Abstract
SummaryA retrospective cohort study was performed to investigate the effectiveness of preemptive postsurgical therapy with cetuximab for patients with a major risk of recurrence or metastasis after clinical complete resection of primary oral squamous cell carcinoma (OSCC). The study period was from 2007 to 2019 for patients treated at the Department of Oral and Maxillofacial Surgery, Dokkyo Medical University School of Medicine. OSCC patients with major risk (n = 88) in the follow-up period were divided into groups with no postsurgical treatment (NP group), with standard postsurgical treatment (SP group), and with postsurgical treatment including cetuximab (CP group), and prognosis were compared among those groups. The 5-year overall survival rate was significantly higher in patients who received postsurgical treatment with cetuximab (CP) compared to that in the other two groups ((CP vs. NP, p = 0.028; CP vs. SP, p = 0.042). Furthermore, we performed multivariate analysis to evaluate the effects of the main components of the treatment. Among CDDP, radiotherapy, and cetuximab, only cetuximab significantly contributed to improved survival by univariate analysis (crude HR:0.228, 95%CI:0.05–0.968, p = 0.045). cetuximab also showed the same tendency in multivariate analysis, although p value did not reach significant level (Adjusted HR: 0.233, 95%CI: 0.053–1.028, p = 0.054). The results suggest that the postsurgical treatment with cetuximab as a preemptive postsurgical therapy after complete surgical resection of a visible tumor is considerably effective for OSCC patients with major risk, in other words, invisible dormant metastasis.
Highlights
Oral squamous cell carcinoma (OSCC) is mainly treated with surgery in combination with chemotherapy, immune checkpoint inhibitors, and radiotherapy
Vascular invasion and lymphatic invasion were excluded from our Invest New Drugs (2021) 39:846–852 definition of major risk factors because our previous basic and clinical research on metastasis suggested that histopathologically detected vascular invasion and lymphatic had little meaning for metastasis formation [5,6,7,8,9]
We have suggested that the main effect of cetuximab in patients with OSCC may be immunological, such as antibody-dependent cellular cytotoxicity (ADCC), rather than signaling blockade [11]
Summary
Oral squamous cell carcinoma (OSCC) is mainly treated with surgery in combination with chemotherapy (including molecular-targeted drugs), immune checkpoint inhibitors, and radiotherapy. The guidelines for head and neck cancer of the National Comprehensive Cancer Network (NCCN) include extranodal extension, positive margins, close margins, pT3 or pT4 primary, pN2 or pN3 nodal disease, nodal disease in levels IV or V, perineural invasion, vascular invasion, and lymphatic invasion as adverse features (AFs) for a poor postsurgical outcome [1] Among these AFs, we included extranodal extension, positive margins, close margins, pN2 or pN3 nodal disease, and nodal disease in levels IV or V, in addition to Yamamoto-Kohama (Y-K) mode of invasion [2, 3] Y-K4C and Y-K4D, in our definition of major risk factors for recurrence or metastasis. We started to use our definition of major risk factors for recurrence or metastasis from 2014
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