Phase II study of panitumumab and paclitaxel as first-line treatment in recurrent or metastatic head and neck cancer. TTCC-2009-03/VECTITAX study

Abstract Objective To evaluate the activity and safety profile of panitumumab in combination with paclitaxel in patients with recurrent or metastatic SCCHN. Materials and methods The VECTITAX phase II, open-label, multicenter study included patients with confirmed metastatic and/or recurrent SCCHN deemed to be untreatable by surgery or radiotherapy and ECOG PS = 0–1. All patients received paclitaxel (80 mg/m 2 /week) and panitumumab (6 mg/kg/2 weeks) until disease progression or unacceptable toxicity. EQ-5D-3L and visual analogic scale (VAS) were used to evaluate impact on quality of life (QoL). Results The study included 40 patients (ITT population): (median age: 61 years; 87% male). Previous treatment: 29 patients (73%) had undergone surgery, 34 (85%) had received prior radiotherapy and 23 (58%) prior systemic treatment for locally advanced disease. Confirmed response was observed in 19 patients (48%) which was a complete response in 15% of patients. Stable disease was observed in 11 patients (28%). Disease control rate was 75%. Median progression-free survival was 7.5 months (95%CI: 4.9–8.3) and median overall survival 9.9 months (95%CI: 7.9–16.3). Most frequent grade 3–4 adverse events were skin rash (25%); asthenia (17%); neurotoxicity (15%); hypomagnesemia (10%); neutropenia (10%). Permanent discontinuation of panitumumab or paclitaxel due to adverse events was required in 10 (25%) and 13 patients (33%), respectively. There was one toxic death due to febrile neutropenia. Patient-reported QoL was preserved with no decline of median VAS scores. Conclusion Panitumumab and paclitaxel is an active combination, providing promising outcomes with preservation of the QoL and a favorable safety profile. (EudraCT: 2010-018898-37; NCT01264328).