412MO - A real-world phase IV superiority study among recurrent or advanced head and neck cancer patients prescribed with low-dose nivolumab and triple metronomic chemotherapy versus paclitaxel carboplatin regimen

Background

In resource-limited settings, most head and neck squamous cell carcinoma (HNSCC) cases are diagnosed at an advanced stage, necessitating multimodal therapy. Personalized medicine advocates for combining induction chemotherapy (IC) with immunotherapy. However, approved regimens are costly and accessible to only 1%-3% of patients in low- and middle-income countries. This study compares the efficacy and safety of low-dose nivolumab (LDNIVO) plus triple metronomic chemotherapy (TMC) against Paclitaxel and Carboplatin (P+C) in advanced HNSCC.

Methods

This was a real-world phase IV superiority study. Adult patients with recurrent or newly diagnosed advanced HNSCC with ECOG PS of 0-1 being treated with palliative intent. Patients were assigned to LDNIVO plus TMC consisting of IV nivolumab 20 mg once every 3 weeks along with oral methotrexate 9 mg/m² once a week, celecoxib 200 mg twice daily, and erlotinib 150 mg once daily (TMC-I), or IV Paclitaxel 175 mg/m² and Carboplatin 5 AUC (P+C) once every 3 weeks. The primary endpoints were PFS, 1-year OS, ORR, and safety. We also calculated the incremental cost-effectiveness ratio (ICER) to understand the feasibility of opting for this regimen.

Results

One hundred and twelve patients were recruited: 60 in the TMC-I arm and 52 in the P+C arm. The TMC-I arm showed superior median PFS of 13.3 months (95% CI, 7.7 to 18.9) compared to the P+C arm, which showed 7.4 months (95% CI, 5.7 to 8.8) (P = .0054). The median OS for TMC-I was 17.1 months (95% CI, 10.2 to 17.6), compared to 10.4 months (95% CI, 9.5 to 16.6) for the P+C arm (P = .0054). The ORR was 68% for TMC-I and 42% for P+C (P < .05). The rate of grade 3 and above adverse events was 45.3% in the TMC-I arm and 57.4% in the P+C arm (P = .08). The ICER between the two arms was INR 6218.

Conclusions

This real-world study demonstrated significant improvement in effectiveness, better tolerability, and reasonable cost-effectiveness when compared with conventional induction chemotherapy regimens for the management of recurrent or advanced head and neck carcinoma. The results imply that TMC-I might be a useful therapeutic alternative, especially in resource-limited setups.

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.