Induction chemotherapy with weekly cetuximab, carboplatin, and paclitaxel in the treatment of locally advanced head and neck cancer: The University of Pennsylvania experience.

Abstract

e16062 Background: Although Tax 324 demonstrated superior survival for induction docetaxel, cisplatin, and 5-fluorouracil (TPF) compared to PF in the management of locally advanced head and neck cancer, TPF is associated with serious toxicities and logistical challenges leading many institutions to seek alternative regimens. One promising regimen, piloted by Kies and Wanebo, combines weekly cetuximab with carboplatin and paclitaxel, which the University of Pennsylvania adopted in 2008. Methods: We retrospectively evaluated all LA-SCCHN patients treated with this regimen from May 2008 to December 2011, during which time it was the only one used. Most commonly, cetuximab was dosed at 400mg/m2 IV alone week one, followed by 250mg/m2 weekly in combination with weekly carboplatin AUC 2 and paclitaxel 90 mg/m2 over eight weeks. Our primary endpoint was feasibility. Results: Thirty patients were included. Median follow-up was 13.7 months (range, 5.0-38.7). Median age was 58.3 (range, 37.4-83.6). All but one had Stage IV SCCHN. 77% had oropharyngeal carcinoma. 70% were smokers. p16 staining as a surrogate for HPV positivity was available on 13 patients, of whom 10 were positive. For induction, high tolerability was observed based on 90% of patients receiving all planned cycles or missing only one cycle. Grade 3-4 toxicities included rash (7%), neutropenia (7%), and infusion reaction (3%). Only 10% were hospitalized at some point during induction therapy. All patients subsequently received definitive chemoradiotherapy (29) or surgery (1). All completed their full treatment course. At the time of post-treatment imaging, 19 (63%) had a complete response and 11 (37%) had a partial response. Of p16 positive patients, 8/10 (80%) had a CR. Of p16 negative patients, 1/3 (33%) had a CR. At the time of last follow-up, 30% of patients had recurrent disease. Median overall survival and progression free survival have not yet been reached; Kaplan-Meir curves will be shown. Conclusions: Induction chemotherapy with weekly, outpatient, cetuximab, carboplatin, and paclitaxel is feasible and well tolerated in LA-SCCHN. Preliminary efficacy results are promising.