At that time, the outcomes of second-line treatment remained bleak with an expected median survival of 3 to 6 months ( 7). However, this progress related only to the first-line setting in platinum-sensitive patients. Since then, the 10-month median survival mark achieved by EXTREME has repeatedly been confirmed in several large randomized trials using this regimen in the comparator arm ( 2, 5, 6). Adding cetuximab, a monoclonal antibody against the epidermal growth factor receptor (EGFR), to a platinum/5-fluorouracil combination improved overall survival by almost 3 months at acceptable toxicity rates and no cetuximab-related deaths ( 3). The major turning point came when the results of the EXTREME trial (Erbitux in first-line treatment of recurrent or metastatic head and neck cancer) were published back in 2008. As for a brief historical review, the combination of a platinum derivate, preferably cisplatin, and 5-fluorouracil emerged as a reference regimen for recurrent and/or metastatic SCCHN already in 1980s, although its impact on overall survival has rather been assumed on a basis of extrapolations than proved in large randomized trials ( 4). In 2016, immune checkpoint inhibitors entered the therapeutic portfolio of squamous cell carcinoma of the head and neck (SCCHN) in the second-line recurrent and/or metastatic setting, and it took another three years that the long-awaited results of the first-line KEYNOTE-048 trial demonstrated superiority relative to the standard cytotoxic doublet with cetuximab ( 1- 3).
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