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Clinical Trial
. 2016 Nov:62:54-59.
doi: 10.1016/j.oraloncology.2016.09.009. Epub 2016 Oct 8.

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

Elvira Del Barco Morillo  1 , Ricard Mesía  2 , Juan Carlos Adansa Klain  1 , Silvia Vázquez Fernández  2 , Joaquina Martínez-Galán  3 , Miguel Pastor Borgoñon  4 , Cyntia González-Rivas  3 , Javier Caballero Daroqui  4 , Alfonso Berrocal  5 , Javier Martínez-Trufero  6 , Ruth Vera  7 , Juan Jesús Cruz-Hernández  8 ; Spanish Head And Neck Cancer Cooperative Group (TTCC)
Affiliations
Clinical Trial

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

Elvira Del Barco Morillo et al. Oral Oncol. 2016 Nov.

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 (80mg/m2/week) and panitumumab (6mg/kg/2weeks) until disease progression or unacceptable toxicity. EQ-5D-3L andvisual 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).

Keywords: Head and neck cancer; Metastatic; Paclitaxel; Panitumumab; Recurrent; Squamous cell carcinoma.

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