CI: 4.1–5.0] and 14months [95% CI: 12.1–16.4], respectively, whereas in patients with initial stable disease (SD) 3.4 [95% CI: 2.7–4.7] and 10.3months [95% CI: 7.3–12.9], respectively. InterpretationA sensitive population of patients more likely to benefit from oxaliplatin reintroduction is defined by the efficacy of induction therapy followed by an OFI of at least 6months between two periods of FOLFOX therapy. OFI of <6months identifies a subgroup of partially-resistant patients who can still benefit from oxaliplatin reintroduction.
Published Version
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