Concurrent chemoradiotherapy with or without nimotuzumab in locally advanced squamous cell lung cancer: a phase 2 randomized trial
Mené entre 2015 et 2020 sur 126 patients atteints d'un cancer épidermoïde du poumon de stade III non résécable, cet essai randomisé de phase II évalue l'efficacité, du point de vue de la survie globale, et la toxicité d'un traitement associant le nimotuzumab à une chimioradiothérapie concomitante
Résumé en anglais
Purpose: The study aimed to evaluate the efficacy and safety of concurrent chemoradiotherapy combined with nimotuzumab in patients with unresectable stage III squamous cell lung cancer (SqCLC).
Methods and Materials: A prospective, single-center, open-label, randomized phase 2 trial was performed in patients with unresectable stage III SqCLC. Patients were randomized to receive thoracic radiation, 65 Gy, for 5 weeks concurrent with docetaxel and cisplatin or the same CCRT regimen combined with 200mg of nimotuzumab (NIMO-CCRT), administered weekly by intravenous infusion. The primary endpoint was overall survival. The secondary endpoints were progression-free survival, objective response rate, failure patterns and treatment-related toxicities.
Results: From August 2015 to June 2020, 126 patients with SqCLC were randomized. Four patients withdrew consent before the start of treatment and 122 patients were included for analysis, including 57 in the NIMO-CCRT group and 65 in the CCRT group. The median OS was 24.9 months in NIMO-CCRT group and 23.5 months in CCRT group (P=0.655). The median PFS was 12.1 months in NIMO-CCRT group and 13.7 months in CCRT group (P=0.968). The NIMO-CCRT group had a significantly lower risk of brain metastasis, with adjusted sub-distribution hazard ratio of 0.099 (95%CI, 0.012-0.81, P=0.031). The incidence of grade ≥3 pneumonitis (P=0.894) and esophagitis (P=0.974) was similar between the two arms. There was no grade 2 or higher skin toxicity in NIMO-CCRT group.
Conclusions: The coincident application of nimotuzumab with CCRT was well tolerated for locally advanced SCCL. The NIMO-CCRT group had similar OS and PFS compared with the CCRT group, but a lower risk of brain metastasis. Further investigations are warranted.
