medwireNews: Adding concurrent chemotherapy to postoperative radiotherapy (RT) did not reduce the risk of locoregional relapse in a phase III study of patients with high-risk cutaneous squamous cell carcinoma of the head and neck (cSCCHN).
The 2-year rate of freedom from locoregional relapse was 88% for the 157 patients randomly assigned to receive a median of 60 Gy after resection of high-risk nodal disease and/or advanced primary disease, falling to 83% after 5 years, the TROG 05.01 trial investigators report.
This did not significantly differ from the 2- and 5-year rates of 89% and 87%, respectively, for the 153 patients who were given RT plus weekly carboplatin to an area under the curve of 2 for up to six cycles.
Similarly, disease-free survival was comparable in the RT and chemoradiotherapy (CRT) arms at 2 years (78 vs 83%) and 5 years (67 vs 73%), as was overall survival at 2 years (88 vs 88%) and 5 years (76 vs 79%).
As reported in the Journal of Clinical Oncology, the majority of RT (96%) and CRT (93%) patients received their full radiation dose, with treatment delayed by at least 6 weeks in 11% and 12% of the groups, respectively. Eleven percent of patients in the CRT arm required a carboplatin dose reduction.
Dermatitis was the most common grade 3 or 4 side effect in both the RT and CRT groups (49 vs 38%), followed by mucositis (10 vs 11%), but other events at these grades were “uncommon”, the researchers say.
For grade 1–2 events in the RT and CRT groups, salivary gland adverse events were the most common (96 vs 93%), followed by oedema (85 vs 81%) and otitis externa (70 vs 61%). Chemotherapy was most frequently associated with nausea (55%), reductions in platelets (18%) and haemoglobin (16%), and vomiting (15%).
The investigators note that just 44% of patients in the study completed health-related quality of life surveys at baseline, but the results were comparable between groups in the Functional Assessment of Cancer Therapy–Head and Neck trial outcome index and its subscales.
Discussing their findings, the researchers highlight several possible explanations for the trial’s negative results, such as the use of carboplatin instead of cisplatin, and recruited patients being at lower risk for locoregional failure than originally expected.
Furthermore, the 2-year freedom from locoregional recurrence rate with postoperative RT only was expected to be 70% rather than the 88% achieved, which they believe “now sets the benchmark for future studies and establishes the control arm in any subsequent randomized trial testing the addition of other agents in the adjuvant setting in immunocompetent patients.”
Sandro Virgilio Porceddu, from Princess Alexandra Hospital in Brisbane, Queensland, Australia, and co-authors conclude: “Given the high [locoregional control], interventions that may affect both [locoregional control] and distant metastases would be preferable for future adjuvant trials.
“Promising results with immune checkpoint inhibitors in advanced cSCCHN warrant further evaluation in the adjuvant setting.”
Porceddu SV, Bressel M, Poulsen MG, et al. Postoperative concurrent chemoradiotherapy versus postoperative radiotherapy in high-risk cutaneous squamous cell carcinoma of the head and neck: The randomized phase III TROG 05.01 trial. J Clin Oncol; Advance online publication 14 March 2018.
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