medwireNews: Phase III trial findings suggest that the addition of concomitant chemotherapy to postoperative radiotherapy does not improve the outcomes of patients with high-risk cutaneous squamous cell carcinoma of the head and neck (SCCHN).
The Trans Tasman Radiation Oncology Group (TROG) 05.01 investigators note that locoregional control was good with radiotherapy alone and “there was no observed benefit with the addition of weekly carboplatin.”
They explain that platinum-based chemoradiotherapy has been shown to boost outcomes relative to radiotherapy alone in patients with high-risk mucosal SCCHN and that these results have been extrapolated to the cutaneous setting, but “high-level evidence to support its use” is lacking.
To address this issue, the team randomly assigned 310 cutaneous SCCHN patients who had undergone surgery for high-risk nodal disease and/or advanced primary disease to receive three-dimensional conformal radiotherapy at a dose of 60–66 Gy either with or without carboplatin to an area under the curve of 2 for up to six weekly cycles. Participants were followed-up for a median of 60 months.
At the 2-year mark, the primary endpoint of freedom from locoregional relapse was achieved by 89% of patients in the chemoradiotherapy group and a comparable 88% of those in the radiotherapy group; at 5 years, the corresponding rates were 87% and 83%.
Disease-free survival and overall survival at 2 and 5 years also did not differ significantly between the treatment arms, Sandro Virgilio Porceddu (Princess Alexandra Hospital, Brisbane, Queensland, Australia) and fellow TROG 05.01 researchers report in the Journal of Clinical Oncology.
They cite a number of factors that could have contributed to the negative outcomes, including the smaller than planned sample size, the use of carboplatin rather than cisplatin, and the patient population, which “did not seem to be as high risk for locoregional failure as originally anticipated.”
Writing in a linked piece, Roy Decker and co-authors, from the Yale School of Medicine in New Haven, Connecticut, USA, commend the study authors for attempting to answer “this important clinical question,” but they agree with the limitations.
And they say: “Unfortunately, we are still left with a clinical dilemma. What is the role of systemic therapy in patients with [cutaneous SCCHN] and high risk of recurrence? What parameters define patients at a high risk of recurrence? Is this the end of platinum drugs in this setting?”
Decker et al hope that data from several ongoing studies assessing various targeted and immunotherapy agents – such as cetuximab and pembrolizumab – will “help inform future practice in this patient population.”
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