Phase II study of combination cetuximab and weekly paclitaxel in patients with metastatic/recurrent squamous cell carcinoma of head and neck (SCCHN): Spanish Head and Neck Cancer Group (TTCC)

Abstract

6012 Background: Cetuximab and paclitaxel have shown to be active in SCCHN pts and preclinical data has demonstrated a possible synergy for the combination. In a variety of tumor types, weekly paclitaxel has demonstrated an improved safety profile and activity as compared to every 3 weeks paclitaxel, providing the rationale to study the combination of cetuximab and weekly paclitaxel in metastatic/recurrent SCCHN. Methods: Pts were required to have a y performance status (KPS) = 70%, measurable disease using RECIST criteria, and may have received one regimen of induction and/or concomitant chemotherapy, but not within the recurrent/metastatic setting. Treatment included weekly paclitaxel 80 mg/m2 and cetuximab (initial dose of 400 mg/m2, followed by a weekly infusion of 250 mg/m2). Biopsies of tumors and samples of blood are being analyzed for correlative markers including EGFR gene copy number -FISH-, polymorphisms of intron 1 of the EGFR, and downstream EGFR pathway markers and mutations. Results: 46 planned pts were enrolled from Ap-2006 to Sep-2006. Median age is 60 years (range 42–78). Median KPS is 80% (range 70–100%). 35 pts are evaluable for response. Complete responses have been observed in 7 pts, partial responses in 18 pts, and stable disease in 6 pts for an overall response rate of 71% and disease control rate of 88%. 44 pts are evaluable for safety. Main grade 3/4 toxicities(NCI): 8 pts had acne- like rash; 7 neutropenia but only 1 febrile neutropenia; 6 asthenia; 3 mucositis; 2 infusion related reactions to paclitaxel and 1 to cetuximab; 2 peripheral neuropathies; 1 diarrhea; 1 vomiting; and 1 conjunctivitis. Conclusions: This trial shows that the combination of cetuximab and weekly paclitaxel is well tolerated and provides very encouraging activity in advanced/recurrent SCCHN. The full data, including biomarker results, will be presented at the annual meeting. No significant financial relationships to disclose.