Abstract
Background: Skin toxicity is a common adverse event during cetuximab (Cmab) treatment. However, few reports have investigated the correlation between skin toxicity and the efficacy of Cmab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).Methods: We retrospectively reviewed 112 R/M SCCHN patients who received palliative chemotherapy with Cmab. Main eligibility criteria included primary disease in the oral cavity, hypopharynx, nasopharynx, oropharynx, or larynx; no prior history of EGFR-directed therapy; receipt of Cmab plus chemotherapy as first-line therapy for recurrent or metastatic disease; and follow-up for more than 90 days. We analyzed the time to first occurrence and time of maximum grade skin toxicity, and its predictive value with regard to treatment efficacy.Results: After a median follow-up of 393 days (range 109–1501 days), 105 (94%) and 20 (18%) patients had skin toxicity of any grade and grade 3, respectively. Among them, 8 patients with grade 3 acneiform rash, skin rash, or paronychia within 90 days after treatment initiation (“early skin toxicity”) had improved progression-free survival (PFS) (log-rank test, P = 0.045; 2-year PFS, 25.0 vs. 2.9%) and overall survival (OS) (log-rank test, P = 0.023, 2-year OS, 50.0 vs. 14.4%) compared with those with < grade 3 toxicity. A greater proportion of patients with early skin toxicity than patients without this toxicity could proceed with Cmab maintenance (88 vs. 44%, P = 0.021). Multivariate analysis identified early skin toxicity as an independent predictor of better PFS (hazard ratio [HR] = 0.363, 95% confidence interval [CI] 0.142–0.924, P = 0.034) and OS (HR = 0.187, 95% CI: 0.045–0.781, P = 0.022).Conclusion: Grade 3 Cmab-induced skin toxicity within 90 days was associated with better survival in R/M SCCHN. Effective rash management therefore seems necessary to realize the benefit of Cmab treatment.
Highlights
Head and neck cancer is the sixth-most common cancer, and more than 600,000 new cases are diagnosed annually worldwide [1, 2]
The phase III EXTREME trial reported that the addition of Cmab to platinum/5FU significantly improved overall survival (OS), progression-free survival (PFS) and response compared with platinum/5FU in first-line treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) [4]
We have reviewed the medical records of R/M SCCHN patients who received palliative chemotherapy with Cmab in various combination (5-FU + cisplatin; CDDP or carboplatin: CBDCA + Cmab, paclitaxel: PTX + CBDCA + Cmab and PTX + Cmab) at the National Cancer Center Hospital East Japan between December, 2012 and December, 2016 (Table 1)
Summary
Head and neck cancer is the sixth-most common cancer, and more than 600,000 new cases are diagnosed annually worldwide [1, 2]. Studies in multiple malignancies have shown that there is no apparent difference in the incidence or severity of Cmab-induced skin toxicity between races, while, the occurrence of more severe Cmab-induced skin toxicity correlates with better treatment response and longer survival [5,6,7,8,9,10,11,12,13,14,15] This correlation of Cmab-induced skin toxicity with efficacy has not been shown for R/M SCCHN. Few reports have investigated the correlation between skin toxicity and the efficacy of Cmab in patients with recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
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