Prospective study of cetuximab, carboplatin and radiotherapy for patients with locally advanced head and neck squamous cell cancer (HNSCC) unfit for cisplatin
Mené sur 60 patients atteints d'un carcinome épidermoïde de l'oropharynx, du larynx ou de l'hypopharynx de stade localement avancé et ne pouvant être traité par cisplatine (âge moyen 66 ans ; durée médiane de suivi : 4 ans), cet essai de phase I/II évalue la faisabilité et la toxicité d'un traitement combinant carboplatine, cétuximab et radiothérapie
Purpose : To report on the outcomes of a novel treatment regimen for patients with LAHNSCC, fit for curative treatment but not fit for cisplatin. Material and Methods : Single arm phase I/II study of previously untreated patients with biopsy proved SCC of the oropharynx, larynx or hypopharynx. The primary endpoint was feasibility of the regimen – defined as the proportion of patients successfully completing treatment. Secondary endpoints were loco-regional control (LRC), failure free survival (FFS), overall survival (OS), and treatment toxicities. Results : Sixty patients. Mean age 66 years (range 42-87 years), 28% of patients were >70 years. The median follow-up was 4 years. Compliance with treatment was very high: feasibility was 55/60 (91.7%, 90% CI [83.3% - 96.7%]) which satisfied the pre-defined criteria. The 4 year LRC was 82% (95% CI [71 – 94]), FFS was 72% (95% CI [60 – 85]) and the OS was 77% (95% CI [66-90]). The cumulative incidences of first failure of any type at 4 years were5.2% local, 1.8% local and distant, 8.5% regional, 1.7% regional and distant, 3.5% distant, and 7.7% death (any cause). The 4 year FFS in the 70 years or less and more than 70 years patients were 71% (95% CI [58-88]) and 73% (95% CI [54-100]), respectively (logrank p=0.801). Their 4-year OS was 79% (95% CI [66-93]) and 73% (95% CI [53-100]), respectively (logrank p=0.708). Significant late treatment toxicities were very few. Conclusion : This treatment regimen was feasible and safe in this patient cohort unfit for cisplatin, 28% of whom were older than 70 years. Carboplatin and cetuximab based chemoradiation regimens warrant further investigation in patients with a contraindication to cisplatin.