Abstract
5594 Background: The addition of cetuximab to weekly paclitaxel have shown high efficacy in the first-line treatment of patients with recurrent /metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN). However, this combination has been widely extended to patients who present resistance to first line chemotherapy (CT) or those who are not candidate to platinum-based CT. Methods: We have retrospectively analyzed the efficacy of cetuximab in combination with weekly paclitaxel in patients with R/M-SCCHN who were not candidate to platinum-based CT or those who present disease progression after platinum schedules. Patients received weekly paclitaxel 80 mg/m2 and cetuximab 250 mg/m2 (initial dose of 400 mg/m2) till progression or unacceptable toxicity. Results: Twenty-one patients were included. Median age was 56 (43-72), ECOG PS (0/1/2): 6/10/5, 18 patients had received prior platinum-based treatment (9 patients were platinum-sensitive and 9 were platinum-refractory). With a median follow-up of 6.18 months (1.3-29.7), overall response rate (ORR) was 47.6% (95% IC 26.3-69%): 1 (4.7%) complete response and 9 (42.9%) partial responses. Median duration response was 10.23 months. There were no differences in response according to platinum sensitivity (55% sensitive vs. 45% refractory; P=0.74). Median progression free survival (PFS) and overall survival (OS) were 4.17 and 9.17 months, respectively. The main toxicity consisted of rash in 70% of patients (55% grade 2-3), with an association between rash severity and ORR (grades 0-1: 33% vs. grades 2-3: 55%; P=0.03) and a trend to better PFS and OS. Conclusions: Weekly paclitaxel in combination with cetuximab is a well tolerated and high active treatment in patients with R/M-SCCHN who experience disease progression after platinum-based CT, including those who present resistant disease. The efficacy of this combination is apparently higher than the published data on single agent cetuximab in this setting.
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