115P Liposomal irinotecan (HR070803) plus fluorouracil and bevacizumab as second-line treatment in patients with advanced colorectal cancer: Cohort A results from a phase II trial

Background: This retrospective analysis evaluates the outcomes of low dose oral tyrosine kinase inhibitor Afatinib in heavily pretreated recurrent or metastatic head neck cancers.Methods: Inclusion criteria included patients with stage III-IV squamous cell carcinoma of the head and neck who had failed definitive treatment with cisplatin based concurrent chemoradiotherapy upto a radiotherapy dose of 70Gy in conventional fractionation and had progressed on palliative chemotherapy using Paclitaxel 175mg/m 2 and Carboplatin (AUC5) and were subsequently treated with low dose oral afatinib 20mg.Patients who had received targeted or immunotherapy were excluded from the analysis.Patients received oral Afatinib at a dose of 20 mg once daily till toxicity or disease progression prevented further administration.Patients were evaluated for symptom response related to pain, dysphagia, anorexia, insomnia, fatigue, and weight loss.Disease status at last follow up and treatment toxicity was evaluated.Toxicity was evaluated as per CTCAE v5 and treatment response was evaluated using RECIST criteria.Results: Twenty five patients were evaluated which included 24 male and 1 female patients.The median age was 58 years with a range from 20 to 70 years.Patients receiving afatinib had ECOG performance scale Grade1,2 3 in 10(40%),13(52%) and 2(8%) at baseline.The median duration of treatment was 2.5 months with range from 20 days to 6 months.12 patients (48%) experienced treatment interruptions due to disease or treatment related factors.Dysphagia improved in 6 patients (24%) from Grade 3 to 2. Oral pain showed improvement from Gr 3 to 2 in 10 patients (40%).Anorexia improved in 15 patients (60%) from Grade 3 to 2. Grade 2 fatigue was reported by 80% patients.Grade 2 oral mucositis was observed in 14 patients (56%) Seven patients (28%) had grade 2 neutropenia.Stable and progressive disease was seen in 9 (36%) and 13(52%) patients.Three patients died during course of treatment.Conclusions: Low dose Afatinib 20mg shows limited antitumor activity but may be selectively used for palliation in recurrent and metastatic head neck cancers.