title: 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: To evaluate the activity and safety profile of panitumumab in combination with paclitaxel in patients with recurrent or metastatic SCCHN.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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).
authors.affiliation: Medical Oncology Service, Hospital Universitario Salamanca-IBSAL, Salamanca, Spain.
authors.forename: Elvira
authors.initials: E
authors.lastname: Del Barco Morillo
authors.affiliation: Medical Oncology Department, Universitat de Barcelona, IDIBELL, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Spain.
authors.forename: Ricard
authors.initials: R
authors.lastname: Mesía
authors.affiliation: Medical Oncology Service, Hospital Universitario Salamanca-IBSAL, Salamanca, Spain.
authors.forename: Juan Carlos
authors.initials: JC
authors.lastname: Adansa Klain
authors.affiliation: Medical Oncology Department, Universitat de Barcelona, IDIBELL, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Spain.
authors.forename: Silvia
authors.initials: S
authors.lastname: Vázquez Fernández
authors.affiliation: Medical Oncology Service, Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Joaquina
authors.initials: J
authors.lastname: Martínez-Galán
authors.affiliation: Medical Oncology Service, Hospital Universitario Politécnico La Fe, Valencia, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Pastor Borgoñon
authors.affiliation: Medical Oncology Service, Hospital Universitario Virgen de las Nieves, Granada, Spain.
authors.forename: Cyntia
authors.initials: C
authors.lastname: González-Rivas
authors.affiliation: Medical Oncology Service, Hospital Universitario Politécnico La Fe, Valencia, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Caballero Daroqui
authors.affiliation: Medical Oncology Service, Hospital General Universitario de Valencia, Valencia, Spain.
authors.forename: Alfonso
authors.initials: A
authors.lastname: Berrocal
authors.affiliation: Medical Oncology Unit, Hospital Miguel Servet, Zaragoza, Spain.
authors.forename: Javier
authors.initials: J
authors.lastname: Martínez-Trufero
authors.affiliation: Medical Oncology Service, Complejo Hospitalario de Navarra, Pamplona, Spain.
authors.forename: Ruth
authors.initials: R
authors.lastname: Vera
authors.affiliation: Medical Oncology Service, Hospital Universitario Salamanca-IBSAL, Salamanca, Spain. Electronic address: ttcc@seom.org.
authors.forename: Juan Jesús
authors.initials: JJ
authors.lastname: Cruz-Hernández
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel; D000077544:Panitumumab; D000077195:Squamous Cell Carcinoma of Head and Neck
chemical_list: D000911:Antibodies, Monoclonal; D000077544:Panitumumab; D017239:Paclitaxel
keywords: Head and neck cancer; Metastatic; Paclitaxel; Panitumumab; Recurrent; Squamous cell carcinoma