1. Description of excluded studies (non‐randomised studies).
| Trial | Description |
| Argiris 2011 | A prospective clinical trial without randomisation investigating serum/tissue biomarkers, which may determine the success or failure of cetuximab therapy in 16 patients with locally advanced oropharyngeal SCC. HPV status was noted at baseline |
| Chen 2013 | A case‐control study evaluating the responsiveness of HPV‐positive and HPV‐negative oropharyngeal cancer to intensity‐modulated radiotherapy (IMRT), using axial imaging obtained daily during the course of image‐guided radiotherapy (IGRT). HPV status was noted at baseline |
| Fakhry 2008 | A prospective study without randomisation investigating 62 patients with locally advanced oropharyngeal SCC who were treated by induction chemotherapy with intravenous paclitaxel and carboplatin followed by concomitant weekly intravenous paclitaxel and standard fractionation radiation therapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) |
| Gilbert 2012 | A prospective study without randomisation, which evaluated the tolerability and clinical efficacy of combined oxaliplatin and pemetrexed as an induction chemotherapy regimen in 27 patients with locally advanced oropharyngeal SCC. A minority of patients consented to HPV status determination by a post hoc analysis |
| Kies 2010 | A prospective trial without randomisation investigating the efficacy of combining cetuximab with chemotherapy in 41 patients with locally advanced oropharyngeal SCC. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) |
| Le 2012 | A prospective study without randomisation, which investigated biomarkers in 274 patients with locally advanced oropharyngeal SCC. The patients were recruited from an existing randomised trial comparing radiotherapy/cisplatin with tirapazamine/cisplatin. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples is an ongoing phase II trial that is open‐label and non‐randomised). The study has so far enrolled 7 patients diagnosed as having stage III‐IV primary oropharyngeal SCC with HPV status ascertained at baseline. Patients will undergo an attenuated chemoradiotherapy regimen with the first results due in September 2015 |
| O'Sullivan 2012 | A prospective study without randomisation, which investigated 358 patients with locally advanced oropharyngeal SCC. The patients were recruited from an existing randomised trial comparing altered fractionation radiotherapy with chemoradiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 status (a post hoc analysis from pre‐treatment biopsy samples) |
| Psyrri 2011 | A prospective study without randomisation, which investigated the clinical outcomes of 38 patients with stage III‐IV HNSCC. Patients were recruited from an existing phase II trial (Eastern Cooperative Oncology Group 2303) of induction chemotherapy with weekly cetuximab, paclitaxel and carboplatin x 6 followed by chemoradiotherapy with weekly cetuximab. Statistical models were used to compare the risk of death or recurrence among patients stratified by p16 IHC status (a post hoc analysis from pre‐treatment biopsy samples) |
| Semrau 2012 | A prospective study without randomisation, which investigated 52 patients with locally advanced oropharyngeal SCC. The patients received either concomitant boost (69.2 Gy) or conventionally fractionated (70 Gy) radiotherapy, with concurrent paclitaxel/carboplatin. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) |
| Snietura 2011 | A prospective study without randomisation, which investigated 66 patients with oropharyngeal SCC. The purpose of the study was to analyse the influence of HPV infection on the outcome of a randomised clinical trial (p‐CAIR) of conventional versus 7 days per week postoperative radiotherapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) |
| Thibaudeau 2011 | A prospective cohort study of 169 patients with locally advanced oropharyngeal SCC treated with chemoradiation therapy. Statistical models were used to compare the risk of death or recurrence among patients stratified by HPV status (a post hoc analysis from pre‐treatment biopsy samples) |
HNSCC: head and neck squamous cell carcinoma HPV: human papillomavirus IHC: immunohistochemistry SCC: squamous cell carcinoma