Abstract
Purpose: We sought to evaluate the efficacy and safety of the combination of cetuximab (Cmab) and paclitaxel (PTX) in patients with squamous cell carcinoma of the head and neck (SCCHN) who had unresectable recurrent or metastatic (R/M) disease after platinum-based chemoradiotherapy.Materials and Methods: Data on 23 patients with SCCHN who received paclitaxel and cetuximab (Cmab) for R/M disease no more than 6 months after CRT completion were retrospectively reviewed. PTX and Cmab were given in a 28-day cycle (PTX, 80 mg/m2 on days 1, 8, and 15; Cmab, loading dose 400 mg/m2 followed by a weekly 250 mg/m2). The differences in prognosis between subgroups in different clinical settings were also assessed.Results: CRT had been delivered as definitive treatment in 13 cases (57%) and as adjuvant treatment in 10 (43%). Median time from CRT completion to disease recurrence or metastasis was 73 days (1–152). The best objective response and disease control rates were 52 and 83%, respectively, with 12 partial responses and seven cases of stable disease by Response Evaluation Criteria in Solid Tumors (RECIST). A total of 17 of 23 patients (74%) achieved a degree of tumor shrinkage. Median progression-free survival (PFS) and overall survival (OS) were 7.0 (95% confidence interval [CI]: 3.7–8.4) and 16.3 months (95% CI: 7.8–23.3), respectively. Patients with a longer duration (≥60 d) from CRT completion to disease progression had a statistically significantly longer OS than the others (median OS 22.3 vs. 8.1 months, log-rank test; p = 0.034). Main Grade 3 toxicities included neutropenia (13%), anemia (13%), and hypomagnesemia (13%). No Grade 4 toxicity or treatment-related death was seen.Conclusion: PTX and Cmab is a tolerable and effective option in SCCHN patients with symptomatic CRT-refractory disease. Its favorable effects on tumor shrinkage will help relieve tumor-associated symptoms.
Highlights
Head and neck cancer is the sixth-most common cancer worldwide, and more than 600,000 new cases of squamous cell carcinoma of the head and neck cancer (SCCHN) are diagnosed annually [1, 2]
To extract a heterogeneous population of platinum-based CRT-refractory patients who received PTX and Cmab as 1st line treatment, we reviewed data for 74 consecutive patients with histologically proven head and neck cancer treated with PTX and Cmab between December 2012 and October 2017 at the National Cancer Center Hospital East, Japan
With a median follow up of 12.9 months, objective overall response (ORR) and disease control rate (DCR) was 52% (95% confidence interval [CI] 33–71%) and 83%, respectively
Summary
Head and neck cancer is the sixth-most common cancer worldwide, and more than 600,000 new cases of squamous cell carcinoma of the head and neck cancer (SCCHN) are diagnosed annually [1, 2] Optimal management of these patients requires a multidisciplinary approach involving radiation oncologists, medical oncologists, and head and neck surgeons. The recurrence rate of stage III/IV disease after curative or post-operative adjuvant chemoradiotherapy is about 30–40% in the first 2 years of follow up [5,6,7]. For these patients, treatment options are scarce and survival is dismal. Patients who progress relatively early in their disease course after the last
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