TTCC-2019-02: real-world evidence of first-line cetuximab plus paclitaxel in recurrent or metastatic squamous cell carcinoma of the head and neck

Abstract

ObjectivesThe aim of this study was to confirm the efficacy of the ERBITAX scheme (paclitaxel 80 mg/m2 weekly and cetuximab 400 mg/m2 loading dose, and then 250 mg/m2 weekly) as first-line treatment for patients with recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN) who are medically unfit for cisplatin-based (PT) chemotherapy.Materials and methodsThis retrospective, non-interventional study involved 16 centers in Spain. Inclusion criteria were to have started receiving ERBITAX regimen from January 2012 to December 2018; histologically confirmed SCCHN including oral cavity, oropharynx, hypopharynx, and larynx; age ≥18 years; and platinum (PT) chemotherapy ineligibility due to performance status, comorbidities, high accumulated dose of PT, or PT refractoriness.ResultsA total of 531 patients from 16 hospitals in Spain were enrolled. The median age was 66 years, 82.7% were male, and 83.5% were current/former smokers. Patients were ineligible to receive PT due to ECOG 2 (50.3%), comorbidities (32%), PT cumulative dose ≥ 225 mg/m2 (10.5%), or PT refractoriness (7.2%). Response rate was 37.7%. Median duration of response was 5.6 months (95% CI: 4.4–6.6). With a median follow-up of 8.7 months (95% CI: 7.7–10.2), median PFS and OS were 4.5 months (95% CI: 3.9–5.0) and 8.9 months (95% CI: 7.8–10.3), respectively. Patients treated with immunotherapy after ERBITAX had better OS with a median of 29.8 months compared to 13.8 months for those who received other treatments. The most common grade ≥ 3 toxicities were acne-like rash in 36 patients (6.8%) and oral mucositis in 8 patients (1.5%). Five (0.9%) patients experienced grade ≥ 3 febrile neutropenia.ConclusionThis study confirms the real-world efficacy and tolerability of ERBITAX as first-line treatment in recurrent/metastatic SCCHN when PT is not feasible. Immunotherapy after treatment with ERBITAX showed remarkable promising survival, despite potential selection bias.

Efficacy of Cetuximab Combined with Paclitaxel in Patients with Recurrent Salivary Gland Carcinoma: A Retrospective Observational Study

“…Accordingly, taxane-based chemotherapy might be more feasible to combine with moleculartargeted therapy than platinum-based anticancer drug in SGC. In patients with head and neck SCC, Cmab-PTX was well-tolerated even in patients with poor general conditions [42]. Because only 1 patient suffered from grade 4 AE despite 85.7% of patients were older than 70 years in this study, Cmab-PTX would be an effective and tolerable regimen to treat SGC.…”

Gold Nanoparticles Enhance the Tumor Growth-Suppressing Effects of Cetuximab and Radiotherapy in Head and Neck Cancer In Vitro and In Vivo

“…This study compared gold nanoparticles with titanium nanoparticles but did not add molecularly targeted drugs, such as cetuximab, which was performed in the current study. In other reports, cetuximab and trastuzumab were used to direct AuNPs toward cancer to enhance the effects of radiotherapy [22][23][24][25][26][27]. Chattopadhyay et al reported that HER2-targeted AuNPs increased the antitumor effect of radiotherapy in a xenograft model of breast cancer and that AuNPs are not harmful to normal tissue in vitro and in vivo [22,23].…”

“…The addition of AuNPs in this study increased the antitumor effects of radiotherapy and cetuximab, but the combination did not completely eliminate tumors in vivo. Cetuximab has been clinically applied in combination with taxane-based anticancer agents, such as paclitaxel, in the treatment of difficult-to-resect tumors [26]. Hallal et al reported that the fixed-dose combination of gold nanoparticles and cetuximab itself was cytotoxic for rectal cancer.…”

Challenges in Optimizing Nanoplatforms Used for Local and Systemic Delivery in the Oral Cavity

“…To reduce severe adverse effects and increase the reactivity of cetuximab, it has been combined with gold nanoparticles and radiotherapy procedures. Gold nanoparticles increased the efficiency of cetuximab, but complete eradication of tumors in vivo was not observed [121].…”