Phase II study of single agent panitumumab in patients with incurable cutaneous squamous cell carcinoma
Mené sur 16 patients atteints d'un carcinome épidermoïde cutané de stade avancé (âge médian : 68 ans), cet essai de phase II évalue l'efficacité, du point de vue du taux de réponse globale, et la toxicité du panitumumab
Background : Although advanced cutaneous squamous cell carcinoma (CSCC) is quite common there are few prospective trials regarding its optimal management. This study evaluated the efficacy and safety of single agent panitumumab in the treatment of patients with CSCC not suitable for local therapy. Patients and Methods : Sixteen patients received single agent panitumumab at a dose of 6 mg/kg repeated every two weeks for a minimum of three cycles and continued until progression, a maximum of nine cycles or dose limiting toxicity. The primary endpoint was the best overall response rate (ORR) as assessed by Response Evaluation Criteria in Solid Tumours (RECIST version 1.1) criteria. Secondary endpoints included evaluation of safety, toxicity and progression free survival. Results : Between May 2010 and May 2012, 16 patients were recruited. Fourteen patients were male and the median age was 68 years. Fifteen patients had locoregionally advanced or recurrent disease with 14 patients receiving previous radiotherapy and 7 patients receiving previous cytotoxic chemotherapy. The best ORR (PR or CR) was 31% (3/16 PR, 2/16 CR) with a further 6 of 16 patients achieving SD. The median PFS and OS were 8 and 11 months respectively. Grade 3 or 4 events were observed in five patients (four being skin toxicity) with one patient ceasing due to skin toxicity. With a median follow up of 24 months, 10 patients died due to progressive disease, 6 are alive, one patient with no evidence of disease at the time of analysis. Conclusions : Single agent panitumumab is safe and effective in the management of patients with advanced CSCC even in a previously extensively pre-treated cohort.
Annals of Oncology 2014