Abstract 440P
Background
In recurrent metastatic or unresectable head and neck non-nasopharyngeal squamous cell carcinoma Pembrolizumab with cisplatin 5FU results in longer OS in comparison to chemotherapy alone. But <3% of the eligible patients in India can afford it. In an Indian study, triple metronomic chemotherapy along with Nivolumab 20mg 3weekly resulted in comparable OS to the the former regimen. In our study we aimed to assess the clinical outcome with nivolumab 40mg every 6 weekly with triple metronomic chemotherapy.
Methods
This was a phase III open label single arm study. Recurrent metastatic or unresectable head and neck squamous cell carcinoma patients received oral methotrexate 9 mg/m2 once a week, celecoxib 200 mg twice daily, and erlotinib 150 mg once daily (TMC) with intravenous nivolumab (N) 40 mg flat dose once every six weeks. Primary endpoint was 1yr PFS, secondary end points were OS, response rate and duration of response.
Results
Thirty-two patients received N+TMC regimen. 14 (43.7%) were previously exposed to cisplatin. Median PFS was 7months (95% CI, 6.82 - 7. 17). ORR (CR+PR`) at 6 months was 56%, with 25% achieving CR. No significant differences in PFS or OS between platinum naive or refractory disease. OS at 1 yr. was 37.5% % with median OS of 10.2 months. 9 (28.1%) patients had grade 3 or above mucositis, 5 (15.6%) patients had grade 3 skin rashes, none had any immunologic adverse events. There were no treatment related mortality.
Conclusions
Low dose Nivolumab 6 weekly 40mg along with TMC results in comparable OS and PFS with 3 weekly Nivolumab or Pembrolizumab and chemotherapy, in recurrent metastatic or unresectable HN non-nasopharyngeal Sq. cell ca. It’s associated with favourable toxicity profile and is more affordable. Key Words: Low; Nivolumab; OMCT; OS; PFS; six weekly.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.