Cisplatin Versus Cetuximab With Radiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Mené sur 70 patients atteints d'un carcinome épidermoïde de la tête et du cou de stade localement avancé, cet essai de phase II compare, du point de vue du nombre de jours d'arrêt du traitement, de la réduction de la dose administrée, de la survie et de la toxicité, l'intérêt du cétuximab et du cisplatine en combinaison avec une radiothérapie concomitante
The trial by Bonner et al1 demonstrated a 10% overall survival (OS) benefit when cetuximab was added to radiation in the treatment of locally advanced head and neck squamous cell carcinoma, and it led to acceptance of cetuximab-based combined modality therapy as a standard of care. Of interest, cetuximab was not shown to worsen common acute radiation toxicities such as mucositis, dysphagia, or pain. Therefore, it was considered the rare drug that improves survival without substantially increasing toxicity. These data came on the heels of several trials and a meta-analysis that demonstrated improved outcomes with chemoradiation compared with radiation alone.2⇓⇓-5 It remained unclear where cetuximab fit among other radiosensitizers. However, the prevailing view, as voiced in an editorial published with the initial trial, was that cisplatin remained the standard radiosensitizer and that cetuximab could be considered in patients who were ineligible for platinum therapy.6 The two main questions regarding cetuximab were the following: How does it compare with cisplatin head to head? And what, if anything, does it add to the cisplatin-radiation backbone? The latter of these questions was answered first, in the RTOG 0522 study, which demonstrated no discernable benefit and an increase in toxicity with the addition of cetuximab to cisplatin-based chemoradiation.7 The more pressing question of cetuximab versus cisplatin went unanswered, although results from a few single-institutional studies that were subject to selection biases and that often lacked critical information regarding association with human papillomavirus (HPV) suggested that cetuximab may be inferior.8⇓⇓-11 Eventually, four randomized studies—RTOG 1016,12 TROG 12.01,13 De-ESCALaTE,14 and a phase II study from Italy—were performed to answer this question.
Journal of Clinical Oncology , éditorial en libre accès, 2015