Efficacy and toxicity of cetuximab with chemotherapy in recurrent and metastatic head and neck cancer: A prospective observational study.

BACKGROUND

In squamous cell carcinoma of the head and neck (SCCHN), epidermal growth factor receptor is expressed at very high levels. Hence, we have done this study to assess the response and tolerability of cetuximab and platinum-based chemotherapy in recurrent and metastatic (R/M) head and neck squamous cell cancer (HNSCC) in view of paucity of data from the Indian subcontinent.

MATERIALS AND METHODS

In this prospective study, patients of R/M SCCHN were randomly enrolled from September 2012 to April 2015. Chemotherapy (cisplatin/carboplatin/5-fluorouracil) and cetuximab-based treatment were administered up to 6 cycles or unacceptable toxicity. The response rates (RRs), progression-free survival (PFS), and overall survival (OS) were analyzed.

RESULTS

In total, fifty patients were enrolled. The median age was 51.0 years. A total of 255 cycles of treatment were administered (median = 6 cycles/patient). Four patients (8.0%) experienced complete response and 21 (42.0%) experienced partial response. Twenty-one patients (42.0%) had stable disease and four patients (8.0%) experienced progressive disease. The disease control rate was 92.0%. Median PFS was 5.3 months (95% confidence interval [CI]: 4.52-6.14 months). Median OS was 9.933 months (95% CI: 8.58-11.28 months). There was statistically significant correlation between overall response and Eastern Cooperative Oncology Group performance status (P = 0.014), site of tumor (P = 0.027), and histological grade of tumor (P = 0.001). The main Grade 3/4 side effects seen were hematological in 44 (88%) and gastrointestinal in 28 (56%) patients.

CONCLUSIONS

The RR of cetuximab plus chemotherapy of> 45% and the promising PFS rates are strong arguments for clinically testing this combination and this treatment schedule further in R/M HNSCC.