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Chapter 2
RESULTS
In total, 5511 participants were recruited into the HN5000 study. Of these, 1816 participants were treated with curative intent for a squamous cell carcinoma of the oropharynx without distant metastases (Appendix 1). Of these participants, 1014 had early-stage and 802 had advanced- stage OPC. Of the early-stage participants, 150 were offered surgery only and 150 were offered RT only. Of the 150 participants offered surgery as single modality, 66 (44%) received surgery only whereas 78 (52%) received adjuvant (chemo (C))RT (50 RT and 28 CRT). Treatment of the remaining 6 participants was converted to (C)RT. Of the 150 early-stage participants offered RT as single modality, 126 participants (84%) received this. The other patients received either CRT (n = 17) or surgery with adjuvant (C)RT (n = 7). Reasons for treatment change or adjuvant treatment were not available. Intended and received treatment are listed in Appendix 2.
Treatment characteristics
Unfortunately, detailed description of surgical techniques were not available for most participants. In 20 (30%) of the 66 participants who received surgery only, the surgery was performed with transoral laser of whom 10 (50%) received a neck dissection and none a reconstruction with a free flap. Of the 46 participants not treated with laser surgery, 15 (33%) received a neck dissection and 8 (17%) a reconstruction with a free flap. Median total RT dose on the tumour and lymph nodes was 65 Gy (range 18–71 Gy). Dose of the elective neck irradiation was not available.
Of the 126 participants who received RT as intended, 9 (7%) received brachytherapy. Of the 204 participants who received RT (either primary or postoperatively), 142 (70%) were treated with Intensity Modulated Radiotherapy (IMRT) (73% of primary RT and 76% of postoperative RT). For 12 participants (6%), it was unknown whether they were treated with IMRT. Of the 126 participants who received RT as intended, 122 (97%) had data on completion of prescribed course of RT available. Three (2%) did not complete the prescribed course due to toxicity (n = 1) or patient choice (n = 2). Of the 78 participants who received postoperative RT, 65 (89%) had data on completion of RT available of whom all completed the prescribed course.
Baseline characteristics
Baseline characteristics are presented in Table 1. Participants who were offered RT only were older, had more comorbidities, were more likely to have a tumour localized in the base of tongue, a T2 tumour, higher TNM-stages, and reported more pre-treatment swallowing problems compared to those offered surgery only. Participants who received RT as intended were also older, more often had a tumour localized in the base of tongue, had more T2 tumours, and higher TNM stages compared to participants who received surgery only as planned. Participants who received postoperative adjuvant treatment had higher T and N classifications and TNM stages, consumed less alcohol, had fewer comorbidities, and were more likely to be HPV positive compared to those who only received surgery only. See Appendix 3 for functional outcomes at baseline.