228MO - Impact of EXTREME regimen and cetuximab, cisplatin, and paclitaxel-based regimen on clinical and humanistic outcomes in patients suffering from recurrent or metastatic head and neck squamous cell cancer

Background

This study aimed to assess the impact of the EXTREME regimen and cetuximab, cisplatin, and paclitaxel-based regimen on clinical and humanistic outcomes in patients suffering from recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC).

Methods

This was a prospective, single-centered, randomized, open-label parallel assignment phase-IV cohort study conducted for 2 years at a tertiary care oncology hospital. A total of 150 patients were recruited for the study and randomly allocated into two different cohorts each consisting of 75 patients. Patients in cohort 1 were prescribed with EXTREME regimen i.e. cetuximab, cisplatin, and 5-fluorouracil, and patients in cohort II were prescribed with cetuximab, cisplatin, and paclitaxel combination. Patients in both cohorts were followed for 6 chemotherapy cycles. The overall survival (OS) and progression-free survival (PFS) were calculated to estimate a clinical outcome and quality-adjusted life years (QALYs) were calculated to estimate a humanistic outcome. The statistical analysis was carried out using SPSS (trial version) for descriptive and inferential analysis.

Results

The median PFS after completion of 6 chemotherapy cycles was 6 months and 9 months for patients in cohorts I and II, respectively. The median OS was 12 months and 13 months in cohorts I and II, respectively which was statistically not significant. The mean QALYs were 0.014 and 0.016 at the time of diagnosis and 0.027 and 0.033 after the completion of 6 chemotherapy cycles. We found the QALYs were statistically significant and showed better tolerance in cohort II patients compared to cohort I.

Conclusions

The cetuximab, cisplatin, and paclitaxel-based regimen was better tolerated and has shown significant improvement in patients' QALYs compared to the EXTREME regimen which was comprised of cetuximab, cisplatin, and 5-fluorouracil. However, this regimen did not improve clinical outcomes compared to the EXTREME regimen in the patient suffering from R/M HNSCC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The author.

Funding

Has not received any funding.

Disclosure

The author has declared no conflicts of interest.