Paclitaxel Plus Cetuximab as 1st Line Chemotherapy in Platinum-Based Chemoradiotherapy-Refractory Patients With Squamous Cell Carcinoma of the Head and Neck

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.

Keywords: cetuximab; chemoradiotherapy; paclitaxel; platinum-refractory; squamous cell carcinoma of the head and neck.

Figure 1

Waterfall plot of the maximum percentage change from baseline on summation of the largest diameter of target lesions for 23 patients. The dashed line indicates a 30% reduction in tumor burden in the target lesion. Black dots indicate patients who had a response according to RECIST version 1.1.

Figure 2

Patient (A) progression-free survival and (B) overall survival of SCCHN patients with platinum-based CRT-refractory R/M disease treated with the combination of PTX and Cmab in 1st line setting.

Figure 3

Overall survival stratified according to the interval between chemoradiotherapy and recurrence or metastasis.

Figure 4

Representative imaging from a tongue squamous cell carcinoma patient who achieved a favorable clinical response after CRT failure, a male initially treated with partial glossectomy and neck dissection and adjuvant CRT. (A–C) The tumor recurred in the trapezius (yellow ellipse), mediastinal lymph nodes, and lung (yellow arrowheads) 5 months after completion of CRT. (D–F) After four cycles of therapy (PTX 80 mg/m², days 1, 8, and 15; and Cmab, 400 mg/m² followed by a weekly 250 mg/m²; 28-day cycle), almost all recurrent lesions had disappeared and occipital pain was completely alleviated.