The aim of this study was to avoid unnecessarily indicated adjuvant radiotherapy. Inclusion criteria were pT1 or pT2, pN1 (ECS/ECE-negative), cM0 tumours (SCC) of the oral cavity and the oropharynx,… Click to show full abstract
The aim of this study was to avoid unnecessarily indicated adjuvant radiotherapy. Inclusion criteria were pT1 or pT2, pN1 (ECS/ECE-negative), cM0 tumours (SCC) of the oral cavity and the oropharynx, treated primarily with surgery with clear resection margins of the primary tumour as well as with at least an ipsilateral neck dissection. After definitive histology, patients with a pN1 (ECS/ECE-neg.) neck status were either randomised or upon their personal preferences, allocated into the observation arm or into the adjuvant radiation arm with 60 Gy. Primary endpoint was overall survival; secondary endpoints were quality of life, recurrence rate, and cost of treatment. While most of the inclusion criteria were well defined, the study protocol failed to describe what an appropriate neck dissection would be in the context of this study. This left participating centers with a lot of freedom with regards to whether they would offer a selective or a comprehensive neck dissection to these patients; in the former case, whether it would include levels I–III (for oral cavity), I–IV (oral cavity and oropharynx) or II–IV (oropharynx); and, more importantly, the required minimum number of harvested lymph nodes was not mentioned among the inclusion criteria. There is evidence that the overall number of harvested regional lymph nodes, also known as the nodal yield of regional lymphadenectomies, is an independent prognostic factor in oral cavity squamous cell carcinoma [1], as well as in case of other primary sites in the head and neck [2]. This applies to node negative cases as well [1, 3, 4]. A recent multicenter analysis also confirmed nodal yield as an independent prognostic factor in patients undergoing selective neck dissection (SND) for oral squamous cell carcinoma (OSCC) [3]. Further, surgical technique has a significant impact on the oncological completeness of a neck dissection [5].
               
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