IntroductionThis paper evaluates tumour control and toxicity especially in relation to swallowing dysfunction in those patients with locally advanced oropharyngeal squamous cell carcinoma who have undergone either primary chemo-radiation or post-operative parotid sparing IMRT. The TOM scoring system was used to assess dysphagia.MethodsAll patients with locally advanced (stage 3/4) squamous cell oropharyngeal cancer and who required either primary or post-operative RT were identified. Toxicity was recorded prospectively. The TOM score (0-5 where 5 indicates that the patient is able to eat a normal diet and 0-2 varying degrees of enteral feeding dependency), weights and trismus was recorded immediately prior to and following radiotherapy.Results24 patients were identified between 1/2003 and 11/2007. Median weight loss during radiotherapy was 9 kg. All but one patient had a gastrostomy (RIG) tube inserted prophylactically. With a mean follow-up of 37.1 months, 62.5% of pts had a TOM score of 5, 12.5% scored 3, 8% scored and 17% scored 0-2.. For those patients whose swallowing function did recover, it took on average 8.7 months. 15% patients experienced trismus secondary to radiotherapy. 2 year overall survival was 92% and disease specific survival 96%.ConclusionExcellent disease control with intensified schedules of radiotherapy with IMRT has been achieved in this patient population. Intermediate toxicity is significant but with longer follow-up, dysphagia continues to improve with 75% of patients not requiring any form of enteral or oral supplementation.
While selective manipulation of the gut microbiome to augment antitumor immune responses is being evaluated in pts with metastatic disease, its feasibility in the LA setting and in the context of CRT has yet to be explored. Microbial Ecosystem Therapeutics (MET-4) is an orally-administered consortium of immune-favorable intestinal bacteria isolated from healthy donor stool samples. To our knowledge, ROMA LA-OPSCC-2 (NCT03838601) is the first study to evaluate the modulation of the gut microbiome in LA-OPSCC pts treated with radical CRT.Trial design: This is a single-centre study involving a prospective cohort of 30 pts with newly diagnosed LA-OPSCC to be treated with standard of care CRT (7 weeks of radiotherapy plus cisplatin three-weekly x 3 doses or weekly x 7 doses) at Princess Margaret Cancer Centre. MET-4 is administered orally daily until week 4 of CRT (as oral mucositis may impact compliance beyond this point), or unacceptable toxicity. The primary endpoint of the study is to evaluate the relative abundance of MET-4 species in stool samples (colonization). Tumor swabs and fresh stool samples are collected at several timepoints to determine oral and gut taxonomic composition using 16s rRNA and shotgun metagenomics. Serial blood sampling for flow cytometry/ CyTOF will be performed to correlate changes in immune cell subsets. Exploratory analyses include blood and stool metabolomics as well as correlation with radiomic imaging analyses. Subjects unable to swallow oral medications or absorption problems are excluded. This is a signal-finding study focusing on correlative studies and hypothesis generation. As of May 16 th , 14 pts have been enrolled.Clinical trial identification: NCT03838601.
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