Translational Research
The HNCG is strongly focusing on translational research projects. The HNCG is in the position to have access to extended clinical data of a number of databases of prospective randomized studies that could be used for translational research purposes. The group took actions to actively involve investigators in the field of preclinical and translational research in the group activities and meetings, and this led to three different translational research project that are currently under development. The HNCG plans to correlate tumor HPV DNA and p16 protein status with therapeutic response and survival in the cohort of patients treated within the EORTC 24971/TAX323 phase III clinical trial. In addition, functional p53 status and b-tubulin expression status will be correlated with response to docetaxel to see whether these biomarkers have the potential to be used both as prognostic and predictive factors. Another research project aims to evaluate the association of excision repair cross complementation group (ERCC1) expression with therapeutic response and survival among patients treated with postoperative irradiation with or without concomitant cisplatin in the EORTC 22931 phase III clinical trial.
Translational research studies are also included in the EORTC 22071-24071 trial, of which one proposal in collaboration with the EORTC Radiation Oncology Group is NOCI-granted. This proposal is focusing on the prediction of radiation-induced normal tissue toxicity based on in vitro lymphocyte apoptosis test and SNPs analysis. In case of positive results of this TR project, in the future we could identify at diagnosis patients that need specific measures to prevent late radiation-induced toxicity (new radiation delivery techniques, use of protective agents, preventive swallowing exercises).
Conversely, treatment intensification would be made possible in the patients that are identified as not being at risk of severe radiation-induced toxicity.
A strong TR component is also present in the study proposal granted by NOCI in 2010. This is a window study in patients affected by locally advanced HNSCC that is deemed to be treated by surgery.
The patients will be treated with the administration of a pan-Her inhibitor or an anti ALK/c-Met inhibitor before surgery, and the activity of the drugs will be evaluated with advanced imaging technique and analysis of the different downstream molecular pathways to explain tumor response and resistance mechanisms.
Quality of life (QoL)
Quality of life assessment will also be included in all new phase III studies, as these new studies do focus on the right balance between efficacy and toxicity. A new proposal on quality of life included in the locally advanced trial (EORTC 24081-22081) will be presented during the next group meeting. Quality of life projects are included in the EORTC 22071-24071 and 24081 trials. The HNCG will also participate in a proposal of the EORTC Quality of Life Group aimed at adjusting the EORTC QLQ-H&N35 to new treatment regimens.