Abstract 33P
Background
This study aimed to evaluate the safety and effectiveness of the EXTREME regimen and nivolumab plus paclitaxel and cisplatin/carboplatin (P + C) based regimen and its impact on clinical and humanistic outcomes irrespective of PD-1/PD-L1 status in recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC).
Methods
This was a prospective single-centered open-label parallel assignment phase-IV cohort study conducted for 2 years at a tertiary care oncology hospital. Patients diagnosed with recurrent or newly identified advanced head and neck squamous cell carcinoma, with palliative care intent, are eligible if they exhibit an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. Patients were allocated into two different cohorts. Patients in cohort 1 were prescribed with EXTREME regimen i.e., Cetuximab, Cisplatin, and 5-fluorouracil, and patients in cohort II were prescribed Nivolumab, Paclitaxel and Cisplatin/Carboplatin. Patients in both cohorts were followed for 1 year. The overall survival (OS), progression-free survival (PFS), and objective response rate (ORR) were calculated to estimate a clinical outcome and quality-adjusted life years (QALYs) were calculated to estimate a humanistic outcome.
Results
A total of 157 patients, cohorts I (n=78) and II (n=79) were compared. The median OS was 5.6 (95% CI, 4.7 to 6.9) and 8.2 (95% CI, 5.6 to 10.8) months, median PFS was 4.7 (95% CI, 4.1 to 5.8) and 6.9 (95% CI, 5.7 to 8.8) months, ORR was 41.7% (95% CI, 29.1 to 53.4) and 52.8% (95% CI, 42.7 to 64.9) amongst cohort I and II, respectively. The mean QALYs were 0.017 and 0.018 at the time of diagnosis and 0.024 and 0.029 after the completion of 6 chemotherapy cycles. The incidence of grade 3 and higher adverse events in cohorts I and II was 55.4% and 48.1%, respectively, with no statistically significant difference (p=.744).
Conclusions
The Nivolumab plus chemotherapy-based regimen demonstrated a greater survival benefit and quality of life compared to the EXTREME regimen irrespective of the combined positive score (CPS). However, this regimen did not show significant improvement in the toxicity profile in the patient suffering from R/M HNSCC.
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.